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All articles and reminders · November 8, 2026

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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76 articles and reminders, grouped by category.

Compliance Sweep

Higher-priority matters

Payment & health plan rules 3 articles and reminders

Payment & health plan rulesCompliance SweepNew in this edition

CMS proposes CARE rule (CMS-3484-P) to remove hospital and CAH obstetric training and OB QAPI requirements set for January 2027, adopt 2024 Life Safety Code, and drop exterior-window rule

On November 5, 2026, CMS issued the Cutting Administrative Requirements for Excellence in Patient Care (CARE) proposed rule, which would revise Conditions of Participation after a review of the CoPs for all 21 provider and supplier types. For hospitals and critical access hospitals (CAHs) it would remove staff training requirements for emergency services readiness (and, for hospitals, transfer protocols) and for obstetric care, and remove the OB-specific Quality Assessment and Performance Improvement (QAPI) requirements that are otherwise effective January 1, 2027. It would adopt the 2024 National Fire Protection Association (NFPA) Life Safety Code and Health Care Facilities Code. CMS estimates $320 million in savings.

Medium priority · Nov 8, 2026 editionRead story →

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 →

Payment & health plan rulesCompliance SweepNew in this edition

OIG updated its Health Care Fraud Self-Disclosure Protocol on October 15, 2026, starting the 90-day investigation clock at initial submission

OIG's updated Health Care Fraud Self-Disclosure Protocol (SDP), issued October 15, 2026, makes what OIG calls additional clarifying changes. One change moves the deadline for submitting the completed internal investigation and damages calculation from 90 days after acceptance into the SDP to 90 days after the initial submission; a disclosing party that cannot finish its investigation before sending its submission must certify in that initial submission that it will finish within 90 days of the date of the initial submission. The updated protocol states a general minimum multiplier of 1.5 times single damages and minimum settlements of $100,000 for kickback-related matters and $20,000 for other matters. Earlier editions did not report this update. OIG also listed an updated self-disclosure FAQ on November 2, 2026. The self-disclosure page now carries a question on where to disclose given the new self-disclosure options in 2026, and says conduct that implicates the False Claims Act (FCA), OIG administrative authorities and CMS administrative authorities should be disclosed to the FCA Self-Disclosure Pilot Program. The page does not mark which FAQ text changed on November 2.

Medium priority · Nov 8, 2026 editionRead story →

Governance & business operations 15 articles and reminders

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 →

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 →

Governance & business operationsCompliance SweepConditional reminder

OHCA first-year provisional NOLA (labor-cost adjustment) requests still due November 16, 2026

California's Office of Health Care Affordability (OHCA) enforces health care spending targets set by its Health Care Affordability Board, and the law lets the Board adjust targets when non-supervisory organized labor costs are expected to grow faster than the target, through a Non-Supervisory Organized Labor Adjustment (NOLA). For the first year, OHCA must receive all requests for a provisional NOLA by November 16, 2026 (by the end of October in future years). NOLAs apply to providers and fully integrated delivery systems, not health plans; a labor union may initiate a request but the regulated entity must attest, and all NOLAs are provisional until confirmed with actual expenditure data.

High priority · Nov 8, 2026 editionRead story →

Governance & business operationsCompliance SweepConditional reminder

StatStrip Gen 2.0 glucose meter Class I correction: interim safeguards until the software update

FDA identified Nova Biomedical's correction of its StatStrip Glucose Hospital Meter System as the most serious type of recall (Class I): on the Gen 2.0 model only, prior patient or quality-control information may remain on the meter screen when a barcode is scanned and, if accepted, assign a glucose result to the wrong patient. FDA issued its communication on October 20, 2026 and updated it on October 30 to clarify the recommended actions. Nova intends to roll out a software update in November 2026 in a phased manner; until then users follow updated instructions or, if an alternative meter is available, stop using the affected meter.

High priority · Nov 8, 2026 editionRead story →

Governance & business operationsCompliance SweepConditional reminder

Medline-brand beds and accessories early alert: fire and entrapment risks, use under updated instructions until repair or replacement

FDA issued an Early Alert, listed October 29, 2026, on a potentially high-risk device issue: Medline told customers on October 14, 2026 that it is removing, discontinuing and exiting the market for all Medline Brand beds and associated components, including homecare, bariatric and long-term care beds, pendants, accessories, replacement parts and bed-containing order packages. Medline identified a potential fire hazard involving the beds, hand-control pendants, control/motor boxes and actuators/motors, and a separate risk of entrapment or asphyxiation when the beds are used with any bed accessories, when a user lies on a pendant being used with the bed, or when the bed is used with loose or wobbly rails, and as of October 20, 2026 had reported two deaths and 16 serious injuries associated with these issues. Under Medline's October 24, 2026 update, covered beds, rails, mattresses and accessories may remain in use under updated instructions until the bed is repaired or replaced.

