SMART Prices Act

Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting, reduced reimbursement rates, and restrictions on beneficiary choice and plan or provider competition in government health programs or private insurance plans H.R. 485 (Protecting Health Care for All Patients Act) S. 1246/S. 1264 (Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act) Senate HELP Committees 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act, Sec. 601, BARDA reasonable pricing requirements, and Sec. 602, CDC reasonable pricing requirements, other contemplated "reasonable pricing price controls and patent prize schemes Repeal of Inflation Reduction Act (IRA), Sec. 5000D, drug price controls product price negotiation and 95% inflation penalty and IRA implementation

Client expense: Not reported · Firm income: $19,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 830/S 1375 - HELP Copays Act S 127 - Pharmacy Benefit Manager Transparency Act HR 2630/ S 652 - Safe Step Act HR 1770/S 2477 - Equitable Community Access to Pharmacist Services Act HR 2407/S 2085 - Medicare Multi-Cancer Early Detection Screening Coverage Act S 1246/HR 4895 - SMART Prices Act HR 4818/S 2407 - Treat and Reduce Obesity Act of 2023 Continuation of the Inflation Reduction Act

Client expense: $130,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting, reduced reimbursement rates, and restrictions on beneficiary choice and plan or provider competition in government health programs or private insurance plans H.R. 485 (Protecting Health Care for All Patients Act) S. 1246/S. 1264 (Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act) Senate HELP Committees 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act, Sec. 601, BARDA reasonable pricing requirements, and Sec. 602, CDC reasonable pricing requirements, other contemplated "reasonable pricing price controls and patent prize schemes Repeal of Inflation Reduction Act (IRA) drug price controls product price negotiation and 95% inflation penalty and IRA implementation

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Generally promoting awareness of the biopharmaceutical and medical technology sectors. Generally opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Generally opposing various legislative and executive efforts to impose an international price index. Generally promoting awareness of increasing antimicrobial/antifungal resistance. Supporting the PASTEUR Act S. 1355 and H.R. 2940. Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503 and S. 2916). Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET (H.R. 1691). Opposing WHO TRIPS waivers. Supporting the extension of the SBIR program. Supporting changes to the small molecule portions of the Inflation Reduction Act (H.R. 7174). Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Opposing proposed FTC changes to non-compete clauses. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Supporting the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283). Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Submitted comments to CMS concerning Transitional Coverage for Emerging Technologies (TCET) pathway. Opposing the SMART Act (S. 1246). Supporting the ORPHAN CURES Act (H.R. 5539). Supporting the Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 5391/S. 2764). Supporting the Treat And Reduce Obesity Act (H.R. 4818, S. 2407).

Client expense: $55,282 · Firm income: Not reported

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

21st Century Cures Act 2.0 340B Contract Pharmacy Policy 340B Drug Discount Program Accelerated Approval Alternative Funding Programs Buy American Executive Order Cancer Moonshot CBO modeling Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R. 1613, The Drug Price Transparency in Medicaid Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 2534, PROTECT 340B Act of 2023 H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency H.R. 4822, Health Care Price Transparency Act of 2023 H.R. 5376, Inflation Reduction Act H.R. 5378, Lower Costs, More Transparency Act H.R. 5416, The Give Kids a Chance Act H.R. 830/S. 1375, HELP Co-pays Act Health industry vertical integration Inflation Reduction Act Implementation Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan drug policy issues Outcomes based contracting/value based arrangements Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Reauthorization of PAHPA S. 1131, Drug Price Transparency Act S. 1133, 340B Accountability Act S. 1246, SMART Prices Act S. 127, The Pharmacy Benefit Manager Transparency Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act S. 1542/H.R. 6283, Delinking Revenue from Unfair Gouging (DRUG) Act S. 1967, Patients Before Middlemen Act S. 2837, 340B Accountability Act 2021 S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3131/H.R. 5539, ORPHAN Cures Act S. 476/HR. 5567 The Maintaining Investments in New Innovations (MINI) Act S. 652/H.R. 2630, Safe Step Act S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023 Step Therapy The Medicaid VBPs for Patients (MVP) Act Transparency policy issues

Client expense: $960,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

S. 150, the Affordable Prescriptions for Patients Act S. 127, the Pharmacy Benefit Manager Transparency Act HR 4343 - Organ Donation Clarification Act of 2023 S.1246 - SMART Prices Act H.R. 2748 - Contact Lens Prescription Modernization Act S.2157 - Protect Drug Innovation Act H.R. 5688 - Bipartisan HSA Improvement Act H.R. 5687 - HSA Modernization Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

21st Century Cures Act 2.0 340B Contract Pharmacy Policy 340B Drug Discount Program Accelerated Approval Alternative Funding Programs Buy American Executive Order Cancer Moonshot CBO modeling Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R. 1613, The Drug Price Transparency in Medicaid Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 2534, PROTECT 340B Act of 2023 H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency H.R. 4822, Health Care Price Transparency Act of 2023 H.R. 5376, Inflation Reduction Act H.R. 5378, Lower Costs, More Transparency Act H.R. 5416, The Give Kids a Chance Act H.R. 830/S. 1375, HELP Co-pays Act Health industry vertical integration Inflation Reduction Act Implementation Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan drug policy issues Outcomes based contracting/value based arrangements Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Reauthorization of PAHPA S. 1131, Drug Price Transparency Act S. 1133, 340B Accountability Act S. 1246, SMART Prices Act S. 127, The Pharmacy Benefit Manager Transparency Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act S. 1542/H.R. 6283, Delinking Revenue from Unfair Gouging (DRUG) Act S. 1967, Patients Before Middlemen Act S. 2837, 340B Accountability Act 2021 S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3131/H.R. 5539, ORPHAN Cures Act S. 476/HR. 5567 The Maintaining Investments in New Innovations (MINI) Act S. 652/H.R. 2630, Safe Step Act S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023 Step Therapy The Medicaid VBPs for Patients (MVP) Act Transparency policy issues

Client expense: $860,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

HR 830/S 1375 - HELP Copays Act S 127 - Pharmacy Benefit Manager Transparency Act HR 2630/ S 652 - Safe Step Act HR 1770/S 2477 - Equitable Community Access to Pharmacist Services Act HR 2407/S 2085 - Medicare Multi-Cancer Early Detection Screening Coverage Act S 1246/HR 4895 - SMART Prices Act HR 4818/S 2407 - Treat and Reduce Obesity Act of 2023 Continuation of the Inflation Reduction Act

Client expense: $130,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Opposing various legislative and executive efforts to impose an international price index. Promoting awareness of increasing antimicrobial/antifungal resistance. Supporting the PASTEUR Act S. 1355 and H.R. 2940. Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503 and S. 2916). Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET. Opposing WHO TRIPS waivers. Supporting the extension of the SBIR program. Supporting the Saving Access to Laboratory Services (SALSA) Act (H.R. 2377 and S. 1000). Supporting changes to the small molecule portions of the Inflation Reduction Act. Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Opposing proposed FTC changes to non-compete clauses. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Submitted comments to the EPA with respect to their proposed amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Commercial Sterilization Facilities source category with respect to Ethylene Oxide, and EPAs Proposed Interim Decision and Draft Risk Assessment Addendum for Ethylene Oxide pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Submitted comments to the FDA's Center for Drug Evaluation and Researchs (CDER) Discussion Paper regarding the use of Artificial Intelligence in Drug Manufacturing. Submitted comments to CMS concerning Transitional Coverage for Emerging Technologies (TCET) pathway. Opposing the SMART Act (S. 1246). Supporting the ORPHAN CURES Act (H.R. 5539). Supporting the Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 5391/S. 2764). Supporting the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283).

Client expense: $59,553 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting, reduced reimbursement rates, and restrictions on beneficiary choice and plan or provider competition in government health programs or private insurance plans H.R. 485 (Protecting Health Care for All Patients Act) S. 1246/S. 1264 (Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act) Senate HELP Committees 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act, Sec. 601, BARDA reasonable pricing requirements, and Sec. 602, CDC reasonable pricing requirements, other contemplated "reasonable pricing price controls and patent prize schemes Repeal of Inflation Reduction Act (IRA) drug price controls product price negotiation and 95% inflation penalty and IRA implementation

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare and Medicaid Issues. H.R.2474 - Strengthening Medicare for Patients and Providers Act, all provisions. H.R.2829 - Chronic Care Management Improvement Act of 2023, all provisions. H.R.2377/S.1000 - Saving Access to Laboratory Services (SALSA) Act, all provisions. H.R.977/S.470 - Patient Access to Higher Quality Health Care Act of 2023, all provisions. H.R.4189 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023, all provisions. S.2016 - A bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes, all provisions. H.R.1745 - Medicare Fraud Detection and Deterrence Act of 2023, all provisions. S.1246 - Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act, all provisions. H.R.3281 - Transparent PRICE Act, all provisions. S.1339 - Pharmacy Benefit Manager Reform Act, all provisions. CONNECT for Health Act. Chronic Care Management Improvement Act of 2023.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R. 2534, PROTECT 340B Act of 2023 340B Contract Pharmacy Policy S. 1133, 340B Accountability Act Accelerated Approval Advanced Research Projects Agency for Health (ARPA-H) Alternative Funding Programs Biosimilar approval and reimbursement policy issues Buy American Executive Order Cancer Moonshot Cell, gene and radioligand therapies Co-pay accumulator programs Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R. 2534, Preserving Rules Ordered for the Entities Covered Through (PROTECT) 340B Act H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 5376, Inflation Reduction Act H.R. 4822, Health Care Price Transparency Act of 2023 Inflation Reduction Act Implementation H.R. 5416, The Give Kids a Chance Act The Medicaid VBPs for Patients (MVP) Act H.R. 830/S. 1375, HELP Co-pays Act H.R. 1613, The Drug Price Transparency in Medicaid Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan drug policy issues Outcomes based contracting/value based arrangements Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Priority Review Voucher (PRV) Reauthorization of PAHPA Regulatory efficiencies policy issues S. 652/H.R. 2630, Safe Step Act S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023 S. 2837, 340B Accountability Act 2021 S. 476/HR. 5567 The Maintaining Investments in New Innovations (MINI) Act H.R. 5539, ORPHAN Cures Act S. 1246, SMART Prices Act S. 127, The Pharmacy Benefit Manager Transparency Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act S. 1542, Delinking Reveue from Unfair Gouging (DRUG) Act S. 1967, Patients Before Middlemen Act S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act H.R. 5378, Lower Costs, More Transparency Act H.R. 2880, Protecting Patients Against PBM Abuses Act Step Therapy Transparency policy issues Utilization management issues Health industry vertical integration CBO modeling 340B Program Implementation & Oversight 340B Accountability Act S. 1182: The 340B Reporting and Accountability Act H.R.2534: PROTECT 340B Act of 2023 H.R.2408: Access to Innovative Treatments Act of 2023 H.R.1790: Biologics Competition Act of 2023 S.113: Prescription Pricing for the People Act of 2023 S.150: Affordable Prescriptions for Patients Act of 2023 Drug Benefit Design

Client expense: $1,360,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 2474, Strengthening Medicare for Patients and Providers Act, all provisions H.R. 4822, Health Care Price Transparency Act of 2023, all provisions H.R. 4507, Transparency in Coverage Act of 2023, all provisions H.R. 4508, Hidden Fee Disclosure Act, all provisions H.R. 3284, Providers and Payers COMPETE Act, all provisions H.R. 4828, Imaging Services Price Transparency Act of 2023, all provisions H.R. 4882, Clinical Laboratory Price Transparency Act of 2023, all provisions H.R. 4839, Hospital and ASC Price Transparency Act of 2023, Section 101 H.R. 5378, Lower Costs, More Transparency Act, all provisions H.R. 5013, Value in Health Care Act of 2023, all provisions H.R. 2389, Resident Physician Shortage Reduction Act of 2023, all provisions S. 1302, Resident Physician Shortage Reduction Act of 2023, all provisions H.R. 751, Fair Access In Residency (FAIR) Act, all provisions H.R. 977, Patient Access to Higher Quality Health Care Act of 2023, all provisions S. 470, Patient Access to Higher Quality Health Care Act of 2023, all provisions H.R. 4189, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023, provisions relating to telehealth S. 2016, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023, provisions relating to telehealth H.R. 1745, Medicare Fraud Detection and Deterrence Act of 2023, all provisions H.R. 1746, Preventing Medicare Telefraud Act, all provisions H.R. 2713, Improving Care and Access to Nurses (ICAN) Act, all provisions S. 2418, Improving Care and Access to Nurses (ICAN) Act, all provisions H.R. 1770, Equitable Community Access to Pharmacist Services Act, all provisions S. 2477, Equitable Community Access to Pharmacist Services Act, all provisions S. 1491, Pharmacy and Medically Underserved Areas Enhancement Act, all provisions H.R. 1610, Chiropractic Medicare Coverage Modernization Act of 2023, all provisions S. 799, Chiropractic Medicare Coverage Modernization Act of 2023, all provisions S. 669, Increasing Mental Health Options Act of 2023, all provisions H.R. 4968, Getting Over Lengthy Delays in Care As Required by Doctors (GOLD CARD) Act of 2023, provisions relating to prior authorization S. 1246, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act, all provisions H.R. 830, Help Ensure Lower Patient (HELP) Copays Act, all provisions S. 1375, Help Ensure Lower Patient (HELP) Copays Act, all provisions H.R. 5506, Hospitals As Naloxone Distribution Sites (HANDS) Act, all provisions H.R. 5687, HSA Modernization Act of 2023, all provisions H.R. 3046, Medical Student Education Authorization Act of 2023, all provisions S. 1403, Medical Student Education Authorization Act of 2023, all provisions H.R. 2829, Chronic Care Management Improvement Act of 2023, all provisions H.R. 2377, Saving Access to Laboratory Services Act, all provisions S. 1000, Saving Access to Laboratory Services Act, all provisions H.R. 3432, Telemental Health Care Access Act of 2023, all provisions S. 712, Connected MOM Act, all provisions H.R. 4818, Treat and Reduce Obesity Act of 2023, all provisions S. 2407, Treat and Reduce Obesity Act of 2023, all provisions H.R. 977, Patient Access to Higher Quality Health Care Act of 2023, all provisions H.R. 1694, Emergency Care Improvement Act, all provisions H.R. 497, Freedom for Health Care Workers Act, all provisions Improving Seniors Timely Access to Care Act of 2022/implementation Opioid Workforce Act/reintroduction Medicare Student Education Authorization Act/draft Doctor Knows Best Act (House discussion draft, prior authorization) Fewer Burdens for Better Care Act/discussion draft Modernizing and Ensuring PBM Accountability (MEPA) Act/draft Medicare program: No Surprises Act implementation Medicare program: 21st Century Cure Act implementation Medicare program: Budget neutrality Medicare program: FY24 Medicare Physician Fee Schedule Medicare program: Medicare Physician Payment Advisory Commission (MedPAC)/Physician payment system reform recommendations Medicare program: Part B Medicare providers/MEI update Medicare program: Merit-based Incentive Payment System (MIPS) Reforms/penalties Medicare program: G2211 Inherent Complexity Code Medicare program: Electronic direct deposits/unauthorized insurer fees Medicare program: Making Care Primary (MCP)/alternative payment model (APM) Medicare program: Medicare Part B/payment geographic disparities/primary care physicians Medicare program: Physician Owned Hospitals Medicare program: Site neutral payment policies Medicare program: Breast reconstruction codes/reimbursement and coverage Medicare program: MIPS/data feedback Medicare program: MIPS hardship exceptions/payment penalties Medicare program: MIPS Measure Development Process Medicare program: Value-based payment models/comorbid conditions Medicare program: Provider compliance/regulatory relief Medicare program: Provider Enrollment, Chain, and Ownership System (PECOS) Enrollment/Revalidation Medicare program: Open Payments Medicare program: Diabetes Medicare program: Scope of practice Medicare program: Electronic Health Records (EHR) certification Medicare program: Quality Payment Program/physician burdens Medicare program: Health IT/physician burdens Medicare program: HIPAA/electronic records Medicare program: Interoperability/data sharing/information blocking Medicare program: Data segmentation Medicare program: Health care attachments/electronic transaction standards Medicare program: Prior authorization reform Medicare program: Episode-based Payment Model Medicare program: Medicare Advantage cuts/Advanced Rate Notice Medicare and Medicaid programs: Data/patient control Medicare and Medicaid programs: Cybersecurity/Information blocking Medicaid program: Medicaid unwinding

Client expense: $3,420,000 · Firm income: Not reported

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

Bayh-Dole march-in & royalty-free rights; IRA drug price negotiation implementation; Affordable Insulin Now Act (S.954); Insulin for All Act (S.727, H.R.1485); S. 1246 SMART Prices Act; Lowering Drug Costs for Families Act (S. 1139), IRA drug price negotiation implementation, NDAA biomedical R&D transparency, licensing, and pricing; access to U.S. government funded medicines and vaccines; Bayh-Dole march-in & royalty-free rights, U.S. government support for the mRNA Hub program, H.R. 1613 (Drug Price Transparency in Medicaid Act), S.1269 INSULIN Act, S.1067 Ensuring Timely Access to Generics Act; S. 1114 Expanding Access to Low-Cost Generics Act; S.1214 RARE Act; S.1339, Pharmacy Benefit Manager Reform Act, S.150; S.148; S.142; S.113; S.79; S.727; S.954; H.R.1488; S.1269; S.1067; S.1114; S.1339; S.775; S.1128; S.574; S.935; S.127, H.R. 2666 (MVP Act); Bayh-Dole march-in & royalty-free rights; government use patent licensing; NIH nomination; Affordable Drug Manufacturing Act; S.1476 (Pharmaceutical Research Transparency Act).

Client expense: $72,000 · Firm income: Not reported

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

Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Opposing various legislative and executive efforts to impose an international price index. Promoting awareness of increasing antimicrobial/antifungal resistance. Supporting the PASTEUR Act S. 1355 and H.R. 2940. Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503 and S. 2916). Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET. Opposing TRIPS waivers. Supporting the extension of the SBIR program. Supporting the Saving Access to Laboratory Services (SALSA) Act (H.R. 2377 and S. 1000). Supporting changes to the small molecule portions of the Inflation Reduction Act. Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Opposing proposed FTC changes to non-compete clauses. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Submitted comments to the EPA with respect to their proposed amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Commercial Sterilization Facilities source category with respect to Ethylene Oxide, and EPAs Proposed Interim Decision and Draft Risk Assessment Addendum for Ethylene Oxide pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Submitted comments to the FDA's Center for Drug Evaluation and Researchs (CDER) Discussion Paper regarding the use of Artificial Intelligence in Drug Manufacturing. Submitted comments to CMS concerning Transitional Coverage for Emerging Technologies (TCET) pathway. Opposing the SMART Act (S. 1246).

Client expense: $60,437 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting, reduced reimbursement rates, and restrictions on beneficiary choice and plan or provider competition in government health programs or private insurance plans H.R. 485 (Protecting Health Care for All Patients Act) S. 1246/S. 1264 (Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act) Senate HELP Committees 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act, Sec. 601, BARDA reasonable pricing requirements, and Sec. 602, CDC reasonable pricing requirements, other contemplated "reasonable pricing price controls and patent prize schemes Inflation Reduction Act drug price controls implementation

Client expense: Not reported · Firm income: $64,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Discount Program ---H.R.2534: PROTECT 340B Act of 2023 ---340B Accountability Act (Discussion Draft) ---Program Implementation & Oversight ---Senate request for information (RFI) on the 340B Drug Pricing Program Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Climate Change ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---American Data Privacy and Protection Act (Discussion Draft) Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.476: Maintaining Investments in New Innovation Act ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.1246: SMART Prices Act ---COVID-19 Pricing-Related Provisions ---Expanding small business exemption in the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Reimbursement Policies ---National Coverage Determination ---Patient Cost-Sharing and Smoothing Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---National Defense Authorization Act for FY 2024 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act of 2023 ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---Pricing and Rebates Opioid Crisis ---SUPPORT Act (Discussion Draft) Orphan Drug Issues ---Expanding drug exclusion in the Inflation Reduction Act (IRA) of 2022 ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act (Discussion Draft) Pandemic Preparedness ---H.R.3066: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Rare Pediatric Disease Priority Review ---Helping Experts Accelerate Rare Treatments (HEART) Act (Discussion Draft) ---Speeding Therapy Access Today (STAT) Act (Discussion Draft) Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---S.652/H.R.2630 Safe Step Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Drug Price Negotiation Act (Discussion Draft) ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act (Discussion Draft) ---Protected Classes ---Seniors Prescription Drug Relief Act (Discussion Draft) ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2940/S.1355: PASTEUR Act ---Adult Immunization ---DISARM Act (Discussion Draft) ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine and Coverage Certainty (VACC) Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2024 Appropriations ---Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---Vaccine Access Improvement Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---VICP CICP (Discussion Draft)

Client expense: $2,200,000 · 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, State, Dept of (DOS), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), White House Office

Medicare and Medicaid Issues. H.R.2474 - Strengthening Medicare for Patients and Providers Act, all provisions. H.R.2829 - Chronic Care Management Improvement Act of 2023, all provisions. H.R.2377/S.1000 - Saving Access to Laboratory Services (SALSA) Act, all provisions. H.R.977/S.470 - Patient Access to Higher Quality Health Care Act of 2023, all provisions. H.R.4189 - Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023, all provisions. S.2016 - A bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes, all provisions. H.R.1745 - Medicare Fraud Detection and Deterrence Act of 2023, all provisions. S.1246 - Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act, all provisions. H.R.3281 - Transparent PRICE Act, all provisions. S.1339 - Pharmacy Benefit Manager Reform Act, all provisions. CONNECT for Health Act. Chronic Care Management Improvement Act of 2023.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Bayh-Dole march-in & royalty-free rights; IRA drug price negotiation implementation; Affordable Insulin Now Act (S.954); Insulin for All Act (S.727, H.R.1485); S. 1246 SMART Prices Act; Lowering Drug Costs for Families Act (S. 1139), IRA drug price negotiation implementation, NDAA biomedical R&D transparency, licensing, and pricing; access to U.S. government funded medicines and vaccines; Bayh-Dole march-in & royalty-free rights, U.S. government support for the mRNA Hub program, H.R. 1613 (Drug Price Transparency in Medicaid Act), S.1269 INSULIN Act, S.1067 Ensuring Timely Access to Generics Act; S. 1114 Expanding Access to Low-Cost Generics Act; S.1214 RARE Act; S.1339, Pharmacy Benefit Manager Reform Act, S.150; S.148; S.142; S.113; S.79; S.727; S.954; H.R.1488; S.1269; S.1067; S.1114; S.1339; S.775; S.1128; S.574; S.935; S.127, H.R. 2666 (MVP Act); Bayh-Dole march-in & royalty-free rights; government use patent licensing; NIH nomination; Affordable Drug Manufacturing Act; S.1476 (Pharmaceutical Research Transparency Act).

Client expense: $72,000 · Firm income: Not reported

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

H.R. 751, Fair Access In Residency (FAIR) Act, all provisions H.R. 1610, Chiropractic Medicare Coverage Modernization Act of 2023, all provisions S. 799, Chiropractic Medicare Coverage Modernization Act of 2023, all provisions H.R. 2474, Strengthening Medicare for Patients and Providers Act, all provisions H.R. 2829, Chronic Care Management Improvement Act of 2023, all provisions H.R. 1770, Equitable Community Access to Pharmacist Services Act, all provisions H.R. 2377, Saving Access to Laboratory Services (SALSA) Act, all provisions S. 1000, Saving Access to Laboratory Services (SALSA) Act, all provisions S. 703, Physicians for Underserved Areas Act, all provisions H.R. 977, Patient Access to Higher Quality Health Care Act of 2023, all provisions S. 470, Patient Access to Higher Quality Health Care Act of 2023, all provisions H.R. 1694, Emergency Care Improvement Act, all provisions H.R. 4189, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023, all provisions S. 2016, A bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes, all provisions H.R. 1745, Medicare Fraud Detection and Deterrence Act of 2023, all provisions H.R. 1746, Preventing Medicare Telefraud Act, all provisions S. 1491, Pharmacy and Medically Underserved Areas Enhancement Act, all provisions S. 1246, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act, all provisions H.R. 2811, Limit, Save, Grow Act of 2023, provisions relating to Medicaid work requirements H.R. 3746, Fiscal Responsibility Act of 2023, provisions relating to Medicaid work requirements H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023, provisions relating to Sections 101 and 105 H.R. 3281, Transparent PRICE Act, all provisions H.R. 3248, Diagnostic Lab Testing Transparency Act, all provisions S. 669, Increasing Mental Health Options Act of 2023, all provisions H.R. 2713, Improving Care and Access to Nurses (I CAN) Act, all provisions H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information, all provisions H.R. 496, Freedom for Health Care Workers Act, all provisions S. 1606, Black Maternal Health Momnibus Act, all provisions S. 712, Connected MOM Act, all provisions S. 1339, Pharmacy Benefit Manager Reform Act, all provisions H.R. 2389, Resident Physician Shortage Reduction Act of 2023, all provisions S. 1302, Resident Physician Shortage Reduction Act of 2023, all provisions Amputation Reduction and Compassion (ARC) Act, all provisions Promoting Responsible and Effective Virtual Experiences through Novel Technology to Deliver Improved Access and Better Engagement with Tested and Evidence-based Strategies (PREVENT DIABETES) Act, all provisions Opioid Workforce Act, all provisions Substance Use Disorder Workforce Act, all provisions Increasing Mental Health Options Act/House draft/psychologists prescribing Value in Healthcare Act CONNECT for Health Act Chronic Care Management Improvement Act of 2023 Medicare program: Making Care Primary/alternative payment model Medicare program: Surprise medical billing Medicare program: Physician payment reform Medicare program: Physician inflation updates/Medicare Economic Index (MEI) Medicare program: Budget neutrality Medicare program: Physician-owned hospitals Medicare program: Merit-based Incentive Payment System (MIPS) reforms/quality/cost/promoting interoperability/data sharing Medicare program: MIPS/MSSP/Data Completeness and eCQM Adoption Medicare program: Quality Payment Program/physician burdens Medicare program: Medicare Payment Advisory Commission (MedPAC)/physician payment reform recommendations Medicare program: Medicare Physician Payment - Add-on code Medicare program: Medicare Advantage/Prior Authorization Medicare program: Prior authorization regulation/include major provisions of Improving Seniors Timely Access to Care Act Medicare program: Site Neutral Payment Policies Medicare program: Medicare telehealth restrictions/permanent repeal Medicare program: Health IT/physician burdens Medicare program: Medicare Advantage cuts/Advanced Rate Notice Medicare program: Electronic Health Records (EHR) certification Medicare program: Remote patient monitoring/local coverage determinations Medicare program: Patient engagement/quality data reporting Medicare program: Residents in teaching settings/supervision through real-time audio visual technology Medicare program: Provider Enrollment, Chain, and Ownership System (PECOS)/enrollment and validation Medicare program: Open Payments Medicare program: Prior authorization study update Medicare and Medicaid programs: 21st Century Cures Act/implementation Medicare and Medicaid programs: Medicare Access and CHIP Reauthorization (MACRA) Act/Broad reform Medicare and Medicaid programs: MACRA/physician burdens Medicare and Medicaid programs: Cybersecurity/Information Blocking Medicare and Medicaid programs: Coding Medicare and Medicaid programs: Substance use disorder Medicare and Medicaid programs: Data privacy Medicare and Medicaid programs: HIPAA/electronic health records Medicare and Medicaid programs: Puerto Rico/physician payment inequities/access to care Medicare and Medicaid programs: Undocumented immigrants/access to care Medicaid program: Unwinding continuous enrollment

Client expense: $4,750,000 · Firm income: Not reported

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

340B Drug Discount Program 340B Accountability Act Accelerated Approval Advanced Research Projects Agency for Health (ARPA-H) Alternative Funding Programs Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American Executive Order Cancer Moonshot Cell, gene and radioligand therapies Co-pay accumulator programs Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R. 2534, Preserving Rules Ordered for the Entities Covered Through (PROTECT) 340B Act H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 5376, Inflation Reduction Act Inflation Reduction Act Implementation H.R. 5416, The Give Kids a Chance Act The Medicaid VBPs for Patients (MVP) Act H.R. 830/S. 1375, HELP Co-pays Act H.R. 1613, The Drug Price Transparency in Medicaid Act H.R. 198, Drug Pricing Transparency and Accountability Act Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan drug policy issues Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Priority Review Voucher (PRV) Reauthorization of PAHPA Regulatory efficiencies policy issues S. 652/H.R. 2630, Safe Step Act S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023 S. 2837, 340B Accountability Act 2021 S. 476, The Maintaining Investments in New Innovations (MINI) Act S. 1246, SMART Prices Act S. 127, The Pharmacy Benefit Manager Transparency Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act Step Therapy Transparency policy issues Utilization management issues H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program (Bucshon Bill) 340B Contract Pharmacy Policy

Client expense: $930,000 · Firm income: Not reported

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

340B Drug Discount Program ---H.R.2534: PROTECT 340B Act of 2023 ---340B Accountability Act (Discussion Draft) ---Program Implementation & Oversight ---Senate request for information (RFI) on the 340B Drug Pricing Program Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Climate Change ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---American Data Privacy and Protection Act (Discussion Draft) Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.476: Maintaining Investments in New Innovation Act ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.1246: SMART Prices Act ---COVID-19 Pricing-Related Provisions ---Expanding small business exemption in the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Reimbursement Policies ---National Coverage Determination ---Patient Cost-Sharing and Smoothing Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---National Defense Authorization Act for FY 2024 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act of 2023 ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---Pricing and Rebates Opioid Crisis ---SUPPORT Act (Discussion Draft) Orphan Drug Issues ---Expanding drug exclusion in the Inflation Reduction Act (IRA) of 2022 ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act (Discussion Draft) Pandemic Preparedness ---H.R.3066: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Rare Pediatric Disease Priority Review ---Helping Experts Accelerate Rare Treatments (HEART) Act (Discussion Draft) ---Speeding Therapy Access Today (STAT) Act (Discussion Draft) Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---S.652/H.R.2630 Safe Step Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Drug Price Negotiation Act (Discussion Draft) ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act (Discussion Draft) ---Protected Classes ---Seniors Prescription Drug Relief Act (Discussion Draft) ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2940/S.1355: PASTEUR Act ---Adult Immunization ---DISARM Act (Discussion Draft) ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine and Coverage Certainty (VACC) Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2024 Appropriations ---Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---Vaccine Access Improvement Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---VICP CICP (Discussion Draft)

Client expense: $2,200,000 · 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, State, Dept of (DOS), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), White House Office

Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Opposing various legislative and executive efforts to impose an international price index. Promoting awareness of increasing antimicrobial/antifungal resistance. Supporting the PASTEUR Act S. 1355 and H.R. 2940. Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503). Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET. Opposing TRIPS waivers. Supporting the extension of the SBIR program. Supporting the Saving Access to Laboratory Services (SALSA) Act (H.R. 2377 and S. 1000). Supporting changes to the small molecule portions of the Inflation Reduction Act. Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Opposing proposed FTC changes to non-compete clauses. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Submitted comments to the EPA comments with respect to their proposed amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Commercial Sterilization Facilities source category with respect to Ethylene Oxide, and EPAs Proposed Interim Decision and Draft Risk Assessment Addendum for Ethylene Oxide pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Submitted comments to the FDA's Center for Drug Evaluation and Researchs (CDER) Discussion Paper regarding the use of Artificial Intelligence in Drug Manufacturing. Opposing the SMART Act (S. 1246).

Client expense: $63,288 · Firm income: Not reported

Government targets: Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Price controls proposals regarding pharmaceuticals or other medical goods or services, including direct government price-setting, reduced reimbursement rates, and restrictions on beneficiary choice and plan or provider competition in government health programs or private insurance plans H.R. 485 (Protecting Health Care for All Patients Act) S. 1246/S. 1264 (Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act) Senate HELP Committees 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act, Sec. 601, BARDA reasonable pricing requirements, and Sec. 602, CDC reasonable pricing requirements

Client expense: Not reported · Firm income: $10,875

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 830 HELP COPAYS ACT - Urging support of the Help Copays Act to ensure affordable access to life-saving medications for all Americans. Provide relief to patients by capping copayments for prescription drugs. S. 1246 SMART PRICES ACT - Urging opposition to the SMART legislation. The emphasis on price controls for prescription drug price negotiations would have adverse effects on future research, investments, and empllyment opportunites in our country. H.R. 3694 WTO'S Expansion of TRIPS Waivers for Drugs - Urging opposition of the waiver to COVID-19 diagnostic devices and treatments, as many WTO members are proposing, would endanger American jobs without improving global health.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE