Protecting Seniors Access to Medicare Act

S. 260 / H.R. 849: Protecting Seniors Access to Medicare Act S. 431 / H.R. 1148: Furthering Access to Stroke Telemedicine (FAST) Act S. 870 / H.R. 4579: CHRONIC Care Act S. 1016 / H.R. 2556: CONNECT for Health Act Preservation of the in-office ancillary exception to the Stark law; appropriate use criteria for imaging services; Medicare coverage of oxygen therapy for cluster headaches; urging changes to the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

Client expense: $620,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.J. Res. 143, Continuing appropriations for fiscal year 2019. (P.L. 115-298) H.R. 6, SUPPORT for Patients and Communities Act. (P.L. 115-271) H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. H.R.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. (P.L. 115-245) H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill to amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3159, Department of Defense Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 6, SUPPORT for Patients and Communities Act. H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. H.R.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill to amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.J. Res. 143, Continuing appropriations for fiscal year 2019. (P.L. 115-298) H.R. 6, SUPPORT for Patients and Communities Act. (P.L. 115-271) H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. H.R.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. (P.L. 115-245) H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill to amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3159, Department of Defense Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Medicare Diabetes Prevention Program; diabetes self-management education; H.R. 3124/S. 1299/Preventing Diabetes in Medicare Act; H.R. 1953/S. 830 Treat and Reduce Obesity Act; Issues related to Medicare Part D included in Section 53116 of H.R. 1892 (Pub. L. 115-123), Bipartisan Budget Act and H.R. 1625 (Pub. L. 115-141), Consolidated Appropriations Act; H.R. 849/S. 260 including coverage gap ("donut hole") access and averting catastrophic coverage Out of Pocket (OOP) "cliff"; Protecting Seniors' Access to Medicare Act of 2017 and S. 251 Protecting Medicare from Executive Action Act of 2017 (IPAB Repeal); H.R. 3921 HEALTHY KIDS Act (CHIP Reauthorization).

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing

Client expense: $580,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Issues related to the repeal of the Independent Payment Advisory Board (IPAB); Protecting Seniors' Access to Medicare Act of 2017 (H.R. 849/S. 260); Protecting Medicare from Executive Action Act of 2017 (S. 251) Treat and Reduce Obesity Act (H.R. 1953/S. 830) Medicare Diabetes Prevention Program; diabetes self-management education; Preventing Diabetes in Medicare Act (H.R. 3124/S. 1299) Issues related to Medicare Part D included in the Bipartisan Budget Act (H.R. 1892); and the Consolidated Appropriations Act (H.R. 1625), including coverage gap ("donut hole") access and averting catastrophic coverage Out of Pocket (OOP) "cliff

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act H.R. 2430 - FDA Reauthorization Act of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 S. 2852 - Pandemic and All Hazards Preparedness Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bil1s, innovation, non-interference, 340B, Hepatitis C, HPV, Shingles, anti-microbial resistance, transparency, Pandemic All Hazards Preparedness Act reauthorization

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), 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

Monitor legislative and administrative action related to Medicare policy. Monitor legislative and administrative action related to Medicaid policy. H.R. 849, Protecting Seniors Access to Medicare Act of 2017. S. 251, Protecting Medicare for Executive Action Act of 2017. S. 260, Protecting Seniors Access to Medicare Act of 2017.

Client expense: $1,320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), 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

H.R. 6, Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act H.R. 35, Health Savings Act of 2017 H.R. 143, Health Insurance Industry Antitrust Enforcement Act of 2017 H.R. 173/S. 40/S. 58, Middle Class Health Benefits Tax Repeal Act of 2017 H.R. 184, Protect Medical Innovation Act of 2017 H.R. 195, Making further continuing appropriations for the fiscal year ending September 30, 2018, and for other purposes H.R. 246, To repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act H.R. 394/S. 85, Restoring Access to Medication Act of 2017 H.R. 620, ADA Education and Reform Act of 2017 H.R. 849/S. 260, Protecting Seniors Access to Medicare Act H.R. 1101, Small Business Health Fairness Act of 2017 H.R. 1175/S. 403, Health Savings Act of 2017 H.R. 1215, Protecting Access to Care Act of 2017 H.R. 1313, Preserving Employee Wellness Programs Act H.R. 1625, Consolidated Appropriations Act, 2018 H.R. 1892, Bipartisan Budget Act of 2018 H.R. 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 H.R. 3798, Save American Workers Act of 2017 H.R. 4284, Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018 H.R. 4616, To amend the Patient Protection and Affordable Care Act to provide for a temporary moratorium on the employer mandate and to provide for a delay in the implementation of the excise tax on high cost employer-sponsored health coverage H.R. 4617, To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on the medical device excise tax H.R. 4618, To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on certain taxes affecting purchases of prescription medication H.R. 4619, To amend the Patient Protection and Affordable Care Act to provide temporary relief from the annual fee imposed on health insurance providers, to the extent that such fee is due to Puerto Rican health insurance H.R. 4620, Protecting Families and Small Businesses Act of 2017 H.R. 4978/S. 2410, Chronic Disease Management Act of 2018 H.R. 5009, Jessies Law H.R. 5041, Safe Disposal of Unused Medication Act H.R. 5138, Bipartisan HSA Improvement Act of 2018 H.R. 5272, To provide additional guidance to grantees seeking funding to treat or prevent mental health or substance use disorders H.R. 5582, Abuse Deterrent Access Act of 2018 H.R. 5788, Synthetics Trafficking and Overdose Prevention (STOP) Act of 2018 H.R. 5892, To establish an Advisory Committee on Opioids and the Workplace to advise the Secretary of Labor on actions the Department of Labor can take to address the impact of opioid abuse on the workplace H.R. 6199, Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 H.R. 6311, Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act of 2018 S. 108, Medical Device Access and Innovation Protection Act S. 191, Patient Freedom Act of 2017 S. 222, Obamacare Replacement Act S. 251, Protecting Medicare from Executive Action Act of 2017 S. 974, Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act of 2017 S. 1835, Lower Premiums Through Reinsurance Act of 2017 S. 1850, Protecting Jessica Grubb's Legacy Act S. 1859, Healthcare Tax Relief Act S. 1978, Small Business and Family Health Tax Relief Act of 2017 S. 2004, Combating the Opioid Epidemic Act S. 2164, To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings S. 3057, Synthetics Trafficking and Overdose Prevention (STOP) Act of 2018 Draft legislation to stabilize individual market premiums for the 2018 and 2019 plan years and provide meaningful State flexibility (Alexander-Murray) Proposed regulation on health reimbursement arrangements and other account-based group health plans (83 Fed. Reg. 54,420-54,477, October 29, 2018) Final Regulation, definition of employer under Section 3(5) of ERISA - association health plans (83 Fed. Reg. 28912-28964, June 21, 2018) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part D's Non-Interference Clause from repeal Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; House Republican Taskforce on Health Care report; A Better Way to Fix Health Care; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; Executive Order 13813, Promoting Healthcare Choice and Competition; addressing the opioids crisis, including end-stage renal disease; balance or surprise billing; single-payer health care options; aligning 42 CFR Part 2 with the Health Insurance Portability and Accountability Act (P.L. 104-191) for the purposes of treatment, payment, and health car operation (TPO); inclusion of prescription drug pricing on 2019 congressional agenda; general advocacy for Congress to reach a working quorum for the board of the Export-Import Bank; section 301 of the Trade Act of 1974; U.N. Convention on the Assignment of Receivables in Int'l Trade

