|
Congressional:
House E&C Health Subcommittee Holds Hearing on the Prescription Drug Supply Chain
On Wednesday, the House Energy & Commerce Health Subcommittee held a hearing on the prescription drug supply chain, the second hearing in the Committee’s health affordability series. During the hearing, full Committee Chair Brett Guthrie (R-KY) pointed to the provisions in the fiscal 2026 spending package enacted this month (PL 119-75), noting that they will improve pharmacy benefit manager (PBM) pricing transparency and reduce incentives for PBMs to promote higher-priced drugs to Medicare Part D beneficiaries. He stressed that the "Historic PBM reform is just the beginning," and more needed to be done throughout the drug supply chain to improve affordability. Other committee Republicans and Democrats focused on the impacts of vertical integration, including insurers owning PBMs or group purchasing organizations (GPOs) and pharmacies. Several Democrats also focused on the details of drugmakers’ meetings and agreements with President Donald Trump regarding voluntary most-favored-nation (MFN) drug pricing deals. Health Subcommittee Chair Morgan Griffith (R-VA) stated after the hearing that he hopes to markup affordability legislation before Memorial Day. Read the witness testimonies here.
Senate Aging Committee Holds Hearing on Federal Policies and Physician Practices
On Wednesday, the Senate Special Committee on Aging held a hearing entitled " The Doctor Is Out: How Washington’s Rules Drove Physicians Out of Medicine.” During the hearing, Chair Rick Scott (R-FL) argued that federal mandates and administrative requirements forced doctors to focus on compliance over care, causing burnout, doctor shortages, and worse patient outcomes, especially in rural and underserved areas. Ranking Member Kirsten Gillibrand (D-NY) acknowledged that burnout remains a major issue and emphasized the importance of regulations to protect patient safety. She called for reforms, including streamlining prior authorization, improving electronic health records, and banning anti-competitive contracts. Witnesses included three CEOs of hospital systems and primary care practices, as well as the CEO of the Lorna Breen Heroes’ Foundation. Read the opening statements and witness testimonies here.
Cornyn Leads GOP Colleagues in Calling on DOJ to Recoup Fraudulent ACA Subsidy Payments
On Wednesday, Senator John Cornyn (R-TX) led 14 of his Senate Republican colleagues in sending a letter to U.S. Department of Justice (DOJ) Civil Division Assistant Attorney General Brett Shumate calling on the Department to investigate and pursue civil remedies to recover Affordable Care Act (ACA) subsidy payments made during the Biden administration to insurance companies due to fraudulent, unauthorized, or improper enrollment in insurance plans. Read the press release and letter here.
House Judiciary Chairmen Jordan, Fitzgerald, and Van Drew Subpoena Insurance Providers for Documents About ACA Fraud
On Tuesday, House Judiciary Committee Chairman Jim Jordan (R-OH), Subcommittee on the Administrative State, Regulatory Reform, and Antitrust Chairman Scott Fitzgerald (R-WI), and Subcommittee on Oversight Chairman Jeff Van Drew (R-NJ) issued subpoenas to eight health insurance companies about fraud in Affordable Care Act (ACA) subsidies. The subpoenas seek information on each company's fraud-protection measures after the companies “failed to fully comply with the Committee's voluntary process.” Read the press release and letters here.
Notable Bills:
Wyden, Senate Democrats Introduce Bill to Restore Quality Care in Nursing Homes
On Thursday, Senate Finance Committee Ranking Member Ron Wyden (D-OR), along with Senators Andy Kim (D-NJ), Cory Booker (D-NJ), Richard Blumenthal (D-CT), Chris Murphy (D-CT), Elizabeth Warren (D-MA), and Ben Ray Lujan (D-NM), introduced the Nurses Belong in Nursing Homes Act. The legislation would restore many provisions of the Biden Administration's nursing home staffing rule. Specifically, the bill would require a nurse to be in a nursing home 24/7, create a federal minimum staffing standard that each resident receives at least three and a half hours of nursing care per day, and provide permanent funding for nursing home inspections, surveys, and enforcement to make sure nursing homes comply with staffing requirements. Read the press release here and the bill here.
Representatives Beyer, Buchanan Introduce Bipartisan Legislation to Protect Hospitals from Natural Disasters
On Wednesday, Representatives Don Beyer (D-VA) and Vern Buchanan (R-FL), Vice Chairman of the House Ways and Means Committee, introduced the bipartisan Protecting Hospitals from Disaster Act to help hospitals, clinics, and other health care facilities prepare for extreme weather and natural disasters without compromising patient care and routine services. The bill would expand the role of Quality Improvement Organizations (QIO) to provide direct support to health care providers as they prepare for and respond to disasters, including mitigating physical risks to facilities and reducing chronic health risks to patients. Read the press release here and the bill here.
Senators Daines and Smith Introduce the Expanded Telehealth Access Act
On Wednesday, Senators Steve Daines (R-MT) and Tina Smith (D-MN) introduced the Expanded Telehealth Access Act, which would increase health care access by expanding the types of health care practitioners who may provide telehealth services under Medicare to include audiologists, physical therapists, occupational therapists, and speech-language pathologists, among others. Read the press release here and the bill here.
Representatives Salinas, Moolenaar, Tokuda, Moylan Lead Bipartisan Effort to Save Rural Hospitals and Clinics
On Wednesday, Representatives Andrea Salinas (D-OR), John Moolenaar (R-MI), Jill Tokuda (D-HI), and James Moylan (R-Guam-AL) introduced the Rural Health Care Facilities Revitalization Act. The legislation would authorize rural health facilities to use federal USDA funds to refinance debt, update technology, and support operating expenses to ensure their long-term financial stability. Read the press release here and the bill here.
Senators Warren, Hawley Introduce Bipartisan Bill to Break Up Big Medicine
On Tuesday, Senators Elizabeth Warren (D-MA) and Josh Hawley (R-MO) introduced the Break Up Big Medicine Act. The legislation would prohibit parent companies from simultaneously owning medical providers or management services organizations and PBMs, insurers, or drug and medical device wholesalers; create automatic penalties for noncompliance, including profit disgorgement and forced asset sales; authorize enforcement actions by the Federal Trade Commission (FTC), Department of Health and Human Services (HHS), Department of Justice (DOJ), state attorneys general, and private parties; and allow the FTC and DOJ to review and block future transactions that would recreate these conflicts of interest. Read the press release here and the bill here.
Representatives Auchincloss and Bergman Introduce Community Health Center Drug Pricing Protection Act
On Tuesday, Representatives Jake Auchincloss (D-MA) and Jack Bergman (R-MI) introduced the Community Health Center Drug Pricing Protection Act to exempt Community Health Centers (CHCs) and Federally Qualified Health Centers (FQHC) from the Trump administration’s proposed 340B Rebate Model Pilot Program. The legislation would exempt FQHCs and CHCs from rebate-based pricing by prohibiting manufacturers from charging more than the 340B ceiling price at the time of purchase, providing CHCs and FQHCs with financial reprieve in the near-term while lawmakers continue to negotiate on the 340B Program. Read the press release here and the bill here.
Senators Marshall, Gillibrand, & Baldwin Introduce Bipartisan Legislation to Strengthen Maternal & Infant Health
On Monday, Senators Roger Marshall (R-KS), Kirsten Gillibrand (D-NY), and Tammy Baldwin (D-WI) introduced bipartisan legislation to reauthorize the Healthy Start program, a federal initiative that supports community-based efforts to improve maternal and child health outcomes before, during, and after pregnancy. Healthy Start provides targeted funding to communities experiencing disproportionately high rates of adverse maternal and infant health outcomes, including infant mortality rates at least 1.5 times the national average, as well as elevated rates of preterm birth, low birth weight, and maternal illness. Read the press release here and the bill here.
Senators Gillibrand, Scott Introduce Legislation to Promote Drug Origin Transparency
Late last week, Senators Kirsten Gillibrand (D-NY) and Rick Scott (R-FL) introduced the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. The legislation would require prescription drug labels to disclose the original manufacturers of prescription drugs and APIs to ensure patients, providers, and regulators have clear, upfront information about where the drugs they rely on day after day are made. Read the press release here and the bill here.
Executive Branch:
CMS Issues Notice of Benefit and Payment Parameters for 2027 Proposed Rule
On Monday, the Centers for Medicare & Medicaid Services (CMS) issued the proposed “Notice of Benefit and Payment Parameters” for the 2027 plan year. The proposed rule would set 2027 payment parameters, risk adjustment and risk adjustment data validation provisions, and user fee rates for issuers selling plans through Federally-facilitated and State-based Exchanges. It would also eliminate standardized plan option requirements and limits on non-standardized plans, allow certification of non-network plans, and revise provider access and essential community provider standards for plan certification. It would expand and codify eligibility for hardship exemptions, update cost-sharing rules for catastrophic and bronze plans, and establish multi-year contract standards for catastrophic coverage. The proposal also includes stronger conduct and marketing oversight of agents, brokers, and web-brokers, increased civil money penalties for issuer noncompliance, implementation of a State Exchange Improper Payment Measurement program, revisions to states’ responsibilities for defraying state-mandated benefits beyond essential health benefits, a prohibition on including routine adult dental services as an essential health benefit, and seeks public comment on potential adjustments to the individual market medical loss ratio standard and other provisions. Comments on the proposed rule are due by March 11. Read the press release here and the fact sheet here.
HRSA Issues Request for Information on 340B Rebate Model Pilot Program
On Friday, the Health Resources and Services Administration (HRSA) issued a Request for Information (RFI) to gather input from interested parties regarding the potential use of rebates to effectuate the ceiling price under the 340B Program, including the standards and procedures that should govern the approval of manufacturer rebate plans and the impacts on all stakeholders. The RFI seeks comments on whether HRSA should implement a rebate model under the 340B Program and how best to operationalize any such rebate framework for stakeholders. Comments are due by March 19, 2026. Read the RFI here.
Secretary Kennedy Announces Management Team Additions
On Thursday, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced several additions to his management team. Chris Klomp will become Chief Counselor at HHS and oversee all operations of the Department. In addition, Secretary Kennedy has named Kyle Diamantas and Grace Graham as Senior Counselors for the Food and Drug Administration (FDA) and John Brooks as Senior Counselor for the Centers for Medicare & Medicaid Services (CMS). Each of these individuals will continue to serve in their current roles in addition to serving in Secretary Kennedy’s office. Read the press release here.
FDA Issues Refusal-to-File Letter for Moderna Flu Vaccine Application
On Tuesday, Vinay Prasad, Director of the Center for Biologics Evaluation and Research (CBER), made public a February 3 refusal-to-file letter to Moderna, stating that the Food and Drug Administration (FDA) would not consider Moderna’s recent application for a seasonal flu vaccine, taking issue with its clinical trial design. Moderna submitted its license application for adults 50 and older two months ago, using a priority review voucher to expedite the review. In the letter, Prasad stated that CBER “does not consider the application to contain a trial ‘adequate and well-controlled.’” “This is because your control arm does not reflect the best-available standard of care in the United States at the time of the study,” Prasad continued. “I note that this determination is consistent with FDA’s advice given to you prior to your study.” Moderna, in response, stated that the letter was “inconsistent with previous written communications” between CBER and Moderna. Read the refusal-to-file letter here.
|