Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018

Health and Human Services Department Reform Health Care Reform (access to dental care, other dental-related issues) Affordable Care Act Repeal and Replace (dental-related programs) Better Care Reconciliation Act of 2017 (H.R. 1628, nature of a substitute) Graham-Cassidy health reform proposal (H.R. 1628, nature of a substitute) Childrens Health Insurance Program (CHIP) reauthorization H.R. 6-Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act H.R. 860-HEALTHIER Act of 2017 H.R. 1606-Dentist and Optometric Care Access Act (DOC Access Act) H.R. 1628-American Health Care Act of 2017 H.R. 1876-Good Samaritan Health Professionals Act of 2017 H.R. 2422-Action for Dental Health Act of 2017 H.R. 2430-FDA Reauthorization Act of 2017 H.R. 3921-HEALTHY KIDS Act H.R. 4684-Ensuring Access to Quality Sober Living Act of 2018 H.R. 5197-Alternatives to Opioids (ALTO) in the Emergency Department Act H.R. 5261-TEACH to Combat Addiction Act of 2018 H.R. 5327-Comprehensive Opioid Recovery Centers Act of 2018 H.R. 5333-Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 H.R. 5687-Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act H.R. 5774-Combatting Opioid Abuse for Care in Hospitals (COACH) Act H.R. 5776-Medicare and Opioid Safe Treatment (MOST) Act H.R. 5806-21st Century Tools for Pain and Addiction Treatments H.R. 5812-Creating Opportunities that Necessitate New and Enhanced Connections that Improve Opioid Navigating Strategies (CONNECTIONS) Act H.R. 6689-Ensuring Lasting Smiles Act H.R. 7000-Tribal Tax Empowerment and Jobs Act of 2018 S. 934-FDA Reauthorization Act of 2017 S. 1827-KIDS Act of 2017 S. 2315-Over-the-Counter Drug Safety, Innovation, and Reform Act S. 2456-CARA 2.0 Act of 2018 S. 2680-Opioid Crisis Response Act of 2018 S. 3016-Action for Dental Health Act of 2018

Client expense: $530,000 · Firm income: Not reported

Government targets: Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Treasury, Dept of

E.O. 13784: Establishing the President's Commission on Combating Drug Addiction and the Opioid Crisis; H.R. 5812: Creating Opportunities that Necessitate New and Enhanced Connections (generally); H.R. 6: Substance Use-Disorder Prevention that Promotes Opioid Recovery (generally); H.R. 4284: INFO Act (generally); S. 2680: Opioid Response Act of 2018 (generally); matters related to opioid data innovation and accessible database for information and resources that can be used by health care providers, state and local governments, pharmacists, advocates, and law enforcement.

Client expense: $460,000 · Firm income: Not reported

Government targets: Defense, Dept of (DOD), Executive Office of the President (EOP), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institute of Standards & Technology (NIST), Navy, Dept of, Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE, Treasury, Dept of, White House Office

CMS Manual - Reimbursement coding HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 HR 2368 Right to Try Act HR 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 S 204 Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 HR 878 Right to Try Act of 2017

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - PDP/MA-PD payments on clean claims from pharmacies S. 428, ACE Kids Act (Grassley) - coordinated care for children with complex medical conditions S. 1016, CONNECT For Health Act (Schatz) - telehealth S. 1169, Medicaid CARE Act (Durbin-Portman) - changes to Medicaid IMD exclusion S. 1688, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 1804, Medicare for All Act (Sanders) - single payer health system S. 1890, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Cardin) - Medigap coverage for beneficiaries with end-stage renal disease S. 1909, BENES Act (Casey) - notifications of Medicare eligibility S. 2027, Medicaid Third Party Liability Act (Portman) - Medicaid third party liability S. 2051, Medicare Care Coordination Improvement Act of 2017 (Portman) - barriers to payment reform models S. 2227, EMPOWER Care Act (Portman-Cantwell) - Medicaid Money Follows the Person Demonstration S. 2707, Informing Seniors About Opioids Act (Nelson) - opioid issues S. 2901, Expanding Telehealth Response to Ensure Addiction Treatment Act (Thune) - opioid issues S. 2904, Medicaid Substance Use Disorder Treatment Via Telehealth Act (Carper) - opioid issues S. 2908, Electronic Prior Authorization in Medicare Part D Act (Roberts) - opioid issues S. 3327, SENIOR Communities Protection Act (Cortez Masto) - preventing fraudulent opioid prescriptions S. 3496, Improving Seniors Access to Quality Benefits Act (Daines-King) - study on MA benchmark cap S. 3497, Medicare Advantage Quality Payment Relief Act (Daines-King) - MA benchmark cap S. 3702, Right Rebate Act (Wyden-Grassley) - Medicaid drug rebate program Draft Bill: Medicare Long-Term Care Services and Supports Act (Pallone) - Long-Term Services and Supports Program H.R. 6, SUPPORT Patients and Families Act (Walden) - opioid initiatives, Medicare and Medicaid issues, budget offsets H.R. 695, Continuing Appropriations Act (Schiff) - Money Follows the Person demonstration, spousal impoverishment protections H.R. 849, Protecting Seniors Access to Medicare Act (Roe) - Independent Payment Advisory Board H.R. 908, Medicare Advantage Quality Payment Relief Act (Kelly) - MA payment cap H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - PDP/MA-PD payments on clean claims from pharmacies H.R. 1148, FAST Act (Griffith) - access to telehealth-eligible stroke services under Medicare H.R. 1316, Prescription Drug Price Transparency Act (Collins) - PBM standards for MA and PDP plans H.R. 1995, V-BID for Better Care Act (Black) - value-based insurance design in Medicare Advantage H.R. 2556, CONNECT For Health Act (Black) - telehealth H.R. 2575, BENES Act (Ruiz) - notifications of Medicare eligibility H.R. 2644, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Marino) - Medigap coverage for beneficiaries with end-stage renal disease H.R. 2687, Medicaid CARE Act (Foster-Fitzpatrick) - changes to Medicaid IMD exclusion H.R. 3044, Supplemental Benefits for Chronically Ill Medicare Advantage Enrollees (Meehan) H.R. 3263, Medicare Independence at Home Model of Care (Burgess) - demonstration program H.R. 3325, ACE Kids Act (Barton) - health homes for children with complex medical conditions H.R. 3360, Telehealth Enhancement Act (Harper) - telehealth in Medicare H.R. 3635, Local Coverage Determination Clarification Act (Jenkins) - procedures for Medicare administrative contractors H.R. 3727, Increasing Telehealth Access in Medicare Act (Black) - telehealth in MA plans H.R. 4143, Dialysis PATIENTS Demonstration Act (Smith) - alternative care delivery models and payment methodologies for patients with end-stage renal disease H.R. 4952, Improving Seniors Access to Quality Benefits Act (Kelly) - MA benchmark cap study H.R. 5306, EMPOWER Care Act (Guthrie) - extension of Money Follows the Person demonstration H.R. 5603, Access to Telehealth Services for Substance Use Disorders Act (Matsui) - opioid issues H.R. 5605, Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act (Ruiz) - opioid issues H.R. 5675, drug management programs for at-risk Medicare beneficiaries (Bilirakis) - opioid issues H.R. 5676, SENIOR Communities Protection Act (MacArthur) - preventing fraudulent opioid prescriptions H.R. 5684, Protecting Seniors from Opioid Abuse Act (Kelly) - opioid issues H.R. 5685, Medicare Opioid Safety Education Act (Faso) - opioid issues H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act (Paulsen) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - communication between Medicare plan sponsors and CMS H.R. 5773, Preventing Addiction for Susceptible Seniors Act (Roskam) - opioid issues H.R. 5797, IMD CARE Act (Walters) - Medicaid IMD exclusion H.R. 5798, Opioid Screening and Chronic Pain Management Alternatives for Seniors Act (Bucshon) - opioid issues H.R. 5799, Medicaid Drug Review, Utilization, Good Governance Improvement Act (Blackburn) - opioid issues H.R. 5800, Medicaid IMD ADDITIONAL INFO Act (Upton) - opioid issues H.R. 5804, Post-Surgical Injections as an Opioid Alternative Act (Shimkus) - opioid issues H.R. 5808, Medicaid Pharmaceutical Home Act (Bilirakis) - opioid issues H.R. 5809, Postoperative Opioid Prevention Act (Peters) - opioid issues H.R. 5810, Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act (Lance) - opioid issues H.R. 5812, Improving Medicaid Data Timeliness Act (Griffith) - opioid issues H.R. 6431, Medigap Consumer Protection Act (Levin) - reforms to Medicare supplemental insurance H.R. 6561, Comprehensive Care for Seniors Act (Walorski) -- Program of All-Inclusive Care for the Elderly H.R. 6563, Lower Out-of-Pocket Costs for Seniors Act (Pallone-Neal) - Medicare Part D cliff H.R. 6662, Empowering Seniors Decision Enrollment Act (Paulsen) - special enrollment period for non-deemed Medicare Cost Plan enrollees H.R. 6690, Fighting Fraud to Protect Care for Seniors Act (Roskam) - Medicare pilot program for smart card technology H.R. 7122, Shared Accountability for Improved Patient Outcomes Act (Paulsen) - value-based payment and delivery arrangements H.R. 7217, IMPROVE Act (Barton) - Money Follows the Person demonstration, ACE Kids Act, Medicare drug rebate program, spousal impoverishment protections H.R. 7223, Right Rebate Act (Schrader-Welch) - Medicaid drug rebate program H.R. 7247, Incentivizing Shared Risk in Medicare Advantage Act (Brady) - MA prior authorization H.R. 7249, Better Prior Authorization Notification Act (Reed) - MA prior authorization H.R. 7250, Prior Authorization Improvement Act (Kelly) - MA prior authorization Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2020 policy and technical regulation for MA and Part D; MA and Part D proposed rule on drug pricing changes for 2020; CMSs price transparency proposal for direct-to-consumer advertisements; issues relating to 2019 Rate Notice and Call Letter; in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Bipartisan Budget Act of 2018 changes to SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); CMS's proposed Part B drug demonstration program; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

Client expense: $1,540,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

H.R.5812 - Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 H.R. 6 - Opioid Package S.2680 - Opioid Crisis Response Act of 2018 H.R.3635 - Local Coverage Determination Clarification Act of 2017 Local Coverage Determination (LCD) Clarification Act (S. 794) Promoting Integrity in Medicare Act (HR 2066) Protecting Seniors' Access to Medicare Act (HR 849) Protecting Access to Medicare Act Protecting Patients from Surprise Medical Bills (Cassidy Language) FDA Technical Assistance to DAIA S. 2582 - Consumer Health Insurance Protection Act S. 284 - End Surprise Billing Act CMS Physician Fee Schedule Registry Measures

Client expense: $325,721 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Public Law 114-198 pharmacy provisions; Implementation of Public Law 114-255 pharmacy provisions; H.R. 1854/S. 778, Prescription Drug Monitoring Act of 2017; S 892 / H.R. 4408, Opioid Addiction Prevention Act of 2017; HR 3528 / S.2460, Every Prescription Conveyed Securely Act; H.R. 3545, Overdose Prevention and Patient Safety Act; S. 1850, Protecting Jessica Grubbs Legacy Act; H.R. 1271, DXM Abuse Prevention Act of 2017; H.R. 1375, Prescriber Support Act of 2017; S. 523, Budgeting for Opioid Addiction Treatment Act; S. 581 / H.R. 5009, Jessies Law; S 1079, Protecting Americans from Dangerous Opioids Act; H.R. 4236, MONITOR Act of 2017; H.R. 3991, Expanded Access to Opioid Abuse Treatment Act of 2017; H.R. 4275, Empowering Pharmacists in the Fight Against Opioid Abuse Act; H.R. 5219, Opioid Prescription Verification Act of 2018; H.R. 5676, SENIOR Communities Protection Act of 2018; H.R. 5773, PASS Act of 2018; Draft legislation, Medicare Care Coordination Improvement Act of 2017; Draft legislation, Pain Care Coordination Act of 2018; S. 2456/H.R. 5311, CARA 2.0 Act of 2018; H.R. 5687, SOUND Disposal and Packaging Act; H.R. 5202, Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018; H.R. 5812, CONNECTIONS Act; H.R. 5801, Medicaid PARTNERSHIP Act; H.R. 6, SUPPORT for Patients and Communities Act; H.R. 5808, Medicaid Pharmaceutical Home Act of 2018; H.R. 5675, To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries; S. 2680, Opioid Crisis Response Act of 2018; S. 2645 / H.R. 5628, Access to Increased Drug Disposal Act of 2018; H.R. 6600 / S. 3282, the DEA Order Clearinghouse Act of 2018; H.R. 6688, ALERT Act of 2018

Client expense: $240,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

H.R. 714 Use of Medicinal Marihuana H.R. 715 Rescheduling of Marihuana H.R. 975 Controlled Substances Act Application to Marihuana H.R. 1781 Synthetic Opioids H.R. 1824 Federal and State Marijuana Policy Gap Reduction S. 581 Opioids Addiction Information in Medical Records S. 780 Federal and State Marijuana Policy Gap Reduction H.R. 2020 Rescheduling of Marijuana H.R. 2063 Opioid Dispensary Registration Training Condition S. 1078 FDA Opioid Approval Procedures S. 1079 FDA Opioid Approval and Revocation S. 1327 Controlled Substance Analogues Regulation H.R. 3374 Drunk Driving H.R. 3534 State Legalized Marijuana S. 1553 Schedule 1 Controlled Substances S. 1554 Controlled Substance Continuing Education S. 1689 Controlled Substances Act H.R. 3964 Registration Requirements for Prescribers of Opioids H.R. 4482 Opioid Abuse and Addiction S. 2008 Opioid Epidemic and Drug Sample Backlogs H.R. 4903 Opioid Usage Reduction Best Practices Study H.R. 4922 Fentanyl Analogues H.R. 5109 Opioid Epidemic Distribution of Resources S. 2437 Opioid Grant Program S. 2440 Opioid Epidemic S. 2535 Opioid Quotas H.R. 5473 Alternative Methods for Data Collection H.R. 5581 Prescribers of Controlled Substances H.R. 5590 Medicare and Opioid Addictions H.R. 5723 Medicare Payment Advisory Commission H.R. 5782 Pharmaceutical Company Accountability S. 2680 Opioid Crisis S. 2691 Pharmaceutical Companies and Illegal Marketing S. 2729 Prevention of Prescription Opioid Misuse S. 2838 Reporting Information on Distribution of Opioids S. 2848 Controlled Substances and Alcohol Testing H.R. 6491 Reporting of Information on Distribution of Opioids H.R. 6608 Prescription Drug Monitoring Programs Data Collection H.R. 5812 Controlled Substance Overdose Prevention Activities

Client expense: $1,030,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Natl Credit Union Administration (NCUA), Natl Economic Council (NEC), Natl Security Council (NSC), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)

S.892 Opioid Addiction Prevention Act of 2017 H.R.4408 - Opioid Addiction Prevention Act of 2017 H.R.3964 - Opioid Addiction Prevention Act of 2017 H.R. 5219 - Opioid Prescription Verification Act H.R. 4275 - Empowering Pharmacists in the Fight Against Opioids Act H.R. 4275 - Safe Disposal of Unused Medication Act H.R. 2063 - Opioid Preventing Abuse through Continuing Education Act S. 3120 Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018 S. 2789, Substance Abuse Prevention Act of 2018 S. 2838, Using Data to Prevent Opioid Diversion Act of 2018 S. 2460, Every Prescription Conveyed Security Act of 2018 H.R. 5812, Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act (CONNECTIONS) Act H.R. 4275, Empowering Pharmacists in the Fight Against Opioid Abuse Act H.R. 3528, Every Prescription Conveyed Securely Act H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act H.R. 5675, To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries H.R. 5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act H.R. 5687, Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act H.R.6 - SUPPORT for Patients and Communities Act S. 2465 - AIDD Act S 2837 - Preventing Drug Diversion Act S. 3282 - DEA Order Clearinghouse Act S. 2383 - Using Data to Prevent Opioid Diversion Act

Client expense: $640,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided; Advocated with Congress on the need for adequate funding for the VHA for FY2019 and the long-term. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Health Information Technology (HIT): The College provided feedback on the Centers for Disease Control and Prevention (CDC) Request for Information (RFI) Regarding a National Test Collaborative (NTC), which sought approaches for developing a NTC that would allow for the field testing of health information technology (HIT) in a live clinical setting; expressed concern that building an entirely new testing network will be prohibitively difficult and execution could go wrong unless it is carefully designed, piloted, and tested. Emailing and conference calling with every level of every organization is labor intensive and getting participants engaged in this process will be an enormous effort; urged the need to address the patient privacy issues associated with production settings. These privacy issues may cause concern amongst hospitals and may prevent them from wanting to participate unless addressed; recommended that CDC consider building a CDC-Vendor-End User communication methodology that may be a more manageable undertaking utilizing existing infrastructures. Such a system could allow for CDC to notify EHR vendors who would notify product users when they receive an alert or guidance from CDC, using a process similar to how software updates are released. This approach does not require the sharing of protected health information nor does it require direct access into the production system. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians. 2019 Physician Fee Schedule (PFS) and Quality Payment Program (QPP): Commented on CMS final rule on the 2019 PFS and QPP including - Urged additional refinements are needed to the final E/M documentation and payment policies to provide for immediate documentation relief, ensure the needs of complex patients are appropriately addressed, and avert negative downstream consequences; supports separate payment for technology-based communication services but urges the Agency to reconsider patient cost sharing and burdensome consent polices which may prevent uptake of these critical services; appreciates the burden relief that will result from allowing physicians to delegate Appropriate Use Criteria (AUC) consultations to appropriate clinical staff, but reiterates need to reimburse clinicians for the additional time required to conduct these consultations and pilot testing AUC in limited clinical priority areas before deploying on a larger scale to prevent widespread payment disruptions. With regard to QPP, urged greater simplifying of MIPS scoring by basing point values for individual measures on their relative value to the total MIPS score, taking every opportunity to award cross category credit, and instituting a consistent minimum 90-day reporting period across all categories; develop more Advanced APMs, particularly for small and specialty practices; opposes the use of cost measures that are deemed unreliable or inaccurate and urges CMS not to increase the weight of the Cost Category until every measure meets rigorous reliability and accuracy standards; reduce overall number of quality measures and use only those deemed valid, relevant, and reliable, such as those recommended by ACPs Performance Measurement Committee. Public Charge: The College provided comments on the Department of Homeland Securitys Notice of Proposed Rulemaking: Inadmissibility on Public Charge Grounds (DHS Docket No. USCIS-2010-0012). ACP oppose the DHS proposed rule on public charge because if finalized it would put the health of millions of children and families at risk. The proposed changes would expand the number of programs that the federal government would consider in public charge determinations to include Medicaid, the Medicare Part D Low-Income Subsidy Program, the Supplemental Nutrition Assistance Program, and potentially the Childrens Health Insurance Program (CHIP), among others. By widening public charge determinations in this way, the proposed rule would make it much more likely that lawfully present immigrants and those seeking to lawfully immigrate to the U.S. could be denied lawful permanent resident status, be denied visas, or even be deported, merely on the basis of seeking essential health, nutrition, and housing services for themselves or their families. The proposed rule would undermine the physician-patient relationship and disrupt care continuity, and it is antithetical to the Colleges mission to ensure meaningful access to health care for our patients. Immigrant Children and Pregnant Women in U.S. Custody: The College commented to the U.S. Department of Homeland Security that conditions in the U.S. Customs and Border Protection (CBP) custody are inconsistent with evidence-based recommendations for appropriate care and treatment of children and pregnant women. As such, they are not appropriate for children or pregnant women. ACP calls for a full, transparent, and public investigation of Jakelin Caal Maquins (from Guatemala) death and the circumstances surrounding it, as well as any other deaths that may have occurred in CBP or Immigration and Customs Enforcement custody. The College strongly urges the Department of Homeland Security (DHS) to implement specific meaningful steps to ensure that all children and pregnant women in CBP custody receive appropriate medical and mental health screening and necessary follow-up care by trained providers.

Client expense: $249,755 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE

Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided; Advocated with Congress on the need for adequate funding for the VHA for FY2019 and the long-term. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Health Information Technology (HIT): The College provided feedback on the Centers for Disease Control and Prevention (CDC) Request for Information (RFI) Regarding a National Test Collaborative (NTC), which sought approaches for developing a NTC that would allow for the field testing of health information technology (HIT) in a live clinical setting; expressed concern that building an entirely new testing network will be prohibitively difficult and execution could go wrong unless it is carefully designed, piloted, and tested. Emailing and conference calling with every level of every organization is labor intensive and getting participants engaged in this process will be an enormous effort; urged the need to address the patient privacy issues associated with production settings. These privacy issues may cause concern amongst hospitals and may prevent them from wanting to participate unless addressed; recommended that CDC consider building a CDC-Vendor-End User communication methodology that may be a more manageable undertaking utilizing existing infrastructures. Such a system could allow for CDC to notify EHR vendors who would notify product users when they receive an alert or guidance from CDC, using a process similar to how software updates are released. This approach does not require the sharing of protected health information nor does it require direct access into the production system. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians. 2019 Physician Fee Schedule (PFS) and Quality Payment Program (QPP): Commented on CMS final rule on the 2019 PFS and QPP including - Urged additional refinements are needed to the final E/M documentation and payment policies to provide for immediate documentation relief, ensure the needs of complex patients are appropriately addressed, and avert negative downstream consequences; supports separate payment for technology-based communication services but urges the Agency to reconsider patient cost sharing and burdensome consent polices which may prevent uptake of these critical services; appreciates the burden relief that will result from allowing physicians to delegate Appropriate Use Criteria (AUC) consultations to appropriate clinical staff, but reiterates need to reimburse clinicians for the additional time required to conduct these consultations and pilot testing AUC in limited clinical priority areas before deploying on a larger scale to prevent widespread payment disruptions. With regard to QPP, urged greater simplifying of MIPS scoring by basing point values for individual measures on their relative value to the total MIPS score, taking every opportunity to award cross category credit, and instituting a consistent minimum 90-day reporting period across all categories; develop more Advanced APMs, particularly for small and specialty practices; opposes the use of cost measures that are deemed unreliable or inaccurate and urges CMS not to increase the weight of the Cost Category until every measure meets rigorous reliability and accuracy standards; reduce overall number of quality measures and use only those deemed valid, relevant, and reliable, such as those recommended by ACPs Performance Measurement Committee. Public Charge: The College provided comments on the Department of Homeland Securitys Notice of Proposed Rulemaking: Inadmissibility on Public Charge Grounds (DHS Docket No. USCIS-2010-0012). ACP oppose the DHS proposed rule on public charge because if finalized it would put the health of millions of children and families at risk. The proposed changes would expand the number of programs that the federal government would consider in public charge determinations to include Medicaid, the Medicare Part D Low-Income Subsidy Program, the Supplemental Nutrition Assistance Program, and potentially the Childrens Health Insurance Program (CHIP), among others. By widening public charge determinations in this way, the proposed rule would make it much more likely that lawfully present immigrants and those seeking to lawfully immigrate to the U.S. could be denied lawful permanent resident status, be denied visas, or even be deported, merely on the basis of seeking essential health, nutrition, and housing services for themselves or their families. The proposed rule would undermine the physician-patient relationship and disrupt care continuity, and it is antithetical to the Colleges mission to ensure meaningful access to health care for our patients. Immigrant Children and Pregnant Women in U.S. Custody: The College commented to the U.S. Department of Homeland Security that conditions in the U.S. Customs and Border Protection (CBP) custody are inconsistent with evidence-based recommendations for appropriate care and treatment of children and pregnant women. As such, they are not appropriate for children or pregnant women. ACP calls for a full, transparent, and public investigation of Jakelin Caal Maquins (from Guatemala) death and the circumstances surrounding it, as well as any other deaths that may have occurred in CBP or Immigration and Customs Enforcement custody. The College strongly urges the Department of Homeland Security (DHS) to implement specific meaningful steps to ensure that all children and pregnant women in CBP custody receive appropriate medical and mental health screening and necessary follow-up care by trained providers.

