U.S. Senators Brian Schatz (D-HI), Roger Wicker (R-MS), Ben Cardin (D-MD), John Thune (R-SD), Mark Warner (D-VA) and Cindy Hyde-Smith (R-MS) led a bipartisan group of 60 senators in reintroducing the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act; the summary of the bill can be found here. The CONNECT for Health Act of 2023 aims to make it easier for patients to connect with their doctors by making COVID-19 era telehealth flexibilities permanent by expanding coverage of telehealth services through Medicare. Read the full press release here. Read the full bill here.

Senate Finance Committee Ranking Member Mike Crapo (R-ID) and House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) released a bicameral Request for Information (RFI) to stakeholders regarding the issue of drug shortages. Responses to the RFI are due by July 7^th. Read the announcement here. Read the letter here.

Last Thursday, June 8, 2023, the Senate Committee on Finance held a hearing to examine the impact of health care consolidation, certain ownership structures, and data transparency on health care costs for purchasers and patients. Read Mehlman Consulting’s full summary of the hearing here.

On Thursday, June 15, 2023, the Senate Committee on Health, Labor & Pensions (HELP) held an Executive Session to consider six bills: S.133 NAPA Reauthorization Act, S.134 Alzheimer’s Accountability and Investment Act, S.265 SIREN Reauthorization Act, S.1844 Animal Drug and Animal Generic Drug User Fee Amendments, S.1852 Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act, and S.1855 Special Diabetes Program Reauthorization Act of 2023. The Committee voted to forward each of the bills to the full Senate.

Last Friday, a bipartisan group of members launched an effort to reauthorize the SUPPORT Act which is set to expire at the end of the fiscal year. The SUPPORT Act has funded opioid use disorder treatment, prevention, recovery, and enforcement. Lawmakers and witnesses discussed several improvements to the bill, including: 1) Expanding the time limit for states to use Medicaid funds to cover addiction treatment in mental health institutions. 2) Expanding access to telehealth services. 3) Providing more funding for treatment centers and sober living homes, and 4) Investing in teen addiction treatment and prevention. Read the full report here.

Next Wednesday, June 21, 2023, the House Energy and Commerce Subcommittee on Health will hold a hearing to examine the 28 legislative proposals that would build upon the SUPPORT Act and address other health issues. The Chairs released the following statement: “With more than 100,000 lives lost from drug overdoses and fentanyl poisonings last year, it’s critical that Congress address all facets contributing to increased rates of substance use disorder.” 

On Wednesday, June 14, the Centers for Medicare & Medicaid Services’ (CMS) Office of the Actuary released projections of National Health Expenditures (NHE) and health insurance enrollment for the years 2022-2031. The report also contains expected impacts from the Inflation Reduction Act and projected out-of-pocket spending on prescriptions drugs, for Medicare Part D enrollees, as Medicare begins to cover certain expenses for 2024 and beyond as several provisions begin to take effect. Read the 2022-2031 projections report here.

The Federal Drug Administration’s (FDA) independent advisers unanimously agreed Friday to recommend the agency grant full approval to an Alzheimer’s drug, Leqembi, which is made by Eisai and Biogen; the drug costs $26,500 a year. The agency is expected to decide by July 6. Leqembi would be available to Medicare recipients who participate in a patient registry to track outcomes and side effects. Read the full report here.

The Centers for Medicare & Medicaid Services (CMS) announced the list of 43 drugs in which Part B beneficiary coinsurances may be lower between July 1- September 30, 2023. The Medicare Prescription Drug Inflation Rebate Program is one of the main tools used by Medicare to address drug costs. The rebate program reduces coinsurance for some people with Part B coverage while also discouraging drug companies from increasing prices faster than inflation. CMS Administrator Chiquita Brooks-LaSure stated, “The Medicare Prescription Drug Inflation Rebate Program is a critical way to address long-term price increases by drug companies, and CMS is continuing our work to make prescription drugs more affordable for people with Medicare”. Read the announcement here. Read the listed prescription drugs here.