Client expense: $15,950,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Energy Regulatory Commission (FERC), Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), Social Security Administration (SSA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.J. Res. 143, Continuing appropriations for fiscal year 2019. (P.L. 115-298) H.R. 6, SUPPORT for Patients and Communities Act. (P.L. 115-271) H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. H.R.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. (P.L. 115-245) H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill to amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3159, Department of Defense Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

Client expense: Not reported · Firm income: $60,000

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.J. Res. 143, Continuing appropriations for fiscal year 2019. (P.L. 115-298) H.R. 6, SUPPORT for Patients and Communities Act. (P.L. 115-271) H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. H.R.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. (P.L. 115-245) H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill to amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3159, Department of Defense Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

Client expense: Not reported · Firm income: $60,000

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

- S. 469/H.R. 1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. - S. 771/H.R. 1776, "Improving Access To Affordable Prescription Drugs Act", regarding all provisions. - H.R. 575, "Cosmetic Modernization Amendments of 2017", regarding all provisions. - H.R. 1271, "DXM Abuse Prevention Act of 2017", regarding all provisions. - S. 404/H.R. 1736, "To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.", regarding all provisions. - Issues regarding drug pricing. - Issues related to diagnostic reform. - S 260/SJ Res 17/HR 849, Protecting Seniors' Access to Medicare Act of 2017, regarding all provisions - S 251/SJ Res 16, Protecting Medicare from Executive Action Act of 2017, regarding all provisions - S 204/HR 878, Right to Try Act of 2017, regarding all provisions - HR 2026, Pharmaceutical Information Exchange Act, regarding all provisions - HR 1703, Medical Product Communications Act of 2017, regarding all provisions - Issues related to VA procurement of medical devices - HR 2474, Medical Product Review Harmonization Act, regarding all provisions - HR 2144, Risk Based Classification of Accessories Act - Issues related to AMA resolution 208(A-16) regarding attorney ads on drug side effects - S.1113, "Personal Care Products Safety Act", regarding all provisions - HR 2790, "Humane Cosmetics Act", regarding all provisions - HR 3271, "Protecting Access to Diabetes Supplies Act", regarding all provisions - Issues regarding medical device repeal - Issues regarding NIH Funding - HR 2164, "Medical Device Safety Act", regarding all provisions - Issues related to 340B - Issues related to HIV vaccines - S. 2852, "Pandemic & All Hazards Preparedness and Advancing Innovations Act of 2018", regarding all provisions. - Issues related to reauthorization of the Pandemic All-Hazards Preparedness Act programs. (House version) - HR 5492, "MOTHER Act of 2018", regarding all provisions. - Issues related to access to essential surgery - Issues related to contact lens safety - HR 6, "SUPPORT for Patients and Communities Act", regarding all provisions. - S. 2315, "Over-the-Counter Drug Safety, Innovation, and Reform Act", regarding all provisions. - HR 5333 "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018", regarding all provisions. - Issues related to antimicrobial resistance - Issues related to regulations on medication product packaging - H.R. 6294, " Re-Valuing Anti-Microbial Products Act of 2018", regarding all provisions - H.R. 1318, "Preventing Maternal Deaths Act of 2018", regarding all provisions

Client expense: $2,340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office

Medicaid access and coverage, Sunshine implementation, EXPERT, medically complex children S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 S. 1827 - Kids Act of 2017 H.R. 3921 - Healthy Kids Act

Client expense: Not reported · Firm income: $60,000

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

drug coverage and reimbursement value based contracting, access and affordability S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 3921 - Healthy Kids Act S. 1827 - Kids Act of 2017 Stark