Client expense: $92,631 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), President of the U.S., SENATE

CMS Manual - Reimbursement coding HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 HR 2368 Right to Try Act HR 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 S 204 Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 HR 878 Right to Try Act of 2017

Client expense: $150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Matters related to opioids data innovation; accessible database for information and resources that can be used by health care providers, state and local governments, pharmacists, advocates, and law enforcement; E.O. 13784: Establishing the President's Commission on Combating Drug Addiction and the Opioid Crisis, H.R. 5812: Creating Opportunities that Necessitate New and Enhanced Connections (generally), H.R. 6: Substance Use-Disorder Prevention that Promotes Opioid Recovery (generally), H.R. 4284: INFO Act (generally), S. 2680: Opioid Response Act of 2018 (generally).

Client expense: $530,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Executive Office of the President (EOP), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - PDP/MA-PD payments on clean claims from pharmacies S. 428, ACE Kids Act (Grassley) - coordinated care for children with complex medical conditions S. 1016, CONNECT For Health Act (Schatz) - telehealth S. 1169, Medicaid CARE Act (Durbin-Portman) - changes to Medicaid IMD exclusion S. 1688, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 1804, Medicare for All Act (Sanders) - single payer health system S. 1827, Keep Kids Insurance Dependable and Secure Act (Hatch-Wyden) - federal CHIP funding S. 1890, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Cardin) - Medigap coverage for beneficiaries with end-stage renal disease S. 2027, Medicaid Third Party Liability Act (Portman) - Medicaid third party liability S. 2227, EMPOWER Care Act (Portman-Cantwell) - Medicaid Money Follows the Person Demonstration S. 2707, Informing Seniors About Opioids Act (Nelson) - opioid issues S. 2901, Expanding Telehealth Response to Ensure Addiction Treatment Act (Thune) - opioid issues S. 2904, Medicaid Substance Use Disorder Treatment Via Telehealth Act (Carper) - opioid issues S. 2908, Electronic Prior Authorization in Medicare Part D Act (Roberts) - opioid issues S. 3327, SENIOR Communities Protection Act (Cortez Masto) - preventing fraudulent opioid prescriptions S. 3496, Improving Seniors Access to Quality Benefits Act (Daines-King) - study on MA benchmark cap S. 3497, Medicare Advantage Quality Payment Relief Act (Daines-King) - MA benchmark cap Draft Bill: Medicare Long-Term Care Services and Supports Act (Pallone) - Long-Term Services and Supports Program Draft Bills: Prior Authorization in Medicare Advantage (House Ways and Means Committee) - prior authorization notifications, report to Congress S. 2051: Medicare Care Coordination Improvement Act of 2017 (Portman) - barriers to payment reform models H.R. 849, Protecting Seniors Access to Medicare Act (Roe) - Independent Payment Advisory Board H.R. 908, Medicare Advantage Quality Payment Relief Act (Kelly) - MA payment cap H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - PDP/MA-PD payments on clean claims from pharmacies H.R. 1148, FAST Act (Griffith) - access to telehealth-eligible stroke services under Medicare H.R. 1316, Prescription Drug Price Transparency Act (Collins) - PBM standards for MA and PDP plans H.R. 1995, V-BID for Better Care Act (Black) - value-based insurance design in Medicare Advantage H.R. 2556, CONNECT For Health Act (Black) - telehealth H.R. 2644, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Marino) - Medigap coverage for beneficiaries with end-stage renal disease H.R. 2687, Medicaid CARE Act (Foster-Fitzpatrick) - changes to Medicaid IMD exclusion H.R. 3044, Supplemental Benefits for Chronically Ill Medicare Advantage Enrollees (Meehan) H.R. 3168, Special Needs Plans (Tiberi-Levin) - SNP reauthorization H.R. 3263, Medicare Independence at Home Model of Care (Burgess) - demonstration program H.R. 3325, ACE Kids Act (Barton) - health homes for children with complex medical conditions H.R. 3360, Telehealth Enhancement Act (Harper) - telehealth in Medicare H.R. 3635, Local Coverage Determination Clarification Act (Jenkins) - procedures for Medicare administrative contractors H.R. 3727, Increasing Telehealth Access in Medicare Act (Black) - telehealth in MA plans H.R. 4143, Dialysis PATIENTS Demonstration Act of 2017 (Smith) - alternative care delivery models and payment methodologies for patients with end-stage renal disease H.R. 4952, Improving Seniors Access to Quality Benefits Act (Kelly) - MA benchmark cap study H.R. 5306, EMPOWER Care Act (Guthrie) - extension of Money Follows the Person Act H.R. 5603, Access to Telehealth Services for Substance Use Disorders Act (Matsui) - opioid issues H.R. 5605, Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act (Ruiz) - opioid issues H.R. 5675, drug management programs for at-risk Medicare beneficiaries (Bilirakis) - opioid issues H.R. 5676, SENIOR Communities Protection Act (MacArthur) - preventing fraudulent opioid prescriptions H.R. 5684, Protecting Seniors from Opioid Abuse Act (Kelly) - opioid issues H.R. 5685, Medicare Opioid Safety Education Act (Faso) - opioid issues H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act (Paulsen) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - communication between Medicare plan sponsors and CMS H.R. 5773, Preventing Addiction for Susceptible Seniors Act (Roskam) - opioid issues H.R. 5797, IMD CARE Act (Walters) - Medicaid IMD exclusion H.R. 5798, Opioid Screening and Chronic Pain Management Alternatives for Seniors Act (Bucshon) - opioid issues H.R. 5799, Medicaid Drug Review, Utilization, Good Governance Improvement Act (Blackburn) - opioid issues H.R. 5800, Medicaid IMD ADDITIONAL INFO Act (Upton) - opioid issues H.R. 5804, Post-Surgical Injections as an Opioid Alternative Act (Shimkus) - opioid issues H.R. 5808, Medicaid Pharmaceutical Home Act (Bilirakis) - opioid issues H.R. 5809, Postoperative Opioid Prevention Act (Peters) - opioid issues H.R. 5810, Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act (Lance) - opioid issues H.R. 5812, Improving Medicaid Data Timeliness Act (Griffith) - opioid issues H.R. 6431, Medigap Consumer Protection Act (Levin) - reforms to Medicare supplemental insurance H.R. 6561, Comprehensive Care for Seniors Act (Walorski) -- Program of All-Inclusive Care for the Elderly H.R. 6563, Lower Out-of-Pocket Costs for Seniors Act (Pallone-Neal) - Medicare Part D cliff H.R. 6662, Empowering Seniors Decision Enrollment Act (Paulsen) - special enrollment period for non-deemed Medicare Cost Plan enrollees H.R. 6690, Fighting Fraud to Protect Care for Seniors Act (Roskam) - Medicare pilot program for smart card technology Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2019 policy and technical regulation for MA and Part D; issues relating to 2019 Rate Notice and Call Letter; in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Bipartisan Budget Act of 2018 changes to SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); CMS's proposed Part B drug demonstration program; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS' substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation. *Add MACPAC to Agency List.

Client expense: $1,500,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of

S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) -PDP/MA-PD payments on clean claims from pharmacies S. 428, ACE Kids Act (Grassley) - coordinated care for children with complex medical conditions S. 1016, CONNECT For Health Act (Schatz) - telehealth S. 1169, Medicaid CARE Act (Durbin-Portman) - changes to Medicaid IMD exclusion S. 1688, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 1804, Medicare for All Act (Sanders) - single payer health system S. 1827, Keep Kids Insurance Dependable and Secure Act (Hatch-Wyden) - federal CHIP funding S. 1890, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Cardin) - Medigap coverage for beneficiaries with end-stage renal disease S. 2027, Medicaid Third Party Liability Act (Portman) - Medicaid third party liability S. 2227, EMPOWER Care Act (Portman-Cantwell) - Medicaid Money Follows the Person Demonstration S. 2707, Informing Seniors About Opioids Act (Nelson) - opioid issues S. 2901, Expanding Telehealth Response to Ensure Addiction Treatment Act (Thune) - opioid issues S. 2904, Medicaid Substance Use Disorder Treatment Via Telehealth Act (Carper) - opioid issues S. 2908, Electronic Prior Authorization in Medicare Part D Act (Roberts) - opioid issues Draft Medicare Long-Term Care Services and Supports Act (Pallone) - Long-Term Services and Supports Program H.R. 195, Extension of Continuing Appropriations Act - CHIP funding extension for 2018-2023 and related provisions H.R. 849, Protecting Seniors Access to Medicare Act (Roe) - Independent Payment Advisory Board H.R. 908, Medicare Advantage Quality Payment Relief Act (Kelly) - MA payment cap H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - PDP/MA-PD payments on clean claims from pharmacies H.R. 1148, FAST Act (Griffith) - access to telehealth-eligible stroke services under Medicare H.R. 1316, Prescription Drug Price Transparency Act (Collins) - PBM standards for MA and PDP plans H.R. 1892, Bipartisan Budget Act (Larson) - permanent authorization of Medicare Advantage Special Needs Plans; MA chronic care reforms: telehealth, supplemental benefits, value-based insurance design, star ratings; changes to Medicare Part D coverage gap and related discounts; CHIP funding extension for 2024-2027; funding for Puerto Ricos Medicaid program H.R. 1995, V-BID for Better Care Act (Black) - value-based insurance design in Medicare Advantage H.R. 2556, CONNECT For Health Act (Black) - telehealth H.R. 2644, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Marino) - Medigap coverage for beneficiaries with end-stage renal disease H.R. 2687, Medicaid CARE Act (Foster-Fitzpatrick) - changes to Medicaid IMD exclusion H.R. 3044, Supplemental Benefits for Chronically Ill Medicare Advantage Enrollees (Meehan) H.R. 3168, Special Needs Plans (Tiberi-Levin) - SNP reauthorization H.R. 3263, Medicare Independence at Home Model of Care (Burgess) - demonstration program H.R. 3325, ACE Kids Act (Barton) - coordinated care for children with complex medical conditions H.R. 3360, Telehealth Enhancement Act (Harper) - telehealth in Medicare H.R. 3727, Increasing Telehealth Access in Medicare Act (Black) - telehealth in MA plans H.R. 3921, HEALTHY KIDS Act (Burgess) - CHIP funding H.R. 4952, Improving Seniors Access to Quality Benefits Act (Kelly) - MA benchmark cap study H.R. 5603, Access to Telehealth Services for Substance Use Disorders Act (Matsui) - opioid issues H.R. 5605, Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act (Ruiz) - opioid issues H.R. 5675, drug management programs for at-risk Medicare beneficiaries (Bilirakis) - opioid issues H.R. 5676, SENIOR Communities Protection Act (MacArthur) - preventing fraudulent opioid prescriptions H.R. 5684, Protecting Seniors from Opioid Abuse Act (Kelly) - opioid issues H.R. 5685, Medicare Opioid Safety Education Act (Faso) - opioid issues H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act (Paulsen) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - communication between Medicare plan sponsors and CMS H.R. 5773, Preventing Addiction for Susceptible Seniors Act (Roskam) - opioid issues H.R. 5797, IMD CARE Act (Walters) - Medicaid IMD exclusion H.R. 5798, Opioid Screening and Chronic Pain Management Alternatives for Seniors Act (Bucshon) - opioid issues H.R. 5799, Medicaid Drug Review, Utilization, Good Governance Improvement Act (Blackburn) - opioid issues H.R. 5800, Medicaid IMD ADDITIONAL INFO Act (Upton) - opioid issues H.R. 5804, Post-Surgical Injections as an Opioid Alternative Act (Shimkus) - opioid issues H.R. 5808, Medicaid Pharmaceutical Home Act (Bilirakis) - opioid issues H.R. 5809, Postoperative Opioid Prevention Act (Peters) - opioid issues H.R. 5810, Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act (Lance) - opioid issues H.R. 5812, Improving Medicaid Data Timeliness Act (Griffith) - opioid issues Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2019 policy and technical regulation for MA and Part D; issues relating to 2019 Rate Notice and Call Letter; in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Bipartisan Budget Act of 2018 changes to SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); CMS's proposed Part B drug demonstration program; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS' substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

Client expense: $1,410,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

H.R. 714 Use of Medicinal Marihuana H.R. 715 Rescheduling of Marihuana H.R. 975 Controlled Substances Act Application to Marihuana H.R. 1781 Synthetic Opioids H.R. 1824 Federal and State Marijuana Policy Gap Reduction S. 581 Opioids Addiction Information in Medical Records S. 780 Federal and State Marijuana Policy Gap Reduction H.R. 2020 Rescheduling of Marijuana H.R. 2063 Opioid Dispensary Registration Training Condition S. 1078 FDA Opioid Approval Procedures S. 1079 FDA Opioid Approval and Revocation S. 1327 Controlled Substance Analogues Regulation H.R. 3374 Drunk Driving H.R. 3534 State Legalized Marijuana S. 1553 Schedule 1 Controlled Substances S. 1554 Controlled Substance Continuing Education S. 1689 Controlled Substances Act H.R. 3964 Registration Requirements for Prescribers of Opioids H.R. 4482 Opioid Abuse and Addiction S. 2008 Opioid Epidemic and Drug Sample Backlogs H.R. 4903 Opioid Usage Reduction Best Practices Study H.R. 4922 Fentanyl Analogues H.R. 5109 Opioid Epidemic Distribution of Resources S. 2437 Opioid Grant Program S. 2440 Opioid Epidemic S. 2535 Opioid Quotas H.R. 5473 Alternative Methods for Data Collection H.R. 5581 Prescribers of Controlled Substances H.R. 5590 Medicare and Opioid Addictions H.R. 5723 Medicare Payment Advisory Commission H.R. 5782 Pharmaceutical Company Accountability S. 2680 Opioid Crisis S. 2691 Pharmaceutical Companies and Illegal Marketing S. 2729 Prevention of Prescription Opioid Misuse S. 2838 Reporting Information on Distribution of Opioids S. 2848 Controlled Substances and Alcohol Testing H.R. 6491 Reporting of Information on Distribution of Opioids H.R. 6608 Prescription Drug Monitoring Programs Data Collection H.R. 5812 Controlled Substance Overdose Prevention Activities

Client expense: $1,070,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Natl Security Council (NSC), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)

CMS Manual - Reimbursement coding HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 HR 2368 Right to Try Act HR 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 S 204 Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 HR 878 Right to Try Act of 2017

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.5812 - Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 H.R. 6 - Opioid Package S.2680 - Opioid Crisis Response Act of 2018 H.R.3635 - Local Coverage Determination Clarification Act of 2017 Local Coverage Determination (LCD) Clarification Act (S. 794) Promoting Integrity in Medicare Act (HR 2066) Protecting Seniors' Access to Medicare Act (HR 849) Protecting Access to Medicare Act Protecting Patients from Surprise Medical Bills (Cassidy Language) FDA Technical Assistance to DAIA S. 2582 - Consumer Health Insurance Protection Act S. 284 - End Surprise Billing Act CMS Physician Fee Schedule Registry Measures

Client expense: $371,117 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Medicare Physician Payment Reform: Advocated in support of H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), which was enacted in April 2015 and repealed Medicares Sustainable Growth Rate (SGR) formula and moved us to a new value-based payment and delivery system under Medicare; Advocated with CMS on numerous aspects of the MACRA proposed and final rules, including: proposing a distinctive alternative scoring methodology, developed by ACP, which combines, simplifies, aligns and reduces the complexity of the four reporting categories that will qualify physicians for FFS payment adjustments; proposing specific alternatives to CMS Advancing Care Information program that replaced the Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Improvement Activities categories; urging CMS to immediately create virtual reporting options and to create safe harbors for smaller practices until such options are available; proposing more options and flexibility, instead of a one-size fits all approach, for practices to be certified as Patient-Centered Medical Homes or Patient-Centered Medical Home specialty practices, qualifying them for the highest possible score for the Clinical Practice Improvement Activity reporting category; Proposing four different options for Medical Home practices to qualify as advanced Alternative Payment Models, instead of the single option proposed by CMS, including options to allow PCMHs to qualify without taking financial risk: Advocated with CMS on Patient Relationship Categories and Codes, as required by MACRA, specifically: that CMS work to ensure that patients, families, and the relationship of patients and families with their physicians are at the forefront of the Agencys thinking in the development of both the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) pathways; that the implementation of these categories and codes is carried out in a manner that fully considers and minimizes the impact of reporting burden on the participating clinicians and that has appropriate flexibility to allow for learning and improvement in the approach by both the Agency and the clinicians. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. The College believes that strong oversight is needed when determining the initial benchmark plan (and whether it reflects the coverage requirements of the Affordable Care Act) and how the package will be updated, particularly if insurers are given the ability to substitute benefits within and across categories. State and the federal government must work in concert with physicians, health care providers and payers to determine and promote use of clinically effective and cost-effective services that result in improved patient health while bending the cost curve. Under the Affordable Care Act, advocated to ensure that people residing in states with health insurance marketplaces operated by the federal government do not lose their cost-sharing reduction subsidies (CSRs) and that those CSRs should be continued indefinitely as part of a larger bipartisan effort to stabilize the individual insurance market. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided; Advocated with Congress on the need for adequate funding for the VHA for FY2019 and the long-term. Immigration: Voiced support to Congress on the need to pass the Development, Relief, and Education for Alien Minors (DREAM) Act of 2017, H.R. 3440. This legislation would establish a three-step pathway to U.S. citizenship through college, work, or the armed services for individuals who were born in another country and brought illegally to the U.S. at a young age (DREAMers). Clinical Labs: Commented to the Centers for Medicare and Medicaid Services (CMS) on issues pertaining to the Protecting Access to Medicare Act of 2014 (PAMA), specifically citing concerns about the potential impacts of PAMA on patient access to critical rapid clinical testing services offered to patients while they are receiving medical care in their physicians office; expressed further concerns about impending cuts on Jan. 1, 2018 for physician office-based testing services. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Repeal the Dickey amendment restricting firearms-related research by federal agencies and support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians. Title X Regulations: Commented to HHS in July on the proposed rule to revise Title X regulations (Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where pregnancy termination is a method of family planning and related statutory requirements. The College asserts that women should have sufficient access to evidence-based family planning and sexual health information and the full range of medically accepted forms of contraception. The College opposes government restrictions that would erode or abrogate a woman's right to continue or discontinue a pregnancy. The College opposes any legislation or regulations that limit access to comprehensive reproductive health care by putting medically unnecessary restrictions on health care professionals or facilities. Kentucky Health Waiver: The College commented to CMS on Kentuckys Health Waiver expressing concern that: it would impose a substantial monthly premium on Medicaid beneficiaries; would also create a six-month lock-out period for certain enrollees who do not pay their premiums on time, which is unduly harsh; that proposed work requirements will impose an unnecessary and unjustified burden on patients to document that they are eligible for an exemption and an unnecessary and unjustified burden on physicians who may be asked to attest that their patients have an exempted medical condition. 2019 Physician Fee Schedule and Quality Payment Program: Advocated to CMS that: cognitive care of more complex patients must be recognized with higher allowed payment rates than less complex care patients; supports the overall direction of CMS's proposal to reduce the burden of documentation for E/M services, but strongly disagrees that such improvements should be contingent on acceptance of the proposal to pay a single flat fee for levels 2-5; CMS not establish a regulatory deadline (e.g. January 1, 2019 or January 1, 2020) for finalizing and implementing its flat fee E/M proposals or possible alternatives that change how E/M services would be paid; calls on CMS to move forward with implementation of their proposal to simplify E/M documentation requirements effective January 1, 2019, while alternatives to the flat fee structure are being developed and pilot-tested; supports implementation on January 1, 2019 of proposals to pay for virtual check-ins, other telehealth and technology-based services, and prolonged face-to-face visits. Short-Term Health Plans: Urged Congress to support the joint resolutions disapproving of the rule related to short-term, limited-duration insurance, as published in the federal register on August 3, 2018, that such rule shall have no force or effect.

Client expense: $279,872 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE

Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Medicare Physician Payment Reform: Advocated in support of H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), which was enacted in April 2015 and repealed Medicares Sustainable Growth Rate (SGR) formula and moved us to a new value-based payment and delivery system under Medicare; Advocated with CMS on numerous aspects of the MACRA proposed and final rules, including: proposing a distinctive alternative scoring methodology, developed by ACP, which combines, simplifies, aligns and reduces the complexity of the four reporting categories that will qualify physicians for FFS payment adjustments; proposing specific alternatives to CMS Advancing Care Information program that replaced the Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Improvement Activities categories; urging CMS to immediately create virtual reporting options and to create safe harbors for smaller practices until such options are available; proposing more options and flexibility, instead of a one-size fits all approach, for practices to be certified as Patient-Centered Medical Homes or Patient-Centered Medical Home specialty practices, qualifying them for the highest possible score for the Clinical Practice Improvement Activity reporting category; Proposing four different options for Medical Home practices to qualify as advanced Alternative Payment Models, instead of the single option proposed by CMS, including options to allow PCMHs to qualify without taking financial risk: Advocated with CMS on Patient Relationship Categories and Codes, as required by MACRA, specifically: that CMS work to ensure that patients, families, and the relationship of patients and families with their physicians are at the forefront of the Agencys thinking in the development of both the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) pathways; that the implementation of these categories and codes is carried out in a manner that fully considers and minimizes the impact of reporting burden on the participating clinicians and that has appropriate flexibility to allow for learning and improvement in the approach by both the Agency and the clinicians. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. The College believes that strong oversight is needed when determining the initial benchmark plan (and whether it reflects the coverage requirements of the Affordable Care Act) and how the package will be updated, particularly if insurers are given the ability to substitute benefits within and across categories. State and the federal government must work in concert with physicians, health care providers and payers to determine and promote use of clinically effective and cost-effective services that result in improved patient health while bending the cost curve. Under the Affordable Care Act, advocated to ensure that people residing in states with health insurance marketplaces operated by the federal government do not lose their cost-sharing reduction subsidies (CSRs) and that those CSRs should be continued indefinitely as part of a larger bipartisan effort to stabilize the individual insurance market. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided; Advocated with Congress on the need for adequate funding for the VHA for FY2019 and the long-term. Immigration: Voiced support to Congress on the need to pass the Development, Relief, and Education for Alien Minors (DREAM) Act of 2017, H.R. 3440. This legislation would establish a three-step pathway to U.S. citizenship through college, work, or the armed services for individuals who were born in another country and brought illegally to the U.S. at a young age (DREAMers). Clinical Labs: Commented to the Centers for Medicare and Medicaid Services (CMS) on issues pertaining to the Protecting Access to Medicare Act of 2014 (PAMA), specifically citing concerns about the potential impacts of PAMA on patient access to critical rapid clinical testing services offered to patients while they are receiving medical care in their physicians office; expressed further concerns about impending cuts on Jan. 1, 2018 for physician office-based testing services. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Repeal the Dickey amendment restricting firearms-related research by federal agencies and support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians. Title X Regulations: Commented to HHS in July on the proposed rule to revise Title X regulations (Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where pregnancy termination is a method of family planning and related statutory requirements. The College asserts that women should have sufficient access to evidence-based family planning and sexual health information and the full range of medically accepted forms of contraception. The College opposes government restrictions that would erode or abrogate a woman's right to continue or discontinue a pregnancy. The College opposes any legislation or regulations that limit access to comprehensive reproductive health care by putting medically unnecessary restrictions on health care professionals or facilities. Kentucky Health Waiver: The College commented to CMS on Kentuckys Health Waiver expressing concern that: it would impose a substantial monthly premium on Medicaid beneficiaries; would also create a six-month lock-out period for certain enrollees who do not pay their premiums on time, which is unduly harsh; that proposed work requirements will impose an unnecessary and unjustified burden on patients to document that they are eligible for an exemption and an unnecessary and unjustified burden on physicians who may be asked to attest that their patients have an exempted medical condition. 2019 Physician Fee Schedule and Quality Payment Program: Advocated to CMS that: cognitive care of more complex patients must be recognized with higher allowed payment rates than less complex care patients; supports the overall direction of CMS's proposal to reduce the burden of documentation for E/M services, but strongly disagrees that such improvements should be contingent on acceptance of the proposal to pay a single flat fee for levels 2-5; CMS not establish a regulatory deadline (e.g. January 1, 2019 or January 1, 2020) for finalizing and implementing its flat fee E/M proposals or possible alternatives that change how E/M services would be paid; calls on CMS to move forward with implementation of their proposal to simplify E/M documentation requirements effective January 1, 2019, while alternatives to the flat fee structure are being developed and pilot-tested; supports implementation on January 1, 2019 of proposals to pay for virtual check-ins, other telehealth and technology-based services, and prolonged face-to-face visits. Short-Term Health Plans: Urged Congress to support the joint resolutions disapproving of the rule related to short-term, limited-duration insurance, as published in the federal register on August 3, 2018, that such rule shall have no force or effect.

Client expense: $97,099 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE

Implementation of Public Law 114-198 pharmacy provisions; Implementation of Public Law 114-255 pharmacy provisions; H.R. 1854/S. 778, Prescription Drug Monitoring Act of 2017; S 892 / H.R. 4408, Opioid Addiction Prevention Act of 2017; HR 3528 / S.2460, Every Prescription Conveyed Securely Act; H.R. 3545, Overdose Prevention and Patient Safety Act; S. 1850, Protecting Jessica Grubbs Legacy Act; H.R. 1271, DXM Abuse Prevention Act of 2017; H.R. 1375, Prescriber Support Act of 2017; S. 523, Budgeting for Opioid Addiction Treatment Act; S. 581 / H.R. 5009, Jessies Law; S 1079, Protecting Americans from Dangerous Opioids Act; H.R. 4236, MONITOR Act of 2017; H.R. 3991, Expanded Access to Opioid Abuse Treatment Act of 2017; H.R. 4275, Empowering Pharmacists in the Fight Against Opioid Abuse Act; H.R. 5219, Opioid Prescription Verification Act of 2018; H.R. 5676, SENIOR Communities Protection Act of 2018; H.R. 5773, PASS Act of 2018; Draft legislation, Medicare Care Coordination Improvement Act of 2017; Draft legislation, Pain Care Coordination Act of 2018; S. 2456/H.R. 5311, CARA 2.0 Act of 2018; H.R. 5687, SOUND Disposal and Packaging Act; H.R. 5202, Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018; H.R. 5812, CONNECTIONS Act; H.R. 5801, Medicaid PARTNERSHIP Act; H.R. 6, SUPPORT for Patients and Communities Act; H.R. 5808, Medicaid Pharmaceutical Home Act of 2018; H.R. 5675, To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries; S. 2680, Opioid Crisis Response Act of 2018; S. 2645 / H.R. 5628, Access to Increased Drug Disposal Act of 2018; H.R. 6600 / S. 3282, the DEA Order Clearinghouse Act of 2018; H.R. 6688, ALERT Act of 2018

Client expense: $290,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

Health and Human Services Department Reform Health Care Reform (access to dental care, other dental-related issues) Affordable Care Act Repeal and Replace (dental-related programs) Better Care Reconciliation Act of 2017 (H.R. 1628, nature of a substitute) Graham-Cassidy health reform proposal (H.R. 1628, nature of a substitute) Childrens Health Insurance Program (CHIP) reauthorization H.R. 6-Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act H.R. 860-HEALTHIER Act of 2017 H.R. 1606-Dentist and Optometric Care Access Act (DOC Access Act) H.R. 1628-American Health Care Act of 2017 H.R. 1876-Good Samaritan Health Professionals Act of 2017 H.R. 2422-Action for Dental Health Act of 2017 H.R. 2430-FDA Reauthorization Act of 2017 H.R. 3921-HEALTHY KIDS Act H.R. 4684-Ensuring Access to Quality Sober Living Act of 2018 H.R. 5197-Alternatives to Opioids (ALTO) in the Emergency Department Act H.R. 5261-TEACH to Combat Addiction Act of 2018 H.R. 5327-Comprehensive Opioid Recovery Centers Act of 2018 H.R. 5333-Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 H.R. 5687-Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act H.R. 5774-Combatting Opioid Abuse for Care in Hospitals (COACH) Act H.R. 5776-Medicare and Opioid Safe Treatment (MOST) Act H.R. 5806-21st Century Tools for Pain and Addiction Treatments H.R. 5812-Creating Opportunities that Necessitate New and Enhanced Connections that Improve Opioid Navigating Strategies (CONNECTIONS) Act H.R. 6689-Ensuring Lasting Smiles Act H.R. 7000-Tribal Tax Empowerment and Jobs Act of 2018 S. 934-FDA Reauthorization Act of 2017 S. 1827-KIDS Act of 2017 S. 2315-Over-the-Counter Drug Safety, Innovation, and Reform Act S. 2456-CARA 2.0 Act of 2018 S. 2680-Opioid Crisis Response Act of 2018 S. 3016-Action for Dental Health Act of 2018

Client expense: $570,000 · Firm income: Not reported

Government targets: Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Treasury, Dept of

S.892 Opioid Addiction Prevention Act of 2017 H.R.4408 - Opioid Addiction Prevention Act of 2017 H.R.3964 - Opioid Addiction Prevention Act of 2017 H.R. 5219 - Opioid Prescription Verification Act H.R. 4275 - Empowering Pharmacists in the Fight Against Opioids Act H.R. 4275 - Safe Disposal of Unused Medication Act H.R. 2063 - Opioid Preventing Abuse through Continuing Education Act S. 3120 Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018 S. 2789, Substance Abuse Prevention Act of 2018 S. 2838, Using Data to Prevent Opioid Diversion Act of 2018 S. 2460, Every Prescription Conveyed Security Act of 2018 H.R. 5812, Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act (CONNECTIONS) Act H.R. 4275, Empowering Pharmacists in the Fight Against Opioid Abuse Act H.R. 3528, Every Prescription Conveyed Securely Act H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act H.R. 5675, To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries H.R. 5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act H.R. 5687, Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act H.R.6 - SUPPORT for Patients and Communities Act S. 2465 - AIDD Act S 2837 - Preventing Drug Diversion Act S. 3282 - DEA Order Clearinghouse Act S. 2383 - Using Data to Prevent Opioid Diversion Act

Client expense: $440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

S.2387, Concentrating on High-value Alzheimer's Needs to Get to an End (CHANGE) Act of 2018, Alzheimer services Reauthorization Older American's Act, generally Addiction and Behavioral Health; and Opioid issues, as follows: H.R.5812, Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 H.R.4635, To direct the Secretary of Veterans Affairs to increase the number of peer-to-peer counselors providing counseling for women veterans, and for other purposes. H.R.6082, Overdose Prevention and Patient Safety Act Monitor the following: Institution of Mental Diseases (IMD) exclusions Hepititis A outbreak related issues Affordable Care Act repeal and replace legislation

Client expense: Not reported · Firm income: $110,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3528/S. 2460, Every Prescription Conveyed Securely Act. Implementation issues related to the Comprehensive Addiction and Recovery Act (P.L. 114-198). H.R. 3919/S. 1908, Commonsense Reporting Act of 2017. H.R. 5812, CONNECTIONS Act of 2018. S. 2680, Opioid Crisis Response Act of 2018

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Advantage; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicaid; Opioids; Air Ambulance; Medicare Part D HR 2575 Introduced May 19, 2017 by Raul Ruiz (R-CA) To amend title XVIII of the Social Security Act to establish a system to educate individuals approaching Medicare eligibility, to simplify and modernize the eligibility enrollment process, and for other purposes. HR 3780 Air Ambulance Quality and Accountability Act Introduced September 14, 2017 by Richard Hudson (R-NC) To amend title XVIII of the Social Security Act to provide under the Medicare program for conditions of participation, reporting requirements, and a quality program with respect to air ambulance services. HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 5228 SCREEN Act Introduced March 8, 2018 by Frank Pallone, Jr. (D-NJ) H.R. 5228 will provide the Food and Drug Administration (FDA) with stronger recall and seizure authority to disrupt the entry of counterfeit and illicit drugs through International Mail Facilities (IMFs). HR 5752 Stop Illicit Drug Importation Act of 2018 Introduced May 10, 2018 by Marsha Blackburn (R-TN) amends the Federal Food, Drug, and Cosmetic Act (FD&C) to strengthen the Food and Drug Administrations (FDA) seizure powers and enhance its authority to detain, refuse, seize, or destroy illegal products offered for import. The legislation would subject more people to debarment and civil penalties under the Act. HR 5806 21st Century Tools for Pain and Addiction Treatment Act Introduced May 15, 2018 by Michael Burgess(R-TX) To require the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain drugs, and for other purposes. HR 5811 Long-Term Opioid Efficacy Act of 2018 Introduced May 15, 2018 by Jerry McNerney (D-CA) To amend the Federal Food, Drug, and Cosmetic Act with respect to post-approval study requirements for certain controlled substances, and for other purposes. HR 5789 Introduced May 15, 2018 by Bill Foster (D-IL) To amend title XIX of the Social Security Act to provide for Medicaid coverage protections for pregnant and postpartum women while receiving inpatient treatment for a substance use disorder, and for other purposes. HR 5715 Strengthening Partnerships to Avoid Opioid Abuse Act Introduced May 9, 2018 by James Renacci (R-OH) To amend title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5716 COMPASS Act Introduced May 9, 2018 by Peter Roskam (R-IL) To amend title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids, and for other purposes. HR 5590 Opioid Addiction Action Plan Act Introduced April 24, 2018 by Adam Kinzinger (R-IL) To require the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment, and for other purposes. HR 5605 Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act Introduced April 24, 2018 by Raul Ruiz (D-CA) establishes a four-year demonstration program to increase access to treatment for opioid use disorder. The demonstration would provide incentive payments and funding for care management services based on criteria such as patient engagement, use of evidence-based treatments, and treatment length and intensity. Under the bill, the Secretary of Health and Human Services would be directed to encourage other payers to coordinate payments for opioid use disorder treatments and to evaluate the extent to which the demonstration reduces hospitalizations, increases the use of medication-assisted treatments, and improves the health outcomes of individuals with opioid use disorders during and after the demonstration. This bill also incorporates H.R. 3528, Every Prescription Conveyed Securely Act, which would require e-prescribing, with exceptions, for coverage of prescribed controlled substances under the Medicare Part D program. HR 5798 Opioid Screening and Chronic Pain Management Alternatives for Seniors Act Introduced May 15, 2018 by Larry Bucshon (R-IN) To amend title XVIII of the Social Security Act to require a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventive physical examination. HR 4684 Ensuring Access to Quality Sober Living Act of 2018 Introduced December 19, 2017 by Judy Chu (D-CA) Authorizes the Substance Abuse and Mental Health Services Administration to develop, publish, and disseminate best practices for operating recovery housing that promotes a safe environment and sustained recovery from substance use disorders. Recovery housing is increasingly recognized as critical to recovery for many individuals, and includes activities and programs such as mediation, one-on-one counseling, group sessions, peer recovery support, medication management, spiritual engagement, and others. HR 5329 Poison Center Network Enhancement Act of 2018 Introduced March 19, 2018 by Susan Brooks (D-IN) reauthorizes the national network of Poison Control Centers. Specifically, the legislation reauthorizes the toll-free number, national media campaign, and grant program under the Public Health Service Act. The legislation increases the share of poison control center funding that could be provided through federal grants, and authorizes $30 million per year over the 2019-2023 period. HR 5580 STOP Fentanyl Deaths Act of 2018 Introduced April 23, 2018 by Ann Kuster (D-NH) To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl, and for other purposes. HR 5587 Peer Support Communities of Recovery Act Introduced April 23, 2018 by Ben Lujan (D-NM) enhances the Comprehensive Addiction and Recovery Acts Building Communities of Recovery Program and authorizes the Department of Health and Human Services (HHS) to award grants to peer support specialist organizations for the development and expansion of recovery services. Grants shall be awarded to nonprofit organizations that support community-based, peer delivered support, including technical support for the establishment of recovery community organizations, independent, nonprofit groups led by people in recovery and their families. HR 5804 Post-Surgical Injections as an Opioid Alternative Act Introduced May 15, 2018 by John Shimkus (R-IL) To amend title XVIII of the Social Security Act to provide for modifications in payment for certain outpatient surgical services. HR 5795 Overdose Prevention and Patient Safety Act Introduced May 15, 2018 by Earl Blumenauer (D-OR) To amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records. HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 Introduced May 15, 2018 by Morgan Griffith (R-VA) Will authorize the Centers for Disease Control and Prevention to carry out certain controlled substances overdose prevention and surveillance activities in order to improve data collection and integration into physician clinical workflow so that timely, complete, and accurate information will get into the hands of providers and dispensers so that they can make the best clinical decisions for their patients. HR 449 Synthetic Drug Awareness Act of 2018 Introduced January 11, 2017 by Hakeem Jeffries (D-NY) requires the U.S. Surgeon General to report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12 to 18 years old in order to further educate parents and the medical community on the health effects of synthetics. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across all relevant Federal agencies, evaluate the effectiveness of these activities, and make specific recommendations for actions that agencies can take to better coordinates the administration of services for patients with OUD and SUD. HR 5002 Advancing Cutting Edge Research Act Introduced February 18, 2018 by Debbie Dingell (D-MI) Provides the National Institutes of Health new authorities to conduct research on innovative non-addictive pain medications. HR 5102 Substance Use Disorder Workforce Loan Repayment Act of 2018 Introduced February 27, 2018 by Katherine Clark (D-MA) creates a loan repayment program for substance use disorder (SUD) treatment providers. Specifically, the legislation offers student loan repayment of up to $250,000 for participants who agree to work as a SUD treatment professional in areas most in need of their services. The program is available to a wide range of direct care providers, including physicians, registered nurses, social workers, and other behavioral health professionals. The bill authorizes $25 million a year for the 2019-2028 period. HR 5009 Jessies Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patients complete health information when making treatment decisions by requiring the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5176 Preventing Overdoses While in Emergency Rooms Act of 2018 Introduced March 6, 2018 by David McKinley (R-VA) requires the Secretary of the Department of Health and Human Services (HHS) to develop protocols and a grant program for health care providers to address the needs of people who survive a drug overdose. Specifically, the protocols would address the provision of naloxone upon discharge, connection with peer-support specialists, and the referral to treatment and other services that best fit the patients needs. The bill authorizes $50 million in FY2019 for the grant program. HR 5197 ALTO Act Introduced March 7, 2018 by Bill Pascrell, Jr. (D-NJ) Directs the Secretary of Health and Human Services (HHS) to carry out a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments. Following the completion of the three-year demonstration, the Secretary of Health and Human Services will submit a report to Congress on the results of the program and issue recommendations for broader implementation. The legislation authorizes $10 million annually in grants for fiscal years 2019-2021. HR 5261 Treatment, Education, and Community Help to Combat Addiction Act of 2018 Introduced March 13, 2018 by Bill Johnson (R-OH) directs the Secretary of Health and Human Services (HHS) to designate regional Centers of Excellence to enhance and improve how health professional are educated in substance abuse disorder prevention, treatment, and recovery through development, evaluation, and distribution of evidence-based curricula for health profession schools. The bill authorizes $4 million annually for grants to those programs over the 2019-2023 period. HR 5272 To provide additional guidance to grantees seeking funding to treat or prevent mental health or substance use disorders. Introduced March 14, 2018 by Steve Stivers (R-OH) Requires the newly established National Mental Health and Substance Use Policy Laboratory to issue guidance to applicants for Substance Abuse and Mental Health Services Administration (SAMHSA) grants that support evidence-based practices. The guidance shall include how best to articulate the rationale for a given program or activity; encourage the funding of evidence-based interventions; and encourage the replication of promising or effective practices. HR 5327 Comprehensive Opioid Recovery Centers Act of 2018 Introduced March 19, 2018 by Brett Guthrie (R-KY) directs the Secretary of Health and Human Services (HHS) to award grants to at least 10 providers that offer treatment services for people with opioid use disorder. These Comprehensive Opioid Recovery Centers would serve as models for comprehensive treatment and recovery and would utilize the full range of Food and Drug Administration approved medications and evidence-based treatments, have strong linkages with the community, generate meaningful outcomes data, and dramatically improve the opportunities for individuals to establish and maintain long-term recovery. Either directly or through coordination with other entities, Centers must provide services including withdrawal management, counseling, recovery housing, community-based and peer recovery support services, job training and placement assistance, pharmacy and toxicology services, and a secure and confidential electronic health information system. HR 5353 Eliminating Opioid Related Infectious Diseases Act of 2018 Introduced March 20, 2018 by Leonard Lance (R-NJ) Authorizes the Centers for Disease Control (CDC) to undertake an injection drug-use associated infection elimination initiative and work with states to improve education, surveillance, and treatment of infections associated with injection drug use. HR 3331 To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Introduced July 20, 2017 by Lynn Jenkins (R-KY) authorizes the Center for Medicare and Medicaid Innovation to test a program offering incentive payments to behavioral health providers that adopt and use certified electronic health record technology. The U.S. government introduced the Meaningful Use program as part of the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act, to encourage health care providers to show "meaningful use" of a certified Electronic Health Record (EHR). In doing so, eligible providers who do so receive incentive payments, but behavioral health providers were not included in the definition of eligible providers. Individual physicians and other eligible health care professionals can each receive up to $44,000 through the Medicare Meaningful Use program or up to $63,750 through the Medicaid Meaningful Use program, depending upon when they begin attesting to the program's requirements. HR 3528 Every Prescription Conveyed Securely Act Introduced July 28, 2017 by Katherine Clark (D-MA) To amend title XVIII of the Social Security Act to require e-prescribing for coverage under Part D of the Medicare program of prescription drugs that are controlled substances. HR 4841 Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Introduced January 18, 2018 by David Schweikert (R-AZ) To amend title XVIII of the Social Security Act to provide for electronic prior authorization under Medicare Part D for covered Part D drugs, and for other purposes. HR 5675 To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries Introduced May 3, 2018 by Gus Bilirakis (R-FL) This bill requires Medicare prescription drug plan (PDP) sponsors, for plan years beginning on or after January 1, 2021, to establish drug management programs for at-risk beneficiaries. Current law authorizes, but does not require, PDP sponsors to establish such programs. HR 5686 Medicare Clear Health Options in Care for Enrollees Act of 2018 Introduced May 7, 2018 by Erik Paulsen (R-MN) To amend title XVIII of the Social Security Act to require prescription drug plans under Medicare part D to include information on the adverse effects of opioid overutilization and of coverage of nonpharmacological therapies and nonopioid medications or devices used to treat pain. HR 5582 Abuse Deterrent Access Act of 2018 Introduced April 23, 2018 by Buddy Carter (R-GA) Requires the Secretary of the Department of Health and Human Services (HHS) to report to Congress on existing barriers to access to abuse-deterrent opioid formulations by Medicare Part C and D beneficiaries. HR 5684 Protecting Seniors From Opioid Abuse Act Introduced May 7, 2018 by Mike Kelly (R-PA) To amend title XVIII of the Social Security Act to expand eligibility for medication therapy management programs established under Part D of the Medicare program to include certain individuals who are at risk for prescription drug abuse.

