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Congressional:
Senate Passes Two Alzheimer's Disease Bills
On Wednesday, the Senate passed two bills by unanimous consent addressing Alzheimer’s disease. The National Alzheimer's Project Act (NAPA) Reauthorization Act would extend through 2035 the National Alzheimer's Project, which supports coordination of federal planning, programs, and other efforts to address Alzheimer's disease and related dementias. The Alzheimer's Accountability and Investment Act would require the National Institutes of Health to annually submit, beginning in FY2024, an estimate of its budget and personnel needs for carrying out initiatives pursuant to the National Alzheimer's Project directly to the President for review and transmittal to Congress. Both bills now move on to the House.
Senate HELP Committee Advances Older Americans Act and Other Health Bills
On Wednesday, the Senate Health, Education, Labor and Pensions (HELP) Committee marked up three health care bills, advancing all three on a bipartisan basis. The Older Americans Act Reauthorization, sponsored by Chairman Bernie Sanders (I-VT) and Ranking Member Bill Cassidy (R-LA), would reauthorize the legislation through 2029, with a 20 percent funding increase from $2.3 billion this year to $2.76 billion in fiscal 2025. The bill additionally authorizes a 44 percent funding increase over the next five years to $3.3 billion in fiscal 2029. The committee also advanced the Autism CARES Act sponsored by Sen. Ben Ray Lujan (D-NM) that would boost funding for federal autism programs and research, and a bill to reauthorize traumatic brain injury programs sponsored by Sen. Markwayne Mullin (R-OK) that would reauthorize the traumatic brain injury program at the Centers for Disease Control and Prevention through 2029. Read Mehlman’s markup summary here.
Senate Appropriations Committee Passes Fiscal 2025 HHS Spending Bill
On Thursday, the Senate Appropriations Committee held a markup on four fiscal year 2025 appropriations bills: Energy & Water, Defense, Labor HHS, and Financial Services. The committee advanced all four bills, with the Fiscal Year 2025 Labor, Health and Human Services, Education, and Related Agencies Appropriations Act (LHHS) advancing on a 25-3 vote. The LHHS bill provides $122.8 billion in discretionary funding for the Department of Health and Human Services and $50.224 billion in base discretionary funding for the National Institutes of Health (NIH). Read the bill text, summaries, and reports here.
Notable Bills Introduced:
Sens. Wyden, Blackburn Introduce Bipartisan Legislation to Tackle Health Care Workforce Shortages
On Thursday, Senators Ron Wyden (D-OR) and Marsha Blackburn (R-TN) introduced bipartisan legislation to address the persistent shortage of health professionals. The Health Workforce Innovation Act provides federal support for innovative, community-led partnerships to educate and train more health care workers, especially in rural and underserved communities. Specifically, the legislation would establish a new federal grant program to support community health centers and rural health clinics to carry out innovative, community-driven models to train and develop a pipeline of a wide range of allied health professionals, including through partnerships with high schools, community colleges, and other entities. Read the press release here and the bill here.
Reps. Wexton and Bilirakis Introduce Bipartisan HEALTHY BRAINS Act to Advance Research into Neurodegenerative Diseases Risks
On Thursday, Reps. Jennifer Wexton (D-VA) and Gus Bilirakis (R-FL) introduced the Harmonizing Environmental Analyses and Launching Therapeutic Hubs to Yield Bolstered Research And Innovation in Neurological Science (HEALTHY BRAINS) Act to bolster research into the environmental risk factors, including environmental toxicants exposures, of neurodegenerative diseases such as Parkinson’s disease and atypical parkinsonian disorders, Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), and multiple sclerosis (MS). The HEALTHY BRAINS Act would catalyze the advancement of research into the environmental risks for neurodegenerative diseases by directing the National Institutes of Health (NIH) to establish Collaborative Centers for Neurodegenerative Disease Environmental Research to conduct and support basic, applied, and clinical research on the effects of environmental risk factors. Read the press release here and the bill here.
Sens. Durbin, Cassidy Introduce Legislation to Lower Drug Prices by Promoting Generic Competition
On Wednesday, Senate Majority Whip Dick Durbin (D-IL) and Senator Bill Cassidy, M.D. (R-LA) introduced a bipartisan bill to tackle certain efforts by the pharmaceutical industry to extend monopolies on lifesaving drugs. The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act would promote competition by removing barriers to Food and Drug Administration (FDA) approval for lower-cost generic drugs. Specifically, the bill would remove incentives for drug manufacturers to file additional patents and would lift barriers that delay generic market entry, allowing generic drug manufacturers to enter the market more easily. Read the press release here and the bill here.