High priority · Nov 8, 2026 editionRead story →

Governance & business operationsCompliance SweepConditional reminder

B. Braun Dialog+ bloodline early alert: three Streamline Bloodline Set lots removed over connector detachment risk

FDA issued an Early Alert on a potentially high-risk device issue: B. Braun Medical Inc. has recommended to customers that lots A2600099, A2600128 and A2600136 of its Streamline Bloodline Set for Dialog+, model SL-2010M2096, be removed from where they are used or sold. B. Braun stated that a required solvent application step during assembly was not performed, leaving the dialyzer connector inadequately bonded, so the bloodline connector may detach or leak during priming or dialysis treatment, potentially leading to blood loss, clotting and occlusion of the extracorporeal circuit, or air entering the blood circuit. B. Braun sent customers a letter on October 20, 2026, and the earlier article reported FDA's device-safety listing of the alert on October 27, 2026.

High priority · Nov 8, 2026 editionRead story →

Governance & business operationsCompliance SweepConditional reminder

HemosIL AcuStar HIT-IgG(PF4-H) lot recall: destroy listed lots and document on the response form

FDA identified as the most serious type of recall the removal of four lots of an assay that, with other laboratory and clinical findings, aids in determining the risk for heparin-induced thrombocytopenia (HIT): HemosIL AcuStar HIT-IgG(PF4-H), from Instrumentation Laboratories (Werfen). Werfen found a performance issue in lots B40005, B40006, B38062 and B38063 that may cause a negative bias, so sample results could be incorrectly reported below the assay cut-off (1.00 U/mL) and be interpreted as HIT IgG antibody negative. The earlier article reported FDA's listing of the confirmed recall on October 30, 2026, and FDA says a supply interruption is expected.

High priority · Nov 8, 2026 editionRead story →

Governance & business operationsCompliance SweepConditional reminder

Transparency in Coverage final rule: phased machine-readable file and phone-disclosure duties still ahead

The Transparency in Coverage final rule (FR Doc. 2026-20447, 91 FR 63748), published in the Federal Register on October 6, 2026 and effective December 7, 2026, sets new disclosure duties for non-grandfathered group health plans and health insurance issuers: in-network rate files for each provider network, out-of-network allowed-amount files for each health insurance market, new contextual files, a website footer link labeled Price Transparency or Transparency in Coverage, attestations in the files, and cost-sharing information available by phone. The duties phase in for plan years (policy years in the individual market) beginning on or after January 1, 2027 (the amended cost-sharing disclosures, including the phone method), on March 6, 2027 (the rate and allowed-amount file changes and attestations) and on September 6, 2027 (the contextual files and footer), with the first utilization file due July 1, 2028; until each date the prior rules continue to apply.

High priority · Nov 8, 2026 editionRead story →

Governance & business operationsCompliance SweepNew in this edition

CDPH AFL 26-33 updates hospital respiratory-virus surge guidance for 2026-2027 and supersedes AFL 23-30

CDPH issued All Facilities Letter (AFL) 26-33 on November 4, 2026 to general acute care hospitals and acute psychiatric hospitals, superseding AFL 23-30. The letter gives planning and response guidance for an anticipated adult and pediatric surge in respiratory illness and updates surge measures and clinical resources for the 2026-2027 season. It says facilities that anticipate needing flexibility to prepare for surges should submit a program flexibility request through the Risk and Safety Solutions (RSS) website and obtain approval for any alternative use of space or bed classification. It restates that, where already applicable, facilities must continue to adhere to the Aerosol Transmissible Diseases (ATD) standard of Cal/OSHA (the California Division of Occupational Safety and Health), and it asks hospitals to prepare for a surge of at least 20 percent over licensed capacity.

Medium priority · Nov 8, 2026 editionRead story →

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 →

Governance & business operationsCompliance SweepNew in this edition

FDA classifies Abiomed Automated Impella Controller removal as Class I

FDA's weekly Enforcement Report dated November 4, 2026 lists three Class I recall entries (Z-0208-2027, Z-0209-2027, Z-0210-2027) for Abiomed Automated Impella Controller (AIC) products, classified October 28, 2026. Abiomed's review of servicing records found controllers needing hardware, firmware or software updates, with issues including failure to recognize the purge cassette, a sticking button and possible loss of console control, and start-up instability. FDA's recall page, updated after this edition's coverage week, says hospital inventory can continue to be used while awaiting service from Abiomed.