Client expense: Not reported · Firm income: $50,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

PL 114-255 - 21st Century Cures, implementation H.R. 878/S. 204 - Right to Try Act H.R. 1231/S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 849/S. 260 - Protecting Seniors' Access to Medicare Act S. 2852 - Pandemic and All Hazards Preparedness Act S.2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act H.R. 6 - SUPPORT for Patients and Communities Act ***no specific bills, importation, supply chain integrity, 304b, biosimilars, orphan drugs, newborn screening, expanded access, priority review, transparency, drug shortages, IPAB

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)

Medicare priorities, coverage and payment policies, discount cards, MedPAC S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 3921 - Healthy Kids Act S. 1827 - Kids Act of 2017 no specific bill, Sunshine implementation, biosimilars, Part B, Medicare Part D, Smoking cessation, donut hole, Part D cliff

Client expense: Not reported · Firm income: $80,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

S. 870 - Chronic Care S. 251 - Protecting Medicare from Executive Action of 2017 H.R. 849/S. 260 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 242/S. 41 - Medicare Prescription Drug Price Negotiation Act of 2017 S. 348 - Prescription Drug and Health Improvement Act of 2017 H.R. 1316 - Prescription Drug Price Transparency Act H.J.Res. 51/S.J.Res. 16 - IPAB discontinuation H.R. 3921 - Healthy Kids Act S. 1827 - Kids Act of 2017 ***, no specific bill(s), Medicare and Medicaid Drug Reimbursement, Medicaid Rebate, dual eligibles, Sunshine, discount cards, MedPAC, biosimilars, Alternative Payment Models, Value based Purchasing, coding, CMMI, Part B, Part D, non-interference, IPAB, donut hole, Part D cliff, prescription drug access and affordability

Client expense: Not reported · Firm income: $80,000

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

prescription drug abuse and deterrence, non-interference PL 114-255 - 21st Century Cures, implementation Multi-modal analgesics S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 3921 - Healthy Kids Act S. 1827 - Kids Act of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act S. 2852 - Pandemic and All Hazards Preparedness Act S. 3282 - DEA Clearinghouse Act of 2018

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 3921 - Healthy Kids Act S. 1827 - Kids Act of 2017 no specific bills, Medicare Part D, Value based purchasing, Medicare Part B, 340B, IPAB repeal, Donut hole, Part D cliff

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare and Medicaid Drug Reimbursement, Medicaid Rebate, Medicare Part D Non-Interference, health care reform, biosimilars, 340B, Sunshine, discount cards, MedPAC, coding, ASP, Part B, donut hole, Part D cliff, prescription drug access and affordability S. 870 - Chronic Care H.R. 3921 - Healthy Kids Act S. 1827 - Kids Act of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017

Client expense: Not reported · Firm income: $80,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

S. 870 - Chronic Care H.R. 3921 - Healthy Kids Act S. 1827 - Kids Act of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 ***, no specific bill(s), Medicare and Medicaid Drug Reimbursement, Medicaid Rebate, Medicare Part D, Non-Interference, health care reform implementation, AMP, Sunshine, conditions of participation, care transitions, immunizations, pipeline, Innovation Center, Part B, Medicaid coverage, ESRD, coverage, innovative payments, diabetes and cardiometabolic health

Client expense: Not reported · Firm income: $50,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

discount programs, pipeline, biosimilars, Part B demonstration, Part D, Noninterference, donut hole, Part D cliff, Rebates, CMM1 S. 251 - Protecting Medicare from Executive Action of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 242/S. 41 - Medicare Prescription Drug Price Negotiation Act of 2017

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 849, S. 260, S. 251 Protecting Seniors Access to Medicare Act, lobbied regarding all biopharmaceutical related provisions. S.771, Improving Access To Affordable Prescription Drugs Act, lobbied regarding all biopharmaceutical related provisions. S.348, Prescription Drug and Health Improvement Act of 2017, lobbied regarding all biopharmaceutical related provisions. S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017, lobbied regarding all biopharmaceutical related provisions. No bill, American Patients First Prescription Drug Blueprint, regarding all biopharmaceutical related provisions. H.R. 6505, Medicare Negotiation and Competitive Licensing Act of 2018, regarding all biopharmaceutical related provisions. H.R. 6642, to amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs, regarding all biopharmaceutical related provisions. S. 2553, H.R. 6144, Know the Lowest Price Act of 2018, regarding all biopharmaceutical related provisions.

Client expense: $940,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

H.R. 1173/S. 448, the Medicare Mental Health Access Act H.R. 849, the Protecting Seniors Access to Medicare Act S. 1301/H.R. 2267, the Resident Physician Shortage Reduction Act H.R. 2276/S. 2575, the Audiology Patient Choice Act H.R. 5594, the Improving Access to Remote Behavioral Health Treatment Act of 2018 S. 2680, the Opioid Crisis Response Act of 2018 H.R. 6, the SUPPORT for Patients and Communities Act H.R. 1925, the At-Risk Youth Medicaid Protection Act H.R. 2509, the Medicare Mental Health Inpatient Equity Act S. 1169, the Medicaid Coverage for Addiction Recovery Expansion Act H.R. 2687, the Medicaid Coverage for Addiction Recovery Expansion Act H.R. 4005, the Medicaid Reentry Act H.R. 4097, the Medicare Beneficiary Opioid Addiction Treatment Act S. 2843/H.R. 5818, the Opioid Workforce Act of 2018 Comments re: the Centers for Medicare & Medicaid Services (CMS) decision to suspend the risk adjustment payments to insurers participating in the individual and small-group marketplaces, as mandated by the Affordable Care Act Support for S.J.Res.63, a joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Secretary of the Treasury, Secretary of Labor, and Secretary of Health and Human Services relating to "Short-Term, Limited Duration Insurance. Comments re: CMSs proposed rule, Revisions to Payment Policies under the Medicare Physician Fee Schedule, Quality Payment Program and Other Revisions to Part B for CY 2019. CMS-1693-P Comments re: CMSs proposed rule, Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Pathways to Success. Comments re: CMSs proposed rule, Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Pathways to Success Comment on the CY 2019 Proposed Rule for the Medicare and Medicaid Programs; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction. Issue relating to suicide prevention; in general Issues relating to the enforcement of mental health parity; in general

Client expense: $250,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), U.S. Immigration & Customs Enforcement (ICE), Veterans Affairs, Dept of (VA)

PL 109-417 - Pandemic and All-Hazards Preparedness Act (PAHPA) PL 114-10 - Medicare and CHIP Reauthorization Act of 2017 Implementation H.R. 6 - SUPPORT for Patients and Communities Act H.R. 5507 - Critical Access Hospital Relief Act of 2018 H. R. 5809 - Postoperative Opioid Prevention Act of 2018 H.R 4143/S. 2065 - Dialysis PATIENTS Demonstration Act of 2017 S. 2852/H.R. 6378 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (PAHPAI) H.R. 5385 - Children's Hospital GME Support Reauthorization Act of 2018 S. 2809 - A bill 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. H.R. 5106 - Investor Choice Against Gun Proliferation Act H.R.1057 - STOP Act of 2017 H.R. 1822, 1876/S. 781 - Good Samaritan Health Professionals Act of 2017 H.R. 880/S. 1022 - Mission Zero Act H.R. 1017/S. 479 - Removing Barriers to Colorectal Cancer Screening Act of 2017 H.R. 820/S. 292 - Childhood Cancer STAR Act H.R. 5160 - Cancer Care Planning and Communications Act of 2018 H.R. 1704 - ACCESS Act of 2017 H.R. 2267 - Resident Physician Shortage Reduction Act of 2017 H.R. 1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R. 4909/S. 2495 - STOP School Violence Act of 2018 H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R. 4206/S. 2051 - Medicare Care Coordination Improvement Act H.R. 1892 - Bipartisan Budget Act of 2018 H.R. 1625 - Omnibus H.R. 2906/S. 1351 - Ensuring Access to General Surgery Act of 2017 H.R. 4434/S.2135 - Fix NICS Act of 2017 H.R. 548/S. 527 - Health Care Safety Net Enhancement Act of 2017 H.R. 849/S. 260, S. 251 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 2843/S.1317 - Medicaid and CHIP Quality Improvement Act of 2017 H.R. 3120 - Electronic Health Record Meaningful Use H.R. 2276/S.2575 - Audiology Patient Choice Act of 2018 H.R. 6157 - Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 H.R. 6545 - Violence Against Women Reauthorization Act of 2018 H.R. 6808 - Patient Navigation Assistance Act of 2018 H.R.4897 - Women and Lung Cancer Research and Preventive Services Act of 2018 H.R. 930/S. 497 - Lymphedema Treatment Act H.R. 7083 - Access to Genetic Counselor Services Act of 2018 H.R. 1318 - Preventing Maternal Deaths Act of 2018 Medicaid GME Transparency Act Bleeding Control for the Injured (Stop The Bleed campaign) Injury Prevention Initiatives Childrens Health Insurance Program Reauthorization Cancer Research and Funding Opioids EHR Clinician Burden/Administrative Burden Mis-valued Codes Medicare Sequestration Congenital Anomalies Global Codes Qualified clinical data registry (QCDR) Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey (S-CAHPS) VA Health Issues DOD Health Issues The Emergency Medical Services for Children Program MIPS cost measure development E-Prior Authorization Digital health systems Sports Medicine Firearms Research Hospital-based violence intervention programs National Trauma System (Military-Civilian Trauma Care) Visa Denial Medicare Fraud Surprise Billing Draft Legislation Stark Law Reform and Medicare Administrative Burden relief Alternative Payment Models (APMs) Physician Fee Schedule Quality Payment Program (QPP) Out-of-Network billing Narrow networks/Network Adequacy Hospital-based Violence Intervention Programs Out of the Crucible: U.S. Military Combat Casualty Care principles

Client expense: $16,092 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE, Veterans Affairs, Dept of (VA)