This week, the Biden-Harris Administration announced new tools to lower prescription drug costs for low-income people with Medicare through the Extra Help program. The Extra Help Act provides eligible seniors and disabled individuals with help paying for their Medicare Part D premiums and cost-sharing. Building onto the existing law, beginning January 1, 2024, the Inflation Reduction Act will expand the Extra Help Act eligibility for the full low-income subsidy benefit to individuals with limited resources and incomes up to 150% of the federal poverty level, or $21,870 per year. The full report, and additional efforts made by the administration, can be found here.

Last Friday, June 9, HHS, through the Health Resources and Services Administration (HRSA), launched the new Pediatric Specialty Loan Repayment Program, a $15 million investment to recruit and retain clinicians who provide health care to children and adolescents. In exchange for three years of service, the Pediatric Specialty Loan Repayment Program will provide up to $100,000 to eligible clinicians providing pediatric medical subspecialty, pediatric surgical specialty, or child and adolescent behavioral health care, including substance use prevention and treatment services. The application deadline is July 20, 2023, at 7:30 p.m. ET. Read the full report here.

COVID-19 coordinator Dr. Ashish Jha is leaving the Administration on June 15 to return to his prior role as Dean of the Brown University School of Public Health. His departure comes after the Biden Administration’s decision to end the public health emergency on May 11. Read the full report here. 

On Thursday, June 15, 2023, U.S. Senators Brian Schatz (D-HI), Roger Wicker (R-MS), Ben Cardin (D-MD), John Thune (R-SD), Mark Warner (D-VA) and Cindy Hyde-Smith (R-MS) led a bipartisan group of 60 senators in reintroducing the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act. The CONNECT for Health Act of 2023 aims to make it easier for patients to connect with their doctors by making COVID-19 era telehealth flexibilities permanent by expanding coverage of telehealth services through Medicare. Note, with telehealth flexibilities set to expire at the end of 2024, beneficiaries will lose access to care due to statutory restrictions, including requirements that only permit beneficiaries to receive telehealth services if they are in rural areas and at certain clinical sites. Previously, Senator Schatz was able to include provisions of the CONNECT for Health Act to the FY23 government funding bill, but they are set to expire in 2025. In the statement, Senator Schatz said, “While telehealth use has skyrocketed these last few years, our laws have not kept up. Telehealth is helping people in every part of the country get the care they need, and it’s here to stay.” Read the full press release here. Read the full bill here.

Senate Finance Committee Ranking Member Mike Crapo (R-ID) and House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) released a bicameral Request for Information (RFI) to stakeholders regarding the issue of drug shortages. Sen. Crapo and Rep. McMorris Rodgers noted that new medication shortages have spiked by close to 30 percent between 2021 and 2022 with the number of reported shortages being at an ‘all-time high’. Responses to the RFI are due by July 7^th. Note, drug shortages were a main theme during a recent House Energy and Commerce Subcommittee hearing on the Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization package; read Mehlman Consulting’s full summary of the hearing here. Republicans largely agreed that drug shortages in the U.S. need to be addressed and expressed a willingness to work on a bipartisan solution outside of the PAHPA reauthorization package. Note, they criticized drug price negotiation provisions in the Inflation Reduction Act (IRA) for exacerbating medical supply chain issues and expressed support for revising federal drug discount programs to ensure transparency. Read the announcement here. Read the letter here.

Last Thursday, June 8, 2023, the Senate Committee on Finance held a hearing to examine the impact of health care consolidation, certain ownership structures, and data transparency on health care costs for purchasers and patients. Members of the Committee focused on various issues such as health insurance consolidation, innovative payment models, pharmacy benefit managers (PBMs), physician payments, and hospital outpatient department cuts. Notably, Sen. Hassan (D-NH) argued that health system consolidation has led to unfair billing practices that increase the cost of care. As such, she referenced her bill with Senators Braun (R-IN) and Kennedy (R-LA), the Site-based Invoicing and Transparency Enhancement (SITE) Act, which would impose site-neutral payments on hospital outpatient departments. Read Mehlman Consulting’s full summary of the hearing here.

·        S.133 NAPA Reauthorization Act

o  Ordered to be Reported Favorably, 20 - 1

·        S.134 Alzheimer’s Accountability and Investment Act 

o  Ordered to be Reported Favorably, 20 - 1

·        S.265 SIREN Reauthorization Act - as amended

o  Ordered to be Reported Favorably, 20 - 1

·        S.1844 Animal Drug and Animal Generic Drug User Fee Amendments of 2023 - as amended

o  Ordered to be Reported Favorably, 21 - 0

·        S.1852 Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023 

o  Ordered to be Reported Favorably, 20 - 1

·        S.1855 Special Diabetes Program Reauthorization Act of 2023 

o  Ordered to be Reported Favorably, 20 - 1

Congressional Interest in Revising Major Opioids Law This Year  

Last Friday, a bipartisan group of members launched an effort to reauthorize the SUPPORT Act which is set to expire at the end of the fiscal year. The SUPPORT Act has funded opioid use disorder treatment, prevention, recovery, and enforcement. Lawmakers and witnesses discussed several improvements to the bill, including: 1) Expanding the time limit for states to use Medicaid funds to cover addiction treatment in mental health institutions. 2) Expanding access to telehealth services. 3) Providing more funding for treatment centers and sober living homes, and 4) Investing in teen addiction treatment and prevention. The law, which passed in 2018 and accounts for $21 billion in spending, has been viewed as the most substantial effort by Congress to tackle the growing opioid crisis. Read the full report here.

Next Wednesday, the House Energy and Commerce Subcommittee on Health will hold a hearing to examine the 28 legislative proposals which would build upon and strengthen the SUPPORT Act. The Chairs released the following statement: “With more than 100,000 lives lost from drug overdoses and fentanyl poisonings last year, it’s critical that Congress address all facets contributing to increased rates of substance use disorder.” Tackling the opioid crisis has remained a bipartisan issue; unless Members of Congress attempt to attach non-germane proposals to the reauthorization package, the bill will likely cross the finish line. The hearing announcement can be found here and the bills that will be examined are listed below:

·        H.R. 824, the Telehealth Benefit Expansion for Workers Act of 2023 (Reps. Tim Walberg, Suzan DelBene, Angie Craig, Ron Estes, Mikie Sherrill, Rick Allen)

·        H.R. 3892, the Improving Mental Health and Drug Treatment Act (Reps. Michael Burgess and Ritchie Torres)

·        H.R. 4091, the Combatting Substance Use Disorder Act (Reps. David Valadao and Mike Garcia)

·        H.R. 3736, the Extending Access to Addiction Treatment Act (Reps. Paul Tonko and Kelly Armstrong)

·        H.R. 4096, A bill to amend title XIX of the Social Security Act to expand the application of Medicaid State programs to monitor antipsychotic medications to all Medicaid beneficiaries. (Reps. Buddy Carter and Jan Schakowsky)

·        H.R. 4056, the Ensuring Medicaid Continuity for Children in Foster Care Act of 2023 (Reps. Gus Bilirakis and Kathy Castor)

·        H.R. 3074, the Due Process Continuity of Care Act (Reps. David Trone and Michael Turner)

·        H.R. 2400, the Reentry Act of 2023 (Reps. Paul Tonko and Michael Turner)

·        H.R. 4089, the Safer Response Act (Reps. Anthony D’Esposito and Josh Harder)

·        H.R. 4063, the FIND Fentanyl Act of 2023 (Reps. Debbie Dingell and Gus Bilirakis)

·        H.R. 4079, the Substance Use Disorder Treatment and Recovery Loan Repayment Program Reauthorization Act of 2023 (Reps. Hal Rogers and Abigail Spanberger)

·        H.R. 4100, To amend the Public Health Service Act to reauthorize a monitoring and education program regarding infections associated with illicit drug use and other risk factors. (Reps. Lori Chavez-DeRemer and Lori Trahan)

·        H.R. 4101, the Road to Recovery Act (Reps. John James and Tony Cardenas)

·        H.R. 4099, the RECONNECTS Act of 2023 (Reps. Morgan Griffith and Angie Craig)

·        H.R. 4088, the CAREER Act (Reps. Andy Barr and Sharice Davids)

·        H.R. 1502, the Comprehensive Opioid Recovery Centers Reauthorization Act of 2023 (Reps. Brett Guthrie, Scott Peters, Larry Bucshon, Paul Tonko)

·        H.R. 4098, the Communities of Recovery Reauthorization Act (Reps. Brittany Pettersen and Zach Nunn)

·        H.R. 4095, the Save Children from Trauma Act (Reps. Monica De La Cruz and Greg Landsman)

·        H.R. 4097, the Mental Health Improvement Act (Reps. Emilia Sykes and John Joyce)

·        H.R. 1839, the Combating Illicit Xylazine Act (Reps. Jimmy Panetta and August Pfluger)

·        H.R. 4053, the Studying Suboxone Act (Reps. Annie Kuster and Buddy Carter)

·        H.R.4106, To amend the 21st Century Cures Act to expressly authorize the use of certain grants to implement substance use disorder and overdose prevention activities with respect to fentanyl and xylazine test strips. (Reps. Jasmine Crockett and Lance Gooden)

·        H.R. 4057, the Keeping Kids Safe Act (Reps. Lisa Blunt Rochester and Brian Fitzpatrick)

·        H.R. 4080, the Trauma-Informed Care Task Force Reauthorization Act of 2023 (Reps. Raul Ruiz and Bob Latta)

·        H.R. 4092, the Protecting Moms and Infants Reauthorization Act (Reps. Marie Gluesenkamp Perez and Young Kim)

·        H.R. 4054, the Trauma Support and Mental Health in Schools Reauthorization Act (Rep. Nikki Budzinski)

·        H.R. 4093, the Remote Opioid Monitoring Act of 2023 (Reps. Troy Balderson and Robin Kelly)

·        H.R. 4007, the HEAL Act (Reps. Kelly Armstrong and Paul Tonko)

On Wednesday, June 14, the Centers for Medicare & Medicaid Services’ (CMS) Office of the Actuary released projections of National Health Expenditures (NHE) and health insurance enrollment for the years 2022-2031. The report also contains expected impacts from the Inflation Reduction Act and projected out-of-pocket spending on prescriptions drugs, for Medicare Part D enrollees, as Medicare begins to cover certain expenses for 2024 and beyond as several provisions begin to take effect. Read the 2022-2031 projections report here.

According to the CMS Actuary, health care spending will make up roughly 20 percent of the American economy by 2031.The latest projections follow a slight decrease in health expenditures as a share of GDP. Health care accounted for 18.3 percent of the economy in 2021 and 17.4 percent in 2022. The Center for Medicare & Medicaid Services (CMS) expects Medicaid enrollment to decline as states begin to ‘cull’ their rolls for the first time after the COVID- era rule to prohibit anyone from losing their eligibility. However, they still expect the uninsured rate to remain below 10 percent as private health insurance growth is expected to grow at 5.4 percent annually between 2022 and 2031. Read the full report here.

The Federal Drug Administration’s (FDA) independent advisers unanimously agreed Friday to recommend the agency grant full approval to an Alzheimer’s drug, Leqembi, which is made by Eisai and Biogen; the drug costs $26,500 a year. The agency is expected to make a decision by July 6. Leqembi would be available to Medicare recipients who participate in a patient registry to track outcomes and side effects. Policymakers such as Sen. Sanders (I-VT) have warned that the drug could take a serious toll on Medicare due to high demand from patients in the early stages of Alzheimer’s. Read the full report here.

The Centers for Medicare & Medicaid Services (CMS) announced the list of 43 drugs in which Part B beneficiary coinsurances may be lower between July 1- September 30, 2023. The Medicare Prescription Drug Inflation Rebate Program is one of the main tools used by Medicare to address drug costs. The rebate program reduces coinsurance for some people with Part B coverage while also discouraging drug companies from increasing prices faster than inflation. CMS Administrator Chiquita Brooks-LaSure stated, “The Medicare Prescription Drug Inflation Rebate Program is a critical way to address long-term price increases by drug companies, and CMS is continuing our work to make prescription drugs more affordable for people with Medicare”. Read the announcement here. Read the listed prescription drugs here.

Medicare Director Meena Seshamani has previously stated that Medicare beneficiaries could save anywhere from $1 to $449 per average dose of a drug on the list during the three-month period ending on September 30. Additionally, HHS released a report on Medicare Part B coverage, revealing that Medicare Part B drug spending per enrollee had an annual increase of 9.2 percent from 2008 to 2021, with the top 20 drugs accounting for more than 50 percent of spending, compared to a 2.6 percent increase for Medicare Part D. Read the announcement here. Read the listed prescription drugs here. More information on the prescription drug rebates and the report can be found here.

This week, the Biden-Harris Administration announced new tools to lower prescription drug costs for low-income people with Medicare through the Extra Help program. The Extra Help Act provides eligible seniors and disabled individuals with help paying for their Medicare Part D premiums and cost-sharing. Beginning January 1, 2024, the Inflation Reduction Act will expand the Extra Help Act eligibility for the full low-income subsidy benefit to individuals with limited resources and incomes up to 150% of the federal poverty level, or $21,870 per year. Currently, roughly three million seniors and people with disabilities who could benefit from the Extra Help program are not enrolled. As such, HHS, via the Administration for Community Living (ACL) and CMS, has announced efforts to reach eligible participants and improve enrollment in Extra Help. The full report and additional details can be found here.

Last Friday, June 9, HHS, through the Health Resources and Services Administration (HRSA), launched the new Pediatric Specialty Loan Repayment Program, a $15 million investment to recruit and retain clinicians who provide health care to children and adolescents. In exchange for three years of service, the Pediatric Specialty Loan Repayment Program will provide up to $100,000 to eligible clinicians providing pediatric medical subspecialty, pediatric surgical specialty, or child and adolescent behavioral health care, including substance use prevention and treatment services. The program will complement HRSA’s existing loan repayment and scholarship programs. On the topic, HRSA Administrator Carole Johnson stated that the agency is “focused on recruiting and training the next generation of the health care workforce” because “the cost of medical training can be a barrier for far too many people.” The application deadline is July 20, 2023, at 7:30 p.m. ET. Read the full report here.

COVID-19 coordinator Dr. Ashish Jha is leaving the Administration on June 15 to return to his prior role as Dean of the Brown University School of Public Health. Jha joined in April 2022 in replacement to Jefferey Zients who later became President Joe Biden’s Chief of Staff. His departure comes after the Biden Administration’s decision to end the public health emergency on May 11. President Biden said in a statement, “He has effectively translated and communicated complex scientific challenges into concrete actions that helped save and improve the lives of millions of Americans…"We are a stronger and healthier nation because of his contributions to public service." Read the full report here. 

House Education and Workforce Committee— Full Committee Markup: H.R.824, Telehealth Benefit Expansion for Workers Act of 2023 and H.R. 3941, Schools not Shelters Act

House Energy and Commerce Subcommittee on Health— Legislative Solutions to Bolster Preparedness and Response for All Hazards and Public Health Security Threats

Tuesday, June 13, 2023  

House Energy and Commerce Committee— “Examining Proposals that Provide Access to Care for Patients and Support Research for Rare Diseases.”

House Energy and Commerce Subcommittee on Health--- “Responding to America’s Overdose Crisis: An Examination of Legislation to Build Upon the SUPPORT Act.”

Senate Veterans’ Affairs Committee: Connections to Care: Improving Substance Use Disorder Care for Veterans in Rural America and Beyond

Wednesday, June 14^, 2023

Senate Aging Committee: Before Disaster Strikes: Planning for Older Americans and People with Disabilities in All Phases of Emergencies

Senate Health, Education, Labor, and Pensions (HELP) Committee: Business meeting to consider S.133, to extend the National Alzheimer's Project, S.134, to require an annual budget estimate for the initiatives of the National Institutes of Health pursuant to reports and recommendations made under the National Alzheimer's Project Act, S.265, to reauthorize the rural emergency medical service training and equipment assistance program, S.1844, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs, S.1852, to amend the Public Health Service Act to reauthorize a sickle cell disease prevention and treatment demonstration program, S.1855, to reauthorize the Special Diabetes Program for Type 1 Diabetes and the Special Diabetes Program for Indians, and other pending calendar business.

Senate HELP Committee: Executive Session to consider S.728, the Paycheck Fairness Act; S.1664, the Healthy Families Act; and S.567, the Richard L. Trumka Protecting the Right to Organize Act of 2023.

Senate Veterans’ Affairs Committee: Examining the Effectiveness of the Office of Integrated Veteran Care