Client expense: $10,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA); ACA Regulations; Opioid Epidemic; ACA Stabilization; Health Savings Accounts (HSAs); Postal Reform; Cost Sharing Reductions (CSRs); Health Care Reform Reinsurance; Market Stability; State Flexibility; Pay-fors; Affordability; 1332 Templates; Healthcare Innovation; Risk Adjustment; Department Reform; Drug Pricing; Association Health Plans; Short Term Limited Duration; Air Ambulances; 42 CFR Part 2; Individual Market Reform; CREATES Act; Marketplace Certainty Act; Individual Market Rules; Small Group Market; Rural Health; Health Information Technology HR 246 Introduced January 4, 2017 by Kristi Noem (R-SD) This bill repeals a provision of the Patient Protection and Affordable Care Act that imposes an annual fee on a health insurance provider based on its net premium income. HR 314 Introduced January 5, 2017 by Marsha Blackburn (R-TN) To repeal Title I of the Patient Protection and Affordable Care Act and to amend the Public Health Service Act to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. HR 1703 Introduced March 23, 2017 by Morgan Griffith (R-VA) To amend the Federal Food, Drug, and Cosmetic Act with respect to determining the intended use of drugs and devices. HR 2051 FAST Generics Act Introduced April 6, 2017 by David McKinley (R-WV) To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2430 Introduced May 10, 2017 by Greg Walden (R-OR) To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. HR 2026 Pharmaceutical Information Exchange Act Introduced April 6, 2017 by Brett Guthrie (R-VA) To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers. HR 1101 Small Business Health Fairness Act of 2017 Introduced February 16, 2017 by Sam Johnson (R-TX) To amend Title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. HR 2400 Introduced May 8, 2017 by Darrell Issa (R-CA) To amend Title 5, United States Code, to allow individuals who are not Federal employees to enroll in the Federal Employees Health Benefits Program, and for other purposes. HR 708 Introduced January 27, 2017 by Larry Bucshon (R-IN) This bill amends the Public Health Service Act to increase the permissible variation based on age for health insurance premiums for coverage offered in the individual or small group market from a factor of three to a factor of five, or to a factor determined by the state. This applies to plan years starting on or after January 1, 2018. HR 2051 Fast Generics Act of 2017 Introduced April 6, 2017 by David McKinley (R-VA) To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2889 Closing Loopholes for Orphan Drugs Act Introduced June 13, 2017 by Peter Welch (D-VT) To amend Title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. HR 2212 CREATES Act Introduced April 27, 2017 by Tom Marino (R-PA) To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1409 Cancer Drug Parity Act of 2017 Introduced by Leonard Lance (R-NJ) To amend the Public Health Service Act to require group and individual health insurance coverage and group health plans to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 749 Lower Drug Cost Through Competition Act Introduced January 30, 2017 by Kurt Schrader (D-OR) To increase competition in the pharmaceutical industry. HR 4666 Premium Relief Act Introduced December 18, 2017 by Ryan Costello (R-PA) To amend the Public Health Service Act to provide for a Patient and State Stability Fund. HR 3976 Access to Marketplace Insurance Act Introduced October 5, 2017 by Kevin Cramer (R-ND) To amend the Patient Protection and Affordable Care Act to allow for certain third-party payments. HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 5228 SCREEN Act Introduced March 8, 2018 by Frank Pallone, Jr. (D-NJ) H.R. 5228 will provide the Food and Drug Administration (FDA) with stronger recall and seizure authority to disrupt the entry of counterfeit and illicit drugs through International Mail Facilities (IMFs). HR 5752 Stop Illicit Drug Importation Act of 2018 Introduced May 10, 2018 by Marsha Blackburn (R-TN) amends the Federal Food, Drug, and Cosmetic Act (FD&C) to strengthen the Food and Drug Administration's (FDA) seizure powers and enhance its authority to detain, refuse, seize, or destroy illegal products offered for import. The legislation would subject more people to debarment and civil penalties under the Act. HR 5806 21st Century Tools for Pain and Addiction Treatment Act Introduced May 15, 2018 by Michael Burgess (R-TX) To require the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain drugs, and for other purposes. HR 4998 Health Insurance for Former Foster Youth Act Introduced February 13, 2018 by Karen Bass (D-CA) To amend Title XIX of the Social Security Act to ensure health insurance coverage continuity for former foster youth. HR 5801 Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act Introduced May 15, 2018 by Morgan Griffith (R-VA) To amend Title XIX of the Social Security Act to provide for requirements under the Medicaid program relating to the use of qualified prescription drug monitoring programs and prescribing certain controlled substances. HR 5715 Strengthening Partnerships to Avoid Opioid Abuse Act Introduced May 9, 2018 by James Renacci (R-OH) To amend Title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare Parts C and D. HR 5716 COMPASS Act Introduced May 9, 2018 by Peter Roskam (R-IL) To amend Title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare Parts C and D. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids, and for other purposes. HR 5590 Opioid Addiction Action Plan Act Introduced April 24, 2018 by Adam Kinzinger (R-IL) To require the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment, and for other purposes. HR 5603 Access to Telehealth Services for Substance Use Disorders Act Introduced April 24, 2018 by Doris Matsui (D-CA) To amend Title XVIIII of the Social Security Act to provide the Secretary of Health and Human Services authority to waive certain Medicare telehealth requirements in the case of certain treatment of an opioid use disorder or co-occurring mental health disorder. HR 5605 Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act Introduced April 24, 2018 by Raul Ruiz (D-CA) establishes a four-year demonstration program to increase access to treatment for opioid use disorder. The demonstration would provide incentive payments and funding for care management services based on criteria such as patient engagement, use of evidence-based treatments, and treatment length and intensity. Under the bill, the Secretary of Health and Human Services would be directed to encourage other payers to coordinate payments for opioid use disorder treatments and to evaluate the extend to which the demonstration reduces hospitalizations, increases the use of medication-assisted treatments, and improves the health outcomes of individuals with opioid use disorders during and after the demonstration. This bill also incorporates H.R. 3528, Every Prescription Conveyed Securely Act, which would require e-prescribing, with exceptions, for coverage of prescribed controlled substances under the Medicare Part D program. HR 5798 Opioid Screening and Chronic Pain Management Alternatives for Seniors Act Introduced May 15, 2018 by Larry Bucshon (R-IN) To amend Title XVIII of the Social Security Act to require a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventive physical examinations. HR 4684 Ensuring Access to Quality Sober Living Act of 2018 Introduced December 19, 2017 by Judy Chu (D-CA) Authorizes the Substance Abuse and Mental Health Services Administration to develop, publish, and disseminate best practices for operating recovery housing that promotes a safe environment and sustained recovery from substance use disorders. Recovery housing is increasingly recognized as critical to recovery for many individuals, and includes activities and programs such as mediation, one-on-one counseling, group sessions, peer recovery support, medication management, spiritual engagement, and others. HR 5329 Poison Center Network Enhancement Act of 2018 Introduced March 19, 2018 by Susan Brooks (D-IN) reauthorizes the national network of Poison Control Centers. Specifically, the legislation reauthorizes the toll-free number, national media campaign, and grant program under the Public Health Service Act. The legislation increases the share of poison control center funding that could be provided through federal grants, and authorizes $30 million per year over the 2019-2023 period. HR 5580 STOP Fentanyl Deaths Act of 2018 Introduced April 23, 2018 by Ann Kuster (D-NH) To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl, and for other purposes. HR 5587 Peer Support Communities of Recovery Act Introduced April 23, 2018 by Ben Lujan (D-NM) enhances the Comprehensive Addiction and Recovery Act's Building Communities of Recovery Program and authorizes the Department of Health and Human Services (HHS) to award grants to peer support specialist organizations for the development and expansion of recovery services. Grants shall be awarded to nonprofit organizations that support community-based, peer delivered support, including technical support for the establishment of recovery community organizations, independent, nonprofit groups led by people in recovery and their families. HR 5804 Post-Surgical Injections as an Opioid Alternative Act Introduced May 15, 2018 by John Shimkus (R-IL) To amend Title XVIII of the Social Security Act to provide for modifications in payment for certain outpatient surgical services. HR 5809 Postoperative Opioid Prevention Act of 2018 Introduced May 15, 2018 by Scott Peters (D-CA) To amend Title XVIII of the Social Security Act to encourage the use of non-opioid analgesics for the management of post-surgical pain under the Medicare program, and for other purposes. HR 5795 Overdose Prevention and Patient Safety Act Introduced May 15, 2018 by Earl Blumenauer (D-OR) To amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records. HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 Introduced May 15, 2018 by Morgan Griffith (R-VA) Will authorize the Centers for Disease Control and Prevention to carry out certain controlled substances overdose prevention and surveillance activities in order to improve data collection and integration into physician clinical workflow so that timely, complete, and accurate information will get into the hands of providers and dispensers so that they can make the best clinical decisions for their patients. HR 449 Synthetic Drug Awareness Act of 2018 Introduced January 11, 2017 by Hakeem Jeffries (D-NY) requires the U.S. Surgeon General to report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12 to 18 years old in order to further educate parents and the medical community on the health effects of synthetics. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across all relevant Federal agencies, evaluate the effectiveness of these activities, and make specific recommendations for actions that agencies can take to better coordinate the administration of services for patients with OUD and SUD. HR 5002 Advancing Cutting Edge Research Act Introduced February 18, 2018 by Debbie Dingell (D-MI) Provides the National Institutes of Health new authorities to conduct research on innovative non-addictive pain medications. HR 5102 Substance Use Disorder Workforce Loan Repayment Act of 2018 Introduced February 27, 2018 by Katherine Clark (D-MA) creates a loan repayment program for substance use disorder (SUD) treatment providers. Specifically, the legislation offers student loan repayment of up to $250,000 for participants who agree to work as a SUD treatment professional in areas most in need of their services. The program is available to a wide range of direct care providers, including physicians, registered nurses, social workers, and other behavioral health professionals. The bill authorizes $25 million a year for the 2019-2028 period. HR 5009 Jessie's Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patient's complete health information when making treatment decisions by requirement the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5176 Preventing Overdoses While in Emergency Room Act of 2018 Introduced March 6, 2018 by David McKinley (R-VA) requires the Secretary of the Department of Health and Human Services (HHS) to develop protocols and a grant program for health care providers to address the needs of people who survive a drug overdose. Specifically, the protocols would address the provision of naloxone upon discharge, connection with peer-support specialists, and the referral to treatment and other services that best fit the patient's needs. The bill authorizes $50 million in FY 2019 for the grant program. HR 5197 ALTO Act Introduced March 7, 2018 by Bill Pascrell, Jr. (D-NJ) Directs the Secretary of Health and Human Services (HHS) to carry out a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments. Following the completion of the three-year demonstration, the Secretary of Health and Human Services will submit a report to Congress on the results of the program and issue recommendations for broader implementation. The legislation authorizes $10 million annually in grants for fiscal years 2019-2021.

Client expense: $10,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA); ACA Regulations; Opioid Epidemic; ACA Stabilization; Health Savings Accounts (HSAs); Postal Reform; Cost Sharing Reductions (CSRs); Health Care Reform Reinsurance; Market Stability; State Flexibility; Pay-fors; Affordability; 1332 Templates; Healthcare Innovation; Risk Adjustment; Department Reform; Drug Pricing; Association Health Plans; Short Term Limited Duration; Air Ambulances; 42 CFR Part 2; Individual Market Reform; CREATES Act; Marketplace Certainty Act; Individual Market Rules; Small Group Market; Rural Health; Health Information Technology HR 246 Introduced January 4, 2017 by Kristi Noem (R-SD) This bill repeals a provision of the Patient Protection and Affordable Care Act that imposes an annual fee on health insurance provider based on its net premium income. HR 314 Introduced January 5, 2017 by Marsha Blackburn (R-TN) to repeal title I of the Patient Protection and Affordable Care Act and to amend the Public Health Service Act to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. HR 2051 FAST Generics Act Introduced April 6, 2017 by David McKinley (R-WV) to amend the Federal Food, Drug and Cosmetic Act to ensure eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2430 Introduced May 10, 2017 by Greg Walden (R-OR) to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs and biosimilar biological products and for other purposes. HR 2400 Introduced May 8, 2017 by Darrell Issa (R-CA) to amend title 5, United States Code. To allow individuals who are not Federal employees to enroll in the Federal Employees Health Benefits Program and for other purposes. HR 708 Introduced January 27, 2017 by Larry Buchshon (R-IN) This bill amends the Public Health Service Act to increase the permissible variation based on age for health insurance premiums for coverage offered in the individual or small group market from a factor of three to a factor of five, or to a factor determined by the state. This applies to plan years starting on or after January 1, 2018. HR 829 Prioritizing the Most Vulnerable Over Lottery Winners Act of 2017 Introduced February 2, 2017 by Fred Upton (R-MI) This bill amends title XIX (Medicaid) to specify how a state must treat qualified lottery winnings and lump sum income for purposes of determining an individuals income-based eligibility for a state Medicaid program. Specifically, a state shall include such winnings or income as income received: (1) in the month in which it was received, if the amount is less than $80,000; (2) over a period of two months, if the amount is at least $80,000 but less than $90,000; (3) over a period of three months, if the amount is at least $90,000 but less than $100,000; and (4) over an additional one-month period for each increment of $10,000 received, not to exceed 120 months. HR 1082 Medicaid Home Improvement Act Introduced February 15, 2017 by Brett Guthrie (R-KY) to amend title XIX of the Social Security Act to eliminate the State option to reduce the home equity exemption amount for purposes of eligibility for long-term care assistance under Medicaid, and for other purposes. HR 3922 Championing Healthy Kids Act Introduced October 3, 2017 by Greg Walden (R-OR) Extends funding for the Childrens Health Insurance Program (CHIP) through Fiscal Year (FY)2022, Federally Qualified Health Centers (FQHCs) through FY2019 and revises CHIP and Medicaid. HR 2051 Fast Generics Act of 2017 Introduced April 6, 2017 by David McKinley (R-VA) to amend the Federal Food, Drug and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products and for other purposes. HR 2889 Closing Loopholes for Orphan Drugs Act Introduced June 13, 2017 by Peter Welch (D-VT) to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. HR 2212 CREATES Act introduced April 27, 2017 by Tom Marino (R-PA) to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1409 Cancer Drug Parity Act of 2017 Introduced March 7, 2017 by Leonard Lance (R-NJ) to amend the Public Health Service Act to require group and individual health insurance coverage and group health plans to provide for cost sharing for oral anticancer drugs on terms no less favorable than the cost sharing provided for anticancer medications administered by a health care provider. HR 749 Lower Drug Cost Through Competition Act Introduced January 30, 2017 by Kurt Schrder (D-OR) to increase competition in the pharmaceutical industry. HR 4666 Premium Relief Act Introduced December 18, 2017 by Ryan Costello (R-PA) To amend the Public Health Service Act to provide for a Patient and State Stability Fund. HR 3976 Access to Marketplace Insurance Act Introduced October 5, 2017 by Kevin Cramer (R-ND) to amend the Patient Protection and Affordable Care Act to allow for certain third-party payments. HR 6 SUPPORT for patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Way and Means Committee. HR 5752 Stop Illicit Drug Importation Act of 2018 introduced May 10, 2018 by Marsha Blackburn (R-TN) amends the Federal Food, Drug, and Cosmetic Act (FD&C) to strengthen the Food and Drug Administrations (FDA) seizure powers and enhance its authority to detain, refuse, seize or destroy illegal products offered for import. The legislation would subject more people to debarment and civil penalties under the Act. HR 5806 21st Century Tools for Pain and Addiction Treatment Act Introduced May 15, 2018 by Michael Burgess (R-TX) to require the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain, drugs and for other purposes. HR 5811 Long-Term Opioid Efficacy Act of 2018 Introduced May 15, 2018 by Jerry McNerney (D-CA) to amend the Federal Food, Drug, and Cosmetic Act with respect to post approval study requirements for certain controlled substances, and for other purposes. HR 1925 At-Risk Youth Medicaid Protection Act of 2018 Introduced April 5, 2017 by Tony Cardenas (D-CA) to amend title XIX of the Social Security Act to protect at-risk youth against termination of Medicaid eligibility while an inmate of a public institution. HR 3192 CHIP Mental Health Parity Act to amend title XXI of the Social Security Act to ensure access to mental health services for children under the Childrens Health Insurance Program and for other purposes. HR 4005 Medicaid Reentry Act Directs the Secretary of Health and Human Services to convene a group of stakeholders and develop and report to Congress on best practices for addressing issues related to health care faced by those returning from incarceration to their communities. In addition, the legislation allows Medicaid payment for medical services furnished to an incarcerated individual during the 30-day period preceding the individuals release. HR 5789 Introduced May 15, 2018 by Bill Foster (D-IL) to amend title XIX of the Social Security Act to [provide for Medicaid coverage protection for pregnant and post-partum women while receiving inpatient treatment for substance use disorder, and for other purposes. HR 5797 Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act Introduced May 15, 2018 by Mimi Walters (D-CA) Allows state Medicaid programs to remove the Institutions for Mental Diseases (IMD) exclusion for Medicaid beneficiaries aged 21-64 with an opioid use disorder for fiscal years 2019 to 2023. By removing the exclusion, Medicaid would pay for up to 30 total days of care in an IMD during a 12-month period for eligible individuals. Opioid use disorder as defined in H.R. HR 5800 Introduced May 15, 2018 by Fred Upton (R-MI) directs the Medicaid and CHIP Payment and Access Commission (MACPAC) to conduct a study on institutions for mental disease that receive Medicaid reimbursement. The study shall report on the requirements and standards that state Medicaid programs have in place for institutions for mental diseases (IMD). MACPAC shall summarize the findings and make recommendations on best practices and data collection no later than January 2020. HR 5810 Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act Introduced May 15, 2018 by Leonard Lance (R-NJ) to amend title XIX of the Social Security Act to provide for an extension of the enhanced FMAP for certain Medicaid health homes for individuals with substance use disorders. HR 5715 Strengthening Partnerships to Avoid Opioid Abuse Act Introduced May 9, 2018 by James Renacci (R-OH) to amend title XVII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5716 COMPASS Act Introduced May 9, 2018 by Peter Roskam (R-IL) to amend title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) to require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids and for other purposes. HR 5590 Opioid Addiction Action Plan Introduced April 24, 2018 by Adam Kinzinger (R-IL) to require the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment and for other purposes. HR 5603 Access to Telehealth Services for Substance Use Disorders Act Introduced April 24, 2018 by Doris Matsui (D-CA) to amend title XVIII of the Social Security Act to provide the Secretary of Health and Human Services Authority to waive certain Medicare telehealth requirements in the case of certain treatment of an opioid use disorder or co-occurring mental health disorder. HR 5605 Advancing Hight Quality Treatment for Opioid Use Disorders in Medicare Act Introduced April 24, 2018 by Raul Ruiz (D-CA) establishes a four-year demonstration program to increase access to treatment for opioid use disorder. The demonstration would provide incentive payments and funding for care management services based on criterial such as patient engagement, use of evidence-based treatments, and treatment length and intensity. Under the bill, the Secretary of Health and Human Services would be directed to encourage other payers to coordinate payments for opioid use disorder treatments and to evaluate the extent to which the demonstration reduces hospitalizations, increases the use of medication-assisted treatments, and improves the health outcomes of individuals with opioid use disorders during and after the demonstration. This bill also incorporates HR 3528 Every Prescription Conveyed Securely Act which would require e-prescribing, with exceptions, for coverage of prescribed controlled substances under the Medicare Part D program. HR 5798 Opioid Screening and Chronic Pain Management Alternatives for Seniors Act Introduced May 15, 2018 by Larry Bucshon (R-IN) to amend title XVII of the Social Security Act to require a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventative physical examination. HR 5329 Poison Center Network Enhancement Act of 2018 Introduced March 19, 2018 by Susan Brooks (D-IN) reauthorizes the national network of Poison Control Centers. Specifically, the legislation reauthorizes the toll-free number, national media campaign, and grant program under the Public Health Poison Control Centers. Specifically, the legislation reauthorizes the toll-free number, national media campaign, and grant program under the Public Health Service Act. The Legislation increases the share of poison control center funding that could be provided through federal grants, and authorizes $30 million per year over the 2019-2023 period. HR 5804 Post Surgical Injections as an Opioid Alternative Act Introduced May 15, 2018 by John Shimkus (R-IL) to amend title XVII of the Social Security act to provide for modifications in payment for certain outpatient surgical services. HR 5809 Postoperative Opioid Prevention Act of 2018 Introduced May 15, 2018 by Scott Peters (D-CA) to amend title XVII of the Social Security Act to encourage the use of non-opioid analgesics for the management of post-surgical pain under the Medicare program and for other purposes. HR 5795 Overdose Prevention and Patient Safety Act Introduced May 15, 2018 by Earl Blumenauer (D-OR) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records. HR 5812 Creating Opportunities that necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 Introduced May 15, 2018 by Morgan Griffith (R-VA) will authorize the Centers for Disease Control and Prevention to carry out certain controlled substances overdose prevention and surveillance activities in order to improve data collection and integration into physician clinical workflow so that timely, complete, and accurate information will get into the hands of providers and dispensers so that they can make the best clinical decisions for their patients. HR 449 Synthetic Drug Awareness act of 2018 Introduced January 11, 2017 by Hakeem Jeffries (D-NY) requires the US Surgeon General to report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12-18 years old in order to further educate parents and the medical community on the health effects of synthetics. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across relevant Federal agencies, evaluate the effectiveness of these activities and make specific recommendations for actions that the agencies can take to better coordinates the administration of services for patients with OUD and SUD. HR 5002 Advancing Cutting-Edge Research Act Introduced February 18, 2018 by Debbie Dingell (D-MI) Provides the National Institutes of Health ne authorities to conduct research on innovative and non-addictive pain medications. HR 5102 Substance Use Disorder Workforce Loan Repayment Act of 2018 Introduced February 27, 2018 by Katherine Clark (D-MA) creates a loan repayment program for substance use disorder (SUD) treatment providers. Specifically, the legislation offers student loan repayment up to $250,000 for participants who agree to work as an SUD professional in areas most in need of their services. The program is available to a wide range of direct care providers, including physicians, registered nurses, social workers, and other behavioral health professionals. The bill authorizes $25 million a year for the 2019-2028 period. HR 5009 Jessies Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patients complete health information when making treatment decisions by requiring the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5176 Preventing Overdoses While in Emergency Rooms Act of 2018 Introduced March 6, 2018 by David McKinley (R-VA) requires the Secretary of the Department of Health and Human Services (HHS) to develop protocols and a grant program for health care providers to address the needs of people who survive a drug overdose. Specifically, the protocols would address the provision of naloxone upon discharge, connection with peer-support specialists, and the referral to treatment and other services that best fit the patients needs. The bill authorizes $50 million in FY 2019 for the grant program.

Client expense: $89,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Advantage; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicaid; Opioids; Air Ambulance; Medicare Part D HR 2575 Introduced May 19, 2017 by Raul Ruiz (R-CA) to amend title XVIII of the Social Security Act to establish a system to educate individuals approaching Medicare eligibility, to simplify and modernize the eligibility enrollment process, and for other purposes. HR 3780 Air Ambulance Quality and Accountability Act Introduced September 14, 2017 by Richard Hudson (R-NC) to amend title VIII of the Social Security Act to provide under the Medicare program for conditions of participation, reporting requirements, and a quality program with respect to air ambulance services. HR 3921 HEALTHY KIDS Act Introduced October 3, 2017 by Michael Burgess (R-TX) to extend funding for the Childrens Health Insurance Program and for other purposes. HR 1148 FAST Act of 2017 Introduced February 16, 2017 by Morgan Griffith (R-VA) to amend title XVII of the Social Security Act to expand access to telehealth-eligible stroke services under the Medicare program. HR 3192 CHIP Mental Health Parity Act Introduced July 12, 2017 by Joseph Kennedy III (D-MA) to amend title XXI of the Social Security Act to ensure access to mental health services for children under the Childrens Health Insurance Program and for other purposes. HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House and Energy and Commerce Committee and the Ways and Means Committee. HR 1925 At-Risk Youth Medicaid Protection Act of 2018 Introduced April 5, 2017 by Tony Cardenas (D-CA) to amend title XIX of the Social Security Act to protect at-risk youth against termination of Medicaid eligibility while an inmate of a public institution. HR 3192 CHIP Mental Health Parity Act to amend title XXI of the Social Security Act to ensure access to mental health services for children under the Childrens Health Insurance Program and for other purposes. HR 5808 Medicaid Pharmaceutical Home Act of 2018 Introduced May 15, 2018 by Gus Bilirakis (R-FL) to amend title XIX of the Social Security Act to require states to operate drug management programs for at-risk beneficiaries and for other purposes. HR 5810 Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act Introduced May 15, 2018 by Leonard Lance (R-NJ) to amend title XIX of the Social Security Act to provide for an extension of the enhanced FMAP for certain Medicaid health homes for individuals with substance use disorders. HR 5715 Strengthening Partnerships to Avoid Opioid Abuse Act Introduced May 9, 2018 by James Renacci (R-OH) to amend title XVII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5716 COMPASS Act Introduced May 9, 2018 by Peter Roskam (R-IL) to amend title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) to require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids and for other purposes. HR 5590 Opioid Addiction Action Plan Introduced April 24, 2018 by Adam Kinzinger (R-IL) to require the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment and for other purposes. HR 5603 Access to Telehealth Services for Substance Use Disorders Act Introduced April 24, 2018 by Doris Matsui (D-CA) to amend title XVIII of the Social Security Act to provide the Secretary of Health and Human Services Authority to waive certain Medicare telehealth requirements in the case of certain treatment of an opioid use disorder or co-occurring mental health disorder. HR 5605 Advancing Hight Quality Treatment for Opioid Use Disorders in Medicare Act Introduced April 24, 2018 by Raul Ruiz (D-CA) establishes a four-year demonstration program to increase access to treatment for opioid use disorder. The demonstration would provide incentive payments and funding for care management services based on criterial such as patient engagement, use of evidence-based treatments, and treatment length and intensity. Under the bill, the Secretary of Health and Human Services would be directed to encourage other payers to coordinate payments for opioid use disorder treatments and to evaluate the extent to which the demonstration reduces hospitalizations, increases the use of medication-assisted treatments, and improves the health outcomes of individuals with opioid use disorders during and after the demonstration. This bill also incorporates HR 3528 Every Prescription Conveyed Securely Act which would require e-prescribing, with exceptions, for coverage of prescribed controlled substances under the Medicare Part D program. HR 5798 Opioid Screening and Chronic Pain Management Alternatives for Seniors Act Introduced May 15, 2018 by Larry Bucshon (R-IN) to amend title XVII of the Social Security Act to require a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventative physical examination. HR 5804 Post Surgical Injections as an Opioid Alternative Act Introduced May 15, 2018 by John Shimkus (R-IL) to amend title XVII of the Social Security act to provide for modifications in payment for certain outpatient surgical services. HR 5809 Postoperative Opioid Prevention Act of 2018 Introduced May 15, 2018 by Scott Peters (D-CA) to amend title XVII of the Social Security Act to encourage the use of non-opioid analgesics for the management of post-surgical pain under the Medicare program and for other purposes. HR 5795 Overdose Prevention and Patient Safety Act Introduced May 15, 2018 by Earl Blumenauer (D-OR) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records. HR 5812 Creating Opportunities that necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 Introduced May 15, 2018 by Morgan Griffith (R-VA) will authorize the Centers for Disease Control and Prevention to carry out certain controlled substances overdose prevention and surveillance activities in order to improve data collection and integration into physician clinical workflow so that timely, complete, and accurate information will get into the hands of providers and dispensers so that they can make the best clinical decisions for their patients. HR 449 Synthetic Drug Awareness act of 2018 Introduced January 11, 2017 by Hakeem Jeffries (D-NY) requires the US Surgeon General to report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12-18 years old in order to further educate parents and the medical community on the health effects of synthetics. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across relevant Federal agencies, evaluate the effectiveness of these activities and make specific recommendations for actions that the agencies can take to better coordinates the administration of services for patients with OUD and SUD. HR 5002 Advancing Cutting-Edge Research Act Introduced February 18, 2018 by Debbie Dingell (D-MI) Provides the National Institutes of Health ne authorities to conduct research on innovative and non-addictive pain medications. HR 5102 Substance Use Disorder Workforce Loan Repayment Act of 2018 Introduced February 27, 2018 by Katherine Clark (D-MA) creates a loan repayment program for substance use disorder (SUD) treatment providers. Specifically, the legislation offers student loan repayment up to $250,000 for participants who agree to work as an SUD professional in areas most in need of their services. The program is available to a wide range of direct care providers, including physicians, registered nurses, social workers, and other behavioral health professionals. The bill authorizes $25 million a year for the 2019-2028 period. HR 5009 Jessies Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patients complete health information when making treatment decisions by requiring the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5176 Preventing Overdoses While in Emergency Rooms Act of 2018 Introduced March 6, 2018 by David McKinley (R-VA) requires the Secretary of the Department of Health and Human Services (HHS) to develop protocols and a grant program for health care providers to address the needs of people who survive a drug overdose. Specifically, the protocols would address the provision of naloxone upon discharge, connection with peer-support specialists, and the referral to treatment and other services that best fit the patients needs. The bill authorizes $50 million in FY 2019 for the grant program. HR 5197 ALTO Act Introduced March 7, 2018 by Bill Pascrell, Jr. (D-NJ) Directs the Secretary of Health and Human Services (HHS) to carry out a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments. Following the completion of the three-year demonstration, the Secretary of Health and Human Services will submit a report to Congress on the results of the program and issue recommendations for broader implementation. The legislation authorizes $10 million annually in grants for fiscal years 2019-2021. HR 5261 Treatment, Education and Community Help to Combat Addiction Act of 2018 Introduced March 13, 2018 by Bill Johnson (R-OH) directs the Secretary of Health and Human Services (HHS) to designate regional Centers of Excellence to enhance and improve how health professionals are educated in substance abuse disorder prevention, treatment and recovery through development, evaluation, and distribution of evidence based curricula for health profession schools. The bill authorizes $4 million annually for grants to those programs over the 2019-2023 period. HR 5272 To provide additional guidance to grantees seeking funding to treat or prevent mental health or substance use disorders. Introduced March 14, 2018 by Steve Stivers (R-OH) Requires the newly established National Mental Health and Substance Use Policy Laboratory to issue guidance to applicants for Substance Abuse and Mental Health Services Administration (SAMHSA) grants that support evidence-based practices. The guidance shall include how best to articulate the rationale for a give program or activity; encourage the funding of evidence-based interventions and encourage the replication of promising or effective practices. HR 5327 Comprehensive Opioid Recovery Centers Act of 2018 Introduced March 19, 2018 by Brett Guthrie (R-KY) directs the Secretary of Health and Human Services (HHS) to award grants to at least 10 providers that offer treatment services for people with opioid use disorder. These comprehensive Opioid Recovery Centers would serve as models for comprehensive treatment and recovery and would utilize the full range of Food and Drug Administration approved medications and evidence-based treatments, have strong linkages with the community, generate meaningful outcomes data and dramatically improve the opportunities for individuals to establish and maintain ling-term recovery. Either directly or through coordination with other entities, centers must provide services including withdrawal management, counseling, recovery housing, community-based and peer recovery support services, job training and placement assistance, pharmacy and toxicology services and a secure and confidential electronic health information system. HR 5353 Eliminating Opioid Related Infectious Diseases Act of 2018 Introduced March 20, 2018 by Leonard Lance (R-NJ) Authorizes the Centers for Disease Control (CDC) to undertake an injection drug-use associated infection elimination initiative and work with states to improve education, surveillance, and treatment of infections associated with injection drug use. HR 3331 To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology introduced July 20, 2017 by Lynn Jenkins (R-KY) authorizes the Center for Medicare and Medicaid Innovation to test a program offering incentive payments to behavioral health providers that adopt and use certified electronic health record technology. The US government introduced the Meaningful Use program as part of the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act, to encourage health care providers to show meaningful use of a certified Electronic Health Record (HER). In doing so, eligible providers who do so receive incentive payments, but behavioral health providers were not included in the definition of eligible providers. Individual physicians and other eligible health care professionals can receive up to $44,000 through the Medicare Meaningful Use program or up to $63,750 through the Medicaid Meaningful Use program, depending on when they begin attesting to the programs requirements. HR 5685 Medicare Opioid Safety Education Act of 2018 Introduced May 7, 2018 by John Faso (R-NY) directs the Centers for Medicare and Medicaid Services (CMS) to compile education resources for beneficiaries regarding opioid us, pain management, and alternative pain management treatments and include these resources in the Medicare and You handbook. HR 3528 Every Prescription Conveyed Securely Act Introduced July 28, 2017 by Katherine Clark (D-MA) to amend title XVIII of the Social Security Act to require e-prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances. HR 4841 Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Introduced January 18, 2018 by David Schweikert (R-AZ) to amend title XVIII of the Social Security Act to provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. HR 5675 To amend title XVII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at risk beneficiaries Introduced May 3, 2018 by Gus Bilirakis (R-FL) this bill requires Medicare prescription drug plan (PDP) sponsors, for plan years beginning on or after January 1, 2021, to establish drug management programs for at-risk beneficiaries. Current law authorizes, but does not require, PDP sponsors to establish such programs. HR 5686 Medicare Clear Health Options in Care for Enrollees Act of 2018 Introduced May 7, 2018 by Erik Paulsen (R-MN) to amend title XVII of the Social Security Act to require prescription drug plans under Medicare part D to include information on the adverse effects of opioid overutilization and of coverage of nonpharmacological therapies and nonopioid medications or devices to treat pain. HR 5582 Abuse Deterrent Access Act of 2018 Introduced April 23, 2018 by Buddy Carter (R-GA) requires the Secretary of the Department of Health and Human Services (HHS) to report to Congress on existing barriers to access to abuse-deterrent opioid formulations by Medicare Part C and D beneficiaries. HR 5684 Protecting Seniors from Opioid Abuse Act Introduced May 7, 2018 by Mike Kelly (R-PA) to amend title XVII of the Social Security Act to expand eligibility for medication therapy management programs established under part D of the Medicare program to include certain individuals who are at risk for prescription drug abuse.

Client expense: $89,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA); ACA Regulations; ACA Stabilization; Health Savings Accounts (HSA); Small Group Market Reform; Short Term Limited Duration (STLD); Cost-sharing Reduction (CSR); Reinsurance; Risk Adjustment; Market Stability; Drug Pricing; Individual Market Reform; CREATES ACT; Health Insurance Tax (HIT); Affordability; Individual Market Rules; Small Group Market; Postal Reform; Association of Health Plans Opioid Epidemic; State Flexibility; Pay-fors; 42 CFR Part 2. HR 246 Introduced January 4, 2017 by Kristi Noem (R-SD) This bill repeals a provision of the Patient Protection and Affordable Care Act that imposes an annual fee on a health insurance provider based on its net premium income. HR 314 Introduced January 5, 2017 by Marsha Blackburn (R-TN) To repeal title I of the Patient Protection and Affordable Care Act and to amend the Public Health Service Act to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. HR 1703 Introduced March 23, 2017 by Morgan Griffith (R-VA) To amend the Federal Food, Drug, and Cosmetic Act with respect to determining the intended use of drugs and devices. HR 2051 FAST Generics Act Introduced April 6, 2017 by David McKinley (R-WV) To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2430 Introduced May 10, 2017 by Greg Walden (R-OR) To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. HR 1101 Small Business Health Fairness Act of 2017 Introduced February 16, 2017 by Sam Johnson (R-TX) To amend title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. HR 708 Introduced January 27, 2017 by Larry Bucshon (R-IN) This bill amends the Public Health Service Act to increase the permissible variation based on age for health insurance premiums for coverage offered in the individual or small group market from a factor of three to a factor of five, or to a factor determined by the state. This applies to plan years starting on or after January 1, 2018. HR 3922 Championing Healthy Kids Act Introduced October 3, 2017 by Greg Walden (R-OR) Extends funding for the Childrens Health Insurance Program (CHIP) through Fiscal Year (FY) 2022, Federally Qualified Health Centers (FQHCs) through FY2019, and revises CHIP and Medicaid. HR 2212 CREATES Act Introduced April 27, 2017 by Tom Marino (R-PA) To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1409 Cancer Drug Parity Act of 2017 Introduced March 7, 2017 by Leonard Lance (R-NJ) To amend the Public Health Service Act to require group and individual health insurance coverage and group health plans to provide for cost sharing for oral anticancer drugs on terms no less favorable than the cost sharing provided for anticancer medications administered by a health care provider. HR 749 Lower Drug Cost Through Competition Act Introduced January 30, 2017 by Kurt Schrader (D-OR) To increase competition in the pharmaceutical industry. HR 4666 Premium Relief Act Introduced December 18, 2017 by Ryan Costello (R-PA) To amend the Public Health Service Act to provide for a Patient and State Stability Fund. HR 3976 Access to Marketplace Insurance Act Introduced October 5, 2017 by Kevin Cramer (R-ND) To amend the Patient Protection and Affordable Care Act to allow for certain third-party payments. HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 5806 21st Century Tools for Pain and Addiction Treatment Act Introduced May 15, 2018 by Michael Burgess(R-TX) To require the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain drugs, and for other purposes. HR 5808 Medicaid Pharmaceutical Home Act of 2018 Introduced May 15, 2018 by Gus Bilirakis (R-FL) To amend title XIX of the Social Security Act to require States to operate drug management programs for at-risk beneficiaries, and for other purposes. HR 5810 Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act Introduced May 15, 2018 by Leonard Lance (R-NJ) To amend title XIX of the Social Security Act to provide for an extension of the enhanced FMAP for certain Medicaid health homes for individuals with substance use disorders. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids, and for other purposes. HR 5590 Opioid Addiction Action Plan Act Introduced April 24, 2018 by Adam Kinzinger (R-IL) To require the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment, and for other purposes. HR 4684 Ensuring Access to Quality Sober Living Act of 2018 Introduced December 19, 2017 by Judy Chu (D-CA) Authorizes the Substance Abuse and Mental Health Services Administration to develop, publish, and disseminate best practices for operating recovery housing that promotes a safe environment and sustained recovery from substance use disorders. Recovery housing is increasingly recognized as critical to recovery for many individuals, and includes activities and programs such as mediation, one-on one counseling, group sessions, peer recovery support, medication management, spiritual engagement, and others. HR 5580 STOP Fentanyl Deaths Act of 2018 Introduced April 23, 2018 by Ann Kuster (D-NH) To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl, and for other purposes. HR 5587 Peer Support Communities of Recovery Act Introduced April 23, 2018 by Ben Lujan (D-NM) enhances the Comprehensive Addiction and Recovery Acts Building Communities of Recovery Program and authorizes the Department of Health and Human Services (HHS) to award grants to peer support specialist organizations for the development and expansion of recovery services. Grants shall be awarded to nonprofit organizations that support community-based, peer delivered support, including technical support for the establishment of recovery community organizations, independent, nonprofit groups led by people in recovery and their families. HR 5795 Overdose Prevention and Patient Safety Act Introduced May 15, 2018 by Earl Blumenauer (D-OR) To amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records. HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 Introduced May 15, 2018 by Morgan Griffith (R-VA) Will authorize the Centers for Disease Control and Prevention to carry out certain controlled substances overdose prevention and surveillance activities in order to improve data collection and integration into physician clinical workflow so that timely, complete, and accurate information will get into the hands of providers and dispensers so that they can make the best clinical decisions for their patients. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across all relevant Federal agencies, evaluate the effectiveness of these activities, and make specific recommendations for actions that agencies can take to better coordinates the administration of services for patients with OUD and SUD. HR 5009 Jessies Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patients complete health information when making treatment decisions by requiring the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5197 ALTO Act Introduced March 7, 2018 by Bill Pascrell, Jr. (D-NJ) Directs the Secretary of Health and Human Services (HHS) to carry out a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments. Following the completion of the three-year demonstration, the Secretary of Health and Human Services will submit a report to Congress on the results of the program and issue recommendations for broader implementation. The legislation authorizes $10 million annually in grants for fiscal years 2019-2021.

Client expense: $40,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.892 Opioid Addiction Prevention Act of 2017 H.R.4408 - Opioid Addiction Prevention Act of 2017 H.R.3964 - Opioid Addiction Prevention Act of 2017 H.R. 5219 - Opioid Prescription Verification Act H.R. 4275 - Empowering Pharmacists in the Fight Against Opioids Act H.R. 4275 - Safe Disposal of Unused Medication Act H.R. 2063 - Opioid Preventing Abuse through Continuing Education Act S. 3120 Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018 S. 2789, Substance Abuse Prevention Act of 2018 S. 2838, Using Data to Prevent Opioid Diversion Act of 2018 S. 2460, Every Prescription Conveyed Security Act of 2018 H.R. 5812, Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act (CONNECTIONS) Act H.R. 4275, Empowering Pharmacists in the Fight Against Opioid Abuse Act H.R. 3528, Every Prescription Conveyed Securely Act H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act H.R. 5675, To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries H.R. 5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act H.R. 5687, Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act H.R.6 - SUPPORT for Patients and Communities Act

Client expense: $520,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Health and Human Services Department Reform Health Care Reform (access to dental care, other dental-related issues) Affordable Care Act Repeal and Replace (dental-related programs) Better Care Reconciliation Act of 2017 (H.R. 1628, nature of a substitute) Graham-Cassidy health reform proposal (H.R. 1628, nature of a substitute) Childrens Health Insurance Program (CHIP) reauthorization H.R. 6-Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act H.R. 860-HEALTHIER Act of 2017 H.R. 1606-Dentist and Optometric Care Access Act (DOC Access Act) H.R. 1628-American Health Care Act of 2017 H.R. 1876-Good Samaritan Health Professionals Act of 2017 H.R. 2422-Action for Dental Health Act of 2017 H.R. 2430-FDA Reauthorization Act of 2017 H.R. 3921-HEALTHY KIDS Act H.R. 4684-Ensuring Access to Quality Sober Living Act of 2018 H.R. 5197-Alternatives to Opioids (ALTO) in the Emergency Department Act H.R. 5261-TEACH to Combat Addiction Act of 2018 H.R. 5327-Comprehensive Opioid Recovery Centers Act of 2018 H.R. 5333-Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 H.R. 5687-Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act H.R. 5774-Combatting Opioid Abuse for Care in Hospitals (COACH) Act H.R. 5776-Medicare and Opioid Safe Treatment (MOST) Act H.R. 5806-21st Century Tools for Pain and Addiction Treatments H.R. 5812-Creating Opportunities that Necessitate New and Enhanced Connections that Improve Opioid Navigating Strategies (CONNECTIONS) Act S. 934-FDA Reauthorization Act of 2017 S. 1827-KIDS Act of 2017 S. 2315-Over-the-Counter Drug Safety, Innovation, and Reform Act S. 2456-CARA 2.0 Act of 2018 S. 2680-Opioid Crisis Response Act of 2018 S. 3016-Action for Dental Health Act of 2018

Client expense: $500,000 · Firm income: Not reported

Government targets: Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Treasury, Dept of

Monitored issues related to H.R. 2368 and H.R. 878, The Right to Try Act of 2017 and S. 204 and H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn & Matthew Bellina Right to Try Act of 2017. Issues related to opioids and prescription drug monitoring programs including H.R. 5812, the CONNECTIONS Act.

Client expense: Not reported · Firm income: $63,750

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Matters related to opioids data innovation; accessible database for information and resources that can be used by health care providers, state and local governments, pharmacists, advocates, and law enforcement; E.O. 13784: Establishing the President's Commission on Combating Drug Addiction and the Opioid Crisis, H.R. 5812: Creating Opportunities that Necessitate New and Enhanced Connections (generally), H.R. 6: Substance Use-Disorder Prevention that Promotes Opioid Recovery (generally), H.R. 4284: INFO Act (generally), S. 2680: Opioid Response Act of 2018 (generally).

Client expense: $870,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Executive Office of the President (EOP), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

H.R. 394, Restoring Access to Medication Act of 2017, all provisions S. 85, Restoring Access to Medication Act of 2017, all provisions S. 2456, CARA 2.0 Act of 2018, all provisions S. 2680, Opioid Crisis Response Act of 2018, all provisions S. 2535, Opioid Quota Reform Act, all provisions H.R. 6, Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, all provisions S. 3120, Helping to End Addiction and Lessen Substance Use Disorders Act of 2018, all provisions S. 2891, Fighting the Opioid Epidemic with Sunshine Act of 2018, all provisions S. 3042, Agriculture Improvement Act of 2018, provisions related to the SNAP Program H.R. 5818, Opioid Workforce Act of 2018, all provisions S. 2843, Opioid Workforce Act of 2018, all provisions H.R. 3692, Addiction Treatment Access Improvement Act of 2017, all provisions H.R. 5812, Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies (CONNECTIONS) Act of 2018, all provisions H.R. 5002, Advancing Cutting Edge (ACE) Research Act, all provisions S. 2406, Advancing Cutting Edge (ACE) Research Act, all provisions H.Amdt.627 to H.R. 2, provisions relating to unpasteurized milk or milk products H.R. 449, Synthetic Drug Awareness Act of 2018, all provisions H.R. 4275, Empowering Pharmacists in the Fight Against Opioid Abuse Act, all provisions H.R. 4284, Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018, all provisions H.R. 5041, Safe Disposal of Unused Medication Act, all provisions H.R. 5202, Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018, all provisions H.R. 5102, Substance Use Disorder Workforce Loan Repayment Act of 2018, all provisions S. 2524, Substance Use Disorder Workforce Loan Repayment Act of 2018, all provisions H.R. 5176, Preventing Overdoses While in Emergency Rooms Act of 2018, all provisions H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act, all provisions H.R. 5261, Treatment, Education, and Community Help (TEACH) to Combat Addiction Act of 2018, all provisions H.R. 5272, Reinforcing Evidence-Based Standards Under Law in Treating Substance Abuse (RESULTS) Act of 2018, all provisions H.R. 5327, Comprehensive Opioid Recovery Centers Act of 2018, all provisions H.R. 5329, Poison Center Network Enhancement Act of 2018, all provisions H.R. 5483, Special Registration for Telemedicine Clarification Act of 2018, all provisions H.R. 5580, Surveillance and Testing of Opioids to Prevent (STOP) Fentanyl Deaths Act of 2018, all provisions H.R. 5687, Securing Opioids and Unused Narcotics with Deliberate (SOUND) Disposal and Packaging Act of 2018, all provisions H.R. 5353, Eliminating Opioid Related Infectious Diseases Act of 2018, all provisions H.R. 5796, Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment (REACH OUT) Act of 2018, all provisions H.R. 1375, Prescriber Support Act of 2017, all provisions H.R. 5788, Synthetics Trafficking and Overdose Prevention (STOP) Act of 2018, all provisions H.R. 1057, Synthetics Trafficking and Overdose Prevention (STOP) Act of 2017, all provisions H.R. 6142, Reducing Drug Waste Act of 2018, all provisions H.R. 4909, Student, Teachers, and Officers Preventing (STOP) School Violence Act of 2018, all provisions H.R. 4477, Fix NICS Act of 2017, all provisions S. 2135, Fix NICS Act of 2017, all provisions H.R. 4240, Public Safety and Second Amendment Rights Protection Act of 2017, all provisions S. 2456, CARA 2.0 Act of 2018, all provisions S. 1803, Marijuana Effective Drug Studies Act of 2017, all provisions S. 1112, Maternal Health Accountability Act of 2017, all provisions Affordable Care Act stability 42 CFR Part 2/Substance abuse confidentiality regulations Substance Use Disorder Prescription Drug Monitoring Program (PDMP) Federal prescription limits Health Savings Accounts - Prescription requirement for over-the-counter medications Sunshine Act Regulations - journal reprints and textbooks Drug pricing transparency Augmented Intelligence (AI) Laboratory testing oversight Laboratory Developed Tests Software as a medical device Drug compounding Breastfeeding Patient Matching Mortality Cybersecurity Transparency in regulatory science Regulatory burdens Gun violence research Bump stocks Physician Assisted Suicide AMA/Google Health Care Interoperability and Innovation Challenge Health insurance premiums Title X funding Virtual Diabetes Prevention Program (DPP)/Telehealth/remote patient monitoring Electronic prescribing of controlled substances Pharmacy Benefits Manager HHS Blueprint to lower drug prices

Client expense: $4,300,000 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), SENATE, Veterans Affairs, Dept of (VA), White House Office

Medicare Advantage; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicaid; Opioids; Air Ambulance; Medicare Part D HR 2575 Introduced May 19, 2017 by Raul Ruiz (R-CA) To amend title XVIII of the Social Security Act to establish a system to educate individuals approaching Medicare eligibility, to simplify and modernize the eligibility enrollment process, and for other purposes. HR 3780 Air Ambulance Quality and Accountability Act Introduced September 14, 2017 by Richard Hudson (R-NC) To amend title XVIII of the Social Security Act to provide under the Medicare program for conditions of participation, reporting requirements, and a quality program with respect to air ambulance services. HR 3921 HEALTHY KIDS Act Introduced October 3, 2017 by Michael Burgess (R-TX) To extend funding for the Children's Health Insurance Program, and for other purposes. HR 1148 FAST Act of 2017 Introduced February 16, 2017 by Morgan Griffith (R-VA) To amend title XVIII of the Social Security Act to expand access to telehealth-eligible stroke services under the Medicare program. HR 3192 CHIP Mental Health Parity Act Introduced July 12, 2017 by Joseph Kennedy III (D-MA) To amend title XXI of the Social Security Act to ensure access to mental health services for children under the Children's Health Insurance Program, and for other purposes. HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 5228 SCREEN Act Introduced March 8, 2018 by Frank Pallone, Jr. (D-NJ) H.R. 5228 will provide the Food and Drug Administration (FDA) with stronger recall and seizure authority to disrupt the entry of counterfeit and illicit drugs through International Mail Facilities (IMFs). HR 5752 Stop Illicit Drug Importation Act of 2018 Introduced May 10, 2018 by Marsha Blackburn (R-TN) amends the Federal Food, Drug, and Cosmetic Act (FD&C) to strengthen the Food and Drug Administrations (FDA) seizure powers and enhance its authority to detain, refuse, seize, or destroy illegal products offered for import. The legislation would subject more people to debarment and civil penalties under the Act. HR 5806 21st Century Tools for Pain and Addiction Treatment Act Introduced May 15, 2018 by Michael Burgess(R-TX) To require the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain drugs, and for other purposes. HR 5811 Long-Term Opioid Efficacy Act of 2018 Introduced May 15, 2018 by Jerry McNerney (D-CA) To amend the Federal Food, Drug, and Cosmetic Act with respect to postapproval study requirements for certain controlled substances, and for other purposes. HR 1925 At-Risk Youth Medicaid Protection Act of 2018 Introduced April 5, 2017 by Tony Cardenas (D-CA) To amend title XIX of the Social Security Act to protect at-risk youth against termination of Medicaid eligibility while an inmate of a public institution. HR 3192 CHIP Mental Health Parity Act To amend title XXI of the Social Security Act to ensure access to mental health services for children under the Children's Health Insurance Program, and for other purposes. HR 4005 Medicaid Reentry Act Directs the Secretary of Health and Human Services to convene a group of stakeholders and develop and report to Congress on best practices for addressing issues related to health care faced by those returning from incarceration to their communities. In addition, the legislation allows Medicaid payment for medical services furnished to an incarcerated individual during the 30-day period preceding the individuals release. HR 4998 Health Insurance for Former Foster Youth Act Introduced February 13, 2018 by Karen Bass (D-CA) To amend title XIX of the Social Security Act to ensure health insurance coverage continuity for former foster youth. HR 5477 Rural DOCS Act Introduced April 11, 2018 by Tom OHalleran (D-AZ) To amend title XIX of the Social Security Act to provide for a demonstration project to increase substance use provider capacity under the Medicaid program. HR 5583 Introduced April 23, 2018 by Yvette Clark (D-NY) requires states to include behavioral health indicators in their annual reports on the quality of care under Medicaid beginning in 2024. The Affordable Care Act (Section 1139B) requires the Secretary of HHS to identify and publish a core set of health care quality measures for adult Medicaid enrollees. The law requires that measures designated for the core set be currently in use. To aid in the assessment of the quality of care for Medicaid-eligible adults, the law calls for HHS to: develop a standardized reporting format for the core set of measures; establish an adult quality measurement program; issue an annual report by the Secretary on the reporting of adult Medicaid quality information; and publish updates to the initial core set of adult health quality measures that reflect new or enhanced quality measures. In the Center for Medicare and Medicaid Services 2018 Core Set of Adult Health Care Quality Measures for Medicaid, there are 11 behavioral health measures included. Under current law, states already voluntarily report many of these measures annually. HR 5789 Introduced May 15, 2018 by Bill Foster (D-IL) To amend title XIX of the Social Security Act to provide for Medicaid coverage protections for pregnant and post-partum women while receiving inpatient treatment for a substance use disorder, and for other purposes. HR 5797 Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act Introduced May 15, 2018 by Mimi Walters (D-CA) Allows state Medicaid programs to remove the Institutions for Mental Diseases (IMD) exclusion for Medicaid beneficiaries aged 21 to 64 with an opioid use disorder for fiscal years 2019 to 2023. By removing the exclusion, Medicaid would pay for up to 30 total days of care in an IMD during a 12-month period for eligible individuals. Opioid use disorder as defined in H.R. 5797 includes, but is not limited to: heroin, fentanyl, oxycodone, tramadol and oxycodone. In addition, the legislation requires states to include in their State plan amendment information on 1) How the State will improve access to outpatient care during the State plan amendment period. 2) The process for transitioning individuals to appropriate. HR 5799 Medicaid Drug Review, Utilization, Good Governance Improvement Act Introduced May 15, 2018 by Marsha Blackburn (R-TN) To amend title XIX of the Social Security Act to require as a condition of receipt of full Federal medical assistance percentage under Medicaid that State Medicaid plans have in place certain drug utilization review activities. HR 5800 Introduced May 15, 2018 by Fred Upton (R-MI) directs the Medicaid and CHIP Payment and Access Commission (MACPAC) to conduct a study on institutions for mental disease that receive Medicaid reimbursement. The study shall report on the requirements and standards that state Medicaid programs have in place for institutions for mental diseases (IMD). MACPAC shall summarize the findings and make recommendations on best practices and data collection no later than January 2020. HR 5801 Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act Introduced May 15, 2018 by Morgan Griffith (R-VA) To amend title XIX of the Social Security Act to provide for requirements under the Medicaid program relating to the use of qualified prescription drug monitoring programs and prescribing certain controlled substances. HR 5808 Medicaid Pharmaceutical Home Act of 2018 Introduced May 15, 2018 by Gus Bilirakis (R-FL) To amend title XIX of the Social Security Act to require States to operate drug management programs for at-risk beneficiaries, and for other purposes. HR 5810 Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act Introduced May 15, 2018 by Leonard Lance (R-NJ) To amend title XIX of the Social Security Act to provide for an extension of the enhanced FMAP for certain Medicaid health homes for individuals with substance use disorders. HR 5715 Strengthening Partnerships to Avoid Opioid Abuse Act Introduced May 9, 2018 by James Renacci (R-OH) To amend title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5716 COMPASS Act Introduced May 9, 2018 by Peter Roskam (R-IL) To amend title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids, and for other purposes. HR 5590 Opioid Addiction Action Plan Act Introduced April 24, 2018 by Adam Kinzinger (R-IL) To require the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment, and for other purposes. HR 5603 Access to Telehealth Services for Substance Use Disorders Act Introduced April 24, 2018 by Doris Matsui (D-CA) To amend title XVIII of the Social Security Act to provide the Secretary of Health and Human Services authority to waive certain Medicare telehealth requirements in the case of certain treatment of an opioid use disorder or co-occurring mental health disorder. HR 5605 Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act Introduced April 24, 2018 by Raul Ruiz (D-CA) establishes a four-year demonstration program to increase access to treatment for opioid use disorder. The demonstration would provide incentive payments and funding for care management services based on criteria such as patient engagement, use of evidence-based treatments, and treatment length and intensity. Under the bill, the Secretary of Health and Human Services would be directed to encourage other payers to coordinate payments for opioid use disorder treatments and to evaluate the extent to which the demonstration reduces hospitalizations, increases the use of medication-assisted treatments, and improves the health outcomes of individuals with opioid use disorders during and after the demonstration. This bill also incorporates H.R. 3528, Every Prescription Conveyed Securely Act, which would require e-prescribing, with exceptions, for coverage of prescribed controlled substances under the Medicare Part D program. HR 5798 Opioid Screening and Chronic Pain Management Alternatives for Seniors Act Introduced May 15, 2018 by Larry Bucshon (R-IN) To amend title XVIII of the Social Security Act to require a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventive physical examination. HR 4684 Ensuring Access to Quality Sober Living Act of 2018 Introduced December 19, 2017 by Judy Chu (D-CA) Authorizes the Substance Abuse and Mental Health Services Administration to develop, publish, and disseminate best practices for operating recovery housing that promotes a safe environment and sustained recovery from substance use disorders. Recovery housing is increasingly recognized as critical to recovery for many individuals, and includes activities and programs such as mediation, one-on-one counseling, group sessions, peer recovery support, medication management, spiritual engagement, and others. HR 5329 Poison Center Network Enhancement Act of 2018 Introduced March 19, 2018 by Susan Brooks (D-IN) reauthorizes the national network of Poison Control Centers. Specifically, the legislation reauthorizes the toll-free number, national media campaign, and grant program under the Public Health Service Act. The legislation increases the share of poison control center funding that could be provided through federal grants, and authorizes $30 million per year over the 2019-2023 period. HR 5580 STOP Fentanyl Deaths Act of 2018 Introduced April 23, 2018 by Ann Kuster (D-NH) To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl, and for other purposes. HR 5587 Peer Support Communities of Recovery Act Introduced April 23, 2018 by Ben Lujan (D-NM) enhances the Comprehensive Addiction and Recovery Acts Building Communities of Recovery Program and authorizes the Department of Health and Human Services (HHS) to award grants to peer support specialist organizations for the development and expansion of recovery services. Grants shall be awarded to nonprofit organizations that support community-based, peer delivered support, including technical support for the establishment of recovery community organizations, independent, nonprofit groups led by people in recovery and their families. HR 5804 Post-Surgical Injections as an Opioid Alternative Act Introduced May 15, 2018 by John Shimkus (R-IL) To amend title XVIII of the Social Security Act to provide for modifications in payment for certain outpatient surgical services. HR 5809 Postoperative Opioid Prevention Act of 2018 Introduced May 15, 2018 by Scott Peters (D-CA) To amend title XVIII of the Social Security Act to encourage the use of non-opioid analgesics for the management of post-surgical pain under the Medicare program, and for other purposes. HR 5795 Overdose Prevention and Patient Safety Act Introduced May 15, 2018 by Earl Blumenauer (D-OR) To amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records. HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 Introduced May 15, 2018 by Morgan Griffith (R-VA) Will authorize the Centers for Disease Control and Prevention to carry out certain controlled substances overdose prevention and surveillance activities in order to improve data collection and integration into physician clinical workflow so that timely, complete, and accurate information will get into the hands of providers and dispensers so that they can make the best clinical decisions for their patients. HR 449 Synthetic Drug Awareness Act of 2018 Introduced January 11, 2017 by Hakeem Jeffries (D-NY) requires the U.S. Surgeon General to report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12 to 18 years old in order to further educate parents and the medical community on the health effects of synthetics. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across all relevant Federal agencies, evaluate the effectiveness of these activities, and make specific recommendations for actions that agencies can take to better coordinates the administration of services for patients with OUD and SUD. HR 5002 Advancing Cutting Edge Research Act Introduced February 18, 2018 by Debbie Dingell (D-MI) Provides the National Institutes of Health new authorities to conduct research on innovative non-addictive pain medications. HR 5102 Substance Use Disorder Workforce Loan Repayment Act of 2018 Introduced February 27, 2018 by Katherine Clark (D-MA) creates a loan repayment program for substance use disorder (SUD) treatment providers. Specifically, the legislation offers student loan repayment of up to $250,000 for participants who agree to work as a SUD treatment professional in areas most in need of their services. The program is available to a wide range of direct care providers, including physicians, registered nurses, social workers, and other behavioral health professionals. The bill authorizes $25 million a year for the 2019-2028 period. HR 5009 Jessies Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patients complete health information when making treatment decisions by requiring the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5176 Preventing Overdoses While in Emergency Rooms Act of 2018 Introduced March 6, 2018 by David McKinley (R-VA) requires the Secretary of the Department of Health and Human Services (HHS) to develop protocols and a grant program for health care providers to address the needs of people who survive a drug overdose. Specifically, the protocols would address the provision of naloxone upon discharge, connection with peer-support specialists, and the referral to treatment and other services that best fit the patients needs. The bill authorizes $50 million in FY2019 for the grant program. HR 5197 ALTO Act Introduced March 7, 2018 by Bill Pascrell, Jr. (D-NJ) Directs the Secretary of Health and Human Services (HHS) to carry out a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments. Following the completion of the three-year demonstration, the Secretary of Health and Human Services will submit a report to Congress on the results of the program and issue recommendations for broader implementation. The legislation authorizes $10 million annually in grants for fiscal years 2019-2021. HR 5261 Treatment, Education, and Community Help to Combat Addiction Act of 2018 Introduced March 13, 2018 by Bill Johnson (R-OH) directs the Secretary of Health and Human Services (HHS) to designate regional Centers of Excellence to enhance and improve how health professional are educated in substance abuse disorder prevention, treatment, and recovery through development, evaluation, and distribution of evidence-based curricula for health profession schools. The bill authorizes $4 million annually for grants to those programs over the 2019-2023 period. HR 5272 To provide additional guidance to grantees seeking funding to treat or prevent mental health or substance use disorders. Introduced March 14, 2018 by Steve Stivers (R-OH) Requires the newly established National Mental Health and Substance Use Policy Laboratory to issue guidance to applicants for Substance Abuse and Mental Health Services Administration (SAMHSA) grants that support evidence-based practices. The guidance shall include how best to articulate the rationale for a given program or activity; encourage the funding of evidence-based interventions; and encourage the replication of promising or effective practices. HR 5327 Comprehensive Opioid Recovery Centers Act of 2018 Introduced March 19, 2018 by Brett Guthrie (R-KY) directs the Secretary of Health and Human Services (HHS) to award grants to at least 10 providers that offer treatment services for people with opioid use disorder. These Comprehensive Opioid Recovery Centers would serve as models for comprehensive treatment and recovery and would utilize the full range of Food and Drug Administration approved medications and evidence-based treatments, have strong linkages with the community, generate meaningful outcomes data, and dramatically improve the opportunities for individuals to establish and maintain long-term recovery. Either directly or through coordination with other entities, Centers must provide services including withdrawal management, counseling, recovery housing, community-based and peer recovery support services, job training and placement assistance, pharmacy and toxicology services, and a secure and confidential electronic health information system. HR 5353 Eliminating Opioid Related Infectious Diseases Act of 2018 Introduced March 20, 2018 by Leonard Lance (R-NJ) Authorizes the Centers for Disease Control (CDC) to undertake an injection drug-use associated infection elimination initiative and work with states to improve education, surveillance, and treatment of infections associated with injection drug use. HR 3331 To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Introduced July 20, 2017 by Lynn Jenkins (R-KY) authorizes the Center for Medicare and Medicaid Innovation to test a program offering incentive payments to behavioral health providers that adopt and use certified electronic health record technology. The U.S. government introduced the Meaningful Use program as part of the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act, to encourage health care providers to show "meaningful use" of a certified Electronic Health Record (EHR). In doing so, eligible providers who do so receive incentive payments, but behavioral health providers were not included in the definition of eligible providers. Individual physicians and other eligible health care professionals can each receive up to $44,000 through the Medicare Meaningful Use program or up to $63,750 through the Medicaid Meaningful Use program, depending upon when they begin attesting to the program's requirements. HR 5685 Medicare Opioid Safety Education Act of 2018 Introduced May 7, 2018 by John Faso (R-NY) directs the Centers for Medicare and Medicaid Services (CMS) to compile education resources for beneficiaries regarding opioid use, pain management, and alternative pain management treatments, and include these resources in the Medicare and You handbook. HR 3528 Every Prescription Conveyed Securely Act Introduced July 28, 2017 by Katherine Clark (D-MA) To amend title XVIII of the Social Security Act to require e-prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances. HR 4841 Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Introduced January 18, 2018 by David Schweikert (R-AZ) To amend title XVIII of the Social Security Act to provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. HR 5675 To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries Introduced May 3, 2018 by Gus Bilirakis (R-FL) This bill requires Medicare prescription drug plan (PDP) sponsors, for plan years beginning on or after January 1, 2021, to establish drug management programs for at-risk beneficiaries. Current law authorizes, but does not require, PDP sponsors to establish such programs. HR 5686 Medicare Clear Health Options in Care for Enrollees Act of 2018 Introduced May 7, 2018 by Erik Paulsen (R-MN) To amend title XVIII of the Social Security Act to require prescription drug plans under Medicare part D to include information on the adverse effects of opioid overutilization and of coverage of nonpharmacological therapies and nonopioid medications or devices used to treat pain. HR 5582 Abuse Deterrent Access Act of 2018 Introduced April 23, 2018 by Buddy Carter (R-GA) Requires the Secretary of the Department of Health and Human Services (HHS) to report to Congress on existing barriers to access to abuse-deterrent opioid formulations by Medicare Part C and D beneficiaries. HR 5684 Protecting Seniors From Opioid Abuse Act Introduced May 7, 2018 by Mike Kelly (R-PA) To amend title XVIII of the Social Security Act to expand eligibility for medication therapy management programs established under part D of the Medicare program to include certain individuals who are at risk for prescription drug abuse.

Client expense: $1,880,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, Vice President of the U.S., White House Office

Affordable Care Act (ACA); ACA Regulations; Opioid Epidemic; ACA Stabilization;; Health Savings Accounts (HSAs); Postal Reform; Cost Sharing Reductions (CSRs); Health Care Reform Reinsurance; Market Stability; State Flexibility; Pay-fors; Affordability; 1332 Templates; Healthcare Innovation; Risk Adjustment; Department Reform; Drug Pricing; Association Health Plans; Short Term Limited Duration; Air Ambulances; 42 CFR Part 2; Individual Market Reform; CREATES Act; Marketplace Certainty Act; Individual Market Rules; Small Group Market; Rural health; Health Information Technology HR 246 Introduced January 4, 2017 by Kristi Noem (R-SD) This bill repeals a provision of the Patient Protection and Affordable Care Act that imposes an annual fee on a health insurance provider based on its net premium income. HR 314 Introduced January 5, 2017 by Marsha Blackburn (R-TN) To repeal title I of the Patient Protection and Affordable Care Act and to amend the Public Health Service Act to provide for cooperative governing of individual health insurance coverage offered in interstate commerce. HR 1703 Introduced March 23, 2017 by Morgan Griffith (R-VA) To amend the Federal Food, Drug, and Cosmetic Act with respect to determining the intended use of drugs and devices. HR 2051 FAST Generics Act Introduced April 6, 2017 by David McKinley (R-WV) To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2430 Introduced May 10, 2017 by Greg Walden (R-OR) To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. HR 2026 Pharmaceutical Information Exchange Act Introduced April 6, 2017 by Brett Guthrie (R-VA) To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers. HR 1101 Small Business Health Fairness Act of 2017 Introduced February 16, 2017 by Sam Johnson (R-TX) To amend title I of the Employee Retirement Income Security Act of 1974 to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees. HR 2400 Introduced May 8, 2017 by Darrell Issa (R-CA) To amend title 5, United States Code, to allow individuals who are not Federal employees to enroll in the Federal Employees Health Benefits Program, and for other purposes. HR 180 To amend title XIX of the Social Security Act to eliminate the requirement for 3 months of retroactive coverage under the Medicaid program Introduced January 3, 2017 by Markwayne Mullin (R-OK) Under current law, a state Medicaid program must provide coverage for up to three months prior to an individual's application for benefits if the individual would have been eligible for benefits during that period. The bill eliminates this requirement and instead specifies that coverage begins in the month during which the individual applies for benefits. HR 708 Introduced January 27, 2017 by Larry Bucshon (R-IN) This bill amends the Public Health Service Act to increase the permissible variation based on age for health insurance premiums for coverage offered in the individual or small group market from a factor of three to a factor of five, or to a factor determined by the state. This applies to plan years starting on or after January 1, 2018. HR 829 Prioritizing the Most Vulnerable Over Lottery Winners Act of 2017 Introduced February 2, 2017 by Fed Upton (R-MI) This bill amends title XIX (Medicaid) to specify how a state must treat qualified lottery winnings and lump sum income for purposes of determining an individual's income-based eligibility for a state Medicaid program. Specifically, a state shall include such winnings or income as income received: (1) in the month in which it was received, if the amount is less than $80,000; (2) over a period of two months, if the amount is at least $80,000 but less than $90,000; (3) over a period of three months, if the amount is at least $90,000 but less than $100,000; and (4) over an additional one-month period for each increment of $10,000 received, not to exceed 120 months. HR 1082 Medicaid Home Improvement Act Introduced February 15, 2017 by Brett Guthrie (R-KY) To amend title XIX of the Social Security Act to eliminate the State option to reduce the home equity exemption amount for purposes of eligibility for long-term care assistance under Medicaid, and for other purposes. HR 1150 Tanning Tax Repeal of 2017 Introduced February 16, 2017 by George Holding (R-NC) To amend the Internal Revenue Code of 1986 to repeal the excise tax on indoor tanning services. HR 3922 Championing Healthy Kids Act Introduced October 3, 2017 by Greg Walden (R-OR) Extends funding for the Childrens Health Insurance Program (CHIP) through Fiscal Year (FY) 2022, Federally Qualified Health Centers (FQHCs) through FY2019, and revises CHIP and Medicaid. HR 2051 Fast Generics Act of 2017 Introduced April 6, 2017 by David McKinley (R-VA) To amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible product developers have competitive access to approved drugs and licensed biological products, so as to enable eligible product developers to develop and test new products, and for other purposes. HR 2889 Closing Loopholes for Orphan Drugs Act Introduced June 13, 2017 by Peter Welch (D-VT) To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. HR 2212 CREATES Act Introduced April 27, 2017 by Tom Marino (R-PA) To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1409 Cancer Drug Parity Act of 2017 Introduced March 7, 2017 by Leonard Lance (R-NJ) To amend the Public Health Service Act to require group and individual health insurance coverage and group health plans to provide for cost sharing for oral anticancer drugs on terms no less favorable than the cost sharing provided for anticancer medications administered by a health care provider. HR 749 Lower Drug Cost Through Competition Act Introduced January 30, 2017 by Kurt Schrader (D-OR) To increase competition in the pharmaceutical industry. HR 4666 Premium Relief Act Introduced December 18, 2017 by Ryan Costello (R-PA) To amend the Public Health Service Act to provide for a Patient and State Stability Fund. HR 3976 Access to Marketplace Insurance Act Introduced October 5, 2017 by Kevin Cramer (R-ND) To amend the Patient Protection and Affordable Care Act to allow for certain third-party payments. HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 5228 SCREEN Act Introduced March 8, 2018 by Frank Pallone, Jr. (D-NJ) H.R. 5228 will provide the Food and Drug Administration (FDA) with stronger recall and seizure authority to disrupt the entry of counterfeit and illicit drugs through International Mail Facilities (IMFs). HR 5752 Stop Illicit Drug Importation Act of 2018 Introduced May 10, 2018 by Marsha Blackburn (R-TN) amends the Federal Food, Drug, and Cosmetic Act (FD&C) to strengthen the Food and Drug Administrations (FDA) seizure powers and enhance its authority to detain, refuse, seize, or destroy illegal products offered for import. The legislation would subject more people to debarment and civil penalties under the Act. HR 5806 21st Century Tools for Pain and Addiction Treatment Act Introduced May 15, 2018 by Michael Burgess(R-TX) To require the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain drugs, and for other purposes. HR 5811 Long-Term Opioid Efficacy Act of 2018 Introduced May 15, 2018 by Jerry McNerney (D-CA) To amend the Federal Food, Drug, and Cosmetic Act with respect to postapproval study requirements for certain controlled substances, and for other purposes. HR 1925 At-Risk Youth Medicaid Protection Act of 2018 Introduced April 5, 2017 by Tony Cardenas (D-CA) To amend title XIX of the Social Security Act to protect at-risk youth against termination of Medicaid eligibility while an inmate of a public institution. HR 3192 CHIP Mental Health Parity Act To amend title XXI of the Social Security Act to ensure access to mental health services for children under the Children's Health Insurance Program, and for other purposes. HR 4005 Medicaid Reentry Act Directs the Secretary of Health and Human Services to convene a group of stakeholders and develop and report to Congress on best practices for addressing issues related to health care faced by those returning from incarceration to their communities. In addition, the legislation allows Medicaid payment for medical services furnished to an incarcerated individual during the 30-day period preceding the individuals release. HR 4998 Health Insurance for Former Foster Youth Act Introduced February 13, 2018 by Karen Bass (D-CA) To amend title XIX of the Social Security Act to ensure health insurance coverage continuity for former foster youth. HR 5477 Rural DOCS Act Introduced April 11, 2018 by Tom OHalleran (D-AZ) To amend title XIX of the Social Security Act to provide for a demonstration project to increase substance use provider capacity under the Medicaid program. HR 5583 Introduced April 23, 2018 by Yvette Clark (D-NY) requires states to include behavioral health indicators in their annual reports on the quality of care under Medicaid beginning in 2024. The Affordable Care Act (Section 1139B) requires the Secretary of HHS to identify and publish a core set of health care quality measures for adult Medicaid enrollees. The law requires that measures designated for the core set be currently in use. To aid in the assessment of the quality of care for Medicaid-eligible adults, the law calls for HHS to: develop a standardized reporting format for the core set of measures; establish an adult quality measurement program; issue an annual report by the Secretary on the reporting of adult Medicaid quality information; and publish updates to the initial core set of adult health quality measures that reflect new or enhanced quality measures. In the Center for Medicare and Medicaid Services 2018 Core Set of Adult Health Care Quality Measures for Medicaid, there are 11 behavioral health measures included. Under current law, states already voluntarily report many of these measures annually. HR 5789 Introduced May 15, 2018 by Bill Foster (D-IL) To amend title XIX of the Social Security Act to provide for Medicaid coverage protections for pregnant and post-partum women while receiving inpatient treatment for a substance use disorder, and for other purposes. HR 5797 Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act Introduced May 15, 2018 by Mimi Walters (D-CA) Allows state Medicaid programs to remove the Institutions for Mental Diseases (IMD) exclusion for Medicaid beneficiaries aged 21 to 64 with an opioid use disorder for fiscal years 2019 to 2023. By removing the exclusion, Medicaid would pay for up to 30 total days of care in an IMD during a 12-month period for eligible individuals. Opioid use disorder as defined in H.R. 5797 includes, but is not limited to: heroin, fentanyl, oxycodone, tramadol and oxycodone. In addition, the legislation requires states to include in their State plan amendment information on 1) How the State will improve access to outpatient care during the State plan amendment period. 2) The process for transitioning individuals to appropriate. HR 5799 Medicaid Drug Review, Utilization, Good Governance Improvement Act Introduced May 15, 2018 by Marsha Blackburn (R-TN) To amend title XIX of the Social Security Act to require as a condition of receipt of full Federal medical assistance percentage under Medicaid that State Medicaid plans have in place certain drug utilization review activities. HR 5800 Introduced May 15, 2018 by Fred Upton (R-MI) directs the Medicaid and CHIP Payment and Access Commission (MACPAC) to conduct a study on institutions for mental disease that receive Medicaid reimbursement. The study shall report on the requirements and standards that state Medicaid programs have in place for institutions for mental diseases (IMD). MACPAC shall summarize the findings and make recommendations on best practices and data collection no later than January 2020. HR 5801 Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients Act Introduced May 15, 2018 by Morgan Griffith (R-VA) To amend title XIX of the Social Security Act to provide for requirements under the Medicaid program relating to the use of qualified prescription drug monitoring programs and prescribing certain controlled substances. HR 5808 Medicaid Pharmaceutical Home Act of 2018 Introduced May 15, 2018 by Gus Bilirakis (R-FL) To amend title XIX of the Social Security Act to require States to operate drug management programs for at-risk beneficiaries, and for other purposes. HR 5810 Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act Introduced May 15, 2018 by Leonard Lance (R-NJ) To amend title XIX of the Social Security Act to provide for an extension of the enhanced FMAP for certain Medicaid health homes for individuals with substance use disorders. HR 5715 Strengthening Partnerships to Avoid Opioid Abuse Act Introduced May 9, 2018 by James Renacci (R-OH) To amend title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5716 COMPASS Act Introduced May 9, 2018 by Peter Roskam (R-IL) To amend title XVIII of the Social Security Act to provide for certain program integrity transparency measures under Medicare parts C and D. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids, and for other purposes. HR 5590 Opioid Addiction Action Plan Act Introduced April 24, 2018 by Adam Kinzinger (R-IL) To require the Secretary of Health and Human Services to provide for an action plan on recommendations for changes under Medicare and Medicaid to prevent opioids addictions and enhance access to medication-assisted treatment, and for other purposes. HR 5603 Access to Telehealth Services for Substance Use Disorders Act Introduced April 24, 2018 by Doris Matsui (D-CA) To amend title XVIII of the Social Security Act to provide the Secretary of Health and Human Services authority to waive certain Medicare telehealth requirements in the case of certain treatment of an opioid use disorder or co-occurring mental health disorder. HR 5605 Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act Introduced April 24, 2018 by Raul Ruiz (D-CA) establishes a four-year demonstration program to increase access to treatment for opioid use disorder. The demonstration would provide incentive payments and funding for care management services based on criteria such as patient engagement, use of evidence-based treatments, and treatment length and intensity. Under the bill, the Secretary of Health and Human Services would be directed to encourage other payers to coordinate payments for opioid use disorder treatments and to evaluate the extent to which the demonstration reduces hospitalizations, increases the use of medication-assisted treatments, and improves the health outcomes of individuals with opioid use disorders during and after the demonstration. This bill also incorporates H.R. 3528, Every Prescription Conveyed Securely Act, which would require e-prescribing, with exceptions, for coverage of prescribed controlled substances under the Medicare Part D program. HR 5798 Opioid Screening and Chronic Pain Management Alternatives for Seniors Act Introduced May 15, 2018 by Larry Bucshon (R-IN) To amend title XVIII of the Social Security Act to require a review of current opioid prescriptions for chronic pain and screening for opioid use disorder to be included in the Welcome to Medicare initial preventive physical examination. HR 4684 Ensuring Access to Quality Sober Living Act of 2018 Introduced December 19, 2017 by Judy Chu (D-CA) Authorizes the Substance Abuse and Mental Health Services Administration to develop, publish, and disseminate best practices for operating recovery housing that promotes a safe environment and sustained recovery from substance use disorders. Recovery housing is increasingly recognized as critical to recovery for many individuals, and includes activities and programs such as mediation, one-on-one counseling, group sessions, peer recovery support, medication management, spiritual engagement, and others. HR 5329 Poison Center Network Enhancement Act of 2018 Introduced March 19, 2018 by Susan Brooks (D-IN) reauthorizes the national network of Poison Control Centers. Specifically, the legislation reauthorizes the toll-free number, national media campaign, and grant program under the Public Health Service Act. The legislation increases the share of poison control center funding that could be provided through federal grants, and authorizes $30 million per year over the 2019-2023 period. HR 5580 STOP Fentanyl Deaths Act of 2018 Introduced April 23, 2018 by Ann Kuster (D-NH) To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl, and for other purposes. HR 5587 Peer Support Communities of Recovery Act Introduced April 23, 2018 by Ben Lujan (D-NM) enhances the Comprehensive Addiction and Recovery Acts Building Communities of Recovery Program and authorizes the Department of Health and Human Services (HHS) to award grants to peer support specialist organizations for the development and expansion of recovery services. Grants shall be awarded to nonprofit organizations that support community-based, peer delivered support, including technical support for the establishment of recovery community organizations, independent, nonprofit groups led by people in recovery and their families. HR 5804 Post-Surgical Injections as an Opioid Alternative Act Introduced May 15, 2018 by John Shimkus (R-IL) To amend title XVIII of the Social Security Act to provide for modifications in payment for certain outpatient surgical services. HR 5809 Postoperative Opioid Prevention Act of 2018 Introduced May 15, 2018 by Scott Peters (D-CA) To amend title XVIII of the Social Security Act to encourage the use of non-opioid analgesics for the management of post-surgical pain under the Medicare program, and for other purposes. HR 5795 Overdose Prevention and Patient Safety Act Introduced May 15, 2018 by Earl Blumenauer (D-OR) To amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records. HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 Introduced May 15, 2018 by Morgan Griffith (R-VA) Will authorize the Centers for Disease Control and Prevention to carry out certain controlled substances overdose prevention and surveillance activities in order to improve data collection and integration into physician clinical workflow so that timely, complete, and accurate information will get into the hands of providers and dispensers so that they can make the best clinical decisions for their patients. HR 449 Synthetic Drug Awareness Act of 2018 Introduced January 11, 2017 by Hakeem Jeffries (D-NY) requires the U.S. Surgeon General to report to Congress on the public health effects of the rise in synthetic drug use among youth aged 12 to 18 years old in order to further educate parents and the medical community on the health effects of synthetics. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across all relevant Federal agencies, evaluate the effectiveness of these activities, and make specific recommendations for actions that agencies can take to better coordinates the administration of services for patients with OUD and SUD. HR 5002 Advancing Cutting Edge Research Act Introduced February 18, 2018 by Debbie Dingell (D-MI) Provides the National Institutes of Health new authorities to conduct research on innovative non-addictive pain medications. HR 5102 Substance Use Disorder Workforce Loan Repayment Act of 2018 Introduced February 27, 2018 by Katherine Clark (D-MA) creates a loan repayment program for substance use disorder (SUD) treatment providers. Specifically, the legislation offers student loan repayment of up to $250,000 for participants who agree to work as a SUD treatment professional in areas most in need of their services. The program is available to a wide range of direct care providers, including physicians, registered nurses, social workers, and other behavioral health professionals. The bill authorizes $25 million a year for the 2019-2028 period. HR 5009 Jessies Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patients complete health information when making treatment decisions by requiring the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5176 Preventing Overdoses While in Emergency Rooms Act of 2018 Introduced March 6, 2018 by David McKinley (R-VA) requires the Secretary of the Department of Health and Human Services (HHS) to develop protocols and a grant program for health care providers to address the needs of people who survive a drug overdose. Specifically, the protocols would address the provision of naloxone upon discharge, connection with peer-support specialists, and the referral to treatment and other services that best fit the patients needs. The bill authorizes $50 million in FY2019 for the grant program. HR 5197 ALTO Act Introduced March 7, 2018 by Bill Pascrell, Jr. (D-NJ) Directs the Secretary of Health and Human Services (HHS) to carry out a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments. Following the completion of the three-year demonstration, the Secretary of Health and Human Services will submit a report to Congress on the results of the program and issue recommendations for broader implementation. The legislation authorizes $10 million annually in grants for fiscal years 2019-2021.

Client expense: $1,880,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, Vice President of the U.S., White House Office

CMS Manual - Reimbursement coding HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 HR 2368 Right to Try Act HR 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 S 204 Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 HR 878 Right to Try Act of 2017

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2387, Concentrating on High-value Alzheimer's Needs to Get to an End (CHANGE) Act of 2018, Alzheimer services Reauthorization Older American's Act, generally Addiction and Behavioral Health; and Opioid issues, as follows: H.R.5812, Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 H.R.4635, To direct the Secretary of Veterans Affairs to increase the number of peer-to-peer counselors providing counseling for women veterans, and for other purposes. H.R.6082, Overdose Prevention and Patient Safety Act Monitor the following: Institution of Mental Diseases (IMD) exclusions Hepititis A outbreak related issues Affordable Care Act repeal and replace legislation

Client expense: Not reported · Firm income: $120,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) -PDP/MA-PD payments on clean claims from pharmacies S. 428, ACE Kids Act (Grassley) - coordinated care for children with complex medical conditions S. 1016, CONNECT For Health Act (Schatz) - telehealth S. 1169, Medicaid CARE Act (Durbin-Portman) - changes to Medicaid IMD exclusion S. 1688, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 1804, Medicare for All Act (Sanders) - single payer health system S. 1827, Keep Kids Insurance Dependable and Secure Act (Hatch-Wyden) - federal CHIP funding S. 1890, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Cardin) - Medigap coverage for beneficiaries with end-stage renal disease S. 2027, Medicaid Third Party Liability Act (Portman) - Medicaid third party liability S. 2227, EMPOWER Care Act (Portman-Cantwell) - Medicaid Money Follows the Person Demonstration S. 2707, Informing Seniors About Opioids Act (Nelson) - opioid issues S. 2901, Expanding Telehealth Response to Ensure Addiction Treatment Act (Thune) - opioid issues S. 2904, Medicaid Substance Use Disorder Treatment Via Telehealth Act (Carper) - opioid issues S. 2908, Electronic Prior Authorization in Medicare Part D Act (Roberts) - opioid issues Draft Medicare Long-Term Care Services and Supports Act (Pallone) - Long-Term Services and Supports Program H.R. 195, Extension of Continuing Appropriations Act - CHIP funding extension for 2018-2023 and related provisions H.R. 849, Protecting Seniors Access to Medicare Act (Roe) - Independent Payment Advisory Board H.R. 908, Medicare Advantage Quality Payment Relief Act (Kelly) - MA payment cap H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - PDP/MA-PD payments on clean claims from pharmacies H.R. 1148, FAST Act (Griffith) - access to telehealth-eligible stroke services under Medicare H.R. 1316, Prescription Drug Price Transparency Act (Collins) - PBM standards for MA and PDP plans H.R. 1892, Bipartisan Budget Act (Larson) - permanent authorization of Medicare Advantage Special Needs Plans; MA chronic care reforms: telehealth, supplemental benefits, value-based insurance design, star ratings; changes to Medicare Part D coverage gap and related discounts; CHIP funding extension for 2024-2027; funding for Puerto Ricos Medicaid program H.R. 1995, V-BID for Better Care Act (Black) - value-based insurance design in Medicare Advantage H.R. 2556, CONNECT For Health Act (Black) - telehealth H.R. 2644, Chronic Kidney Disease Improvement in Research and Treatment and Medigap Access (Marino) - Medigap coverage for beneficiaries with end-stage renal disease H.R. 2687, Medicaid CARE Act (Foster-Fitzpatrick) - changes to Medicaid IMD exclusion H.R. 3044, Supplemental Benefits for Chronically Ill Medicare Advantage Enrollees (Meehan) H.R. 3168, Special Needs Plans (Tiberi-Levin) - SNP reauthorization H.R. 3263, Medicare Independence at Home Model of Care (Burgess) - demonstration program H.R. 3325, ACE Kids Act (Barton) - coordinated care for children with complex medical conditions H.R. 3360, Telehealth Enhancement Act (Harper) - telehealth in Medicare H.R. 3727, Increasing Telehealth Access in Medicare Act (Black) - telehealth in MA plans H.R. 3921, HEALTHY KIDS Act (Burgess) - CHIP funding H.R. 4952, Improving Seniors Access to Quality Benefits Act (Kelly) - MA benchmark cap study H.R. 5603, Access to Telehealth Services for Substance Use Disorders Act (Matsui) - opioid issues H.R. 5605, Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act (Ruiz) - opioid issues H.R. 5675, drug management programs for at-risk Medicare beneficiaries (Bilirakis) - opioid issues H.R. 5676, SENIOR Communities Protection Act (MacArthur) - preventing fraudulent opioid prescriptions H.R. 5684, Protecting Seniors from Opioid Abuse Act (Kelly) - opioid issues H.R. 5685, Medicare Opioid Safety Education Act (Faso) - opioid issues H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act (Paulsen) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - communication between Medicare plan sponsors and CMS H.R. 5773, Preventing Addiction for Susceptible Seniors Act (Roskam) - opioid issues H.R. 5797, IMD CARE Act (Walters) - Medicaid IMD exclusion H.R. 5798, Opioid Screening and Chronic Pain Management Alternatives for Seniors Act (Bucshon) - opioid issues H.R. 5799, Medicaid Drug Review, Utilization, Good Governance Improvement Act (Blackburn) - opioid issues H.R. 5800, Medicaid IMD ADDITIONAL INFO Act (Upton) - opioid issues H.R. 5804, Post-Surgical Injections as an Opioid Alternative Act (Shimkus) - opioid issues H.R. 5808, Medicaid Pharmaceutical Home Act (Bilirakis) - opioid issues H.R. 5809, Postoperative Opioid Prevention Act (Peters) - opioid issues H.R. 5810, Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act (Lance) - opioid issues H.R. 5812, Improving Medicaid Data Timeliness Act (Griffith) - opioid issues Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2019 policy and technical regulation for MA and Part D; issues relating to 2019 Rate Notice and Call Letter; in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Bipartisan Budget Act of 2018 changes to SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); CMS's proposed Part B drug demonstration program; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS' substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

Client expense: $1,410,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

Implementation of Public Law 114-198 pharmacy provisions; Implementation of Public Law 114-255 pharmacy provisions; H.R. 1854/S. 778, Prescription Drug Monitoring Act of 2017; S 892 / H.R. 4408, Opioid Addiction Prevention Act of 2017; HR 3528 / S.2460, Every Prescription Conveyed Securely Act; H.R. 3545, Overdose Prevention and Patient Safety Act; S. 1850, Protecting Jessica Grubbs Legacy Act; H.R. 1271, DXM Abuse Prevention Act of 2017; H.R. 1375, Prescriber Support Act of 2017; S. 523, Budgeting for Opioid Addiction Treatment Act; S. 581 / H.R. 5009, Jessies Law; S 1079, Protecting Americans from Dangerous Opioids Act; H.R. 4236, MONITOR Act of 2017; H.R. 3991, Expanded Access to Opioid Abuse Treatment Act of 2017; H.R. 4275, Empowering Pharmacists in the Fight Against Opioid Abuse Act; H.R. 5219, Opioid Prescription Verification Act of 2018; H.R. 5676, SENIOR Communities Protection Act of 2018; H.R. 5773, PASS Act of 2018; Draft legislation, Medicare Care Coordination Improvement Act of 2017; Draft legislation, Pain Care Coordination Act of 2018; S. 2456/H.R. 5311, CARA 2.0 Act of 2018; H.R. 5687, SOUND Disposal and Packaging Act; H.R. 5202, Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018; H.R. 5812, CONNECTIONS Act; H.R. 5801, Medicaid PARTNERSHIP Act; H.R. 6, SUPPORT for Patients and Communities Act; H.R. 5808, Medicaid Pharmaceutical Home Act of 2018; H.R. 5675, To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries; S. 2680, Opioid Crisis Response Act of 2018; S. 2645 / H.R. 5628, Access to Increased Drug Disposal Act of 2018;

Client expense: $320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

H.R. 3528/S. 2460, Every Prescription Conveyed Securely Act. Implementation issues related to the Comprehensive Addiction and Recovery Act (P.L. 114-198). H.R. 3919/S. 1908, Commonsense Reporting Act of 2017. H.R. 5812, CONNECTIONS Act of 2018. S. 2680, Opioid Crisis Response Act of 2018.

Client expense: $160,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R.5812 - Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 S.2680 - Opioid Crisis Response Act of 2018 H.R.3635 - Local Coverage Determination Clarification Act of 2017 Local Coverage Determination (LCD) Clarification Act (S. 794) Promoting Integrity in Medicare Act (HR 2066) Protecting Seniors' Access to Medicare Act (HR 849) Protecting Access to Medicare Act (HR 3635)

Client expense: $259,965 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Medicare Physician Payment Reform: Advocated in support of H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), which was enacted in April 2015 and repealed Medicares Sustainable Growth Rate (SGR) formula and moved us to a new value-based payment and delivery system under Medicare; Advocated with CMS on numerous aspects of the MACRA proposed and final rules, including: proposing a distinctive alternative scoring methodology, developed by ACP, which combines, simplifies, aligns and reduces the complexity of the four reporting categories that will qualify physicians for FFS payment adjustments; proposing specific alternatives to CMS Advancing Care Information program that replaced the Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Improvement Activities categories; urging CMS to immediately create virtual reporting options and to create safe harbors for smaller practices until such options are available; proposing more options and flexibility, instead of a one-size fits all approach, for practices to be certified as Patient-Centered Medical Homes or Patient-Centered Medical Home specialty practices, qualifying them for the highest possible score for the Clinical Practice Improvement Activity reporting category; Proposing four different options for Medical Home practices to qualify as advanced Alternative Payment Models, instead of the single option proposed by CMS, including options to allow PCMHs to qualify without taking financial risk: Advocated with CMS on Patient Relationship Categories and Codes, as required by MACRA, specifically: that CMS work to ensure that patients, families, and the relationship of patients and families with their physicians are at the forefront of the Agencys thinking in the development of both the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) pathways; that the implementation of these categories and codes is carried out in a manner that fully considers and minimizes the impact of reporting burden on the participating clinicians and that has appropriate flexibility to allow for learning and improvement in the approach by both the Agency and the clinicians. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. The College believes that strong oversight is needed when determining the initial benchmark plan (and whether it reflects the coverage requirements of the Affordable Care Act) and how the package will be updated, particularly if insurers are given the ability to substitute benefits within and across categories. State and the federal government must work in concert with physicians, health care providers and payers to determine and promote use of clinically effective and cost-effective services that result in improved patient health while bending the cost curve. Under the Affordable Care Act, advocated to ensure that people residing in states with health insurance marketplaces operated by the federal government do not lose their cost-sharing reduction subsidies (CSRs) and that those CSRs should be continued indefinitely as part of a larger bipartisan effort to stabilize the individual insurance market. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Maternal Health: Advocated for the Preventing Maternal Deaths Act, H.R. 1318, which supports state Maternal Mortality Review Committees, and promotes national information sharing through the Centers for Disease Control and Prevention (CDC), so that states can continue to learn from best practices and collaborate as needed. This bill will also put data to work through demonstration projects to eliminate disparities in maternal health outcomes. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided. Non-discrimination Protections: Urged the U.S. Department of Health and Human Services not to weaken nondiscrimination protections for lesbian, gay, bisexual, transgender, and questioning (LGBTQ) individuals under Section 1557 of the Affordable Care Act. Immigration: Voiced support to Congress on the need to pass the Development, Relief, and Education for Alien Minors (DREAM) Act of 2017, H.R. 3440. This legislation would establish a three-step pathway to U.S. citizenship through college, work, or the armed services for individuals who were born in another country and brought illegally to the U.S. at a young age (DREAMers). Clinical Labs: Commented to the Centers for Medicare and Medicaid Services (CMS) on issues pertaining to the Protecting Access to Medicare Act of 2014 (PAMA), specifically citing concerns about the potential impacts of PAMA on patient access to critical rapid clinical testing services offered to patients while they are receiving medical care in their physicians office; expressed further concerns about impending cuts on Jan. 1, 2018 for physician office-based testing services. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Repeal the Dickey amendment restricting firearms-related research by federal agencies and support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians.

Client expense: $388,427 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE

Preserve Access to Primary Care Services: Address the shortage of primary care physicians; provide scholarships and loan forgiveness in exchange for primary care service commitments to practice in critical shortage areas; provide grants for medical school mentorship programs and primary care training in community health centers; increase Title VII funding for primary care health programs; increase funding for the National Health Service Corps, provide regulatory relief for primary care physicians; H.R. 7192/S. 1174, the Preserving Patient Access to Primary Care Act (as first introduced in the 111th Congress). Support the Affordable Care Act (P.L. 111-148, P.L. 111-152) by: Expanding coverage and improving Medicare benefits; Providing needed protections to guard against insurance practices that unfairly limit, deny or rescind coverage based on health status; public and private health insurers should encourage preventive health care by providing full coverage, with no cost-sharing, for preventive services recommended by an expert advisory group, such as the U.S. Preventive Services Task Force; Ensuring access to primary care physicians; and beginning to bend the cost curve; Prohibiting insurers from excluding or charging excessive rates to children based on pre-existing conditions, which later will be expanded to all persons; Covering young adults on their parents' plans; Eliminating lifetime and annual limits on health insurance coverage; Requiring that health insurers spend more on patient care and less on administration; support enactment of S. 248, the Empowering States to Innovate Act, which amends the Patient Protection and Affordable Care Act (ACA) to: (1) allow states to apply for waivers of certain health insurance coverage requirements in such Act (including requirements for the establishment of qualified health plans and health insurance exchanges) for plan years beginning on or after January 1, 2014 (currently, January 1, 2017), and (2) require the waiver application process to begin not later than 180 days after the enactment of this Act; Phasing out the Medicare Part D doughnut hole; Eliminating patient cost-sharing for preventive services offered by Medicare or private insurers; Increasing Medicare and Medicaid payments to primary care physicians; Supporting the Patient-Centered Outcomes Research Institute to help physicians and patients make care decisions based on the best available evidence; Supporting the Center on Medicare and Medicaid Innovation to fund pilots of delivery models to improve outcomes and reduce costs, including patient-centered medical homes. Medicare Physician Payment Reform: Advocated in support of H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), which was enacted in April 2015 and repealed Medicares Sustainable Growth Rate (SGR) formula and moved us to a new value-based payment and delivery system under Medicare; Advocated with CMS on numerous aspects of the MACRA proposed and final rules, including: proposing a distinctive alternative scoring methodology, developed by ACP, which combines, simplifies, aligns and reduces the complexity of the four reporting categories that will qualify physicians for FFS payment adjustments; proposing specific alternatives to CMS Advancing Care Information program that replaced the Meaningful Use program; proposing additional improvements to simplify the reporting requirements for the Quality, Advancing Care Information and Improvement Activities categories; urging CMS to immediately create virtual reporting options and to create safe harbors for smaller practices until such options are available; proposing more options and flexibility, instead of a one-size fits all approach, for practices to be certified as Patient-Centered Medical Homes or Patient-Centered Medical Home specialty practices, qualifying them for the highest possible score for the Clinical Practice Improvement Activity reporting category; Proposing four different options for Medical Home practices to qualify as advanced Alternative Payment Models, instead of the single option proposed by CMS, including options to allow PCMHs to qualify without taking financial risk: Advocated with CMS on Patient Relationship Categories and Codes, as required by MACRA, specifically: that CMS work to ensure that patients, families, and the relationship of patients and families with their physicians are at the forefront of the Agencys thinking in the development of both the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) pathways; that the implementation of these categories and codes is carried out in a manner that fully considers and minimizes the impact of reporting burden on the participating clinicians and that has appropriate flexibility to allow for learning and improvement in the approach by both the Agency and the clinicians. Improve Access to Primary Care in the Context of Comprehensive Healthcare Reform Legislation (H.R. 3962/H.R. 3590/H.R. 4872): Provide sliding scale subsidies based on income to buy coverage from qualified plans; Qualified plans should: provide evidence-based benefits, including preventive services; and be prohibited from excluding persons with pre-existing conditions, charging them more, cherry-picking enrollees, or cancelling or failing to renew coverage; Expand Medicaid to cover all persons below the Federal Poverty Level and ensure fair payments to participating physicians; As coverage becomes affordable, all persons should participate and coverage should be guaranteed; Responsibility for financing should be shared by individuals, employers and government. The College believes that strong oversight is needed when determining the initial benchmark plan (and whether it reflects the coverage requirements of the Affordable Care Act) and how the package will be updated, particularly if insurers are given the ability to substitute benefits within and across categories. State and the federal government must work in concert with physicians, health care providers and payers to determine and promote use of clinically effective and cost-effective services that result in improved patient health while bending the cost curve. Under the Affordable Care Act, advocated to ensure that people residing in states with health insurance marketplaces operated by the federal government do not lose their cost-sharing reduction subsidies (CSRs) and that those CSRs should be continued indefinitely as part of a larger bipartisan effort to stabilize the individual insurance market. Pilot test Medicare payment models that re-align incentives to support effective, efficient, patient-centered, coordinated care. Priority should be given to models designed to support the value of services provided by primary care physicians as well as to models that would create incentives, across physician specialties and sites of services, to improve the quality, effectiveness, and efficiency of care provided. Policy criteria for selecting the most promising models for pilot testing should be developed, in consultation with outside experts; The Patient-Centered Medical Home (PCMH), which has shown great promise in meeting the policy objectives suggested above, should be among the models selected for broader testing on a national pilot basis; the use of the medical home model for treatment or services under private health plans, the requirement of health plans to provide incentives to promote and report on medical home services provided, the establishment of community health teams and a primary care extension program to educate and support primary care practices in the delivery of medical home services, and the establishment of a demonstration project to educate physicians and other clinicians in training in the competencies required to deliver care consistent with the medical home care model. Maternal Health: Advocated for the Preventing Maternal Deaths Act, H.R. 1318, which supports state Maternal Mortality Review Committees, and promotes national information sharing through the Centers for Disease Control and Prevention (CDC), so that states can continue to learn from best practices and collaborate as needed. This bill will also put data to work through demonstration projects to eliminate disparities in maternal health outcomes. Veterans Care: Regarding the VA Mission Act of 2018 (H.R. 5674), the College urged Congress to ensure that veterans have access to timely, contiguous care across the spectrum of health care services, with coordination and management of that care in the hands of a primary clinician or clinical care team; that the expansion of care to non-VHA facilities does not come at the cost of maintaining or improving existing VHA services or infrastructure; and that recruitment and retention of clinicians to the VHA is valued appropriately, including reimbursement for services provided. Non-discrimination Protections: Urged the U.S. Department of Health and Human Services not to weaken nondiscrimination protections for lesbian, gay, bisexual, transgender, and questioning (LGBTQ) individuals under Section 1557 of the Affordable Care Act. Immigration: Voiced support to Congress on the need to pass the Development, Relief, and Education for Alien Minors (DREAM) Act of 2017, H.R. 3440. This legislation would establish a three-step pathway to U.S. citizenship through college, work, or the armed services for individuals who were born in another country and brought illegally to the U.S. at a young age (DREAMers). Clinical Labs: Commented to the Centers for Medicare and Medicaid Services (CMS) on issues pertaining to the Protecting Access to Medicare Act of 2014 (PAMA), specifically citing concerns about the potential impacts of PAMA on patient access to critical rapid clinical testing services offered to patients while they are receiving medical care in their physicians office; expressed further concerns about impending cuts on Jan. 1, 2018 for physician office-based testing services. Expand Coverage and Stabilizing the Insurance Market: Congress should work to help stabilize the individual health insurance market and expand coverage. Specifically by develop and introduce comprehensive market stabilization legislation that includes reinsurance options to help stabilize the markets; Expanding cost-sharing assistance eligibility to purchase insurance in the exchanges as well as increase the level of premium tax credits and cost sharing subsidies offered to purchase a qualified health plan; Introducing legislation that would block the expansion of access to short-term health plans or Association Health Plans that allow insurers to charge more to individuals with pre-existing conditions and permit them to exclude from coverage essential medical care; Supporting $690 million in discretionary funding for federal exchanges within CMS Program Operations as part of the FY2019 Labor, Health and Human Services, and Education Appropriations bill. Reduce Unnecessary Administrative Tasks on Physicians and Patients: Congress should accelerate its efforts to reduce administrative burdens on clinicians and patients, including: Passing the Standardizing Electronic Prior Authorization for Safe Prescribing Act (H.R. 4841), which standardizes electronic prior authorization for prescription drugs under Medicare Part D. Adopt even greater harmonization of such standards across the health care industry; Passing the CONNECTIONS Act (H.R. 5812) by Reps. Griffith (R-VA) and Pallone (D-NJ) that would authorize CDC grants to state-run PDMPs to improve data collection and integration into physician clinical workflow specifically, of controlled substances overdose prevention and surveillance activities; Urging health care committees in Congress with jurisdiction over Medicare to exercise their oversight authority of CMS effort to overhaul clinical documentation guidelines with input from practicing clinicians; Passing the Improving Access to Medicare Coverage Act of 2017 (S. 568/H.R. 1421), which deems patients under observation as inpatients for the purposes of satisfying the Medicare 3-day inpatient stay requirement. Reduce Prescription Drug Costs: Congress should increase transparency and accountability in prescription drug pricing and improve access to lower-cost generic medications by passing the Drug Price Transparency in Communications Act (S. 2157), which would require drug companies to disclose the Wholesale Acquisition Cost of an Rx in Direct-to-Consumer Advertising. Representatives should introduce the companion bill; Passing the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017 (S. 974/H.R. 2212), which would improve patient access to alternative low-cost prescription drugs and biological products by preventing prescription drug manufacturers from misusing the FDAs Risk Evaluation and Mitigation Strategies (REMS) process to make it difficult for competing generics to be brought to the market; Passing the Medicare Prescription Drug Price Negotiation Act of 2017 (S. 41/H.R. 242), which would grant authority to the Secretary of HHS to negotiate prescription drug prices with manufacturers for high�cost drugs and biologics covered under Part D; Passing the Fair Accountability and Innovative Research (FAIR) Pricing Act (S. 1131/H.R. 2439), which would require drug manufacturers to disclose and provide more information about planned drug price increases, including R&D costs. Fund Workforce, Medical and Health Services Research, Public Health Initiatives: Congress should ensure funding in FY 2019 for federal programs/initiatives designed to support primary care and reject funding rescissions that would harm childrens health coverage or CMS Innovation Center. This includes funding the Primary Care and Training Enhancement (PCTE) at $71 million in order to maintain and expand the pipeline for individuals training in primary care; Funding the National Health Service Corps (NHSC) at least at $415 million in total program funding to fund scholarships and loan repayment to health care professionals to help expand the countrys primary care workforce and meet the health care needs of underserved communities; Funding the Centers for Disease Control and Prevention (CDC) and Prevention and Public Health Fund (PPHF) at $8.45 billion; including PPHF funding at $805 million; Funding the Agency for Healthcare Research and Quality (AHRQ) at $454 million, restoring the agency to its FY2010 enacted level adjusting for inflation after cuts in FY2016 and FY2017 and a small increase in FY2018 so it can help clinicians help patients by making evidence-informed decisions, fund research that serves as the evidence engine for much of the private sectors work to keep patients safe; Funding the National Institutes of Health (NIH) at $39 billion so that this nations biomedical research can continue to fund cures for disease and maintain the U.S. standing as the world leader in medical and biomedical research. Promote Continued Action to Address the Epidemic of Opioid Use: Congress should pass a comprehensive legislative package to improve prevention, education, treatment and recovery for those suffering from opioid-related addictions, including: Providing for sufficient and increased funding to address the opioid epidemic, building and expanding upon the $4.65 billion in the omnibus bill approved by Congress, with at least $1 billion for programs as authorized by CARA 2.0; Expanding access and coverage for medication assisted treatment (methadone, buprenorphine, and naltrexone to prevent opioid and substance use disorders; Rejecting any proposal to impose a three day prescribing limit for initial opioid prescriptions to ensure that doctors have appropriate flexibility to determine the proper duration of each opioid prescription; Passing the Comprehensive Addiction and Recovery Act 2.0 of 2018 (S. 2456/H.R. 5311) as a step toward a more comprehensive opioids-related package. Reduce Firearms-Related Injury and Death: Congress should pass the Assault Weapons Ban of 2018 (S. 2095/H.R. 5077), which would ban the sale of high velocity, rapid file assault rifles and large capacity ammunition magazines and bump stocks; Pass the Brady Background Expansion Act (S. 2009), to expand background checks to virtually all firearm sales in the United States; Pass the Stop Illegal Trafficking in Firearms Act of 2017 (S. 1185), and the Stop Straw Purchases Act (H.R. 5134). Both would increase penalties for individuals who unlawfully purchase firearms for other persons who are prohibited from possessing firearms (known as straw purchasers); Repeal the Dickey amendment restricting firearms-related research by federal agencies and support $50 million in funding for the CDC to conduct such research; Pass S. 834/H.R. 1832 that authorizes funding for the CDC to conduct such research. Make Graduate Medical Education (GME) Funding More Effective: Congress should develop and pass legislation to reform GME to prioritize funding toward physician specialties where millions of patients lack access, including internal medicine specialists trained in comprehensive primary care, to: Increase the number of GME slots by at least 3,000 per year over five years for specialties facing shortages, including internal medicine, as contained in the Resident Physician Shortage Reduction Act of 2017 (S. 1301/H.R. 2267); Combine DGME/IME into a single, more functional program; broaden the GME financing structure to include all payers; Allocate GME funds transparently and to activities that further the educational mission of teaching and training residents/fellows with input from practicing clinicians and in collaboration with their professional organizations; Support continued adequate funding for the VHA and its substantial contributions to the ongoing training of the next generation of physicians.

Client expense: $89,568 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE