Comments are due in less than a month on the Centers for Medicare & Medicaid Services (“CMS”) proposals to make significant structural reforms to Medicare’s Competitive Bidding Program (“CBP”) for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (“DMEPOS”) and DMEPOS accreditation requirements as well as major revisions to the Medicare provider enrollment rules for all Medicare provider and supplier types (the “Proposed Rule”). Comments must be submitted no later than 5 p.m. EDT on September 2, 2025.
Continue Reading Major Policy Changes Proposed for Medicare Payment, Accreditation, and Prior Authorization for DME Suppliers

I. Overview of Telehealth and Tele-Prescribing Landscape

Since the end of the Public Health Emergency (“PHE”) exceptions in 2023, states have continued to re-evaluate the broad telehealth and tele-prescribing flexibilities granted during the pandemic. Over the past year, many jurisdictions, including New York, California, Delaware, Florida, New Hampshire, and Texas, have either enacted or proposed legislation codifying, modifying, or rolling back pandemic-era waivers related to remote patient care. These regulatory changes touch on several key areas of remote care, including the use of telehealth modalities for the initial “in-person” visit requirement for prescribing controlled substances remotely and remote visitation protocols…
Continue Reading Telehealth and “In-Person Visits”: Tracking Federal and State Updates to Pandemic Era Telehealth Exceptions

The Centers for Medicare & Medicaid Services recently published the calendar year (“CY”) 2026 proposed rule for Medicare payment for services provided in hospital outpatient departments under the Outpatient Prospective Payment System (“OPPS”) and services provided in ambulatory surgery centers (“ASCs”) (“the Proposed Rule”). Comments are due by September 15, 2025.
Continue Reading Proposed Medicare Payment Policies for Hospital Outpatient and Ambulatory Surgery Center Services

On August 6, 2025, the New York State Department of Health (DOH) finalized amendments to its Certificate of Need (CON) regulations in 10 N.Y.C.R.R. Part 710, raising the financial thresholds for full review, expanding exemptions, and introducing a self-certification pathway for certain capital projects. The final rule is published in the New York State Register (Vol. XLVII, Issue 31, Aug. 6, 2025) and is available here.
Continue Reading New York Adopts Major Certificate of Need Amendments Effective August 6, 2025

On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”), that would dramatically change the way in which participating drug manufacturers provide discounts to healthcare entities eligible to participate in the 340B Program.
Continue Reading HRSA Launches and Seeks Comments on 340B Rebate Model Pilot Program

Among the many sweeping changes to the Medicaid program included in the One Big Beautiful Bill Act (“OBBBA”), Congress established new statutory caps on state-directed payments (“SDPs”) in Medicaid managed care. SDPs have long served as a critical mechanism for states pursuing value-based payment (“VBP”) reforms, addressing network adequacy, and advancing health equity for underserved populations. OBBBA imposes explicit Medicare-based caps on new SDPs, time-limited exceptions for certain SDPs that were approved or in development on or before July 4, 2025, and a phased transition to new payment caps beginning January 1, 2028, that will reshape state payment policy tools…
Continue Reading State-Directed Payments, Value-Based Care, and the “One Big Beautiful” Bill: A Comprehensive Analysis

On July 9, 2025, the U.S. Department of Justice (“DOJ”) announced it sent more than 20 subpoenas to physicians and clinics involved in providing gender-affirming care to minors, and that the subpoenas related to investigations into healthcare fraud, false statements and other misconduct.[i] DOJ’s recent announcement, combined with the other actions described below, signal the government’s interest in pursuing action against providers that bill federal healthcare programs for gender-affirming care for minors, including puberty blockers, hormone therapy and surgeries. Specifically, these actions strongly suggest that the government will investigate not only criminal claims but also civil claims under the…
Continue Reading Potential False Claims Act Liability for Providers of Gender-Affirming Care for Minors

Following Sheppard Mullin’s recent webinar on Health Equity Impact Assessments (HEIAs), one thing is clear: providers and investors cannot afford to treat equity requirements as an afterthought in the Certificate of Need (CON) process.
Continue Reading What Health Equity Means for CON — and Why It Matters Now

At the end of June, Texas enacted the “Texas Responsible Artificial Intelligence Governance Act” (the “Act”), adding to the patchwork of growing AI laws. This summary addresses the Act’s most significant provisions.
Continue Reading Texas Enacts Responsible AI Governance Act Adding to Patchwork of AI Laws

On July 11, 2025, in United States v. Schena,[1] the Ninth Circuit adopted an expansive interpretation of the Eliminating Kickbacks in Recovery Act (EKRA), applying the law to any payment that could have the effect of inducing a referral, even downstream, regardless of who received the payment. The court affirmed laboratory operator Mark Schena’s convictions for violating EKRA resulting from his percentage-based payments to marketing intermediaries who provided misleading information to referring providers.
Continue Reading Inside the Ninth Circuit’s Interpretation of EKRA: Clarity for Kickback Law

Nearly three years ago, the passage of California Bill AB 890, effective January 1, 2023, set in motion a future pathway for qualified nurse practitioners (“NPs”) to practice independently under a new category of licensure. Specifically, AB 890 delineated two potential pathways for California NPs to practice without standardized procedures in certain settings:[1] as “103 NPs” and “104 NPs” (described below). On January 1, 2026, nurse practitioners licensed in California will be eligible for “104 NP” status for the first time. Here, we explore interim legal developments since AB 890 took effect, and discuss how healthcare organizations can incorporate…
Continue Reading Pulse Check: How is Your California Practice Leveraging “103 NPs” – and Preparing for the Arrival of “104 NPs” in 2026?

Last month, New York State began a formal review of its Certificate of Need (CON) process for nursing homes, launching a timely conversation about how best to align regulatory oversight with evolving system needs. A new advisory committee, convened by the Public Health and Health Planning Council (PHHPC), has been charged with evaluating the state’s current CON framework and recommending changes to improve transparency in ownership, strengthen financial accountability, and streamline decision-making.
Continue Reading Policy Brief: Aligning Nursing Home Bed Planning with New York’s Certificate of Need Reform Goals

On July 2, 2025, the Departments of Justice and Health & Human Services announced a joint working group aimed at “strengthening their ongoing collaboration to advance priority enforcement areas” under the False Claims Act (FCA) – described in the announcement as “one of the government’s most effective and successful tools” for fighting fraud. In Fiscal Year 2024, the Department of Justice recovered more than $2.9 billion through settlements and judgments under the FCA, with $1.6 billion (57%) coming from healthcare-related matters.
Continue Reading DOJ and HHS Announce Joint False Claims Act Working Group and Enforcement Priorities