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Compliance Sweep · 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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Governance & business operationsCompliance SweepNew in this edition

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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Governance & business operationsCompliance SweepNew in this edition

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.

Medium priority · Nov 8, 2026 editionRead story →

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Payment & health plan rulesCompliance SweepNew in this edition

OIG adds FAQ: a gift card offered to a Federal health care program beneficiary to induce transfer to an affiliated hospital implicates the anti-kickback statute, and the Beneficiary Inducements CMP for Medicare and State health care program beneficiaries

On November 5, 2026 HHS OIG added a third question to its FAQ page on the application of certain fraud and abuse authorities to certain types of arrangements. The new FAQ addresses whether a hospital may offer a Federal health care program beneficiary or family member a gift card as an incentive to transfer to another hospital in the same health system. For that arrangement, OIG says it would have significant concerns, that the Federal anti-kickback statute would be implicated, that the Beneficiary Inducements Civil Monetary Penalty (CMP) would be implicated if the patient is a Medicare or State health care program beneficiary, and that no safe harbor or exception would apply. OIG defines 'same health system' broadly to cover any affiliated hospital. It lists unfair competition and steering, higher program costs (for example a transfer to a critical access hospital) and quality-of-care risk, and says other forms of transfer remuneration should be evaluated case by case. The FAQ states it does not supersede EMTALA requirements or hospital Conditions of Participation.

Medium priority · Nov 8, 2026 editionRead story →

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Governance & business operationsCompliance SweepNew in this edition

Off-campus provider-based departments need a separate NPI and a provider-based attestation (by December 31, 2027 for departments furnishing services on or before January 1, 2028), or lose OPPS payment from January 1, 2028

CMS codified section 6225 of the Consolidated Appropriations Act, 2026 at new 42 CFR 419.23 and 413.65(b)(6). No Outpatient Prospective Payment System (OPPS) payment may be made for items and services furnished on or after January 1, 2028, by an off-campus outpatient department unless the department has its own NPI separate from the main provider and the main provider has submitted an initial provider-based attestation. For departments furnishing services on or before January 1, 2028, initial attestations must be submitted between January 1, 2026 and December 31, 2027; a department is all hospital operations at one physical address listed in the Provider Enrollment, Chain, and Ownership System (PECOS). Before attesting, the main provider must obtain an NPI for each department and update PECOS. Departments that received an affirmative provider-based determination before January 1, 2026 must submit a new attestation. A timely attestation counts even if CMS has not issued a determination by the first date of service. CMS will use a standardized form and a centralized electronic system, will not require supporting documentation with the initial attestation, and will use risk-based review, remote audits and site visits; until the new system is final, attestations may go to the Medicare Administrative Contractor (MAC) under existing 413.65(b)(3)(ii).

Medium priority · Nov 8, 2026 editionRead story →

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