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By: Hall, Render, Killian, Heath & Lyman, P.C.

Latest from Hall, Render, Killian, Heath & Lyman, P.C. Blog - Page 6

The U.S. Department of Health & Human Services Office of Inspector General (“OIG”) has long been the north star for health care entities seeking guidance on creating and implementing an effective compliance program. As the author of the General Compliance Program Guidance (“GCPG”), OIG has used its years of investigative and oversight experience with health care entities to identify and recommend best practices for a wide range of entities in the U.S. health care industry.

To further OIG’s assistance…
Continue Reading Medicare Advantage Industry Segment-Specific Compliance Program Guidance Issued

The Indiana Court of Appeals recently affirmed a regular commitment to a state hospital of a gravely disabled patient based on evidence that the patient’s symptoms impaired his judgment and his refusal to take medication and behavior demonstrated his inability to function independently. In re Commitment of G.S. v. Richmond State Hosp., No. 25A-MH-2033, 2026 WL 555535 (Ind. Ct. App. Feb. 27, 2026) (mem.).
Background
G.S. had a long history of mental health treatment and involvement with the…
Continue Reading Indiana Appeals Court Affirms Patient’s Ongoing Refusal of Treatment and History of Mental Illness Can Establish Grave Disability

The Centers for Medicare and Medicaid Services (“CMS“) issued a wide-ranging Request for Information (“RFI”) on February 26, which could reshape current program integrity efforts to prevent and detect fraud, waste and abuse in  government health care programs. CMS, under its new Comprehensive Regulations to Uncover Suspicious Healthcare (“CRUSH”) initiative, is seeking stakeholder input on potential regulatory and operational changes aimed at strengthening program integrity across Medicare, Medicaid, CHIP and the Health Insurance Marketplace (“Marketplace”). The RFI spans topics…
Continue Reading CMS Issues Sweeping Anti-Fraud RFI Under New CRUSH Initiative

  • New federal law will require hospitals to obtain separate NPIs and submit provider‑based attestations for off‑campus hospital outpatient departments (“HOPDs”) as a condition of Medicare payment starting in 2028. The changes remove prior flexibility for HOPDs by stiffening ownership, compliance and structuring requirements for these facilities.
  • Echoing other recent reports, a recent VMG Healthcare M&A Report found that overall health care M&A deal volume in 2025 remained below pre‑pandemic levels, while total deal value rebounded due to larger, strategic

    • …
    Continue Reading Weekly Hospital Real Estate Briefing

    The continued expansion of GLP-1 weight-loss therapies has introduced both commercial opportunity and evolving legal and regulatory considerations across the health care landscape. Novo Nordisk’s (“Novo”) recent federal lawsuit against Hims & Hers (“Hims”) illustrates how brand manufacturers may increasingly use patent and regulatory frameworks to challenge the marketing and sale of compounded versions of these products. This case may signal a broader shift in how compounding practices, telehealth platforms and pharmaceutical patent rights intersect.

    On Monday, February 9,…
    Continue Reading Evolving Legal and Regulatory Considerations for Weight Loss Therapies

    Congress recently enacted the Consolidated Appropriations Act of 2026, which includes new Medicare conditions of payment for off-campus hospital outpatient departments. Beginning January 1, 2028, Medicare payments will not be made for items and services furnished by an off-campus department unless the hospital satisfies new requirements related to location-specific National Provider Identifiers (“NPIs”) and provider-based attestations.
    The new statutory requirement applies to all off-campus outpatient departments of hospitals that are paid under the Outpatient Prospective Payment System, including excepted…
    Continue Reading Separate NPI and Attestation Requirements for Off-Campus Departments: Steps Hospitals Should Take Now

    The Indiana Court of Appeals (the “Court”) confirmed that evidence about the patient’s indirect threats of physical and sexual violence can satisfy the Petitioner’s burden to clearly and convincingly prove that the patient is dangerous. In re Commitment of W.C. v. Richmond State Hosp., 272 N.E.3d 983 (Ind. Ct. App. 2025) (unpublished table opinion).
    Background
    W.C. had been involuntarily committed for nearly 20 years. In 2001, he pled guilty to a crime under IC § 35-42-4-3 and was sentenced…
    Continue Reading Indiana Appeals Court Confirms Indirect Threats Can Establish Dangerousness

  • Good Samaritan Medical Center (FL) announced massive plans to redevelop its West Palm Beach campus into a mixed-use health care district. Plans include a new 225-bed hospital, a medical office tower, workforce housing, luxury condos, a hotel and other mixed-use amenities along the water. The project is estimated to cost between $2B to $3B.
  • Cleveland Clinic announced key milestones for its new 200-bed hospital and ASC in West Palm Beach, Florida. Demolition and site preparation work will begin this

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    Continue Reading Weekly Hospital Real Estate Briefing: Two Major Hospital Projects in West Palm Beach | UT Moves New Medical Center Project | St. Jude Advances New Research Center Project

    HIPAA covered entities and Part 2 Programs should be aware of two important compliance deadlines that may require prompt action.
    Annual HIPAA Small Breach Reporting
    Under the Breach Notification Rule, HIPAA covered entities are required to submit reports of certain breaches of unsecured protected health information (“PHI”) affecting fewer than 500 individuals to the HHS Office for Civil Rights (“OCR”) on an annual basis. No later than March 1, 2026, covered entities must submit breaches discovered in 2025 through…
    Continue Reading Important Deadlines for HIPAA Covered Entities and Part 2 Programs

    Significant updates to the ALTA/NSPS Land Title Survey Standards will impact health care real estate transactions beginning February 23, 2026. The American Land Title Association (“ALTA”) and the National Society of Professional Surveyors (“NSPS”) have adopted updated Minimum Standard Detail Requirements for ALTA/NSPS Land Title Surveys (the “2026 Standards”), which take effect February 23, 2026, and replace the 2021 version. Although the fundamental purpose of an ALTA survey remains the same, the 2026 Standards introduce clarifications and new requirements…
    Continue Reading New 2026 ALTA/NSPS Survey Standards: What Developers and Counsel Should Know

  • In a recent interview, Alison Flynn Gaffney, CEO of two Banner Health hospitals, discussed how she applies a real estate perspective to hospital leadership. Prior to becoming CEO, she spent two years as president of the health care division at JLL, which imparted a unique perspective on leveraging hospital real estate portfolios for the benefit of the hospital mission.
  • The number of health care private equity deals rose 9.5% in 2025, with an estimated 747 deals announced or

    • …
    Continue Reading Weekly Hospital Real Estate Briefing

    The Indiana Court of Appeals (the “Court”) affirmed the trial court’s regular commitment of a patient whose mental illness stemmed from a traumatic brain injury (“TBI”). In its reasoning, the Court connected the past event to the patient’s current aggressiveness, emotional outbursts, inability to provide for basic needs and lack of insight into illness as support for its decision. B.D. v. Richmond State Hosp., 270 N.E.3d 515 (Ind. Ct. App. 2025) (unpublished table decision).
    Background
    B.D. was admitted to…
    Continue Reading Indiana Court of Appeals Affirms Regular Commitment of Patient Whose Mental Illness Is a Result of a Traumatic Brain Injury

    On December 15, 2025, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 25‑11 (“Advisory Opinion”) and concluded it would not impose administrative sanctions under the federal Anti‑Kickback Statute (“AKS”) on a biopharmaceutical manufacturer for a series of discounts and rebates offered on multiple vaccines. Although portions of the arrangement failed to meet the technical requirements of the discount safe harbor (42 CFR § 1001.952(h)), OIG determined that the overall fraud and abuse risk was sufficiently low.

    This…
    Continue Reading OIG Offers Contemporary Guidance on Various Discount Constructs in Recent Advisory Opinion

    On January 26, 2026, the Centers for Medicare & Medicaid Services (“CMS”) issued an Advance Notice of Proposed Rulemaking (“ANPRM”) seeking public input on potential policies to strengthen the domestic supply chain for personal protective equipment (“PPE”) and essential medicines used by Medicare‑participating hospitals. The initiative reflects lessons learned during the COVID‑19 public health emergency and signals a possible shift toward incentivizing or requiring greater reliance on U.S.-manufactured medical products within the Medicare program. This focus on domestic sourcing…
    Continue Reading CMS Solicits Comments on Potential Approaches to Strengthen the American-Made Supply Chain

    The fiscal year (“FY”) 2027 H-1B cap season will be the first to operate under a weighted selection system that replaces the prior fully random lottery. Employers should understand how this new process affects both the regular (bachelor’s) cap and the advanced degree (master’s) cap, as it changes selection mechanics but not the overall annual numerical limits.

    The Congressional limits and the online registration process are unchanged:

    • 65,000 regular (bachelor’s) cap.
    • 20,000 advanced degree (U.S. master’s or higher) cap.

    …
    Continue Reading FY 2027 H-1B Cap: What Employers Need to Know About the New System

    On February 12, 2026, the U.S. District Court for the Eastern District of Texas (the “Court”) struck down the Federal Trade Commission’s (“FTC”) rule expanding the scope of the Hart-Scott-Rodino (“HSR”) Act Premerger Notification Form. See Chamber of Com. of the U.S. v. Fed. Trade Comm’n, No. 6:25-CV-9-JDK, 2026 WL 402498 (E.D. Tex. Feb. 12, 2026). The Court deemed the new rule “arbitrary and capricious” under the Administrative Procedure Act (“APA”) and ruled the FTC failed to show that…
    Continue Reading Texas District Court Strikes Down Updated HSR Act