Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) and Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) released the following statement today applauding inclusion of key health care provisions in the fiscal year 2023 omnibus funding package:
“The omnibus includes a number of key provisions championed by Energy and Commerce Committee Democrats to improve the health and well-being of the American people. It will strengthen our nation’s health agencies, better prepare us to respond to future public health emergencies, provide additional resources to address the mental health and substance use disorder crises, and improve access to care for millions of Americans.
“The bill makes key improvements to the Food and Drug Administration’s (FDA) ability to carry out its mission. The omnibus reforms the accelerated approval program to better ensure the safety and efficacy of drugs and biologics that are approved through this pathway. The legislation makes important changes to clinical trials to help improve the diversity of participants.
“The omnibus also provides additional resources to address the mental health and substance use disorder crises facing the nation, including among our youth. It reauthorizes key programs that support Americans’ mental health prevention and crisis care and substance use recovery needs, expands access to medication assisted treatment, supports the integration of care and workforce capacity and training, and establishes new programs and services including a national maternal mental health hotline and task force.
“The funding agreement includes a number of important changes to Medicaid to help improve access to high-quality health care for American families struggling to make ends meet. The bill requires 12 months of continuous coverage for children enrolled in Medicaid and CHIP and makes the state option to provide 12 months of continuous coverage during the postpartum period permanent. This coverage is critical for mothers and will help us address the unacceptable maternal mortality crisis disproportionately affecting women of color.
“Finally, the legislation authorizes the Advanced Research Projects Agency for Health, a new agency that will accelerate transformative breakthroughs to find cures and treat the world’s deadliest diseases.
“We’re incredibly proud of the health care provisions included in the omnibus and look forward to seeing them signed into law by President Biden this week.”
The omnibus includes a number of key health care provisions that were championed and negotiated by the Energy and Commerce Committee, including:
The omnibus modernizes and strengthens FDA’s ability to oversee drugs that are approved through the accelerated approval pathway. The bill requires FDA to specify conditions for required postapproval studies and authorizes the agency to require postapproval studies to be underway at the time of approval or within a specified time period following approval. The omnibus also clarifies and streamlines the existing authority to withdraw approvals where sponsors fail to conduct studies with due diligence.
The omnibus establishes the Advanced Research Projects Agency – Health (ARPA-H), an advance research entity that will accelerate innovation in health and medicine by investing in novel, broadly applicable, high-risk, high-reward research projects.
Clinical Trial Diversity:
The omnibus requires FDA to take a series of actions intended to modernize and improve clinical trials including increasing the diversity and engagement of trial participants.
The omnibus strengthens FDA’s ability to regulate the safety of cosmetics and personal care products. The bill empowers FDA to establish good manufacturing practices, requires manufacturers to report adverse events, requires manufacturing facilities to be registered, requires cosmetic product labels to list fragrance allergens and contact information to report adverse event reports, and provides FDA with mandatory recall authority. Pallone has long been a champion of cosmetics reform.
Lymphedema Compression Treatment:
The omnibus provides Medicare Part B coverage of compression garments for the treatment of lymphedema.
Medicaid and the Children’s Health Insurance Program (CHIP):
The omnibus extends funding for CHIP for two years through fiscal year 2029, requires children to be provided with 12 months of continuous coverage in Medicaid and CHIP effective January 1, 2024, and makes permanent a state option to allow states to continue to provide 12 months of continuous coverage during the postpartum period in Medicaid or CHIP.
Medicaid Funding for the U.S. Territories:
The omnibus extends Puerto Rico’s higher federal Medicaid match of 76 percent through fiscal year 2027 and permanently extends a higher federal Medicaid match of 83 percent for American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and the U.S. Virgin Islands.
Medication Assisted Treatment (MAT) & Medication Access and Training Expansion (MATE):
The omnibus expands patient access to opioid addiction treatment by making it easier for health care providers to dispense buprenorphine for opioid use disorder maintenance or detoxification treatment. The bill also requires health care providers to complete a training requirement on identifying and treating patients with substance use disorders.
Mental Health Care:
The omnibus includes a number of provisions to address the nation’s mental health crisis by strengthening, expanding, and establishing more than 30 critical programs that collectively support mental health care and substance use disorder prevention, care, treatment, peer support, and recovery support services. It reauthorizes the National Suicide Prevention Lifeline Program, the Community Mental Health Service Block Grants, and the renamed Substance Use and Prevention, Treatment, and Recovery Block Grants. The bill also includes grant funding to support the maternal mental programs, establishes a maternal mental health hotline and a related task force. It extends mental health parity to state and local government workers and bolsters the mental health and substance use disorder workforce through increased capacity and training. It also provides Medicare Part B coverage of mental health counselor and therapist services.
The omnibus provides important new authorities for improving the Strategic National Stockpile to ensure critical pandemic supplies are operational, resilient, and ready to deploy in times of need. The bill also provides critical support to the public health workforce by encouraging investments in the next generation of health care workers through grants and public health loan forgiveness.
The omnibus continues Medicare’s expanded access to telehealth by extending COVID-19 telehealth flexibilities for an additional two years, through December 31, 2024.
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