Abuse Deterrent Access Act of 2018

H.R. 6, Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act H.R. 35, Health Savings Act of 2017 H.R. 143, Health Insurance Industry Antitrust Enforcement Act of 2017 H.R. 173/S. 40/S. 58, Middle Class Health Benefits Tax Repeal Act of 2017 H.R. 184, Protect Medical Innovation Act of 2017 H.R. 195, Making further continuing appropriations for the fiscal year ending September 30, 2018, and for other purposes H.R. 246, To repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act H.R. 394/S. 85, Restoring Access to Medication Act of 2017 H.R. 620, ADA Education and Reform Act of 2017 H.R. 849/S. 260, Protecting Seniors Access to Medicare Act H.R. 1101, Small Business Health Fairness Act of 2017 H.R. 1175/S. 403, Health Savings Act of 2017 H.R. 1215, Protecting Access to Care Act of 2017 H.R. 1313, Preserving Employee Wellness Programs Act H.R. 1625, Consolidated Appropriations Act, 2018 H.R. 1892, Bipartisan Budget Act of 2018 H.R. 3331, To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology H.R. 3798, Save American Workers Act of 2017 H.R. 4284, Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018 H.R. 4616, To amend the Patient Protection and Affordable Care Act to provide for a temporary moratorium on the employer mandate and to provide for a delay in the implementation of the excise tax on high cost employer-sponsored health coverage H.R. 4617, To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on the medical device excise tax H.R. 4618, To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on certain taxes affecting purchases of prescription medication H.R. 4619, To amend the Patient Protection and Affordable Care Act to provide temporary relief from the annual fee imposed on health insurance providers, to the extent that such fee is due to Puerto Rican health insurance H.R. 4620, Protecting Families and Small Businesses Act of 2017 H.R. 4978/S. 2410, Chronic Disease Management Act of 2018 H.R. 5009, Jessies Law H.R. 5041, Safe Disposal of Unused Medication Act H.R. 5138, Bipartisan HSA Improvement Act of 2018 H.R. 5272, To provide additional guidance to grantees seeking funding to treat or prevent mental health or substance use disorders H.R. 5582, Abuse Deterrent Access Act of 2018 H.R. 5788, Synthetics Trafficking and Overdose Prevention (STOP) Act of 2018 H.R. 5892, To establish an Advisory Committee on Opioids and the Workplace to advise the Secretary of Labor on actions the Department of Labor can take to address the impact of opioid abuse on the workplace H.R. 6199, Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 H.R. 6311, Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act of 2018 S. 108, Medical Device Access and Innovation Protection Act S. 191, Patient Freedom Act of 2017 S. 222, Obamacare Replacement Act S. 251, Protecting Medicare from Executive Action Act of 2017 S. 974, Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act of 2017 S. 1835, Lower Premiums Through Reinsurance Act of 2017 S. 1850, Protecting Jessica Grubb's Legacy Act S. 1859, Healthcare Tax Relief Act S. 1978, Small Business and Family Health Tax Relief Act of 2017 S. 2004, Combating the Opioid Epidemic Act S. 2164, To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings S. 3057, Synthetics Trafficking and Overdose Prevention (STOP) Act of 2018 Draft legislation to stabilize individual market premiums for the 2018 and 2019 plan years and provide meaningful State flexibility (Alexander-Murray) Proposed regulation on health reimbursement arrangements and other account-based group health plans (83 Fed. Reg. 54,420-54,477, October 29, 2018) Final Regulation, definition of employer under Section 3(5) of ERISA - association health plans (83 Fed. Reg. 28912-28964, June 21, 2018) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part D's Non-Interference Clause from repeal Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; House Republican Taskforce on Health Care report; A Better Way to Fix Health Care; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; Executive Order 13813, Promoting Healthcare Choice and Competition; addressing the opioids crisis, including end-stage renal disease; balance or surprise billing; single-payer health care options; aligning 42 CFR Part 2 with the Health Insurance Portability and Accountability Act (P.L. 104-191) for the purposes of treatment, payment, and health car operation (TPO); inclusion of prescription drug pricing on 2019 congressional agenda; general advocacy for Congress to reach a working quorum for the board of the Export-Import Bank; section 301 of the Trade Act of 1974; U.N. Convention on the Assignment of Receivables in Int'l Trade

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

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

-Abuse Deterrent Formulations of opioid analgesics -Hearings related to prescription drug abuse and prevention -H.R. 5582 Abuse Deterrent Access Act of 2018 -H.R. 6 Support for Patients and Communities Act/Opioid Crisis Response Act

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

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

-Abuse Deterrent Formulations of opioid analgesics -Hearings related to prescription drug abuse and prevention -H.R. 5582 Abuse Deterrent Access Act of 2018 -H.R. 6 Support for Patients and Communities Act/Opioid Crisis Response Act

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

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

Support for H.R. 5582 - Abuse Deterrent Access Act of 2018.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5582: Abuse Deterrent Access Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2157: Drug-Price Transparency in Communications Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) HR6, SUPPORT for Patients and Communities Act, Provisions related to BBA technical correction (Part D) HR 394/S 85 - Restoring Access to Medication Act of 2017Vaccine manufacturing practices HR 4297/S2103, Protecting Seniors Through Immunization Act; HR4993/S3253, Vaccine Access Improvement Act; HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018Durbin/Grassley Amendment HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 H.R.6378 To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act' S.2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

Client expense: $1,130,000 · 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 - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder records H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018 - Provisions related to substance use disorder information H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to loan repayment program H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5582: Abuse Deterrent Access Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2157: Drug-Price Transparency in Communications Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3428: Lessening Addiction by Enhancing Labeling Opiods Act of 2018 S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Client expense: $5,990,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

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

S. 2460, Every Prescription Conveyed Securely Act (Bennet) - opioid issues S. 2680, Opioid Crisis Response Act (Alexander) - opioid initiatives, mental health parity S. 2789, Substance Abuse Prevention Act (Cornyn) - opioid initiatives, restrictions on step therapy S. 2812, Air Ambulance Consumer Protection Act (McCaskill) - air ambulance S. 2828, Sober Home Fraud Detection Act (Rubio) - best practices for identifying fraud in recovery housing S. 2891, Fighting the Opioid Epidemic with Sunshine Act (Grassley) - opioid issues S. 2892, Peer Support Enhancement and Evaluation Review Act (Cardin) - opioid issues S. 2898, Medication-Assisted Treatment Improvement Act (Casey) - opioid issues S. 2899, Caring Recovery for Infants and Babies Act (Brown) - opioid issues S. 2900, Comprehensive Screenings for Seniors Act (Brown) - opioid issues S. 2902, Better Data Sharing to Combat the Opioid Crisis Act (Cassidy) - opioid issues S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act (Toomey) - opioid issues S. 2910, Telehealth for Childrens Access to Services and Treatment Act (Roberts) - opioid issues S. 2911, Enhancing Patient Access to Non-Opioid Treatment Options (Heller) - opioid issues S. 2912, Opioid Addiction Treatment Programs Enhancement Act (Cassidy) - opioid issues S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act (McCaskill) - opioid issues S. 2922, Help for Moms and Babies Act (Stabenow) - opioid issues S. 2923, Building Capacity for Family-Focused Residential Treatment Act (Grassley) - opioid issues S. 2924, Supporting Family-Focused Residential Treatment Act (Scott) - opioid issues S. 3016, Action for Dental Health Act (Booker) - grants for oral health programs S. 3120, the HEAL Substance Use Disorders Act (Hatch) - opioid initiatives S. 3158, Labor-HHS-Education Appropriations Act (Blunt) - HHS funding S. 3254, Eliminating Kickbacks in Recovery Act (Rubio) - anti-kickback penalties for body brokers Draft Bill: Protecting Patients From Surprise Medical Bills Act (Cassidy) - surprise medical bills H.R. 6, SUPPORT Patients and Families Act (Walden) - opioid initiatives, Medicare and Medicaid issues, budget offsets H.R. 302, FAA Reauthorization Act - air ambulance issues H.R. 1215, Protecting Access to Care Act (King) - medical liability reform H.R. 1313, Preserving Employee Wellness Programs Act (Foxx) - employee wellness programs H.R. 2422, Action for Dental Health Act (Kelly) - oral health services and education for underserved populations H.R. 3331, adoption and use of EHR technology by behavioral health providers (Jenkins) - opioid issues H.R. 3528, Every Prescription Conveyed Securely Act (Clark) - opioid issues H.R. 4684, Ensuring Access to Quality Sober Living Act (Chu) - best practices for recovery housing H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act (Schweikert) - opioid issues H.R. 4998, Health Insurance for Former Foster Youth Act (Bass) - opioid issues H.R. 5100, Recovery Home Certification Act (Knight) -- anti-kickback penalties for body brokers H.R. 5477, Rural DOCS Act (O'Halleran) - opioid issues H.R. 5515, National Defense Authorization Act (Thornberry) H.R. 5562, Protecting NAS Babies Act (Jenkins) - opioid issues H.R. 5582, Abuse Deterrent Access Act (Carter) - opioid issues H.R. 5583, State reporting on certain adult health quality measures (Clarke) - opioid issues H.R. 5590, CMS Action Plan (Kinzinger) - opioid issues H.R. 5714, Education for Disposal of Unused Opioids Act (Black) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - opioid issues H.R. 5716, COMPASS Act (Roskam) - opioid issues H.R. 5723, Expanding Oversight of Opioid Prescribing and Payment Act (Tenney) - opioid issues H.R. 5725, BEST Act (Roskam) - opioid issues H.R. 5774, Combating Opioid Abuse for Care in Hospitals Act (Curbelo) - opioid issues H.R. 5775, Providing Reliable Options for Patients and Educational Resources Act (Paulsen) - opioid issues H.R. 5776, MOST Act (Neal) - opioid issues H.R. 5789, protections for pregnant and post-partum women (Foster) - opioid issues H.R. 5795, Overdose Prevention and Patient Safety Act (Blumenauer) - confidential sharing of substance use disorder information H.R. 5796, Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment Act (Fitzpatrick) - opioid issues H.R. 5801, PARTNERSHIP Act (Griffith) - opioid issues H.R. 6082, Overdose Prevention and Patient Safety Act (Mullin) - confidential sharing of substance use disorder information H.R. 6147, Interior, Environment, Financial Services, Agriculture, FDA, Transportation, and Housing Appropriations Act (Calvert) - FDA funding H.R. 6157, Defense-Labor-HHS-Education Appropriations Act (Granger) - HHS funding H.R. 6753, Strengthening the Health Care Fraud Prevention Task Force Act (Walden) - codification of Healthcare Fraud Prevention Partnership H.R. 6878, Eliminating Kickbacks in Recovery Act (Deutch) - anti-kickback penalties for body brokers H.R. 6902, Eliminating Kickbacks in Recovery Act (Knight) - anti-kickback penalties for body brokers Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers including the health plan identifier, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues relating to similarly sized subscriber group (SSSG) and MLR requirements under the FEHBP; implementation of the health savings account provisions of the Medicare Act; issues related to Medicare Secondary Payer requirements; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital consolidation; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; prescription drug pricing; issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues relating to the annual fee on health insurance providers; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to family caregivers; and other issues relating to health care reform implementation.

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

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

S. 1625, FY 2018 Consolidated Appropriations Act (Royce) - funding for HHS programs and agencies, opioid initiatives, ACA risk corridors S. 2460, Every Prescription Conveyed Securely Act (Bennet) - opioid issues S. 2680, Opioid Crisis Response Act (Alexander) - opioid initiatives, mental health parity S. 2789, Substance Abuse Prevention Act (Cornyn) - opioid initiatives, restrictions on step therapy S. 2812, Air Ambulance Consumer Protection Act (McCaskill) - air ambulance S. 2891, Fighting the Opioid Epidemic with Sunshine Act (Grassley) - opioid issues S. 2892, Peer Support Enhancement and Evaluation Review Act (Cardin) - opioid issues S. 2898, Medication-Assisted Treatment Improvement Act (Casey) - opioid issues S. 2899, Caring Recovery for Infants and Babies Act (Brown) - opioid issues S. 2900, Comprehensive Screenings for Seniors Act (Brown) - opioid issues S. 2902, Better Data Sharing to Combat the Opioid Crisis Act (Cassidy) - opioid issues S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act (Toomey) - opioid issues S. 2910, Telehealth for Childrens Access to Services and Treatment Act (Roberts) - opioid issues S. 2911, Enhancing Patient Access to Non-Opioid Treatment Options (Heller) - opioid issues S. 2912, Opioid Addiction Treatment Programs Enhancement Act (Cassidy) - opioid issues S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act (McCaskill) - opioid issues S. 2922, Help for Moms and Babies Act (Stabenow) - opioid issues S. 2923, Building Capacity for Family-Focused Residential Treatment Act (Grassley) - opioid issues S. 2924, Supporting Family-Focused Residential Treatment Act (Scott) - opioid issues S. 2987, National Defense Authorization Act (Inhofe) S. 3120, the HEAL Substance Use Disorders Act (Hatch) - opioid initiatives S. 3158, FY 2019 Labor, HHS, Education Appropriations Act (Blunt) - HHS funding, ACA issues House version of FY 2019 Labor, HHS, Education Appropriations Act (Cole) - HHS funding, ACA issues H.R. 6, SUPPORT Patients and Families Act (Walden) - opioid initiatives, budget offsets H.R. 1215, Protecting Access to Care Act (King) - medical liability reform H.R. 1313, Preserving Employee Wellness Programs Act (Foxx) - employee wellness programs H.R. 2422, Action for Dental Health Act (Kelly) - oral health services and education for underserved populations H.R. 3331, adoption and use of EHR technology by behavioral health providers (Jenkins) - opioid issues H.R. 3528, Every Prescription Conveyed Securely Act (Clark) - opioid issues H.R. 3759, RAISE Family Caregivers Act (Harper-Castor) - support for family caregivers H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act (Schweikert) - opioid issues H.R. 4998, Health Insurance for Former Foster Youth Act (Bass) - opioid issues H.R. 5477, Rural DOCS Act (O'Halleran) - opioid issues H.R. 5562, Protecting NAS Babies Act (Jenkins) - opioid issues H.R. 5582, Abuse Deterrent Access Act (Carter) - opioid issues H.R. 5583, State reporting on certain adult health quality measures (Clarke) - opioid issues H.R. 5590, CMS Action Plan (Kinzinger) - opioid issues H.R. 5515, National Defense Authorization Act (Thornberry) H.R. 5714, Education for Disposal of Unused Opioids Act (Black) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - opioid issues H.R. 5716, COMPASS Act (Roskam) - opioid issues H.R. 5723, Expanding Oversight of Opioid Prescribing and Payment Act (Tenney) - opioid issues H.R. 5725, BEST Act (Roskam) - opioid issues H.R. 5774, Combating Opioid Abuse for Care in Hospitals Act (Curbelo) - opioid issues H.R. 5775, Providing Reliable Options for Patients and Educational Resources Act (Paulsen) - opioid issues H.R. 5776, MOST Act (Neal) - opioid issues H.R. 5789, protections for pregnant and post-partum women (Foster) - opioid issues H.R. 5795, Overdose Prevention and Patient Safety Act (Blumenauer) - confidential sharing of substance use disorder information H.R. 5796, Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment Act (Fitzpatrick) - opioid issues H.R. 5801, PARTNERSHIP Act (Griffith) - opioid issues H.R. 6082, Overdose Prevention and Patient Safety Act (Mullin) - confidential sharing of substance use disorder information Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers including the health plan identifier, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues relating to similarly sized subscriber group (SSSG) and MLR requirements under the FEHBP; implementation of the health savings account provisions of the Medicare Act; issues related to Medicare Secondary Payer requirements; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital consolidation; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; prescription drug pricing; issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues relating to the annual fee on health insurance providers; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to family caregivers; and other issues relating to health care reform implementation.

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

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

-Abuse Deterrent Formulations of opioid analgesics -Hearings related to prescription drug abuse and prevention -H.R. 5582 Abuse Deterrent Access Act of 2018 -H.R. 6 Support for Patients and Communities Act/Opioid Crisis Response Act

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

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

-Abuse Deterrent Formulations of opioid analgesics -Hearings related to prescription drug abuse and prevention -H.R. 5582 Abuse Deterrent Access Act of 2018 -H.R. 6 Support for Patients and Communities Act/Opioid Crisis Response Act

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

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

H.R. 6, Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act H.R. 35, Health Savings Act of 2017 H.R. 143, Health Insurance Industry Antitrust Enforcement Act of 2017 H.R. 173/S. 40/S. 58, Middle Class Health Benefits Tax Repeal Act of 2017 H.R. 184, Protect Medical Innovation Act of 2017 H.R. 195, Making further continuing appropriations for the fiscal year ending September 30, 2018, and for other purposes H.R. 246, To repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act H.R. 394/S. 85, Restoring Access to Medication Act of 2017 H.R. 620, ADA Education and Reform Act of 2017 H.R. 849/S. 260, Protecting Seniors Access to Medicare Act H.R. 1101, Small Business Health Fairness Act of 2017 H.R. 1175/S. 403, Health Savings Act of 2017 H.R. 1215, Protecting Access to Care Act of 2017 H.R. 1313, Preserving Employee Wellness Programs Act H.R. 1625, Consolidated Appropriations Act, 2018 H.R. 1892, Bipartisan Budget Act of 2018 H.R. 3331, To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology H.R. 3798, Save American Workers Act of 2017 H.R. 4284, Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018 H.R. 4616, To amend the Patient Protection and Affordable Care Act to provide for a temporary moratorium on the employer mandate and to provide for a delay in the implementation of the excise tax on high cost employer-sponsored health coverage H.R. 4617, To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on the medical device excise tax H.R. 4618, To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on certain taxes affecting purchases of prescription medication H.R. 4619, To amend the Patient Protection and Affordable Care Act to provide temporary relief from the annual fee imposed on health insurance providers, to the extent that such fee is due to Puerto Rican health insurance H.R. 4620, Protecting Families and Small Businesses Act of 2017 H.R. 4978/S. 2410, Chronic Disease Management Act of 2018 H.R. 5009, Jessies Law H.R. 5041, Safe Disposal of Unused Medication Act H.R. 5138, Bipartisan HSA Improvement Act of 2018 H.R. 5272, To provide additional guidance to grantees seeking funding to treat or prevent mental health or substance use disorders H.R. 5582, Abuse Deterrent Access Act of 2018 H.R. 5788, Synthetics Trafficking and Overdose Prevention (STOP) Act of 2018 H.R. 5892, To establish an Advisory Committee on Opioids and the Workplace to advise the Secretary of Labor on actions the Department of Labor can take to address the impact of opioid abuse on the workplace H.R. 6199, Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 H.R. 6311, Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act of 2018 S. 108, Medical Device Access and Innovation Protection Act S. 191, Patient Freedom Act of 2017 S. 222, Obamacare Replacement Act S. 251, Protecting Medicare from Executive Action Act of 2017 S. 974, Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act of 2017 S. 1835, Lower Premiums Through Reinsurance Act of 2017 S. 1850, Protecting Jessica Grubb's Legacy Act S. 1859, Healthcare Tax Relief Act S. 1978, Small Business and Family Health Tax Relief Act of 2017 S. 2004, Combating the Opioid Epidemic Act S. 2164, To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings S. 3057, Synthetics Trafficking and Overdose Prevention (STOP) Act of 2018 Draft legislation to stabilize individual market premiums for the 2018 and 2019 plan years and provide meaningful State flexibility (Alexander-Murray) Proposed regulations on definition of employer under section 3(5) of ERISA-association health plans (83 Fed. Reg. 614-636, January 5, 2018) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; House Republican Taskforce on Health Care report, A Better Way to Fix Health Care; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; Executive Order 13813, Promoting Healthcare Choice and Competition; addressing the opioids crisis, including end-stage renal disease; balance or surprise billing; single-payer health care options

Client expense: $17,560,000 · Firm income: Not reported

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

Prescription drug abuse policy issues Provisions related to abuse-deterrent opioid formulary placement Provisions related to abuse-deterrent opioid coverage and access in Medicare H.R. 5582, the Abuse Deterrent Access Act regarding access to abuse-deterrent opioids in Medicare S. 2789, the Substance Abuse Prevention Act of 2018 regarding access to abuse-deterrent opioids

Client expense: $164,000 · Firm income: Not reported

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

Prodrug therapies and improving abuse deterrence and consumer safety Anti-opioid abuse deterrent legislation H.R. 6 (SUPPORT for Patients and Communities Act), provisions relating to HHS study on abuse deterrent formulations access barriers under Medicare H.R. 5582 (Abuse Deterrent Access Act of 2018), all provisions Pharmaceutical anti-opioid prodrug regulatory bill

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

-Abuse Deterrent Formulations of opioid analgesics -Hearings related to prescription drug abuse and prevention -H.R. 5582 Abuse Deterrent Access Act of 2018

Client expense: $310,000 · Firm income: Not reported

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

-Abuse Deterrent Formulations of opioid analgesics -Hearings related to prescription drug abuse and prevention -H.R. 5582 Abuse Deterrent Access Act of 2018

Client expense: $310,000 · Firm income: Not reported

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

Advocated for access to abuse-deterrent formulations. Support for H.R. 5582 - Abuse Deterrent Access Act of 2018. Support for Sec. 6001 of H.R. 6 - SUPPORT for Patients and Communities Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3331, To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology, all provisions S. 1732, Improving Access to Behavioral Health Information Technology Act, all provisions S. 2904, Medicaid Substance Use Disorder Treatment via Telehealth Act, all provisions S. 2910, Telehealth for Children's Access to Services and Treatment (TeleCAST) Act, all provisions S. 2707, Informing Seniors about Opioids Act of 2018, all provisions S. 2900, Comprehensive Screenings for Seniors Act of 201, all provisions H.R. 3528, Every Prescription Conveyed Securely Act, all provisions S. 2460, Every Prescription Conveyed Securely Act, all provisions S. 2908, A bill to amend title XVIII of the Social Security Act to provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes, all provisions S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act of 2018, all provisions H.R. 4552, Advancing Medical Resident Training in Community Hospitals Act of 2017, all provisions S. 1291, Advancing Medical Resident Training in Community Hospitals Act of 2017, all provisions H.R. 284, Advancing Medical Resident Training in Community Hospitals Act of 2017, all provisions H.R. 5605, Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act, all provisions H.R. 5801, Medicaid Providers Are Required To Note Experiences in Record Systems to Help In-need Patients (PARTNERSHIP) Act, all provisions H.R. 5797, Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution (IMD CARE) Act, all provisions H.R. 5800, Medicaid Institutes for Mental Disease Are Decisive in Delivering Inpatient Treatment for Individuals but Opportunities for Needed Access are Limited without Information Needed about Facility Obligations (IMD ADDITIONAL INFO) Act, all provisions H.R. 5799, Medicaid Drug Review, Utilization, Good Governance (DRUG) Improvement Act, all provisions H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018, all provisions H.R. 5603, Access to Telehealth Services for Substance Use Disorders Act, all provisions H.R. 5808, Medicaid Pharmaceutical Home Act of 2018, all provisions H.R. 5685, Medicare Opioid Safety Education Act of 2018, all provisions H.R. 5675, To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries, all provisions H.R. 1925, At-Risk Youth Medicaid Protection Act of 2018, all provisions H.R. 3192, CHIP Mental Health Parity Act, all provisions H.R. 4005, Medicaid Reentry Act, all provisions H.R. 4998, Health Insurance for Former Foster Youth Act, all provisions H.R. 5477, Rural Development of Opioid Capacity Services (DOCS) Act, all provisions H.R. 5582, Abuse Deterrent Access Act of 2018, all provisions H.R. 5583, To amend title XI of the Social Security Act to require States to annually report on certain adult health quality measures, and for other purposes, all provisions H.R. 5684, Protecting Seniors From Opioid Abuse Act, all provisions H.R. 5776, Medicare and Opioid Safe Treatment (MOST) Act, all provisions H.R. 5789, 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, all provisions H.R. 5810, Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged (HOME) Act, all provisions H.R. 5716, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors (COMPASS) Act, all provisions H.R. 5773, Preventing Addiction for Susceptible Seniors (PASS) Act of 2018, all provisions H.R. 5775, Providing Reliable Options for Patients and Educational Resources (PROPER) Act of 2018, all provisions H.R. 5798, Opioid Screening and Chronic Pain Management Alternatives for Seniors Act, all provisions H.R. 5686, Medicare Clear Health Options in Care for Enrollees (CHOICE) Act of 2018, all provisions H.R. 6138, Ambulatory Surgical Center (ASC) Payment Transparency Act of 2018, all provisions H.R. 5774, Combating Opioid Abuse for Care in Hospitals (COACH) Act of 2018, all provisions H.R. 4206, Medicare Care Coordination Improvement Act of 2017, all provisions S. 2051, Medicare Care Coordination Improvement Act of 2017, all provisions H.R. 4143, Dialysis Patient Access To Integrated-care, Empowerment, Nephrologists, Treatment, and Services (PATIENTS) Demonstration Act of 2017, all provisions H.R. 4554, Medicare Common Access Card Act of 2017, all provisions H.R. 2788, Health Equity and Access under the Law (HEAL) for Immigrant Women and Families Act of 2017, all provisions H.R. 2687, Medicaid Coverage for Addiction Recovery Expansion Act, all provisions S. 1169, Medicaid Coverage for Addiction Recovery Expansion Act, all provisions S. 1291, Advancing Medical Resident Training in Community Hospitals Act of 2017, all provisions Medicare program: Draft legislation relating to the prescribing of opioids for individuals eligible for Medicare Part A & B Medicare program: Creating Access to Residency Education Act (draft bill) Medicare program: Medicare Access and Chip Reauthorization (MACRA) implementation Medicare program: Quality Payment Program Medicare program: Merit-Based Incentive Payment System (MIPS)/quality, cost, interoperability, improvement activities Medicare program: MIPS quality measure reporting period Medicare program: Protecting Access to Medicare Act (PAMA)/clinical testing reimbursement Medicare program: Alternative Payment Models (APMs) Medicare program: APMs/PTAC Medicare program: Medicare Shared Savings Program Medicare program: Graduate Medical Education (GME) Medicare program: Electronic prescribing of controlled substances Medicare program: Regulatory Relief Medicare program: Self-referral Medicare program: Anti-kickback Medicare program: Program Integrity - Recovery Audit Contractors (RACs) Medicare program: Regulatory Relief - E & M Guidelines Medicare program: Virtual Diabetes Prevention Program (DPP)/Telehealth/remote patient monitoring Medicare program: Drug pricing transparency Medicare program: Coding Medicare program: Prior authorization Medicare program: Documentation errors Medicare program: Health Information Technology burdens Medicare program: Cybersecurity Medicare program: Interoperability Medicare program: Group Purchasing Organizations/Stark Laws Medicare program: Substance abuse disorder/quality, research Medicare program: Electronic payments Medicare program: Electronic clinical attachments Medicare program: Ambulatory blood pressure monitoring Medicare program: Physician billing/MACs Medicare program: Open Payments Medicare program: PECOS/Medicare Enrollment/Revocations/Revalidations Medicare program: Medicare Diabetes Prevention Program Medicare program: Misvalued codes Medicare program: Pharmacy Benefits Manager

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

H.R. 6, Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act H.R. 35, Health Savings Act of 2017 H.R. 143, Health Insurance Industry Antitrust Enforcement Act of 2017 H.R. 173/S. 40/S. 58, Middle Class Health Benefits Tax Repeal Act of 2017 H.R. 184, Protect Medical Innovation Act of 2017 H.R. 195, Making further continuing appropriations for the fiscal year ending September 30, 2018, and for other purposes H.R. 246, To repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act H.R. 394/S. 85, Restoring Access to Medication Act of 2017 H.R. 849/S. 260, Protecting Seniors Access to Medicare Act H.R. 1101, Small Business Health Fairness Act of 2017 H.R. 1175/S. 403, Health Savings Act of 2017 H.R. 1215, Protecting Access to Care Act of 2017 H.R. 1313, Preserving Employee Wellness Programs Act H.R. 1625, Consolidated Appropriations Act, 2018 H.R. 1628, American Health Care Act of 2017 H.R. 1892, Bipartisan Budget Act of 2018 H.R. 3331, To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology H.R. 4284, Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018 H.R. 4616, To amend the Patient Protection and Affordable Care Act to provide for a temporary moratorium on the employer mandate and to provide for a delay in the implementation of the excise tax on high cost employer-sponsored health coverage H.R. 4617, To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on the medical device excise tax H.R. 4618, To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on certain taxes affecting purchases of prescription medication H.R. 4619, To amend the Patient Protection and Affordable Care Act to provide temporary relief from the annual fee imposed on health insurance providers, to the extent that such fee is due to Puerto Rican health insurance H.R. 4620, Protecting Families and Small Businesses Act of 2017 H.R. 4978/S. 2410, Chronic Disease Management Act of 2018 H.R. 5009, Jessies Law H.R. 5041, Safe Disposal of Unused Medication Act H.R. 5138, Bipartisan HSA Improvement Act of 2018 H.R. 5272, To provide additional guidance to grantees seeking funding to treat or prevent mental health or substance use disorders H.R. 5582, Abuse Deterrent Access Act of 2018 H.R. 5788, Synthetics Trafficking and Overdose Prevention (STOP) Act of 2018 S. 108, Medical Device Access and Innovation Protection Act S. 191, Patient Freedom Act of 2017 S. 222, Obamacare Replacement Act S. 251, Protecting Medicare from Executive Action Act of 2017 S. 974, Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act of 2017 S. 1835, Lower Premiums Through Reinsurance Act of 2017 S. 1850, Protecting Jessica Grubb's Legacy Act S. 1859, Healthcare Tax Relief Act S. 1978, Small Business and Family Health Tax Relief Act of 2017 S. 2164, To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings Draft legislation titled To stabilize individual market premiums for the 2018 and 2019 plan years and provide meaningful State flexibility (Alexander-Murray) Proposed regulations on definition of employer under section 3(5) of ERISA-association health plans (83 Fed. Reg. 614-636, January 5, 2018) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; House Republican Taskforce on Health Care report, A Better Way to Fix Health Care; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; Executive Order 13813, Promoting Healthcare Choice and Competition; addressing the opioid crisis

Client expense: $15,190,000 · Firm income: Not reported

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

Prodrug therapies and improving abuse deterrence and consumer safety Anti-opioid abuse deterrent legislation H.R. 6 (SUPPORT for Patients and Communities Act), provisions relating to HHS study on abuse deterrent formulations access barriers under Medicare H.R. 5582 (Abuse Deterrent Access Act of 2018), all provisions Pharmaceutical anti-opioid prodrug regulatory bill

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1625, FY 2018 Consolidated Appropriations Act (Royce) - funding for HHS programs and agencies, opioid initiatives, ACA risk corridors S. 2460, Every Prescription Conveyed Securely Act (Bennet) - opioid issues S. 2680, Opioid Crisis Response Act (Alexander) - opioid initiatives, mental health parity S. 2789, Substance Abuse Prevention Act (Cornyn) - opioid initiatives, restrictions on step therapy S. 2812, Air Ambulance Consumer Protection Act (McCaskill) - air ambulance S. 2891, Fighting the Opioid Epidemic with Sunshine Act (Grassley) - opioid issues S. 2892, Peer Support Enhancement and Evaluation Review Act (Cardin) - opioid issues S. 2898, Medication-Assisted Treatment Improvement Act (Casey) - opioid issues S. 2899, Caring Recovery for Infants and Babies Act (Brown) - opioid issues S. 2900, Comprehensive Screenings for Seniors Act (Brown) - opioid issues S. 2902, Better Data Sharing to Combat the Opioid Crisis Act (Cassidy) - opioid issues S. 2905, Strengthening Partnerships to Prevent Opioid Abuse Act (Toomey) - opioid issues S. 2910, Telehealth for Childrens Access to Services and Treatment Act (Roberts) - opioid issues S. 2911, Enhancing Patient Access to Non-Opioid Treatment Options (Heller) - opioid issues S. 2912, Opioid Addiction Treatment Programs Enhancement Act (Cassidy) - opioid issues S. 2920, Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act (McCaskill) - opioid issues S. 2922, Help for Moms and Babies Act (Stabenow) - opioid issues S. 2923, Building Capacity for Family-Focused Residential Treatment Act (Grassley) - opioid issues S. 2924, Supporting Family-Focused Residential Treatment Act (Scott) - opioid issues S. 2987, National Defense Authorization Act (Inhofe) S. 3120, the HEAL Substance Use Disorders Act (Hatch) - opioid initiatives S. 3158, FY 2019 Labor, HHS, Education Appropriations Act (Blunt) - HHS funding, ACA issues House version of FY 2019 Labor, HHS, Education Appropriations Act (Cole) - HHS funding, ACA issues H.R. 6, SUPPORT Patients and Families Act (Walden) - opioid initiatives, budget offsets H.R. 1215, Protecting Access to Care Act (King) - medical liability reform H.R. 1313, Preserving Employee Wellness Programs Act (Foxx) - employee wellness programs H.R. 2422, Action for Dental Health Act (Kelly) - oral health services and education for underserved populations H.R. 3331, adoption and use of EHR technology by behavioral health providers (Jenkins) - opioid issues H.R. 3528, Every Prescription Conveyed Securely Act (Clark) - opioid issues H.R. 3759, RAISE Family Caregivers Act (Harper-Castor) - support for family caregivers H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act (Schweikert) - opioid issues H.R. 4998, Health Insurance for Former Foster Youth Act (Bass) - opioid issues H.R. 5477, Rural DOCS Act (O'Halleran) - opioid issues H.R. 5562, Protecting NAS Babies Act (Jenkins) - opioid issues H.R. 5582, Abuse Deterrent Access Act (Carter) - opioid issues H.R. 5583, State reporting on certain adult health quality measures (Clarke) - opioid issues H.R. 5590, CMS Action Plan (Kinzinger) - opioid issues H.R. 5515, National Defense Authorization Act (Thornberry) H.R. 5714, Education for Disposal of Unused Opioids Act (Black) - opioid issues H.R. 5715, Strengthening Partnerships to Prevent Opioid Abuse Act (Renacci) - opioid issues H.R. 5716, COMPASS Act (Roskam) - opioid issues H.R. 5723, Expanding Oversight of Opioid Prescribing and Payment Act (Tenney) - opioid issues H.R. 5725, BEST Act (Roskam) - opioid issues H.R. 5774, Combating Opioid Abuse for Care in Hospitals Act (Curbelo) - opioid issues H.R. 5775, Providing Reliable Options for Patients and Educational Resources Act (Paulsen) - opioid issues H.R. 5776, MOST Act (Neal) - opioid issues H.R. 5789, protections for pregnant and post-partum women (Foster) - opioid issues H.R. 5795, Overdose Prevention and Patient Safety Act (Blumenauer) - confidential sharing of substance use disorder information H.R. 5796, Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment Act (Fitzpatrick) - opioid issues H.R. 5801, PARTNERSHIP Act (Griffith) - opioid issues H.R. 6082, Overdose Prevention and Patient Safety Act (Mullin) - confidential sharing of substance use disorder information Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers including the health plan identifier, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues relating to similarly sized subscriber group (SSSG) and MLR requirements under the FEHBP; implementation of the health savings account provisions of the Medicare Act; issues related to Medicare Secondary Payer requirements; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital consolidation; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; prescription drug pricing; issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues relating to the annual fee on health insurance providers; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to family caregivers; and other issues relating to health care reform implementation.

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

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

Prescription drug abuse policy issues Provisions related to abuse-deterrent opioid formulary placement Provisions related to abuse-deterrent opioid coverage and access in Medicare H.R. 5582, the Abuse Deterrent Access Act regarding access to abuse-deterrent opioids in Medicare S. 2789, the Substance Abuse Prevention Act of 2018 regarding access to abuse-deterrent opioids

Client expense: $147,000 · Firm income: Not reported

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