Restoring Access to Medication Act of 2017

Monitor legislative and federal activity related to tax reform. Monitor legislative and federal activity related to Treasury Regulations proposed under section 385 of the Internal Revenue Code. Monitor legislative and administrative action related to implementation of H.R. 1, Tax Cuts and Jobs Act. S. 85, Restoring Access to Medication Act of 2017. S. 108, Medical Device Access and Innovation Protection Act. H.R. 184, Protect Medical Innovation Act of 2017. H.R. 394, Restoring Access to Medication Act of 2017. H.R. 1268, Veterinary Medicine Loan Repayment Program Enhancement Act. 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.

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

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

Issues related to the eligibility of over the counter drugs to be purchased using HSA and FSA accounts, including H.R.394 and S.85, both entitled Restoring Access to Medication Act of 2017, H. R. 4618, and H. R. 6199.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advocate against H.R. 1150, the Tanning Tax Repeal Act of 2017, and S. 2600, the Tanning Tax Repeal act of 2018, to repeal excise tax on indoor tanning services. Advocate against the inclusion of repealing the tax on indoor tanning services in tax-related legislation (H.R. 3798, the Save Americas Workers Act of 2017; and H.R. 6760, The Protecting Family and Small Business Tax Cuts Act of 2018). Advocate for legislation that would allow for Flexible Spending Accounts (FSAs) to be used to cover over-the-counter (OTC) drugs (S.85/H.R. 394, Restoring Access to Medication Act and H.R. 6199, the Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018.)

Client expense: $360,000 · Firm income: Not reported

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

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

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

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

H.R. 1316, Prescription Drug Price Transparency Act; H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act; S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act; H.R. 592, Pharmacy and Medically Underserved Areas Enhancement Act; S. 109, Pharmacy and Medically Underserved Areas Enhancement Act; H.R.1939 - To amend title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes; S.637 Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; HR 394/ S 85, Restoring Access to Medication Act; HR 3921/S 1827, KIDS Act of 2017; HR 3271, Protecting Access to Diabetes Supplies Act of 2017; S. 870, Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017; Centers for Medicare and Medicaid Services (CMS) Proposed Rule for the 2019 Medicare Part D Plan Year, pharmacy provisions; S.2553 / H.R. 6144, Know the Lowest Price Act of 2018; S.2554 / H.R. 6143, Patient Right to Know Drug Prices Act; H.R. 5343, Prescription Transparency Act of 2018; H.R. 5958, Phair Pricing Act of 2018; CMS Call Letter for 2019 Medicare Part D and Medicare Advantage Plans; H.R. 6733, Know the Cost Act of 2018; H.R. 6641, COST Act; H.R. 7339, Medicare for America Act of 2018; Proposed Rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"

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

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

- S.85/H.R.394, "Restoring Access to Medication Act of 2017", regarding all provisions. - Issues related to Mobile Workforce legislation. - Issues related to OECD tax reporting. - Issues related to Puerto Rico tax treatment. - Regulations implementing PL 115-97, "Tax Cut & Jobs Act", regarding all provisions.

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

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

Tax on indoor tanning services, including related provisions in H.R. 1150, the Tanning Tax Repeal Act of 2017 and S. 2600, the Tanning Tax Repeal Act of 2018, and section 5 of H.R. 3798, the Save American Workers Act, as amended in the House of Representatives; allow Flexible Spending Accounts (FSA) use for over-the-counter (OTC) medicines, including related provisions in S. 85 & H.R. 394, the Restoring Access to Medication Act.

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

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

Americans with Disabilities Act Tailored Regulation H.J.Res.111/S.J.Res.47 S.J.Res.57 H.R. 394/S.85, Restoring Access to Medication Act of 2017 H.R.35, Health Savings Act of 2017 H.R.1476, The Native American Health Savings Improvement Act H.R.1457, MOBILE Act of 2017 H.R. 1175/ S. 403, The Health Savings Act of 2017 H.R. 4028, PROTECT Act of 2017 H.R. 4978 / S. 2410, Chronic Disease Management Act of 2018 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 H.R. 6743, Consumer Information Notification Requirement Act Arbitration Clauses in Financial Contracts Fair Lending Laws Small Dollar Lending Military Lending Act

Client expense: $2,130,000 · Firm income: Not reported

Government targets: Consumer Financial Protection Bureau (CFPB), Federal Reserve System, HOUSE OF REPRESENTATIVES, Housing & Urban Development, Dept of (HUD), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of

