Health Care PRICE Transparency Act

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.4293: Pharmacy Benefit Manager Transparency Act 42 CFR Part 1001 RIN 0936-AA08: 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 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Client expense: $1,908,258 · Firm income: Not reported

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

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: 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 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: 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 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.6833: Affordable Insulin Now Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.799: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: 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 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.4293: Pharmacy Benefit Manager Transparency Act 42 CFR Part 1001 RIN 0936-AA08: 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 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: 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 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2003 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: 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 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2003 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: 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 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2003 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

H.R. 1319 - American Rescue Plan Act of 2021 - support passage H.R. 5376, Build Back Better Act, support passage S. 898- Fair Accountability and Innovative Research Drug Pricing Act of 2021 - support passage S. 368/H.R. 1332 - Telehealth Modernization Act - support passage S.464/H.R. 2163- Safe Step Act, support passage H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 - support passage H.R. 4418 - SPIKE Act- "To amend title XI of the Social Security Act to provide for drug manufacturer price transparency."- support passage S.2210-."Better Care Better Jobs Act"- support passage S.2164- "Lower Costs, More Cures Act of 2021"- support passage S.1524/H.R. 3029- "Health Care PRICE Transparency Act"- support passage S.1428/H.R. 2891-"Preserve Access to Affordable Generics and Biosimilars Act"- support passage S.1427/H.R. 2869-"Increasing Access to Biosimilars Act of 2021"- support passage H.R.2846-"Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021"-support passage H.R.2843-"STOP GAMES Act of 2021"- support passage H.R.3-"Elijah E. Cummings Lower Drug Costs Now Act" - support passage H.R.2855-"Star Rating for Biosimilars Act"- support passage S.164-"Advancing Education on Biosimilars Act of 2021"- support passage H.R.19- "Lower Costs, More Cures Act of 2021"- support passage Wyden Releases Principles For Lowering Drug Prices for Americans, support passage H.R. 2503, Social Determinants Accelerator Act of 2021, support passage S.1524/H.R.3029- Health Care Price Transparency Act, support passage H.R. 2884- Affordable Prescriptions for Patients Through Improvement t o Patent Litigation Act, support passage H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021, support passage H.R. 5365, Primary Health Services Enhancement Act, support passage H.R. 2575, Social Security Disability Insurance Return to Work Act, monitor for position determination S.2565- Expanding Access to Palliative Care Act, monitor for impact on people affected by MS H.R. 4714- Disabled Access Credit Expansion Act of 2021- support passage S. 1435, Affordable Prescriptions for Patients Act of 2021, monitor for position determination H.R. 3971, Double Dip Elimination Act, monitor for position determination H.R. 3765, Disability Employment Incentive Act, support passage H.R. 5801, Help Copays Act, support passage

H.R. 31 - Health Coverage Choice Act - Rep. Biggs, Andy [R-AZ-5] - short-term, limited-duration health insurance plans H.R. 145 - Continuing Coverage for Preexisting Conditions Act of 2021 - Rep. Joyce, David P. [R-OH-14] - pre-existing conditions H.R. 317 - To amend the Public Health Service Act to establish a health insurance Federal Invisible Risk Sharing Program - Rep. Schweikert, David [R-AZ-6] - federal risk sharing program H.R. 477 - Allys Act - Rep. Neguse, Joe [D-CO-2] - coverage for hearing devices H.R. 533 - Stop COVID-19 Test Surprise Medical Bills Act of 2021 - Rep. Fletcher, Lizzie [D-TX-7] - surprise medical bills H.R. 689 - Premium Relief Act of 2021 - Rep. Burgess, Michael C. [R-TX-26] - Patient and State Stability Fund H.R. 796 - Coverage for COVID-19 Treatment Act of 2021 - Rep. Blunt Rochester, Lisa [D-DE-At Large] - coverage for COVID-19 drugs H.R. 892 - Pre-existing Conditions Protection Act of 2021 - Rep. McMorris Rodgers, Cathy [R-WA-5] - pre-existing conditions H.R. 1255 - Living Donor Protection Act of 2021 - Rep. Nadler, Jerrold [D-NY-10] - coverage for organ donors H.R. 1790 - Fair Indexing for Health Care Affordability Act - Rep. Axne, Cynthia [D-IA-3] - maximum out of pocket costs and premium tax credits H.R. 2264 - Tele-Mental Health Improvement Act - Rep. Trone, David J. [D-MD-6] - telehealth H.R. 2808 - Health Freedom and Flexibility Act - Rep. Rosendale Sr., Matthew M. [R-MT-At Large] - HSAs H.R. 3029 - Health Care PRICE Transparency Act - Rep. Davidson, Warren [R-OH-8] - price transparency H.R. 3783 - Medical Nutrition Equity Act of 2021 - Rep. McGovern, James P. [D-MA-2] - coverage of medical foods H.R. 3947 - Justice for Patients Act - Rep. Porter, Katie [D-CA-45] - health insurance contracts H.R. 3969 - To amend title XXVII of the Public Health Service Act to include activities to address social determinants of health in the calculation of medical loss ratios - Rep. Curtis, John R. [R-UT-3] - SDOH and MLRs H.R. 4123 - Increasing Health Coverage through HRAs Act of 2021 - Rep. Bishop, Dan [R-NC-9] - health reimbursement arrangements H.R. 4289 - WISH Act - Rep. Suozzi, Thomas R. [D-NY-3] - long-term care insurance benefits H.R. 4385 - Cancer Drug Parity Act of 2021 - Rep. Higgins, Brian [D-NY-26] - cost sharing for oral anticancer drugs H.R. 4480 - Telehealth Coverage and Payment Parity Act - Rep. Phillips, Dean [D-MN-3] - payment parity for telehealth services H.R. 4669 - Capping Costs for Consumers Act of 2021 - Rep. Schrier, Kim [D-WA-8] - cost-sharing reductions H.R. 4911 - Medicare Advantage Quality Payment Relief Act of 2021 - Rep. Kind, Ron [D-WI-3] - Medicare Advantage payments H.R. 5157 - Direct Primary Care for America Act - Rep. Crenshaw, Dan [R-TX-2] - HSAs and spending requirements H.R. 5214 - To amend the Internal Revenue Code of 1986 to permit expenditures from health savings accounts, flexible spending arrangements, and health reimbursement arrangements for dietary supplements - Rep. Curtis, John R. [R-UT-3] - HSAs and spending requirements H.R. 5390 - COBRA Subsidy Extension for Workers and Families Act - Rep. Mrvan, Frank J. [D-IN-1] - COBRA coverage H.R. 5432 - COVID-19 Testing Coverage Act of 2021 - Rep. Miller-Meeks, Mariannette [R-IA-2] - COVID-19 testing coverage H.R. 5536 - SMART Act - Rep. Rush, Bobby L. [D-IL-1] - outpatient physical therapy payment rules in rural areas H.R. 5610 - Easy Enrollment in Health Care Act - Rep. Bera, Ami [D-CA-7] - health insurance affordability programs and minimum essential coverage H.R. 5981 - Telehealth Expansion Act of 2021 - Rep. Steel, Michelle [R-CA-48] - telehealth services and high deductible health plans H.R. 6271 - Health Savings Act of 2021 - Rep. LaTurner, Jake [R-KS-2] - HSAs S. 125 - Protecting Life in Health Savings Accounts Act - Sen. Lee, Mike [R-UT] - HSAs S. 377 - Living Donor Protection Act of 2021 - Sen. Gillibrand, Kirsten E. [D-NY] - coverage for organ donors S. 380 - Health Savings Act of 2021 - Sen. Rubio, Marco [R-FL] - HSAs S. 660 - Tele-Mental Health Improvement Act - Sen. Smith, Tina [D-MN] - SUD and mental health S. 754 - Ensuring Lasting Smiles Act - Sen. Baldwin, Tammy [D-WI] - insurance benefits S. 756 - Continuing Coverage for Preexisting Conditions Act of 2021 - Sen. Kennedy, John [R-LA] - pre-existing conditions S. 1524 - Health Care PRICE Transparency Act- Sen. Braun, Mike [R-IN] - price transparency S. 2097 - TELEHEALTH HSA Act of 2021 - Sen. Kennedy, John [R-LA] - HSAs S. 2099 - Health Savings Account Expansion Act of 2021 - Sen. Sasse, Ben [R-NE] - HSAs S. 3001 - Easy Enrollment in Health Care Act - Sen. Van Hollen, Chris [D-MD] - health insurance affordability programs and minimum essential coverage S. 3139 - Healthy Competition for Better Care Act - Sen. Braun, Mike [R-IN] - anticompetitive terms in insurance contracts S. 3239 - Healthy MOM Act - Sen. Brown, Sherrod [D-OH] - SEPs for pregnant women Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to COBRA continuation coverage; issues related to behavioral health benefits; issues related to encouraging impaired workers to stay in/return to the workforce; issues related to expanding long-term care insurance coverage; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health equity; issues related to vaccination; issues related to coverage in non-Medicaid Expansion States (e.g., Gap Population); issues related to the No Surprises Act, enacted as part of the Consolidated Appropriations Act in December 2020, including disclosure of agent broker compensation (Section 202c); issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; issues related to changes to prior authorization regulations, electronic documentation, and related issues; issues relating to Medicaid best price; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; issues related to repeal of the antitrust-related portions of the McCarran-Ferguson Act; implementation of the Mental Health Parity Act requirements; implementation of the 21st Century Cures Act requirements; summary of benefits and coverage disclosures; prior authorization; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; health reimbursement accounts; dependent coverage; treatment of expatriate plans; issues related to surprise medical bills; issues related to all payor claims databases; issues related to association health plans; issues related to substance abuse and provider treatment records (42 CFR Part 2); issues related to medical management; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues relating to dental coverage; issues relating to proposals for single-payer and Medicare/Medicaid buy-in options; issues related to implementation of the Telephone Consumer Protection Act; issues relating to third party payment of premiums; issues related to cost-sharing reductions (CSRs); issues related to interoperability and price transparency; issues related to the employer market; issues relating to the individual market; and other issues relating to health care reform implementation.

H.R. 1319 - American Rescue Plan Act of 2021 - support passage H.R. 5376, Build Back Better Act, support passage S. 898- Fair Accountability and Innovative Research Drug Pricing Act of 2021 - support passage S. 368/H.R. 1332 - Telehealth Modernization Act - support passage S.464/H.R. 2163- Safe Step Act, support passage H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 - support passage H.R. 4418 - SPIKE Act- "To amend title XI of the Social Security Act to provide for drug manufacturer price transparency."- support passage S.2210-."Better Care Better Jobs Act"- support passage S.2164- "Lower Costs, More Cures Act of 2021"- support passage S.1524/H.R. 3029- "Health Care PRICE Transparency Act"- support passage S.1428/H.R. 2891-"Preserve Access to Affordable Generics and Biosimilars Act"- support passage S.1427/H.R. 2869-"Increasing Access to Biosimilars Act of 2021"- support passage H.R.2846-"Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021"-support passage H.R.2843-"STOP GAMES Act of 2021"- support passage H.R.3-"Elijah E. Cummings Lower Drug Costs Now Act" - support passage H.R.2855-"Star Rating for Biosimilars Act"- support passage S.164-"Advancing Education on Biosimilars Act of 2021"- support passage H.R.19- "Lower Costs, More Cures Act of 2021"- support passage Wyden Releases Principles For Lowering Drug Prices for Americans, support passage H.R. 2503, Social Determinants Accelerator Act of 2021, support passage S.1524/H.R.3029- Health Care Price Transparency Act, support passage H.R. 2884- Affordable Prescriptions for Patients Through Improvement t o Patent Litigation Act, support passage H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021, support passage H.R. 5365, Primary Health Services Enhancement Act, support passage H.R. 2575, Social Security Disability Insurance Return to Work Act, monitor for position determination S.2565- Expanding Access to Palliative Care Act, monitor for impact on people affected by MS H.R. 4714- Disabled Access Credit Expansion Act of 2021- support passage S. 1435, Affordable Prescriptions for Patients Act of 2021, monitor for position determination H.R. 3971, Double Dip Elimination Act, monitor for position determination H.R. 3765, Disability Employment Incentive Act, support passage H.R. 5801, Help Copays Act, support passage

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5623: The Insulin Cost Reduction Act, To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under Part D of Medicare, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: 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

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act 42 CFR Part 1001 RIN 0936-AA08: 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

Client expense: $1,918,904 · Firm income: Not reported

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: 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

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act 42 CFR Part 1001 RIN 0936-AA08: 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

Client expense: $1,918,904 · Firm income: Not reported

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2855: Star Ratings for Biosimilars Act S.1523: The Drug Price Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs, More Cures Act of 2021 H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.2815: BIOSIM Act S.464 / H.R.2163: Safe Step Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.4418: SPIKE Act H.R.5237: A bill to amend titles XI, XVIII, and XIX of the Social Security Act to lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients' out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes. H.R.5260: Reduced Costs and Continued Cures Act H.R.3684: The Infrastructure Investment and Jobs Act, Sec.90006, Moratorium on implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates H.R.5376: The Build Back Better Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: 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

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act 42 CFR Part 1001 RIN 0936-AA08: 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

H.R. 31 - Health Coverage Choice Act - Rep. Biggs, Andy [R-AZ-5] - short-term, limited-duration health insurance plans H.R. 145 - Continuing Coverage for Preexisting Conditions Act of 2021 - Rep. Joyce, David P. [R-OH-14] - pre-existing conditions H.R. 317 - To amend the Public Health Service Act to establish a health insurance Federal Invisible Risk Sharing Program - Rep. Schweikert, David [R-AZ-6] - federal risk sharing program H.R. 477 - Allys Act - Rep. Neguse, Joe [D-CO-2] - coverage for hearing devices H.R. 533 - Stop COVID-19 Test Surprise Medical Bills Act of 2021 - Rep. Fletcher, Lizzie [D-TX-7] - surprise medical bills H.R. 689 - Premium Relief Act of 2021 - Rep. Burgess, Michael C. [R-TX-26] - Patient and State Stability Fund H.R. 796 - Coverage for COVID-19 Treatment Act of 2021 - Rep. Blunt Rochester, Lisa [D-DE-At Large] - coverage for COVID-19 drugs H.R. 892 - Pre-existing Conditions Protection Act of 2021 - Rep. McMorris Rodgers, Cathy [R-WA-5] - pre-existing conditions H.R. 1255 - Living Donor Protection Act of 2021 - Rep. Nadler, Jerrold [D-NY-10] - coverage for organ donors H.R. 1790 - Fair Indexing for Health Care Affordability Act - Rep. Axne, Cynthia [D-IA-3] - maximum out of pocket costs and premium tax credits H.R. 2264 - Tele-Mental Health Improvement Act - Rep. Trone, David J. [D-MD-6] - telehealth H.R. 2808 - Health Freedom and Flexibility Act - Rep. Rosendale Sr., Matthew M. [R-MT-At Large] - HSAs H.R. 3029 - Health Care PRICE Transparency Act - Rep. Davidson, Warren [R-OH-8] - price transparency H.R. 3783 - Medical Nutrition Equity Act of 2021 - Rep. McGovern, James P. [D-MA-2] - coverage of medical foods H.R. 3947 - Justice for Patients Act - Rep. Porter, Katie [D-CA-45] - health insurance contracts H.R. 3969 - To amend title XXVII of the Public Health Service Act to include activities to address social determinants of health in the calculation of medical loss ratios - Rep. Curtis, John R. [R-UT-3] - SDOH and MLRs H.R. 4123 - Increasing Health Coverage through HRAs Act of 2021 - Rep. Bishop, Dan [R-NC-9] - health reimbursement arrangements H.R. 4289 - WISH Act - Rep. Suozzi, Thomas R. [D-NY-3] - long-term care insurance benefits H.R. 4385 - Cancer Drug Parity Act of 2021 - Rep. Higgins, Brian [D-NY-26] - cost sharing for oral anticancer drugs H.R. 4480 - Telehealth Coverage and Payment Parity Act - Rep. Phillips, Dean [D-MN-3] - payment parity for telehealth services H.R. 4669 - Capping Costs for Consumers Act of 2021 - Rep. Schrier, Kim [D-WA-8] - cost-sharing reductions H.R. 4911 - Medicare Advantage Quality Payment Relief Act of 2021 - Rep. Kind, Ron [D-WI-3] - Medicare Advantage payments H.R. 5157 - Direct Primary Care for America Act - Rep. Crenshaw, Dan [R-TX-2] - HSAs and spending requirements H.R. 5214 - To amend the Internal Revenue Code of 1986 to permit expenditures from health savings accounts, flexible spending arrangements, and health reimbursement arrangements for dietary supplements - Rep. Curtis, John R. [R-UT-3] - HSAs and spending requirements H.R. 5390 - COBRA Subsidy Extension for Workers and Families Act - Rep. Mrvan, Frank J. [D-IN-1] - COBRA coverage H.R. 5432 - COVID-19 Testing Coverage Act of 2021 - Rep. Miller-Meeks, Mariannette [R-IA-2] - COVID-19 testing coverage S. 125 - Protecting Life in Health Savings Accounts Act - Sen. Lee, Mike [R-UT] - HSAs S. 377 - Living Donor Protection Act of 2021 - Sen. Gillibrand, Kirsten E. [D-NY] - coverage for organ donors S. 380 - Health Savings Act of 2021 - Sen. Rubio, Marco [R-FL] - HSAs S. 660 - Tele-Mental Health Improvement Act - Sen. Smith, Tina [D-MN] - SUD and mental health S. 754 - Ensuring Lasting Smiles Act - Sen. Baldwin, Tammy [D-WI] - insurance benefits S. 756 - Continuing Coverage for Preexisting Conditions Act of 2021 - Sen. Kennedy, John [R-LA] - pre-existing conditions S. 1524 - Health Care PRICE Transparency Act- Sen. Braun, Mike [R-IN] - price transparency S. 2097 - TELEHEALTH HSA Act of 2021 - Sen. Kennedy, John [R-LA] - HSAs S. 2099 - Health Savings Account Expansion Act of 2021 - Sen. Sasse, Ben [R-NE] - HSAs Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to COBRA continuation coverage; issues related to behavioral health benefits; issues related to encouraging impaired workers to stay in/return to the workforce; issues related to expanding long-term care insurance coverage; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health equity; issues related to vaccination; issues related to coverage in non-Medicaid Expansion States (e.g., Gap Population); issues related to the No Surprises Act, enacted as part of the Consolidated Appropriations Act in December 2020, including disclosure of agent broker compensation (Section 202c); issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; issues related to changes to prior authorization regulations, electronic documentation, and related issues; issues relating to Medicaid best price; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; issues related to repeal of the antitrust-related portions of the McCarran-Ferguson Act; implementation of the Mental Health Parity Act requirements; implementation of the 21st Century Cures Act requirements; summary of benefits and coverage disclosures; prior authorization; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; health reimbursement accounts; dependent coverage; treatment of expatriate plans; issues related to surprise medical bills; issues related to all payor claims databases; issues related to association health plans; issues related to substance abuse and provider treatment records (42 CFR Part 2); issues related to medical management; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues relating to dental coverage; issues relating to proposals for single-payer and Medicare/Medicaid buy-in options; issues related to implementation of the Telephone Consumer Protection Act; issues relating to third party payment of premiums; issues related to cost-sharing reductions (CSRs); issues related to interoperability and price transparency; issues related to the employer market; issues relating to the individual market; and other issues relating to health care reform implementation.

H.R. 1319 - American Rescue Plan Act of 2021 - support passage H.R. 5376, Build Back Better Act, support passage S. 898- Fair Accountability and Innovative Research Drug Pricing Act of 2021 - support passage S. 368/H.R. 1332 - Telehealth Modernization Act - support passage S.464/H.R. 2163- Safe Step Act, support passage H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 - support passage H.R. 4418 - SPIKE Act- "To amend title XI of the Social Security Act to provide for drug manufacturer price transparency."- support passage S.2210-."Better Care Better Jobs Act"- support passage S.2164- "Lower Costs, More Cures Act of 2021"- support passage S.1524/H.R. 3029- "Health Care PRICE Transparency Act"- support passage S.1428/H.R. 2891-"Preserve Access to Affordable Generics and Biosimilars Act"- support passage S.1427/H.R. 2869-"Increasing Access to Biosimilars Act of 2021"- support passage H.R.2846-"Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021"-support passage H.R.2843-"STOP GAMES Act of 2021"- support passage H.R.3-"Elijah E. Cummings Lower Drug Costs Now Act" - support passage H.R.2855-"Star Rating for Biosimilars Act"- support passage S.164-"Advancing Education on Biosimilars Act of 2021"- support passage H.R.19- "Lower Costs, More Cures Act of 2021"- support passage Wyden Releases Principles For Lowering Drug Prices for Americans, support passage H.R. 2503, Social Determinants Accelerator Act of 2021, support passage S.1524/H.R.3029- Health Care Price Transparency Act, support passage H.R. 2884- Affordable Prescriptions for Patients Through Improvement t o Patent Litigation Act, support passage H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021, support passage H.R. 5365, Primary Health Services Enhancement Act, support passage H.R. 2575, Social Security Disability Insurance Return to Work Act, monitor for position determination S.2565- Expanding Access to Palliative Care Act, monitor for impact on people affected by MS H.R. 4714- Disabled Access Credit Expansion Act of 2021- support passage S. 1435, Affordable Prescriptions for Patients Act of 2021, monitor for position determination H.R. 3971, Double Dip Elimination Act, monitor for position determination H.R. 3765, Disability Employment Incentive Act, support passage

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act / Affordable Prescriptions for Patients Through Promoting Competition Act H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program 42 CFR Part 1001 RIN 0936-AA08: 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

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, direct and indirect remuneration (DIR), pharmacy networks, and mail-service pharmacy Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 H.R.2355: Opioid Prescription Verification Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524: Health Care PRICE Transparency Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.2164: Lower Costs More Cures Act 42 CFR Part 1001 RIN 0936-AA08: 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

Client expense: $1,601,681 · Firm income: Not reported

H.R. 1319 - American Rescue Plan Act of 2021 - support passage S. 898- Fair Accountability and Innovative Research Drug Pricing Act of 2021 - support passage S. 368/H.R. 1332 - Telehealth Modernization Act - support passage H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 - support passage H.R. 4418 - SPIKE Act- "To amend title XI of the Social Security Act to provide for drug manufacturer price transparency."- support passage S.2210-."Better Care Better Jobs Act"- support passage S.2164- "Lower Costs, More Cures Act of 2021"- support passage S.1524/H.R. 3029- "Health Care PRICE Transparency Act"- support passage S.1428/H.R. 2891-"Preserve Access to Affordable Generics and Biosimilars Act"- support passage S.1427/H.R. 2869-"Increasing Access to Biosimilars Act of 2021"- support passage H.R.2846-"Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021"-support passage H.R.2843-"STOP GAMES Act of 2021"- support passage H.R.3-"Elijah E. Cummings Lower Drug Costs Now Act" - support passage H.R.2855-"Star Rating for Biosimilars Act"- support passage S.164-"Advancing Education on Biosimilars Act of 2021"- support passage H.R.19- "Lower Costs, More Cures Act of 2021"- support passage

Client expense: $43,590 · Firm income: Not reported

H.R. 31 - Health Coverage Choice Act - Rep. Biggs, Andy [R-AZ-5] - short-term, limited-duration health insurance plans H.R. 145 - Continuing Coverage for Preexisting Conditions Act of 2021 - Rep. Joyce, David P. [R-OH-14] - pre-existing conditions H.R. 317 - To amend the Public Health Service Act to establish a health insurance Federal Invisible Risk Sharing Program - Rep. Schweikert, David [R-AZ-6] - federal risk sharing program H.R. 477 - To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, the Internal Revenue Code of 1986, and the Patient Protection and Affordable Care Act to require coverage of hearing devices and systems in certain private health insurance plans, and for other purposes - Rep. Neguse, Joe [D-CO-2] - coverage for hearing devices H.R. 533 - Stop COVID-19 Test Surprise Medical Bills Act of 2021 - Rep. Fletcher, Lizzie [D-TX-7] - surprise medical bills H.R. 689 - Premium Relief Act of 2021 - Rep. Burgess, Michael C. [R-TX-26] - Patient and State Stability Fund H.R. 796 - Coverage for COVID-19 Treatment Act of 2021 - Rep. Blunt Rochester, Lisa [D-DE-At Large] - coverage for COVID-19 drugs H.R. 892 - Pre-existing Conditions Protection Act of 2021 - Rep. McMorris Rodgers, Cathy [R-WA-5] - pre-existing conditions H.R. 1255 - Living Donor Protection Act of 2021 - Rep. Nadler, Jerrold [D-NY-10] - coverage for organ donors H.R. 1790 - To amend the Patient Protection and Affordable Care Act to require the Secretary of Health and Human Services to set forth a method of determining maximum out-of-pocket limits and annual updates to premium tax credit eligibility - Rep. Axne, Cynthia [D-IA-3] - maximum out of pocket costs and premium tax credits H.R. 2264 - Tele-Mental Health Improvement Act - Rep. Trone, David J. [D-MD-6] - telehealth H.R. 2808 - To amend the Internal Revenue Code of 1986 to make improvements to Health Savings Accounts - Rep. Rosendale Sr., Matthew M. [R-MT-At Large] - HSAs H.R. 3029 - Health Care PRICE Transparency Act - Rep. Davidson, Warren [R-OH-8] - price transparency H.R. 3783 - Medical Nutrition Equity Act of 2021 - Rep. McGovern, James P. [D-MA-2] - coverage of medical foods H.R. 3947 - To prohibit the inclusion of mandatory predispute arbitration clauses and clauses limiting class action lawsuits in health insurance contracts - Rep. Porter, Katie [D-CA-45] - health insurance contracts H.R. 3969 - To amend title XXVII of the Public Health Service Act to include activities to address social determinants of health in the calculation of medical loss ratios - Rep. Curtis, John R. [R-UT-3] - SDOH and MLRs H.R. 4123 - To codify certain rules related to health reimbursement arrangements and other account-based group health plans - Rep. Bishop, Dan [R-NC-9] - health reimbursement arrangements H.R. 4289 - To amend title II of the Social Security Act to provide for long-term care insurance benefits - Rep. Suozzi, Thomas R. [D-NY-3] - long-term care insurance benefits S. 125 - Protecting Life in Health Savings Accounts Act - Sen. Lee, Mike [R-UT] - HSAs S. 377 - Living Donor Protection Act of 2021 - Sen. Gillibrand, Kirsten E. [D-NY] - coverage for organ donors S. 380 - Health Savings Act of 2021 - Sen. Rubio, Marco [R-FL] - HSAs S. 660 - A bill to require parity in the coverage of mental health and substance use disorder services provided to enrollees in private insurance plans, whether such services are provided in-person or through telehealth - Sen. Smith, Tina [D-MN] - SUD and mental health S. 754 - A bill to provide health insurance benefits for outpatient and inpatient items and services related to the diagnosis and treatment of a congenital anomaly or birth defect - Sen. Baldwin, Tammy [D-WI] - insurance benefits S. 756 - A bill to amend the Patient Protection and Affordable Care Act to ensure that preexisting condition exclusions with respect to enrollment in health insurance coverage and group health plans continue to be prohibited - Sen. Kennedy, John [R-LA] - pre-existing conditions S. 1524 - Health Care PRICE Transparency Act- Sen. Braun, Mike [R-IN] - price transparency S. 2097 - A bill to amend the Internal Revenue Code of 1986 to make permanent the permissible first-dollar coverage of telehealth services for purposes of health savings accounts - Sen. Kennedy, John [R-LA] - HSAs S. 2099 - A bill to amend the Internal Revenue Code of 1986 to allow individuals who are not enrolled in a high deductible health plan to have access to health savings accounts - Sen. Sasse, Ben [R-NE] - HSAs Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to COBRA continuation coverage; issues related to behavioral health benefits; issues related to encouraging impaired workers to stay in/return to the workforce; issues related to expanding long-term care insurance coverage; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health equity; issues related to vaccination; issues related to coverage in non-Medicaid Expansion States (e.g., Gap Population); issues related to the No Surprises Act, enacted as part of the Consolidated Appropriations Act in December 2020, including disclosure of agent broker compensation (Section 202c); issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; issues related to changes to prior authorization regulations, electronic documentation, and related issues; issues relating to Medicaid best price; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; issues related to repeal of the antitrust-related portions of the McCarran-Ferguson Act; implementation of the Mental Health Parity Act requirements; implementation of the 21st Century Cures Act requirements; summary of benefits and coverage disclosures; prior authorization; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; health reimbursement accounts; dependent coverage; treatment of expatriate plans; issues related to surprise medical bills; issues related to all payor claims databases; issues related to association health plans; issues related to substance abuse and provider treatment records (42 CFR Part 2); issues related to medical management; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues relating to dental coverage; issues relating to proposals for single-payer and Medicare/Medicaid buy-in options; issues related to implementation of the Telephone Consumer Protection Act; issues relating to third party payment of premiums; issues related to cost-sharing reductions (CSRs); issues related to interoperability and price transparency; issues related to the employer market; issues relating to the individual market; and other issues relating to health care reform implementation.

H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 467, protecting patient access to life-saving COVID-19 drugs act of 2021 H.R. 959/S. 346, Black maternal health momnibus act of 2021; HSA/FSA for dietary supplements H.R. 796: Coverage for COVID-19 Treatment Act of 2021 - Provisions related to COVID-19 treatments H.R. 841, Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021 H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1978, Protecting Seniors Through Immunization Act H.R. 2484: Lowest Price for Patients Act - Provisions related to prescription drug pricing and transparency H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions HR 3236 - AMIGOS Act H.R. 3932: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections. - Provisions related to antimicrobial resistance policy issues S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1523: Drug Price Transparency Act of 2021 - Provisions related to prescription drug pricing transparency S. 1524: Health Care PRICE Transparency Act - Provisions related to prescription drug pricing transparency S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections. - Provisions related to antimicrobial resistance policy issues 21st Century Cures 2.0 (discussion draft) American Jobs Plan American Families Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Prescription drug take back and secure disposal policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) Interim Final Rule with comment period; Most Favord Nation (MFN) Model Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021 DHSEA 2.0 DISARM Act of Provisions related to antimicrobial drug development Infrastructure bill - potential inclusion of drug pricing proposals

H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 796: Coverage for COVID-19 Treatment Act of 2021 - Provisions related to COVID-19 treatments H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 2078: Social and Economic Equity Promotion Act - CBO analyses H.R. 2366: STOP Fentanyl Act of 2021 H.R. 2484: Lowest Price for Patients Act - Provisions related to prescription drug pricing and transparency H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3932: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to antimicrobial resistance policy issues S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1523: Drug Price Transparency Act of 2021 - Provisions related to prescription drug pricing transparency S. 1524: Health Care PRICE Transparency Act - Provisions related to prescription drug pricing transparency S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to antimicrobial resistance policy issues 21st Century Cures 2.0 (discussion draft) American Jobs Plan American Families Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Prescription drug take back and secure disposal policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) Interim Final Rule with comment period; Most Favord Nation (MFN) Model Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients