The Regulator

December 15: that is the deadline to comment on the Medicare proposal that would police what pharmacy benefit managers (PBMs) earn from Part D drug plans, which the Federal Register published today. The Centers for Medicare & Medicaid Services (CMS) issued the proposed rule, CMS-4214-P, on October 16 to carry out three sections of the Consolidated Appropriations Act, 2026. Section 6224 would limit PBM pay tied to Part D drug use, require data reporting to plans and CMS, add transparency for PBM price guarantees and for terms of PBM-manufacturer agreements, and let CMS recover (disgorge) money paid in violation. Section 6220 sets Medicare Advantage provider directory duties, including verification, annual accuracy reporting and in-network cost-sharing protection for patients misled by a wrong listing, starting in contract year 2028, with public display of accuracy scores in 2029. Section 6219 cuts the generic drug copay from $1 to $0 for the poorest full-benefit dual-eligibles from January 1, 2028. Who it hits: Part D plan sponsors, PBMs and their affiliates, and Medicare Advantage plans. CMS gave no cost or savings estimate, and its fact sheet does not give an effective date for the PBM provisions. This continues our October 17 coverage; the new development is the formal comment clock. Confidence: High on the deadline and provisions. Sources: Federal Register, CMS-4214-P (2026-21420), CMS fact sheet on CMS-4214-P.

The Food and Drug Administration (FDA) approved GSK’s immunotherapy Jemperli on October 19 for certain rectal cancers, a drug that may let patients skip chemotherapy, radiation and surgery. The accelerated approval covers adults with previously untreated stage II or III locally advanced rectal cancer whose tumors are mismatch repair deficient or microsatellite instability-high, about 3% of such cancers. In the 154-patient interim analysis of the phase 2 AZUR-1 trial, almost three-fourths of patients had not needed surgery, radiotherapy or chemotherapy after a median follow-up of more than two years. FDA says longer follow-up is needed to show how long responses last, and GSK must confirm benefit to keep the approval. The review finished nearly four months early under the Commissioner’s National Priority Voucher pilot, its 11th approval. The release gives no price. So what: payers and hospitals will weigh a drug course against what a surgery-based pathway costs, but no cost data is public yet. Confidence: High on the approval and trial figures. Sources: FDA press announcement.

CMS announced $16.4 million for rural health care workforce training and retention in Maryland on October 19. The money comes from the $50 billion Rural Health Transformation Program. Maryland plans to use it for registered apprenticeships and job training, reducing the financial barriers to certification, recruiting and retaining nurses, physician assistants, physicians and dentists, and preparing middle and high school students for health careers, including support for dental assistant tuition, transportation and uniforms. CMS named no grantees and gave no split by activity. Who it hits: rural Maryland employers and trainees, and it follows similar awards to Ohio, New Hampshire and Montana last week. Confidence: High on the amount. Sources: CMS press release.

A Connecticut physician and his two practices will pay $866,539 and be excluded from federal health programs for three years to settle False Claims Act allegations. The Office of Inspector General (OIG) of the Department of Health and Human Services posted the October 16 settlement with Dr. Steven Murphy, Murphy Medical Associates and Diagnostic and Medical Specialists of Greenwich, both in Stamford, with the U.S. Attorney’s Office for the District of Connecticut. OIG’s page describes the matter as COVID-19-related fraud and health care fraud, but does not state the billing period or specific conduct. So what: a three-year exclusion means no Medicare or Medicaid payment for services he orders or provides. Confidence: High on amount and exclusion; Low on the underlying conduct. Sources: HHS-OIG enforcement action.

The U.S. Attorney’s Office for the District of Puerto Rico created an Interagency Fraud Enforcement Task Force on October 16. Acting U.S. Attorney Héctor Ramírez Carbó announced a coordinated effort to detect, investigate and prosecute fraud against government programs and the public funds behind them, bringing together federal law enforcement, state partners and inspectors general. OIG’s posting names no agencies, dollar figures or health-specific targets, so how much of the work will focus on Medicare or Medicaid is not confirmed. Confidence: High on the creation; Low on health care scope. Sources: HHS-OIG enforcement posting.