Flexible spending arrangements (FSA) and health savings accounts (HSA) Graham-Cassidy Bill, no bill number. Graham-Cassidy contained a provision (section 108) to repeal the Affordable Care Act (ACA) requirement that patients obtain a prescriptions prior to using an FSA or HSA to purchase OTC medicine. Better Care Reconciliation Act (H.R. 1628). BCRA contained a provision(section 209)to repeal the Affordable Care Act (ACA) requirement that patients obtain a prescription prior to using an FSA or HSA to purchase OTC Medicines. American Healthcare Act (AHCA), no bill number. AHCA contained a provision(section 208)to repeal the Affordable Care Act (ACA) requirement that patients obtain a prescription prior to using an FSA or HSA to purchase OTC Medicines. H.R. 394/S. 85 - Restoring Access to Medication Act of 2017. Repeals prohibition in Patient Protection and Affordable Care Act (P.L. 111-148, P.L. 111-152) against use of flexible spending arrangement (FSA) and health savings account (HSA) funds on over-the-counter (OTC) medications; all sections. H.R. 1175/S.403 - Health Savings Act of 2017 - Codifies OTC medications as qualified medical expenses; Section 301 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. Temporarily repeals prohibition in Patient Protection and Affordable Care Act (P.L. 111-148, P.L. 111-152) against use of flexible spending arrangement (FSA) and health savings account (HSA) funds on over-the-counter (OTC) medications. H.R.1625 - Consolidated Appropriations Act, 2018. Omnibus appropriations package. H.R. 6199 -- To amend the Internal Revenue Code of 1986 to include certain over-the-counter medical products as qualified medical expenses. Repeals provisions of the Internal Revenue Code, as added by the Patient Protection and Affordable Care Act, that limit payments for medications from health savings accounts, medical savings accounts, health flexible spending arrangements, and health reimbursement arrangements to only prescription drugs or insulin (thus allowing distributions from such accounts for over-the-counter drugs). The bill also allows the accounts to be used for menstrual care products.

Client expense: $197,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

H.R. 1776/S. 771 - Improving Access To Affordable Prescription Drugs Act H.R. 592/S. 109 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 394/S. 85 - Restoring Access to Medication Act H.R.3528 - Every Prescription Conveyed Securely Act S.2460- Every Prescription Conveyed Securely Act H.R. 5799, Medicaid DRUG Improvement Act H.R. 5801, Medicaid PARTNERSHIP Act H.R. 5808, Medicaid Pharmaceutical Home Act of 2018 H.R. 3325 - Advancing Care for Exceptional (ACE) Kids Act

