|
Congressional:
Senate Continues to Negotiate Appropriation Bill Package, Shutdown Possibility Looms
Senate Democratic and Republican leaders continue working on a time agreement to allow passage of five of the remaining six spending bills, as well as providing a two-week continuing resolution (CR) to support programs under the Department of Homeland Security (DHS) spending bill. The deal would provide funding through September 30 for five of the six outstanding FY2026 funding bills, including Health and Human Services, plus a bipartisan health care package, and a short-term DHS CR through February 13, to give Congress additional time to negotiate policy reforms within DHS. Should the compromise funding measure pass the Senate, the House of Representatives would have to pass the funding bills as well. The House is scheduled to return to Washington on Monday, but some press reports indicate that the House Rules Committee may meet Sunday afternoon if the Senate is successful in passing the bills.
The compromise came together following the Senate's rejection by a vote of 45-55 of a procedural move to advance the six-bill House-passed spending package, the Consolidated Appropriations Act, 2026 (H.R.7148), on Thursday. The House passed the current bills last Thursday, January 22, by a vote of 341-88 for H.R.7148, and by a vote of 220-207 for H.R.7147, the Department of Homeland Security Act, 2026, but they were combined (with an additional two bills) when sent to the Senate.
Representative Buchanan Announces Retirement After 10 Terms
On Tuesday, Representative Vern Buchanan (R-FL), Chair of the Ways and Means Health Subcommittee, announced that he will not seek reelection this year after nearly two decades in Congress. Buchanan is a longtime member of the Ways and Means Committee and a founding member of the House's "Make America Healthy Again Caucus."
Executive Branch:
President Trump Launches the “Great American Recovery Initiative” to Address the Addiction Crisis
On Thursday, President Donald Trump signed an executive order (EO) directing the federal government to coordinate a response to substance use. Trump, joined by Cabinet members and advisers in the Oval Office, said the "Great American Recovery Initiative" would lead the country to prevent addiction rather than reacting to it. The initiative will be led by Health and Human Services Secretary Robert F. Kennedy Jr. and Kathryn Burgum, the spouse of Interior Secretary Doug Burgum. Members of the initiative will also include several Cabinet secretaries and agency directors across the government. According to the EO, the initiative will be tasked with recommending steps to coordinate the government's response to addiction, setting goals for progress, and providing updates to the public while increasing awareness about addiction. It will also advise agencies about integrating prevention, early intervention, treatment, recovery support, and reentry into public health, health care, criminal justice, workforce, education, housing, and social services systems. Read the fact sheet here and the EO here.
Department of Labor Proposes Pharmacy Benefit Manager Fee Disclosure Rule
On Thursday, the Department of Labor’s Employee Benefits Security Administration announced a proposed rule that would require transparency into pharmacy benefit managers’ (PBMS) compensation and referral fees paid to brokers. Issued under ERISA’s statutory service provider prohibited transaction exemption, the proposed rule would, for the first time, require PBMs to disclose rebates and other payments received from drug manufacturers, compensation received when the price paid by the plan for a prescription drug exceeds the amount reimbursed to the pharmacy, and payments recouped from pharmacies in connection with prescription drugs dispensed to the plan. The proposed regulation would also permit plan fiduciaries to audit the accuracy of PBM disclosures and would provide additional relief for plan fiduciaries if a PBM fails to meet its disclosure obligations. Read the press release here and the proposed rule here.
CMS Proposes Rule to Strengthen Oversight of Organ Procurement Organizations
On Wednesday, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule to strengthen federal oversight of Organ Procurement Organizations (OPOs). The proposed rule would enhance performance measures and documentation by excluding pancreata used for islet cell research from transplantation rate measures and strengthening recordkeeping; define and deter unsafe practices through clearer standards, expanded reporting of adverse events, and stronger quality-improvement expectations; improve use of medically complex organs by requiring OPOs to assess and strengthen placement performance; increase accountability and competition by building on the 2020 framework to address underperformance and remove disincentives for high-performing OPOs; and remove outdated barriers to new OPO certification. The proposed rule is open for public comment until March, 31. Read the press release here and the proposed rule here.
HHS Issues New Guidance for Prescription Drugs Through Direct-to-Consumer Programs
On Tuesday, the Department of Health and Human Services (HHS) announced new guidance clarifying how pharmaceutical manufacturers can offer lower-cost prescription drugs directly to patients, including Medicare and Medicaid enrollees. The guidance issued provides pharmaceutical manufacturers with assurance that they may sell prescription drugs directly to patients who choose to pay cash, including patients enrolled in federal health care programs, when the arrangement meets specific conditions. These include ensuring the drug is not billed to Medicare, Medicaid, or other federal programs, is not used to market other federally reimbursable products, and is not tied to future purchases or referrals. Read the press release here, and the guidance here.
CMS Announces Selection of Drugs for Third Cycle of Medicare Drug Price Negotiation Program, Including First-Ever Part B Drugs
On Tuesday, the Centers for Medicare & Medicaid Services (CMS) announced the selection of 15 high-cost prescription drugs covered under Medicare Part D and, for the first time, drugs payable under Medicare Part B for the third cycle of the Medicare Drug Price Negotiation Program. CMS also selected one previously negotiated drug for the program’s first renegotiations. Negotiations with participating drug companies will occur in 2026, and any negotiated and renegotiated prices will become effective January 1, 2028. Drug companies with a selected drug for the third cycle of negotiations will have until February 28, 2026, to decide if they will participate in negotiations. Read the press release here.
CMS Proposes 2027 Medicare Advantage and Part D Payment Policies
On Monday, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2027 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies. If finalized, the proposed policies in the CY 2027 Advance Notice are projected to result in a net average year-over-year payment increase of 0.09 percent, or over $700 million in MA payments to plans in CY 2027. In the proposed rule, CMS says this increase takes into account various factors affecting MA payments, such as growth rates in underlying costs, 2026 Star Ratings for 2027 quality bonus payments, and risk adjustment updates. CMS is also proposing updates to the Part D risk adjustment model that include accounting for Inflation Reduction Act changes to the Part D benefit for CY 2027, reflecting more current costs, and aligning sources of diagnoses for use in risk adjustment to be consistent with similar policies proposed for MA. Read the fact sheet here and the press release here.
CMS Seeks Public Input on Strengthening Domestic Supply Chain for PPE, Essential Medicines
On Monday, the Centers for Medicare & Medicaid Services (CMS) issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking public feedback on potential approaches to strengthen the American-made supply chain for personal protective equipment (PPE) and essential medicines. The ANPRM seeks comments on new avenues the agency may consider to promote domestic purchasing by hospitals that participate in the Medicare program, including the potential creation of a new “Secure American Medical Supplies” designation for hospitals committed to American-made purchasing, and streamlined payment approaches to help offset the resource costs of domestic procurement. Comments are due by March 30. Read the press release here and ANPRM here.
Secretary Kennedy Appoints New Interagency Autism Coordinating Committee
On Wednesday, the Department of Health and Human Services (HHS) announced the appointment of 21 new public stakeholder members to the Interagency Autism Coordinating Committee (IACC). The committee, first established in 2000, is an independent panel of experts that provides recommendations to HHS and other member agencies and organizations. HHS Deputy Assistant Secretary for Media Relations, Andrew Nixon, stated that the previous committee members' terms expired last year. The committee also has 20 additional federal members, officials from federal agencies working on autism-related issues, but Nixon stated that he has not yet received an updated list of those members. Read the press release and bios of the new public stakeholder members here.
|