Medium priority · Nov 8, 2026 editionRead story →

Governance & business operationsCompliance SweepNew in this edition

Cardinal Health Presource kits with recalled BD Alaris infusion sets: correction posted in FDA recall database

FDA's medical device recall database posted on November 2, 2026 a Cardinal Health correction (record Z-0217-2027) for Presource kits containing BD Alaris pump infusion sets that were themselves recalled for performance issues; the record lists 415,636 kits. Cardinal's September 24, 2026 notice asked consignees to discontinue use of the affected BD Alaris pump infusion sets as the enclosed Becton Dickinson notice describes and, where affected kits are found, to quarantine them, alert clinicians, and affix a warning label to each kit telling clinicians to remove and discard the recalled components. Those instructions belong to record Z-0217-2027. A separate FDA recall page for Presource kits, updated November 9, 2026 (after this edition's coverage week), says the FDA has identified the recall it describes as the most serious type. The FDA records reviewed for this entry do not show that page and database record Z-0217-2027 to be the same recall event, so the classification of Z-0217-2027 is not established here.

Medium priority · Nov 8, 2026 editionRead story →

Governance & business operationsCompliance SweepNew in this edition

Baxter TruSystem surgical tables: correction for unexpected lift drop posted in FDA recall database

FDA's recall database posted on November 3, 2026 a set of Baxter correction entries (including Z-0350-2027) for TruSystem surgical tables and columns. Baxter reports the main lift may unexpectedly drop to its lowest position during use and the tabletop may not rise again, which could cause abrupt patient displacement during surgery; Baxter has three complaints and no reported patient injury. Baxter's September 29, 2026 letter tells customers to keep monitoring the table, stop using it if an unusual noise occurs, and post the notice by the devices until the correction is done.

Medium priority · Nov 8, 2026 editionRead story →

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 →

Governance & business operationsCompliance SweepNew in this edition

CDPH notices readoption of acute psychiatric hospital nurse-to-patient ratio emergency regulations; 5-day period ran November 2 to 6

CDPH issued All Facilities Letter (AFL) 26-32 on October 30, 2026, giving acute psychiatric hospitals a 5-day notice that it proposes to readopt, on an emergency basis, Title 22 sections 71213.1 and 71215.1, which set nurse-to-patient ratio standards under Health and Safety Code section 1276.4. The 5-working-day period ran from November 2 to November 6, 2026, during this edition's coverage week. CDPH stated it will submit the readoption to the Office of Administrative Law (OAL) on November 9, 2026, to be in effect November 28, 2026, and that OAL allows five calendar days for comments after submission.

Medium priority · Nov 8, 2026 editionRead story →

More matters and continuing watch

Privacy & health information 1 articles and reminders

AI & digital health 1 articles and reminders

Governance & business operations 4 articles and reminders

Enforcement Briefing

Higher-priority matters

Billing fraud & false claims 5 articles and reminders

Billing fraud & false claimsEnforcement BriefingConditional reminder

DOJ reports California physician Violetta Mailyan sentenced to 15 years in prison in Medicare Botox billing case

A federal court sentenced California physician Violetta Mailyan to 15 years in prison on October 29, 2026, DOJ announced on October 30. DOJ reports that she used her medical practice to fraudulently bill Medicare more than $45 million for Botox injection services that were medically unnecessary and never provided, and that after a six-day jury trial ending in May 2026 she was convicted of nine counts of wire fraud and three counts of obstruction of a criminal investigation of a health care offense. The court ordered $32,904,049.41 in restitution to Medicare and the immediate forfeiture of over $16,029,742 worth of seized property.

High priority · Nov 8, 2026 editionRead story →

Billing fraud & false claimsEnforcement BriefingConditional reminder

Adult day-care owner pleads guilty in $65 million Medicaid scheme

Ahsan Ijaz, an owner of two social adult day care centers and a home health care fiscal intermediary in Brooklyn, New York, pleaded guilty to conspiracy to commit health care fraud, the Justice Department announced on October 2, 2026. DOJ reports that he pleaded guilty to defrauding New York State Medicaid of approximately $65 million through claims for social adult day care and home health care services that were not provided; according to court documents, the businesses paid cash kickbacks and bribes to Medicaid recipients to induce enrollment and billed for services not provided, including when certain Medicaid recipients were not in the United States at the time of service. Sentencing is scheduled for March 10, 2027.

