On January 21, 2026, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) submitted its Fall 2025 Semiannual Report to Congress, identifying investigative outcomes relating to HHS program administration and operations during the six‑month period from April 1, 2025 through September 30, 2025. Similar to prior semiannual reports, OIG’s findings provide a helpful roadmap for identifying risk areas and enforcement priorities as regulatory scrutiny continues in 2026.

This blog post highlights four areas of particular interest for health care stakeholders and outlines practical regulatory compliance considerations.

Wound Care (Skin Substitutes)

    OIG identified Medicare Part B spending on skin substitutes as a significant and growing HHS program integrity concern. Specifically, OIG reported that Part B spending on skin substitutes provided in non‑institutional settings had increased 640% in just two years, exceeding $10 billion annually, with notable disparities between original Medicare Part B and Medicare Advantage (“MA”) utilization.

    For health care stakeholders, certain key compliance takeaways include:

    • Evaluating whether skin substitute utilization and units billed per patient are clinically appropriate and supported by documentation.
    • Assessing site‑of‑service patterns, particularly the use of skin substitutes in home care settings that drive significantly higher per‑patient costs.
    • Reviewing product selection practices and rapid shifts to high‑cost skin substitute products for consistency with clinical decision‑making rather than reimbursement incentives.
    • Understanding and monitoring potential risks created by Medicare’s payment methodology for skin substitutes, including higher payments for new products, payment delays that can inflate reimbursement, and incentives tied to percentage‑based add‑on payments.
    • Identifying and remediating billing patterns that OIG has associated with potential risk, including excessive quantities, use for non‑approved conditions, use without prior conservative treatment, and billing concentrated among atypical provider specialties.

    Remote Patient Monitoring

      Remote patient monitoring (“RPM”) recently became a priority area for OIG as Medicare payments for RPM reached $536 million in 2024, representing a 31% increase from 2023. Based on OIG’s report, here are some key compliance considerations:

      • Monitoring growth in RPM enrollment to ensure billing reflects supportable clinical expansion rather than an onset of new patients.
      • Confirming that a prior in‑person or telehealth relationship exists with patients before billing for RPM.
      • Ensuring RPM services include ongoing treatment management, with providers frequently reviewing patient data and using it to make clinical care decisions.
      • Reviewing whether RPM is being billed for patients who are also receiving RPM services from other providers, which may indicate, according to OIG, duplicative or unnecessary services and thus, billing.
      • Verifying that billing reflects no more than one RPM device per patient per month, absent clear justification, to avoid potential duplicative billing or billing for unnecessary devices.
      • Using internal auditing and monitoring to identify and assess RPM billing patterns that OIG has flagged as potentially warranting further scrutiny, including high percentages of patients without prior history of RPM use.

      Managed Care

      Given the scale of enrollment in managed care plans and government expenditures relating to such enrollment, OIG continues to prioritize oversight of MA and Medicaid managed care organizations. OIG’s report highlights audits identifying overpayments tied to potentially inaccurate or otherwise noncompliant risk‑adjustment program diagnosis coding.

      Some key compliance takeaways for plans and providers providing and billing for these services include:

      • Strengthening controls around diagnosis code submission for MA risk adjustment to ensure codes are supported by medical records and reflect active conditions.
      • Identifying high‑risk diagnoses that may warrant heightened review, particularly where unsupported coding may result in inflated risk‑adjusted payments.
      • Evaluating the effectiveness of compliance and ethics programs designed to prevent, detect, and address potentially improper payments, including retrospective reviews and corrective action processes.
      • Reviewing whether the plan receives and incorporates State or Medicaid Fraud Control Unit training and feedback on referrals of potential fraud, given OIG’s finding that training is associated with higher referral rates.
      • Ensuring fraud referral staff have sufficient focus and resources dedicated to Medicaid managed care, rather than being spread across multiple lines of business.

      Nursing Homes

      As explained in its report, OIG continues to identify systemic quality‑of‑care deficiencies in nursing homes, including understaffing, infection control failures, underreporting of resident falls, and noncompliance with employee background check requirements. OIG’s report highlights enforcement actions, including False Claims Act settlements and exclusions, tied to allegedly substandard care and resident harm.

