ALTO Act

Essential emergency medication shortages Mental health services for emergency psychiatric patients Price transparency, out-of-network reimbursement of emergency medical services H.Res.906-Congratulating the American College of Emergency Physicians on its 50th anniversary H.R.6-Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act H.R.372-Competetive Health Insurance Reform Act of 2017 H.R.548-Health Care Safety Net Enhancement Act of 2017 H.R.767-Stop, Observe, Ask, and Respond (SOAR) to Health and Wellness Act of 2017 H.R.817-End Surprise Billing Act of 2017 H.R.880-Military Injury Surgical Systems Integrated Operationally Nationwide to Achieve ZERO Preventable Deaths Act H.R.1057-Synthetics Trafficking and Overdose Prevention Act of 2017 H.R.1215-Protecting Access to Care Act of 2017 H.R.1323-Reducing Unnecessary Emergency Room Visits under Medicaid Act H.R.1492-Medical Controlled Substances Transportation Act of 2017 H.R.1565-Saving Lives, Saving Costs Act H.R.1822-Good Samaritan Health Professionals Act of 2017 H.R.1876-Good Samaritan Health Professionals Act of 2017 H.R.2200-Frederick Douglass Trafficking Victims Prevention and Protection Reauthorization Act of 2017 H.R.2410-Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2017 H.R.2851-Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017 H.R.2957-Save Rural Hospitals Act H.R.3181-Medicare Choices Empowerment and Protection Act H.R.3258-Marketplace Certainty Act H.R.3545-Overdose Prevention and Patient Safety (OPPS) Act H.R.4922-Stopping Overdoses of Fentanyl Analogues Act H.R.5176-Preventing Overdoses While in Emergency Rooms Act of 2018 H.R.5197-Alternatives to Opioids (ALTO) in the Emergency Department Act H.R.5531-Opioid Emergency Response Act H.R.5558-Alternatives to Opioids Prescribing Act H.R.5678-Rural Emergency Medical Center Act of 2018 H.R.5734-Resident Education Deferred Interest Act H.R.6082-Overdose Prevention and Patient Safety (OPPS) Act H.R.6143-Patient Right to Know Drug Prices Act H.R.6144-Know the Lowest Price Act of 2018 H.R.6372-To require the Secretary of Health and Human Services issue regulations to ensure due process rights for physicians furnishing emergency medical services H.R.6502-Reducing Unnecessary Senior Hospitalizations Act of 2018 H.R.6733-Know the Cost Act of 2018 Senate resolution congratulating the American College of Emergency Physicians on its 50th anniversary S.191-Patient Freedom Act of 2017 S.256-SOAR to Health and Wellness Act of 2017 S.284-End Surprise Billing Act of 2017 S.372- Synthetics Trafficking and Overdose Prevention Act of 2017 S.527-Health Care Safety Net Enhancement Act of 2017 S.568-Improving Access to Medicare Coverage Act of 2017 S.781-Good Samaritan Health Professionals Act of 2017 S.1016-Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2017 S.1022-Military Injury Surgical Systems Integrated Operationally Nationwide to Achieve ZERO Preventable Deaths Act S.1130-Rural Emergency Acute Care Hospital (REACH) Act S.1462-Marketplace Certainty Act S.1530- Medicare Choices Empowerment and Protection Act S.1553-Stopping Overdoses of Fentanyl Analogues Act S.1835-Lower Premiums Through Reinsurance Act of 2017 S.2465-Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2018 S.2516-Alternatives to Opioids (ALTO) in the Emergency Department Act S.2544-Patient Right to Know Drug Prices Act S.2553-Know the Lowest Price Act of 2018 S.2609-Recovery Coaches Offer Addiction Counseling and Healing (COACH) Act S.2610-Preventing Overdoses While in Emergency Departments Act of 2018 S.2680-Opioid Crisis Response Act of 2018 S.3531-Emergency Care Improvement Act

Client expense: $402,721 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6-Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act H.R.1057-Synthetics Trafficking and Overdose Prevention Act of 2017 H.R.1492-Medical Controlled Substances Transportation Act of 2017 H.R.2851-Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017 H.R.3545-Overdose Prevention and Patient Safety (OPPS) Act H.R.4922-Stopping Overdoses of Fentanyl Analogues Act H.R.5176-Preventing Overdoses While in Emergency Rooms Act of 2018 H.R.5197-Alternatives to Opioids (ALTO) in the Emergency Department Act H.R.5531-Opioid Emergency Response Act H.R.5558-Alternatives to Opioids Prescribing Act H.R.6082-Overdose Prevention and Patient Safety (OPPS) Act S.372-Synthetics Trafficking and Overdose Prevention Act of 2017 S.1327-Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017 S.1553-Stopping Overdoses of Fentanyl Analogues Act S.2516-Alternatives to Opioids (ALTO) in the Emergency Department Act S.2609-Recovery Coaches Offer Addiction Counseling and Healing (COACH) Act S.2610-Preventing Overdoses While in Emergency Departments Act of 2018 S.2680-Opioid Crisis Response Act of 2018

Client expense: $402,721 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

Opioid issues (S. 2680, the Opioid Crisis Response Act of 2018; H.R. 5176, Preventing Overdoses While in Emergency Rooms (POWER) Act; H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act; H.R. 5009, Jessies Law; H.R. 5818 / S. 2843, the Opioid Workforce Act; H.R. 5797, the IMD CARE Act; H.R. 6082/H.R. 5795, the Overdose Prevention and Patient Safety Act; S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act; S. 2460, Every Prescription Conveyed Securely Act; S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act; H.R. 5582, the Abuse Deterrent Access Act; H.R. 5685, the Medicare Opioid Safety Education Act; Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018; H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act; S. 2899, Caring Recovery for Infants and Babies Act; S. 2898, Medication-Assisted Treatment Improvement Act; S.2911, Enhancing Patient Access to Non-Opioid Treatment Options) Draft Protecting Patients from Surprise Medical Bills Act HIPAA policy in mental and behavioral health information sharing 21st Century Cures Act implementation Pandemic and All Hazards Preparedness Reauthorization, including Hospital Preparedness Program (S. 2852, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2018) S.781/ HR 1876. Good Samaritan Health Professional Act of 2017 Health workforce reauthorizations (H.R. 959, the Title VIII Nursing Workforce Reauthorization Act; H.R. 3728, the Educating Medical Professionals and Optimizing Workforce Efficiency Readiness (EMPOWER) Act; H.R. 1676, the Palliative Care and Hospice Education and Training Act Liver allocation policy (H.R. 6458 National Organ Transplant Act Amendments of 2018; H.R. 6517 Fairness in Liver Allocation Act of 2018) H.R. 5678, Rural Emergency Medical Center (REMC) Act of 2018) Disproportionate share hospital payments (H.R. 1892, Bipartisan Budget Act of 2018; implementation of the S-10 worksheet) H.R. 2267 / S. 1301, Resident Physician Shortage Reduction Act H.R. 5818 / S. 2843, Opioid Workforce Act Telehealth payment (H.R. 1892, Bipartisan Budget Act of 2018; H.R. 6, SUPPORT for Patients and Communities Act) Stark law reform Hospital outpatient payment policy Site neutral payment policy included in outpatient prospective payment system proposed rule Physician fee schedule rule Evaluation and management coding and payment policy in physician fee schedule rule S. 2597 / H.R. 5385, Children's Hospital GME Support Reauthorization Act of 2018 Opioid funding (CARA implementation; S. 2004, Combating the Opioid Epidemic Act; H.R. 1892, Bipartisan Budget Act of 2018; Consolidated Appropriations Act, 2018) Behavioral health funding (H.R. 1892, Bipartisan Budget Act of 2018; Consolidated Appropriations Act, 2018; H.R. 6157) HR 6470 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 H.R. 5645, the Standard Merger and Acquisition Reviews Through Equal Rules (SMARTER) Act Public Charge proposed rule Q4 Submitted Letters SUBJECT: DHS Docket No. USCIS-2010-0012, Inadmissibility on Public Charge Grounds; Proposed Rule SUBJECT: Docket No. FDA-2018-N-3272, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions SUBJECT: CMS-1701-P, Medicare Program: Medicare Shared Savings Program; Accountable Care Organizations Pathways to Success Proposed Rule SUBJECT: OIG-0803-N, Request for Information Regarding Anti-Kickback Statute and Beneficiary Inducements CMP SUBJECT: CMS-3346-P, Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction SUBJECT: Notice of Proposed Rulemaking, 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Effective Date Change

Client expense: $317,828 · 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, Social Security Administration (SSA)

Repeal of the Affordable Care Act H.R. 1628 The American Health Care Act Development of legislation to protect essential hospitals Issues related to telehealth Mental Health Essential Health Benefits created by the Affordable Care Act Access to hospital emergency services Issues related to the 340B Drug Pricing Program HR1628 Better Care Reconciliation Act ACA Cost Sharing Reduction Subsidies Graham-Cassidy Amendment to HR 1628 340B drug pricing program HR3545-Overdose, Prevention and Patient Advocacy Act HR4392 CMS OPPS 340b rule moratorium HR4710 340b PAUSE Act Bipartisan Healthcare Stabilization Act of 2017 Opioid Crisis Response Act of 2018 42 CFR Part 2 IMD Exclusion Prescription drug monitoring programs H.R. 5197, S. 2516, Alternatives to opioids in the emergency dept Act H.R. 5102, Substance Use Disorder Workforce Loan Repayment Act H.R. 5261, Treatment, Education, and Community Help to Combat Opioid Addiction Act Poison Center Network Enhancement Act A Bill to support the peer support specialist workforce HR6 Support for Patients and Communities Act H.R. 4710 PAUSE Act HELP Act S. 2312 HR6378 Pandemic and All Hazards Preparedness and Advancing Innovation Act S.974 CREATES Act S.2843 Opioid Workforce Act HEAL Act S.3120 SERV Communities Act H. R. 6071 S.428, H.R. 3325 The Advancing Care for Exceptional (ACE) Kids Act Cassidy Surprise Billing Draft H.R.6 Support for Patients and Communities Act Protecting Patients from Surprise Medical Bills Hassan Surprise Billing-S. 3592, No more Surprise Medical Bills Act H.R. 7328, Pandemic and All-Hazards Preparedness and Advancing Innovation Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

340B Drug Pricing Program Opioid issues (S. 2680, the Opioid Crisis Response Act of 2018; H.R. 5176, Preventing Overdoses While in Emergency Rooms (POWER) Act; H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act; H.R. 5009, Jessies Law; H.R. 5818 / S. 2843, the Opioid Workforce Act; H.R. 5797, the IMD CARE Act; H.R. 6082/H.R. 5795, the Overdose Prevention and Patient Safety Act; S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act; S. 2460, Every Prescription Conveyed Securely Act; S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act; H.R. 5582, the Abuse Deterrent Access Act; H.R. 5685, the Medicare Opioid Safety Education Act; Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018; H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act; S. 2899, Caring Recovery for Infants and Babies Act; S. 2898, Medication-Assisted Treatment Improvement Act; S.2911, Enhancing Patient Access to Non-Opioid Treatment Options) Draft Protecting Patients from Surprise Medical Bills Act HIPAA policy in mental and behavioral health information sharing 21st Century Cures Act implementation Pandemic and All Hazards Preparedness Reauthorization, including Hospital Preparedness Program (S. 2852 / H.R. 6378, H.R. 7328, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2018) S.781/ HR 1876. Good Samaritan Health Professional Act of 2017 Health workforce reauthorizations (H.R. 959, the Title VIII Nursing Workforce Reauthorization Act; H.R. 3728, the Educating Medical Professionals and Optimizing Workforce Efficiency Readiness (EMPOWER) Act; H.R. 1676, the Palliative Care and Hospice Education and Training Act Liver allocation policy S.2554, Patient Right to Know Drug Prices Act Consumer-directed health care proposals (Associations Health Plans, Short-term Limited Duration Insurance plans, Section 1332 waivers) Maternal health legislation (H.R. 315, Improving Access to Maternity Care Act and H.R. 1318, Preventing Maternal Deaths Act)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 204/H.R. 878 (Trickett Wendler Right to Try Act of 2017); authorizes the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with state law. S. 469/H.R. 1245 (Affordable and Safe Prescription Drug Importation Act); amends the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors. S. 670/H.R. 1652 (Over-the-Counter Hearing Aid Act of 2017); provides for the regulation of over-the-counter hearing aids. S. 297/H.R. 749 (Increasing Competition in Pharmaceuticals Act/Lower Drug Costs through Competition Act); amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs in some circumstances. S. 974/ H.R. 2212 (CREATES Act of 2017); alters the market for drugs and biological products by changing the requirements for generic and biosimilar versions of drugs and biological products. R. 5247 (Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018); with regard to liability issues. S. 2315 (Over-the-Counter Drug Safety, Innovation, and Reform Act); amends the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application. H.R. 5795/ H.R. 6082 (Overdose Prevention and Patient Safety Act); amends the Public Health Service Act to protect the confidentiality of substance use disorder patient records by restricting use of patient records in any civil action. H.R. 5176 (Preventing Overdoses While in Emergency Rooms Act of 2018); requires the Department of Health and Human Services to establish a grant program to: (1) develop protocols for discharging patients who are treated for a drug overdose, and (2) enhance the integration and coordination of postdischarge care and treatment options for individuals with a substance use disorder. H.R. 5197 (ALTO Act); requires and provides funds for, the Department of Health and Human Services to carry out a three-year demonstration program awarding grants to hospitals and emergency departments to develop, implement, enhance, or study alternative pain management protocols and treatments that promote limited use of opioids in emergency departments. H.R. 5009 (Jessie's Law); requires the Department of Health and Human Services (HHS) to develop and disseminate best practices for health care providers and state agencies regarding the display of a patient's history of opioid addiction in the patient's medical records. S. 2981 (Opioid Overdose Reduction Act of 2018); limits an individual's civil liability for harm caused by the emergency administration of an opioid overdose reversal drug (e.g., naloxone). S. 2680 (Opioid Crisis Response Act of 2018); comprehensive bill to address the opioid crisis. S. 2315 (Over-the-Counter Drug Safety, Innovation, and Reform Act); to clarify the regulatory framework with respect to certain nonprescrption drugs that are marketed without an approved new drug application. General lobbying with regard to the federal preemption of state causes of action involving medical device and drug manufacturers. General lobbying with regard to off label promotion of pharmaceutical products. General lobbying with regard to pharmaceutical drug advertising. General lobbying with regard to pharmaceutical price-gouging. General lobbying with regard to biosimilar naming and labeling. General lobbying with regard to updating generic drug labeling responsibilities. General lobbying with regard to opioid manufacturer liability. General lobbying with regard to opioid superfund and Medicare Secondary Payer issues. General lobbying with regard to OTC monograph federal preemption issues.

Client expense: $1,300,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)

S.1109/H.R.959 - Title VIII Nursing Workforce Reauthorization Act of 2017 H.R.3692, S.2317 - Addiction Treatment Access Improvement Act of 2017 HR6, SUPPORT for Patients and Communities Act (Public Law No: 115-271) H.R. 5102, S. 2524 - Substance Use Disorder Workforce Loan Repayment Act S.2456 - CARA 2.0 Act of 2018 H.R. 4284- INFO Act H.R. 5197, Alternatives to Opioids in the Emergency Room Department H.R. 5718, Perioperative Reduction of Opioids (PRO) Act H.R. 5774, Combating Opioid Abuse for Care in Hospitals (COACH) Act H.R. 5002, Ace Research Act H.R. 1783- Improving Veterans Access to Quality Care Act of 2017

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

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

H.R. 3692, Addiction Treatment Access Improvement Act of 2017: Medically assisted treatment; opioids H.R. 5761, Ending Maternal Mortality Act of 2018: Maternal mortality H.R. 5718, Perioperative Reduction of Opioids Act: Opioids H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act: Medically assisted treatment; opioids S. 2516, Alternatives to Opioids (ALTO) in the Emergency Department Act: Medically assisted treatment; opioids S.2680, Opioid Crisis Response Act of 2018: Medically assisted treatment; opioids S.2456, CARA 2.0 Act of 2018: Medically assisted treatment; opioids H.R. 1565, Saving Lives, Saving Costs S.1475, Saving Lives, Saving Costs Comprehensive Addiction and Recovery Act of 2016 (PL 114-198) Affordable Care Act reform efforts H.R. 1628, American Health Care Act of 2017 S. Amdt. 1030 to H.R. 1628, "Graham-Cassidy" Better Care Reconciliation Act of 2017 H.R. 1492, Medical Controlled Substances Transportation Act of 2017 H.R. 1215, Protecting Access to Care Act of 2017 H.R. 3545, Overdose Prevention and Patient Safety Act H.R. 3446, Restoring Board Immunity Act of 2017: Professional Licensing S.2260, Opioids and STOP Pain Initiative ACT:opioids 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care H.R.3928, Truth in Healthcare Marketing Act of 2017 H.R. 5734, Resident Education Deferred Interest Act: student loan debt repayment for residents 21st Century Cures Initiative Drug Shortages - FDA, DEA, HHS, CMS, GAO, House Energy and Commerce Committee, Senate HELP Committee DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee FDA SMART TOTS - pediatric anesthesia research USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Sequestration Opioids and Opioid abuse; Brain health

