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    • HEALTH CARE REIMBURSEMENT NEWS—Federal rule targets IDR process inefficiencies with new disclosure and communication mandates
    • ADMINISTRATION OF FDC ACT—FDA GUIDANCE NOTICES: Statistical approaches to establishing bioequivalence guidance issued
    • ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: Hospice enrollment denied after it failed to demonstrate operational status
    • ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: Medicare enrollment effective date set to approved application receipt, not prior rejected filings
    • Dietary Supplements—D.D.C.: Manufacturer’s cost-of-compliance calculation violated non-aggregation principle
    • FALSE CLAIMS ACT—SETTLEMENT AGREEMENTS: Oglethorpe Inc. and executives agree to pay $32 million to resolve False Claims Act liability over Medicare overpayment retention
    • MEDICAL DEVICES—FDA GUIDANCE NOTICES: Content of human factors information in medical device marketing submissions guidance issued
    • REGULATION TRACKER—Information on pending or recently adopted regulations and regulation amendments
    • STRATEGIC PERSPECTIVES—Mail access to mifepristone continues for now but faces more potential obstacles
    • WORTH NOTING—Other Health Law litigation and regulatory developments
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    Health Law Daily Wrap Up, WORTH NOTING—Other Health Law litigation and regulatory developments, (Jun 1, 2026)

    By WK Editorial Staff

    A roundup of other items of interest to the Health Law community.

    ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: The ALJ affirmed that the CMS properly determined the effective date of reactivation of the Providers Medicare billing ...

    By WK Editorial Staff

    A roundup of other items of interest to the Health Law community.

    ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: The ALJ affirmed that the CMS properly determined the effective date of reactivation of the Providers Medicare billing privileges pursuant to 42 C.F.R. 424.540(d)(2) because the Medicare contractor received a subsequently approved revalidation application on that date, and no earlier effective date was permitted. The ALJ also concluded that he lacked authority to review the deactivation of billing privileges or to grant equitable relief or retrospective reimbursement for services furnished during the period of deactivation (A C Ojascastro Inc., DAB No. CR6841, Doc. No. C-25-780 (Feb. 26, 2026)).

    ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: The ALJ affirmed that the CMS properly determined the effective date of reassignment of the Providers Medicare benefits pursuant to 42 C.F.R. 424.522(a) and 424.521(a)(1) because the Provider filed a subsequently approved reassignment application on that date, and no earlier effective date was permitted. The ALJ also concluded that he lacked authority to review the deactivation or reactivation of related billing privileges or to grant equitable relief (Hallie B. Brooks, MD, DAB No. CR6844, Doc. No. C-26-98 (Feb. 26, 2026)).

    ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: The ALJ affirmed that the Inspector General (IG) properly excluded the Provider from participation in Medicare, Medicaid, and all federal health care programs for 10 years pursuant to section 1128(a)(2) of the Social Security Act because the Provider was convicted of criminal offenses related to the abuse of a patient in connection with the delivery of a health care item or service. The ALJ also concluded that the 10-year exclusion was reasonable based on the presence of two aggravating factors and the absence of any mitigating factor (Rajesh Patel, DAB No. CR6835, Doc. No. C-25-867 (Feb. 11, 2026)).

    ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: The ALJ affirmed that the Inspector General (IG) properly excluded the Provider from participation in Medicare, Medicaid, and all federal health care programs for seven years pursuant to section 1128(a)(3) of the Social Security Act because the Provider was convicted of a felony offense related to fraud in connection with the delivery of a health care item or service. The ALJ also concluded that the seven-year exclusion was reasonable based on the presence of an aggravating factor and the absence of any mitigating factor (Clifford Glassman, DAB No. CR6838, Doc. No. C-25-941 (Feb. 18, 2026)).

    ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: The ALJ affirmed that the CMS properly determined the effective date of reactivation of the Providers Medicare billing privileges pursuant to 42 C.F.R. 424.540(d)(2) because the Medicare contractor received a subsequently approved reactivation application on that date, and no earlier effective date was permitted. The ALJ also concluded that he lacked authority to review the rejection of an earlier application or to grant retrospective reimbursement for services furnished during the period of deactivation (Nephrology Associates, Inc., DAB No. CR6842, Doc. No. C-26-18 (Feb. 25, 2026)).

    ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: The ALJ affirmed that the CMS properly determined that the Provider was not in substantial compliance with Medicare participation requirements pursuant to 42 C.F.R. 483.25(d) because the Provider failed to provide adequate supervision and maintain an environment free of accident hazards for two high-risk residents, which resulted in falls causing injuries that required hospital treatment and sutures. The ALJ also concluded that the noncompliance caused actual harm, and that the $2,140 per-day civil money penalty for 42 days and denial of payment for new admissions imposed by the CMS were reasonable (Generations Oakton Pavillion v. CMS, DAB No. CR6834, Doc. No. C-25-576 (Feb. 11, 2026)).

    PRODUCTS LIABILITY (DRUGS)—E.D. Pa.: The court denied a motion to limit the opinions of an expert witness who would testify as to the manufacturer's responsibility as it relates to a duty to warn (In Re Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAS) Products Liability Litigation, No. 2:24-md-03094-KSM (E.D. Pa. May 18, 2026)).

    PRODUCTS LIABILITY (DRUGS)—E.D. La.: The court dismissed product liability claims against Actavis, finding they were preempted (In Re Taxotere (Docetaxel) Eye Injury Products Liability Litigation, No. 2:22-md-03023-JTM-MBN (E.D. La. May 19, 2026)).

    DIETARY SUPPLEMENTS—N.D. Cal.: The court dismissed claims alleging that Traditional Medicinals' herbal supplements were unlawfully labeled because they claimed to support joints, digestion, heart health, and sleep, and did not include the FDA's structure function claim disclaimer that the statements were not evaluated by the FDA (Desrys v. Traditional Medicinals, Inc., No. 4:25-cv-07898-HSG (N.D. Cal. May 18, 2026)).

    PRODUCTS LIABILITY (DEVICES)—Ill. App.: The appellate court found that the trial court properly granted defendant's motion for summary judgment and denied plaintiff's cross-motion for partial summary judgment in a strict product liability case (Babczak v. AbbVie Corp., Inc., No. 3-25-0414 (Ill. App. May 18, 2026)).

    MEDICAID—OTHER AGENCY DOCUMENTS: Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Guide for States: Coverage in the Medicaid Benefit for Children (CMS Report, (May 13, 2026)).

    END-STAGE RENAL DISEASE—CMS LETTERS: Relocating and Revising CMS Surveyor Guidance for End-Stage Renal Disease (ESRD) Facilities (CMS Letter, No. QSO-26-09-ESRD (May 15, 2026)).

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