On Wednesday, the House adopted a motion to vacate the chair, removing Speaker Kevin McCarthy from his leadership role in a 216-210 vote. Eight Republicans led by Congressman Matt Gaetz (R-FL) voted with all House Democrats to remove McCarthy. Rep. Patrick McHenry (R-NC) was named Speaker Pro Tempore.

On Saturday afternoon, the House passed a Continuing Resolution (CR) to fund the government for 45 days through November 17 by a vote of 335-91. Later that day, the Senate passed the bill by a vote of 88-9. President Biden signed the CR into law on Saturday night.

On Tuesday, the Biden-Harris Administration announced that manufacturers of all ten drugs selected for negotiation have signed agreements to participate in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. The agency is expected to send its first offer to the companies on Feb. 1, 2024, and finalize negotiations on August 1st of next year.

On Saturday night, the Senate passed the House’s stopgap measure to fund the government for the next 45 days by a vote of 88-9. The bill, which passed the House on Saturday by a vote of 335-91, was signed by President Biden on September 30 and will fund the government through November 17. The legislation includes $16 billion in disaster relief funding and an extension of the Federal Aviation Administration (FAA) authorization but excludes Ukraine aid.

Health provisions in the CR bill include delaying cuts to the hospital disproportionate share program (DSH), reducing funding in the Medicaid Improvement Fund to $6.36 billion from $7 billion, allowing authorities to respond to certain public health threats, and extending the FDA Animal Durg User Fee Through 2028. It also extends the Community Health Center Program, the Teaching Health Center Program, the National Health Service Corps, and the Special Diabetes Program through Nov. 17.

Read the bill here.

On Saturday, the Senate unanimously passed the bipartisan, bicameral Maternal and Child Health Stillbirth Prevention Act (S. 2231), which would ensure certain stillbirth prevention initiatives can qualify for federal funding. Senator Chuck Grassley (R-IA) introduced the bill alongside Sens. Jeff Merkley (D-OR) and Bill Cassidy (R-LA), as well as Reps. Ashley Hinson (R-IA) and Alma Adams (D-NC). The bill now moves onto the House.

On Tuesday, Sen. Edward Markey (D-MA) and Rep. Barbara Lee (D-CA) led 18 of their colleagues in urging the Biden-Harris administration to develop and publicly announce a national fentanyl harm reduction strategy specifically focused on enhancing public health infrastructure and addressing the collateral consequences that stem from drug arrests and convictions. The lawmakers emphasized that this strategy should support increased availability of local overdose prevention centers (OPCs) and expanded access to vital medical interventions, including naloxone, drug testing strips, sterile syringes and pipes, methadone, and buprenorphine. Read the press release here and the letter here.

On Tuesday, Sen. Elizabeth Warren (D-MA) and Rep. Pramila Jayapal (D-WA) asked antitrust regulators to examine UnitedHealth Group Inc.’s planned $3.3 billion purchase of home-health provider Amedisys Inc. and challenge deals that bring medical providers under the same ownership as health insurers. The letter renews attention to the investigation of the deal initiated by the Department of Justice (DOJ) in August. Warren and Jayapal urged the antitrust regulators to “to closely scrutinize” the deal and “oppose the growing trend of insurers buying up health care providers to reduce competition.” Read the letter here.

On Wednesday, Reps. Van Duyne (R-TX), Blumenauer (D-OR), Wenstrup (R-OH), and Panetta (D-CA) from the House Ways and Means Committee sent a letter to CMS outlining their concerns with CMS’ proposed hospice rule echoing concerns by major hospice associations. In its 2024 proposed home health pay rule, CMS said it would use Medicare hospice data, including surveys and claims data, to identify hospices that should be in the program and rank hospices. In the letter, the lawmakers stated the metrics CMS will use to make decisions, including onsite surveys and the Hospice Care Index, often have missing data, and hospices that provide all information requested could risk being placed in the program. The members proposed CMS should return to expert-panel recommendations and offer hospices a preview of their rankings using the metrics the agency decides on. Read the letter here.

On Friday, Senate Health, Education, Labor and Pensions (HELP) Ranking Member Bill Cassidy (R-LA) called on Congress to examine the Food and Drug Administration’s (FDA) recently proposed rule amending FDA regulations to classify Laboratory Developed Tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act. The proposed rule would increase FDA’s regulatory oversight and enforcement over the development, production, and distribution of LDTs. Cassidy stated the FDA "does not have the authority to unilaterally expand its regulatory jurisdiction." House Energy and Commerce Chair Cathy McMorris Rodgers (R-WA) echoed Cassidy's comments Friday, stating, "Any LDT policy should go through the legislative process with deliberative consideration by the committees of jurisdiction." HELP Chair Bernie Sanders (I-VT) and Energy and Commerce Ranking Member Frank Pallone (D-NJ) have not commented on the FDA's proposed rule. Read the FDA proposed rule here, Cassidy’s statement here, and Rodger's statement here. 

Notable Bills Introduced:

On Wednesday, Senators Kyrsten Sinema (I-AZ), Marsha Blackburn (R-TN), and Amy Klobuchar (D-MN) introduced the Sustainable Cardiopulmonary Rehabilitation Services in the Home Act, bipartisan legislation that would permanently restore Medicare patients’ ability to receive cardiac and pulmonary rehabilitation services at home through telehealth. The ability of Medicare providers and beneficiaries to receive in-home, virtual cardiac rehabilitation ended with the end of the Public Health Emergency on May 11, 2023. Read the press release here and the bill here.

Late last week, Representatives Debbie Dingell (D-MI) and David Valadao (R-CA), co-chairs of the Congressional Asthma and Allergy Caucus, along with Brian Fitzpatrick (R-PA), and Lisa Blunt Rochester (D-DE) reintroduced the Elijah E. Cummings Family Asthma Act. The bill (1) expands the CDC’s National Asthma Control Program to all 50 states, (2) directs the CDC to collaborate with state and local health departments to provide information and education to the public regarding asthma, and (3) requires the development of state plans around public health responses to asthma, particularly for disproportionately affected populations, and mandates the collection and coordination of data on the impact of asthma. Read the press release here and the bill here.

Late last week, Representatives Steve Cohen (R-TN) and Garret Graves (R-LA) and Senator Chris Van Hollen (D-MD) introduced the Nationally Enhancing the Wellbeing of Babies through Outreach and Research Now (NEWBORN) Act, which would create infant mortality-focused pilot programs in high-risk areas of the country, educating at-risk and potential mothers about pregnancy and prenatal care. The legislation would also create a better understanding of the causes of infant mortality and best practices for preventing it. Read the press release here. 

On Tuesday, the Biden-Harris Administration announced that manufacturers of all ten drugs selected for negotiation have signed agreements to participate in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. In total, the 10 drugs selected for negotiation accounted for $3.4 billion in out-of-pocket costs for an estimated 9 million Medicare enrollees in 2022. The Centers for Medicare and Medicaid Services (CMS) is scheduled to hold listening sessions with patients, caregivers, consumer organizations, and others from Oct. 30 to Nov. 15. The agency is expected to send its first offer to the companies on Feb. 1, 2024, and finalize negotiations Aug. 1 of next year. Prices would be published Sept. 1, taking effect in 2026. Read the press release here.

On Tuesday, the Departments of Health and Human Services, Labor, and the Treasury announced a request for information (RFI) on how best to ensure coverage and access to over-the-counter (OTC) preventive services, including the benefits of requiring most health insurance plans to cover these services at no cost and without a prescription by a health care provider. The RFI solicits comments on access to a range of OTC items recommended by experts for preventive care that can be purchased without a prescription, including contraceptives, tobacco smoking cessation products, folic acid during pregnancy, and breastfeeding supplies. Read the press release here and the RFI here.

Late last week, the Department of Health and Human Services (HHS), through CMS, sent a letter to state health officials reinforcing that states must provide 12 months of continuous coverage for children under the age of 19 on Medicaid and the Children’s Health Insurance Program (CHIP) beginning January 1, 2024. The letter describes policies related to implementing continuous coverage for children as required by the Consolidated Appropriations Act of 2023 and reminds states that they can request section 1115 demonstration authority under the Social Security Act to extend the continuous coverage period for children beyond 12 months and to adopt continuous coverage for adults eligible for Medicaid. Read the press release here and the letter here.

On Wednesday, HHS through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced nearly $35 million in grant funding has been awarded this month to bring essential behavioral health services and HIV prevention and care to historically underserved populations. The grant awards facilitate ongoing efforts throughout the nation in treatment, recovery support, and harm reduction. Read the press release here.

On Wednesday, Lisa Gomez, the Assistant Secretary for Employee Benefits Security at the Department of Labor (DOL), invited the public to contact the agency if they believe they face “especially high hurdles” to get mental health or substance disorder benefits from their employer health plan. In a DOL blog post, Gomez stated that the Mental Health Parity and Addiction Equity Act (MHPAEA) requires that employers that provide mental health benefits “not make it more difficult for someone to use their plan to access care for a mental health condition or substance use disorder than to access medical or surgical care, but that promise has not been kept.” The agency, along with HHS and the Internal Revenue Service, have responded with a proposed rule that states what employers must do to comply with the law. Read the post here.

On Monday, the HHS’ Office of Inspector General (OIG), released a report which examined the prices and costs related to biosimilars in Medicare Part B from 2015 to 2021 and concluded opportunities for substantial spending reductions still exist. The report found that biosimilars and the associated biologics’ prices generally both fell after biosimilars were introduced. However, if biosimilars had been used more often, Part B spending could have fallen by $179 million, or 4 percent, in 2021. And basing payment on the lowest-cost drug could have cut spending by $419 million in 2021. Read the report here.

On Tuesday, the FDA granted an emergency authorization to an updated COVID-19 vaccine from Novavax Inc., the only approved traditional protein-based COVID-19 vaccine on the market. The authorization comes after the agency approved updated shots from Moderna Inc. and Pfizer Inc./BioNTech SE-ADR last month but delayed Novavax's authorization. Read the press release here. 

On Friday, U.S. District Judge Michael J. Newman of the Southern District of Ohio denied a U.S. Chamber of Commerce request for an injunction to block the Biden administration's drug pricing negotiation program, allowing it to continue for now. The lawsuit, filed by the U.S. Chamber and three other chambers, argues the program, which requires manufacturers of some of the costliest drugs to negotiate lower prices with HHS, violates the First Amendment, due process rights, and other laws. Newman said the Chamber did not demonstrate a strong likelihood of success or irreparable harm in their case. Newman also rejected the Biden administration's motion to dismiss, which argued the chamber does not have standing to sue because it is not directly participating in the negotiation program. Newman requires the chamber to amend its initial complaint by Oct. 13 to address the Biden administration's standing arguments. Read the case here.

On Friday, U.S. District Judge John D. Bates of the District of Columbia ruled CMS must withdraw a Trump-era rule on copay assistance programs, following claims from drug industry-backed patient groups that the policy has allowed health plans to increase out-of-pocket prescription drug costs for consumers. The 2020 rule said pharmacy benefit managers do not have to count drugmaker copay assistance toward patients’ out-of-pocket costs. Bates stated the rule from the Centers for Medicare & Medicaid Services appears to conflict with the definition of “cost-sharing” in the Affordable Care Act and federal regulations. The ruling is a win for the HIV + Hepatitis Policy Institute, the Diabetes Leadership Council, and the Diabetes Patient Advocacy Coalition, which filed the lawsuit in August 2022. Read the ruling here.

AstraZeneca Settles Heartburn Drug Lawsuit For $425 Million

On Tuesday, AstraZeneca announced it will pay $425 million to settle thousands of lawsuits from users who claimed the company's heartburn drugs caused damage to their kidneys. The settlement resolves all but one claim arguing that AstraZeneca did not adequately warn patients of the impacts of Prilosec and Nexium. The lawsuits allege that the medications cause kidney injuries that often lead to chronic kidney disease and end-stage renal failure.

On Wednesday, Amgen Inc., Gilead Sciences Inc., Novartis AG, Merck & Co., AbbVie Inc., and about two dozen other life sciences organizations and trade associations created a coalition to oppose changes to federal antitrust deal review. The Partnership for the US Life Science Ecosystem, or PULSE, launches Wednesday with 31 members. The group says it will work to raise awareness of the value of mergers and acquisitions in the sector in response to the Federal Trade Commission and Justice Department efforts to crack down on deal activity with new merger guidelines and changes to the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

On Wednesday, more than 75,000 Kaiser Permanente workers went on strike in the largest US healthcare walkout in history. The three-day action could stall services for almost 13 million people in at least half a dozen states and is expected to shut down nonessential services. Kaiser Permanente is one of America’s largest healthcare providers, operating 39 hospitals nationwide.