Client expense: $200,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

Implementation/Expansion of CDC Falls Program Implementation of Affordable Care Act - provisions pertaining to Essential Health Benefits & Health Insurance Exchanges AHRQ provisions pertaining to PT Physician self-referra/Stark Law American Cures Act H.R. 930/S.497 Lymphadema Treatment Act Health Information Technology Nominations to PCORI Methodology Committees Medicaid Expansion HR. 1639/S.619 Physical Therapist Workforce & Patient Access Act Physician owned distributerships H.R. 302/S.808 Sports Medicine Licensure Clarity Act MACRA/MIPS APMS IMPACT/PAC reform Network adequacy Insurance Benefit parameters H.R. 1361/S.486 Ensuring Access to Quality CRT Medicare Telehealth Parity Act HR2550 American Healthcare Act of 2017/CONNECT - H.R. 2556/S1016 H.R. 1628 - American Health Care Action of 2017 Opioid Epidemic/Pain Management Better Care Reconciliation Act of 2017 H.R.2066 Promoting Integrity in Medicare H.R. 2063 Opioid Pace Act of 2017 H.R. 5261 Teach Act H.R. 5197 Alto Act H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act H.R. 5773, Preventing Addiction for Susceptible Seniors Act H.R. 5774, Combating Opioid Abuse for Care in Hospitals Act H.R. 5718, Perioperative Reduction for Opioids Act H.R. 5719, Reduce Overprescribing Opioids in Treatment Act H.R. 5722, Dr. Todd Graham Pain Management Improvement Act H.R. 6, Substance-Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act S. 3120, the HEAL Act S. 2680, Opioid Crisis Response Act Association Retirement Plans State Relief and Empowerment Waivers D.O.L Information Collection Request Extensions Health Reimbursement Accounts HR 7217: Improve Act

Client expense: $252,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Education, Dept of, Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Small Business Administration (SBA), Veterans Affairs, Dept of (VA), White House Office

H.R. 807/S.253 Medicare Access to Rehabilitation Services Act (Medicare Appeals Procedures) QPP Prevention Initiatives for Fraud and Abuse in The Medicare program Accountable health care organizations/patient centered medical homes Electronic health records/health information technology incentives for Physical Therapists Local coverage determinations/EMG NCCI Edits Protection of programs related to physical therapy in deficit reduction Medicare Advantage PCORI National priority for research and research agenda Health information technology Functional Limitation Reporting Therapy Cap: Targeted Medical Review Essential Health Benefits MIPS/PPP Medicaid essential health benefits EHR/LTPAC settings: transitions of care Medicare improvement standards Bundled payment models/CJR Common assessment tool for Medicare post-acute care Medicare appeals process Inclusion of physical therapists in quality programs Self-referral Coverage of telehealth APTA Registry Quality Programs Accelerating Innovation in Medicine Act (AIM) IMPACT Medicare Pilot Programs Chronic Care Management New evaluation and reevaluation CPT codes & misvalued codes Orthotics and Prosthetics Medicare Private Contracting S.870 - Chronic Care Act SNF 3-Day Rule Registry- ACI HR 2042 - Frontline Act Youth Concussion Management DME HR 3446 RBI Act H.R. 5261 Teach Act Opioid related H.R. 5197 Alto Act Opioid related Administrative Burden H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act H.R. 5773, Preventing Addiction for Susceptible Seniors Act H.R. 5774, Combating Opioid Abuse for Care in Hospitals Act H.R. 5718, Perioperative Reduction for Opioids Act H.R. 5719, Reduce Overprescribing Opioids in Treatment Act H.R. 5722, Dr. Todd Graham Pain Management Improvement Act H.R. 6, Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. S. 3120, HEAL Act S. 2680, Opioid Crisis Response Act PTA Differential in Medicare Prior Authorization in Medicare Advantage Plans Alternative payment models Certified EHR technology HR 7217 Improving Medicaid Programs and Opportunities for Eligible Beneficiaries Act (IMPROVE ACT) S. 3458: Improvements to Home Health HR 3635: Local Coverage Determination Clarification Act of 2018

Client expense: $252,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Education, Dept of, Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Small Business Administration (SBA), Veterans Affairs, Dept of (VA), White House Office

S. 204/H.R. 878 (Trickett Wendler Right to Try Act of 2017); authorizes the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law. S. 469/H.R. 1245 (Affordable and Safe Prescription Drug Importation Act); amends the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors. S. 670/H.R. 1652 (Over-the-Counter Hearing Aid Act of 2017); provides for the regulation of over-the-counter hearing aids. S. 297/H.R. 749 (Increasing Competition in Pharmaceuticals Act/Lower Drug Costs through Competition Act); amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs in some circumstances. S. 974 (CREATES Act of 2017); alters the market for drugs and biological products by changing the requirements for generic and biosimilar versions of drugs and biological products. R. 5247 (Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018); with regard to liability issues. S. 2315 (Over-the-Counter Drug Safety, Innovation, and Reform Act); amends the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application. H.R. 5795/ H.R. 6082 (Overdose Prevention and Patient Safety Act); amends the Public Health Service Act to protect the confidentiality of substance use disorder patient records by restricting use of patient records in any civil action. H.R. 5176 (Preventing Overdoses While in Emergency Rooms Act of 2018); requires the Department of Health and Human Services to establish a grant program to: (1) develop protocols for discharging patients who are treated for a drug overdose, and (2) enhance the integration and coordination of postdischarge care and treatment options for individuals with a substance use disorder. H.R. 5197 (ALTO Act); requires and provides funds for, the Department of Health and Human Services to carry out a three-year demonstration program awarding grants to hospitals and emergency departments to develop, implement, enhance, or study alternative pain management protocols and treatments that promote limited use of opioids in emergency departments. H.R. 5009 (Jessie's Law); requires the Department of Health and Human Services (HHS) to develop and disseminate best practices for health care providers and state agencies regarding the display of a patient's history of opioid addiction in the patient's medical records. S. 2981 (Opioid Overdose Reduction Act of 2018); limits an individual's civil liability for harm caused by the emergency administration of an opioid overdose reversal drug (e.g., naloxone). S. 2680 (Opioid Crisis Response Act of 2018); comprehensive bill to address the opioid crisis. General lobbying with regard to the preemption of states causes of action involving medical device and drug manufacturers. General lobbying with regard to off label promotion of pharmaceutical products. General lobbying with regard to pharmaceutical drug advertising. General lobbying with regard to pharmaceutical price-gouging. General lobbying with regard to biosimilar naming and labeling. General lobbying with regard to updating generic drug labeling responsibilities. General lobbying with regard to opioid manufacturer liability. General lobbying with regard to opioid superfund and Medicare Secondary Payer issues. General lobbying with regard to OTC monograph preemption issues.

Client expense: $1,430,000 · Firm income: Not reported

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

S. 204/H.R. 878 (Trickett Wendler Right to Try Act of 2017); authorizes the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with state law. S. 469/H.R. 1245 (Affordable and Safe Prescription Drug Importation Act); amends the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors. S. 670/H.R. 1652 (Over-the-Counter Hearing Aid Act of 2017); provides for the regulation of over-the-counter hearing aids. S. 297/H.R. 749 (Increasing Competition in Pharmaceuticals Act/Lower Drug Costs through Competition Act); amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs in some circumstances. S. 974 (CREATES Act of 2017); alters the market for drugs and biological products by changing the requirements for generic and biosimilar versions of drugs and biological products. R. 5247 (Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018); with regard to liability issues. S. 2315 (Over-the-Counter Drug Safety, Innovation, and Reform Act); amends the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application. H.R. 5795/ H.R. 6082 (Overdose Prevention and Patient Safety Act); amends the Public Health Service Act to protect the confidentiality of substance use disorder patient records by restricting use of patient records in any civil action. H.R. 5176 (Preventing Overdoses While in Emergency Rooms Act of 2018); requires the Department of Health and Human Services to establish a grant program to: (1) develop protocols for discharging patients who are treated for a drug overdose, and (2) enhance the integration and coordination of postdischarge care and treatment options for individuals with a substance use disorder. H.R. 5197 (ALTO Act); requires and provides funds for, the Department of Health and Human Services to carry out a three-year demonstration program awarding grants to hospitals and emergency departments to develop, implement, enhance, or study alternative pain management protocols and treatments that promote limited use of opioids in emergency departments. H.R. 5009 (Jessie's Law); requires the Department of Health and Human Services (HHS) to develop and disseminate best practices for health care providers and state agencies regarding the display of a patient's history of opioid addiction in the patient's medical records. S. 2981 (Opioid Overdose Reduction Act of 2018); limits an individual's civil liability for harm caused by the emergency administration of an opioid overdose reversal drug (e.g., naloxone). S. 2680 (Opioid Crisis Response Act of 2018); comprehensive bill to address the opioid crisis. General lobbying with regard to the federal preemption of state causes of action involving medical device and drug manufacturers. General lobbying with regard to off label promotion of pharmaceutical products. General lobbying with regard to pharmaceutical drug advertising. General lobbying with regard to pharmaceutical price-gouging. General lobbying with regard to biosimilar naming and labeling. General lobbying with regard to updating generic drug labeling responsibilities. General lobbying with regard to opioid manufacturer liability. General lobbying with regard to opioid superfund and Medicare Secondary Payer issues. General lobbying with regard to OTC monograph federal preemption issues.

Client expense: $1,510,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)

Insurance market policies (Bipartisan Health Care Stabilization Act; Short-term, Limited Duration Health Insurance rule; Association Health Plans rule) Risk adjustment payments Cost sharing reduction payments Insurance navigator funding 340B Drug Pricing Program (H.R. 4392; H.R. 4710, 340B PAUSE Act; S. 2453, Ensuring the Value of the 340B Program Act; H.R. 6071, Stretching Entity Resources for Vulnerable Communities Act; H.R. 2889, Closing Loopholes for Orphan Drugs Act; H.R. 5598, 340B Optimization Act; H.R. 6240, Drug Discount Accountability Act; H.R. 6273, Creating Access to Rape Kit Exams (CARE) for Survivors Act) Opioid issues (S. 2680, the Opioid Crisis Response Act of 2018; H.R. 5176, Preventing Overdoses While in Emergency Rooms (POWER) Act; H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act; H.R. 5009, Jessies Law; H.R. 5818 / S. 2843, the Opioid Workforce Act; H.R. 5797, the IMD CARE Act; H.R. 6082/H.R. 5795, the Overdose Prevention and Patient Safety Act; S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act; S. 2460, Every Prescription Conveyed Securely Act; S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act; H.R. 5582, the Abuse Deterrent Access Act; H.R. 5685, the Medicare Opioid Safety Education Act; Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018; H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act; S. 2899, Caring Recovery for Infants and Babies Act; S. 2898, Medication-Assisted Treatment Improvement Act; S.2911, Enhancing Patient Access to Non-Opioid Treatment Options) IV and medication shortages Drug prices (American Patients First, Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs; S. 2554 / H.R. 6143, Patient Right to Know Drug Prices Act; S. 2553, Know the Lowest Price Act; H.R. 6733, Know the Cost Act) Draft Protecting Patients from Surprise Medical Bills Act HIPAA policy in mental and behavioral health information sharing 21st Century Cures Act implementation Pandemic and All Hazards Preparedness Reauthorization, including Hospital Preparedness Program (S. 2852, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2018) S.781/ HR 1876. Good Samaritan Health Professional Act of 2017 Health workforce reauthorizations (H.R. 959, the Title VIII Nursing Workforce Reauthorization Act; H.R. 3728, the Educating Medical Professionals and Optimizing Workforce Efficiency Readiness (EMPOWER) Act; H.R. 1676, the Palliative Care and Hospice Education and Training Act Consumer Directed Health Plans Legislation (H.R. 6311 would modify the definition of a qualified health plan and allow individuals purchasing health insurance in the individual market to purchase a "copper" plan or use the premium tax credit to buy off-marketplace coverage; H.R. 6301 to allow CDHPs to provide coverage for services like telehealth, chronic disease management, or primary care visits below the minimum deductible; H.R. 6317 to allow coverage of direct primary care service arrangements; H.R. 6305 to permit use of CDHPs to receive certain employment-related health services like onsite clinics; H.R. 6309 to allow individuals only enrolled in Medicare Part A to contribute to health savings accounts; H.R. 6199 to include certain over-the-counter medical products as qualified medical expenses; H.R. 6306 to increase the current contribution limits for HSAs; H.R. 6312, Personal Health Investment Today (PHIT) Act to count sports equipment and exercise costs toward medical expenses; H.R. 6313 to allow carry-forward of flexible spending account balances each year; H.R. 6314 to allow bronze and catastrophic plans in connection with health savings accounts, allowing plans categorized as catastrophic and bronze in the individual and small group markets to qualify for HSA contributions) H.R. 4616 to delay the implementation of the excise tax on high cost employer-sponsored health coverage; and place a moratorium on the employer mandate Liver allocation policy

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 880/ S. 1022 the MISSION ZERO Act; H.R. 959, the Title VIII Nursing Workforce Reauthorization Act; H.R. 767/S. 256 SOAR to Health and Wellness Act; H.R. 3780 Air Ambulance Quality and Accountability Act; H.R. 1876/ S. 781 Good Samaritan Health Professionals Act; H.R. 5223 Health Care Workplace Violence Prevention Act; H.R. 5176/ S. 2610 Preventing Overdoses While in Emergency Rooms (POWER) Act; H.R. 5197/ S. 2516 Alternatives to Opioids (ALTO) in the ED Act; H.R. 5329 Poison Center Network Enhancement Act; S. 2852 Pandemic and All-Hazards Preparedness Act; H.R. 6 SUPPORT for Patients and Communities Act (Opioids bill); H.R. 2485/ S. 1167 Airplance KiTS Act; FAA Reauthorization;H.R. 6748/ S. 3482 Emergency Medical Services for Children Program Reauthorization Act

Client expense: $32,200 · Firm income: Not reported

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

Repeal of the Affordable Care Act H.R. 1628 The American Health Care Act Development of legislation to protect essential hospitals Issues related to telehealth Mental Health Essential Health Benefits created by the Affordable Care Act Access to hospital emergency services Issues related to the 340B Drug Pricing Program HR1628 Better Care Reconciliation Act ACA Cost Sharing Reduction Subsidies Graham-Cassidy Amendment to HR 1628 340B drug pricing program HR3545-Overdose, Prevention and Patient Advocacy Act HR4392 CMS OPPS 340b rule moratorium HR4710 340b PAUSE Act Bipartisan Healthcare Stabilization Act of 2017 Opioid Crisis Response Act of 2018 42 CFR Part 2 IMD Exclusion Prescription drug monitoring programs H.R. 5197, S. 2516, Alternatives to opioids in the emergency dept Act H.R. 5102, Substance Use Disorder Workforce Loan Repayment Act H.R. 5261, Treatment, Education, and Community Help to Combat Opioid Addiction Act Poison Center Network Enhancement Act A Bill to support the peer support specialist workforce HR6 Support for Patients and Communities Act H.R. 4710 PAUSE Act HELP Act S. 2312 HR6378 Pandemic and All Hazards Preparedness and Advancing Innovation Act S.974 CREATES Act S.2843 Opioid Workforce Act HEAL Act S.3120 SERV Communities Act H. R. 6071 S.428, H.R. 3325 The Advancing Care for Exceptional (ACE) Kids Act Cassidy Surprise Billing Draft H.R.6 Support for Patients and Communities Act Protecting Patients from Surprise Medical Bills

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

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

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

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

H.R. 807/S.253 Medicare Access to Rehabilitation Services Act (Repeal of Therapy Caps) QPP Prevention Initiatives for Fraud and Abuse in The Medicare program Accountable health care organizations/patient centered medical homes Electronic health records/health information technology incentives for Physical Therapists Local coverage determinations/EMG NCCI Edits Protection of programs related to physical therapy in deficit reduction Medicare Advantage PCORI National priority for research and research agenda Health information technology Functional Limitation Reporting Therapy Cap: Targeted Medical Review Essential Health Benefits MIPS/PPP Medicaid essential health benefits EHR/LTPAC settings: transitions of care Medicare improvement standards Bundled payment models/CJR Common assessment tool for Medicare post-acute care Medicare appeals process Inclusion of physical therapists in quality programs Self-referral Coverage of telehealth APTA Registry Quality Programs Accelerating Innovation in Medicine Act (AIM) IMPACT Medicare Pilot Programs Chronic Care Management New evaluation and reevaluation CPT codes & misvalued codes Orthotics and Prosthetics Medicare Private Contracting S.870 - Chronic Care Act SNF 3-Day Rule Registry- ACI HR 2042 - Frontline Act Youth Concussion Management DME HR 3446 RBI Act H.R. 5261 Teach Act Opioid related H.R. 5197 Alto Act Opioid related Administrative Burden H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act H.R. 5773, Preventing Addiction for Susceptible Seniors Act H.R. 5774, Combating Opioid Abuse for Care in Hospitals Act H.R. 5718, Perioperative Reduction for Opioids Act H.R. 5719, Reduce Overprescribing Opioids in Treatment Act H.R. 5722, Dr. Todd Graham Pain Management Improvement Act H.R. 6, Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. S. 3120, HEAL Act S. 2680, Opioid Crisis Response Act PTA Differential in Medicare Prior Authorization in Medicare Advantage Plans Alternative payment models Certified EHR technology

Client expense: $251,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Education, Dept of, Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Small Business Administration (SBA), Veterans Affairs, Dept of (VA), White House Office