High priority · Nov 8, 2026 editionRead story →

Billing fraud & false claimsEnforcement BriefingNew in this edition

California lab and its owner agree to pay $1.25 million to resolve allegations of kickbacks to marketers

DOJ's Civil Division and the U.S. Attorney's Office for the Eastern District of California announced on November 6 that Lab Genomics LLC, a Fountain Valley, California clinical laboratory, and its owner Leena Dalal agreed to pay $1,250,000 to resolve False Claims Act allegations. The United States alleged that from January 2020 through September 2022 Lab Genomics and Dalal knowingly and willfully paid value- and volume-based commissions to three independent contractor marketers to induce them to arrange for or recommend that providers order lab tests, and structured invoices so the commissions looked like flat fees. The matter came from a qui tam suit; the relators will receive $225,000. The settlement agreement states $625,000 of the amount is restitution and that the agreement is neither an admission of liability by the laboratory and its owner nor a concession by the United States that its claims are not well founded. DOJ states the claims are allegations only and there has been no determination of liability. No Corporate Integrity Agreement is mentioned.

Medium priority · Nov 8, 2026 editionRead story →

Billing fraud & false claimsEnforcement BriefingNew in this edition

Quest Diagnostics pays $13 million and signs five-year CIA to resolve allegations of free sports entertainment for referral sources

The U.S. Attorney for the District of New Jersey announced on November 6 that Quest Diagnostics, Inc. paid $13,014,576 plus interest to resolve allegations that it submitted false claims to Medicare and to New York and New Jersey Medicaid. The United States alleged that from July 25, 2013 to August 3, 2022 Quest gave referral decisionmakers free entertainment tied to its New York Giants sponsorship, including suite seats, training-camp access and other events, to induce referrals, and that it measured the return on investment from those events for the 2013 through 2016 seasons. Quest also entered a five-year Corporate Integrity Agreement (CIA) with HHS-OIG that requires an independent review organization to evaluate its risk assessments and audits of remuneration exchanged with referral sources. Three relators share $2,472,769. DOJ states the claims are allegations only, and the agreement states it is not an admission of liability.

Medium priority · Nov 8, 2026 editionRead story →

Billing fraud & false claimsEnforcement BriefingNew in this edition

Tennessee physician group agrees to pay $2.8 million to resolve allegations that non-physician services were billed under physicians' NPIs

The U.S. Attorney for the Middle District of Tennessee announced on November 2 that Premier Medical Group, P.C., a multi-physician practice in Clarksville, Tennessee, agreed to pay $2.8 million to resolve False Claims Act allegations. The United States alleged that from November 1, 2018 through May 31, 2023 Premier billed Medicare and TRICARE for services performed by non-physician practitioners using physicians' National Provider Identifier numbers. DOJ states the claims are allegations only and there has been no determination of liability. The release names no relator and no Corporate Integrity Agreement.

Medium priority · Nov 8, 2026 editionRead story →

Consumer & business misconduct 1 articles and reminders

Consumer & business misconductEnforcement BriefingNew in this edition

Four state AGs settle with medical transcription vendor Perry Johnson & Associates over 13.3 million-person breach

New York Attorney General Letitia James, with the attorneys general of Connecticut, Michigan and New Jersey, announced on November 6 a settlement with Perry Johnson & Associates, Inc. (PJ&A) and related companies over a March 2023 breach affecting 13.3 million people, including about 4.2 million New Yorkers. The release says hackers used a coding employee's credentials when the company did not require multi-factor authentication (MFA) for remote access. The companies will pay at least $300,000 in penalties, with an additional $9,700,000 due if they fail to meet the agreement's terms, and any Perry Johnson company that maintains protected health information (PHI) must keep an information security program and incident response protocol, multi-factor authentication, password management, encryption and asset management safeguards, annual HIPAA-consistent risk assessments, and policies on the collection, use, retention and disposal of health information. The New York Assurance of Discontinuance (AOD) makes findings against specific companies in the group, including that named entities acting as HIPAA business associates never conducted a HIPAA risk analysis and did not meet subcontractor requirements; The Assurance names PJ&A, PJ&A Coding and PJ&A Radiology as the business associates that never conducted a HIPAA risk analysis and did not meet the subcontractor requirements. The respondents neither admit nor deny the findings, and the assurance describes four of the companies (PJ&A, PJ&A Coding, PJ&A Radiology and Medical Transcription and Coding, Inc.) as insolvent and inactive as of the assurance's Effective Date.

Medium priority · Nov 8, 2026 editionRead story →

More matters and continuing watch

Billing fraud & false claims 4 articles and reminders

Health plan oversight 1 articles and reminders

Consumer & business misconduct 5 articles and reminders

Medicare & Medicaid Sweep

Higher-priority matters

Billing & payment 13 articles and reminders

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 →

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 →

Billing & paymentMedicare & Medicaid SweepConditional reminder

CY 2027 ESRD PPS final rule: base rate, low-volume attestation and quality changes

CMS's calendar year (CY) 2027 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) final rule, Federal Register document 2026-22194, was published October 30, 2026 and takes effect January 1, 2027. It sets the unadjusted bundled payment base rate at $297.52 per treatment, up from $281.71 in 2026, and sets the CY 2027 base payment for dialysis furnished by ESRD facilities to beneficiaries with acute kidney injury (AKI) at $297.52 before the applicable geographic adjustment. For payment year 2027, an eligible facility seeking the low-volume payment adjustment (LVPA) must provide its attestation by December 31, 2026, the temporary pediatric ESRD add-on ends that day, and ESRD Quality Incentive Program (QIP) measure changes begin with payment year 2029.

High priority · Nov 8, 2026 editionRead story →

Billing & paymentMedicare & Medicaid SweepNew in this edition

CMS seeks emergency clearance to expand the home health Review Choice Demonstration to California

On November 2, CMS published an emergency Paperwork Reduction Act notice for a revision of the CMS-10599 information collection for the Review Choice Demonstration for Home Health Services, stating that approval is essential so the demonstration is expanded to California within the specified timeframe. The notice says the demonstration already operates in Illinois, Ohio, North Carolina, Florida and Texas, and that providers in demonstration states may choose 100 percent pre-claim review or 100 percent post-payment review until they reach a target affirmation or claim approval rate. A November 4 correction removed one sentence from the notice and states that the option referenced in that language is no longer part of the information collection request. Comments are due November 16, 2026, and the correction states the comment period is unchanged.

Medium priority · Nov 8, 2026 editionRead story →

Billing & paymentMedicare & Medicaid SweepNew in this edition

CMS says the home health Review Choice Demonstration expands to California for billing periods from January 18, 2027, pending paperwork approval

CMS says it is expanding the Review Choice Demonstration for Home Health Services to California for billing periods beginning on or after January 18, 2027, pending approval of revisions to Paperwork Reduction Act (PRA) package CMS-10599. The posting date of that statement was not established. Read it with the emergency paperwork notice CMS published for the same expansion, reported separately in this edition.

Medium priority · Nov 8, 2026 editionRead story →

Billing & paymentMedicare & Medicaid SweepNew in this edition

CY 2027 Home Health PPS final rule (CMS-1844-F) expands the grounds for retroactive Medicare enrollment revocations, across provider types; the printed effective date for those provisions predates the rule

On November 4, 2026, CMS issued the CY 2027 Home Health Prospective Payment System (PPS) final rule, published November 9, 2026 at 91 FR 72022. Beyond home health payment, the published rule says it adds grounds for denying or revoking a provider's or supplier's Medicare enrollment and expands the reasons for which CMS can apply a retroactive effective date to a revocation; the CMS fact sheet words this as a policy to make all revocation grounds retroactive and says most of the enrollment provisions apply to all provider types. Home health agencies, hospices and suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) with certain changes in majority ownership must reenroll as new providers. CMS estimates aggregate home health payments increase 2.4% ($415 million) for CY 2027. The published Dates section states that, with the exception of the home health payment and quality provisions and the regulatory changes at 42 CFR 484.245, "these regulations are effective on January 4, 2026", a date before the rule was issued; the Federal Register record listed no correction on November 10, 2026. Until CMS corrects it, the effective date of the enrollment provisions is unresolved.

Medium priority · Nov 8, 2026 editionRead story →

Billing & paymentMedicare & Medicaid SweepNew in this edition

CMS issues State Operations Manual Transmittal 251: revised CAH rural and distance evaluation guidance, new-hospital re-evaluation, decennial reviews from 2033

CMS issued State Operations Manual (Pub. 100-07) Transmittal 251 on November 4, 2026, effective and implemented the same day, revising section 2256A on critical access hospital (CAH) verification criteria. The guidance adds guidance on confirming necessary provider status (including types of evidence the CAH must supply), and directs CMS Locations to review existing CAHs' location and distance compliance when a new acute-care hospital is certified nearby. An affected CAH generally gets one year to reclassify as rural, convert to a hospital or rural emergency hospital, or face termination. Beginning in CY 2033 all existing CAHs will be evaluated every ten years.

Medium priority · Nov 8, 2026 editionRead story →

Billing & paymentMedicare & Medicaid SweepUpdated

October NCD coding update (R13968) is implemented; a related NCD 110.23 stem-cell coding instruction, R14035CP, was issued for April 5, 2027

The October National Coverage Determination (NCD) coding update (R13968, CR 14464) took effect for October 1 dates of service and was implemented October 5; it had removed the NCD 110.23 stem-cell requirements for a later April 2027 change request. A related NCD 110.23 instruction, R14035CP (CR 14645), was issued November 5; whether it is the deferred requirement itself was not confirmed by comparing the two. It is effective for dates of service from June 30, 2026, with April 5, 2027 implementation. Reconciling the October edits and retrospective claims is recommended work for providers with affected claims; the transmittals direct contractors to adjust claims brought to their attention. The April 5, 2027 implementation date of R14035CP is ahead. Checked: the CMS 2026 transmittals list and both transmittal PDFs on 2026-11-10.

Medium priority · Nov 8, 2026 editionRead story →

Billing & paymentMedicare & Medicaid SweepNew in this edition

CMS finalizes CY 2027 OPPS update: 2.3 percent increase factor, $99.970 conversion factor, $7,150 outlier threshold

CMS published the CY 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) final rule with comment period on November 6, 2026, effective January 1, 2027. The outpatient department (OPD) fee schedule increase factor is 2.3 percent (3.2 percent market basket less a 0.9 percentage point productivity adjustment); the proposal had been 2.4 percent with a 0.8 point adjustment, and the rule says the change reflects more recent data. The final conversion factor is $99.970; hospitals that fail Hospital Outpatient Quality Reporting (OQR) requirements get a reporting ratio of 0.9804 and a reduced conversion factor of $98.011. The outlier fixed-dollar threshold rises from $6,225 (CY 2026) to $7,150 with the 1.75 multiplier unchanged. CMS estimates total CY 2027 OPPS payments of about $114.4 billion and a net 1.7 percent increase from all finalized policies, with urban hospitals up 2.0 percent, rural hospitals up 5.6 percent, major teaching hospitals down 2.0 percent and government-owned hospitals down 1.1 percent.

Medium priority · Nov 8, 2026 editionRead story →

Billing & paymentMedicare & Medicaid SweepNew in this edition

340B remedy offset rises from 0.5 percent to 2 percent of the OPPS conversion factor for CY 2027, running to an estimated CY 2031

CMS finalized an increase in the annual reduction to the Hospital Outpatient Prospective Payment System (OPPS) conversion factor for non-drug items and services, used to offset the estimated $7.8 billion in additional non-drug payments made to hospitals from CY 2018 through 2022 as a result of the prior 340B payment policy, from 0.5 percent to 2 percent starting in CY 2027. The rule limits the 0.5 percent reduction to CY 2026 and adds a new paragraph (13) for the 2.0 percent reduction, which continues until reductions reach $7.769 billion, estimated to occur in CY 2031. CMS estimates the offset reduces payments to affected providers by $1.6 billion in CY 2027.

Medium priority · Nov 8, 2026 editionRead story →

Billing & paymentMedicare & Medicaid SweepNew in this edition

Imaging without contrast at excepted off-campus PBDs moves to the PFS-equivalent rate on January 1, 2027

Using its volume-control authority under section 1833(t)(2)(F), CMS will pay the site-specific Physician Fee Schedule (PFS)-equivalent rate (currently 40 percent of the Hospital Outpatient Prospective Payment System (OPPS) amount) for imaging without contrast services in ambulatory payment classifications (APCs) 5521 through 5524 and composite APCs 8004, 8005 and 8007 when furnished at excepted off-campus provider-based departments (PBDs) billing modifier PO. The policy is not budget neutral and has no phase-in. Rural sole community hospitals are exempt. CMS estimates a $260 million decrease in CY 2027 payments ($190 million Medicare, $70 million beneficiary copayments).

Medium priority · Nov 8, 2026 editionRead story →

Billing & paymentMedicare & Medicaid SweepNew in this edition

CMS removes 637 more services from the inpatient only list and adds at least 619 procedures (618 in the rule summary, plus CPT 64629) to the ASC covered procedures list for CY 2027

In the second year of a three-year phase-out, CMS finalized removal of 637 services from the inpatient only (IPO) list for CY 2027, from the auditory, digestive, endocrine, female genital, hemic and lymphatic, integumentary, male genital, maternity care and delivery, mediastinum and diaphragm, respiratory and urinary families; 1,438 services had remained on the list. The remaining families, which include the neurological and cardiovascular families and solid organ, intestinal and islet cell transplants, are expected to come off for CY 2028. CMS added 618 of the removed procedures to the ambulatory surgical center (ASC) covered procedures list (CPL) plus CPT 64629 at commenters' request. CMS restated that procedures removed from the IPO list since January 1, 2021, are exempt from site-of-service claim denials, initial medical review contractor referrals to Recovery Audit Contractors (RACs) and RAC patient-status reviews until Medicare claims data for a single calendar year show the procedure performed more than 50 percent of the time on an outpatient basis; CMS also noted that the end of each procedure's exemption would be announced through rulemaking, so the threshold alone does not end it. CMS also restated that MA plans must follow the 2-midnight benchmark.

Medium priority · Nov 8, 2026 editionRead story →

Billing & paymentMedicare & Medicaid SweepNew in this edition

Eight more botulinum toxin injection codes need Medicare OPD prior authorization for dates of service on or after July 1, 2027

CMS finalized adding eight botulinum toxin injection codes to the existing Botulinum Toxin Injections category of the hospital outpatient department (OPD) prior authorization process (42 CFR 419.83), for services on or after July 1, 2027. Table 102 lists CPT 64611, 64616, 64617, 64642, 64644, 64646 and 64647 and HCPCS J0589. CMS cited a 42.8 percent rise in claims for these codes from 2017 to 2024. Bladder injections are not among the added codes. CMS says it intends to provide education and implementation guidance well in advance of the July 1, 2027 effective date.

Medium priority · Nov 8, 2026 editionRead story →

Coverage & clinical policy 2 articles and reminders

Coverage & clinical policyMedicare & Medicaid SweepUpdated

Noridian A57079 R7 (tendon, ligament and ganglion cyst injections) now in effect

The R7 revision took effect on November 1, 2026. The CMS Medicare Coverage Database now shows A57079 at revision effective date 11/01/2026, with R7 the latest entry in the revision history; R6 (conformity with Local Coverage Determination (LCD) L40265) also carries a revision effective date of 11/01/2026. The R7 notice's summary of changes carries the instruction to use M72.0 for CPT codes 20527 and 26341; the earlier revision's text was not compared.

Medium priority · Nov 8, 2026 editionRead story →

Coverage & clinical policyMedicare & Medicaid SweepNew in this edition

Noridian peripheral nerve injection LCD L40265 and article A60300 take effect November 1; nerve blockade LCD L35456 and article A56034 retired October 31

The Medicare Coverage Database (MCD) lists Noridian Local Coverage Determination (LCD) L40265 (Peripheral Nerve Injections and Procedures for Chronic Pain) and billing article A60300 as effective November 1, 2026, and lists the Noridian Nerve Blockade for Treatment of Chronic Pain and Neuropathy LCD L35456 and article A56034 as retired October 31, 2026. Noridian's JE Part A and Part B update lists posted R1 notices for L40265 and A60300 on October 22, 2026, each stating an effective date of November 1, 2026. The LCD focuses on therapeutic injections or blocks and percutaneous denervation, usually radiofrequency ablation or cryotherapy, for the management of chronic pain, and does not address regional anesthesia, surgical pain, acute pain, and diagnostic injections unless specified; the billing article adds that the related LCD does not apply to botulinum toxins, blocks used to manage pain related to active malignancy refractory to medical management, spasticity treatment, joint impingement syndromes, or pain due to sympathetic neuropathies or neurotomies. Among its utilization parameters, the billing article states that no more than 2 radiofrequency sessions per knee for genicular nerve radiofrequency ablation, and a maximum of 4 occipital nerve blocks for occipital neuralgia, will be reimbursed per rolling 12 months.

Medium priority · Nov 8, 2026 editionRead story →

Medi-Cal & Medicaid policy 4 articles and reminders

Medi-Cal & Medicaid policyMedicare & Medicaid SweepConditional reminder

Medi-Cal youth gender-affirming services (APL 26-018): federal reimbursement limit from October 13, 2026 and hormone transition through April 12, 2027

DHCS All Plan Letter (APL) 26-018, Federal Reimbursement Limitation on Gender-Affirming Care Services for Youth, is listed in the DHCS letter index with the date 09/30/2026. As the October 11 article reported it, the letter limits reimbursement from October 13 for specified gender-affirming surgery, puberty blockers and hormone therapy for Medi-Cal members under 18 and Children's Health Insurance Program (CHIP) members under 19 (services for other medical indications and treatment of complications remain covered when medically necessary), keeps a transition through April 12, 2027 for hormones already being taken as of October 13 (for affected plan members, only under the medical benefit), and requires plans to submit policies, an attestation and copies within 90 calendar days of release, which the article gave as December 29.

High priority · Nov 8, 2026 editionRead story →

Medi-Cal & Medicaid policyMedicare & Medicaid SweepConditional reminder

DHCS warns assisted living waiver facilities of denials and reprocessing

In a notice published October 9, 2026, DHCS said claims for Assisted Living Waiver (ALW) services may be non-payable due to non-compliance with program requirements, that it is reviewing previously paid claims, which may result in the reprocessing of claims that were erroneously paid, and that it will follow up with additional information tailored to specific facilities that have non-payable claims. To prevent claim denials, the notice says facilities must verify ALW eligibility before delivering services and submitting claims, using the approved processes outlined by DHCS and their Care Coordination Agency, fully comply with all ALW standards, policies and contract requirements, submit claims with correct procedure codes and modifiers, consistent with program guidance referenced in ALW program integrity correspondence, and review internal processes for accurate claiming and documentation; it states no agency deadline. First reported in the October 11 edition.

High priority · Nov 8, 2026 editionRead story →

Medi-Cal & Medicaid policyMedicare & Medicaid SweepConditional reminder

DHCS notice (October 9): Medi-Cal clinic institutional claims submitted from October 15 require diagnosis codes

In a notice published October 9, 2026, DHCS said that for all Medi-Cal claims submitted on or after October 15, 2026, at least one clinically appropriate ICD-10-CM code is required on a UB-04 claim form or the 837I electronic form by Federally Qualified Health Centers (FQHCs), Rural Health Clinics (RHCs), Indian Health Services (IHS) Memorandum of Agreement (MOA) 638 providers and Tribal FQHCs. The trigger is the claim submission date, not a new date-of-service limit, and the notice says updated provider manual sections will be released in a future Medi-Cal Update. First reported in the October 11 edition.

High priority · Nov 8, 2026 editionRead story →

Medi-Cal & Medicaid policyMedicare & Medicaid SweepNew in this edition

Medi-Cal: members with Unsatisfactory Immigration Status move from managed care to fee-for-service on January 1, 2027; clinic billing rules posted

On November 6, 2026 the Medi-Cal provider site published billing and reimbursement policy for Federally Qualified Health Centers and Rural Health Clinics serving members with Unsatisfactory Immigration Status, who move from Medi-Cal managed care plans to the fee-for-service delivery system effective January 1, 2027. The notice says the transition does not change a member's eligibility, and that members keep full-scope coverage through state funding if they renew on time. From January 1, 2027 these clinics must submit claims directly to the Medi-Cal fiscal intermediary (the notice says there is no change in how they submit dental claims) and will receive the Prospective Payment System rate for eligible visits; claims for a managed care plan differential (wrap) rate for services on or after that date will be denied. Clinics already enrolled in Medi-Cal need no additional enrollment. In the same week the site published a notice of change on Treatment Authorization Requests for these members (November 2) and a fee-for-service provider toolkit for the transition (November 6).

Medium priority · Nov 8, 2026 editionRead story →

Provider operations 2 articles and reminders

Provider operationsMedicare & Medicaid SweepConditional reminder

Hospice election addendum: mandatory since October 1; CMS enforcement discretion on missing or incomplete addenda ends December 31

In the FY 2027 Hospice Prospective Payment System final rule, CMS made the hospice election statement addendum mandatory for every election on or after October 1, 2026: it must be furnished in writing (paper or electronic) within 5 calendar days of the effective date of the election, any update must be furnished within 3 calendar days of a plan-of-care change, and the condition for payment is met when a valid signed addendum is in the beneficiary's medical record with the hospice. From October 1 to December 31, 2026, CMS is exercising enforcement discretion, under which Medicare Administrative Contractors (MACs) will not deny claims solely because the addendum is missing or incomplete; furnishing the addendum remains required.

High priority · Nov 8, 2026 editionRead story →

Provider operationsMedicare & Medicaid SweepNew in this edition

CDPH AFL 26-34 (dated November 9): CDPH says it will send Medi-Cal revalidation intent letters to facilities beginning November 9; no response within 35 calendar days means termination from Medi-Cal

CDPH's All Facilities Letter (AFL) 26-34 is dated November 9, 2026, after this edition's window. It says that beginning November 9, 2026 its License Renewal and Certification Branch will send Medi-Cal revalidation intent letters to each health care facility's physical address and mailing address (if different), based on the current information in CDPH's system of record, asking enrolled providers to revalidate their enrollment or voluntarily withdraw. The letter states that failure to respond to the intent letter within 35 calendar days will result in termination and deactivation from the Medi-Cal program, and cites Title 22 California Code of Regulations section 51000.55(c). After a facility confirms it intends to continue, the branch emails instructions to the licensee's primary contact and the facility administrator at the addresses on file with CDPH. The letter cites the federal requirement that a State Medicaid agency revalidate every provider at least every five years. The letter itself was read on November 10, 2026.

High priority · Nov 8, 2026 editionRead story →

More matters and continuing watch

Billing & payment 7 articles and reminders

Coverage & clinical policy 4 articles and reminders

Medicare Advantage & Part D 1 articles and reminders

Medi-Cal & Medicaid policy 2 articles and reminders

Audits & program integrity 1 articles and reminders

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