Right Rebate Act of 2019

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies. Most Favored Nation (MFN) Model - (CMS-5528-IFC)

Client expense: $1,090,000 · Firm income: Not reported

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

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.

H.R. 803 / S. 988, Improving Transparency and Accuracy in Medicare Part D Drug Spending Act; H.R. 1034 / S. 640, Phair Pricing Act of 2019; H.R. 1035, Prescription Drug Price Transparency Act, S. 475, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, S. 476, Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs; H.R.448 / S. 99, Medicare Drug Price Negotiation Act; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019; H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019; H.R. 366, Insulin Access for All Act of 2019; S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019; S. 205 / H.R. 937, Right Rebate Act of 2019; H.R. 1046 / S. 377, Medicare Negotiation and Competitive Licensing Act of 2019; H.R. 1781 / S. 801, the Payment Commission Data Act of 2019; H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting (STAR) Act of 2019; H.R. 2115, To amend title XI of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers; Proposed rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"; Proposed rule, "Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, OIG-0936-P"; Proposed rule, Medicaid Program; Medicaid and Childrens Health Insurance Plan (CHIP) Managed Care - CMS-2408-P; H.R. 1323, Rural Hospital Frontier Fairness Act; S. 551, REFUND Act of 2019; S. 691, Medicare Extra Rx HELP Act of 2019; S. 773, Telehealth Innovation and Improvement Act of 2019; S. 814, Expanding Access to Diabetes Self-Management Training Act of 2019; H.R. 1384 / S. 1129, Medicare for All Act of 2019; H.R. 3417, The Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act of 2019; H.R. 3408, Shop Rx Act of 2019; S. 1384, Prescription Drug Rebate Reform Act of 2019; H.R. 2113, Prescription Drug STAR Act; H.R. 2115, Public Disclosure of Drug Discounts Act S. 2447, the Phair Relief Act; S. 2771, the Protecting Home Oxygen and Medical Equipment Act of 2019; S. 1861 / H.R. 3924, the Streamlining Part D Appeals Process Act; H.R. 4946, the Ensuring Seniors Access to Local Pharmacies Act of 2019; H.R. 5281, the Drug Price Transparency in Medicaid Act of 2019; H.R. 5442, the Lowest Price for Patients Act; Report language for H.R.1865, the Further Consolidated Appropriations Act; Pharmacist Provider Status draft legislation

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;

H.R. 803 / S. 988, Improving Transparency and Accuracy in Medicare Part D Drug Spending Act; H.R. 1034 / S. 640, Phair Pricing Act of 2019; H.R. 1035, Prescription Drug Price Transparency Act, S. 475, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, S. 476, Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs; H.R.448 / S. 99, Medicare Drug Price Negotiation Act; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019; H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019; H.R. 366, Insulin Access for All Act of 2019; S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019; S. 205 / H.R. 937, Right Rebate Act of 2019; H.R. 1046 / S. 377, Medicare Negotiation and Competitive Licensing Act of 2019; H.R. 1781 / S. 801, the Payment Commission Data Act of 2019; H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting (STAR) Act of 2019; H.R. 2115, To amend title XI of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers; Proposed rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"; Proposed rule, "Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, OIG-0936-P"; Proposed rule, Medicaid Program; Medicaid and Childrens Health Insurance Plan (CHIP) Managed Care - CMS-2408-P; H.R. 1323, Rural Hospital Frontier Fairness Act; S. 551, REFUND Act of 2019; S. 691, Medicare Extra Rx HELP Act of 2019; S. 773, Telehealth Innovation and Improvement Act of 2019; S. 814, Expanding Access to Diabetes Self-Management Training Act of 2019; H.R. 1384 / S. 1129, Medicare for All Act of 2019; H.R. 3417, The Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act of 2019; H.R. 3408, Shop Rx Act of 2019; S. 1384, Prescription Drug Rebate Reform Act of 2019; H.R. 2113, Prescription Drug STAR Act; H.R. 2115, Public Disclosure of Drug Discounts Act S. 2447, the Phair Relief Act; S. 2771, the Protecting Home Oxygen and Medical Equipment Act of 2019; S. 1861 / H.R. 3924, the Streamlining Part D Appeals Process Act; H.R. 4946, the Ensuring Seniors Access to Local Pharmacies Act of 2019; H.R. 5281, the Drug Price Transparency in Medicaid Act of 2019; H.R. 5442, the Lowest Price for Patients Act; Report language for H.R.1865, the Further Consolidated Appropriations Act; Pharmacist Provider Status draft legislation

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.

H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and prescription drug price negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 2650: Medicare Prescription Drug Savings and Choice Act of 2019 - Provisions related to Part D and prescription drug pricing S. 2817: End Price Gouging for Insulin Act - Provisions related to prescription drug international reference pricing S. 2911: Seniors Prescription Drug Relief Act of 2019 - Provisions related to Part D and patient cost-sharing S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3457: Preserving Patient Access to Home Infusion Act - Provisions related to Medicare and prescription drug access Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Policy issues related to patient medication information Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues CMS Healthy Adult Opportunity (HAO) initiative and related policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Proposed Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-P)

H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and prescription drug price negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 2650: Medicare Prescription Drug Savings and Choice Act of 2019 - Provisions related to Part D and prescription drug pricing S. 2817: End Price Gouging for Insulin Act - Provisions related to prescription drug international reference pricing S. 2911: Seniors Prescription Drug Relief Act of 2019 - Provisions related to Part D and patient cost-sharing S. 3129: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3457: Preserving Patient Access to Home Infusion Act - Provisions related to Medicare and prescription drug access Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Policy issues related to patient medication information Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Tennessee Section 1115 Medicaid waiver CMS Healthy Adult Opportunity (HAO) initiative and related policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Proposed Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-P)

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; S. 844, Short on Competition Act - provisions related to the importation of prescription drugs; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act;

H.R. 803 / S. 988, Improving Transparency and Accuracy in Medicare Part D Drug Spending Act; H.R. 1034 / S. 640, Phair Pricing Act of 2019; H.R. 1035, Prescription Drug Price Transparency Act, S. 475, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, S. 476, Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs; H.R.448 / S. 99, Medicare Drug Price Negotiation Act; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019; H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019; H.R. 366, Insulin Access for All Act of 2019; S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019; S. 205 / H.R. 937, Right Rebate Act of 2019; H.R. 1046 / S. 377, Medicare Negotiation and Competitive Licensing Act of 2019; H.R. 1781 / S. 801, the Payment Commission Data Act of 2019; H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting (STAR) Act of 2019; H.R. 2115, To amend title XI of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers; Proposed rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"; Proposed rule, "Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, OIG-0936-P"; Proposed rule, Medicaid Program; Medicaid and Childrens Health Insurance Plan (CHIP) Managed Care - CMS-2408-P; H.R. 1323, Rural Hospital Frontier Fairness Act; S. 551, REFUND Act of 2019; S. 691, Medicare Extra Rx HELP Act of 2019; S. 773, Telehealth Innovation and Improvement Act of 2019; S. 814, Expanding Access to Diabetes Self-Management Training Act of 2019; H.R. 1384 / S. 1129, Medicare for All Act of 2019; H.R. 3417, The Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act of 2019; H.R. 3408, Shop Rx Act of 2019; S. 1384, Prescription Drug Rebate Reform Act of 2019; H.R. 2113, Prescription Drug STAR Act; H.R. 2115, Public Disclosure of Drug Discounts Act S. 2447, the Phair Relief Act; S. 2771, the Protecting Home Oxygen and Medical Equipment Act of 2019; S. 1861 / H.R. 3924, the Streamlining Part D Appeals Process Act; H.R. 4946, the Ensuring Seniors Access to Local Pharmacies Act of 2019; H.R. 5281, the Drug Price Transparency in Medicaid Act of 2019; H.R. 5442, the Lowest Price for Patients Act; Report language for H.R.1865, the Further Consolidated Appropriations Act; Pharmacist Provider Status draft legislation

Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 3, Keeping Health Insurance Affordable Act - provisions related to prescription drug pricing; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 340, H.R. 965, The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act - provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems; H.R. 1034, Phair Pricing Act of 2019 - provisions related to Part D and manufacturer rebates; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 2296, S. 1391, FAIR Drug Pricing Act of 2019 - provisions related to prescription drug pricing and transparency; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; Proposed FDA guidance on gastroparesis clinical trials; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after discharge from active duty;

H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3910: Equality in Medicare and Medicaid Treatment Act of 2019 - Provisions related to CMMI models H.R. 3925: Reducing Barriers to Substance Use Treatment Act - Provisions related to prior authorization requirements H.R. 4178: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates H.R. 4455: BIOSIM Act - Provisions related to biosimilar approval and reimbursement H.R. 4619: Pharmaceutical Rebates for Excessive Pricing Above Inflation Act - Provisions related to Part D and manufacturer rebates H.R. 4628: Better Tools to Lower Costs Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4649: Capping Drug Costs for Seniors Act of 2019 - Provisions related to Part D and patient cost-sharing H.R. 4650: Medicare Dental Act of 2019 - Provisions related to Medicare coverage of dental procedures H.R. 4655: Enhancing Retirement Security for Medicare Beneficiaries Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4663: Freedom from Price Gouging Act - Provisions related to Part B and manufacturer rebates H.R. 4669: Maximizing Drug Coverage for Low-Income Seniors Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4913: Ensuring Access to Lower-Cost Medicines for Seniors Act - Provisions related to Part D prescription drug plans and formularies H.R. 5039: Life-Sustaining Prescription Drug Price Relief Act of 2019 - Provisions related to Part D, prescription drug negotiation, reference pricing and other provisions H.R. 5057: Pass-Through Technical Corrections Act - Provisions related to Medicare prescription drug pass-through payment status S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 709: Prescription Drug Pricing Dashboard Act - Provisions related to prescription drug pricing transparency S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1497: Health Care Price Check Act of 2019 - Provisions related to Medicare pricing transparency S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1987: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing S. 1999: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans S. 2051: Strengthening Average Sales Price Reporting Act - Provisions related to Medicare pricing transparency and rebates S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 2252: Empowering States to Address Drug Costs Act - Provisions related to prescription drug pricing transparency S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Policy issues related to patient medication information Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Tennessee Section 1115 Medicaid waiver Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Medicare and State Healthcare Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, 84 Fed. Reg. 55694 (10/17/19)