      For health care stakeholders owning, operating, and providing services in nursing homes, certain key compliance considerations include:

      • Reviewing whether falls resulting in major injury and hospitalization are fully and accurately reported in required resident assessments.
      • Evaluating reporting practices for younger residents, male residents, short‑stay residents, and residents covered by Medicare only, where OIG reported finding higher rates of unreported serious falls.
      • Confirming that required background checks are completed before employees begin work, consistent with Federal requirements and industry standards.
      • Verifying that required neglect and abuse registry queries are completed before employees begin work, where applicable under State law.

      OIG’s Fall 2025 Semiannual Report reflects an increased reliance on data analytics, coordinated enforcement, and program‑wide audits. Organizations operating in these areas should consider prospective, concurrent, and/or retrospective compliance auditing and monitoring, as well as targeted enhancements to address and potentially mitigate exposure as government scrutiny continues to intensify.

      Proskauer’s Health Care Group remains apprised of OIG’s Semiannual Reports to Congress and updates in the areas identified by OIG in its reports.

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      Lara Feder

      Lara Feder is a law clerk in the Corporate Department and is a member of the Health Care Group.

      Photo of Matthew J. Westbrook Matthew J. Westbrook

      Matt Westbrook is a senior counsel in the Corporate Department and a member of the Health Care Group. His practice focuses on providing regulatory compliance advice for the Firm’s health care clients, including service providers, health plans, operators, investors, and lenders, among others.

      Matt Westbrook is a senior counsel in the Corporate Department and a member of the Health Care Group. His practice focuses on providing regulatory compliance advice for the Firm’s health care clients, including service providers, health plans, operators, investors, and lenders, among others. Matt specifically provides advice on fraud and abuse matters arising under the Federal False Claims Act (FCA), Civil Monetary Penalties Law, Federal Anti-Kickback Statute (AKS), and Physician Self-Referral Law (Stark Law), as well as on the regulations promulgated by the Drug Enforcement Administration (DEA) and the Department of Health and Human Services, including the Office of Inspector General (OIG), Centers for Medicare & Medicaid Services (CMS), and Food and Drug Administration (FDA).

      Before joining the Firm, Matt served as senior counsel in OIG’s Administrative and Civil Remedies Branch. At OIG, Matt was responsible for determining whether to impose administrative sanctions, including civil money penalties and Federal health care program exclusions, against health care providers and suppliers, and whether to impose civil money penalties on hospitals and physicians in connection with matters referred to CMS under the Emergency Medical Treatment and Labor Act (EMTALA). During his tenure, Matt also litigated exclusion appeals before administrative law judges and appellate panels of the Departmental Appeals Board; advised United States Attorney’s Offices on exclusions appealed to Federal district courts; resolved voluntary self-disclosures submitted by providers and grant and contract recipients; and participated in the negotiations and settlements of FCA matters by the Department of Justice involving the AKS, Stark Law, CMS reimbursement issues, and DEA and FDA compliance issues. In connection with certain FCA resolutions, Matt also negotiated and monitored corporate integrity agreements.

      On the Florida junior circuit and in college, Matt was a competitive tennis player. Matt played on the varsity team and was captain his senior year at Rhodes College, earning ITA Division III and SCAC All-Academic Honor Roll awards his sophomore, junior, and senior years. Matt is an active member of the American Health Law Association (AHLA) and currently serves as a Vice Chair of AHLA’s Fraud and Abuse Practice Group.

      Articles:

      Matthew J. Westbrook and David M. Blank, “Using OIG’s Cross-Component Audit and Enforcement Data to Strengthen Your Compliance Program,” Compliance Today (February 2024).

      Ed Kornreich, Matthew Westbrook, and Angela Gichinga, “Bracing for the Impact of the No Surprises Act,” Westlaw Today (June 16, 2022).

