Increasing Access to Biosimilars Act of 2023

Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352/S.3934: Increasing Access to Biosimilars Act of 2023. Medicaid Generics Penalty.

Client expense: $800,000 · Firm income: Not reported

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

Draft, Medicare Compare Website (no bill number) - Rep. Guthrie, Brett - improvements to CMS Medicare compare website H.R. 35 - Close the Medigap Act of 2023 - Rep. Doggett, Lloyd - Medigap policies H.R. 3746 - Fiscal Responsibility Act of 2023 - Rep. McHenry, Patrick - work requirements for federal programs H.R. 3875 - Expanded Telehealth Access Act - Rep. Sherrill, Mikie - Medicare payment for telehealth services H.R. 4411 - Medicare Advantage Integrity Act - Resident Commissioner Gonzalez-Colon, Jenniffer - disparity in MA benchmark rates H.R. 4818 - Treat and Reduce Obesity Act of 2023 - Rep. Wenstrup, Brad -Medicare Coverage of weight loss treatment H.R. 5526 - Seniors' Access to Critical Medications Act of 2023 - Rep. Harshbarger, Diana - exception for physician self-referral H.R. 5584 - Medicaid Third Party Liability Act - Rep. Burgess, Michael - amends Medicaid Third Party liability requirements H.R. 5746 - Addressing Whole Health in Medicare Advantage Act - Rep. Bilirakis, Gus - Medicare Advantage supplemental benefits H.R. 5854 - Medicare Advantage Consumer Protection and Transparency Act - Rep. Porter, Katie - Medicare Advantage organization reporting H.R. 6364 - Medicare Telehealth Privacy Act of 2023 - Rep. Balderson, Troy - Provider privacy provisions for telehealth under Medicare H.R. 6400 - To amend title XVIII of the Social Security Act to extend eligibility for certain payment increases for biosimilar biological products under the Medicare program - Rep. Cardenas, Tony - Medicare payment increase for biosimilars H.R. 6445 - Medicare Audiology Access Improvement Act of 2023 - Rep. Bilirakis, Gus - Medicare Audiology Coverage H.R. 7147 - Medicare Transaction Fraud Prevention Act - Rep. Schweikert, David - oversight of payments for medical equipment & clinical DLTs under Medicare H.R. 7148 - Medicare Home Health Accessibility Act - Rep. Smucker, Lloyd - occupational therapy eligibility for home health coverage under Medicare H.R. 7254 - Hearing Device Coverage Clarification Act - Rep. Fischbach, Michelle - excludes fully implanted active middle ear hearing devices from the hearing aid coverage exclusion under Medicare H.R. 7274 - Connecting Caregivers to Medicare Act of 2024 - Rep. Carey, Mike - outreach, education, and simplify information for family caregivers on Medicare benefits H.R. 7432 - Sickle Cell Disease Comprehensive Care Act - Rep. Burgess, Michael - enables State Medicaid programs to provide coordinated care through health home to individuals with sickle cell disease H.R. 7512 - Real-Time Benefit Tool Implementation Act - Rep. Arrington, Jodey - implementation of real-time benefit tools under part D of under Medicare H.R. 7573 - Stop Unfair Medicaid Recoveries Act - Rep. Schakowsky, Janice - Medicaid Estate Recovery Program H.R. 7619 - Expand the Behavioral Health Workforce Now Act - Rep. Neguse, Joe - education, training, recruitment, and retention of mental health and substance use disorder providers under Medicaid and CHIP H.R. 7623 - Telehealth Modernization Act of 2024 - Rep. Carter, Earl L. Buddy - makes certain telehealth flexibilities permanent under Medicare and adds requirements for Part D plan contracts with PBMs including reporting and delinking provisions H.R. 7856 - Promoting Responsible and Effective Virtual Experiences through Novel Technology to Deliver Improved Access and Better Engagement with Tested and Evidence-based Strategies Act (PREVENT DIABETES Act)- Rep. DeGette, Diana - Medicare, coverage, preventive care, chronic care H.R. 7863 - To require the Secretary of Health and Human Services to issue guidance on furnishing behavioral health services via telehealth to individuals with limited English proficiency under Medicare program. - Rep. Steel, Michelle - Medicare, behavioral health, telehealth, accessibility H.R. 7939 - Patient Access to Innovative New Technologies Act of 2024 - Rep. Carey, Mike - Medicare, quality, medical devices, coverage H.R. 7996 - Improving CARE for Youth Act - Rep. Dunn, Neal - allows for same-day billing for mental health services for youth Medicaid beneficiaries who are being seen for a primary care service H.R. 8018 - Alleviating Barriers for Caregivers Act- Rep. Cammack, Kat - review and simplify caregiver paperwork, CHIP, Medicare, Medicaid H.R. 8064 - Help Extend Auditory Relief Act of 2024- Rep. Cartwright, Matt - Medicare coverage of hearing aids H.R. 8075 - Improving Access to Home Dialysis Act of 2024- Rep. Miller, Carol - Medicare coverage of home dialysis H.R. 8115 - To amend title XIX of the Social Security Act to allow for the deferral or disallowance of portions of payments for certain managed care violations under Medicaid- Rep. Sarbanes, John - Medicaid managed care payment deferral H.R. 8261 - Preserving Telehealth, Hospital, and Ambulance Access Act- Rep. Schweikert, David - extend flexibilities and payment for Medicare H.R. 8702 - Improving Seniors Timely Access to Care Act - Rep. Mike Kelly - prior authorization, transparency, MA S. 838 - Improving Access to Mental Health Act - Sen. Stabenow, Debbie - mental health services in Medicare S. 948 - Healthy Moms and Babies Act - Sen. Grassley, Chuck - establishes programs and requirements to support maternal health services under Medicaid and CHIP S. 1002 - No UPCODE Act - Sen. Cassidy, Bill - modifies certain factors that are used to determine Medicare Advantage (MA) payments, particularly relating to health status and related data S. 2880 - Expanded Telehealth Access Act - Sen. Daines, Steve - Medicare payment for telehealth services S. 3573 - Medicare Advantage Supplemental Benefits Transparency Act- Sen. Warner, Mike - MA, data transparency, supplemental benefits S. 3578 - Protect Medicaid Act - Sen. Cassidy, Bill - prohibits federal payments under Medicaid for noncitizens, requires reporting to HHS of states that provide such health benefits S. 3630 - Medicare Transaction Fraud Prevention Act- Sen. Braun, Mike- pilot program for predictive risk-scoring algorithm, oversight, Medicare S. 3651 - Telemental Health Care Access Act of 2024- Sen. Cassidy, Bill - Medicare, mental health services, telehealth S. 3766 - Connecting Caregivers to Medicare Act of 2024- Sen. Tillis, Thomas - Medicare, outreach and education, caregivers S. 3882 - Helping States Integrate Medicare and Medicaid Act- Sen. Casey, Robert - dual eligibles, quality measures, access, enrollment S. 3934 - Increasing Access to Biosimilars Act of 2023- Sen. Cornyn, John - Medicare drug access S. 3950 - Delivering Unified Access to Lifesaving Services Act of 2024 - Sen. Cassidy, Bill - reforming Integrated Medicare/Medicaid Care Programs for Dually Eligible Individuals S. 4094 - PREVENT DIABETES Act - Sen. Scott, Tim - Medicare, coverage, preventive care, chronic care S. 4532 - Improving Seniors Timely Access to Care Act - Sen. Marshall, Roger - prior authorization, transparency, MA S. 4767 - Insurance Fraud Accountability Act - Sen. Wyden, Ron - reduces fraudulent enrollments in qualified health plans Issues related to mental health and Medicare; Medicare and Medicaid funding; Medicaid expansion; State innovation waivers; Medicaid and CHIP; Medicaid FMAP; Medicare Supplement Coverage; Medicare Transparency in Coverage; Medicaid Access Final Rule; Medicaid Redeterminations; Medicaid rate actuarial soundness; value of Medicaid Managed Care; Medicare Advantage Health Risk Assessment and chart reviews; Medicare Advantage supplemental benefits and Social Determinants of health; coverage of weight loss drugs; and Inflation Reduction Act implementation.

H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 - Rep. Carter, Earl - spread-pricing by PBMs for Medicaid H.R. 2880 - Protecting Patients Against PBM Abuses Act - Rep. Carter, Earl - PBM transparency H.R. 4818 - Treat and Reduce Obesity Act - Rep. Wenstrup, Brad - weight loss coverage H.R. 5372 - Expanding Seniors Access to Lower Cost Medicines Act of 2023 - Rep. Joyce, John - generic drugs, biosimilars cost H.R. 5378 - Lower Costs, More Transparency Act - Rep. McMorris Rodgers, Cathy - PBM transparency H.R. 5385 - Medicare PBM Accountability Act - Rep. Landsman, Greg McMorris - PBM transparency H.R. 6283 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 6963 - Pediatric Cancer Drug Supply Act of 2024 - Rep. Eshoo, Anna - establishes agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs H.R. 7635 - The 340B PATIENTS Act of 2024- Rep. Matsui, Doris - ensures accessibility of drugs under 340B drug discount program S. 79 - Interagency Patent Coordination and Improvement Act of 2023 - Sen. Durbin, Richard - prescription drug patenting S. 113 - Prescription Pricing for the People Act of 2023 - Sen. Grassley, Chuck - PBM transparency S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 - Sen. Cantwell, Maria - PBM transparency S. 142 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - pharmacy and biosimilar prescription drugs S. 148 - Stop STALLING Act - Sen. Klobuchar, Amy - pharmacy market approval processes S. 150 - Affordable Prescriptions for Patients Act of 2023 - Sen. Cornyn, John - pharmacy and prescription drug prices, prevent patent thickets S. 574 - Increasing Prescription Drug Competition Act - Sen. Hassan, Maggie - closure of pharmaceutical patent loophole S. 652 - Safe Step Act - Sen. Murkowski, Lisa - medication step therapy protocol S. 954 - Affordable Insulin Now Act of 2023 - Sen. Warnock, Raphael - insulin pricing and cost sharing S. 1038 - Drug Price Transparency in Medicaid Act of 2023 - Sen. Welch, Peter - drug pricing transparency S. 1269 - INSULIN Act of 2023 - Sen. Shaheen, Jeanne - insulin pricing S. 1339 - Pharmacy Benefit Manager Reform Act - Sen. Sanders, Bernie - PBM transparency S. 1542 - DRUG Act - Sen. Marshall, Roger - PBM regulation S. 2973 - Modernizing and Ensuring PBM Accountability Act - Sen. Wyden, Ron - Plan implementation S. 3934 - Increasing Access to Biosimilars Act of 2023- Sen. Cornyn, John - Medicare drug access Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; coverage of weight loss drugs; high priced drugs; patent reforms; Pharmacy Benefit Managers; and copay coupons.

Issues related to intellectual property, including copyright reform and artificial intelligence; counterfeits, including the SHOP Safe Act (S. 3934 / H.R. 8684), music licensing, and issues related to patent reform, intermediary liability, and rights of publicity. Issues related to patent reform, including the PREVAIL Act (S. 2220) and the Patent Eligibility Restoration Act (S. 2140).

Client expense: $4,380,000 · Firm income: Not reported

Medicare Part D Reform. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023. H.R.1352/S.3934: Increasing Access to Biosimilars Act of 2023. Medicare Rebate Penalty.

Client expense: $530,000 · Firm income: Not reported

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

Issues related to intellectual property, including copyright reform and artificial intelligence; counterfeits, including the SHOP Safe Act (S. 3934 / H.R. 8684), music licensing, and issues related to patent reform, intermediary liability, and rights of publicity.

Client expense: $4,470,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 - Rep. Carter, Earl - spread-pricing by PBMs for Medicaid H.R. 2880 - Protecting Patients Against PBM Abuses Act - Rep. Carter, Earl - PBM transparency H.R. 5372 - Expanding Seniors Access to Lower Cost Medicines Act of 2023 - Rep. Joyce, John - generic drugs, biosimilars cost H.R. 5378 - Lower Costs, More Transparency Act - Rep. McMorris Rodgers, Cathy - PBM transparency H.R. 5385 - Medicare PBM Accountability Act - Rep. Landsman, Greg McMorris - PBM transparency H.R. 6283 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 6963 - Pediatric Cancer Drug Supply Act of 2024 - Rep. Eshoo, Anna - establishes agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs H.R. 7635 - The 340B PATIENTS Act of 2024- Rep. Matsui, Doris - ensures accessibility of drugs under 340B drug discount program S. 79 - Interagency Patent Coordination and Improvement Act of 2023 - Sen. Durbin, Richard - prescription drug patenting S. 113 - Prescription Pricing for the People Act of 2023 - Sen. Grassley, Chuck - PBM transparency S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 - Sen. Cantwell, Maria - PBM transparency S. 142 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - pharmacy and biosimilar prescription drugs S. 148 - Stop STALLING Act - Sen. Klobuchar, Amy - pharmacy market approval processes S. 150 - Affordable Prescriptions for Patients Act of 2023 - Sen. Cornyn, John - pharmacy and prescription drug prices, prevent patent thickets S. 574 - Increasing Prescription Drug Competition Act - Sen. Hassan, Maggie - closure of pharmaceutical patent loophole S. 652 - Safe Step Act - Sen. Murkowski, Lisa - medication step therapy protocol S. 954 - Affordable Insulin Now Act of 2023 - Sen. Warnock, Raphael - insulin pricing and cost sharing S. 1038 - Drug Price Transparency in Medicaid Act of 2023 - Sen. Welch, Peter - drug pricing transparency S. 1269 - INSULIN Act of 2023 - Sen. Shaheen, Jeanne - insulin pricing S. 1339 - Pharmacy Benefit Manager Reform Act - Sen. Sanders, Bernie - PBM transparency S. 2973 - Modernizing and Ensuring PBM Accountability Act - Sen. Wyden, Ron - Plan implementation S. 3934 - Increasing Access to Biosimilars Act of 2023- Sen. Cornyn, John - Medicare drug access Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; coverage of weight loss drugs; patent reforms; Pharmacy Benefit Managers; and copay coupons.

Draft, Broker Accountability Act (no bill number) - ACA Agent/Broker accountability H.R. 35 - Close the Medigap Act of 2023 - Rep. Doggett, Lloyd - Medigap policies H.R. 3746 - Fiscal Responsibility Act of 2023 - Rep. McHenry, Patrick - work requirements for federal programs H.R. 3875 - Expanded Telehealth Access Act - Rep. Sherrill, Mikie - Medicare payment for telehealth services H.R. 4411 - Medicare Advantage Integrity Act - Resident Commissioner Gonzalez-Colon, Jenniffer - disparity in MA benchmark rates H.R. 4818 - Treat and Reduce Obesity Act of 2023 - Rep. Wenstrup, Brad -Medicare Coverage of weight loss treatment H.R. 5526 - Seniors' Access to Critical Medications Act of 2023 - Rep. Harshbarger, Diana - exception for physician self-referral H.R. 5584 - Medicaid Third Party Liability Act - Rep. Burgess, Michael - amends Medicaid Third Party liability requirements H.R. 5746 - Addressing Whole Health in Medicare Advantage Act - Rep. Bilirakis, Gus - Medicare Advantage supplemental benefits H.R. 5854 - Medicare Advantage Consumer Protection and Transparency Act - Rep. Porter, Katie - Medicare Advantage organization reporting H.R. 6364 - Medicare Telehealth Privacy Act of 2023 - Rep. Balderson, Troy - Provider privacy provisions for telehealth under Medicare H.R. 6400 - To amend title XVIII of the Social Security Act to extend eligibility for certain payment increases for biosimilar biological products under the Medicare program - Rep. Cardenas, Tony - Medicare payment increase for biosimilars H.R. 6445 - Medicare Audiology Access Improvement Act of 2023 - Rep. Bilirakis, Gus - Medicare Audiology Coverage H.R. 7147 - Medicare Transaction Fraud Prevention Act - Rep. Schweikert, David - oversight of payments for medical equipment & clinical DLTs under Medicare H.R. 7148 - Medicare Home Health Accessibility Act - Rep. Smucker, Lloyd - occupational therapy eligibility for home health coverage under Medicare H.R. 7254 - Hearing Device Coverage Clarification Act - Rep. Fischbach, Michelle - excludes fully implanted active middle ear hearing devices from the hearing aid coverage exclusion under Medicare H.R. 7274 - Connecting Caregivers to Medicare Act of 2024 - Rep. Carey, Mike - outreach, education, and simplify information for family caregivers on Medicare benefits H.R. 7432 - Sickle Cell Disease Comprehensive Care Act - Rep. Burgess, Michael - enables State Medicaid programs to provide coordinated care through health home to individuals with sickle cell disease H.R. 7512 - Real-Time Benefit Tool Implementation Act - Rep. Arrington, Jodey - implementation of real-time benefit tools under part D of under Medicare H.R. 7573 - Stop Unfair Medicaid Recoveries Act - Rep. Schakowsky, Janice - Medicaid Estate Recovery Program H.R. 7619 - Expand the Behavioral Health Workforce Now Act - Rep. Neguse, Joe - education, training, recruitment, and retention of mental health and substance use disorder providers under Medicaid and CHIP H.R. 7623 - Telehealth Modernization Act of 2024 - Rep. Carter, Earl L. Buddy - makes certain telehealth flexibilities permanent under Medicare H.R. 7856 - Promoting Responsible and Effective Virtual Experiences through Novel Technology to Deliver Improved Access and Better Engagement with Tested and Evidence-based Strategies Act (PREVENT DIABETES Act)- Rep. DeGette, Diana - Medicare, coverage, preventive care, chronic care H.R. 7863 - To require the Secretary of Health and Human Services to issue guidance on furnishing behavioral health services via telehealth to individuals with limited English proficiency under Medicare program. - Rep. Steel, Michelle - Medicare, behavioral health, telehealth, accessibility H.R. 7939 - Patient Access to Innovative New Technologies Act of 2024 - Rep. Carey, Mike - Medicare, quality, medical devices, coverage H.R. 8018 - Alleviating Barriers for Caregivers Act- Rep. Cammack, Kat - review and simplify caregiver paperwork, CHIP, Medicare, Medicaid H.R. 8064 - Help Extend Auditory Relief Act of 2024- Rep. Cartwright, Matt - Medicare coverage of hearing aids H.R. 8075 - Improving Access to Home Dialysis Act of 2024- Rep. Miller, Carol - Medicare coverage of home dialysis H.R. 8115 - To amend title XIX of the Social Security Act to allow for the deferral or disallowance of portions of payments for certain managed care violations under Medicaid- Rep. Sarbanes, John - Medicaid managed care payment deferral H.R. 8261 - Preserving Telehealth, Hospital, and Ambulance Access Act- Rep. Schweikert, David - extend flexibilities and payment for Medicare H.R. 8702 - Improving Seniors Timely Access to Care Act - Rep. Mike Kelly - prior authorization, transparency, MA S. 838 - Improving Access to Mental Health Act - Sen. Stabenow, Debbie - mental health services in Medicare S. 2880 - Expanded Telehealth Access Act - Sen. Daines, Steve - Medicare payment for telehealth services S. 3573 - Medicare Advantage Supplemental Benefits Transparency Act- Sen. Warner, Mike - MA, data transparency, supplemental benefits S. 3578 - Protect Medicaid Act - Sen. Cassidy, Bill - prohibits federal payments under Medicaid for noncitizens, requires reporting to HHS of states that provide such health benefits S. 3630 - Medicare Transaction Fraud Prevention Act- Sen. Braun, Mike- pilot program for predictive risk-scoring algorithm, oversight, Medicare S. 3651 - Telemental Health Care Access Act of 2024- Sen. Cassidy, Bill - Medicare, mental health services, telehealth S. 3766 - Connecting Caregivers to Medicare Act of 2024- Sen. Tillis, Thomas - Medicare, outreach and education, caregivers S. 3882 - Helping States Integrate Medicare and Medicaid Act- Sen. Casey, Robert - dual eligibles, quality measures, access, enrollment S. 3934 - Increasing Access to Biosimilars Act of 2023- Sen. Cornyn, John - Medicare drug access S. 3950 - Delivering Unified Access to Lifesaving Services Act of 2024 - Sen. Cassidy, Bill - reforming Integrated Medicare/Medicaid Care Programs for Dually Eligible Individuals S. 4094 - PREVENT DIABETES Act - Sen. Scott, Tim - Medicare, coverage, preventive care, chronic care S. 4532 - Improving Seniors Timely Access to Care Act - Sen. Marshall, Roger - prior authorization, transparency, MA Issues related to mental health and Medicare; Medicare and Medicaid funding; Medicaid expansion; State innovation waivers; Medicaid and CHIP; Medicaid FMAP; Medicare Supplement Coverage; Medicaid Access Final Rule; Medicaid Redeterminations; value of Medicaid Managed Care; Medicare Advantage Health Risk Assessment; coverage of weight loss drugs; and Inflation Reduction Act implementation.

Issues related to intellectual property, including copyright reform and online infringement, counterfeits, including the SHOP Safe Act (S. 3934), music licensing, patent reform, Copyright Office modernization, issues related to the Digital Millennium Copyright Act, and issues related to intermediary liability.

Client expense: $4,350,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)

H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 - Rep. Carter, Earl - spread-pricing by PBMs for Medicaid H.R. 2880 - Protecting Patients Against PBM Abuses Act - Rep. Carter, Earl - PBM transparency H.R. 5372 - Expanding Seniors Access to Lower Cost Medicines Act of 2023 - Rep. Joyce, John - generic drugs, biosimilars cost H.R. 5378 - Lower Costs, More Transparency Act - Rep. McMorris Rodgers, Cathy - PBM transparency H.R. 5385 - Medicare PBM Accountability Act - Rep. Landsman, Greg McMorris - PBM transparency H.R. 6283 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 6963 - Pediatric Cancer Drug Supply Act of 2024 - Rep. Eshoo, Anna - establishes agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs H.R. 7635- The 340B PATIENTS Act of 2024- Rep. Matsui, Doris - ensures accessibility of drugs under 340B drug discount program S. 79 - Interagency Patent Coordination and Improvement Act of 2023 - Sen. Durbin, Richard - prescription drug patenting S. 113 - Prescription Pricing for the People Act of 2023 - Sen. Grassley, Chuck - PBM transparency S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 - Sen. Cantwell, Maria - PBM transparency S. 142 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - pharmacy and biosimilar prescription drugs S. 148 - Stop STALLING Act - Sen. Klobuchar, Amy - pharmacy market approval processes S. 150 - Affordable Prescriptions for Patients Act of 2023 - Sen. Cornyn, John - pharmacy and prescription drug prices S. 574 - Increasing Prescription Drug Competition Act - Sen. Hassan, Maggie - closure of pharmaceutical patent loophole S. 652 - Safe Step Act - Sen. Murkowski, Lisa - medication step therapy protocol S. 954 - Affordable Insulin Now Act of 2023 - Sen. Warnock, Raphael - insulin pricing and cost sharing S. 1038 - Drug Price Transparency in Medicaid Act of 2023 - Sen. Welch, Peter - drug pricing transparency S. 1269 - INSULIN Act of 2023 - Sen. Shaheen, Jeanne - insulin pricing S. 1339 - Pharmacy Benefit Manager Reform Act - Sen. Sanders, Bernie - PBM transparency S. 3934- Increasing Access to Biosimilars Act of 2023- Sen. Cornyn, John - Medicare drug access Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; contraceptive coverage; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; issues related to coverage of EUA drugs under Medicare Part D; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; direct-to-consumer advertising for prescription drugs; issues relating to access for investigational drugs; issues related to comparative effectiveness research and quality-adjusted life years; issues related to health plan step-therapy; and other issues relating to health care reform implementation.

H.R. 35 - Close the Medigap Act of 2023 - Rep. Doggett, Lloyd - Medigap policies H.R. 3746 - Fiscal Responsibility Act of 2023 - Rep. McHenry, Patrick - work requirements for federal programs H.R. 3875 - Expanded Telehealth Access Act - Rep. Sherrill, Mikie - Medicare payment for telehealth services H.R. 4411 - Medicare Advantage Integrity Act - Resident Commissioner Gonzalez-Colon, Jenniffer - disparity in MA benchmark rates H.R. 5526 - Seniors' Access to Critical Medications Act of 2023 - Rep. Harshbarger, Diana - exception for physician self-referral H.R. 5584 - Medicaid Third Party Liability Act - Rep. Burgess, Michael - amends Medicaid Third Party liability requirements H.R. 5746 - Addressing Whole Health in Medicare Advantage Act - Rep. Bilirakis, Gus - Medicare Advantage supplemental benefits H.R. 5854 - Medicare Advantage Consumer Protection and Transparency Act - Rep. Porter, Katie - Medicare Advantage organization reporting H.R. 6364 - Medicare Telehealth Privacy Act of 2023 - Rep. Balderson, Troy - Provider privacy provisions for telehealth under Medicare H.R. 6400 - To amend title XVIII of the Social Security Act to extend eligibility for certain payment increases for biosimilar biological products under the Medicare program - Rep. Cardenas, Tony - Medicare payment increase for biosimilars H.R. 6445 - Medicare Audiology Access Improvement Act of 2023 - Rep. Bilirakis, Gus - Medicare Audiology Coverage H.R. 7147 - Medicare Transaction Fraud Prevention Act - Rep. Schweikert, David - oversight of payments for medical equipment & clinical DLTs under Medicare H.R. 7274 - Connecting Caregivers to Medicare Act of 2024 - Rep. Carey, Mike - outreach, education, and simplify information for family caregivers on Medicare benefits H.R. 7432 - Sickle Cell Disease Comprehensive Care Act - Rep. Burgess, Michael - enables State Medicaid programs to provide coordinated care through health home to individuals with sickle cell disease H.R. 7512 - Real-Time Benefit Tool Implementation Act - Rep. Arrington, Jodey - implementation of real-time benefit tools under part D of under Medicare H.R. 7573 - Stop Unfair Medicaid Recoveries Act - Rep. Schakowsky, Janice - Medicaid Estate Recovery Program H.R. 7619 - Expand the Behavioral Health Workforce Now Act - Rep. Neguse, Joe - education, training, recruitment, and retention of mental health and substance use disorder providers under Medicaid and CHIP H.R. 7623 - Telehealth Modernization Act of 2024 - Rep. Carter, Earl L. - makes certain telehealth flexibilities permanent under Medicare S. 838 - Improving Access to Mental Health Act - Sen. Stabenow, Debbie - mental health services in Medicare S. 2880 - Expanded Telehealth Access Act - Sen. Daines, Steve - Medicare payment for telehealth services S. 3573- Medicare Advantage Supplemental Benefits Transparency Act- Sen. Warner, Mike - MA, data transparency, supplemental benefits S. 3578- Protect Medicaid Act - Sen. Cassidy, Bill - prohibits federal payments under Medicaid for noncitizens, requires reporting to HHS of states that provide such health benefits S. 3630- Medicare Transaction Fraud Prevention Act- Sen. Braun. Mike- pilot program for predictive risk-scoring algorithm, oversight, Medicare S. 3651- Telemental Health Care Access Act of 2024- Sen. Cassidy, Bill - Medicare, mental health services, telehealth S. 3766- Connecting Caregivers to Medicare Act of 2024- Sen. Tillis, Thomas - Medicare, outreach and education, caregivers S. 3882- Helping States Integrate Medicare and Medicaid Act- Sen. Casey, Robert - dual eligibles, quality measures, access, enrollment S. 3934- Increasing Access to Biosimilars Act of 2023- Sen. Cornyn, John - Medicare drug access S. 3950 - Delivering Unified Access to Lifesaving Services Act of 2024 - Sen. Cassidy, Bill - reforming Integrated Medicare/Medicaid Care Programs for Dually Eligible Individuals Issues related to mental health and Medicare; Medicare and Medicaid funding; Medicaid expansion; State innovation waivers; Medicaid and CHIP; Medicaid FMAP; issues related to Medicare Advantage payment, including Medicare Payment Advisory Commission analyses and the 2025 Advance Rate Notice for MA and Part D; MedPAC analysis of MA payments, MA CY 2025 rate notice; MA risk adjustment; prior authorization in Medicare and Medicaid; MA coverage in rural areas; and issues related to implementation of the Inflation Reduction Act, including reform of the Medicare Part D program. Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and risk adjustment data validation (RADV) audit issues including RADV regulation for MA; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); issues related to Medicare for All, Medicare buy-in, reduced Medicare eligibility age, and public option; issues relating to 2024 Rate Notice; issues related to the expiration of Medicaid continuous eligibility and transitions in coverage; issues related to coverage in non-Medicaid Expansion States (e.g., Gap Population); issues related to expanded Medicare fee for service benefits (dental, hearing and vision); issues related to specialty infant formula; issues related to the Inflation Reduction Act implementation; contraceptive coverage and reproductive health; Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; issues related to Managed Long Term Services and Supports (MLTSS); issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to the end of the public health emergency, including the Medicaid unwinding; telehealth; issues related to the cost of insulin, including price, copays, rebates, and medical management tools; issues related to health equity; issues related to artificial intelligence; issues related to vaccination; issues related to audio-only telehealth; issues related to addressing the social determinants of health, including housing, transportation, nutrition, educational opportunities, and MA supplemental benefits; issues related to Medicaid presumptive eligibility and continuous eligibility; issues relating to Medicaid best price; in-home health risk assessments; Medicare Medical Loss Ratio issues; issues related to changes to prior authorization regulations or legislation, electronic documentation, and related issues; issues relating to sequestration under the Medicare Advantage and Part D programs; implications of physician fee schedule on MA; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); issues related to the international price index; issues related to child and maternal health; issues related to Medicaid supplemental and disproportionate share hospital (DSH) funding; issues related to Medicaid funding for territories; issues related to medical management; issues relating to MA supplemental benefits; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value based payment models; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; issues relating to MACRA, including implications for MA and Part D plans; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); issues relating to potential Medicare mental health parity requirements; Medicaid managed care regulations and policies, including the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues related to health homes for children with medically complex conditions; socioeconomic status impacts on star ratings related to MA and Part D programs; issues related to private equity ownership transparency; and other issues relating to health care reform implementation.

Issues related to intellectual property, including copyright reform and online infringement, counterfeits, including the SHOP Safe Act (S. 3934), music licensing, patent reform, Copyright Office modernization, issues related to the Digital Millennium Copyright Act, and issues related to intermediary liability.

Client expense: $4,460,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)