PL 109-417 - Pandemic and All-Hazards Preparedness Act (PAHPA) PL 114-10 - Medicare and CHIP Reauthorization Act of 2017 Implementation H.R. 6 - SUPPORT for Patients and Communities Act H.R. 5507 - Critical Access Hospital Relief Act of 2018 H. R. 5809 - Postoperative Opioid Prevention Act of 2018 H.R 4143/S. 2065 - Dialysis PATIENTS Demonstration Act of 2017 S. 2852/H.R. 6378 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (PAHPAI) H.R. 5385 - Children's Hospital GME Support Reauthorization Act of 2018 S. 2809 - A bill 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. H.R. 5106 - Investor Choice Against Gun Proliferation Act H.R.1057 - STOP Act of 2017 H.R. 1822, 1876/S. 781 - Good Samaritan Health Professionals Act of 2017 H.R. 880/S. 1022 - Mission Zero Act H.R. 1017/S. 479 - Removing Barriers to Colorectal Cancer Screening Act of 2017 H.R. 820/S. 292 - Childhood Cancer STAR Act H.R. 5160 - Cancer Care Planning and Communications Act of 2018 H.R. 1704 - ACCESS Act of 2017 H.R. 2267 - Resident Physician Shortage Reduction Act of 2017 H.R. 1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R. 4909/S. 2495 - STOP School Violence Act of 2018 H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R. 4206/S. 2051 - Medicare Care Coordination Improvement Act H.R. 1892 - Bipartisan Budget Act of 2018 H.R. 1625 - Omnibus H.R. 2906/S. 1351 - Ensuring Access to General Surgery Act of 2017 H.R. 4434/S.2135 - Fix NICS Act of 2017 H.R. 548/S. 527 - Health Care Safety Net Enhancement Act of 2017 H.R. 849/S. 260, S. 251 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 2843/S.1317 - Medicaid and CHIP Quality Improvement Act of 2017 H.R. 3120 - Electronic Health Record Meaningful Use H.R. 2276/S.2575 - Audiology Patient Choice Act of 2018 H.R. 6157 - Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 H.R. 6545 - Violence Against Women Reauthorization Act of 2018 H.R. 6808 - Patient Navigation Assistance Act of 2018 H.R.4897 - Women and Lung Cancer Research and Preventive Services Act of 2018 H.R. 930/S. 497 - Lymphedema Treatment Act H.R. 7083 - Access to Genetic Counselor Services Act of 2018 H.R. 1318 - Preventing Maternal Deaths Act of 2018 Medicaid GME Transparency Act Bleeding Control for the Injured (Stop The Bleed campaign) Injury Prevention Initiatives Childrens Health Insurance Program Reauthorization Cancer Research and Funding Opioids EHR Clinician Burden/Administrative Burden Mis-valued Codes Medicare Sequestration Congenital Anomalies Global Codes Qualified clinical data registry (QCDR) Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey (S-CAHPS) VA Health Issues DOD Health Issues The Emergency Medical Services for Children Program MIPS cost measure development E-Prior Authorization Digital health systems Sports Medicine Firearms Research Hospital-based violence intervention programs National Trauma System (Military-Civilian Trauma Care) Visa Denial Medicare Fraud Surprise Billing Draft Legislation Stark Law Reform and Medicare Administrative Burden relief Alternative Payment Models (APMs) Physician Fee Schedule Quality Payment Program (QPP) Out-of-Network billing Narrow networks/Network Adequacy Hospital-based Violence Intervention Programs Out of the Crucible: U.S. Military Combat Casualty Care principles

Client expense: $16,092 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE, Veterans Affairs, Dept of (VA)

PL 109-417 - Pandemic and All-Hazards Preparedness Act (PAHPA) PL 114-10 - Medicare and CHIP Reauthorization Act of 2017 Implementation H.R. 6 - SUPPORT for Patients and Communities Act H.R. 5507 - Critical Access Hospital Relief Act of 2018 H. R. 5809 - Postoperative Opioid Prevention Act of 2018 H.R 4143/S. 2065 - Dialysis PATIENTS Demonstration Act of 2017 S. 2852/H.R. 6378 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (PAHPAI) H.R. 5385 - Children's Hospital GME Support Reauthorization Act of 2018 S. 2809 - A bill 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. H.R. 5106 - Investor Choice Against Gun Proliferation Act H.R.1057 - STOP Act of 2017 H.R. 1822, 1876/S. 781 - Good Samaritan Health Professionals Act of 2017 H.R. 880/S. 1022 - Mission Zero Act H.R. 1017/S. 479 - Removing Barriers to Colorectal Cancer Screening Act of 2017 H.R. 820/S. 292 - Childhood Cancer STAR Act H.R. 5160 - Cancer Care Planning and Communications Act of 2018 H.R. 1704 - ACCESS Act of 2017 H.R. 2267 - Resident Physician Shortage Reduction Act of 2017 H.R. 1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R. 4909/S. 2495 - STOP School Violence Act of 2018 H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R. 4206/S. 2051 - Medicare Care Coordination Improvement Act H.R. 1892 - Bipartisan Budget Act of 2018 H.R. 1625 - Omnibus H.R. 2906/S. 1351 - Ensuring Access to General Surgery Act of 2017 H.R. 4434/S.2135 - Fix NICS Act of 2017 H.R. 548/S. 527 - Health Care Safety Net Enhancement Act of 2017 H.R. 849/S. 260, S. 251 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 2843/S.1317 - Medicaid and CHIP Quality Improvement Act of 2017 H.R. 3120 - Electronic Health Record Meaningful Use H.R. 2276/S.2575 - Audiology Patient Choice Act of 2018 H.R. 6157 - Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 H.R. 6545 - Violence Against Women Reauthorization Act of 2018 H.R. 6808 - Patient Navigation Assistance Act of 2018 H.R.4897 - Women and Lung Cancer Research and Preventive Services Act of 2018 H.R. 930/S. 497 - Lymphedema Treatment Act H.R. 7083 - Access to Genetic Counselor Services Act of 2018 H.R. 1318 - Preventing Maternal Deaths Act of 2018 Medicaid GME Transparency Act Bleeding Control for the Injured (Stop The Bleed campaign) Injury Prevention Initiatives Childrens Health Insurance Program Reauthorization Cancer Research and Funding Opioids EHR Clinician Burden/Administrative Burden Mis-valued Codes Medicare Sequestration Congenital Anomalies Global Codes Qualified clinical data registry (QCDR) Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey (S-CAHPS) VA Health Issues DOD Health Issues The Emergency Medical Services for Children Program MIPS cost measure development E-Prior Authorization Digital health systems Sports Medicine Firearms Research Hospital-based violence intervention programs National Trauma System (Military-Civilian Trauma Care) Visa Denial Medicare Fraud Surprise Billing Draft Legislation Stark Law Reform and Medicare Administrative Burden relief Alternative Payment Models (APMs) Physician Fee Schedule Quality Payment Program (QPP) Out-of-Network billing Narrow networks/Network Adequacy Hospital-based Violence Intervention Programs Out of the Crucible: U.S. Military Combat Casualty Care principles

Client expense: $169,817 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE, Veterans Affairs, Dept of (VA)

PL 109-417 - Pandemic and All-Hazards Preparedness Act (PAHPA) PL 114-10 - Medicare and CHIP Reauthorization Act of 2017 Implementation H.R. 6 - SUPPORT for Patients and Communities Act H.R. 5507 - Critical Access Hospital Relief Act of 2018 H. R. 5809 - Postoperative Opioid Prevention Act of 2018 H.R 4143/S. 2065 - Dialysis PATIENTS Demonstration Act of 2017 S. 2852/H.R. 6378 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (PAHPAI) H.R. 5385 - Children's Hospital GME Support Reauthorization Act of 2018 S. 2809 - A bill 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. H.R. 5106 - Investor Choice Against Gun Proliferation Act H.R.1057 - STOP Act of 2017 H.R. 1822, 1876/S. 781 - Good Samaritan Health Professionals Act of 2017 H.R. 880/S. 1022 - Mission Zero Act H.R. 1017/S. 479 - Removing Barriers to Colorectal Cancer Screening Act of 2017 H.R. 820/S. 292 - Childhood Cancer STAR Act H.R. 5160 - Cancer Care Planning and Communications Act of 2018 H.R. 1704 - ACCESS Act of 2017 H.R. 2267 - Resident Physician Shortage Reduction Act of 2017 H.R. 1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R. 4909/S. 2495 - STOP School Violence Act of 2018 H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R. 4206/S. 2051 - Medicare Care Coordination Improvement Act H.R. 1892 - Bipartisan Budget Act of 2018 H.R. 1625 - Omnibus H.R. 2906/S. 1351 - Ensuring Access to General Surgery Act of 2017 H.R. 4434/S.2135 - Fix NICS Act of 2017 H.R. 548/S. 527 - Health Care Safety Net Enhancement Act of 2017 H.R. 849/S. 260, S. 251 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 2843/S.1317 - Medicaid and CHIP Quality Improvement Act of 2017 H.R. 3120 - Electronic Health Record Meaningful Use H.R. 2276/S.2575 - Audiology Patient Choice Act of 2018 H.R. 6157 - Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 H.R. 6545 - Violence Against Women Reauthorization Act of 2018 H.R. 6808 - Patient Navigation Assistance Act of 2018 H.R.4897 - Women and Lung Cancer Research and Preventive Services Act of 2018 H.R. 930/S. 497 - Lymphedema Treatment Act H.R. 7083 - Access to Genetic Counselor Services Act of 2018 H.R. 1318 - Preventing Maternal Deaths Act of 2018 Medicaid GME Transparency Act Bleeding Control for the Injured (Stop The Bleed campaign) Injury Prevention Initiatives Childrens Health Insurance Program Reauthorization Cancer Research and Funding Opioids EHR Clinician Burden/Administrative Burden Mis-valued Codes Medicare Sequestration Congenital Anomalies Global Codes Qualified clinical data registry (QCDR) Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey (S-CAHPS) VA Health Issues DOD Health Issues The Emergency Medical Services for Children Program MIPS cost measure development E-Prior Authorization Digital health systems Sports Medicine Firearms Research Hospital-based violence intervention programs National Trauma System (Military-Civilian Trauma Care) Visa Denial Medicare Fraud Surprise Billing Draft Legislation Stark Law Reform and Medicare Administrative Burden relief Alternative Payment Models (APMs) Physician Fee Schedule Quality Payment Program (QPP) Out-of-Network billing Narrow networks/Network Adequacy Hospital-based Violence Intervention Programs Out of the Crucible: U.S. Military Combat Casualty Care principles

Client expense: $169,817 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE, Veterans Affairs, Dept of (VA)

