Health Law Advisor

Global hospital budgets, where hospitals receive a fixed amount of revenue for the upcoming year for a specific patient population (e.g., Medicare and/or Medicaid), are the opposite of fee for service reimbursement.

The Center for Medicare and Medicaid Services (CMS) and state Medicaid programs have taken interest in global hospital budgets and hospitals in impacted states will need to prepare.  This article summarizes two of these programs: the federal Advancing All-Payer Health Equity Approaches and Development (AHEAD) model and New York’s Health Equity Reform 1115 Medicaid Waiver.

In our ongoing series of blog posts, we have examined key negotiating points for tenants in triple net health care leases. We also have offered suggestions for certain lease provisions designed to protect tenants from overreaching and unfair expenses, overly burdensome obligations, and ambiguous terms with respect to the rights and responsibilities of the parties. These suggestions are intended to result in efficient lease negotiations and favorable lease terms from a tenant’s perspective.

In our previous blog posts, we considered the importance of negotiating initial terms and renewal terms, operating expense provisions, assignment and subletting terms, maintenance and repair obligations, holdover provisions and surrender terms. This latest blog post focuses on negotiating lease terms governing tenant improvement allowances. A tenant should negotiate for landlord to provide a tenant improvement allowance to prepare the leased premises for the tenant’s occupancy and should consider important factors including the amount of the tenant improvement allowance, whether tenant or landlord will complete the work, and how and when the tenant improvement allowance will be paid.

New from the Diagnosing Health Care Podcast: The game has changed—are you positioned to adapt? Over the past 12 months, the federal government has been heavily regulating private investment in health care entities.

Simultaneously, multiple states have enacted or introduced new laws restricting or requiring approval of such investments. The question arises: What do you do if you already have investments in these health care entities?

On this episode, Leslie Norwalk, Strategic Counsel at Epstein Becker Green (EBG), joins EBG attorneys Josh Freemire, Tim Murphy, and Ted Kennedy, Jr., to discuss how health care entities, investors, and board members should be responding to an evolving political and regulatory environment that has increased the scrutiny of private investment in health care entities.

This month, I explore just how old medical devices are as measured by the date they were cleared or approved by the FDA, using the Global Unique Device Identification Database.

That database is the only one that FDA maintains that gives insight into specifically what devices are currently marketed in the United States.  And of course, this being unpacking averages, I don’t just want the average, but I want to understand the range.

On July 31, the Centers for Medicare and Medicaid Services (“CMS”) published its mammoth proposed rule entitled “Medicare and Medicaid Programs: Calendar Year 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments” (“CY25 PFS Proposed Rule”).

The CY25 PFS Proposed Rule came on the heels of another CMS rule, published on July 22, covering “Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems”—and more (“CY25 OPPS Proposed Rule”). Both rules have a comment period that closes on September 9.

The recent Supreme Court decisions of SEC v. Jarkesy[1] and Loper Bright Enterprises v. Raimondo[2] have the potential to meaningfully impact the implementation and enforcement of the Drug Supply Chain Security Act[3] (“DSCSA”) as industry transitions away from the “stabilization period” ending on November 27, 2024.  The DSCSA statute contemplated that the Enhanced Drug Distribution Security system (“EDDS”) was to be effective November 27, 2023.[4]  Recognizing that many Trading Partners were not yet ready to fully comply with the November 27, 2023 deadline, in August 2023, the FDA issued a compliance policy guidance document with regard to EDDS.[5]  This guidance document provided Trading Partners with a one-year “stabilization period”, through November 27, 2024, during which the FDA would not enforce the statutory EDDS requirements.[6] The stabilization period was implemented to avoid supply chain disruption and to ensure continued patient access to prescription drug products, while Trading Partners continue to work towards compliance with the EDDS requirements.

As we move from the “stabilization period” to perhaps a period of greater enforcement, each of these decisions favor the potential positions of regulated trading partners over the FDA in application to the DSCSA.

To honor the 34th anniversary of the Americans with Disabilities Act (ADA), on July 26, 2024, the U.S. Department of Justice (DOJ) signed a long-awaited final rule to improve access to medical diagnostic equipment (MDE) for people with disabilities (the “MDE Regulations”). Stressing that accessible MDE is essential for people with disabilities to have equal access to medical care and avoid poor health outcomes, the MDE Regulations, which were published by the Federal Register on August 9, 2024, amend Title II of the ADA (“Title II”) and apply to hospitals and health care clinics operated by state or local governments. The MDE Regulations create enforceable minimum standards for accessible design (as initially issued by the U.S. Access Board) covering MDE, including examination tables, weight scales, dental chairs, x-ray machines, mammography machines, and other radiological equipment commonly used for diagnostic purposes by health care professionals.

In full, the MDE Regulations and the accessibility standards they incorporate stand well in excess of 100 pages. To help our clients more readily understand what the MDE Regulations do and do not require, we are answering some of the most commonly asked questions here.

Stakeholders are continuing to analyze the implications of the mammoth proposed rule on “Medicare and Medicaid Programs: [Calendar Year (CY)] 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments” (the “CY 2025 PFS Proposed Rule”).

While it’s not easy to reach the end of the title, let alone the 1053-page rule, False Claims Act (FCA) attorneys should note with interest that last topic—Medicare overpayments. As the CY 2025 PFS Proposed Rule would, if finalized, change Medicare regulations regarding requirements for reporting and returning Parts A and B overpayments, stakeholders and their counsel need to understand their obligations.

While the Supreme Court decision in Loper Bright Enterprises v. Raimondo was making headlines, other courts were considering recent regulations of another agency—the Centers for Medicare and Medicaid Services (CMS)—that are material to Medicare Advantage. On July 3, a judge in Texas partially granted motions for a stay in a lawsuit challenging a CMS rule issued in April (“2025 Final Rule”) impacting plan agreements with agents and brokers to limit administrative payments, standardize compensation payments, and to restrict plan agreements with third-party marketing organizations (“TPMOs”).

For plans and TPMOs, the decision means they can revert to operating under the compensation/administrative services rules as those existed prior to CMS's issuance of the 2025 Final Rule. CMS has already issued revised 2025 fair market value (“FMV”) compensation amounts to reflect the stay that was granted by the court. In a July 18 memo, CMS announced FMV limits that are $100 less than the previously announced FMV standards. CMS also alerted plans that they must submit their annual reporting of compensation amounts to be paid to independent agents and brokers. Plans may continue to pay compensation at or below the FMV limit and may continue to pay separate administrative costs, subject to the requirement that these be paid at their FMV.

I may be jumping the gun here, but I’m anxious to understand how the new flurry of AI medical devices is performing in the marketplace, or more specifically, whether the devices are failing to perform in a way that jeopardizes health.

FDA keeps a list these days of medical devices that involve AI, and here’s the recent growth in clearances or other approvals. 

Click to enlarge the image. 

Note for calendar year 2024, we only have first-quarter data.

The growth is notable. As these devices enter the market, they are subject to all the typical medical device postmarket regulatory ...