EPCS 2.0 Act

340B Program/Transparency; generics access; Clinical Trial Diversity S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] H.R.6094 - Providing Realistic Opportunity To Equal and Comparable Treatment (PROTECT) for Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.4741 - PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Sen. Tillis, Thomas [R-NC] HR 6465 PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Rep. Hudson, Richard [R-NC-9] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] H.R.1359 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Rep. Norcross, Donald [D-NJ-1] S.644 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Sen. Markey, Edward J. [D-MA]

Client expense: $140,000 · 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), SENATE, White House Office

Issues Generics access; Cell & Gene therapy; Step Therapy Bills H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] " S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] H.R. 6094 - PROTECT Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S. 142 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Amy Klobuchar (D-MN) S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS]

Electronic Prescribing of Controlled Substances (EPCS) legislation. Issues relating to patient identification. Issues pertaining to Cybersecurity. Health Information Technology issues. H.R.7312 - Electronic Prescribing for Controlled Substances Act. H.R.7379 - Patient Matching And Transparency in Certified Health IT Act of 2024.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Covid Therapeutics; Cell & Gene therapy; Step Therapy H.R.5372 - Expanding Seniors' Access to Lower Cost Medicines Act of2023 -To amend Title XVlll of the Social Security Act to facilitate midyear formulary changes for biosimilars. -Sponsor: Rep. Joyce, John [R-PA-13] H.R.7312 - EPCS 2.0 Act -To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. -Sponsor: Rep. Kuster, Ann M. [D-NH-2] H.R.5376 - Inflation Reduction Act of2022 -Prescription Drug Pricing Refonn -Sponsor: Rep. Yarmuth, John A. [D-KY-3]

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Generics access; Cell & Gene therapy; Step Therapy H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] " S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] H.R. 6094 - PROTECT Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S. 142 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Amy Klobuchar (D-MN) S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA]

Electronic Prescribing of Controlled Substances (EPCS) legislation. Issues relating to patient identification. Issues pertaining to Cybersecurity. Health Information Technology issues. H.R.7312 - Electronic Prescribing for Controlled Substances Act. H.R.7379 - Patient Matching And Transparency in Certified Health IT Act of 2024.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues Generics access; Cell & Gene therapy; Step Therapy Bills H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] " S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] H.R. 6094 - PROTECT Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S. 142 - Preserve Access to Affordable Generics and Biosimilars Act A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Amy Klobuchar (D-MN) S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS]

Generics Access; Cell and Gene Therapy; Step Therapy HR 6094, PROTECT Rare Act, by Rep. Doris Matsui (D-CA). To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. HR 7312, EPCS 2.0 Act, by Rep. Ann Kuster (D-NH). To provide requirements for electronic prescribing for controlled substances under group health plans and group and individual health insurance coverage. S 127, Pharmacy Benefit Manager Transparency Act of 2023, by Sen. Maria Cantwell (D-WA). To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. S 142, Preserve Access to Affordable Generics and Biosimilars Act, by Sen. Amy Klobuchar (D-MN). A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. S 148, Stop STALLING Act, by Sen. Amy Klobuchar (D-MN). A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. S 150, Affordable Prescriptions for Patients Act of 2023, by Sen. John Cornyn (R-TX). To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. S 1114, Expanding Access to Low-Cost Generics Act, by Sen. Tina Smith (D-MN). To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. S 1339, Pharmacy Benefit Manager Reform Act, by Sen. Bernie Sanders (I-VT). To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. S 1542, DRUG Act, by Sen. Roger Marshall (R-KS). To improve services provided by pharmacy benefit managers. S 2305, Biosimilar Red Tape Elimination Act, by Sen. Mike Lee (R-UT). To improve the requirements for making a determination of interchangeability of a biological product and its reference product. S 2666, EPCS 2.0 Act, by Sen. Margaret Wood Hassan (D-NH). To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage.

Generics Access; Cell and Gene Therapy; Step Therapy HR 6094, PROTECT Rare Act, by Rep. Doris Matsui (D-CA). To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. HR 7312, EPCS 2.0 Act, by Rep. Ann Kuster (D-NH). To provide requirements for electronic prescribing for controlled substances under group health plans and group and individual health insurance coverage. S 127, Pharmacy Benefit Manager Transparency Act of 2023, by Sen. Maria Cantwell (D-WA). To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. S 142, Preserve Access to Affordable Generics and Biosimilars Act, by Sen. Amy Klobuchar (D-MN). A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. S 148, Stop STALLING Act, by Sen. Amy Klobuchar (D-MN). A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. S 150, Affordable Prescriptions for Patients Act of 2023, by Sen. John Cornyn (R-TX). To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. S 1114, Expanding Access to Low-Cost Generics Act, by Sen. Tina Smith (D-MN). To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. S 1339, Pharmacy Benefit Manager Reform Act, by Sen. Bernie Sanders (I-VT). To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. S 1542, DRUG Act, by Sen. Roger Marshall (R-KS). To improve services provided by pharmacy benefit managers. S 2305, Biosimilar Red Tape Elimination Act, by Sen. Mike Lee (R-UT). To improve the requirements for making a determination of interchangeability of a biological product and its reference product. S 2666, EPCS 2.0 Act, by Sen. Margaret Wood Hassan (D-NH). To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage.

H.R. 547/S. 100, Better Care Better Jobs Act H.R. 1770/S. 2477, Equitable Community Access to Pharmacist Services Act H.R. 5013/S. 3503, Value in Health Care Act H.R. 7050, Substance Use Disorder Workforce Act H.R. 7312/S. 2666, Electronic Prescribing for Controlled Substances 2.0 Act H.R. 7623/S. 3967, Telehealth Modernization Act H.R. 7856/S. 4094, PREVENT DIABETES Act H.R. 8261, Preserving Telehealth, Hospital, and Ambulance Access Act CMS-2434-F: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program

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

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

H.R. 7050, Substance Use Disorder Workforce Act H.R. 7312, Electronic Prescribing for Controlled Substances 2.0 Act S. 2666, Electronic Prescribing for Controlled Substances Act

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Electronic Prescribing of Controlled Substances (EPCS) legislation. Issues relating to patient identification. Issues pertaining to Cybersecurity. Health Information Technology issues. S.2666/H.R.7312 - EPCS 2.0 Act. Patient Matching.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Covid Therapeutics; Cell & Gene therapy; Step Therapy H.R.5372 - Expanding Seniors' Access to Lower Cost Medicines Act of 2023 To amend Title XVIII of the Social Security Act to facilitate midyear formulary changes for biosimilars. Sponsor: Rep. Joyce, John [R-PA-13] H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] H.R.5376 - Inflation Reduction Act of 2022 Prescription Drug Pricing Reform Sponsor: Rep. Yarmuth, John A. [D-KY-3] S. 1067 Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] " S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] HR 6094 PROTECT Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7]

Covid Therapeutics; Cell & Gene therapy; Step Therapy H.R.5372 - Expanding Seniors' Access to Lower Cost Medicines Act of2023 -To amend Title XVlll of the Social Security Act to facilitate midyear formulary changes for biosimilars. -Sponsor: Rep. Joyce, John [R-PA-13] H.R.7312 - EPCS 2.0 Act -To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. -Sponsor: Rep. Kuster, Ann M. [D-NH-2] H.R.5376 - Inflation Reduction Act of2022 -Prescription Drug Pricing Refonn -Sponsor: Rep. Yarmuth, John A. [D-KY-3]

Client expense: $10,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

COVID Therapeutics; Cell and Gene Therapy; Step Therapy HR 5372 (118th Congress), Expanding Seniors' Access to Lower Cost Medicines Act of 2023, by Rep. John Joyce (R-PA). To amend Title XVIII of the Social Security Act to facilitate midyear formulary changes for biosimilars. HR 5376 (117th Congress), Inflation Reduction Act of 2022, by Rep. John Yarmuth (D-KY). Requires the Centers for Medicare & Medicaid Services (CMS) to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. HR 7312 (118th Congress), EPCS 2.0 Act, by Rep. Ann Kuster (D-NH). To provide requirements for electronic prescribing for controlled substances under group health plans and group and individual health insurance coverage.

Client expense: $10,000 · 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), SENATE, White House Office

COVID Therapeutics; Cell and Gene Therapy; Step Therapy HR 5372 (118th Congress), Expanding Seniors' Access to Lower Cost Medicines Act of 2023, by Rep. John Joyce (R-PA). To amend Title XVIII of the Social Security Act to facilitate midyear formulary changes for biosimilars. HR 5376 (117th Congress), Inflation Reduction Act of 2022, by Rep. John Yarmuth (D-KY). Requires the Centers for Medicare & Medicaid Services (CMS) to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. HR 7312 (118th Congress), EPCS 2.0 Act, by Rep. Ann Kuster (D-NH). To provide requirements for electronic prescribing for controlled substances under group health plans and group and individual health insurance coverage.

Client expense: $210,000 · 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), SENATE, White House Office

H.R. 766/S. 114, Preventive Health Savings Act H.R. 1310, States Handling Access to Reciprocity for Employment Act H.R. 1770/S. 2477, Equitable Community Access to Pharmacist Services Act H.R. 2940/S. 1355, Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act H.R. 5013, Value in Health Care Act H.R. 5762, Health Communication Access and Resources for Everyone Act H.R. 5829, Health Care Practitioner Disaster Protection Act H.R. 6033, Supporting Patient Education and Knowledge H.R. 6205/S. 3211, Healthcare Workforce Resilience Act H.R. 7050, Substance Use Disorder Workforce Act H.R. 7153/S. 3679, Dr. Lorna Breen Health Care Provider Protection Act H.R. 7165/S. 3702, Credit for Caring Act H.R. 7312, Electronic Prescribing for Controlled Substances 2.0 Act S. 2666, Electronic Prescribing for Controlled Substances Act S. 3393, SUPPORT for Patients and Communities Reauthorization Act OIG-1123-N: Solicitation of Proposals for New and Modified Safe Harbors and Special Fraud Alerts CMS-2024-0006: Advance Notice of Methodological Changes for Calendar Year 2025 for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies CMS-2447-IFC: CMS Enforcement of State Compliance With Reporting and Federal Medicaid Renewal Requirements Under Section 1902(tt) of the Social Security Act CMS-4205-P: Medicare Program; Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation Specifications CMS-9895-P: HHS Patient Protection and Affordable Care Act; Notice of Benefit and Payment Parameters for 2025 Incorporate Patient Perspectives Throughout Medicare Drug Price Negotiation Implementation Process Medicare Prescription Payment Plan: Draft Part Two Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025, and Solicitation of Comments Revised Section 1332 State Innovation Waiver Application NIST Docket ID No. 230831-0207: Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights

H.R. 766/S. 114, Preventive Health Savings Act H.R. 1310, States Handling Access to Reciprocity for Employment Act H.R. 1770/S. 2477, Equitable Community Access to Pharmacist Services Act H.R. 2940/S. 1355, Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act H.R. 5013, Value in Health Care Act H.R. 5762, Health Communication Access and Resources for Everyone Act H.R. 5829, Health Care Practitioner Disaster Protection Act H.R. 6033, Supporting Patient Education and Knowledge H.R. 6205/S. 3211, Healthcare Workforce Resilience Act H.R. 7050, Substance Use Disorder Workforce Act H.R. 7153/S. 3679, Dr. Lorna Breen Health Care Provider Protection Act H.R. 7165/S. 3702, Credit for Caring Act H.R. 7312, Electronic Prescribing for Controlled Substances 2.0 Act S. 2666, Electronic Prescribing for Controlled Substances Act S. 3393, SUPPORT for Patients and Communities Reauthorization Act OIG-1123-N: Solicitation of Proposals for New and Modified Safe Harbors and Special Fraud Alerts CMS-2024-0006: Advance Notice of Methodological Changes for Calendar Year 2025 for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies CMS-2447-IFC: CMS Enforcement of State Compliance With Reporting and Federal Medicaid Renewal Requirements Under Section 1902(tt) of the Social Security Act CMS-4205-P: Medicare Program; Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation Specifications CMS-9895-P: HHS Patient Protection and Affordable Care Act; Notice of Benefit and Payment Parameters for 2025 Incorporate Patient Perspectives Throughout Medicare Drug Price Negotiation Implementation Process Medicare Prescription Payment Plan: Draft Part Two Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025, and Solicitation of Comments Revised Section 1332 State Innovation Waiver Application NIST Docket ID No. 230831-0207: Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights

H.R. 7050, Substance Use Disorder Workforce Act H.R. 7312, Electronic Prescribing for Controlled Substances 2.0 Act S. 2666, Electronic Prescribing for Controlled Substances Act

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE