A new chapter in the 340B Drug Pricing Program is unfolding as the Health Resources & Services Administration (“HRSA”) pursues its 340B Rebate Model Pilot Program (the “Pilot Program”)—a move signifying both innovation and the intensification of longstanding industry debate. After announcing the program in August, HRSA has since published several FAQs on the Pilot Program’s application process and operational considerations.[i] The comment period for the Pilot Program ended on September 8, 2025 and HRSA received over 1,200 comments from stakeholders.
Continue Reading HRSA’s 340B Rebate Pilot Program: Industry Debates, Congressional Response, and Program Implications

Regulators and courts are expanding enforcement against digital health apps and online platforms that share sensitive health data without true consent, though these companies fall outside the scope of the Health Insurance Portability and Accountability Act (“HIPAA”). In order to reach non-covered entities, agencies and private claimants are now drawing on a patchwork of authorities to rein in misleading or undisclosed data practices:…
Continue Reading A New Era of Privacy Enforcement: Lessons for Digital Health Players

The Executive Order

Earlier this summer, the White House confirmed that President Trump is actively reviewing policy proposals developed in response to his executive order (“EO”) aimed at expanding access to in vitro fertilization (“IVF”).[1] Signed on February 18, 2025, the EO acknowledges the importance of family formation and the high financial barriers to fertility treatments. Accordingly, the EO solicits policy proposals “protecting IVF access and aggressively reducing out-of-pocket and health plan costs for such treatments.” [2] The initial submission deadline passed in May.
Continue Reading Shifting Landscapes: How Federal and State Policies are Expanding Access to IVF

With increased consolidation of traditional medical practices and declining reimbursement rates, many physicians are turning to alternative models like concierge medicine to preserve their independence. Concierge medicine allows physicians to offer personalized, high-quality care to patients in exchange for a membership fee. This model is governed by private service agreements that outline the relationship between the patient and healthcare provider, detailing the services provided, terms of access, and financial obligations. Unlike traditional practices, concierge medicine operates with a smaller patient panel, fewer insurance constraints, and a focus on improved patient access.
Continue Reading So You Want to Start a Concierge Medicine Practice? Here are Five Key Legal Considerations

The White House announced it is launching a health data tracking system early next year that involves an unprecedented partnership between the federal government, providers, payors, and private sector technology companies. The stated objective is to enable patients to more easily access and share their personal health data and medical records across different platforms, including through apps operated by private technology companies (the “Tracking System”). While the initiative may ultimately aspire to improve patient care through expanded data sharing, it raises notable legal and privacy concerns.
Continue Reading White House Announces National Health Data Tracking System of Personal Health Data

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