Implementation/Expansion of CDC Falls Program Implementation of Affordable Care Act - provisions pertaining to Essential Health Benefits & Health Insurance Exchanges AHRQ provisions pertaining to PT Physician self-referra/Stark Law American Cures Act H.R. 930/S.497 Lymphadema Treatment Act Health Information Technology Nominations to PCORI Methodology Committees Medicaid Expansion HR. 1639/S.619 Physical Therapist Workforce & Patient Access Act Physician owned distributerships H.R. 302/S.808 Sports Medicine Licensure Clarity Act MACRA/MIPS APMS IMPACT/PAC reform Network adequacy Insurance Benefit parameters H.R. 1361/S.486 Ensuring Access to Quality CRT Medicare Telehealth Parity Act HR2550 American Healthcare Act of 2017/CONNECT - H.R. 2556/S1016 H.R. 1628 - American Health Care Action of 2017 Opioid Epidemic/Pain Management Better Care Reconciliation Act of 2017 H.R.2066 Promoting Integrity in Medicare H.R. 2063 Opioid Pace Act of 2017 H.R. 5261 Teach Act H.R. 5197 Alto Act H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act H.R. 5773, Preventing Addiction for Susceptible Seniors Act H.R. 5774, Combating Opioid Abuse for Care in Hospitals Act H.R. 5718, Perioperative Reduction for Opioids Act H.R. 5719, Reduce Overprescribing Opioids in Treatment Act H.R. 5722, Dr. Todd Graham Pain Management Improvement Act H.R. 6, Substance-Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act S. 3120, the HEAL Act S. 2680, Opioid Crisis Response Act

Client expense: $251,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Education, Dept of, Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Small Business Administration (SBA), Veterans Affairs, Dept of (VA), White House Office

S.1109/H.R.959 - Title VIII Nursing Workforce Reauthorization Act of 2017 H.R.3692, S.2317 - Addiction Treatment Access Improvement Act of 2017 HR6, SUPPORT for Patients and Communities Act H.R. 5102, S. 2524 - Substance Use Disorder Workforce Loan Repayment Act S.2456 - CARA 2.0 Act of 2018 H.R. 4284- INFO Act H.R. 6 - SUPPORT for Patients and Communities Act H.Res.1099 - Providing for the concurrence by the House in the Senate amendment to H.R. 6, with an amendment H.R. 5197, Alternatives to Opioids in the Emergency Room Department H.R. 5718, Perioperative Reduction of Opioids (PRO) Act H.R. 5774, Combating Opioid Abuse for Care in Hospitals (COACH) Act H.R. 5002, Ace Research Act H.R. 1783- Improving Veterans Access to Quality Care Act of 2017 Nursing Workforce Development; Chronic Pain management

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

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

H.R. 3692, Addiction Treatment Access Improvement Act of 2017: Medically assisted treatment; opioids H.R. 5761, Ending Maternal Mortality Act of 2018: Maternal mortality H.R. 5718, Perioperative Reduction of Opioids Act: Opioids H.R.5197, Alternatives to Opioids (ALTO) in the Emergency Department Act: Medically assisted treatment; opioids S. 2516, Alternatives to Opioids (ALTO) in the Emergency Department Act: Medically assisted treatment; opioids S.2680, Opioid Crisis Response Act of 2018: Medically assisted treatment; opioids S.2456, CARA 2.0 Act of 2018: Medically assisted treatment; opioids H.R. 1565, Saving Lives, Saving Costs S.1475, Saving Lives, Saving Costs Comprehensive Addiction and Recovery Act of 2016 (PL 114-198) Affordable Care Act reform efforts H.R. 1628, American Health Care Act of 2017 S. Amdt. 1030 to H.R. 1628, "Graham-Cassidy" Better Care Reconciliation Act of 2017 H.R. 1492, Medical Controlled Substances Transportation Act of 2017 H.R. 1215, Protecting Access to Care Act of 2017 H.R. 3545, Overdose Prevention and Patient Safety Act H.R. 3446, Restoring Board Immunity Act of 2017: Professional Licensing S.2260, Opioids and STOP Pain Initiative ACT:opioids 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care H.R.3928, Truth in Healthcare Marketing Act of 2017 21st Century Cures Initiative Drug Shortages - FDA, DEA, HHS, CMS, GAO, House Energy and Commerce Committee, Senate HELP Committee DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee FDA SMART TOTS - pediatric anesthesia research USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Sequestration Opioids and Opioid abuse; Brain health

Client expense: $180,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

Essential emergency medication shortages Mental health services for emergency psychiatric patients Price transparency of emergency medical services Due process rights for physicians furnishing emergency medical services H.Res.906-Congratulating the American College of Emergency Physicians on its 50th anniversary H.R.6-Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act H.R.372-Competetive Health Insurance Reform Act of 2017 H.R.548-Health Care Safety Net Enhancement Act of 2017 H.R.767-Stop, Observe, Ask, and Respond (SOAR) to Health and Wellness Act of 2017 H.R.817-End Surprise Billing Act of 2017 H.R.880-Military Injury Surgical Systems Integrated Operationally Nationwide to Achieve ZERO Preventable Deaths Act H.R.1057-Synthetics Trafficking and Overdose Prevention Act of 2017 H.R.1215-Protecting Access to Care Act of 2017 H.R.1323-Reducing Unnecessary Emergency Room Visits under Medicaid Act H.R.1492-Medical Controlled Substances Transportation Act of 2017 H.R.1565-Saving Lives, Saving Costs Act H.R.1822-Good Samaritan Health Professionals Act of 2017 H.R.1876-Good Samaritan Health Professionals Act of 2017 H.R.2200-Frederick Douglass Trafficking Victims Prevention and Protection Reauthorization Act of 2017 H.R.2851-Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017 H.R.2957-Save Rural Hospitals Act H.R.3181-Medicare Choices Empowerment and Protection Act H.R.3258-Marketplace Certainty Act H.R.3545-Overdose Prevention and Patient Safety (OPPS) Act H.R.4922-Stopping Overdoses of Fentanyl Analogues Act H.R.5176-Preventing Overdoses While in Emergency Rooms Act of 2018 H.R.5197-Alternatives to Opioids (ALTO) in the Emergency Department Act H.R.5531-Opioid Emergency Response Act H.R.5558-Alternatives to Opioids Prescribing Act H.R.5678-Rural Emergency Medical Center Act of 2018 H.R.6082-Overdose Prevention and Patient Safety (OPPS) Act S.191-Patient Freedom Act of 2017 S.256-SOAR to Health and Wellness Act of 2017 S.284-End Surprise Billing Act of 2017 S.372- Synthetics Trafficking and Overdose Prevention Act of 2017 S.527-Health Care Safety Net Enhancement Act of 2017 S.568-Improving Access to Medicare Coverage Act of 2017 S.781-Good Samaritan Health Professionals Act of 2017 S.1016-Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2017 S.1022-Military Injury Surgical Systems Integrated Operationally Nationwide to Achieve ZERO Preventable Deaths Act S.1130-Rural Emergency Acute Care Hospital (REACH) Act S.1462-Marketplace Certainty Act S.1530- Medicare Choices Empowerment and Protection Act S.1553-Stopping Overdoses of Fentanyl Analogues Act S.1835-Lower Premiums Through Reinsurance Act of 2017 S.2516-Alternatives to Opioids (ALTO) in the Emergency Department Act S.2609-Recovery Coaches Offer Addiction Counseling and Healing (COACH) Act S.2610-Preventing Overdoses While in Emergency Departments Act of 2018

Client expense: $702,392 · Firm income: Not reported

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

H.R.6-Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act H.R.1057-Synthetics Trafficking and Overdose Prevention Act of 2017 H.R.1492-Medical Controlled Substances Transportation Act of 2017 H.R.2851-Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017 H.R.3545-Overdose Prevention and Patient Safety (OPPS) Act H.R.4922-Stopping Overdoses of Fentanyl Analogues Act H.R.5176-Preventing Overdoses While in Emergency Rooms Act of 2018 H.R.5197-Alternatives to Opioids (ALTO) in the Emergency Department Act H.R.5531-Opioid Emergency Response Act H.R.5558-Alternatives to Opioids Prescribing Act H.R.6082-Overdose Prevention and Patient Safety (OPPS) Act S.372-Synthetics Trafficking and Overdose Prevention Act of 2017 S.1327-Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017 S.1553-Stopping Overdoses of Fentanyl Analogues Act S.2516-Alternatives to Opioids (ALTO) in the Emergency Department Act S.2609-Recovery Coaches Offer Addiction Counseling and Healing (COACH) Act S.2610-Preventing Overdoses While in Emergency Departments Act of 2018

Client expense: $702,392 · Firm income: Not reported

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Advantage; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicaid; Opioids; Medicare Part D. HR 2575 Introduced May 19, 2017 by Raul Ruiz (R-CA) To amend title XVIII of the Social Security Act to establish a system to educate individuals approaching Medicare eligibility, to simplify and modernize the eligibility enrollment process, and for other purposes. HR 3921 HEALTHY KIDS Act Introduced October 3, 2017 by Michael Burgess (R-TX) To extend funding for the Children's Health Insurance Program, and for other purposes. HR 1148 FAST Act of 2017 Introduced February 16, 2017 by Morgan Griffith (R-VA) To amend title XVIII of the Social Security Act to expand access to telehealth-eligible stroke services under the Medicare program. HR 3192 CHIP Mental Health Parity Act Introduced July 12, 2017 by Joseph Kennedy III (D-MA) To amend title XXI of the Social Security Act to ensure access to mental health services for children under the Children's Health Insurance Program, and for other purposes. HR 6 SUPPORT for Patients and Communities Act Introduced June 13, 2018 by Greg Walden (R-OR) includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl. The policies contained in the legislation were advanced through regular order by the House Energy and Commerce Committee and the Ways and Means Committee. HR 5752 Stop Illicit Drug Importation Act of 2018 Introduced May 10, 2018 by Marsha Blackburn (R-TN) amends the Federal Food, Drug, and Cosmetic Act (FD&C) to strengthen the Food and Drug Administrations (FDA) seizure powers and enhance its authority to detain, refuse, seize, or destroy illegal products offered for import. The legislation would subject more people to debarment and civil penalties under the Act. HR 5806 21st Century Tools for Pain and Addiction Treatment Act Introduced May 15, 2018 by Michael Burgess(R-TX) To require the Secretary of Health and Human Services to issue guidance with respect to the expedited approval of certain drugs, and for other purposes. HR 3192 CHIP Mental Health Parity Act To amend title XXI of the Social Security Act to ensure access to mental health services for children under the Children's Health Insurance Program, and for other purposes. HR 5796 Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act of 2018 Introduced May 15, 2018 by Brian Fitzpatrick (R-PA) To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids, and for other purposes. HR 5605 Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act Introduced April 24, 2018 by Raul Ruiz (D-CA) establishes a four-year demonstration program to increase access to treatment for opioid use disorder. The demonstration would provide incentive payments and funding for care management services based on criteria such as patient engagement, use of evidence-based treatments, and treatment length and intensity. Under the bill, the Secretary of Health and Human Services would be directed to encourage other payers to coordinate payments for opioid use disorder treatments and to evaluate the extent to which the demonstration reduces hospitalizations, increases the use of medication-assisted treatments, and improves the health outcomes of individuals with opioid use disorders during and after the demonstration. This bill also incorporates H.R. 3528, Every Prescription Conveyed Securely Act, which would require e-prescribing, with exceptions, for coverage of prescribed controlled substances under the Medicare Part D program. HR 5587 Peer Support Communities of Recovery Act Introduced April 23, 2018 by Ben Lujan (D-NM) enhances the Comprehensive Addiction and Recovery Acts Building Communities of Recovery Program and authorizes the Department of Health and Human Services (HHS) to award grants to peer support specialist organizations for the development and expansion of recovery services. Grants shall be awarded to nonprofit organizations that support community-based, peer delivered support, including technical support for the establishment of recovery community organizations, independent, nonprofit groups led by people in recovery and their families. HR 5809 Postoperative Opioid Prevention Act of 2018 Introduced May 15, 2018 by Scott Peters (D-CA) To amend title XVIII of the Social Security Act to encourage the use of non-opioid analgesics for the management of post-surgical pain under the Medicare program, and for other purposes. HR 4284 INFO Act Introduced November 7, 2017 by Robert Latta (R-OH) directs the Department of Health and Human Services (HHS) to create a public and easily accessible electronic dashboard linking to all of the nationwide efforts to combat the opioid crisis. In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder (OUD) and other substance use disorder (SUD) research, services, and prevention activities across all relevant Federal agencies, evaluate the effectiveness of these activities, and make specific recommendations for actions that agencies can take to better coordinates the administration of services for patients with OUD and SUD. HR 5009 Jessies Law Introduced February 13, 2018 by Tim Walberg (R-MI) Ensures medical professionals have access to a consenting patients complete health information when making treatment decisions by requiring the Department of Health and Human Services (HHS) to develop and annually disseminate best practices regarding the prominent display of substance use disorder (SUD) history in records of patients who have previously provided this information to a health care provider. HR 5197 ALTO Act Introduced March 7, 2018 by Bill Pascrell, Jr. (D-NJ) Directs the Secretary of Health and Human Services (HHS) to carry out a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments. Following the completion of the three-year demonstration, the Secretary of Health and Human Services will submit a report to Congress on the results of the program and issue recommendations for broader implementation. The legislation authorizes $10 million annually in grants for fiscal years 2019-2021. HR 5261 Treatment, Education, and Community Help to Combat Addiction Act of 2018 Introduced March 13, 2018 by Bill Johnson (R-OH) directs theSecretary of Health and Human Services (HHS) to designate regional Centers of Excellence to enhance and improve how health professional are educated in substance abuse disorder prevention, treatment, and recovery through development, evaluation, and distribution of evidence-based curricula for health profession schools. The bill authorizes $4 million annually for grants to those programs over the 2019-2023 period. HR 5272 To provide additional guidance to grantees seeking funding to treat or prevent mental health or substance use disorders. Introduced March 14, 2018 by Steve Stivers (R-OH) Requires the newly established National Mental Health and Substance Use Policy Laboratory to issue guidance to applicants for Substance Abuse and Mental Health Services Administration (SAMHSA) grants that support evidence-based practices. The guidance shall include how best to articulate the rationale for a given program or activity; encourage the funding of evidence-based interventions; and encourage the replication of promising or effective practices. HR 5327 Comprehensive Opioid Recovery Centers Act of 2018 Introduced March 19, 2018 by Brett Guthrie (R-KY) directs the Secretary of Health and Human Services (HHS) to award grants to at least 10 providers that offer treatment services for people with opioid use disorder. These Comprehensive Opioid Recovery Centers would serve as models for comprehensive treatment and recovery and would utilize the full range of Food and Drug Administration approved medications and evidence-based treatments, have strong linkages with the community, generate meaningful outcomes data, and dramatically improve the opportunities for individuals to establish and maintain long-term recovery. Either directly or through coordination with other entities, Centers must provide services including withdrawal management, counseling, recovery housing, community-based and peer recovery support services, job training and placement assistance, pharmacy and toxicology services, and a secure and confidential electronic health information system. HR 3331 To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Introduced July 20, 2017 by Lynn Jenkins (R-KY) authorizes the Center for Medicare and Medicaid Innovation to test a program offering incentive payments to behavioral health providers that adopt and use certified electronic health record technology. The U.S. government introduced the Meaningful Use program as part of the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act, to encourage health care providers to show "meaningful use" of a certified Electronic Health Record (EHR). In doing so, eligible providers who do so receive incentive payments, but behavioral health providers were not included in the definition of eligible providers. Individual physicians and other eligible health care professionals can each receive up to $44,000 through the Medicare Meaningful Use program or up to $63,750 through the Medicaid Meaningful Use program, depending upon when they begin attesting to the program's requirements. HR 3528 Every Prescription Conveyed Securely Act Introduced July 28, 2017 by Katherine Clark (D-MA) To amend title XVIII of the Social Security Act to require e-prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances. HR 4841 Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Introduced January 18, 2018 by David Schweikert (R-AZ) To amend title XVIII of the Social Security Act to provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

S. 204/H.R. 878 (Trickett Wendler Right to Try Act of 2017); authorizes the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law. S. 469/H.R. 1245 (Affordable and Safe Prescription Drug Importation Act); amends the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors. S. 670/H.R. 1652 (Over-the-Counter Hearing Aid Act of 2017); provides for the regulation of over-the-counter hearing aids. S. 297/H.R. 749 (Increasing Competition in Pharmaceuticals Act/Lower Drug Costs through Competition Act); amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs in some circumstances. S. 974 (CREATES Act of 2017); alters the market for drugs and biological products by changing the requirements for generic and biosimilar versions of drugs and biological products. R. 5247 (Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018); with regard to liability issues. S. 2315 (Over-the-Counter Drug Safety, Innovation, and Reform Act); amends the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application. H.R. 5795/ H.R. 6082 (Overdose Prevention and Patient Safety Act); amends the Public Health Service Act to protect the confidentiality of substance use disorder patient records by restricting use of patient records in any civil action. H.R. 5176 (Preventing Overdoses While in Emergency Rooms Act of 2018); requires the Department of Health and Human Services to establish a grant program to: (1) develop protocols for discharging patients who are treated for a drug overdose, and (2) enhance the integration and coordination of postdischarge care and treatment options for individuals with a substance use disorder. H.R. 5197 (ALTO Act); requires and provides funds for, the Department of Health and Human Services to carry out a three-year demonstration program awarding grants to hospitals and emergency departments to develop, implement, enhance, or study alternative pain management protocols and treatments that promote limited use of opioids in emergency departments. H.R. 5009 (Jessie's Law); requires the Department of Health and Human Services (HHS) to develop and disseminate best practices for health care providers and state agencies regarding the display of a patient's history of opioid addiction in the patient's medical records. S. 2981 (Opioid Overdose Reduction Act of 2018); limits an individual's civil liability for harm caused by the emergency administration of an opioid overdose reversal drug (e.g., naloxone). S. 2680 (Opioid Crisis Response Act of 2018); comprehensive bill to address the opioid crisis. General lobbying with regard to the preemption of states causes of action involving medical device and drug manufacturers. General lobbying with regard to off label promotion of pharmaceutical products. General lobbying with regard to pharmaceutical drug advertising. General lobbying with regard to pharmaceutical price-gouging. General lobbying with regard to biosimilar naming and labeling. General lobbying with regard to updating generic drug labeling responsibilities. General lobbying with regard to opioid manufacturer liability. General lobbying with regard to opioid superfund and Medicare Secondary Payer issues. General lobbying with regard to OTC monograph preemption issues.

Client expense: $1,430,000 · Firm income: Not reported

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

H.R. 1253 the Mental Health and Substance Abuse Treatment Accessibility Act; H.R. 880/ S. 1022 the MISSION ZERO Act; H.R. 959, the Title VIII Nursing Workforce Reauthorization Act; H.R. 767/S. 256 SOAR to Health and Wellness Act; ACA repeal and replace legislation; H.R. 3780 Air Ambulance Quality and Accountability Act; H.R. 1876/ S. 781 Good Samaritan Health Professionals Act; H.R. 5223 Health Care Workplace Violence Prevention Act; H.R. 5176/ S. 2610 Preventing Overdoses While in Emergency Rooms (POWER) Act; H.R. 5197/ S. 2516 Alternatives to Opioids (ALTO) in the ED Act; H.R. 5329 Poison Center Network Enhancement Act; S. 2852 Pandemic and All-Hazards Preparedness Act; H.R. 6 SUPPORT for Patients and Communities Act (Opioids bill)

Client expense: $51,900 · Firm income: Not reported

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

H.R. 6, SUPPORT for Patients and Communities Act and issues related to buprenorphine and prescribing authority for MAT. H.R. 3692, Addiction Treatment Access Improvement Act of 2017. Issues related to drug shortages. H.R. 5718, Perioperative Reduction of Opioids Act. H.R. 5774, Combating Opioid Abuse for Care in Hospitals Act of 2018. H.R. 5197, Alternative to Opioids (ALTO) in The Emergency Department. S. 2680, The Opioid Crisis Response Act of 2018.

Client expense: Not reported · Firm income: $52,500

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

-- H.R. 5197 / S. 2516 - Alternatives to Opioids (ALTO) in the Emergency Department Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1892, Bipartisan Budget Act of 2018 Insurance market policies (Bipartisan Health Care Stabilization Act; S. 2052/H.R. 4200, Healthcare Market Certainty and Mandate Relief Act; H.R. 4666, the Premium Relief Act; 2019 Payment Notice Rule; Short-term, Limited Duration Health Insurance proposed rule; Association Health Plans proposed rule) Cost sharing reduction payments 340B Drug Pricing Program (H.R. 4392; H.R. 4710, 340B PAUSE Act; S. 2453, Ensuring the Value of the 340B Program Act; H.R. 6071, Stretching Entity Resources for Vulnerable Communities Act; H.R. 2889, Closing Loopholes for Orphan Drugs Act; H.R. 5598, 340B Optimization Act; H.R. 6240, Drug Discount Accountability Act; H.R. 6273, Creating Access to Rape Kit Exams (CARE) for Survivors Act) Opioid issues (S. 2680, the Opioid Crisis Response Act of 2018; H.R. 5176, Preventing Overdoses While in Emergency Rooms (POWER) Act; H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act; H.R. 5009, Jessies Law; H.R. 5818 / S. 2843, the Opioid Workforce Act; H.R. 5797, the IMD CARE Act; H.R. 5795, the Overdose Prevention and Patient Safety Act; S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act; S. 2460, Every Prescription Conveyed Securely Act; S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act; H.R. 5582, the Abuse Deterrent Access Act; H.R. 5685, the Medicare Opioid Safety Education Act; Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018; H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act; S. 2899, Caring Recovery for Infants and Babies Act; S. 2898, Medication-Assisted Treatment Improvement Act; S.2911, Enhancing Patient Access to Non-Opioid Treatment Options) IV and medication shortages Drug prices (American Patients First, Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs) HIPAA policy in mental and behavioral health information sharing Pandemic and All Hazards Preparedness Reauthorization, including Hospital Preparedness Program (S. 2852, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2018) S.781/ HR 1876. Good Samaritan Health Professional Act of 2017 Health workforce reauthorizations (H.R. 959, the Title VIII Nursing Workforce Reauthorization Act; H.R. 3728, the Educating Medical Professionals and Optimizing Workforce Efficiency Readiness (EMPOWER) Act; H.R. 1676, the Palliative Care and Hospice Education and Training Act)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

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

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

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

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

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

Repeal of the Affordable Care Act H.R. 1628 The American Health Care Act Development of legislation to protect essential hospitals Issues related to telehealth Mental Health Essential Health Benefits created by the Affordable Care Act Access to hospital emergency services Issues related to the 340B Drug Pricing Program HR1628 Better Care Reconciliation Act ACA Cost Sharing Reduction Subsidies Graham-Cassidy Amendment to HR 1628 340B drug pricing program HR3545-Overdose, Prevention and Patient Advocacy Act HR4392 CMS OPPS 340b rule moratorium HR4710 340b PAUSE Act Bipartisan Healthcare Stabilization Act of 2017 Opioid Crisis Response Act of 2018 42 CFR Part 2 IMD Exclusion Prescription drug monitoring programs H.R. 5197, S. 2516, Alternatives to opioids in the emergency dept Act H.R. 5102, Substance Use Disorder Workforce Loan Repayment Act H.R. 5261, Treatment, Education, and Community Help to Combat Opioid Addiction Act Poison Center Network Enhancement Act A Bill to support the peer support specialist workforce HR6 Support for Patients and Communities Act H.R. 4710 PAUSE Act HELP Act S. 2312 HR6378 Pandemic and All Hazards Preparedness and Advancing Innovation Act S.974 CREATES Act S.2843 Opioid Workforce Act HEAL Act S.3120 SERV Communities Act H. R. 6071

Client expense: $220,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

H.R. 3692, Addiction Treatment Access Improvement Act of 2017: Medically assisted treatment; opioids H.R. 5761, Ending Maternal Mortality Act of 2018: Maternal mortality H.R. 5718, Perioperative Reduction of Opioids Act: Opioids H.R.5197, Alternatives to Opioids (ALTO) in the Emergency Department Act: Medically assisted treatment; opioids S. 2516, Alternatives to Opioids (ALTO) in the Emergency Department Act: Medically assisted treatment; opioids S.2680, Opioid Crisis Response Act of 2018: Medically assisted treatment; opioids S.2456, CARA 2.0 Act of 2018: Medically assisted treatment; opioids H.R. 1565, Saving Lives, Saving Costs S.1475, Saving Lives, Saving Costs Comprehensive Addiction and Recovery Act of 2016 (PL 114-198) Affordable Care Act reform efforts H.R. 1628, American Health Care Act of 2017 S. Amdt. 1030 to H.R. 1628, "Graham-Cassidy" Better Care Reconciliation Act of 2017 H.R. 1492, Medical Controlled Substances Transportation Act of 2017 H.R. 1215, Protecting Access to Care Act of 2017 H.R. 3545, Overdose Prevention and Patient Safety Act H.R. 3446, Restoring Board Immunity Act of 2017: Professional Licensing S.2260, Opioids and STOP Pain Initiative ACT:opioids 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records: appropriate access to patient information essential for providing whole-person care H.R.3928, Truth in Healthcare Marketing Act of 2017 21st Century Cures Initiative Drug Shortages - FDA, DEA, HHS, CMS, GAO, House Energy and Commerce Committee, Senate HELP Committee DEA Scheduling Propofol Comparative Effectiveness Research - PCORI HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Safe Use Initiative Pain Management FTC Letters to States re: Interventional Pain Medicine & Advanced Practice Nurses & Competition in Healthcare Anesthesia Research Funding (Pediatric and others) Scope of Practice FDA Operating Room Fires Naloxone FDA Opioids Prescription Drug Abuse FDA Network of Experts NIH Interagency Pain Research Coordinating Committee FDA SMART TOTS - pediatric anesthesia research USP - US Pharmacopeia National Pain Strategy Nondiscrimination Compounding FDA Nominations to Advisory Committees (Anesthesia Drugs, Anesthesia Devices, Compounding) Agency for Healthcare Research and Quality (AHRQ) funding Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Sequestration Opioids and Opioid abuse; Brain health

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

Imputed Floor (FY 19 IPPS rule) 340B Drug Pricing Program Opioids SUD patient record sharing (H.R. 3545/S. 1850) 190-day limit on inpatient psychiatric care under Medicare (HR 2509) IMD exclusion (H.R. 2938/S. 1169) Veterans mental health and SUD at non-VA facilities (no specific bill) Observation status (H.R. 1421/S. 568) MISSION ZERO (H.R. 880/S. 1022) ALTO (H.R. 5197/S. 2516)

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

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

Implementation/Expansion of CDC Falls Program Implementation of Affordable Care Act - provisions pertaining to Essential Health Benefits & Health Insurance Exchanges AHRQ provisions pertaining to PT Physician self-referra/Stark Law American Cures Act H.R. 930/S.497 Lymphadema Treatment Act Health Information Technology Nominations to PCORI Methodology Committees Medicaid Expansion HR. 1639/S.619 Physical Therapist Workforce & Patient Access Act Physician owned distributerships H.R. 302/S.808 Sports Medicine Licensure Clarity Act MACRA/MIPS APMS IMPACT/PAC reform Network adequacy Insurance Benefit parameters H.R. 1361/S.486 Ensuring Access to Quality CRT Medicare Telehealth Parity Act HR2550 American Healthcare Act of 2017/CONNECT - H.R. 2556/S1016 H.R. 1628 - American Health Care Action of 2017 Opioid Epidemic/Pain Management Better Care Reconciliation Act of 2017 H.R.2066 Promoting Integrity in Medicare H.R. 2063 Opioid Pace Act of 2017 H.R. 5261 Teach Act H.R. 5197 Alto Act H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act H.R. 5773, Preventing Addiction for Susceptible Seniors Act H.R. 5774, Combating Opioid Abuse for Care in Hospitals Act H.R. 5718, Perioperative Reduction for Opioids Act H.R. 5719, Reduce Overprescribing Opioids in Treatment Act H.R. 5722, Dr. Todd Graham Pain Management Improvement Act H.R. 6, Substance-Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act S. 3120, the HEAL Act S. 2680, Opioid Crisis Response Act

Client expense: $292,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Education, Dept of, Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Small Business Administration (SBA), Veterans Affairs, Dept of (VA), White House Office

H.R. 807/S.253 Medicare Access to Rehabilitation Services Act (Repeal of Therapy Caps) QPP Prevention Initiatives for Fraud and Abuse in The Medicare program Accountable health care organizations/patient centered medical homes Electronic health records/health information technology incentives for Physical Therapists Local coverage determinations/EMG NCCI Edits Protection of programs related to physical therapy in deficit reduction Medicare Advantage PCORI National priority for research and research agenda Health information technology Functional Limitation Reporting Therapy Cap: Targeted Medical Review Essential Health Benefits MIPS/PPP Medicaid essential health benefits EHR/LTPAC settings: transitions of care Medicare improvement standards Bundled payment models/CJR Common assessment tool for Medicare post-acute care Medicare appeals process Inclusion of physical therapists in quality programs Self-referral Coverage of telehealth APTA Registry Quality Programs Accelerating Innovation in Medicine Act (AIM) IMPACT Medicare Pilot Programs Chronic Care Management New evaluation and reevaluation CPT codes & misvalued codes Orthotics and Prosthetics Medicare Private Contracting S.870 - Chronic Care Act SNF 3-Day Rule Registry- ACI HR 2042 - Frontline Act Youth Concussion Management DME HR 3446 RBI Act H.R. 5261 Teach Act Opioid related H.R. 5197 Alto Act Opioid related Administrative Burden H.R. 5686, Medicare Clear Health Options in Care for Enrollees Act H.R. 5773, Preventing Addiction for Susceptible Seniors Act H.R. 5774, Combating Opioid Abuse for Care in Hospitals Act H.R. 5718, Perioperative Reduction for Opioids Act H.R. 5719, Reduce Overprescribing Opioids in Treatment Act H.R. 5722, Dr. Todd Graham Pain Management Improvement Act H.R. 6, Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. S. 3120, HEAL Act S. 2680, Opioid Crisis Response Act

Client expense: $292,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Education, Dept of, Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Small Business Administration (SBA), Veterans Affairs, Dept of (VA), White House Office

H.R. 5138 "Bipartisan Health Savings Accounts (HSAs) Improvement Act" H.R. 5625 "Easy Enrollment Act" H.R. 1876 "Good Samaritan Health Professionals Act" S. 2278 "State Offices of Rural Health Reathorization Act" H.R. 5674 "VA Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act" H.R. 5102 "Substance Use Disorder Workforce Loan Repayment Act" H.R. 5261 "Treatment, Education, and Community Help to Combat Addiction Act" S. 2680 "Opioid Crisis Response Act" which included S. 1850 "Jessie's Law" S. 2597 "Children's Hospital GME Support Reauthorization Act" S. 2852 "Pandemic and All-Hazards Preparedness and Advancing Innovation Act" S. 204 "Right to Try Act" H.R. 2026 "Pharmaceutical Information Exchange (PIE) Act" H.R. 5795 "Overdose Prevention and Patient Safety Act" H.R. 3545 "Overdose Prevention and Patient Safety Act" H.R. 6082 "Overdose Prevention and Patient Safety Act" H.R. 4613 "Ensuring Access to Patient Healthcare Records Act" S. 1732 "Improving Access to Behavioral Health Information Technology Act" H.R. 5603 "Access to Telehealth Services for Opioid Use Disorder Act" H.R. 5483 "Special Registration for Telemedicine Clarification Act" H.R. 2 "Agricultural and Nutrition Act" S. 925 "Veterans in E-Health and Telemedicine Support Act" (H.R. 2123) S. 2315 "Over-the-Counter Drug Safety, Innovation, and Reform Act" H.R. 2953 / S. 2164 a bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings S. 1028 RAISE Family Caregivers Act (P.L. 115-119) S. 445 "home Health Planning Improvement Act" H.R. 1617 "Promoting Access to Diabetic Shoes Act" H.R. 5385 "Children's Hospital GME Support Reauthorization Act" S. 2483 "Opioid Workforce Act" H.R. 5176 "Preventing Overdoses while in Emergency Rooms (POWER) Act of 2018" H.R. 5327 "Comprehensive Opioid Recovery Centers (CORC) Act of 2018" H.R. 5261 "Training, Education, and Community Help (TEACH) to Combat Addiction Act of 2018" H.R. 5695 "Emmett's Law" H.R. 5735 "Transitional Housing for Recovery in Viable Environments (THRIVE) Act" H.R. 5041 "Safe Disposal of Unused Medication Act" H.R. 4684 "Ensuring Access to Quality Sober Living Act of 2018" H.R. 5587 "Peer Support Communities of Recovery Act" H.R. 449 "Synthetic Drug Awareness Act" H.R. 4275 "Empowering Pharmacists in the Fight Against Opioid Abuse Act" H.R. 5197 "Alternatives to Opioids (ALTO) in the Emergency Department Act" H.R. 6 "Support for Patients and Communities Act" H.R. 1565 "Saving Lives, Saving Costs Act" S. 1850 "Protecting Jessica Grubb's Legacy Act" P.L. 115-141 omnibus appropriations

Client expense: $210,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Imputed Floor (FY 19 IPPS rule), 340B Drug Pricing Program, Opioids: SUD patient record sharing (H.R. 3545/S. 1850), 190-day limit on inpatient psychiatric care under Medicare (HR 2509), IMD exclusion (H.R. 2938/S. 1169), Veterans mental health and SUD at non-VA facilities (no specific bill), Observation status (H.R. 1421/S. 568), MISSION ZERO (H.R. 880/S. 1022), ALTO (H.R. 5197/S. 2516)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.1057-Synthetics Trafficking and Overdose Prevention Act of 2017 H.R.1492-Medical Controlled Substances Transportation Act of 2017 H.R.2851-Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017 H.R.3545-Overdose Prevention and Patient Safety (OPPS) Act H.R.5176-Preventing Overdoses While in Emergency Rooms Act of 2018 H.R.5197-Alternatives to Opioids (ALTO) in the Emergency Department Act S.372-Synthetics Trafficking and Overdose Prevention Act of 2017 S.1327-Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017 S.2516-Alternatives to Opioids (ALTO) in the Emergency Department Act S.2609-Recovery Coaches Offer Addiction Counseling and Healing (COACH) Act S.2610-Preventing Overdoses While in Emergency Departments Act of 2018

Client expense: $520,414 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)