      Presentations:

      Bill Mathias and Matt Westbrook, “‘Lightning Round’:  A Fraud & Abuse Due Diligence Game Show,” American Health Law Association (Health Care Transactions Conference, May 5–6, 2025).

      Matthew J. Westbrook and David M. Blank, “Recent Trends in CMPL Enforcement, American Health Law Association (Webinar, May 24, 2023).

      Photo of Devin Cohen Devin Cohen

      Devin Cohen is a partner in the Corporate Department and a member of Proskauer’s Health Care Group.

      Devin counsels leading health care organizations and private equity sponsors operating at the cutting edge of the industry on their most important transactional and regulatory matters.

      Devin Cohen is a partner in the Corporate Department and a member of Proskauer’s Health Care Group.

      Devin counsels leading health care organizations and private equity sponsors operating at the cutting edge of the industry on their most important transactional and regulatory matters. He has a deep understanding of both deal mechanics and the evolving regulatory landscapes in the areas of strategic investment, vertical integration, insurance and brokerage, as well as research.

      Over the course of his career, Devin has advised a wide range of health care organizations and investors on value-based care arrangements and initiatives, and routinely advises insurers and providers to structure collaborative care models and Medicare Advantage. In addition, Devin has worked with clients on matters related to pharmaceutical and medical device research and development and clinical trials, including fraud and abuse considerations, human subject protections requirements, animal welfare standards, sponsored and investigator-initiated research negotiations, and compliance monitoring.

      Clients value Devin’s responsiveness, as well as his ability to cut through complexity to provide clear, actionable guidance. They also appreciate the strong people skills he brings to the table, which are particularly helpful in negotiations.

      Devin’s passion for health care extends to his community service and pro bono efforts in the Boston area. He works with Heading Home and other non-profits providing shelter to those in need throughout the Commonwealth of Massachusetts, among others.

      Devin joins Proskauer from Ropes & Gray LLP where he was a partner in the firm’s Health Care practice.

      Experience

      Devin regularly works with a wide range of health care organizations — including physician groups, academic medical centers, clinical networks, hospitals, dental and management services organizations, insurers, brokers/agents, pharmaceutical and medical device manufacturers, and provider organizations — as well as industry investors, across areas such as:

      Health care transactions and investments

      • Provide transactional and regulatory counsel to providers and investors. Examples include:
      • Assisted multiple regional health plans in their mergers and acquisitions of new plans to expand insurance product offerings.
      • Advised a private equity firm on its investment in an online insurance brokerage platform.
      • Counsel investors on emerging state health care transaction laws, corporate practice of medicine, and MSO/DSO structuring.
      • Advise multiple private sponsors on CRO and SMO investments

      Value-based care arrangements

      • Counsel a wide range of providers, payors, practice management organizations, vendors and industry investors in the areas of Medicare Advantage, CMMI program participation, state risk-bearing implications and insurance requirements.
      • Advise on strategic partnerships and joint ventures, including innovative collaborations aimed at expanding access to value-based primary care for Medicare beneficiaries.

      Regulatory and compliance

      • Routinely counsel Medicare Advantage Organizations, FDRs and program vendors on Medicare Advantage regulatory and contracting standards.
      • Advise investors and brokers/agencies on emerging Medicare requirements, including emerging standards related to sales commissions payments.
      • Advise medical device and pharmaceutical manufacturers on regulatory standards related to customer and patient interactions, marketing and clinician education standards, industry and jointly sponsored CME, patient assistance programs, and related compliance program requirements.

      Clinical research and related activities

      • Regularly provide guidance on drug and drug component development/commercialization considerations for sites, investigators and sponsors.
      • Routinely advise institutional and start-up manufacturers, as well as CROs and trial sites, on cutting-edge clinical trial contracting negotiations.
      • Provide counsel on research affiliation agreements, including advising a large academic medical center on developing and implementing its research affiliation agreement with a local pediatric health network.
      • Conduct regulatory diligence for private equity clients regarding their planned investments in companies that participate in the clinical research enterprise.
      • Advise academic medical centers on research misconduct matters.