Wade’s Health Law Highlights for January 13, 2026

Advisory Opinions

• The Department of Health and Human Services Office of Inspector General issued Advisory Opinion 25-11 addressing whether a biopharmaceutical manufacturer’s vaccine discount arrangements would violate the federal Anti-Kickback Statute. The manufacturer sought guidance on four types of discounts for three vaccines reimbursed under different Medicare programs: upfront discounts, upfront discounts with purchase requirements, bundled upfront discounts with purchase requirements, and bundled rebates. OIG determined that upfront discounts and upfront discounts with purchase requirements qualify for safe harbor protection when they are transparent, known at the time of sale, and do not require services from purchasers. The agency found that bundled discounts involving vaccines reimbursed under different methodologies do not meet safe harbor definitions but concluded it would not impose sanctions because the risk of fraud and abuse was low due to factors including equal benefit to Medicare reimbursement systems and the presence of competing products with similar prices. OIG emphasized that safe harbor compliance depends on how discount programs are structured, disclosed, and applied. Source: Arnall Golden Gregory LLP
• The Office of Inspector General issued an unfavorable advisory opinion determining that a home care agency’s proposal to offer sign-on bonuses to prospective employees would violate federal law. The agency planned to market the bonuses to attract attendants who would provide Medicaid-reimbursable in-home support services primarily to their own family members. OIG concluded the arrangement would violate both the Federal anti-kickback statute and the Beneficiary Inducements Civil Monetary Penalty because the attendants would serve as decision-makers selecting the agency on behalf of their family members, creating an inextricable link between employment and client referrals. The employee safe harbor exception does not apply because the bonus advertisement functions as solicitation for referrals before employment begins. The arrangement presents risks of inappropriate steering, unfair competition among agencies, and potential diversion of resources from client care. Source: OIG Advisory Opinion No. 25-12

Artificial Intelligence

• HHS issued a Request for Information seeking public comments on strategies to accelerate the adoption of artificial intelligence in clinical care. The RFI focuses on three policy levers: regulation, reimbursement, and research and development. Comments are due by February 23, 2026, and will inform future HHS policy and program design. The initiative aligns with the HHS Artificial Intelligence Strategy and White House directives. HHS is also seeking a three-year extension of its Paperwork Reduction Act clearance to enable data collection from stakeholders including state, local, tribal, and territorial governments, private sector companies, healthcare providers, manufacturers, and community organizations, with an estimated burden of over 350,000 hours. Source: Hinshaw & Culbertson LLP
• OpenAI launched OpenAI for Healthcare, a suite of HIPAA-compliant products that includes ChatGPT for Healthcare and the OpenAI API. ChatGPT for Healthcare is now rolling out to institutions including AdventHealth, Boston Children’s Hospital, Cedars-Sinai Medical Center, HCA Healthcare, Memorial Sloan Kettering Cancer Center, Stanford Medicine Children’s Health, and UCSF. The platform runs on GPT-5.2 models and provides evidence retrieval with citations from peer-reviewed research, institutional policy integration, workflow templates, and data controls including Business Associate Agreements to support HIPAA compliance. More than 260 physicians across 60 countries evaluated over 600,000 model outputs during development. Companies including Abridge, Ambience, and EliseAI are using the OpenAI API to build healthcare applications for patient chart summarization, clinical documentation, and appointment scheduling. Source: OpenAI
• AI technology is being implemented in healthcare to capture visit notes, document patient records, and streamline imaging reviews, but nurses remain skeptical about its safety and effectiveness. Research shows nurses are open to new technology but require proof it improves quality and patient safety before they will trust it, leading to protests and legislation to prevent the term “nurse” from appearing in AI-driven technology names. A 2024 McKinsey survey found 73% of nurses indicated that nursing input into AI tool design and optimization would help alleviate their concerns about using AI in healthcare. Nurses require the ability to override AI predictions in favor of their clinical intuition and want technology that reduces documentation burden rather than increases it. Florida State University launched the nation’s first Master of Science in Nursing with a concentration in AI in 2024, while a 2024 American Medical Association survey found 66% of physicians currently use AI in their practice. Source: Baxter
• CVS Health introduced an AI-native consumer engagement platform at its December 2025 investor day that connects CVS Pharmacy, CVS Caremark, Aetna, and its health care delivery businesses into a single digital interface. The company, which reaches 185 million consumers annually, embedded AI throughout the platform to enable personalization, automation, and predictive insights across consumer and operational workflows. CVS already uses AI across pharmacy operations, benefits administration, and clinical settings, including conversational tools for customer inquiries and ambient AI tools for clinician documentation. The company raised its 2025 revenue outlook to at least $400 billion and expects mid-teens adjusted earnings-per-share growth through 2028. CVS plans to commercialize elements of its engagement platform as “engagement as a service” to employers, payers, and other partners, though it did not provide revenue targets or timelines. Source: Digital Commerce 360

Commercial Payers

• Baptist Health System filed a lawsuit against UnitedHealthcare on Dec. 22 in state district court, alleging the insurer has underpaid for emergency room services provided to patients with ACA coverage. The San Antonio-based health system, which operates seven acute-care hospitals and five neighborhood hospitals, is not in network with UnitedHealthcare’s exchange plans but is required under federal law to provide emergency care regardless of a patient’s coverage or ability to pay. The lawsuit claims UnitedHealthcare has reimbursed the hospitals at rates substantially below typical charges for those services. Baptist Health System is seeking more than $1 million in reimbursements after the two sides attempted to mediate disputes over 108 claims last year but were unable to reach an agreement. Source: Becker’s Payer Issues

Enforcement

• California, Texas, and Virginia are setting the direction for state privacy enforcement in 2026, shifting focus from general privacy laws to specific consumer concerns including children’s online privacy, biometric usage, and location data. California operates two enforcement agencies targeting location data collection, opt-out systems, and dark patterns, with CalPrivacy issuing its largest judgment of $1.35 million against Tractor Supply Co. Texas focuses on children’s data, vendor agreements, genetic data, and geolocation requirements that require explicit consent for processing. Virginia emphasizes children’s geolocation data, social media regulations including one-hour daily screen time limits, and reproductive health information protections. All three states use consumer complaint databases, media attention, and personal experience to identify enforcement targets, with Texas and Virginia offering permanent “right to cure” provisions that allow companies to fix violations before facing charges. Source: Bloomberg Law

HIPAA

• HIPAA covered entities must revise their Notice of Privacy Practices by February 16, 2026, marking the first required update for many since 2013. The updates stem from requirements to incorporate substance use disorder information protections under 42 C.F.R. Part 2, which remained in effect after a court vacated reproductive health information amendments in June 2025. Part 2 Programs that are HIPAA covered entities must update both HIPAA and Part 2 notices, though they may use a single combined document. The requirement extends to any HIPAA covered entity that has received Part 2 records from other entities or business associates, as these records carry restrictions beyond standard HIPAA requirements and cannot be used in legal proceedings without patient consent or a court order. The U.S. Department of Health and Human Services’ Office for Civil Rights may issue further guidance, and additional changes could follow if proposed coordinated care rules are finalized. Source: Holland & Knight
• The Office for Civil Rights issued five HIPAA enforcement settlements in 2025 totaling $944,500 against healthcare organizations and business associates for violations ranging from delayed patient record access to failures in cybersecurity risk management. Concentra paid $112,500 for failing to provide patient records within the required 30-day timeframe, marking OCR’s 54th Right of Access enforcement action. Cadia Healthcare paid $182,000 for posting patient names, photographs, and treatment information as “success stories” without written authorization, affecting 150 patients. BST & Co. CPAs paid $175,000 and Syracuse ASC paid $250,000 following ransomware incidents where both entities failed to conduct risk analyses, with Syracuse ASC also failing to timely notify 24,891 affected individuals. Deer Oaks paid $225,000 after a coding error exposed patient information online from December 2021 to May 2023, followed by a network breach affecting 171,871 individuals, with OCR finding the organization never conducted a thorough risk analysis. Source: Shumaker, Loop & Kendrick, LLP
• Denton County MHMR Center in Denton, Texas, reported a data breach affecting 108,967 patients to the Department of Health and Human Services’ Office for Civil Rights. An unauthorized third party accessed the clinic’s computer network from December 24 to December 25, 2024, compromising patient names, addresses, identification numbers, dates of birth, diagnoses, medical history, treatment information, lab results, medication records, vaccination records, insurance information, and biometric identifiers. The organization reported the breach to HHS OCR on November 5, 2025, and notified affected individuals a year after the incident occurred. Denton County MHMR Center offered credit monitoring and identity protection services to patients and stated no misuse of the data had been detected at the time of notification. The clinic engaged third-party cybersecurity experts to implement network security enhancements and updated its data protection policies. Source: HIPAA Journal

Medicare Reimbursement

• The Trump administration announced on November 6, 2025, that Medicare will cover GLP-1 medications starting April 2026 for members with obesity and related comorbidities, marking a reversal from its prior position against covering anti-obesity medications. Medicare will price GLP-1 injections at $245 per month with patient copays capped at $50 per month, while the TrumpRx platform will offer the injections at $350 per month for cash-paying customers. Manufacturers will receive expedited FDA review for oral GLP-1 products, with the first product expected to receive a decision in December 2025 at $149 per month for the lowest dosage. The pricing represents a reduction from list prices that often exceed $1,000 per month, but creates uncertainty about how the program will interact with Medicare Drug Price Negotiation Program prices ranging from $274 to $385 that take effect in 2027. The change threatens the business model of telehealth companies that have relied on subscription models or compounded GLP-1 offerings to compete on cost. Source: McDermott Will & Emery

Private Equity

• States are enacting laws to regulate private equity investment in healthcare after firms spent hundreds of billions of dollars acquiring healthcare companies over the past decade. Lawmakers have expressed concern that profits could be prioritized over patients and that non-healthcare entities may influence clinical decisions. California passed two laws in October: SB 351 codifies corporate practice of medicine doctrines, restricts interference with physicians’ judgment, and prohibits certain non-compete clauses, while AB 1415 expands the state’s “mini-HSR” law to include private equity groups in reporting requirements. Healthcare providers must structure deals to comply with corporate practice of medicine restrictions and accommodate state review processes. Failure to comply can result in enforcement actions, financial penalties, and unwinding of transactions. Source: Thompson Coburn LLP
• Healthcare providers who receive acquisition offers from private equity firms should consider expanding their own practices instead of selling. Private equity interest serves as a signal that the local market presents opportunities for acquisitions. Physicians, dentists, and other healthcare providers may want to pursue a “buy now and sell later” approach rather than accepting immediate buyout offers. Source: Health Care Law Matters

Physicians

• Texas enacted a law allowing foreign-trained doctors to practice without completing a second U.S. residency, joining 17 other states in creating an alternative licensing pathway to address physician shortages. Under House Bill 2038, the Texas Medical Board approved rules in January 2026 for provisional licenses that require foreign doctors to have five years of experience, pass U.S. licensing exams, and work four years under supervision before qualifying for a full license. The law targets foreign-trained doctors already living in the U.S. rather than recruiting from abroad, as Texas faces a projected shortage of 10,000 doctors by 2032 despite having 100,000 licensed physicians, with about 25,000 trained outside the country. President Trump’s executive order raising H-1B visa fees to $100,000 has created uncertainty for recruiting efforts, though employers may cover the cost in exchange for multi-year commitments. Critics question whether the program addresses a genuine shortage or creates opportunities for lower-paid physicians, while supporters say it will help staff underserved areas. Source: The Texas Tribune

Public Opinion

• Cost concerns dominate American views of the health care system, with 29% of adults identifying expense as the nation’s top health problem. A Gallup poll of 1,300 adults conducted between November 3 and November 25 found that 23% of respondents said the system is in crisis or has problems, one of the highest levels ever recorded. The survey showed 81% of Democrats and 64% of Republicans view the health care system as being in serious trouble, with concerns about costs rising 12 percentage points among Democrats and 10 points among Republicans since last year. A separate KFF survey found that more than one-third of Americans delayed or skipped medical care because of cost, and about one in five reported their health worsened as a result. The polling comes as Affordable Care Act subsidies are set to expire at year-end, which could cause premiums to more than double according to KFF estimates. Source: Renal and Urology News

Rural Health

• More than 40 million Americans live in rural areas that lack primary care providers, with projections showing that by 2037, physician supply will meet only 68 percent of demand. In 2023, 92 percent of rural counties were designated as primary care health professional shortage areas, including 199 counties without any primary care physicians. Thirty-eight percent of rural adults used emergency rooms for care that could have been provided at a primary care practice, while only 19 percent received primary care via telehealth, compared to 29 percent of nonrural residents. H.R. 1 allocates $50 billion over five years through the Rural Health Transformation Program to strengthen care delivery, though other provisions in the law are projected to reduce hospital and health system revenue by up to $87 billion over 10 years. Source: Commonwealth Fund