H.R. 2276/S. 2575, the "Audiology Patient Choice Act," all provisions. Medicare physician payment reform and implementation of the Medicare and CHIP Reauthorization Act of 2015, in general. Medicare physician payment reform and implementation of the Medicare and CHIP Reauthorization Act of 2015 related to the cost domain of the Merit-based Incentive Payment System. H.R. 1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions. H.R. 849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions. Comments outlining concern with the November 2017 Medicare Payment Advisory Commission (MedPAC) discussion titled, "Rebalancing the physician fee schedule towards primary care services." Issues pertaining to scope of practice, in general. Comments urging the Centers for Medicare and Medicaid Services (CMS) to reduce the 2018 Merit-based Incentive Payment System (MIPS) reporting period from a calendar year to a minimum of 90 consecutive days. Comments on the Medicare Hospital IPPS FY 2019 Proposed Rule communicating concerns about the agencys plans to remove the Public Health and Clinical Data Exchange objective by 2022. Comments urging leaders of the U.S. Senate Committee on Finance not to co-sponsor and oppose any efforts to advance the "Audiology Patient Choice Act" (S. 2575). Comments to the Centers for Medicare and Medicaid Services (CMS) regarding Medicare's designation of CPT Code 31241 Nasal/sinus endoscopy, surgical; with ligation of sphenopalatine artery. Coalition letter to leaders of the U.S. House Committees on Ways & Means and Energy & Commerce regarding the Medicare Appropriate Use Criteria (AUC) Program for Advanced Diagnostic Imaging. Coalition letter to leaders of the U.S. Senate Committee on Finance regarding the Medicare Appropriate Use Criteria (AUC) Program for Advanced Diagnostic Imaging. Coalition letter to U.S. House Committees on Ways & Means and Energy and Commerce and U.S. Senate Committee on Finance regarding payment cuts for clinical lab tests in the Medicare program. Coalition letter to the CMS Administrator urging HHS to allow eligible clinicians utilizing a certified electronic health record to participate in a clinician-led qualified clinical data registry to qualify them as fully achieving all points from the MIPS program. Coalition letter to the CMS Administrator regarding the Evaluation and Management coding and payment recommendations included in the CY19 Medicare Physician Fee Schedule Proposed Rule. Coalition letter to U.S. House of Representatives requesting support of a letter to HHS Secretary Alex Azar regarding data information blocking guidelines as related to Qualified Clinical Data Registries. Comments on the CY19 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule communicating support for proposed changes to reduce site of service disparities, as well as removal of CPT 31241 (Nasal/sinus endoscopy, surgical; with ligation of sphenopalatine artery) from the Inpatient Only List. Comments on the CY19 Medicare Physician Fee Schedule Proposed Rule regarding the proposed changes to documentation requirements, coding and payment for Evaluation and Management (E/M) services, application of the MPPR to E/M services, and the pricing and composition of balloon sinus surgery kits. Coalition Letter to leaders of the U.S. Senate Committee on Finance and U.S. House Committees on Ways and Means and Energy and Commerce regarding cuts to clinical laboratory services implemented by the Protecting Access to Medicare Act (PAMA) of 2014. Coalition letter to U.S. Senate Finance Committee and U.S. House Committees on Ways and Means and Energy and Commerce expressing concerns with CMS proposal to require Qualified Clinical Data Registry (QCDR) measure owners to enter into licensing agreements with CMS that would permit any other approved QCDR to submit data on the licensed measure for purposes of MIPS reporting. Comments on the CY19 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule regarding changes to reduce site of service disparities, as well as removal of CPT 31241 (Nasal/sinus endoscopy, surgical; with ligation of sphenopalatine artery) from the Inpatient Only List. Comments on the CY 2019 Physician Fee Schedule Final Rule regarding the changes to documentation requirements, coding and payment for Evaluation and Management (E/M) services, application of the MPPR to E/M services, and the pricing and composition of balloon sinus surgery kits. Coalition letter to CMS expressing several concerns with Qualified Clinical Data Registries and MIPS. Coalition letter to CMS in response to an RFI regarding reporting requirements under the Open Payments Program for educational materials.

Client expense: $230,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 849 and S. 360) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Visited multiple House and Senate offices in Washington and in their state and districts is support of IPAB repeal. As part of the PACT coalition lobbied in support of HR 1920 and S 1304 to cancel the prompt pay discount for Part B medicines. Worked with the Protect Medicare Part D Working Group and others to protect Medicare Part D by opposing the elimination of the non-interference and opposing recommendations to allow the importation of medicines. RetireSafe joined with the Alliance for Safe Biological Medicines to influence the regulations and rules at FDA to ensure that biosimilars are safe and trusted. Worked specifically to prevent the non-medical switching of biologics and/or biosimilars. RetireSafe lobbied against proposed legislation that would allow the importation of prescription drugs and against the repeal of the non-interference clause. Joined with AIR340b to advocate for reform of the 340b drug discount program.

Client expense: $7,192 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Supporting Independent Payment Advisory Board Repeal - H.R.849/S.260, Protecting Seniors' Access to Medicare Act and S.251, Protecting Medicare from Executive Action, enacted into law Supporting Medical Liability Reform - H.R.1215, Protecting Access to Care Act ACA Repeal and Replace - not supporting Supporting H.R.4206, Medicare Care Coordination Improvement Act Comments on FY 2018 Hospital Outpatient Prospective Payment System Final Rule submitted to CMS, the agency corrected placement of vascular ultrasound codes Supporting H.R.2267, Resident Physician Shortage Reduction Act Supporting H.R.1876/S.781 - Good Samaritan Health Professionals Act Opposing Medicare Payment Advisory Commission's proposal to rebalance the physician fee schedule towards primary care Following opioid legislation, Stark Act Reform to allow for physician self referral under alternative payment models

Client expense: $50,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)

Supporting Independent Payment Advisory Board Repeal - H.R.849/S.260, Protecting Seniors' Access to Medicare Act and S.251, Protecting Medicare from Executive Action, enacted into law Supporting Medical Liability Reform - H.R.1215, Protecting Access to Care Act ACA Repeal and Replace - not supporting Supporting H.R.4206, Medicare Care Coordination Improvement Act Comments on FY 2018 Hospital Outpatient Prospective Payment System Final Rule submitted to CMS, the agency corrected placement of vascular ultrasound codes Supporting H.R.2267, Resident Physician Shortage Reduction Act Supporting H.R.1876/S.781 - Good Samaritan Health Professionals Act Opposing Medicare Payment Advisory Commission's proposal to rebalance the physician fee schedule towards primary care Following opioid legislation, Stark Act Reform to allow for physician self referral under alternative payment models

Client expense: $50,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 6, SUPPORT for Patients and Communities Act. H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. H.R.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill to amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3159, Department of Defense Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 6, SUPPORT for Patients and Communities Act. H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. H.R.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill to amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3159, Department of Defense Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)

Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor federal and legislative activity related to Medicare Reimbursement. Monitor federal issues and legislation associated with health care policy. Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 6, SUPPORT for Patients and Communities Act. H.R. 849, Protecting Seniors' Access to Medicare Act of 2017. H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act. H.R. 1316, Prescription Drug Price Transparency Act. H.R. 1628, American Health Care Act of 2017. H.R. 1703, Medical Product Communications Act of 2017. H.R. 1898, To improve access to, and utilization of, bone mass measurement benefits. H.R. 1920, To amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. H.R.2077, Restoring the Patient's Voice Act of 2017. H.R. 2141, Conrad State 30 and Physician Access Reauthorization Act. H.R. 2267, Resident Physician Shortage Reduction Act of 2017. H.R. 2641, Promoting Life-Saving New Therapies for Neonates Act of 2017. H.R. 2999, Patients' Access to Treatments Act of 2017. H.R. 3635, Local Coverage Determination Clarification Act of 2017. H.R. 3728, EMPOWER Act of 2017. H.R. 3767, Ensuring Children's Access to Specialty Care Act of 2017. H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018. H.R.6157, Defense and Labor, Health and Human Services Consolidated Appropriations Act, 2019. H.R. 6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 251, Protecting Medicare from Executive Action Act of 2017. S. 260, Protecting Seniors' Access to Medicare Act of 2017. S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017. S. 794, Local Coverage Determination Clarification Act of 2017. S. 898, Conrad State 30 and Physician Access Reauthorization Act. S. 989, Ensuring Children's Access to Specialty Care Act of 2017. S. 1301, Resident Physician Shortage Reduction Act of 2017. S. 1304, A bill to amend part B of title XVIII of the Social Security Act to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare, and for other purposes. S. 2553, Know the Lowest Price Act of 2018 (P.L. 115-262). S. 2554, Patient Right to Know Drug Prices Act (P.L. 115-263). S. 2908, To provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. S. 3158, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019. S. 3159, Department of Defense Appropriations Act, 2019. S. 3160, To improve access to, and utilization of, bone mass measurement benefits.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)

Issues related to the repeal of the Independent Payment Advisory Board (IPAB); Protecting Seniors' Access to Medicare Act of 2017 (H.R. 849/S. 260); Protecting Medicare from Executive Action Act of 2017 (S. 251) Diabetes prevention, generally Implementation of the Clinical Care Commission Act (Pub.L. 115-80) World Hemophilia Day Issues related to medication affordability and access, generally American Health Care Act/Better Care Reconciliation Act (H.R. 1628)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act H.R. 2430 - FDA Reauthorization Act of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 S. 2852 - Pandemic and All Hazards Preparedness Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bil1s, innovation, non-interference, 340B, Hepatitis C, HPV, Shingles, anti-microbial resistance, transparency, Pandemic All Hazards Preparedness Act reauthorization

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), 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 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

drug coverage and reimbursement value based contracting, access and affordability S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 3921 - Healthy Kids Act S. 1827 - Kids Act of 2017 Stark

Client expense: Not reported · Firm income: $50,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing

Client expense: $1,330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

- S. 469/H.R. 1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. - S. 771/H.R. 1776, "Improving Access To Affordable Prescription Drugs Act", regarding all provisions. - H.R. 575, "Cosmetic Modernization Amendments of 2017", regarding all provisions. - H.R. 1271, "DXM Abuse Prevention Act of 2017", regarding all provisions. - S. 404/H.R. 1736, "To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.", regarding all provisions. - Issues regarding drug pricing. - Issues related to diagnostic reform. - S 260/SJ Res 17/HR 849, Protecting Seniors' Access to Medicare Act of 2017, regarding all provisions - S 251/SJ Res 16, Protecting Medicare from Executive Action Act of 2017, regarding all provisions - S 204/HR 878, Right to Try Act of 2017, regarding all provisions - HR 2026, Pharmaceutical Information Exchange Act, regarding all provisions - HR 1703, Medical Product Communications Act of 2017, regarding all provisions - Issues related to VA procurement of medical devices - HR 2474, Medical Product Review Harmonization Act, regarding all provisions - HR 2144, Risk Based Classification of Accessories Act - Issues related to AMA resolution 208(A-16) regarding attorney ads on drug side effects - S.1113, "Personal Care Products Safety Act", regarding all provisions - HR 2790, "Humane Cosmetics Act", regarding all provisions - HR 3271, "Protecting Access to Diabetes Supplies Act", regarding all provisions - Issues regarding medical device repeal - Issues regarding NIH Funding - HR 2164, "Medical Device Safety Act", regarding all provisions - Issues related to 340B - Issues related to HIV vaccines - S. 2852, "Pandemic & All Hazards Preparedness and Advancing Innovations Act of 2018", regarding all provisions. - Issues related to reauthorization of the Pandemic All-Hazards Preparedness Act programs. (House version) - HR 5492, "MOTHER Act of 2018", regarding all provisions. - Issues related to access to essential surgery - Issues related to contact lens safety - HR 6, "SUPPORT for Patients and Communities Act", regarding all provisions. - S. 2315, "Over-the-Counter Drug Safety, Innovation, and Reform Act", regarding all provisions. - HR 5333 "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018", regarding all provisions. - Issues related to antimicrobial resistance - Issues related to regulations on medication product packaging - H.R. 6294, " Re-Valuing Anti-Microbial Products Act of 2018", regarding all provisions

Client expense: $1,980,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office