Healthcare developments · November 8, 2026

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Published November 8, 2026 · Reporting window November 1–7, 2026, Pacific. Later developments are labelled. Source coverage is incomplete; the complete reports describe the limitations.

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Eugia recalls one lot of vancomycin injection to the hospital level for glass particulate

Eugia US LLC announced a voluntary nationwide recall of one lot (3VM26026A) of Vancomycin Hydrochloride for Injection USP (United States Pharmacopeia) 1.25g/Vial-30mL to the hospital/healthcare facility/user level because a glass particle was identified inside a vial. The company announcement is dated November 6, 2026; FDA's publish date is November 9, 2026. The company says the entire lot shipped to wholesalers nationwide from September 2 through September 15, 2026, and that it has not received any adverse event reports. Holders of the lot are told to discontinue use and quarantine it immediately.

High priority · Nov 8, 2026 editionRead story →

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Governance & business operationsCompliance SweepNew in this edition

FDA early alert: ButterflyBVM bag-valve-mask resuscitators, removal of lots 000109 to 000117 and pre-use test for others

FDA issued an Early Alert on November 3, 2026 about Compact Medical's "Urgent Medical Device Recall" for certain lots of ButterflyBVM single-use bag-valve-mask resuscitators. Lots 000109 through 000117 are to be removed; individually listed earlier lots, numbered between 000081 and 000108 on the FDA page, get a correction: perform the Pre-Use Test before every use and do not use any unit that fails. The reason is a potential hole in the bellows, which FDA says can cause inadequate ventilation and hypoxia. Compact Medical sent letters on September 26 and October 7, 2026, and as of November 2, 2026 had reported no serious injuries or deaths.

High priority · Nov 8, 2026 editionRead story →

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Billing & paymentMedicare & Medicaid SweepNew in this edition

CMS issues CY 2027 Physician Fee Schedule final rule (CMS-1848-F): conversion factors fall, same-day E/M and 0-day global payment cut, new 340B Part D claims repository duty

On November 4, 2026, CMS released the CY 2027 Physician Fee Schedule (PFS) final rule, effective January 1, 2027; the rule was published in the Federal Register on November 9, 2026. CMS projects the qualifying alternative payment model (APM) conversion factor at $32.95 and the non-qualifying APM conversion factor at $32.63, decreases of 1.83% and 2.31% from CY 2026, after the one-year 2.50% CY 2026 statutory increase lapses. CMS finalized a payment reduction when a separately identifiable office/outpatient evaluation and management (E/M) visit is furnished on the same day as a 0-day global procedure, paying the most expensive service at 100% and the others at 80%, narrower than proposed. The proposal covered a visit furnished by the same physician (or a physician in the same practice) on the same day as a 0-, 10- or 90-day global procedure; the fact sheet says CMS made two significant modifications to it and does not restate the same-physician condition for the final policy. G2211 becomes modifier B1 (16% increase to the E/M code), and a voluntary B2 modifier (32%) is created for practitioners in a Shared Savings Program Accountable Care Organization (ACO) and Participant Providers in a Long-term Enhanced ACO Design (LEAD) Model ACO. The fact sheet says providers and suppliers that are 340B covered entities must submit claim data for covered Part D drugs billed to Medicare Part D and dispensed by the entity or its contractors (such as contract pharmacies) under a 340B discount to the Medicare Part D Claims Data 340B Repository, beginning with claims with dates of service on or after January 1, 2027, with the first quarterly submission deadline moved to September 30, 2027.

High priority · Nov 8, 2026 editionRead story →

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Billing & paymentMedicare & Medicaid SweepNew in this edition

Medicare to pay ASP minus 28 percent for separately payable 340B-acquired drugs at non-exempt hospitals from January 1, 2027 (pass-through drugs, vaccines and non-opioid pain relief drugs excluded); every separately paid OPPS drug line must carry modifier JG, TB or ND

Based on its 2026 drug acquisition cost survey, CMS finalized payment for separately payable 340B-acquired drugs, other than drugs with pass-through payment status, vaccines and non-opioid pain relief drugs with status indicator K1, at average sales price (ASP) minus 28 percent for CY 2027 and subsequent years, choosing its alternative proposal over the proposed ASP minus 33.4 percent; separately payable non-340B drugs are generally still paid at ASP plus 6 percent. The cut is budget neutral within the Hospital Outpatient Prospective Payment System (OPPS), raising non-drug payment rates by an estimated 7.50 percent, and also applies (not budget neutral) to 340B drugs furnished in non-excepted off-campus provider-based departments (PBDs). Rural sole community hospitals (SCHs), children's hospitals and prospective payment system (PPS)-exempt cancer hospitals are exempt, and no add-on payment was adopted. From January 1, 2027, every separately paid OPPS drug claim line must carry JG (a separately payable drug acquired under the 340B Program at a hospital subject to the cut; it triggers the reduction), TB (informational; the rule's summary lists it for 340B-acquired drugs at exempt hospitals and for pass-through and non-opioid pain relief drugs, while the detailed discussion describes TB as marking drugs bought with a 340B discount) or ND (not acquired under 340B; the proposal used placeholder XX). How a pass-through or non-opioid pain relief drug bought without a 340B discount is reported should be confirmed against the rule's final modifier table and CMS claims instructions. CMS estimates OPPS 340B drug payments fall about $4.65 billion and total 340B drug spending about $5.45 billion in CY 2027.

High priority · Nov 8, 2026 editionRead story →

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Labor Department finalizes PBM fee-disclosure rule for large self-insured ERISA health plans

The Labor Department's Employee Benefits Security Administration (EBSA) published a final rule (Regulation Identifier Number (RIN) 1210-AB37, 29 CFR part 2550) requiring providers of pharmacy benefit management services, and affiliated brokerage and consulting providers, to disclose compensation to fiduciaries of large self-insured Employee Retirement Income Security Act (ERISA) group health plans as a condition of the ERISA section 408(b)(2) prohibited transaction exemption. The rule is effective January 4, 2027, and applies to plan years beginning on or after July 1, 2027. Initial disclosures are due in writing reasonably in advance of the date the contract or arrangement is entered into, extended or renewed; for an extension or renewal, the rule text deems 90 calendar days in advance a reasonable period, and the preamble describes that as applying absent an agreement between the provider and the plan to a longer timeframe, followed by semiannual disclosures or quarterly at the plan's request. Under the administrative exemption, if a service provider does not comply with a written request within 90 calendar days, the responsible plan fiduciary must decide whether to terminate or continue the arrangement and document the basis.