On Thursday, the Senate passed the National Defense Authorization Act of 2024 (NDAA) (H.R. 2670), following the House passing the legislation last Wednesday. The legislation proposes $886.3 billion in national security spending, mostly within the Department of Defense. The bill now heads to President Biden and he is expected to sign it into law soon.

On Monday, the House advanced the Lower Costs, More Transparency Act, as amended (H.R. 5378). The legislation codifies and expands transparency reporting requirements for insurers, hospitals, and pharmacy benefit managers (PBMs). It also renews several federal health programs, including extensions for community health centers, the National Health Service Corps, and the special diabetes program.

On Tuesday, the Senate Health Education Labor and Pensions (HELP) Committee advanced four bills, including Senate HELP Chairman Bernie Sanders (I-VT) and Ranking Member Bill Cassidy’s (R-LA) bipartisan bill, the SUPPORT for Patients and Communities Reauthorization Act. The Committee also advanced the SCREENS for Cancer Act of 2023 (S. 1840), the Advancing Research in Education Act (S. 3392), and the Modernizing Opioid Treatment Access Act (S. 644).

On Thursday, the Biden Administration announced that dozens of pharmaceutical companies will be required to pay rebates to Medicare for price hikes on prescription drugs taken by over 750,000 Medicare beneficiaries. The Administration also announced a new requirement to include a fair pricing clause under contracts for medical countermeasures developed or bought under an HHS Administration for Strategic Preparedness and Response (ASPR) contract. 

On Monday, the House advanced the Lower Costs, More Transparency Act, as amended (H.R. 5378), in a 320-71 vote. The legislation would codify and expand transparency reporting requirements for insurers, hospitals, and pharmacy benefit managers (PBMs).  It also renewed several federal health programs, including extensions for community health centers, the National Health Service Corps, and the special diabetes program. Additionally, it would require site-neutral payments for physician-administered drugs provided in hospital outpatient departments and provide relief for hospitals from upcoming disproportionate share hospital (DSH) payment reductions. Ranking Member of the Ways and Means Committee Richard Neal (D-MA) opposed the bill, stating it lacked ownership transparency requirements for private equity firms' purchases of health facilities, including nursing homes. Democratic leadership was split, with House Minority Leader Hakeem Jeffries (D-NY) and Minority Whip Katherine Clark (D-MA) supporting and Rep. Pete Aguilar (D-CA), chair of the House Democratic Caucus, opposing.

On Tuesday, the House also passed the Support for Patients and Communities Reauthorization Act (SUPPORT Act), as amended (H.R. 4531), in a 386-37 vote. The legislation reauthorizes several expired federal drug overdose prevention programs through fiscal year 2028, that provide access to substance use disorder treatment and recovery support services, prevention programming, and long-term recovery services. The bill would also classify the animal tranquilizer xylazine as a controlled substance for the first time by placing it as a Schedule III drug. House Energy and Commerce Republican supporters of the legislation stated that veterinarians and ranchers could still use the tranquilizer as initially intended in animals under the bill’s provisions. The bill’s passage followed the Senate Health, Education, Labor, and Pension (HELP) Committee’s advancement of the SUPPORT for Patients and Communities Reauthorization Act (S. 3393), which reauthorizes many of the same programs as the SUPPORT Act.

On Thursday, the House passed Dr. Emmanuel Bilirakis and Honorable Jennifer Wexton National Plan to End Parkinson’s Act, as amended (H.R. 2365) in a 407-9 vote. The legislation would require the Department of Health and Human Services (HHS) to carry out research to prevent and cure Parkinson's disease, known as the National Parkinson's Project.

On Thursday, the Senate passed the National Defense Authorization Act of 2024 (NDAA) (H.R. 2670), following the House passing the legislation last Wednesday. The legislation proposes $886.3 billion in national security spending, mostly within the Department of Defense. Healthcare provisions in the NDAA report included:

The package did not include House Republican-supported language barring coverage of gender-affirming care for troops or a prohibition on Covid-related mask mandates in military facilities. It also did not include a pilot program on medical marijuana use for veterans, a report on telemental health care given to service members, Senate-passed provisions targeting fentanyl trafficking, artificial insemination, and assisted reproductive technology as mandatory health care services for troops and dependents. The legislation also stripped a reauthorization of the Radiation Exposure Compensation Act (RECA) and a substantial expansion of that program with compensation and benefits for those harmed by government radiation that had been included in the Senate version of the bill. In addition, an extension of the 9-11 health fund was offset by a one-month extension in 2033 of across-the-board Medicare sequester cuts. The bill now heads to President Biden, where he is expected to sign it into law soon. Read the text of the conference report, summary, and joint explanatory statement of the FY24 NDAA conference.

On Tuesday, the Senate Health Education Labor and Pensions (HELP) Committee advanced four bills, including Senate HELP Chairman Bernie Sanders (I-VT) and Ranking Member Bill Cassidy’s (R-LA) bipartisan bill, the SUPPORT for Patients and Communities Reauthorization Act, that would reauthorize portions of a 2018 opioid law. The Committee also advanced the SCREENS for Cancer Act of 2023 (S. 1840), the Advancing Research in Education Act (S. 3392), and the Modernizing Opioid Treatment Access Act (S. 644), which would loosen restrictions on prescribing and dispensing methadone, used to treat opioid use disorder. The HELP Committee adopted seven amendments, including a substitute amendment, to the opioid reauthorization bill. The amendments included measures to authorize the review and assessment of opioid analgesic drugs, require the Department of Health and Human Services and the U.S. Attorney General to issue a joint report stating recommendations related to the criminal background check process for individuals who become peer support specialists and establish a grant program supporting trauma violence intervention and violence prevention programs. See the bill summaries and vote results here.

On Thursday, the Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT), called on Congress to ban junk food advertising to kids during a hearing on the nation's diabetes epidemic. Sanders noted other countries like Ireland, South Korea and Spain have implemented similar bans. Ranking Member Bill Cassidy (R-LA) noted the committee lacks jurisdiction over advertising, saying that Sanders shifted the original focus of the hearing away from public health topics under HELP's umbrella. The hearing also discussed policy proposals to enact a $35 copay cap. Sanders stated he is introducing legislation that would lower the costs of prescription drugs by 50% as part of his ongoing efforts to address soaring costs. Read the witness testimonies here.

On Wednesday, members of the House Energy and Commerce Committee signaled further interest during a hearing in revisiting work on a national data privacy standard in the face of the growing artificial intelligence (AI) field. During the hearing, Republicans remained concerned about potentially handicapping the cutting-edge technology with heavy-handed regulation. Officials from the Health and Human Services, Commerce, and Energy departments testified on how their offices are monitoring AI in the wake of growing backlash. Hearing witness Dr. Micky Tripathi, National Coordinator for Health Information Tech at HHS, said the HHS rule finalized Wednesday morning, which implements transparency requirements for developers of AI products, was akin to a “nutrition label.” Tripathi stated he hopes the transparency required of vendors will engender trust, spur adoption by clinicians, and trickle down to third-party companies that use the algorithms to populate their products. The HHS ONC office is also planning to formalize a two-part safety plan in April and October outlining infrastructure and resources for properly testing AI products and how to best store and use AI-related information reporting to inform future guidance. It is also planning to issue a plan around AI in drug development in October. Read the hearing witness testimonies here.

On Thursday, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffth (R-VA) on behalf of the Health and Oversight Republicans sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf demanding answers to questions about the agency’s work conducting inspections of drug facilities abroad. The letter cites a Bloomberg report showing that the FDA abruptly ended a program to conduct unannounced inspections in India in part due to concerns that the project would hinder efforts to deepen relations with the country. It also refers to FDA efforts to undermine the Defense Department’s bid to examine drug quality through independent testing. The letter follows up on a previous request for information about the agency’s foreign drug inspection program and comes amid the Committee’s work addressing drug shortages. Read the press release and letter here.

On Tuesday, Senate Finance Committee Chair Ron Wyden (D-OR), along with Representatives Pramila Jayapal (D-WA) and Sara Jacobs (D-CA), released the results of a new inquiry that found major pharmacy chains failed to protect the privacy of their customers. The lawmakers found that none of the major pharmacies polled required a warrant to share prescription records with law enforcement agencies unless a state law requires one. Of the eight major pharmacies they questioned, only CVS Health had committed to publishing annual transparency reports about law enforcement requests for records, though Walgreen Boots Alliance and the Kroger Company also agreed to produce transparency reports after being questioned. The members are asking the Department of Health and Human Services to improve federal health privacy regulations to better protect Americans’ prescriptions and other health records held by pharmacies, and to conduct follow-up pharmacy privacy policy surveys and publish the findings. Read the full letter here, see each pharmacy’s privacy practices here, and read the press release here.

On Thursday, Representatives Mariannette Miller-Meeks (R-IA), Ami Bera (D-CA), Larry Bucshon (R-IN), and Kim Schrier (D-WA) sent a letter, signed by 193 Members of Congress, to House and Senate leadership urging Congressional action to prevent the impending 3.37% cut in Medicare reimbursement to physicians. In the letter, the members highlighted the impacts of the cuts on seniors and underserved areas, stating, “The effects of these cuts will be exacerbated in rural and underserved areas, which continue to face significant healthcare access challenges. Medicare physicians and other providers do not receive inflationary updates in the Medicare program, which is partially why eliminating these potential cuts is so crucial.” Read the press release and letter here.

On Tuesday, Reps. Buddy Carter (R-GA), Nanette Diaz Barragán (D-CA), and Mariannette Miller-Meeks (R-IA) led a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra, Department of the Treasury Secretary Janet Yellen, and Department of Labor Acting Secretary Julie Su urging them to protect patients’ access to life-saving medications by affirming the 2020 Notice of Benefit and Payment Parameters (NBPP) Final Rule requiring that copay assistance count towards a patient’s deductible and annual limitation on cost-sharing in most instances. The letter comes after HHS filed a notice of appeal of the U.S. District Court for the District of Columbia’s decision vacating the provision of the 2021 NBPP Final Rule that allows for health insurers and plans to pocket copay assistance without applying the dollars to a patient’s deductible or out-of-pocket maximum. The letter, signed by 48 total members, is led by sponsors of the Help Ensure Lower Patient (HELP) Copays Act, which would ensure that patient’s copay assistance counts towards their deductible and out-of-pocket maximum. Read the letter here.

Late last week, Senators Bill Cassidy (R-LA), Elizabeth Warren (D-MA), Marsha Blackburn (R-TN), and Catherine Cortez Masto (D-NV) sent a letter to the Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, raising concerns about shortfalls in CMS’s data collection and reporting practices for Medicare Advantage (MA) plans. The senators are urging CMS to close data gaps to strengthen oversight of MA plans and improve care for Medicare beneficiaries. Read the press release here and the letter here.

On Wednesday, Senators Shelley Moore Capito (R-WV) and Amy Klobuchar (D-MN) introduced the Increasing Access to Quality Cardiac Rehabilitation Care Act of 2023. The bipartisan legislation would expand and expedite access to cardiac and pulmonary rehabilitation services by authorizing physician assistants, nurse practitioners, and clinical nurse specialists to order cardiac rehabilitation. Read the press release here.

On Tuesday, Representative Bonnie Watson Coleman (D-NJ) announced the reintroduction of legislation to expand healthcare options for expectant mothers. The bill, the Healthy Maternal and Obstetric Medicine (Healthy MOM) Act, would ensure that all women eligible for coverage through the Affordable Care Act (ACA) insurance marketplaces, as well as women eligible for other individual or group health plan coverage, can access affordable health coverage throughout their pregnancies. The bill would do this by establishing a special enrollment period (SEP) for expectant mothers. Senator Sherrod Brown (D-OH) will be introducing a companion bill in the U.S. Senate. Read the press release here and the bill here.

On Tuesday, Representative Vern Buchanan (R-FL), Vice Chairman of the House Ways and Means Committee and Chairman of the Health Subcommittee, introduced the Lung Cancer Screening and Prevention Act, which would ensure timely access to advanced screenings for lung cancer. The legislation would give CMS the flexibility to cover new tests already approved by the FDA without having to wait for the board to evaluate the tests. Read the press release here and the bill here.

Late last week, Reps. Mike Lawler (R-NY) and Dan Kildee (D-MI), co-chair of the bipartisan Congressional PFAS Task Force, introduced bipartisan legislation to ensure doctors have up-to-date information on how best to treat patients exposed to toxic PFAS. The Better Care for PFAS Patients Act, would require the U.S. Agency for Toxic Substances and Disease Registry (ATSDR) to work with the U.S. National Academies of Sciences, Engineering, and Medicine to update its per- and polyfluoroalkyl substances (PFAS) clinical guidance every five years, at a minimum. In 2019, ATSDR published PFAS clinical guidance in response to demand among doctors for up-to-date information on how best to treat those exposed. However, there is no requirement that ATSDR regularly update that guidance. Read the press release here.

On Tuesday, the White House announced actions and new data reflecting the administration's commitment to expanding access to long-term care and investing in the direct care workforce. New data released by the Centers for Medicare and Medicaid Services (CMS) show that the American Rescue Plan is helping to deliver about $37 billion in support across all 50 states for activities and investments that enhance, expand, and strengthen home and community-based services programs. The Centers for Medicare and Medicaid Services (CMS) is also releasing new guidance outlining how states can use worker registries for Medicaid-funded Home and community-based services to ensure beneficiaries have awareness of and access to qualified workers to deliver these critical services. Read the fact sheet here, the CMS press release here, and CMS guidance here.

Biden-⁠Harris Administration Announces Dozens of Pharma Companies Raised Prices Faster than Inflation, Triggering Medicare Rebates

On Thursday, the Biden Administration announced dozens of pharmaceutical companies will be required to pay rebates to Medicare for price hikes on prescription drugs taken by over 750,000 Medicare beneficiaries. The Department of Health and Human Services (HHS) has also announced a new list of 48 Medicare Part B drugs that raised their prices faster than inflation and may be subject to inflation rebates in the first quarter of 2024 as a result of the Inflation Reduction Act. The announcement also included a new requirement to include a fair pricing clause under contracts for medical countermeasures developed or bought under an HHS Administration for Strategic Preparedness and Response (ASPR)contract.  Read the White House fact sheet here and the HHS press release here.

HHS to Improve Maternal Health Outcomes with New CMS Care Model that Expands Access to Services, Other Proven Maternal Health Approaches 

On Friday, the Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced innovative actions to improve maternal health and birth outcomes for pregnant and postpartum women and their infants through the new Transforming Maternal Health (TMaH) Model. This 10-year payment and care-delivery model will support participating state Medicaid agencies (SMAs) in developing and implementing a whole-person approach to pregnancy, childbirth, and postpartum care for women with Medicaid and Children's Health Insurance Program (CHIP) coverage. The goal of the TMaH Model is to ensure pregnant and postpartum mothers with Medicaid or CHIP health insurance receive personalized care that can improve their health outcomes, including fewer low-risk cesarean sections, and fewer instances of severe maternal morbidity. Each participating state Medicaid agency will be eligible for up to $17 million during the model’s 10-year period. Read the press release here.

On Wednesday, HHS finalized new regulations requiring more transparency on artificial intelligence used in clinical settings to help providers avert potential risk. The regulations will apply to clinicians who use decision-support software that is HHS-certified, which the majority of hospitals and doctor’s offices nationwide use. The regulations from the Office of the National Coordinator (ONC) for Health IT fulfill requirements under President Joe Biden’s recent AI executive order and offer clarity on how algorithms work. ONC’s rules will go into effect by the end of 2024. The FDA also began regulating AI, and ONC said it worked with the agency to align regulations to reduce the burden for developers. Read the HHS press release here and the White House brief here.

On Wednesday, the Centers for Medicare & Medicaid Services (CMS) sent a letter to pharmacy benefit managers and insurers surrounding concerns about the sustainability of independent and small pharmacies and urged them to engage in sustainable and fair practices for reimbursement of vaccines and drugs with all pharmacies, including independent pharmacies. The letter stated, “CMS is very concerned about payment practices that may impede access to recommended vaccinations, and it is imperative that plans and PBMs take immediate steps to ensure adequate payment for and access to vaccines.” It also warned PBMs and plans of anti-competitive behavior of steering patients toward their own pharmacies. CMS said it closely monitors compliance with network adequacy standards and other requirements. Read the letter here.

On Tuesday, the Department of Health and Human Services (HHS) named the first five organizations that can join its nationwide health data-sharing initiative, a major milestone in a process that Congress set off in 2016. Electronic health record giant Epic; health information network eHealth Exchange; interoperability platform Health Gorilla; KONZA, a nonprofit that supports health information exchanges; and health IT firm MedAllies are the first that will go live in HHS’ Trusted Exchange Framework and Common Agreement. The five entities are called qualified health information networks, or QHINS, and can begin the process of sharing information in the network-to-network exchange. HHS has asked the nonprofit The Sequoia Project to oversee the effort. HHS believes the project can bolster patient care by allowing providers to have a longer-term picture of patients’ medical history, enhance research and ensure patients have ready access to their health records. The initiative also aims to better connect providers, public health agencies, researchers, and others in medicine through a nationwide network and facilitate sharing of patient information. Read the press release here.

On Tuesday, in a new report, the Government Accountability Office (GAO) found the number of disputes between providers and insurers over surprise medical bill payments in the federal independent dispute resolution process, established by the No Surprises Act and overseen by the Departments of Labor, HHS, and Treasury has been challenging over 490,000 disputes submitted from April 2022 - June of 2023, about 20 times more than they estimated. The report also found 61% of the disputes were unresolved as of June 2023. Services provided in emergency rooms constituted 73% of dispute resolution requests in the second quarter of 2023, and inpatient hospital stays constituted 16% of the dispute requests. Both providers and insurers told GAO they believe the process, which has drawn several legal challenges, is flawed, open to bias, and marred by a lack of consistency in the decisions arbitrators’ hand down. Read the report here and highlights here.

Late last week, the Medicare Payment Advisory Commission (MedPAC), a congressional advisory that provides Congress with analysis and policy advice on the Medicare program, released draft recommendations for Congress to reduce Medicare payments to nursing homes, home health agencies, and inpatient rehabilitation facilities in 2025. The draft recommendations call for base payment rate cuts of 7% for home health agencies, 5% for inpatient rehabilitation facilities, and 3% for nursing homes in 2025. The proposals reflect commission findings of significant profit margins on Medicare fee-for-service beneficiaries for each service provider type. The commission’s draft recommendations will be formally voted on in January 2024. If finalized, the recommendations will then be included in the commission’s March 2024 report to Congress on Medicare payment policy. Read the meeting transcript here.