Rep. Guthrie Introduces Bill to Increase Access to Life-saving Drugs
On Tuesday, Brett Guthrie (KY-02), Chairman of the House Energy & Commerce’s Health Subcommittee, introduced the Patient Access Act (H.R. 9184) to help provide greater access to life-saving therapies, including potentially curative cell-and-gene therapies. The legislation would allow drug manufacturers of life-saving therapies to cover the costs of incidentals for a patient and up to two caregivers throughout the duration of the treatments. Read the press release here and the bill here.
Sens. Casey, Braun Introduce Bill to Expand Access to Comprehensive Care for People with Complex Medical Needs Through the Program of All-Inclusive Care for the Elderly
Late last week, Senators Bob Casey (D-PA) and Mike Braun (R-IN), Chairman and Ranking Member of the Senate Special Committee on Aging, introduced the bipartisan PACE Anytime Act. The bill would expand access to the PACE program. Currently, eligible older adults and people with disabilities can only enroll in a PACE program on the first of every month. The PACE Anytime Act removes enrollment barriers by allowing eligible individuals to enroll anytime during the month. Read the press release here and the bill summary here.
Executive Branch:
CMS Releases FY 2025 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule
On Thursday, the Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), issued the fiscal year (FY) 2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) final rule. The rule finalized a mandatory payment model for select hospitals participating in Medicare to improve care after surgery and reduce costs. The five-year model would begin in 2026 and will test whether lump sum payments for all of the care surrounding five common, costly procedures can reduce Medicare expenditures. CMS estimated the model will save Medicare $481 million over five years. The rule also increased the operating payment rates for certain acute care hospitals in FY 2025 by 2.9% and will increase the LTCH PPS standard Federal payment rate by 3.0%. Additionally, CMS will pay small independent hospitals to establish and maintain a buffer stock of essential drugs to help mitigate drug shortages. Read the press release here and the fact sheet here.
CMS Releases 2025 Medicare Part D Bid Information and Announces Premium Stabilization Demonstration
On Monday, the Centers for Medicare & Medicaid Services (CMS) released preliminary technical Medicare Part D bid information for contract year 2025 to help Part D plan sponsors finalize their Part D and Medicare Advantage (MA) offerings and prepare for Medicare Open Enrollment. The average monthly beneficiary premium for Medicare prescription drug coverage is expected to be $36.78 next year, or $2.08 more than in 2024. Additionally, CMS announced a voluntary, nationwide payment demonstration designed to help Part D drug plans adjust to the changing coverage landscape under the Inflation Reduction Act, which changed the basic Medicare Part D drug benefit. In 2025, the legislation caps beneficiary out-of-pocket drug costs at $2,000 and allows beneficiaries to spread out their drug costs over the entire year. Read the fact sheet here.
Deadline For Medicare Drug Price Negotiation Ends, Prices to Be Announced by Next Month
Thursday was the deadline for the Centers for Medicare and Medicaid Services (CMS) to wrap up negotiations with drug makers on the prices of the first ten drugs eligible under the 2022 Inflation Reduction Act (IRA). CMS has until September 1 to announce what the negotiated prices are. It is possible the announcement could come earlier and coincide with the Democratic National Convention later this month. The negotiated prices will not go into effect until 2026.
FDA Approves Guardant's Colorectal Cancer Blood Test
On Monday, the Food and Drug Administration approved Guardant's colorectal cancer blood test, making it the first FDA-backed blood test for primary screening for colorectal cancer and a potential supplement to colonoscopies for cancer screening. The blood test, marketed as Shield, is approved for adults ages 45 and older who are at moderate risk of developing colon cancer. Guardant expects that the test will be eligible for Medicare coverage. A panel of FDA's independent advisors back in May voted that the test is safe and effective and that its benefits outweigh its risks. Read the press release here.
NIST Releases Artificial Intelligence Risk Management Guidance
Late last week, the National Institute of Standards and Technology released broad guidance on AI risk, stating that the technology sector should address the risks that generative artificial intelligence models will leak private health information, enable cyberattacks, and produce incorrect answers. The guidance called on technology companies to carefully review the data they use to train their models to ensure it does not include confidential information, allow people to remove their personal information from the data used to train AI systems, and identify racial and gender bias in training data to prevent discriminatory outcomes. The standards are voluntary but meant to serve as a starting point for global leaders, US officials, and technology companies to discuss guardrails for the technology. NIST standards on other topics are often cited in legislation. President Biden directed NIST to write the guidelines in a broad executive order last October. Read the guidelines here.
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