Generic Substitution Noninterference Act

1. Patient Protection and Affordable Health Care Act, implementation of provisions regarding high risk insurance pools, implementation of state based health exchanges, eligibility for health insurance premium subsidies, cost sharing subsidies, proposals for special enrollment period 2. Stabilization of Affordable Care Act insurance marketplaces 3. Administration proposals on prescription drug pricing 4. Administration proposals for COVID testing and vaccine distribution 5. S. 779, Protecting Americans with Pre-Existing Conditions Act of 2021, entire bill 6. H.R. 597, Pandemic Treatment Access and Affordability Act of 2021, entire bill 7. Vaccine access under the American Rescue Plan 8. H.R. 7472, The Discounted Drugs for Clinical Trials Act, entire bill 9. S. 4053, The Discounted Drugs for Clinical Trials Act, entire bill 10. H.R. 7474, The Pharmaceutical Research and Transparency Act, entire bill 11. S. 4034, The Pharmaceutical Research and Transparency Act, entire bill 12. H.R. 7473, The Generic Substitution Non-Interference Act, entire bill 13. H.R. 7828, Price Relief, Innovation, and Competition for Essential Drugs Act (PRICED Act), entire bill 14. H.R. 5376, Inflation Reduction Act of 2022, provisions relating to premium subsidies under the Affordable Care Act

Client expense: $70,000 · Firm income: Not reported

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

Medicare Observation Stays. The Improving Access to Medicare Coverage Act of 2021 (H.R. 3650 and S. 2048): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Drug Costs (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act. Drug Costs. Pharmaceutical Research and Transparency Act of 2022 (S. 4037): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Drug Costs. Discounted Drugs for Clinical Trials Act (S. 4026): Proposal to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer. Drug Costs. Generic Substitution Non-Interference Act (H.R. 7473): Proposal would block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. These campaigns increase drug spending by encouraging overuse of brand drugs when cheaper, equally effective generic alternative is available. Drug Costs. The Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act, (S. 583): Proposal to reduce the period after Food and Drug Administration approval where a brand manufacturer could exclusively market their drug in the United States from 12 years to five years. This reduced exclusivity period would hasten the introduction of lower cost biosimilars to the market, helping bring down cost for consumers. Drug savings. Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 383): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. The Lowering Medicare Premiums and Prescription Drug Costs Act (S. 1844): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal to allow Medicare to negotiate prices with drug makers, cap prices at inflation in Part B and D, cap beneficiary out-of-pocket costs in Part D, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and raise the income threshold for the low-income subsidy. The Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3): Proposal to allow Medicare to negotiate prices with drug makers, cap prices at inflation in Part B and D, cap beneficiary out-of-pocket costs in Part D. Medicare Reform. Assuring Medicares Promise Act (H.R. 8323): Proposal to close the loophole for wealthy individuals to bypass paying net investment income tax (NIIT) and would direct the revenue to the Hospital Insurance Fund, which pays for Medicare Part A that covers inpatient care in hospitals. Medicare Dental Coverage. Medicare Dental Benefit Act (S. 97 and H.R. 502): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Medicare Hearing Aid Coverage Act of 2021 (H.R. 1118): Proposal to expand Medicare coverage to include hearing aids and services for seniors under Part B of the Medicare program. Medicare premiums (No bill): Proposals to lower the cost of the 2022 Medicare Part B premium that was inappropriately raised to cover the overestimated cost of the Alzheimers drug Aduhelm. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with HHS/CMS. Public Health emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage. Seniors Timely Access to Care Act (H.R. 3173): Proposal to create transparency around Medicare Advantage plans use of prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Advantage. Medicare Advantage Consumer Protection and Transparency Act (H.R. 9019). Proposal to create transparency around Medicare Advantage plans use of prior authorization. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid. Inflation Reduction Act (Public Law No: 117-169): Proposals to expand Medicaid home and community-based services and the Medicare savings programs.

Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.

Medicare Observation Stays. The Improving Access to Medicare Coverage Act of 2021 (H.R. 3650 and S. 2048): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Drug Costs. Proposals to allow Medicare to negotiate drug prices, allow for the reimportation of drugs, require manufacturer rebates for drugs used under Medicare Parts B and D for the amount prices rise above the rate of inflation, restructure the benefit, and cap beneficiary out-of-pocket costs in Part D. Drug Costs. Pharmaceutical Research and Transparency Act of 2022 (S. 4037): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Drug Costs. Discounted Drugs for Clinical Trials Act (S. 4026): Proposal to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer. Drug Costs. Generic Substitution Non-Interference Act (H.R. 7473): Proposal would block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. These campaigns increase drug spending by encouraging overuse of brand drugs when cheaper, equally effective generic alternative is available. Drug Costs. The Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act, (S. 583): Proposal to reduce the period after Food and Drug Administration approval where a brand manufacturer could exclusively market their drug in the United States from 12 years to five years. This reduced exclusivity period would hasten the introduction of lower cost biosimilars to the market, helping bring down cost for consumers. Drug savings. More Help for Seniors Act of 2021 (H.R. 2464): Proposal to expand eligibility for low-income subsidies under the Medicare prescription drug benefit by raising the maximum allowable income for beneficiaries to qualify from 150 percent to 200 percent of the federal poverty line. Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 383): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. The Lowering Medicare Premiums and Prescription Drug Costs Act (S. 1844): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. The Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3): Proposals to allow Medicare to negotiate prices with drug makers, cap prices at inflation in Part B and D, cap beneficiary out-of-pocket costs in Part D. Medicare Reform. Assuring Medicares Promise Act (H.R. 8323): Proposal to close the loophole for wealthy individuals to bypass paying net investment income tax (NIIT) and would direct the revenue to the Hospital Insurance Fund, which pays for Medicare Part A that covers inpatient care in hospitals. Medicare reform. Build Back Better Act (H.R. 5376): Proposals to add dental, hearing and vision and a total out-of-pocket cap to Medicare. Proposals to means test Medicare. Proposals to create vouchers for hearing, dental and vision benefits. Medicare Dental Coverage. Medicare Dental Benefit Act (S. 97 and H.R. 502): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Medicare Hearing Aid Coverage Act of 2021 (H.R. 1118): Proposal to expand Medicare coverage to include hearing aids and services for seniors under Part B of the Medicare program. Medicare premiums (No bill): Proposals to lower the cost of the 2022 Medicare Part B premium that was inappropriately raised to cover the overestimated cost of the Alzheimers drug Aduhelm. Medicaid. Build Back Better Act (H.R. 5376): Proposals to expand Medicaid home and community-based services and the Medicare savings programs. COVID funding (H.R. 7007): Proposal to enact COVID relief supplemental appropriations legislation to provide additional federal funding to develop and distribute COVID vaccines, test kits and treatments to keep seniors and other vulnerable populations safe. Public Health emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Privatization (No bill): Proposal to create transparency around Medicare Advantage plans use of prior authorization. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans.

H.R.7473 Generic Substitution Noninterference Act - in support H.R.7474 - Pharmaceutical Research Transparency Act of 2022 - in support H.R.7529 - Plain Prescription Prices Act - in support H.R.7828 - PRICED Act - in support H.R.8289 - Banning Misleading Drug Ads Act of 2022 - in support H.R.7472 - Discounted Drugs for Clinical Trials Act - in support

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

1. Patient Protection and Affordable Health Care Act, implementation of provisions regarding high risk insurance pools, implementation of state based health exchanges, eligibility for health insurance premium subsidies, cost sharing subsidies, proposals for special enrollment period 2. Stabilization of Affordable Care Act insurance marketplaces 3. Administration proposals on prescription drug pricing 4. Administration proposals for COVID testing and vaccine distribution 5. S. 779, Protecting Americans with Pre-Existing Conditions Act of 2021, entire bill 6. H.R. 597, Pandemic Treatment Access and Affordability Act of 2021, entire bill 7. Vaccine access under the American Rescue Plan 8. H.R. 7472, The Discounted Drugs for Clinical Trials Act, entire bill 9. S. 4053, The Discounted Drugs for Clinical Trials Act, entire bill 10. H.R. 7474, The Pharmaceutical Research and Transparency Act, entire bill 11. S. 4034, The Pharmaceutical Research and Transparency Act, entire bill 12. H.R. 7473, The Generic Substitution Non-Interference Act, entire bill 13. H.R. 7828, Price Relief, Innovation, and Competition for Essential Drugs Act (PRICED Act), entire bill

Client expense: $80,000 · Firm income: Not reported