Anti-Kickback Statute
- The D.C. Circuit held that a manufacturer’s offer of up to $70,000 in fertility support to patients prescribed its gene therapy would violate the Anti-Kickback Statute. In Vertex Pharmaceuticals, Inc. v. U.S. Department of Health and Human Services, No. 25-5133 (D.C. Cir. Sept. 4, 2026), the court read “induce” to carry its ordinary meaning of influencing a person and “remuneration” to reach anything of value, joining the Second and Fourth Circuits. The court reversed HHS’s separate conclusion that the program would violate the Civil Monetary Penalties Law, finding the agency’s one-sentence rejection of the Promotes Access to Care Exception arbitrary and capricious, and remanded that question. It also set aside HHS regulations that started the 60-day advisory opinion clock at “formal acceptance” and tolled it while the agency sought additional information, holding that HHS has no authority to pause the clock and grant itself more time. Casgevy, the therapy at issue, treats sickle cell disease and transfusion-dependent beta-thalassemia through a course requiring chemotherapy that can impair fertility, and Vertex had limited the program to privately insured patients before asking HHS whether it could extend the support to federal beneficiaries. Source: Quarles
- OIG approved a referral service that connects patients with hearing professionals who pay a fee to receive the referrals. The requestor’s parent company makes a hand-held ENT device that lets a primary care clinician examine the ear canal, remove cerumen, and run a hearing check, and when the software flags a result outside normal ranges the clinician may offer the patient a referral. A licensed audiologist employed by the requestor verifies the ear canal was clear and the results fell outside normal ranges before forwarding the patient’s information to a participating audiology, hearing aid, or ENT group, which reports the treatment outcome back to the primary care clinician. Each participating group pays an annual fee set in advance at the cost of operating the service, apportioned by number of affiliated professionals and reconciled each year against actual costs, without regard to the volume of referrals or whether any patient receives care. OIG concluded the arrangement implicates the Federal anti-kickback statute but meets every condition of the referral services safe harbor at 42 C.F.R. § 1001.952(f), including the five required disclosures signed by each patient, and said it would impose no sanctions. Source: Advisory Opinion 26-18
False Claims Act
- The Eleventh Circuit reversed a district court holding that the False Claims Act’s qui tam provisions violate the Appointments Clause. In United States ex rel. Zafirov v. Florida Medical Associates, LLC, No. 24-13581 (11th Cir. Sept. 1, 2026), the court held that a relator is not an “Officer of the United States” because a relator does not occupy a continuing position established by law, pointing to a relator’s temporary tenure, absence of a continuing emolument, and duties tied to the single action filed. The decision joins the Fifth, Sixth, Ninth, and Tenth Circuits in rejecting Appointments Clause challenges to relators, creating no circuit split. The court did not reach whether relators exercise executive power or significant authority, and it remanded the defendants’ Take Care Clause and Vesting Clause arguments for the district court to address in the first instance. Relators may continue to file under 31 U.S.C. § 3730(b), where a complaint stays under seal for at least 60 days while the government decides whether to intervene. Source: Buchanan Ingersoll & Rooney
HIPAA & Patient Privacy
- OCR continues to treat patient access to medical records as an enforcement priority under its Right of Access Initiative. HIPAA requires a provider to produce requested records without unreasonable delay and within 30 days, and to send any denial inside that window; one 30-day extension is available only if the patient is notified of the delay within the initial 30 days. Records must be produced in the form and format requested when readily producible, and paper copies may be substituted only if the patient declines every electronic format the provider can produce. Fees are limited to labor for creating and delivering the copy, postage, and supply costs, or a flat fee of no more than $6.50 for an electronic copy, and federal law does not permit the flat search fee that Alabama law allows. A provider must verify that the requester is the patient before releasing records, because third parties have posed as patients to reach the access-request fee cap. Source: Burr & Forman
- HIPAA bars a medical practice from confirming that the author of an online review was ever a patient, even when the reviewer posts under a real name and describes the treatment received. A practice may post a generic response inviting the reviewer to call the office, but it cannot correct the account with facts from the record. Businesses outside health care face no equivalent restriction and can answer an accusation with their own evidence, such as security footage. Source: Medical Economics
Reimbursement & Payment
- Texas restructured its Medicaid directed payment program for physician groups for state fiscal year 2026, cutting Component 1 to 55% of program value and reintroducing Component 2 as a 35% pay-for-performance scorecard. The Texas Incentives for Physicians and Professional Services program (TIPPS) pays Component 1 as a percentage increase on professional services at claim adjudication, limited to physician groups owned or operated by a health-related institution named in Section 63.002 of the Texas Education Code or contracted with a hospital receiving the indirect medical education add-on. Component 2 was absent from the SFY 2025 program, and a group that misses its performance requirements forfeits those funds to other groups in the same Service Delivery Area and class. Component 3 carries 10% of program value, applies to evaluation and management CPT codes 99202 through 99215, and is open to every eligible group, including managed care network groups that are neither health-related institution nor IME groups. Because TIPPS payments raise professional collections without a matching change in wRVUs, benchmarks such as collections per wRVU and compensation-to-collections ratios can shift, and organizations should document how the funds are allocated to show that compensation reflects services performed rather than a pass-through of supplemental Medicaid funding. Source: VMG Health
Employer Health Plans & Wellness Programs
- The Departments of Labor, Health and Human Services, and the Treasury will not enforce retroactive payment of a wellness program reward against a plan that pays the reward only for the period after a participant satisfies a reasonable alternative standard. FAQs Part 74, issued August 26, 2026, addresses a gap between the preamble to the 2013 final rules, which stated that an individual who satisfies an alternative standard partway through the plan year must receive the same full reward as one who meets the initial standard, and the regulatory text, which does not require retroactive application. The enforcement relief reaches tobacco cessation programs and other health-contingent programs, and it does not alter the requirements that a program be reasonably designed to promote health or prevent disease and that it not operate as a subterfuge for discrimination based on a health factor. A program relying on the relief must still allow participants sufficient time to complete the alternative standard and earn a reward. The FAQs also confirm that the notice of a reasonable alternative standard is required only in plan materials describing the program’s terms, so a summary of benefits and coverage noting that cost sharing may vary without describing those terms does not trigger the notice. Source: U.S. Department of Labor
Professional Licensure & Discipline
- The Texas Medical Board revoked the license of a Stephenville orthopedic surgeon on September 4, 2026, after finding he prescribed an “abortive” to a patient with whom he had an inappropriate sexual relationship. The notice states the December 2023 prescription violated the Texas abortion ban, and that a violation of the Health and Safety Code provision carries revocation. William Evans, licensed in Texas for 27 years, operated Cross Timbers Orthopaedics, whose website states the office closed effective immediately and that the practice is contacting patients. The board’s ruling is final, and Evans may appeal within 30 days of the revocation. In June 2020 the board found Evans operated on the wrong knee of a patient, misinformed the spouse to obtain consent for the wrong knee, and did not discuss the matter with hospital staff; he neither admitted nor denied the findings and completed a remedial plan of continuing education and a $500 administrative fee by September 2020. Source: WFAA
Hospital Operations & Safety
- A hospital security guard shot a patient multiple times in the torso in the emergency room at Memorial Hermann Memorial City Medical Center in Houston. Houston police report that a man in his early 30s experiencing a mental health crisis was admitted the evening of September 5, 2026, and placed in a secluded room at the back of the emergency room around 6 p.m. Shortly before 9 p.m. he produced a knife and refused to put it down, and at least three security guards tried to talk him into surrendering it. Guards used tasers to take the knife away, and after he went down, got back up, and reached for the knife again, one guard fired. The patient received medical treatment immediately, the police department is investigating, and Memorial Hermann said it is cooperating with law enforcement and cannot comment further because of patient privacy laws. Source: ABC7