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

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

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

S. 28, Health Savings Account Expansion Act (Flake) - HSA improvements S. 85, Restoring Access to Medications Act (Roberts) - paying for OTC products with HSA funds S. 403, Health Savings Act (Hatch) - HSA and FSA improvements S. 761, Health Care Options Act (Alexander) - using premiums for off-Exchange plans S. 1859, Healthcare Tax Relief Act (Gardner) - suspension of ACA health insurance tax S. 1978, Small Business and Family Health Tax Relief Act (Heitkamp) - suspension of ACA health insurance tax S. 2410, Chronic Disease Management Act (Thune) - flexibility for high-deductible health plans S. 3063, Health Insurance Tax Relief Act (Barrasso) - suspension of ACA health insurance tax H.R. 246, Jobs and Premium Protection Act (Noem-Sinema) - repeal of ACA health insurance tax H.R. 247, Health Savings Account Expansion Act (Brat) - HSA improvements H.R. 394, Restoring Access to Medications Act (Jenkins) - paying for OTC products with HSA funds H.R. 1175, Health Savings Act (Paulsen) - HSA and FSA improvements H.R. 3798, Save American Workers Act (Walorski) - delay in Cadillac tax H.R. 4616 (Nunes) - delay in ACA excise tax on employer-provided health coverage H.R. 4618 (Jenkins) - use of HSA funds for OTC medications H.R. 4620, Protecting Families and Small Businesses Act (Noem) - relief from ACA health insurance tax H.R. 4894, Harmful Tax Prevention Act (Noem) - relief from ACA health insurance tax H.R. 4978, Chronic Disease Management Act (Black) - flexibility for high-deductible health plans H.R. 5138, Bipartisan HSA Improvement Act (Kelly) - HSA changes H.R. 5963, Health Insurance Premium Reduction Act (Noem) - suspension of ACA health insurance tax H.R. 6199, Restoring Access to Medication Act (Jenkins) - OTC medical products as qualified medical expense, HSA improvements H.R. 6301, Promoting High-Value Health Care Through Flexibility for High Deductible Health Plans Act (Roskam) - flexibility on first dollar coverage for HSA plans H.R. 6305, Bipartisan HSA Improvement Act (Kelly) - HSA flexibility; treatment of certain employment-related services; FSA and HRA conversions H.R. 6306, Health Care Security Act (Paulsen) - HSA contribution limits, spousal catch-up contributions, grace period for medical expenses H.R. 6309, Allowing Working Seniors to Keep Their Health Savings Accounts Act (Paulsen) - HSA contributions by Medicare-eligible individuals H.R. 6311, Increasing Access to Lower Premium Plans and Expanding HSAs Act (Roskam) - suspension of health insurance tax, HSA improvements H.R. 6312, Personal Health Investment Today Act (Smith) - medical care tax deduction for qualified sports and fitness expenses H.R. 6313, RAISE Health Benefits Act (Stivers) - Health FSA rollovers H.R. 6314, Health Savings Act (Burgess) - definition of high-deductible health plan H.R. 6317, Primary Care Enhancement Act (Paulsen) - participation by HSA-eligible individuals in direct primary care (DPC) arrangements Regulatory Issues: Annual insurer provider fees; issues concerning the patient-centered outcomes research fee; employer and individual coverage mandate; W-2 reporting requirements; health reimbursement accounts; deductibility limits for insurer compensation; health insurer and employer reporting of health coverage; issues related to implementation of health insurance tax; issues related to the refundable credit for coverage under a qualified health plan; issues related to coverage of chronic conditions in high deductible health plans; issues related to health savings accounts; issues related to the deductibility of employer-sponsored health coverage; issues related to enhancing tax treatment of long-term care insurance; issues related to qualified small employer health reimbursement accounts (QSEHRAs); issues related to implementation of the excise tax on high cost employer-sponsored health coverage; 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. 28, Health Savings Account Expansion Act (Flake) - HSA improvements S. 85, Restoring Access to Medications Act (Roberts) - paying for OTC products with HSA funds S. 403, Health Savings Act (Hatch) - HSA and FSA improvements S. 761, Health Care Options Act (Alexander) - using premiums for off-Exchange plans S. 1859, Healthcare Tax Relief Act (Gardner) - suspension of ACA health insurance tax S. 1978, Small Business and Family Health Tax Relief Act (Heitkamp) - suspension of ACA health insurance tax S. 2410, Chronic Disease Management Act (Thune) - flexibility for high-deductible health plans S. 3063, Health Insurance Tax Relief Act (Barrasso) - suspension of ACA health insurance tax H.R. 195, Extension of Continuing Appropriations Act - one-year suspension of ACA health insurance tax, two-year delay in ACA excise tax on employer-sponsored health plans H.R. 246, Jobs and Premium Protection Act (Noem-Sinema) - repeal of ACA health insurance tax H.R. 247, Health Savings Account Expansion Act (Brat) - HSA improvements H.R. 394, Restoring Access to Medications Act (Jenkins) - paying for OTC products with HSA funds H.R. 1175, Health Savings Act (Paulsen) - HSA and FSA improvements H.R. 4616 (Nunes) - delay in ACA excise tax on employer-provided health coverage H.R. 4618 (Jenkins) - use of HSA funds for OTC medications H.R. 4620, Protecting Families and Small Businesses Act (Noem) - relief from ACA health insurance tax H.R. 4894, Harmful Tax Prevention Act (Noem) - relief from ACA health insurance tax H.R. 4978, Chronic Disease Management Act (Black) - flexibility for high-deductible health plans H.R. 5138, Bipartisan HSA Improvement Act (Kelly) - HSA changes H.R. 5963, Health Insurance Premium Reduction Act (Noem) - suspension of ACA health insurance tax H.R. 6199, Restoring Access to Medication Act (Jenkins) -- OTC medical products as qualified medical expense H.R. 6301, Promoting High-Value Health Care Through Flexibility for High Deductible Health Plans Act (Roskam) - flexibility on first dollar coverage for HSA plans H.R. 6305, Bipartisan HSA Improvement Act (Kelly) - HSA flexibility H.R. 6314, Health Savings Act (Burgess) - definition of high-deductible health plan Regulatory Issues: Annual insurer provider fees; issues concerning the patient-centered outcomes research fee; employer and individual coverage mandate; W-2 reporting requirements; health reimbursement accounts; deductibility limits for insurer compensation; health insurer and employer reporting of health coverage; issues related to implementation of health insurance tax; issues related to the refundable credit for coverage under a qualified health plan; issues related to coverage of chronic conditions in high deductible health plans; issues related to health savings accounts; issues related to the deductibility of employer-sponsored health coverage; issues related to qualified small employer health reimbursement accounts (QSEHRAs); issues related to implementation of the excise tax on high cost employer-sponsored health coverage; 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

Advocate against H.R. 1150, the Tanning Tax Repeal Act of 2017, and S. 2600, the Tanning Tax Repeal act of 2018, to repeal excise tax on indoor tanning services. Advocate for legislation that would allow for Flexible Spending Accounts (FSAs) to be used to cover over-the-counter (OTC) drugs (S.85/H.R. 394, Restoring Access to Medication Act and H.R. 6199, the Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018. Advocate against the inclusion of the repeal of the excise tax on indoor tanning services in the Save American Workers Act (H.R. 3798).

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

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

- S.85/H.R.394, "Restoring Access to Medication Act of 2017", regarding all provisions. - Issues related to Mobile Workforce legislation. - Issues related to OECD tax reporting. - Issues related to Puerto Rico tax treatment. - Regulations implementing PL 115-97, "Tax Cut & Jobs Act", regarding all provisions.

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

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

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

Tax on indoor tanning services, including related provisions in H.R. 1150, the Tanning Tax Repeal Act of 2017 and S. 2600, the Tanning Tax Repeal Act of 2018, and section 5 of H.R. 3798, the Save American Workers Act, as amended in the House of Representatives; allow Flexible Spending Accounts (FSA) use for over-the-counter (OTC) medicines, including related provisions in S. 85 & H.R. 394, the Restoring Access to Medication Act.

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

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

Monitor legislative and federal activity related to tax reform. Monitor legislative and federal activity related to Treasury Regulations proposed under section 385 of the Internal Revenue Code. Monitor legislative and administrative action related to implementation of H.R. 1, Tax Cuts and Jobs Act. S. 85, Restoring Access to Medication Act of 2017. S. 108, Medical Device Access and Innovation Protection Act. H.R. 184, Protect Medical Innovation Act of 2017. H.R. 394, Restoring Access to Medication Act of 2017. H.R. 1268, Veterinary Medicine Loan Repayment Program Enhancement Act. 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.

Client expense: $1,700,000 · Firm income: Not reported

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

Monitor legislative and federal activity related to tax reform. Monitor legislative and federal activity related to Treasury Regulations proposed under section 385 of the Internal Revenue Code. Monitor legislative and administrative action related to implementation of H.R. 1, Tax Cuts and Jobs Act. S. 85, Restoring Access to Medication Act of 2017. S. 108, Medical Device Access and Innovation Protection Act. H.R. 184, Protect Medical Innovation Act of 2017. H.R. 394, Restoring Access to Medication Act of 2017. H.R. 1268, Veterinary Medicine Loan Repayment Program Enhancement Act. 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.

Client expense: $1,600,000 · Firm income: Not reported

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

Issues related to the eligibility of over the counter drugs to be purchased using HSA and FSA accounts, including H.R.394 and S.85, both entitled Restoring Access to Medication Act of 2017, H. R. 4618, and H. R. 6199.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1267, Personal Health Investment Today (PHIT) Act, all provisions H.R. 4240, Public Safety and Second Amendment Rights Protection Act of 2017, all provisions H.R. 6142, Reducing Drug Waste Act of 2018, all provisions H.R. 6301, Promoting High-Value Health Care Through Flexibility for High Deductible Health Plans Act of 2018, all provisions H.R. 6199, Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018, all provisions H.R. 6305, Bipartisan HSA Improvement Act of 2018, all provisions H.R. 6306, Health Care Security Act of 2018, all provisions H.R. 6313, Responsible Additions and Increases to Sustain Employee Health Benefits Act of 2018, all provisions H.R. 6314, Health Savings Act of 2018, all provisions H.R. 6317, Primary Care Enhancement Act of 2018, all provisions H.R. 6082, Overdose Prevention and Patient Safety Act, all provisions H.R. 6, Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, all provisions S. 2680, Opioid Crisis Response Act of 2018, all provisions S. 3120, Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018, provisions relating to human services H.R. 6733, Know the Cost Act of 2018, all provisions S. 2554, Patient Right to Know Drug Prices Act, all provisions S. 2020, Cyber Shield Act of 2017, all provisions H.R. 394, Restoring Access to Medication Act of 2017, all provisions S. 85, Restoring Access to Medication Act of 2017, all provisions H.R. 1375, Prescriber Support Act of 2017, all provisions S. 1016, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2017, provisions relating to telehealth S. 2456, CARA 2.0 Act of 2018, all provisions H.R. 4825, Marijuana Effective Drug Studies (MEDS) Act of 2018, all provisions S. 1112, Maternal Health Accountability Act of 2017, all provisions Diagnostic Accuracy and Innovation Prescription Drug Pricing Affordable Care Act (ACA) risk-adjustment program 42 CFR Part 2/Substance abuse confidentiality regulations Software as a Medical Device (SaMD) SaMD Transparency Certificate-of-Need Reform Physician-Owned Hospitals Augmented Intelligence (AI) Cybersecurity ACA Navigator program funding cuts Electronic Health Records (EHR) EHR Vendor Reporting Program EHR Interoperability In-Office Compounding Opioids Consent2Share demonstration Prescription drug costs and pricing Substance use disorder Medical price transparency Administrative burdens and simplification Telehealth Laboratory developed tests (LDTs) Health Savings Accounts - Prescription requirement for over-the-counter medications Electronic prescribing of controlled substances Prescription Drug Monitoring Program (PDMP) Federal prescription limits Sunshine Act Regulation - Journal reprints and textbooks Direct-to-consumer (DTC) advertising - prescription drug price disclosure Biosimilar Regulations Generic Drug Regulations Pharmacy Benefit Managers (PBMs) Surprise billing

Client expense: $4,120,000 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE, Veterans Affairs, Dept of (VA), White House Office

Americans with Disabilities Act Tailored Regulation H.J.Res.111/S.J.Res.47 S.J.Res.57 H.R. 394/S.85, Restoring Access to Medication Act of 2017 H.R.35, Health Savings Act of 2017 H.R.1476, The Native American Health Savings Improvement Act H.R.1457, MOBILE Act of 2017 H.R. 1175/ S. 403, The Health Savings Act of 2017 H.R. 4028, PROTECT Act of 2017 H.R. 4978 / S. 2410, Chronic Disease Management Act of 2018 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 H.R. 6743, Consumer Information Notification Requirement Act Arbitration Clauses in Financial Contracts Fair Lending Laws Small Dollar Lending Military Lending Act

Client expense: $2,130,000 · Firm income: Not reported

Government targets: Federal Reserve System, HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

H.R. 1316, Prescription Drug Price Transparency Act; H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act; S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act; H.R. 592, Pharmacy and Medically Underserved Areas Enhancement Act; S. 109, Pharmacy and Medically Underserved Areas Enhancement Act; H.R.1939 - To amend title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes; S.637 Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; HR 394/ S 85, Restoring Access to Medication Act; HR 3921/S 1827, KIDS Act of 2017; HR 3271, Protecting Access to Diabetes Supplies Act of 2017; S. 870, Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017; Centers for Medicare and Medicaid Services (CMS) Proposed Rule for the 2019 Medicare Part D Plan Year, pharmacy provisions; S.2553 / H.R. 6144, Know the Lowest Price Act of 2018; S.2554 / H.R. 6143, Patient Right to Know Drug Prices Act; H.R. 5343, Prescription Transparency Act of 2018; H.R. 5958, Phair Pricing Act of 2018; CMS Call Letter for 2019 Medicare Part D and Medicare Advantage Plans; H.R. 6733, Know the Cost Act of 2018; H.R. 6641, COST Act

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

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

Flexible spending arrangements (FSA) and health savings accounts (HSA) Graham-Cassidy Bill, no bill number. Graham-Cassidy contained a provision (section 108) to repeal the Affordable Care Act (ACA) requirement that patients obtain a prescriptions prior to using an FSA or HSA to purchase OTC medicine. Better Care Reconciliation Act (H.R. 1628). BCRA contained a provision(section 209)to repeal the Affordable Care Act (ACA) requirement that patients obtain a prescription prior to using an FSA or HSA to purchase OTC Medicines. American Healthcare Act (AHCA), no bill number. AHCA contained a provision(section 208)to repeal the Affordable Care Act (ACA) requirement that patients obtain a prescription prior to using an FSA or HSA to purchase OTC Medicines. H.R. 394/S. 85 - Restoring Access to Medication Act of 2017. Repeals prohibition in Patient Protection and Affordable Care Act (P.L. 111-148, P.L. 111-152) against use of flexible spending arrangement (FSA) and health savings account (HSA) funds on over-the-counter (OTC) medications; all sections. H.R. 1175/S.403 - Health Savings Act of 2017 - Codifies OTC medications as qualified medical expenses; Section 301 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. Temporarily repeals prohibition in Patient Protection and Affordable Care Act (P.L. 111-148, P.L. 111-152) against use of flexible spending arrangement (FSA) and health savings account (HSA) funds on over-the-counter (OTC) medications. H.R.1625 - Consolidated Appropriations Act, 2018. Omnibus appropriations package. H.R. 6199 -- To amend the Internal Revenue Code of 1986 to include certain over-the-counter medical products as qualified medical expenses. Repeals provisions of the Internal Revenue Code, as added by the Patient Protection and Affordable Care Act, that limit payments for medications from health savings accounts, medical savings accounts, health flexible spending arrangements, and health reimbursement arrangements to only prescription drugs or insulin (thus allowing distributions from such accounts for over-the-counter drugs). The bill also allows the accounts to be used for menstrual care products.

Client expense: $198,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

H.R. 1776/S. 771 - Improving Access To Affordable Prescription Drugs Act H.R. 592/S. 109 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 394/S. 85 - Restoring Access to Medication Act H.R.3528 - Every Prescription Conveyed Securely Act S.2460- Every Prescription Conveyed Securely Act H.R. 5799, Medicaid DRUG Improvement Act H.R. 5801, Medicaid PARTNERSHIP Act H.R. 5808, Medicaid Pharmaceutical Home Act of 2018 H.R. 3325 - Advancing Care for Exceptional (ACE) Kids Act

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

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

Patient Protection and Affordable Care Act (P.L. 111-148) and Health Care and Education Reconciliation Act of 2010 (P.L. 111-152); ACA reporting requirements; ERISA; tax treatment of employer-sponsored health coverage; employer-sponsored wellness programs; H.R. 173/S. 58 - ACA 40 percent excise tax repeal; H.R. 394/S. 85 - consumer directed health products/over-the-counter; H.R. 246 - HIT repeal; H.R. 1628 (FY17 reconciliation); COBRA; H.R. 3919/S. 1908 - Commonsense Reporting Act; HR 5138 - Bipartisan HSA Improvement Act; H.R. 6 - SUPPORT for Patients and Communities Act; H.R. 6301 - high deductible health plans with first dollar coverage; H.R. 6305 - Bipartisan HSA Improvement Act; H.R. 6312 - Personal Health Investment Today (PHIT) Act; H.R. 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act; H.R. 4616 - temporary moratorium on the employer mandate and to provide for a delay of 40-percent excise tax; H.R. 3798 - Save American Workers Act; H.R. 6311 - Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act.

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

Government targets: Commerce, Dept of (DOC), Consumer Financial Protection Bureau (CFPB), Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Telecommunications & Information Administration (NTIA), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), White House Office

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. 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. 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. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program HR 4993 Vaccine Access Improvement Act HR 4297/S 2103 Protecting Seniors Through Immunization Act H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - To require improved packaging and disposal methods with respect to certain drugs H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste HR 6378/S 2852 Pandemic and All Hazards Preparedness Act reauthorization HR 6294 REVAMP Act 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. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1327: SITSA Act - Provisions related to controlled substances 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 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy TRICARE pharmacy pilot program 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) Pandemic and All-Hazards Preparedness Act, provisions related to emerging infectious diseases and antimicrobial resistance. HR 6 - SUPPORT for Patients and Communities Act HR 5687 - SOUND Disposal and Packaging ActHR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform ActHR 394/S 85 - Restoring Access to Medication Act of 2017 HR 6199 - To amend the Internal Revenue Code of 1986 to include certain over-the-counter medical products as qualified medical expenses. HR 6157 - FY19 Defense Appropriations ActS 3159 - FY19 Defense Appropriations ActS 3158 - FY19 Labor-HHS-Education Appropriations ActHouse Draft - FY19 Labor-HHS-Education Appropriations ActPatient Access in Medicaid program340B Discount Drug ProgramHR 4710 - 340B PAUSE ActHR 5598 - 340B Optimization Act HR 5958 - Phair Pricing Act of 2018

Client expense: $1,400,000 · Firm income: Not reported

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

Monitor legislative and federal activity related to tax reform. Monitor legislative and federal activity related to Treasury Regulations proposed under section 385 of the Internal Revenue Code. Monitor legislative and administrative action related to implementation of H.R. 1, Tax Cuts and Jobs Act. S. 85, Restoring Access to Medication Act of 2017. S. 108, Medical Device Access and Innovation Protection Act. H.R. 184, Protect Medical Innovation Act of 2017. H.R. 394, Restoring Access to Medication Act of 2017. H.R. 1268, Veterinary Medicine Loan Repayment Program Enhancement Act. 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.

Client expense: $1,670,000 · Firm income: Not reported

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

Monitor legislative and federal activity related to tax reform. Monitor legislative and federal activity related to Treasury Regulations proposed under section 385 of the Internal Revenue Code. Monitor legislative and administrative action related to implementation of H.R. 1, Tax Cuts and Jobs Act. S. 85, Restoring Access to Medication Act of 2017. S. 108, Medical Device Access and Innovation Protection Act. H.R. 184, Protect Medical Innovation Act of 2017. H.R. 394, Restoring Access to Medication Act of 2017. H.R. 1268, Veterinary Medicine Loan Repayment Program Enhancement Act. 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.

Client expense: $3,420,000 · Firm income: Not reported

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

H.R. 1776/S. 771 - Improving Access To Affordable Prescription Drugs Act H.R. 592/S. 109 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 394/S. 85 - Restoring Access to Medication Act H.R.3528 - Every Prescription Conveyed Securely Act S.2460- Every Prescription Conveyed Securely Act H.R. 5799, Medicaid DRUG Improvement Act H.R. 5801, Medicaid PARTNERSHIP Act H.R. 5808, Medicaid Pharmaceutical Home Act of 2018

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

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

Americans with Disabilities Act Tailored Regulation H.J.Res.111/S.J.Res.47 S.J.Res.57 H.R. 394/S.85, Restoring Access to Medication Act of 2017 H.R.35, Health Savings Act of 2017 H.R.1476, The Native American Health Savings Improvement Act H.R.1457, MOBILE Act of 2017 H.R. 1175/ S. 403, The Health Savings Act of 2017 H.R. 4028, PROTECT Act of 2017 H.R. 4978 / S. 2410, Chronic Disease Management Act of 2018 Arbitration Clauses in Financial Contracts Fair Lending Laws Small Dollar Lending Military Lending Act

Client expense: $2,500,000 · Firm income: Not reported

Government targets: Federal Reserve System, HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

Patient Protection and Affordable Care Act (P.L. 111-148) and Health Care and Education Reconciliation Act of 2010 (P.L. 111-152); ACA reporting requirements; ERISA; tax treatment of employer-sponsored health coverage; employer-sponsored wellness programs; H.R. 173/S. 58 - ACA 40 percent excise tax repeal; H.R. 394/S. 85 - consumer directed health products/over-the-counter; H.R. 246 - HIT repeal; H.R. 1628 (FY17 reconciliation); COBRA; H.R. 3919/S. 1908 - Commonsense Reporting Act; HR 5138 - Bipartisan HSA Improvement Act; H.R. 6 - SUPPORT for Patients and Communities Act; H.R. 6301 - high deductible health plans with first dollar coverage; H.R. 6305 - Bipartisan HSA Improvement Act; H.R. 6312 - Personal Health Investment Today (PHIT) Act; H.R. 6199 - over the counter medical products as qualified medical expenses; H.R. 4616 - temporary moratorium on the employer mandate and to provide for a delay of 40-percent excise tax; H.R. 3798 - Save American Workers Act.

Client expense: $720,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Consumer Financial Protection Bureau (CFPB), Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Telecommunications & Information Administration (NTIA), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), White House Office

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

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

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

Advocate against H.R. 1150, the Tanning Tax Repeal Act of 2017, and S. 2600, the Tanning Tax Repeal act of 2018, to repeal excise tax on indoor tanning services. Advocate for legislation that would allow for Flexible Spending Accounts (FSAs) to be used to cover over-the-counter (OTC) drugs (S.85/H.R. 394, Restoring Access to Medication Act).

Client expense: $400,000 · Firm income: Not reported

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

- S.85/H.R.394, "Restoring Access to Medication Act of 2017", regarding all provisions. - Issues related to tax reform. - Issues related to Mobile Workforce legislation. - Issues related to OECD tax reporting. - Issues related to Puerto Rico tax treatment. - Regulations implementing PL 115-97, "Tax Cut & Jobs Act", regarding all provisions.

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

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

Tax on indoor tanning services, including related provisions in H.R. 1150, the Tanning Tax Repeal Act of 2017 and S. 2600, the Tanning Tax Repeal Act of 2018; allow Flexible Spending Accounts (FSA) use for over-the-counter (OTC) medicines, including related provisions in S. 85 & H.R. 394, the Restoring Access to Medication Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 28, Health Savings Account Expansion Act (Flake) - HSA improvements S. 85, Restoring Access to Medications Act (Roberts) - paying for OTC products with HSA funds S. 403, Health Savings Act (Hatch) - HSA and FSA improvements S. 761, Health Care Options Act (Alexander) - using premiums for off-Exchange plans S. 1859, Healthcare Tax Relief Act (Gardner) - suspension of ACA health insurance tax S. 1978, Small Business and Family Health Tax Relief Act (Heitkamp) - suspension of ACA health insurance tax S. 2410, Chronic Disease Management Act (Thune) - flexibility for high-deductible health plans S. 3063, Health Insurance Tax Relief Act (Barrasso) - suspension of ACA health insurance tax H.R. 195, Extension of Continuing Appropriations Act - one-year suspension of ACA health insurance tax, two-year delay in ACA excise tax on employer-sponsored health plans H.R. 246, Jobs and Premium Protection Act (Noem-Sinema) - repeal of ACA health insurance tax H.R. 247, Health Savings Account Expansion Act (Brat) - HSA improvements H.R. 394, Restoring Access to Medications Act (Jenkins) - paying for OTC products with HSA funds H.R. 1175, Health Savings Act (Paulsen) - HSA and FSA improvements H.R. 4616 (Nunes) - delay in ACA excise tax on employer-provided health coverage H.R. 4618 (Jenkins) - use of HSA funds for OTC medications H.R. 4620, Protecting Families and Small Businesses Act (Noem) - relief from ACA health insurance tax H.R. 4894, Harmful Tax Prevention Act (Noem) - relief from ACA health insurance tax H.R. 4978, Chronic Disease Management Act (Black) - flexibility for high-deductible health plans H.R. 5138, Bipartisan HSA Improvement Act (Kelly) - HSA changes H.R. 5963, Health Insurance Premium Reduction Act (Noem) - suspension of ACA health insurance tax H.R. 6199, Restoring Access to Medication Act (Jenkins) -- OTC medical products as qualified medical expense H.R. 6301, Promoting High-Value Health Care Through Flexibility for High Deductible Health Plans Act (Roskam) - flexibility on first dollar coverage for HSA plans H.R. 6305, Bipartisan HSA Improvement Act (Kelly) - HSA flexibility H.R. 6314, Health Savings Act (Burgess) - definition of high-deductible health plan Regulatory Issues: Annual insurer provider fees; issues concerning the patient-centered outcomes research fee; employer and individual coverage mandate; W-2 reporting requirements; health reimbursement accounts; deductibility limits for insurer compensation; health insurer and employer reporting of health coverage; issues related to implementation of health insurance tax; issues related to the refundable credit for coverage under a qualified health plan; issues related to coverage of chronic conditions in high deductible health plans; issues related to health savings accounts; issues related to the deductibility of employer-sponsored health coverage; issues related to qualified small employer health reimbursement accounts (QSEHRAs); issues related to implementation of the excise tax on high cost employer-sponsored health coverage; and other issues relating to health care reform implementation.

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

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

H.R. 1316, Prescription Drug Price Transparency Act; H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act; S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act; H.R. 592, Pharmacy and Medically Underserved Areas Enhancement Act; S. 109, Pharmacy and Medically Underserved Areas Enhancement Act; H.R.1939 - To amend title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes; S.637 Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; HR 394/ S 85, Restoring Access to Medication Act; HR 3921/S 1827, KIDS Act of 2017; HR 3271, Protecting Access to Diabetes Supplies Act of 2017; S. 870, Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017; Centers for Medicare and Medicaid Services (CMS) Proposed Rule for the 2019 Medicare Part D Plan Year, pharmacy provisions; S.2553 / H.R. 6144, Know the Lowest Price Act of 2018; S.2554 / H.R. 6143, Patient Right to Know Drug Prices Act; H.R. 5343, Prescription Transparency Act of 2018; H.R. 5958, Phair Pricing Act of 2018; CMS Call Letter for 2019 Medicare Part D and Medicare Advantage Plans

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

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

H.R.1, Tax Reform Act H.R.25, FairTax Act of 2017 H.R.116, Main Street Fairness Act H.R.631, Death Tax Repeal Act of 2017 H.R.1393, Mobile Workforce State Income Tax Simplification Act of 2017 H.R.1696, S Corporation Modernization Act of 2017 H.R.1866, Stop Animal Fat Tax Credits Act of 2017 H.R.1932, Stop Tax Haven Abuse Act H.R.2193, Remote Transactions Parity Act of 2017 S.18, Fair Tax Act of 2017 S.85, Stop Tax Haven Abuse Act S.205, Death Tax Repeal Act of 2017 S.321, A bill to amend the Internal Revenue Code of 1986 to exempt amounts paid for aircraft management services from the excise taxes imposed on transportation by air. S.540, Mobile Workforce State Income Tax Simplification Act of 2017 S.707, Main Street Fairness Act S.711, S Corporation Modernization Act of 2017 S.1549, NEW GIG Act of 2017

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Flexible spending arrangements (FSA) and health savings accounts (HSA) Graham-Cassidy Bill, no bill number. Graham-Cassidy contained a provision (section 108) to repeal the Affordable Care Act (ACA) requirement that patients obtain a prescriptions prior to using an FSA or HSA to purchase OTC medicine. Better Care Reconciliation Act (H.R. 1628). BCRA contained a provision(section 209)to repeal the Affordable Care Act (ACA) requirement that patients obtain a prescription prior to using an FSA or HSA to purchase OTC Medicines. American Healthcare Act (AHCA), no bill number. AHCA contained a provision(section 208)to repeal the Affordable Care Act (ACA) requirement that patients obtain a prescription prior to using an FSA or HSA to purchase OTC Medicines. H.R. 394/S. 85 - Restoring Access to Medication Act of 2017. Repeals prohibition in Patient Protection and Affordable Care Act (P.L. 111-148, P.L. 111-152) against use of flexible spending arrangement (FSA) and health savings account (HSA) funds on over-the-counter (OTC) medications; all sections. H.R. 1175/S.403 - Health Savings Act of 2017 - Codifies OTC medications as qualified medical expenses; Section 301 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. Temporarily repeals prohibition in Patient Protection and Affordable Care Act (P.L. 111-148, P.L. 111-152) against use of flexible spending arrangement (FSA) and health savings account (HSA) funds on over-the-counter (OTC) medications. H.R.1625 - Consolidated Appropriations Act, 2018. Omnibus appropriations package. H.R. 6199 -- To amend the Internal Revenue Code of 1986 to include certain over-the-counter medical products as qualified medical expenses. Repeals provisions of the Internal Revenue Code, as added by the Patient Protection and Affordable Care Act, that limit payments for medications from health savings accounts, medical savings accounts, health flexible spending arrangements, and health reimbursement arrangements to only prescription drugs or insulin (thus allowing distributions from such accounts for over-the-counter drugs). The bill also allows the accounts to be used for menstrual care products.

Client expense: $255,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

Issues related to the eligibility of over the counter drugs to be purchased using HSA and FSA accounts, including H.R.394 and S.85, both entitled Restoring Access to Medication Act of 2017, H. R. 4618, and H. R. 6199.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advocate against H.R. 1150, the Tanning Tax Repeal Act of 2017, to repeal excise tax on indoor tanning services. Advocate for legislation that would allow for Flexible Spending Accounts (FSAs) to be used to cover over-the-counter (OTC) drugs (S.85/H.R. 394, Restoring Access to Medication Act).

Client expense: $470,000 · Firm income: Not reported

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

Monitor legislative and federal activity related to tax reform. Monitor legislative and federal activity related to Treasury Regulations proposed under section 385 of the Internal Revenue Code. Monitor legislative and administrative action related to implementation of H.R. 1, Tax Cuts and Jobs Act. S. 85, Restoring Access to Medication Act of 2017. S. 108, Medical Device Access and Innovation Protection Act. H.R. 184, Protect Medical Innovation Act of 2017. H.R. 394, Restoring Access to Medication Act of 2017. H.R. 1268, Veterinary Medicine Loan Repayment Program Enhancement Act. 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.

Client expense: $3,450,000 · Firm income: Not reported

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

Patient Protection and Affordable Care Act (P.L. 111-148) and Health Care and Education Reconciliation Act of 2010 (P.L. 111-152); ACA reporting requirements; ERISA; tax treatment of employer-sponsored health coverage; employer-sponsored wellness programs; H.R. 173/S. 58 - ACA 40 percent excise tax repeal; H.R. 394/S. 85 - consumer directed health products/over-the-counter; H.R. 246 - HIT repeal; H.R. 1628 (FY17 reconciliation); COBRA; H.R. 3919/S. 1908 - Commonsense Reporting Act; HR 5138 - Bipartisan HSA Improvement Act; HR 195 - Continuing Resolution which included the suspension of health related taxes.

Client expense: $670,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Consumer Financial Protection Bureau (CFPB), Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Federal Communications Commission (FCC), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Telecommunications & Information Administration (NTIA), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), White House Office