S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 99, Medicare Drug Price Negotiation Act (Sanders) - Part D price negotiations, formulary changes S. 205, Right Rebate Act (Wyden) - Medicaid drug rebate program S. 317, ACE Kids Act (Grassley) - health homes for children with medically complex conditions S. 377, Medicare Negotiation and Competitive Licensing Act (Brown) - Part D price negotiation S. 470, Medicare at 50 Act (Stabenow) - Medicare buy-in option S. 475, RxCAP Act (Wyden) - Part D cost-sharing S. 489, State Public Option Act (Schatz) - Medicaid buy-in option S. 516, Prescription Drug Monitoring Act (Klobuchar) - required use of PDMPs S. 548, EMPOWER Care Act (Portman) - MFP demonstration S. 640, Phair Pricing Act (Kennedy) -- Part D rebates at the point of sale S. 691, Medicare Extra Rx HELP Act (Casey) - Part D assistance for low-income seniors S. 709, Prescription Drug Pricing Dashboard Act (Casey) - interactive dashboard with drug price and utilization data for federal programs S. 773, Telehealth Innovation and Improvement Act (Gardner) - testing expanded coverage of telehealth services in Medicare S. 988, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - payments on clean claims S. 1114, Medicare Advantage Quality Payment Relief Act (Daines-King) - MA benchmark cap S. 2081, Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019 (Peters)- drugs in Part B S. 2252, Empowering States to Address Drug Costs Act (Van Hollen)- drug pricing S. 2446, Medicare Audiologist Access and Services Act of 2019 (Warren)-Medicare coverage of audiologist services S. 2650 - Medicare Prescription Drug Savings and Choice Act of 2019 (Durbin) - lowering prescription drug costs S. 2807, Hospice Care Improvement Act of 2019 (Portman) - Medicare hospice programs S. 2846, Protecting Patients Transportation to Care Act (Isakson) - Medicaid coverage of transportation S. 2911, Seniors Prescription Drug Relief Act of 2019 (Cassidy) - Part D smoothing S. 3000, Patient Shared Savings Act (Cassidy) - prescription drug plans S. 3001, Permanent Relief for Seniors and Medicare, Medicaid, Human Services Extension Act of 2019 (Toomey) - extensions S. 3029, Territories Medicare Prescription Drug Assistance Equity Act of 2019 (Menendez) - Territories, low-income Medicare part D beneficiaries S. 3078, Audit & Appeals Fairness, Integrity, and Reforms in Medicare Act of 2019 (Grassley) - Medicare appeals process S. 3129, Lower Costs, More Cures Act of 2019 (Crapo) - drug pricing H.R. 19, Lower Costs, More Cures Act of 2019 (Walden) - drug pricing H.R. 259, Medicaid Extenders Act (Pallone) - MFP demonstration, spousal impoverishment protections H.R. 448, Medicare Drug Price Negotiation Act (Cummings) - Part D price negotiations, formulary changes H.R. 789, Improving Transparency and Accuracy in Medicare Part D Spending Act (Welch) - payments on clean claims H.R. 937, Right Rebate Act (Schrader) - Medicaid drug rebate program H.R. 1034, Phair Pricing Act (Collins) - Part D rebates at the point of sale H.R. 1035, Prescription Drug Price Transparency Act (Collins) - Medicare PBM standards H.R. 1046, Medicare Negotiation and Competitive Licensing Act (Doggett) - Part D price negotiation H.R. 1226, ACE Kids Act (Castor) - health homes for children with medically complex conditions H.R. 1277, State Public Option Act (Lujan) - Medicaid buy-in option H.R. 1301, Mental Health Telemedicine Expansion Act (DelBene) - Medicare coverage of mental health telehealth services H.R. 1342, EMPOWER Care Act (Dingell) - MFP demonstration H.R. 1343, Protecting Married Seniors from Impoverishment Act (Dingell) - spousal impoverishment protections H.R. 1346, Medicare Buy-In and Health Care Stabilization Act (Higgins) - Medicare buy-in option H.R. 1375, PAID Act (Kind) - transparency of Medicare secondary payer information H.R. 1394, Medigap Consumer Protection Act (Doggett) - Medicare supplemental consumer protections H.R. 1551, Quality Care for Moms and Babies Act (Engel) - quality measures in Medicaid and CHIP H.R. 1781, Payment Commission Data Act (Carter) - MedPAC and MACPAC access to drug pricing and rebate data in Medicare and Medicaid H.R. 1839, Medicaid Services Investment and Accountability Act (Ruiz) - MFP demonstration, spousal impoverishment protections, ACE Kids Act, Medicaid drug rebate program, health homes for children with medically complex conditions H.R. 2131, Medicare Advantage Quality Payment Relief Act (Kind-Kelly) - MA benchmark cap H.R. 2757, Creating Lower Cost Alternatives for Your Prescription Drugs Act (Cunningham) - eliminate copay for generic drugs in Medicare Part D H.R. 3107, Improving Seniors' Timely Access to Care Act (DelBene) - Medicare Advantage prior authorization H.R. 3253, Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act (Dingell) - MFP demonstration, spousal impoverishment protections, Medicaid drug rebate program H.R. 3417, Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act (Neal) - funding for quality measurement initiatives, Medicare coverage of mental health telehealth services, real-time benefit tools in Medicare Part D, Medicare eligibility and enrollment notices H.R. 3461, Community-Based Independence for Seniors Act (Sanchez-Kelly) - Community-Based Institutional Special Needs Plan H.R. 3613, State Accountability, Flexibility, and Equity for Hospitals Act of 2019 (Bilirakis) -Medicaid DSH payments H.R. 3631, Territories Health Care Improvement Act (Soto) -Medicaid funding H.R. 3644, Independence at Home Demonstration Act of 2019 (Burgess)-Medicare demonstration program H.R. 3925, Reducing Barriers to Substance Use Treatment Act (Tonko)- Opioids H.R. 3935, Protecting Patients Transportation to Care Act (Carter)-Medicaid coverage for transportation H.R. 4378, Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 (Lowey)-Health extenders H.R. 4453, Protecting Seniors from Health Care Fraud Act of 2019 (Ruiz)-Distributing information to Medicare beneficiaries to prevent fraud H.R. 4527, Expanding Health Care Options for Early Retirees Act (Malinowski)-Option for first responders to buy-in to Medicare H.R. 4529, Promoting Access to Broadband Act of 2019 (Maloney)-Medicaid H.R. 4583, Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 (Schneider) - prescription drug affordability H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 (Peters) - biosimilars, Part B H.R. 4618, Medicare Hearing Act of 2019 (McBath) - coverage for certain hearing items and services under part B H.R. 4619, Pharmaceutical Rebates for Excessive Pricing Above Inflation Act (Schakowsky) - drug rebates, Part D H.R. 4620, More Help for Seniors Act of 2019 (Rose) - expand eligibility for low-income subsidies under Part D of the Medicare program H.R. 4621, Collecting and Analyzing Resources Integral and Necessary for Guidance for Social Determinants Act of 2019 (Blunt Rochester) - best practices re social determinants of health H.R. 4628, Better Tools to Lower Costs Act of 2019 (Scanlon) - resource requirements H.R. 4629, Star Rating for Biosimilars Act (Tonko) - biosimilars H.R. 4632, Better Transparency in Information for Medicare Beneficiaries Act of 2019 (Kind) - provides consumers information regarding premiums under LIS benchmark plans H.R. 4649, Capping Drug Costs for Seniors Act of 2019 (Horsford) - cap on beneficiary liability under part D of the Medicare program H.R. 4650, Medicare Dental Act of 2019 (Kelly) - Medicare dental coverage H.R. 4655, Enhancing Retirement Security for Medicare Beneficiaries Act of 2019 (Lee) - eligibility of individuals for premium and cost-sharing subsidies under part D H.R. 4661, Advancing Enrollment and Reducing Drug Costs Act of 2019 (Pappas) - Medicaid in territories H.R. 4663, Freedom from Price Gouging Act (Porter) - drug rebates, Part B H.R. 4665, Medicare Vision Act of 2019 (Schrier) - vision items and services under part B H.R. 4666, To amend title XVIII of the Social Security Act to provide certain low-income territorial residents with automatic eligibility for premium and cost-sharing subsidies under the Medicare program, and for other purposes (Shalala) - Medicare in territories H.R. 4669, Maximizing Drug Coverage for Low-Income Seniors Act of 2019 (Stevens) - auto enrollment and intelligent assignment H.R. 4671, Helping Seniors Afford Health Care Act (Kim) - Medicare affordability and low income beneficiaries H.R. 4676, Protecting Medicare Beneficiaries with Pre-Existing Conditions Act (Schneider) - Medigap H.R. 4699, To amend title XIX of the Social Security Act to remove the matching requirement for a territory to use specially allocated Federal funds for Medicare covered part D drugs for low-income individuals (Gonzales-Colon) - Part D, territories H.R. 4769, Medicare Prescription Drug Savings and Choice Act of 2019 (Schakowsky) - lowering prescription drug costs H.R. 4946, Ensuring Seniors Access to Local Pharmacies Act of 2019 (Welch) - equal access of Medicare beneficiaries to community pharmacies in underserved areas H.R. 4996, Helping Medicaid Offer Maternity Services Act of 2019 (Kelly) - State extension of Medicaid H.R. 5006, Expanding Access to Inpatient Mental Health Act (Emmer) - Medicaid coverage for SUD/mental health for institutionalized H.R. 5039, Life Sustaining Prescription Drug Price Relief Act of 2019 (Lipinski) - part D H.R. 5057, Pass- Through Technical Corrections Act (Tonko) - drug pass-through status under Medicare outpatient payment H.R. 5201, Telemental Health Expansion Act of 2019 (Matsui) - Medicare coverage of mental telehealth H.R. 5232, Road to Recovery Act (Fitzpatrick) - Medicaid and CHIP SUD treatment H.R. 5281, Drug Price Transparency in Medicaid Act of 2019 (Carter) - transparency and spread pricing affordability Discussion Draft, Medicare Part D Reform (Neal-Pallone-Brady-Walden) - maximum out-of-pocket limit, federal reinsurance payments Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and risk adjustment data validation (RADV) audit issues including proposed RADV regulation for MA; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2021 policy and technical regulation for MA and Part D; MA and Part D proposed rule on drug pricing changes for 2020; Part D reform, out of pocket limits; issues related to Medicare for All, Medicare buy-in and public option; CMSs price transparency proposal for direct-to-consumer advertisements; issues relating to 2021 Rate Notice and Call Letter; issues related to MLTSS; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); issues related to the international price index; issues related to child and maternal health; issues related to Medicaid supplemental and disproportionate share hospital (DSH) funding; issues related to Medicaid funding for territories; issues related to medical management; issues relating to MA supplemental benefits; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; issues related to health homes for children with medically complex conditions; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 19: Lower Costs, More Cures Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3910: Equality in Medicare and Medicaid Treatment Act of 2019 - Provisions related to CMMI models H.R. 3925: Reducing Barriers to Substance Use Treatment Act - Provisions related to prior authorization requirements H.R. 4178: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates H.R. 4455: BIOSIM Act - Provisions related to biosimilar approval and reimbursement H.R. 4619: Pharmaceutical Rebates for Excessive Pricing Above Inflation Act - Provisions related to Part D and manufacturer rebates H.R. 4628: Better Tools to Lower Costs Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4649: Capping Drug Costs for Seniors Act of 2019 - Provisions related to Part D and patient cost-sharing H.R. 4650: Medicare Dental Act of 2019 - Provisions related to Medicare coverage of dental procedures H.R. 4655: Enhancing Retirement Security for Medicare Beneficiaries Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4663: Freedom from Price Gouging Act - Provisions related to Part B and manufacturer rebates H.R. 4669: Maximizing Drug Coverage for Low-Income Seniors Act of 2019 - Provisions related to Part D and low-income subsidies H.R. 4913: Ensuring Access to Lower-Cost Medicines for Seniors Act - Provisions related to Part D prescription drug plans and formularies H.R. 5039: Life-Sustaining Prescription Drug Price Relief Act of 2019 - Provisions related to Part D, prescription drug negotiation, reference pricing and other provisions H.R. 5057: Pass-Through Technical Corrections Act - Provisions related to Medicare prescription drug pass-through payment status H.R. 5242: Opioid Settlement Accountability Act - Provisions related to Medicaid and opioid litigation related funds H.R. 5364: End Price Gouging for Insulin Act - Provisions related to prescription drug international reference pricing S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 709: Prescription Drug Pricing Dashboard Act - Provisions related to prescription drug pricing transparency S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1497: Health Care Price Check Act of 2019 - Provisions related to Medicare pricing transparency S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1987: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing S. 1999: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans S. 2051: Strengthening Average Sales Price Reporting Act - Provisions related to Medicare pricing transparency and rebates S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 2252: Empowering States to Address Drug Costs Act - Provisions related to prescription drug pricing transparency S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Policy issues related to patient medication information Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Tennessee Section 1115 Medicaid waiver Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Medicare and State Healthcare Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, 84 Fed. Reg. 55694 (10/17/19)

Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; S. 2675 STOP Neglected Diseases of Poverty Act - provisions related to Dengue;

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

H.R. 803 / S. 988, Improving Transparency and Accuracy in Medicare Part D Drug Spending Act; H.R. 1034 / S. 640, Phair Pricing Act of 2019; H.R. 1035, Prescription Drug Price Transparency Act, S. 475, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, S. 476, Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs; H.R.448 / S. 99, Medicare Drug Price Negotiation Act; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019; H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019; H.R. 366, Insulin Access for All Act of 2019; S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019; S. 205 / H.R. 937, Right Rebate Act of 2019; H.R. 1046 / S. 377, Medicare Negotiation and Competitive Licensing Act of 2019; H.R. 1781 / S. 801, the Payment Commission Data Act of 2019; H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting (STAR) Act of 2019; H.R. 2115, To amend title XI of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers; Proposed rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"; Proposed rule, "Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, OIG-0936-P"; Proposed rule, Medicaid Program; Medicaid and Childrens Health Insurance Plan (CHIP) Managed Care - CMS-2408-P; H.R. 1323, Rural Hospital Frontier Fairness Act; S. 551, REFUND Act of 2019; S. 691, Medicare Extra Rx HELP Act of 2019; S. 773, Telehealth Innovation and Improvement Act of 2019; S. 814, Expanding Access to Diabetes Self-Management Training Act of 2019; H.R. 1384 / S. 1129, Medicare for All Act of 2019; H.R. 3417, The Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act of 2019; H.R. 3408, Shop Rx Act of 2019; S. 1384, Prescription Drug Rebate Reform Act of 2019; H.R. 2113, Prescription Drug STAR Act; H.R. 2115, Public Disclosure of Drug Discounts Act S. 2447, the Phair Relief Act; S. 2771, the Protecting Home Oxygen and Medical Equipment Act of 2019; S. 1861 / H.R. 3924, the Streamlining Part D Appeals Process Act; H.R. 4946, the Ensuring Seniors Access to Local Pharmacies Act of 2019; H.R. 5281, the Drug Price Transparency in Medicaid Act of 2019; H.R. 5442, the Lowest Price for Patients Act; Report language for H.R.1865, the Further Consolidated Appropriations Act

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions

Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 3, Keeping Health Insurance Affordable Act - provisions related to prescription drug pricing; S. 61, H.R. 478, The Safe and Affordable Drugs from Canada Act 0f 2019 - provisions related to importation; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); S. 340, H.R. 965, The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act - provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems; H.R. 1034, Phair Pricing Act of 2019 - provisions related to Part D and manufacturer rebates; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 2296, S. 1391, FAIR Drug Pricing Act of 2019 - provisions related to prescription drug pricing and transparency; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; Proposed FDA guidance on gastroparesis clinical trials; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after discharge from active duty;

___ H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions ___ H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates ___ H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation ___ H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification ___ H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates ___ H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers ___ H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing ___ H.R. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights ___ H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification ___ H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation ___ H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing ___ H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans ___ H.R. 3523: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing ___ H.R. 3910: Equality in Medicare and Medicaid Treatment Act of 2019 - Provisions related to CMMI models ___ S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation ___ S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification ___ S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing ___ S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing ___ S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation ___ S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers ___ S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates ___ S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs ___ S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting ___ S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation ___ S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation ___ S. 1497: Health Care Price Check Act of 2019 - Provisions related to Medicare pricing transparency ___ S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates ___ S. 1801: Affordable Medications Act - Provisions relate to Part D drug pricing negotiation, importation, IP issues and pricing transparency ___ S. 1895: Lowering Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues ___ S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling ___ S. 1987: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing ___ S. 1999: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans ___ S. 2051: Strengthening Average Sales Price Reporting Act - Provisions related to Medicare pricing transparency and rebates ___ S. 2081: Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019 - Provisions related to prescription drug pricing and manufacturer rebates ___ S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates ___ S. 2252: Empowering States to Address Drug Costs Act - Provisions related to prescription drug pricing transparency ___ S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions ___ Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues ___ Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues ___ Part D policy issues including non-interference and rebates policy issues ___ Part B reform including MedPAC recommendations and other policy issues and local coverage decisions ___ Drug cost and pricing policy issues ___ Transparency policy issues ___ Alternative payment models policy issues ___ Value-based purchasing arrangements policy issues ___ Anti-Kickback Statute policy issues ___ Center for Medicare and Medicaid Innovation (CMMI) policy issues ___ Medicaid rebates and waiver policy issues ___ Prescription drug abuse policy issues ___ ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) ___ Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) ___ Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) ___ Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) ___ Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Monograph Reform and HSA/FSAs

H.R. 3: Lower Drug Costs Now Act of 2019 - Provisions related to prescription drug pricing, foreign reference pricing, Part D, manufacturer rebates, and other provisions H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3523: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing H.R. 3910: Equality in Medicare and Medicaid Treatment Act of 2019 - Provisions related to CMMI models S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting S. 981: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation S. 1497: Health Care Price Check Act of 2019 - Provisions related to Medicare pricing transparency S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1801: Affordable Medications Act - Provisions related to Part D drug pricing negotiation, importation, IP issues and pricing transparency S. 1895: Lowering Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 1987: End Price Gouging for Medications Act - Provisions related to prescription drug pricing and foreign reference pricing S. 1999: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans S. 2051: Strengthening Average Sales Price Reporting Act - Provisions related to Medicare pricing transparency and rebates S. 2081: Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019 - Provisions related to prescription drug pricing and manufacturer rebates S. 2247: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 2252: Empowering States to Address Drug Costs Act - Provisions related to prescription drug pricing transparency S. 2543: Prescription Drug Pricing Reduction Act of 2019 - Provisions related to prescription drug pricing, transparency, manufacturer rebates and other provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Policy issues related to patient medication information Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)

S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 99, Medicare Drug Price Negotiation Act (Sanders) - Part D price negotiations, formulary changes S. 205, Right Rebate Act (Wyden) - Medicaid drug rebate program S. 317, ACE Kids Act (Grassley) - health homes for children with medically complex conditions S. 377, Medicare Negotiation and Competitive Licensing Act (Brown) - Part D price negotiation S. 470, Medicare at 50 Act (Stabenow) - Medicare buy-in option S. 475, RxCAP Act (Wyden) - Part D cost-sharing S. 489, State Public Option Act (Schatz) - Medicaid buy-in option S. 516, Prescription Drug Monitoring Act (Klobuchar) - required use of PDMPs S. 548, EMPOWER Care Act (Portman) - MFP demonstration S. 640, Phair Pricing Act (Kennedy) -- Part D rebates at the point of sale S. 691, Medicare Extra Rx HELP Act (Casey) - Part D assistance for low-income seniors S. 709, Prescription Drug Pricing Dashboard Act (Casey) - interactive dashboard with drug price and utilization data for federal programs S. 773, Telehealth Innovation and Improvement Act (Gardner) - testing expanded coverage of telehealth services in Medicare S. 988, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - payments on clean claims S. 1114, Medicare Advantage Quality Payment Relief Act (Daines-King) - MA benchmark cap S. 2081, Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019 (Peters)- drugs in Part B S. 2252, Empowering States to Address Drug Costs Act (Van Hollen)- drug pricing S. 2446, Medicare Audiologist Access and Services Act of 2019 (Warren)-Medicare coverage of audiologist services H.R. 259, Medicaid Extenders Act (Pallone) - MFP demonstration, spousal impoverishment protections H.R. 448, Medicare Drug Price Negotiation Act (Cummings) - Part D price negotiations, formulary changes H.R. 789, Improving Transparency and Accuracy in Medicare Part D Spending Act (Welch) - payments on clean claims H.R. 937, Right Rebate Act (Schrader) - Medicaid drug rebate program H.R. 1034, Phair Pricing Act (Collins) - Part D rebates at the point of sale H.R. 1035, Prescription Drug Price Transparency Act (Collins) - Medicare PBM standards H.R. 1046, Medicare Negotiation and Competitive Licensing Act (Doggett) - Part D price negotiation H.R. 1226, ACE Kids Act (Castor) - health homes for children with medically complex conditions H.R. 1277, State Public Option Act (Lujan) - Medicaid buy-in option H.R. 1301, Mental Health Telemedicine Expansion Act (DelBene) - Medicare coverage of mental health telehealth services H.R. 1342, EMPOWER Care Act (Dingell) - MFP demonstration H.R. 1343, Protecting Married Seniors from Impoverishment Act (Dingell) - spousal impoverishment protections H.R. 1346, Medicare Buy-In and Health Care Stabilization Act (Higgins) - Medicare buy-in option H.R. 1375, PAID Act (Kind) - transparency of Medicare secondary payer information H.R. 1394, Medigap Consumer Protection Act (Doggett) - Medicare supplemental consumer protections H.R. 1551, Quality Care for Moms and Babies Act (Engel) - quality measures in Medicaid and CHIP H.R. 1781, Payment Commission Data Act (Carter) - MedPAC and MACPAC access to drug pricing and rebate data in Medicare and Medicaid H.R. 1839, Medicaid Services Investment and Accountability Act (Ruiz) - MFP demonstration, spousal impoverishment protections, ACE Kids Act, Medicaid drug rebate program, health homes for children with medically complex conditions H.R. 2131, Medicare Advantage Quality Payment Relief Act (Kind-Kelly) - MA benchmark cap H.R. 2757, Creating Lower Cost Alternatives for Your Prescription Drugs Act (Cunningham) - eliminate copay for generic drugs in Medicare Part D H.R. 3107, Improving Seniors' Timely Access to Care Act (DelBene) - Medicare Advantage prior authorization H.R. 3253, Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act (Dingell) - MFP demonstration, spousal impoverishment protections, Medicaid drug rebate program H.R. 3417, Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act (Neal) - funding for quality measurement initiatives, Medicare coverage of mental health telehealth services, real-time benefit tools in Medicare Part D, Medicare eligibility and enrollment notices H.R. 3461, Community-Based Independence for Seniors Act (Sanchez-Kelly) - Community-Based Institutional Special Needs Plan Discussion Draft, Medicare Part D Reform (Neal-Pallone-Brady-Walden) - maximum out-of-pocket limit, federal reinsurance payments H.R. 3613, State Accountability, Flexibility, and Equity for Hospitals Act of 2019 (Bilirakis) -Medicaid DSH payments H.R. 3631, Territories Health Care Improvement Act (Soto) -Medicaid funding H.R. 3644, Independence at Home Demonstration Act of 2019 (Burgess)-Medicare demonstration program H.R. 3925, Reducing Barriers to Substance Use Treatment Act (Tonko)- Opioids H.R. 3935, Protecting Patients Transportation to Care Act (Carter)-Medicaid coverage for transportation H.R. 4378, Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 (Lowey)-Health extenders H.R. 4453, Protecting Seniors from Health Care Fraud Act of 2019 (Ruiz)-Distributing information to Medicare beneficiaries to prevent fraud H.R. 4527, Expanding Health Care Options for Early Retirees Act (Malinowski)-Option for first responders to buy-in to Medicare H.R. 4529, Promoting Access to Broadband Act of 2019 (Maloney)-Medicaid Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and risk adjustment data validation (RADV) audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2020 policy and technical regulation for MA and Part D; MA and Part D proposed rule on drug pricing changes for 2020; Part D reform, out of pocket limits; issues related to Medicare for All, Medicare buy-in and public option; CMSs price transparency proposal for direct-to-consumer advertisements; issues relating to 2020 Rate Notice and Call Letter; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); issues related to the international price index; issues related to child and maternal health; issues related to Medicaid supplemental and disproportionate share hospital (DSH) funding; issues related to Medicaid funding for territories; issues related to medical management; issues relating to MA supplemental benefits; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; issues related to health homes for children with medically complex conditions; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions.

H.R. 803 / S. 988, Improving Transparency and Accuracy in Medicare Part D Drug Spending Act; H.R. 1034 / S. 640, Phair Pricing Act of 2019; H.R. 1035, Prescription Drug Price Transparency Act, S. 475, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, S. 476, Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs; H.R.448 / S. 99, Medicare Drug Price Negotiation Act; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019; H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019; H.R. 366, Insulin Access for All Act of 2019; S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019; S. 205 / H.R. 937, Right Rebate Act of 2019; H.R. 1046 / S. 377, Medicare Negotiation and Competitive Licensing Act of 2019; H.R. 1781 / S. 801, the Payment Commission Data Act of 2019; H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting (STAR) Act of 2019; H.R. 2115, To amend title XI of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers; Proposed rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"; Proposed rule, "Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, OIG-0936-P"; Proposed rule, Medicaid Program; Medicaid and Childrens Health Insurance Plan (CHIP) Managed Care - CMS-2408-P; H.R. 1323, Rural Hospital Frontier Fairness Act; S. 551, REFUND Act of 2019; S. 691, Medicare Extra Rx HELP Act of 2019; S. 773, Telehealth Innovation and Improvement Act of 2019; S. 814, Expanding Access to Diabetes Self-Management Training Act of 2019; H.R. 1384 / S. 1129, Medicare for All Act of 2019; H.R. 3417, The Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act of 2019; H.R. 3408, Shop Rx Act of 2019; S. 1384, Prescription Drug Rebate Reform Act of 2019; H.R. 2113, Prescription Drug STAR Act; H.R. 2115, Public Disclosure of Drug Discounts Act S. 2447, the Phair Relief Act; S. 2771, the Protecting Home Oxygen and Medical Equipment Act of 2019

H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1781: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3107: Improving Seniors' Timely Access to Care Act of 2019 - Provisions related to Medicare Advantage insurance plans H.R. 3276: Fair AMP Act - Provisions related to Medicaid drug rebates S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1801: Affordable Medications Act - Provisions relate to Part D drug pricing negotiation, importation, IP issues and pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 1926: PrEP Access and Coverage Act - PrEP insurance coverage requirement and grant program for uninsured S. __: Patient Affordability Value and Efficiency Act - Value-based arrangements Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)

P.L. 111-148, Patient Protection and Affordable Care Act - provisions related to PCORI reauthorization; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; H.R. 938, The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (the BLOCKING Act) - provisions related to 180 day generic prescription drug exclusivity; H.R. 1188, S. 366, FLAT Prices Act - provisions related to prescription drug exclusivity periods and pricing; S. 340, H.R. 965, The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act - provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems; H.R. 1034, Phair Pricing Act of 2019 - provisions related to Part D and manufacturer rebates; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 73, End Taxpayer Subsidies for Drug Ads Act - provisions related to direct-to-consumer prescription drug advertising; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, Safe Step Act - provisions related to step therapy policy; Patient Affordability Value and Efficiency Act (Not Yet Introduced) - to amend titles XI, XVIII, and XIX of the Social Security Act to promote value-based arrangements; S. 2004, Emergency Access to Insulin Act of 2019 - provisions related to biologics exclusivity; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; S. 659, Biologic Patent Transparency Act - provisions related to prescription drug patent disclosures; H.R. 2069, S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 - provisions related to increases in the wholesale acquisition costs of prescription drugs; S. 977, Transparent Drug Pricing Act of 2019 - provisions related to transparency and drug pricing; S.1140, Protecting Access to Biosimilars Act of 2019 - provisions related to biological products; H.R. 2296, S. 1391, FAIR Drug Pricing Act of 2019 - provisions related to prescription drug pricing and transparency; H.R. 2455, S. 1169, Ensuring Timely Access to Generics Act of 2019 - provisions related to citizen petitions; S. 1416, Affordable Prescriptions for Patients Act of 2019 - provisions related to prescription drug patents; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; Bayh-Dole march-in rights policy issues; S. 3, Keeping Health Insurance Affordable Act - provisions related to prescription drug pricing;

S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 99, Medicare Drug Price Negotiation Act (Sanders) - Part D price negotiations, formulary changes S. 205, Right Rebate Act (Wyden) - Medicaid drug rebate program S. 317, ACE Kids Act (Grassley) - health homes for children with medically complex conditions S. 377, Medicare Negotiation and Competitive Licensing Act (Brown) - Part D price negotiation S. 470, Medicare at 50 Act (Stabenow) - Medicare buy-in option S. 475, RxCAP Act (Wyden) - Part D cost-sharing S. 489, State Public Option Act (Schatz) - Medicaid buy-in option S. 516, Prescription Drug Monitoring Act (Klobuchar) - required use of PDMPs S. 548, EMPOWER Care Act (Portman) - MFP demonstration S. 640, Phair Pricing Act (Kennedy) -- Part D rebates at the point of sale S. 691, Medicare Extra Rx HELP Act (Casey) - Part D assistance for low-income seniors S. 709, Prescription Drug Pricing Dashboard Act (Casey) - interactive dashboard with drug price and utilization data for federal programs S. 773, Telehealth Innovation and Improvement Act (Gardner) - testing expanded coverage of telehealth services in Medicare S. 988, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - payments on clean claims S. 1114, Medicare Advantage Quality Payment Relief Act (Daines-King) - MA benchmark cap H.R. 259, Medicaid Extenders Act (Pallone) - MFP demonstration, spousal impoverishment protections H.R. 448, Medicare Drug Price Negotiation Act (Cummings) - Part D price negotiations, formulary changes H.R. 789, Improving Transparency and Accuracy in Medicare Part D Spending Act (Welch) - payments on clean claims H.R. 937, Right Rebate Act (Schrader) - Medicaid drug rebate program H.R. 1034, Phair Pricing Act (Collins) - Part D rebates at the point of sale H.R. 1035, Prescription Drug Price Transparency Act (Collins) - Medicare PBM standards H.R. 1046, Medicare Negotiation and Competitive Licensing Act (Doggett) - Part D price negotiation H.R. 1226, ACE Kids Act (Castor) - health homes for children with medically complex conditions H.R. 1277, State Public Option Act (Lujan) - Medicaid buy-in option H.R. 1301, Mental Health Telemedicine Expansion Act (DelBene) - Medicare coverage of mental health telehealth services H.R. 1342, EMPOWER Care Act (Dingell) - MFP demonstration H.R. 1343, Protecting Married Seniors from Impoverishment Act (Dingell) - spousal impoverishment protections H.R. 1346, Medicare Buy-In and Health Care Stabilization Act (Higgins) - Medicare buy-in option H.R. 1375, PAID Act (Kind) - transparency of Medicare secondary payer information H.R. 1394, Medigap Consumer Protection Act (Doggett) - Medicare supplemental consumer protections H.R. 1551, Quality Care for Moms and Babies Act (Engel) - quality measures in Medicaid and CHIP H.R. 1781, Payment Commission Data Act (Carter) - MedPAC and MACPAC access to drug pricing and rebate data in Medicare and Medicaid H.R. 1839, Medicaid Services Investment and Accountability Act (Ruiz) - MFP demonstration, spousal impoverishment protections, ACE Kids Act, Medicaid drug rebate program, health homes for children with medically complex conditions H.R. 2131, Medicare Advantage Quality Payment Relief Act (Kind-Kelly) - MA benchmark cap H.R. 2757, Creating Lower Cost Alternatives for Your Prescription Drugs Act (Cunningham) - eliminate copay for generic drugs in Medicare Part D H.R. 3107, Improving Seniors' Timely Access to Care Act (DelBene) - Medicare Advantage prior authorization H.R. 3253, Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act (Dingell) - MFP demonstration, spousal impoverishment protections, Medicaid drug rebate program H.R. 3417, Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act (Neal) - funding for quality measurement initiatives, Medicare coverage of mental health telehealth services, real-time benefit tools in Medicare Part D, Medicare eligibility and enrollment notices H.R. 3461, Community-Based Independence for Seniors Act (Sanchez-Kelly) - Community-Based Institutional Special Needs Plan Discussion Draft, Medicare Part D Reform (Neal-Pallone-Brady-Walden) - maximum out-of-pocket limit, federal reinsurance payments Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and risk adjustment data validation (RADV) audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2020 policy and technical regulation for MA and Part D; MA and Part D proposed rule on drug pricing changes for 2020; Part D reform, out of pocket limits; issues related to Medicare for All, Medicare buy-in and public option; CMSs price transparency proposal for direct-to-consumer advertisements; issues relating to 2020 Rate Notice and Call Letter; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); CMS's proposed Part B drug demonstration program; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; issues related to health homes for children with medically complex conditions; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1781: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3107: Improving Seniors' Timely Access to Care Act of 2019 - Provisions related to Medicare Advantage insurance plans H.R. 3276: Fair AMP Act - Provisions related to Medicaid drug rebates S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1801: Affordable Medications Act - Provisions relate to Part D drug pricing negotiation, importation, IP issues and pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 1926: PrEP Access and Coverage Act - PrEP insurance coverage requirement and grant program for uninsured S. __: Patient Affordability Value and Efficiency Act - Value-based arrangements Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)

H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1781: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting H.R. 1788: Medicare Part B Fairness Act - Provisions related to Part B enrollment H.R. 1839: Medicaid Services Investment and Accountability Act - Provisions related to Medicaid drug rebates and drug classification H.R. 2000: Medicare-X Choice Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2452: Medicare for America Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 2463: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation H.R. 2757: Creating Lower cost Alternative for Your prescription drugs Act - Provisions related to Part D and patient cost-sharing H.R. 3029: Improving Low-Income Access to Prescription Drugs Act of 2019 - Provisions related to Part D prescription drug plans H.R. 3107: Improving Seniors' Timely Access to Care Act of 2019 - Provisions related to Medicare Advantage insurance plans H.R. 3276: Fair AMP Act - Provisions related to Medicaid drug rebates S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 691: Medicare Extra Rx Higher Eligibility Limits in Part D Act of 2019 - Provisions related to Part D and patient out-of-pocket costs S. 801: Payment Commission Data Act - Provisions related to prescription drug pricing transparency and reporting S. 1129: Medicare for All Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 1261: Choose Medicare Act - Provisions related to Part D and drug pricing negotiation S. 1785: Fair AMP Act - Provisions related to Medicaid drug rebates S. 1801: Affordable Medications Act - Provisions relate to Part D drug pricing negotiation, importation, IP issues and pricing transparency S. 1895: Lower Health Care Costs Act - Provisions related to prescription drug pricing, transparency and patent issues S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 1926: PrEP Access and Coverage Act - PrEP insurance coverage requirement and grant program for uninsured S. __: Patient Affordability Value and Efficiency Act - Value-based arrangements Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions

H.R. 803 / S. 988, Improving Transparency and Accuracy in Medicare Part D Drug Spending Act; H.R. 1034 / S. 640, Phair Pricing Act of 2019; H.R. 1035, Prescription Drug Price Transparency Act, S. 475, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, S. 476, Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs; H.R.448 / S. 99, Medicare Drug Price Negotiation Act; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019; H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019; H.R. 366, Insulin Access for All Act of 2019; S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019; S. 205 / H.R. 937, Right Rebate Act of 2019; H.R. 1046 / S. 377, Medicare Negotiation and Competitive Licensing Act of 2019; H.R. 1781 / S. 801, the Payment Commission Data Act of 2019; H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting (STAR) Act of 2019; H.R. 2115, To amend title XI of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers; Proposed rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"; Proposed rule, "Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, OIG-0936-P"; Proposed rule, Medicaid Program; Medicaid and Childrens Health Insurance Plan (CHIP) Managed Care - CMS-2408-P; H.R. 1323, Rural Hospital Frontier Fairness Act; S. 551, REFUND Act of 2019; S. 691, Medicare Extra Rx HELP Act of 2019; S. 773, Telehealth Innovation and Improvement Act of 2019; S. 814, Expanding Access to Diabetes Self-Management Training Act of 2019; H.R. 1384 / S. 1129, Medicare for All Act of 2019; H.R. 3417, The Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act of 2019; H.R. 3408, Shop Rx Act of 2019; S. 1384, Prescription Drug Rebate Reform Act of 2019; H.R. 2113, Prescription Drug STAR Act; H.R. 2115, Public Disclosure of Drug Discounts Act

H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1781: Payment Commission Data Act of 2019 - Provisions related to prescription drug pricing transparency and reporting H.R. 1839: Medicaid Services Investment and Accountability Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 801: To amend titles XVIII and XIX of the Social Security Act to provide the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP (RIN 0936-AA10) Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Services Fees (RIN 0936-AA08)

S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act (Klobuchar) - Part D price negotiations S. 99, Medicare Drug Price Negotiation Act (Sanders) - Part D price negotiations, formulary changes S. 205, Right Rebate Act (Wyden) - Medicaid drug rebate program S. 317, ACE Kids Act (Grassley) - health homes for children with medically complex conditions S. 377, Medicare Negotiation and Competitive Licensing Act (Brown) - Part D price negotiation S. 470, Medicare at 50 Act (Stabenow) - Medicare buy-in option S. 475, RxCAP Act (Wyden) - Part D cost-sharing S. 489, State Public Option Act (Schatz) - Medicaid buy-in option S. 516, Prescription Drug Monitoring Act (Klobuchar) - required use of PDMPs S. 548, EMPOWER Care Act (Portman) - MFP demonstration S. 640, Phair Pricing Act (Kennedy) -- Part D rebates at the point of sale S. 691, Medicare Extra Rx HELP Act (Casey) - Part D assistance for low-income seniors S. 709, Prescription Drug Pricing Dashboard Act (Casey) - interactive dashboard with drug price and utilization data for federal programs S. 773, Telehealth Innovation and Improvement Act (Gardner) - testing expanded coverage of telehealth services in Medicare S. 988, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - payments on clean claims H.R. 259, Medicaid Extenders Act (Pallone) - MFP demonstration, spousal impoverishment protections H.R. 448, Medicare Drug Price Negotiation Act (Cummings) - Part D price negotiations, formulary changes H.R. 789, Improving Transparency and Accuracy in Medicare Part D Spending Act (Welch) - payments on clean claims H.R. 937, Right Rebate Act (Schrader) - Medicaid drug rebate program H.R. 1034, Phair Pricing Act (Collins) - Part D rebates at the point of sale H.R. 1035, Prescription Drug Price Transparency Act (Collins) - Medicare PBM standards H.R. 1046, Medicare Negotiation and Competitive Licensing Act (Doggett) - Part D price negotiation H.R. 1226, ACE Kids Act (Castor) - health homes for children with medically complex conditions H.R. 1277, State Public Option Act (Lujan) - Medicaid buy-in option H.R. 1301, Mental Health Telemedicine Expansion Act (DelBene) - Medicare coverage of mental health telehealth services H.R. 1342, EMPOWER Care Act (Dingell) - MFP demonstration H.R. 1343, Protecting Married Seniors from Impoverishment Act (Dingell) - spousal impoverishment protections H.R. 1346, Medicare Buy-In and Health Care Stabilization Act (Higgins) - Medicare buy-in option H.R. 1375, PAID Act (Kind) - transparency of Medicare secondary payer information H.R. 1384, Medicare for All Act (Jayapal) - Medicare for All health care system H.R. 1394, Medigap Consumer Protection Act (Doggett) - Medicare supplemental consumer protections H.R. 1551, Quality Care for Moms and Babies Act (Engel) - quality measures in Medicaid and CHIP H.R. 1781, Payment Commission Data Act (Carter) - MedPAC and MACPAC access to drug pricing and rebate data in Medicare and Medicaid H.R. 1839, Medicaid Services Investment and Accountability Act (Ruiz) - MFP demonstration, spousal impoverishment protections, ACE Kids Act, Medicaid drug rebate program Draft Medicare Advantage Quality Payment Relief Act (Kelly-Kind) - MA benchmark cap Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and risk adjustment data validation (RADV) audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); calendar year 2020 policy and technical regulation for MA and Part D; MA and Part D proposed rule on drug pricing changes for 2020; CMSs price transparency proposal for direct-to-consumer advertisements; issues relating to 2019 Rate Notice and Call Letter; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Bipartisan Budget Act of 2018 changes to SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); CMS's proposed Part B drug demonstration program; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) and the Bipartisan Budget Act of 2018 changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS's substantial revisions to the managed care regulations, mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; issues relating to prescription drug price blueprint; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; issues related to health homes for children with medically complex conditions; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

Proposals for the Pandemic and All-Hazards Preparedness, specifically the provisions related to the Biomedical Advanced Research and Development Authority reauthorization; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing; S. 64, The Preserve Access to Affordable Generics and Biosimilars Act; S. 102, H.R. 465, The Prescription Drug Price Relief Act of 2019; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act; S. 205, The Right Rebate Act of 2019; S. 366, H.R. 1188, FLAT Prices Act; S. 340, H.R. 965, The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act; H.R. 1034, The Phair Price Act; H.R. 1035, The Prescription Drug Price Transparency Act; S. 474, The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 985, The Fair Access for Safe and Timely (FAST) Generics Act of 2019; S. 658, A bill to provide for an accelerated approval pathway for certain drugs that are authorized to be lawfully marketed in other countries; H.R. 1499, To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; H.R. 1506, Fair and Immediate Release (FAIR) of Generic Drugs Act; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 1503, Orange Book Transparency Act of 2019; Short on Competition Act (not yet introduced); S. 659, Biologic Patent Transparency Act; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute;

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

H.R. 107: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs - Provisions related to Medicaid drug rebates H.R. 275: Medicare Prescription Drug Price Negotiation Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 366: Insulin Access for All Act of 2019 - Provisions related to insulin cost-sharing H.R. 448: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation H.R. 937: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification H.R. 1034: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates H.R. 1035: Prescription Drug Price Transparency Act - Provisions related to drug pricing transparency and pharmacy benefit managers H.R. 1046: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing H.R. 1346: Medicare Buy-In and Health Care Stabilization Act of 2019 - Provisions related to Part D and drug pricing negotiation H.R. 1384: Medicare for All Act of 2019 - Provisions related to Part D, drug pricing negotiation and march-in rights H.R. 1781: Payment Commission Data Act of 2019 - Provisions related to prescription drug pricing transparency and reporting H.R. 1839: Medicaid Services Investment and Accountability Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 - Provisions related to Part D and drug pricing negotiation S. 99: Medicare Drug Price Negotiation Act - Provisions related to Part D and drug pricing negotiation S. 205: Right Rebate Act of 2019 - Provisions related to Medicaid drug rebates and drug classification S. 377: Medicare Negotiation and Competitive Licensing Act of 2019 - Provisions related to Part D, drug pricing negotiation and compulsory licensing S. 470: Medicare at 50 Act - Provisions related to Part D and drug pricing negotiation S. 475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCap) Act of 2019 - Provisions related to Part D and patient cost-sharing S. 476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 551: Recovering Excessive Funds for Unused and Needless Drugs Act of 2019 - Provisions related to prescription drug vial sizes and rebates S. 640: Phair Pricing Act of 2019 - Provisions related to Part D and manufacturer rebates S. 801: To amend titles XVIII and XIX of the Social Security Act to provide the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP (RIN 0936-AA10) Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Services Fees (RIN 0936-AA08)

H.R. 803 / S. 988, Improving Transparency and Accuracy in Medicare Part D Drug Spending Act; H.R. 1034 / S. 640, Phair Pricing Act of 2019; H.R. 1035, Prescription Drug Price Transparency Act, S. 475, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, S. 476, Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act; H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs; H.R.448 / S. 99, Medicare Drug Price Negotiation Act; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019; H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019; H.R. 366, Insulin Access for All Act of 2019; S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019; S. 205 / H.R. 937, Right Rebate Act of 2019; H.R. 1046 / S. 377, Medicare Negotiation and Competitive Licensing Act of 2019; H.R. 1781 / S. 801, the Payment Commission Data Act of 2019; H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting (STAR) Act of 2019; H.R. 2115, To amend title XI of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers; Proposed rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"; Proposed rule, "Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, OIG-0936-P"; Proposed rule, Medicaid Program; Medicaid and Childrens Health Insurance Plan (CHIP) Managed Care - CMS-2408-P; H.R. 1323, Rural Hospital Frontier Fairness Act; S. 551, REFUND Act of 2019; S. 691, Medicare Extra Rx HELP Act of 2019; S. 773, Telehealth Innovation and Improvement Act of 2019; S. 814, Expanding Access to Diabetes Self-Management Training Act of 2019; H.R. 1384 / S. 1129, Medicare for All Act of 2019

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions.