Providing Realistic Opportunity To Equal and Comparable Treatment for Rare Act

Reimbursement for hemophilia services and treatments in Medicare Reimbursement for hemophilia services and treatments in Medicaid Issues related to 1115 Waivers in Medicaid Preserving and expanding access to Medicaid Providing Realistic Opportunity to Equal and Comparable Treatment (PROTECT) for Rare Act (H.R. 6094) The Menstrual Equity for All Act (H.R. 3646) Medicaid VBPs for Patients (MVP) Act (H.R. 2666/S.4204) Accelerating Kids Access to Care Act (S. 2372)

Client expense: Not reported · Firm income: $50,000

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

Implementation of the Inflation Reduction Act of 2022; Issues related to protecting patient access to medicines in Medicare; Issues related to access to medicines for Parkinson's disease patients; Issues Related to Antipsychotic use in Medicaid (HR 4096); Orphan Cures Act (HR 5539 / S 3131); National Plan to End Parkinson's Act (HR 2365 / S 1064); Protect Rare Act (HR 6094); EPIC Act (HR 7174); BIOSECURE Act (HR 7085); The Mini Act (HR 5547 / S 476).

Client expense: $510,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Inflation Reduction Act of 2022; Issues Related to the Orphan Drug Tax Credit; Help Copays Act (HR 830 / S 1375); Orphan Cures Act (HR 5539 / S 3131); National Plan to End Parkinson's Act (HR 2365 / S 1064); Protect Rare Act (HR 6094); The Creating Hope Reauthorization Act (HR 7384 / S 4583) / HR 3433); BIOSECURE Act (HR 7085); The American Recovery Act (HR 10545).

Client expense: $510,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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: $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

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

H.R. 5547, Maintaining Investments in New Innovation (MINI) Act H.R.7174, Ensuring Pathways to Innovative Cures (EPIC) Act H.R. 6094, Providing Realistic Opportunity To Equal and Comparable Treatment for (PROTECT) Rare Act H.R. 6664, Innovation in Pediatric Drugs Act H.R. 7384, Creating Hope Reauthorization Act H.R. 7383, Retaining Access and Restoring Exclusivity (RARE) Act H.R.7024, Tax Relief for American Families and Workers Act of 2024 H.R.3433 / S.2897, Give Kids a Chance Act

Client expense: $150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Newborn Screening Save Lives Reauthorization Act; Telehealth; Appropriations; S. 526, H.R. 1092 - Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT Act); Access to Genetic Counselor Services Act; Precision Medicine Answers for Kids Today Act (PMAKTA); MVP Act; H.R. 830 - HELP Copays Act; Safe Step Act; Accelerating Kids Access to Care Act; Technical corrections to the IRA; H.R. 6094 - PROTECT Rare Act; H.R. 7384, S. 4583 - Creating Hope Reauthorization Act; H.R. 7383, S. 1214 - RARE Act; H.R. 3433 - Give Kids a Chance Act of 2023; H.R. 6664 - Innovation in Pediatric Drugs Act of 2023; H.R. 9979 - Scientific External Process for Educated Review of Therapeutics (EXPERT) Act of 2024; H.R. 3433 - Give Kids a Chance Act

Client expense: $20,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Inflation Reduction Act of 2022; Help Copays Act (HR 830 / S 1375); Orphan Cures Act (HR 5539 / S 3131); National Plan to End Parkinson's Act (HR 2365 / S 1064); Protect Rare Act (HR 6094); The Creating Hope Reauthorization Act (HR 7384 / S 4583) / HR 3433); BIOSECURE Act (HR 7085).

Client expense: $220,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Inflation Reduction Act of 2022; Issues related to protecting patient access to medicines in Medicare; Issues related to access to medicines for Parkinson's disease patients; Issues Related to Antipsychotic use in Medicaid (HR 4096); Orphan Cures Act (HR 5539 / S 3131); National Plan to End Parkinson's Act (HR 2365 / S 1064); Protect Rare Act (HR 6094); EPIC Act (HR 7174); BIOSECURE Act (HR 7085).

Client expense: $220,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2666: MEDICAID VBPS FOR PATIENTS ACT (MVP ACT); ALL PROVISIONS OF THE BILL HR 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS OF THE BILL HR 6094: PROVIDING REALISTIC OPPORTUNITY TO EQUAL AND COMPARABLE TREATMENT FOR RARE ACT (PROTECT RARE ACT); ALL PROVISIONS OF THE BILL S 4204: MEDICAID VBPS FOR PATIENTS ACT (MVP ACT); ALL PROVISIONS OF THE BILL S 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING MEDICAID ACCESS TO RARE DISEASE THERAPIES AND ACCESS TO OUT OF STATE PROVIDER TELEHEALTH

Client expense: $240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitored issues regarding PPS exempt hospitals. Issues concerning reimbursement for hospital services. Issues regarding hospital transparency. Monitored H.R.2389 / S. 1302, Resident Physician Shortage Reduction Act of 2023. H.R. 977, Patient Access to Higher Quality Health Care Act of 2023. Issues regarding healthcare sector consolidation. H.R. 5378, the Lower Costs, More Transparency Act, as it relates to hospitals. Issues concerning drug shortages. Issues involving the extension of the Acute Care Hospital at Home program. H.R. 6213, National Quantum Initiative Reauthorization Act. Monitored H.R.5159 / S. 2137, the Preserving Access to Home Health Care Act of 2023. Issues related to telehealth. H.R. 4758 / S. 2372, Accelerating Kids Access to Care Act. H.R. 6094, Providing Realistic Opportunity to Equal and Comparable Treatments (PROTECT) Rare Act. Issues concerning cybersecurity. H.R. 8261, Preserving Telehealth, Hospital, and Ambulance Access Act. Issues regarding the IOTA Model proposed rule.

Client expense: Not reported · Firm income: $40,000

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

H.R. 5547, Maintaining Investments in New Innovation (MINI) Act H.R.7174 Ensuring Pathways to Innovative Cures (EPIC) Act H.R. 6094, Providing Realistic Opportunity To Equal and Comparable Treatment for (PROTECT) Rare Act H.R. 6664, Innovation in Pediatric Drugs Act H.R. 7384, Creating Hope Reauthorization Act H.R. 7383, Retaining Access and Restoring Exclusivity (RARE) Act H.R.7024 - Tax Relief for American Families and Workers Act of 2024

Client expense: $150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Gene therapies; Prescription drug affordability 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, the Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] 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] 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.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS]

Client expense: $1,910,000 · 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

Gene therapies; Prescription drug affordability 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. Comyn, John [R-TX] H.R. 6094 - PROTECT Rare Act To amend titles XVlll and XIX of the Social Security Act and title XXVll of the Public Health Service Act to refine the set of information sources for detennining 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 0. [D-CA-7] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS]

Client expense: $269,075 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Gene therapies; Prescription drug affordability S. 775, the Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] 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. Comyn, John [R-TX] H.R. 6094 - PROTECT Rare Act To amend titles XVlll and XIX of the Social Security Act and title XXVll 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 0. [D-CA-7] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS]

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

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]

Client expense: $31,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Newborn Screening Save Lives Reauthorization Act; Telehealth; Appropriations; S. 526, H.R. 1092 - Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT Act); Access to Genetic Counselor Services Act; Precision Medicine Answers for Kids Today Act (PMAKTA); MVP Act; H.R. 830 - HELP Copays Act; Safe Step Act; Accelerating Kids Access to Care Act; Technical corrections to the IRA; H.R. 6094 - PROTECT Rare Act; H.R. 7384, S. 4583 - Creating Hope Reauthorization Act; H.R. 7383, S. 1214 - RARE Act; H.R. 3433 - Give Kids a Chance Act of 2023; H.R. 6664 - Innovation in Pediatric Drugs Act of 2023

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Gene Therapies; Prescription Drug Affordability 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. HR 9070, Affordable Prescriptions for Patients Act of 2024, by Rep. Darrell Issa (R-CA). To amend title 35, United States Code, to prohibit product hopping. 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. S 775, Increasing Transparency in Generic Drug Applications Act, by Sen. Margaret Hassan (D-NH). To provide for increased transparency in generic drug applications. S 1542, DRUG Act, by Sen. Roger Marshall (R-KS). To improve services provided by pharmacy benefit managers.

Client expense: $20,000 · 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

Gene Therapies; Prescription Drug Affordability 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. HR 9070, Affordable Prescriptions for Patients Act of 2024, by Rep. Darrell Issa (R-CA). To amend title 35, United States Code, to prohibit product hopping. 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. S 775, Increasing Transparency in Generic Drug Applications Act, by Sen. Margaret Hassan (D-NH). To provide for increased transparency in generic drug applications. S 1542, DRUG Act, by Sen. Roger Marshall (R-KS). To improve services provided by pharmacy benefit managers.

Client expense: $220,000 · 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

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]

Client expense: $1,430,000 · 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

HR 2666: MEDICAID VBPS FOR PATIENTS ACT (MVP ACT); ALL PROVISIONS OF THE BILL HR 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS OF THE BILL HR 6094: PROVIDING REALISTIC OPPORTUNITY TO EQUAL AND COMPARABLE TREATMENT FOR RARE ACT (PROTECT RARE ACT); ALL PROVISIONS OF THE BILL S 4204: MEDICAID VBPS FOR PATIENTS ACT (MVP ACT); ALL PROVISIONS OF THE BILL S 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING MEDICAID ACCESS TO RARE DISEASE THERAPIES AND ACCESS TO OUT OF STATE PROVIDERS

Client expense: $180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Reimbursement for hemophilia services and treatments in Medicare Reimbursement for hemophilia services and treatments in Medicaid Implementation of the Hemophilia SNF Access Act Coverage for Telehealth Services Closing the Medicaid coverage gap Issues related to 1115 Waivers in Medicaid Medicaid unwinding, the process for redetermination of Medicaid eligibility Preserving and expanding access to Medicaid Sickle Cell Disease Comprehensive Care Act (H.R. 1672/S.996) PROTECT Rare Act (H.R. 6094) MVP Act (H.R. 2666)

Client expense: Not reported · Firm income: $50,000

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

Monitored issues regarding PPS exempt hospitals. Issues concerning reimbursement for hospital services. Issues regarding hospital transparency. Monitored H.R.2389 / S. 1302, Resident Physician Shortage Reduction Act of 2023. H.R. 977, Patient Access to Higher Quality Health Care Act of 2023. Issues regarding healthcare sector consolidation. H.R. 5378, the Lower Costs, More Transparency Act, as it relates to hospitals. Issues concerning drug shortages. Issues involving the extension of the Acute Care Hospital at Home program. H.R. 6213, National Quantum Initiative Reauthorization Act. Monitored H.R.5159 / S. 2137, the Preserving Access to Home Health Care Act of 2023. Issues related to telehealth. H.R. 4758 / S. 2372, Accelerating Kids Access to Care Act. H.R. 6094, Providing Realistic Opportunity to Equal and Comparable Treatments (PROTECT) Rare Act. Issues concerning cybersecurity. H.R. 8261, Preserving Telehealth, Hospital, and Ambulance Access Act.

Client expense: Not reported · Firm income: $40,000

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

Implementation of the Inflation Reduction Act of 2022; Help Copays Act (HR 830 / S 1375); Orphan Cures Act (HR 5539 / S 3131); National Plan to End Parkinson's Act (HR 2365 / S 1064); Protect Rare Act (HR 6094); The Creating Hope Reauthorization Act (HR 7384 / S 4583); Protecting and Preserving Social Security Act (S 4583).

Client expense: $450,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Inflation Reduction Act of 2022; Issues related to protecting patient access to medicines in Medicare; Issues related to access to medicines for Parkinson's disease patients; Issues Related to Antipsychotic use in Medicaid (HR 4096); Orphan Cures Act (HR 5539 / S 3131); National Plan to End Parkinson's Act (HR 2365 / S 1064); Protect Rare Act (HR 6094); EPIC Act (HR 7174).

Client expense: $450,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the development of therapies for rare diseases: drug pricing; Medicare and Medicaid; R&D tax expensing. H.R. 5547, Maintaining Investments in New Innovation (MINI) Act H.R.7174 Ensuring Pathways to Innovative Cures (EPIC) Act H.R. 6094, Providing Realistic Opportunity To Equal and Comparable Treatment for (PROTECT) Rare Act H.R. 6664, Innovation in Pediatric Drugs Act H.R. 7384, Creating Hope Reauthorization Act H.R. 7383, Retaining Access and Restoring Exclusivity (RARE) Act H.R.7024 - Tax Relief for American Families and Workers Act of 2024

Client expense: $150,000 · Firm income: Not reported

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]

Client expense: $31,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6664 - Innovation in Pediatric Drugs Act of 2023 H.R.7384 - Creating Hope Reauthorization Act of 2024 H.Res.1307 - Expressing support for the designation of June 20, 2024, as "World FSHD Day". H.R. 7432, Sickle Cell Disease Comprehensive Care Act H.R. 7384, Creating Hope Reauthorization Act of 2024 S. 652, Safe Step Act H.R.1092, Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 S. 1852, Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023 H.R. 830/S. 1375, HELP Copays Act H.R. 883/S. 320, Stop the Wait Act of 2023 H.R. 4758/S.2372, Accelerating Kids Access to Care Act H.R. 6094, Providing Realistic Opportunity To Equal and Comparable Treatment for (PROTECT) Rare Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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.

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

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.

Client expense: $240,000 · 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

Newborn Screening Save Lives Reauthorization Act; Telehealth; Appropriations; S. 526, H.R. 1092 - Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT Act); Access to Genetic Counselor Services Act; Precision Medicine Answers for Kids Today Act (PMAKTA); MVP Act; H.R. 830 - HELP Copays Act; Safe Step Act; Accelerating Kids Access to Care Act; Technical corrections to the IRA; H.R. 6094 - PROTECT Rare Act; H.R. 7384, S. 4583 - Creating Hope Reauthorization Act; H.R. 7383, S. 1214 - RARE Act; H.R. 3433 - Give Kids a Chance Act of 2023; H.R. 6664 - Innovation in Pediatric Drugs Act of 2023

Client expense: $50,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Reimbursement for hemophilia services and treatments in Medicare Reimbursement for hemophilia services and treatments in Medicaid Implementation of the Hemophilia SNF Access Act Coverage for Telehealth Services Closing the Medicaid coverage gap Issues related to 1115 Waivers in Medicaid Medicaid unwinding, the process for redetermination of Medicaid eligibility Preserving and expanding access to Medicaid Sickle Cell Disease Comprehensive Care Act (H.R. 1672/S.996) PROTECT Rare Act (H.R. 6094) MVP Act (H.R. 2666) Comments Re: Medicaid; CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements Under Section 1902(t) of the Social Security Act (CMS-2447-IFC) Comments RE: Notice of Benefit and Payment Parameters for 2025 Proposed Rule (CMS-9895-P). Comments Re: Proposed Rescission of Association Health Plan Final Rule (RIN 1210-AC16)

Client expense: Not reported · Firm income: $50,000

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

Monitored issues regarding PPS exempt hospitals. Issues concerning hospital reimbursement for services. Issues regarding hospital transparency. Monitored H.R. 2389 / S. 1302, Resident Physician Shortage Reduction Act of 2023. H.R. 977, Patient Access to Higher Quality Health Care Act of 2023. Issues regarding health care sector consolidation. H.R. 5378, the Lower Costs, More Transparency Act, as it relates to hospitals. Issues concerning drug shortages. Issues involving the extension of the Acute Care Hospital at Home program. H.R. 6213, National Quantum Initiative Reauthorization Act. Monitored H.R.5159 / S. 2137, the Preserving Access to Home Health Care Act of 2023. Issues related to telehealth. H.R.2872, Further Additional Continuing Appropriations and Other Extensions Act, 2024, as it relates to the Medicaid Disproportionate Share hospital payments. H.R.4366, Consolidated Appropriations Act, 2024, as it relates to Medicaid Disproportionate Share hospital payments and hospital reimbursement. H.R.2882, Further Consolidated Appropriations Act, 2024, as it relates to hospitals. H.R. 4758/S. 2372, Accelerating Kids Access to Care Act. H.R. 6094, Providing Realistic Opportunity to Equal and Comparable Treatments (PROTECT) Rare Act.

Client expense: Not reported · Firm income: $40,000

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

Client expense: $1,940,000 · 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

Newborn Screening Save Lives Reauthorization Act; Telehealth; Appropriations; S. 526, H.R. 1092 - Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT Act); Access to Genetic Counselor Services Act; Precision Medicine Answers for Kids Today Act (PMAKTA); MVP Act; H.R. 830 - HELP Copays Act; Safe Step Act; Accelerating Kids Access to Care Act; Technical corrections to the IRA; H.R. 6094 - PROTECT Rare Act; H.R. 7384 - Creating Hope Reauthorization Act; H.R. 7383; S. 1214 - RARE Act

Client expense: $20,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Inflation Reduction Act of 2022; Help Copays Act (HR 830 / S. 1375); Orphan Cures Act (HR 5539 / S. 3131); National Plan to End Parkinson's Act (HR 2365 / S. 1064); Protect Rare Act (HR 6094); The Creating Hope Act (HR 7384).

Client expense: $250,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Inflation Reduction Act of 2022; Issues related to protecting patient access to medicines in Medicare; Issues related to access to medicines for Parkinson's disease patients; Issues Related to Antipsychotic use in Medicaid (HR 4096); Orphan Cures Act (HR 5539 / S. 3131); National Plan to End Parkinson's Act (HR 2365 / S. 1064); Protect Rare Act (HR 6094); EPIC Act (HR 7174).

Client expense: $250,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2666: MEDICAID VBPS FOR PATIENTS (MVP) ACT; ALL PROVISIONS OF THE BILL HR 5539: OPTIMIZING RESEARCH PROGRESS HOPE AND NEW CARES ACT (ORPHAN CURES ACT); ALL PROVISIONS OF THE BILL HR 6094: PROVIDING REALISTIC OPPORTUNITY TO EQUAL AND COMPARABLE TREATMENT FOR RARE ACT (PROTECT RARE ACT); ALL PROVISIONS OF THE BILL S 3131: OPTIMIZING RESEARCH PROGRESS HOPE AND NEW CARES ACT (ORPHAN CURES ACT); ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING MEDICAID ACCESS TO RARE DISEASE THERAPIES

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Reimbursement for hemophilia services and treatments in Medicare Reimbursement for hemophilia services and treatments in Medicaid Implementation of the Hemophilia SNF Access Act Coverage for Telehealth Services Closing the Medicaid coverage gap Issues related to 1115 Waivers in Medicaid Medicaid unwinding, the process for redetermination of Medicaid eligibility Preserving and expanding access to Medicaid Sickle Cell Disease Comprehensive Care Act (H.R. 1672/S.996) PROTECT Rare Act (H.R. 6094) MVP Act (H.R. 2666)

Client expense: Not reported · Firm income: $50,000

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

Implementation of the Inflation Reduction Act of 2022; Help Copays Act (HR 830 / S. 1375); Orphan Cures Act (HR 5539); Issues related to rare disease research incentives; National Plan to End Parkinson's Act (HR 2365 / S. 1064); Protect Rare Act (HR 6094).

Client expense: $240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Inflation Reduction Act of 2022; Six Protected Classes: Issues related to protecting patient access to medicines in Medicare; Nursing Home Quality: Issues related to access to medicines for Parkinson's disease patients; HR 4096 - Issues Related to Antipsychotic use in Medicaid; HR 5539 - Orphan Cures Act; HR 2365 / S. 1064 - National Plan to End Parkinson's Act; HR 6094 - Protect Rare Act.

Client expense: $240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Newborn Screening Save Lives Reauthorization Act; Telehealth; Appropriations; S. 526, H.R. 1092 - Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT Act); Access to Genetic Counselor Services Act; Precision Medicine Answers for Kids Today Act (PMAKTA); MVP Act; H.R. 830 - HELP Copays Act; Safe Step Act; Accelerating Kids Access to Care Act; Technical corrections to the IRA; H.R. 6094 - PROTECT Rare Act

Client expense: $20,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE