Medicare Drug Price Negotiation Act

Hearing Health Care Services. S. 2575/H.R. 2276, Audiology Patient Choice Act of 2018: Proposal to expand access to hearing health care services for Medicare beneficiaries. Hearing Aids. H.R. 3426, Medicare Hearing Aid Coverage Act: Proposal to provide Medicare coverage of hearing aids. Medicare Dental, Vision, and Hearing Coverage. H.R. 508, Seniors Have Eyes, Ears and Teeth Act and H.R. 3111, Medicare Dental, Vision, and Hearing Benefit Act of 2017: Proposals to expand Medicare coverage to include comprehensive coverage of dental, vision, and hearing care. Medicare Observation Status. S. 568/H.R. 1421, Improving Access to Medicare Coverage Act of 2017: Proposal to count days in the hospital in observation status toward meeting the three-day prior hospitalization requirement for skilled nursing facility care eligibility. Opioid Treatment. S. 2704/H.R. 4097, Medicare Beneficiary Opioid Addiction Treatment Act: Proposal to provide for coverage of methadone under Medicare Part B. Dementia and Alzheimers. S. 2076/H.R. 4256, Building Our Largest Dementia Infrastructure for Alzheimers Act (BOLD Act): Proposal to apply a public health approach to combat Alzheimers disease and related dementias; Alzheimers Disease. S. 2387/H.R. 4957, Concentrating on High-Value Alzheimers Needs to Get to an End (CHANGE) Act of 2018: Proposal to aid Alzheimers disease suffers, their families and caregivers, including authorization of a cognitive impairment detection benefit in the Medicare annual wellness visit and initial preventive physical examination. Drug Price Negotiation. S. 2011/H.R. 4138, Medicare Drug Price Negotiation Act: Proposals to lower prescription drug prices in the Medicare Part D program, including allowing Medicare to negotiate directly with prescription drug manufacturers and requiring drug manufacturers to rebate to the federal government for drugs covered under Medicare Part D for low-income Medicare beneficiaries. Generic Drug Introduction. S. 974/H.R. 2212, CREATES Act: Proposal to speed the introduction of generic competition by curbing brand drug maker abuses of safety procedures as a means to limit generic manufacturer access to the drug samples needed to obtain Food and Drug Administration approval. Prescription Drug costs. S. 2553/H.R. 6144, the Know the Lowest Price Act: Proposal to prohibit health plans and pharmacy benefits managers from utilizing contract gag clauses prohibiting pharmacists from disclosing to consumers when it costs less to pay out-of-pocket for a prescription than it would using their insurance coverage. Medicare Part B Drug Costs . H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018: Proposal to reduce Medicare Part B drug costs by requiring Medicare to rebate to the government the amount by which a drug price increase exceeds an inflation limit. Medicare Beneficiary Education. (No bill): Efforts to improve the Centers for Medicare and Medicaid outreach and education during open enrollment.

Client expense: $260,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), President of the U.S., SENATE, Social Security Administration (SSA), Treasury, Dept of, Vice President of the U.S.

General Medicare Protection, Prevention of Fraud, Waste, and Abuse: H.R. 2460 and H.R. 4841 and H.R. 4704, Prescription Drug Re-Importation: S. 92 and S. 469 and H.R. 1245, Negotiation of Prescription Drug Prices: H.R. 242 and S. 41, General Prescription Drug Affordability: S. 124 and S. 771 and H.R. 1776 and H.R. 4138 and H.R. 4116 and H.R. 4117 and S. 2011 and S. 974 and H.R. 2212 and S. 2553, Medicare Enrollment Simplification: H.R. 2575 and S. 1909, Expanding Medicare Coverage: H.R. 5083 and H.R. 4957 and S. 2387 and H.R. 807 and H.R. 3098 and H.R. 4701 and H.R. 508 and H.R. 2276 and S. 2575 and H.R. 5083.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculation Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---Value-based Contracting and Communications ---CMS Hospital Inpatient Proposed Rule ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations for FY 2018

Client expense: $2,370,000 · Firm income: Not reported

340B Drug Discount Program ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act ---S. 2453: Ensuring the Value of the 340B Program Act Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples for Testing ---Columbia Biologics Regulation ---Coding ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---H.R. 2871: Preserving Patient Access to Compound Medications Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 International Biosecurity Policies Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Discussion Drafts House/Senate Orphan Drug Issues ---Technical Amendments ---Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---CMS Hospital Inpatient Proposed Rule ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act ---H.R. 1892: Bipartisan Budget Act of 2018 ---H.R. 1625: Consolidated Appropriations Act for FY 2018 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---H.R. 4993: Vaccine Access Improvement Act

S. 771/HR 1776-Improving access to affordable Prescription Drugs act, S 2157-Drug Price transparency in Communications Act, S 2011/HR 4138-Medicare drug price negotiation act of 2017, S 1688-Empowering medicare seniors to negotiate drug prices of 2017, S 252-Medicare drug savings act of 2017, S 1369/HR 2974-Stop Price gouging act, S 124-Preserve access to affordable generics act, S 974/HR 2212-CREATES Act of 2017, S 495-Medical Innovation and Prize Fund Act, S 1131/HR 2439-FAIR drug pricing act, Over-the-counter Monograph Safety, Innovation, and Reform Act of 2018, HR 4117-Competitive DRUGS Act of 2017), HR 2051- FAST Generics Act of 2017), Prescription drug pricing, PACED Act, S 771/HR 1776 (Improving access to affordable prescription drugs act, S 1509/HR 1223 OPEN Act), S 1309-Stronger patents act, HR 5150 Protecting Medicare from excessive price increases act, S 2476-Expanding access to low cost generics act, S 637 (c-thru act), S 1348-SPIKE act,

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

Government targets: HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)

2018 Medicare Open Enrollment (No bill). The Center for Medicare and Medicaid Services Administrations public outreach and education around the 2018 Medicare open enrollment. Medicare Dental, Vision, and Hearing Coverage. H.R. 508, Seniors Have Eyes, Ears and Teeth Act and H.R. 3111, Medicare Dental, Vision, and Hearing Benefit Act of 2017: Proposals to expand Medicare coverage to include comprehensive coverage of dental, vision, and hearing care. Medicare Hearing Coverage. H.R. 3426, Medicare Hearing Aid Coverage Act: Proposal to provide Medicare coverage of hearing aids. Medicare Observation Status. S. 568, H.R. 1421, Improving Access to Medicare Coverage Act of 2017: Proposal to count days in the hospital in observation status toward meeting the three-day prior hospitalization requirement for skilled nursing facility care eligibility. Beneficiary Enrollment Notification and Eligibility . S. 1909, H. R. 2575, Beneficiary Enrollment Notification and Eligibility Simplification Act: Proposals to improve Medicare Part B enrollment and to align Part B, Medicare Advantage and Part D rules. Opioid Treatment for Seniors. H.R. 5085, Expanding Access to Evidence-Based Opioid Treatment for Seniors Act of 2018: Proposal to require Medicare to recognize substance abuse treatment facilities as independent providers. Dementia and Alzheimers. S. 2076, Building Our Largest Dementia Infrastructure for Alzheimers Act (BOLD Act), Proposal for applying a public health approach to combat Alzheimers disease and related dementias. Medicare Privatization (No bill). Proposals to transform traditional Medicare into a private insurance carrier program. Medicare Eligibility Age (No bill). Proposal to raise the eligibility age for Medicare from 65 to 67. National Survey of Older Americans Act Participants (No bill). Proposal to have the Administration for Community Living reinstate a demographic question on gender identity. Money Follows the Person (No bill). Proposal to reauthorize a demonstration that provides funding and support for states to transition individuals living in institutional care settings into settings that are more integrated with their communities. Alex M. Azars Nomination to head the Department of Health and Human Services (No bill). Questions pertaining to Mr. Azars positions on the Affordable Care Act, Medicaid block granting, and his background as a pharmaceutical executive. Medicare Part B Prices. H.R. 5150, Protecting Medicare from Excessive Price Increases Act of 2018: Proposal to require drug manufacturers to rebate to the Secretary of Health and Human Services the amount by which a drug exceeds past prices above inflation. Drug Price Negotiation. S. 2011, H.R. 4138, Medicare Drug Price Negotiation Act: Proposals to lower prescription drug prices in the Medicare Part D program, including allowing Medicare to negotiate directly with prescription drug manufacturers. Requires drug manufacturers to provide a rebate to the federal government for drugs covered under Medicare Part D for low-income Medicare beneficiaries. Generic Drug Market Anticompetitive Behavior. S.974, H.R.2212, CREATES Act of 2017: Proposal to curb abuses by brand drug makers that prevent or delay generic drug manufacturers from getting sufficient samples of the brand drugs needed to obtain FDA approval, keeping generics off the market and driving up drug costs.

General Medicare Protection, Prevention of Fraud, Waste, and Abuse: H.R. 2460 and H.R. 4841 and H.R. 4704, Prescription Drug Re-Importation: S. 92 and S. 469 and H.R. 1245, Negotiation of Prescription Drug Prices: H.R. 242 and S. 41, General Prescription Drug Affordability: S. 124 and S. 771 and H.R. 1776 and H.R. 4138 and H.R. 4116 and H.R. 4117 and S. 2011 and S. 974 and H.R. 2212, Medicare Enrollment Simplification: H.R. 2575 and S. 1909, Expanding Medicare Coverage: H.R. 5083 and H.R. 4957 and S. 2387 and H.R. 807 and H.R. 3098 and H.R. 4701.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---Value-based Contracting and Communications ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act

Client expense: $2,360,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education

S 771/HR1776-Improving access to affordable prescription drugs act, S 2011/HR 4138-Medicare Price Negotiation Act of 2017, S 252-Medicare Drug Savings Act of 2017, S 1369/HR 2974-Stop Price Gouging Act, S 124-Preserve access to affordable generics act, HR 4117-Competitive DRUGS Act of 2017, S 974/HR 2212-CREATES act of 2017, HR 2051-FAST generics Act of 2017, S 495-Medicare Innovation Prize Fund Act, S 1131.HR 2439-FAIR Drug Pricing act, HR 4116-Transparent Drug Pricing Act of 2017, S 1509-Orphan Products extension accelerating cures and treatments, HR 1223-OPEN act, S 1390-Stronger Patriots Act of 2017, S 1827-KIDS Act of 2017, HR 1628-American Health care act of 2017, HR 3921-Healthy KIDS Act, HR 4116-Transparent drug pricing act of 2017, Bipartisan Health Care Stabilization Act of 2017, biologic market exclusivity, inter partes review, direct to consumer advertising, Over-the-counter Monograph Safety Innovation and Reform act of 2017, Azar HHS nomination,

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

Government targets: Agriculture, Dept of (USDA), Education, Dept of, Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Office of Government Ethics (OGE), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR), White House Office

General Medicare Protection, Prevention of Fraud, Waste, and Abuse, Prescription Drug Re-Importation: S. 92 and S. 469 and H.R. 1245, Negotiation of Prescription Drug Prices: H.R. 242 and S. 41, General Prescription Drug Affordability: S. 124 and S. 771 and H.R. 1776 and H.R. 4138 and H.R. 4116 and H.R. 4117 and S. 2011, Medicare Enrollment Simplification: H.R. 2575 and S. 1909.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE