Pharmacy DIR Reform To Reduce Senior Drug Costs Act

H.R. 3554 / S.1909 - Pharmacy DIR Reform To Reduce Senior Drug Costs Act Inflation Reduction Act Drug Provisions Pharmacy Direct and Indirect Remuneration Fee reform Pharmacy Benefit Manager (PBM) transparency Pharmacy quality measures Standardized pharmacy performance measures Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (CMS-4192-P) H.R.2617 - Consolidated Appropriations Act, 2023

Client expense: $391,438 · Firm income: Not reported

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

S.4449 Laboratory diagnostic services, schedule reimbursement. H.R.7213 Pharmacist equitable access, health equity. S.1909, H.R.3554 Pharmacy DIR Reform to Reduce Senior Drug Costs Act. H.R. 3258 Timely Access to Cancer Treatment.

Client expense: $810,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.1909, H.R.3554 Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.5376 The Inflation Reduction Act

Client expense: $810,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pre-approval information exchange - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. HR 7008/HR 7667/HR 9297/HR 2617 S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S. 3791/HR 7051 - Access to Prescription Digital Therapeutics Act of 2022 - to create a benefit category in Medicare and Medicaid for prescription digital therapeutics HR 7213 - Equitable Community Access to Pharmacy Services Act of 2022 - to reimburse certain COVID-19 care services provided by pharmacists under Medicare Part B

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pre-approval information exchange - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. HR 7008/HR 7667/HR 9297/HR 2617 S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S. 3791/HR 7051 - Access to Prescription Digital Therapeutics Act of 2022 - to create a benefit category in Medicare and Medicaid for prescription digital therapeutics HR 7213 - Equitable Community Access to Pharmacy Services Act of 2022 - to reimburse certain COVID-19 care services provided by pharmacists under Medicare Part B

Client expense: $90,000 · Firm income: Not reported

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

H.R. 3554 / S.1909 - Pharmacy DIR Reform To Reduce Senior Drug Costs Act Inflation Reduction Act Drug Provisions Pharmacy Direct and Indirect Remuneration Fee reform Pharmacy Benefit Manager (PBM) transparency Pharmacy quality measures Standardized pharmacy performance measures Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (CMS-4192-P) H.R.2617 - Consolidated Appropriations Act, 2023

Client expense: $391,438 · Firm income: Not reported

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

Issues related to medication adherence, drug pricing transparency, and COVID testing and vaccination, including the Federal Retail Pharmacy Program. S. 1909, The Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R. 7213, The Equitable Community Access to Pharmacist Services Act P.L. 117-328, FY2023 Consolidated Appropriations Act

Client expense: $3,790,000 · Firm income: Not reported

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

S.4449 Laboratory diagnostic services, schedule reimbursement. H.R.7213 Pharmacist equitable access, health equity. S.1909, H.R.3554 Pharmacy DIR Reform to Reduce Senior Drug Costs Act. H.R. 3258 Timely Access to Cancer Treatment.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.1909, H.R.3554 Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.5376 The Inflation Reduction Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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: $2,578,869 · 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)

Client expense: $2,578,869 · 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 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 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 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: $2,578,869 · 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

Inflation Reduction Act (H.R. 5376) Misc pharmacy benefit manager (PBM) issues including DIR fees, delaying cancer patients' treatments, step therapy (no specific bills) Pharmacy DIR Reform To Reduce Senior Drug Costs Act (S. 1909) Pharmacy Benefit Manager Transparency Act of 2022 (S. 4293) TACT Act (HR 3258) to ensure cancer patients get their oral cancer drugs from PBMs within 72 hours. Exposing hospitals not complying with HHS/CMS regulations to publish price transparency data. (no specific bills) Working on 340B legislation that ensures patients in need receive the discounts, not DSH hospital systems. Hospital and PBM consolidation. CMS/CMMI payment models, including the OCM and OCF. Inflation Reduction Act (HR 5376) CMMI Oncology Payment Reform

Client expense: $228,000 · Firm income: Not reported

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

H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals; S. 3700, the Affordable Insulin Now Act; H.R. 7213, Equitable Community Access to Pharmacist Services Act; CY 2023 Medicare Advantage and Part D Final Rule (CMS-4192-F); Draft legislation, the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; H.R. 5376, the Inflation Reduction Act of 2022; Draft legislation on pharmacy DIR fee reform

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Small Business Administration (SBA), White House Office

IPC supports The Pharmacy Benefit Manager Transparency Act of 2022 IPC supports S. 1909/H.R. 3554, the Pharmacy DIR Reform to Reduce Senior Drug Costs Act. Support regulations/laws that would eliminate pharmacy DIR. Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs(CMS-4192-P). Support with amendments. IPC supports Pharmacists as Providers under Medicare Part B. IPC supports Pharmacy and Medically Underserved Areas Enhancement Act, H.R. 2759/S. 1362 IPC supports Pharmacists as Immunizers IPC supports 340B Program and contract pharmacies IPC supports Federal Retail Pharmacy COVID-19 Vaccination Program expansion. IPC supports MCO Medicaid reform and elimination of spread pricing IPC supports FTC investigation into vertical PBM arrangements IPC is against decreased pharmacy reimbursement in the TRICARE program IPC is neutral and sought clarifications on the drug pricing provisions of the Inflation Reduction Act of 2022.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, White House Office

H.R. 3554 / S.1909 - Pharmacy DIR Reform To Reduce Senior Drug Costs Act H.R. 5376 - Build Back Better Act Pharmacy Direct and Indirect Remuneration Fee reform Pharmacy Benefit Manager (PBM) transparency Pharmacy quality measures Standardized pharmacy performance measures Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (CMS-4192-P)

Client expense: $272,776 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

Extend the moratorium on the application of the sequester cut to Medicare payments into 2022 (no specific bill) Misc pharmacy benefit manager (PBM) issues including DIR fees, delaying cancer patients' treatments, step therapy (no specific bills) Pharmacy DIR Reform To Reduce Senior Drug Costs Act (S 1909) Pharmacy Benefit Manager Transparency Act of 2022 (S. 4293) CMS proposed rule to reform PBM DIR fees TACT Act (HR 3258) to ensure cancer patients get their oral cancer drugs from PBMs within 72 hours. Exposing hospitals not complying with HHS/CMS regulations to publish price transparency data. (no specific bills) Working on 340B legislation that ensures patients in need receive the discounts, not DSH hospital systems. Hospital and PBM consolidation. CMS/CMMI payment models, including the OCM and OCF. Inflation Reduction Act (HR 5376) CMMI Oncology Payment Reform

Client expense: $178,000 · Firm income: Not reported

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

Issues related to medication adherence, drug pricing transparency, and COVID testing and vaccination, including the Federal Retail Pharmacy Program. S. 1909, The Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R. 7213, The Equitable Community Access to Pharmacist Services Act P.L. 117-169, The Inflation Reduction Act of 2022

Client expense: $1,620,000 · Firm income: Not reported

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

S.1909, H.R.3554 Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.5376 The Inflation Reduction Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.4449 Laboratory diagnostic services, schedule reimbursement. H.R.7213 Pharmacist equitable access, health equity. S.1909,H.R.3554 Pharmacy DIR Reform to Reduce Senior Drug Costs Act. H.R. 3258 Timely Access to Cancer Treatment.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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 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 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 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)

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

* H.R. 3173/S. 3018, the Improving Seniors Timely Access to Care Act of 2021. * H.R. 3554/S. 1909, the Pharmacy DIR Reform to Reduce Senior Drug Costs Act. * Issues related to Pharmacy Direct and Indirect Remuneration (DIR), including the Contract Year (CY) 2023 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit (Part D) Programs proposed rule. * Issues related to the Centers for Medicare & Medicaid Services Maryland Total Cost of Care Model.

Client expense: $2,940,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3554 / S.1909 - Pharmacy DIR Reform To Reduce Senior Drug Costs Act Inflation Reduction Act Drug Provisions Pharmacy Direct and Indirect Remuneration Fee reform Pharmacy Benefit Manager (PBM) transparency Pharmacy quality measures Standardized pharmacy performance measures Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (CMS-4192-P)

Client expense: $228,940 · Firm income: Not reported

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

Inform policymaker on issues related to H.R. 3173/S. 3018, the Improving Seniors' Timely Access to Care Act of 2021; H.R. 3554/S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Cost Act; and issues related to Pharmacy Direct and Indirect Remuneration (DIR), including Contract Year (CY) 2023 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit (Part D) Programs proposed rule.

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Cures 2.0 - This bill is in discussion draft form. Lobbying on issues in bill related to medication adherence, caregiver training, pre-approval information exchange, cell and gene therapies, digital therapeutics, and confirmatory studies for accelerated approval drugs. H.R. 7008 - Pre-approval information exchange act of 2022 - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S.2416 - NOVEL Act - A bill relating to the assignment of HCPCS codes and national coverage determinations for certain novel pharmaceutical products H.R. 7667 - PDUFA Reauthorization - lobbying for the inclusion of HR 7008 in HR 7667 and passage.

Client expense: $100,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1868 - To prevent across-the-board direct spending cuts, and for other purposes. The bill continues to exempt Medicare from sequestration until December 31, 2021. Cures 2.0 - Lobbying on issues in bill related to medication adherence, caregiver training, pre-approval information exchange, cell and gene therapies, digital therapeutics, and confirmatory studies for accelerated approval drugs. Pre-approval information exchange - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S.2416 - NOVEL Act - A bill relating to the assignment of HCPCS codes and national coverage determinations for certain novel pharmaceutical products

Client expense: $100,000 · Firm income: Not reported

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

H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals; S. 3700, the Affordable Insulin Now Act; H.R. 7213, Equitable Community Access to Pharmacist Services Act; CY 2023 Medicare Advantage and Part D Final Rule (CMS-4192-F); Draft legislation, the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act; H.R. 5376, the Inflation Reduction Act of 2022

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Small Business Administration (SBA), White House Office

IPC supports The Pharmacy Benefit Manager Transparency Act of 2022 IPC supports S. 1909/H.R. 3554, the Pharmacy DIR Reform to Reduce Senior Drug Costs Act. Support regulations/laws that would eliminate pharmacy DIR. Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs(CMS-4192-P). Support with amendments. IPC supports Pharmacists as Providers under Medicare Part B. IPC supports Pharmacy and Medically Underserved Areas Enhancement Act, H.R. 2759/S. 1362 IPC supports Pharmacists as Immunizers IPC supports 340B Program and contract pharmacies IPC supports Federal Retail Pharmacy COVID-19 Vaccination Program expansion. IPC supports MCO Medicaid reform and elimination of spread pricing IPC supports FTC investigation into vertical PBM arrangements IPC is against decreased pharmacy reimbursement in the TRICARE program IPC is neutral and sought clarifications on the drug pricing provisions of the Inflation Reduction Act of 2022.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE, White House Office

HR 1868 - To prevent across-the-board direct spending cuts, and for other purposes. The bill continues to exempt Medicare from sequestration until December 31, 2021. Cures 2.0 - Lobbying on issues in bill related to medication adherence, caregiver training, pre-approval information exchange, cell and gene therapies, digital therapeutics, and confirmatory studies for accelerated approval drugs. Pre-approval information exchange - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S.2416 - NOVEL Act - A bill relating to the assignment of HCPCS codes and national coverage determinations for certain novel pharmaceutical products

Client expense: $90,000 · Firm income: Not reported

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

Cures 2.0 - This bill is in discussion draft form. Lobbying on issues in bill related to medication adherence, caregiver training, pre-approval information exchange, cell and gene therapies, digital therapeutics, and confirmatory studies for accelerated approval drugs. H.R. 7008 - Pre-approval information exchange act of 2022 - lobbying for the introduction of a bill to codify FDA guidance creating a safe harbor for the practice of pre-approval information exchange between drug manufacturers and health plans. S.1909/HR. 3554 - A bill relating to direct and indirect remuneration in Medicare Part D. S. 1362 - Pharmacy and Medically Underserved Areas Enhancement Act - to provide for coverage under the Medicare program of pharmacist services S.2416 - NOVEL Act - A bill relating to the assignment of HCPCS codes and national coverage determinations for certain novel pharmaceutical products H.R. 7667 - PDUFA Reauthorization - lobbying for the inclusion of HR 7008 in HR 7667 and passage.

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General Medicare/Medicaid Issues,; Prescription Drug Price Reform. Transparency Requirements. Strategic National Stockpile. COVID-19 Response. Drug pricing and transparency, access and adherence H.R.3 and H.R.19,; The Improving Seniors' Timely Access to Care Act H.R.3173,; Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.1909 and H.R.3554,;The Safe Step Act H.R.2163 and S.464.

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

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

Pharmacy provider status, retail pharmacy H.R.2759 and S.1362,; Pharmacy DIR Reform to Reduce Senior Drug Costs Act S.1909 and H.R.3554,; Drug pricing and transparency, access and adherence H.R.3 and H.R.19

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to pharmacy provider status. H.R. 3554 / S. 1909; issues related to direct and indirect remuneration fees in Medicare. H.R. 7213 Equitable Community Access to Pharmacist Services Act; issues related to access to pharmacist services.

Client expense: $430,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.3554/S.1909 - Pharmacy DIR Reform To Reduce Senior Drug Costs Act. Medicaid pharmacy issues in H.R.5376 - Build Back Better Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

* Issues related to the Advance Notice of Methodological Changes for Calendar Year (CY) 2023 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies. * H.R. 3554/S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act. * H.R. 3173/S. 3018, the Improving Seniors Timely Access to Care Act of 2021. * H.R. 5376, Issues related to Medicaid coverage in the Build Back Better Act. * Issues related to Pharmacy Direct and Indirect Remuneration (DIR), including the Contract Year (CY) 2023 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit (Part D) Programs proposed rule. * Proposals that impact Medicare Part D such as formulary requirements, pharmacy benefit manager (PBM) disclosure provisions, closing the Part D coverage gap and direct negotiation of prescription drug prices. * S. 3593, Telehealth Extension and Evaluation Act. * Issues related to the Centers for Medicare & Medicaid Services Maryland Total Cost of Care Model.

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

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

Issues related to medication adherence, drug pricing transparency, and COVID testing and vaccination, including the Federal Retail Pharmacy Program. /S. 1909, The Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R. 7213, The Equitable Community Access to Pharmacist Services Act

Client expense: $1,470,000 · Firm income: Not reported

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

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)

Client expense: $1,457,755 · 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.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)

Client expense: $1,457,755 · 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 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: $1,457,755 · 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

H.R. 3554 / S.1909 - Pharmacy DIR Reform To Reduce Senior Drug Costs Act H.R. 5376 - Build Back Better Act Pharmacy Direct and Indirect Remuneration Fee reform Pharmacy Benefit Manager (PBM) transparency Pharmacy quality measures Standardized pharmacy performance measures Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (CMS-4192-P)

Client expense: $242,618 · Firm income: Not reported

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

Inform policymaker on issues related to the Advance Notice of Methodological Changes for Calendar Year (CY) 2023 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies; H.R. 3554/S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; Issues related to Pharmacy Direct and Indirect Remuneration (DIR), including the Contract Year (CY) 2023 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit (Part D) Programs proposed rule; Proposals that impact Medicare Part D such as formulary requirements, pharmacy benefit manager (PBM) disclosure provisions, closing the Part D coverage gap and direct negotiation of prescription drug prices; S. 3593, Telehealth Extension and Evaluation Act.

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Extend the moratorium on the application of the sequester cut to Medicare payments into 2022 (no specific bill) Misc pharmacy benefit manager (PBM) issues including DIR fees, delaying cancer patients' treatments, step therapy (no specific bills) Pharmacy DIR Reform To Reduce Senior Drug Costs Act (S 1909) Pharmacy Benefit Manager Transparency Act of 2022 (S. 4293) CMS proposed rule to reform PBM DIR fees TACT Act (HR 3258) to ensure cancer patients get their oral cancer drugs from PBMs within 72 hours. Exposing hospitals not complying with HHS/CMS regulations to publish price transparency data. (no specific bills) Working on 340B legislation that ensures patients in need receive the discounts, not DSH hospital systems. Hospital and PBM consolidation. CMS/CMMI payment models, including the OCM and OCF.

Client expense: $146,500 · Firm income: Not reported

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

H.R. 3554 / S. 1909, the Pharmacy DIR Reform To Reduce Senior Drug Costs Act; H.R. 2608, the Ensuring Seniors Access to Local Pharmacies Act; H.R. 2759 / S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 3682, the Improving Transparency to Lower Drug Costs Act; H.R. 2484, the Lowest Price for Patients Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 / S. 2164, the Lower Costs, More Cures Act of 2021; H.R. 3173, the Improving Seniors Timely Access to Care Act of 2021; H.R. 4121, the PRO Seniors Act; Proposed inclusion of Medicaid managed care spread pricing prohibition to pay for H.R. 3684, the Infrastructure Investment and Jobs Act; H.R. 5237, the Reduced Costs and Continued Cures Act of 2021 H.R. 5376, the Build Back Better Act; H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act of 2021; H.R. 6101, the Drug Price Transparency in Medicaid Act of 2021; Part B billing and COVID oral antivirals; S. 3700, the Affordable Insulin Now Act; H.R. 7213, Equitable Community Access to Pharmacist Services Act; CY 2023 Medicare Advantage and Part D Proposed Rule (CMS-4192-P); Draft legislation, the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act

Client expense: $460,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Small Business Administration (SBA), White House Office