Health Law Advisor

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 ...

On July 25, 2024, a federal “Health Over Wealth Act” was introduced in the U.S. Senate and House of Representatives. The bill would amend the Public Health Service Act, requiring the Secretary of Health and Human Services (HHS) to enforce certain transparency, accountability, and other requirements with respect to for-profit corporations that own health care systems.

S. 4804 was introduced by Senator Edward D. Markey (D-Mass), chair of the Health, Education, Labor, and Pensions Committee on Primary Health, and Retirement Security, before being referred to the Committee on Finance. H.R. 9156 was introduced by Representative Pramila Jayapal (WA-07), member of the House Judiciary Subcommittee on Health, Employment, Labor, and Pensions.

New from the Diagnosing Health Care Podcast: Knock, knock! If the Drug Enforcement Administration (DEA) is already at your door, it may be too late.

Enforcement is on the rise, and the microscope is fixed on controlled substances. What can industry stakeholders do to prevent penalties and protect themselves from DEA scrutiny?

On this episode, Epstein Becker Green attorneys Melissa Jampol, David Johnston, and Avery Schumacher discuss recent and pending updates to DEA rules and guidance, outline steps stakeholders can take to prepare for an inspection, and share tips on what to do when the DEA arrives.

In our ongoing series of blog posts, we examined key negotiating points for tenants in triple net health care leases. We also offered suggestions for certain lease provisions that will 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, when implemented, 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, and holdover provisions. This latest blog post focuses on negotiating surrender terms. Tenants should understand and negotiate their obligations for removal of alterations, equipment and other personal property, and the condition in which leased premises must be surrendered at the expiration or earlier termination of the lease term. Failure to do so could result in delays in a tenant’s ability to vacate the leases premises as well as unforeseen significant costs.

Most commercial leases provide that alterations and improvements made by or on behalf of a tenant become the property of landlord and must be surrendered with the leased premises upon expiration or earlier termination of the lease unless landlord requires removal. We suggest tenants request language in the lease requiring landlord to advise at the time it consents to such alterations and improvements whether or not the same must be removed, rather than landlord having the right pursuant to the terms of the lease to demand removal at the time of expiration or earlier termination. Having such a term in place eliminates the element of surprise and provides tenant with certainty as to which alterations and improvements tenant is required to remove. Tenants may also want to limit the removal requirement so that any alterations or improvements that cannot be removed without significant damage are to remain in the leased premises upon expiration of the lease term.

In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”)[1], that it will not extend the one-year stabilization period for the enhanced drug distribution requirements beyond November 27, 2024.[2] At the same time, the FDA also issued exemptions, through November 27, 2026, for small pharmacies from certain DSCSA requirements, and is allowing all other trading partners to request waivers or exemptions from the enhanced drug distribution security requirements.[3]

DSCSA Background

The DSCSA provides for the tracking and tracing of drug products from drug manufacturers through the supply chain down to dispensers, requirements for investigating and dispositioning suspect and illegitimate drug products and federal licensing requirements for wholesalers and third-party logistics providers. The driving force behind the DSCSA is to prevent counterfeit drugs from entering the supply chain and to prevent such drugs from harming patients if they do enter the supply chain. Under the law, manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers (“Trading Partners”) each have affirmative obligations governing how they must transfer ownership of prescription drug products and the specific product data or tracking data that must be maintained and shared between buyers and sellers of such products. Further, Trading Partners must have processes in place for drug product verification, as well as an affirmative obligation to identify, investigate and manage suspect or illegitimate products, such as counterfeit or intentionally adulterated products.

On June 11, 2024, U.S. Senators Ed Markey and Elizabeth Warren from Massachusetts, introduced proposed legislation titled The Corporate Crimes Against Health Care Act (“CCAHCA”), aimed at addressing a perceived “looting” of health care systems by for profit private equity investors. According to Sen. Warren, the bill was introduced to “root out corporate greed and private equity abuse in the health care system,” “prevent exploitative private equity practices,” and to specifically ensure that actions such as “looting” do not happen again by addressing trigger events and targeting real estate investment trusts.

The CCAHCA proposes to impose significant criminal penalties, compensation clawbacks, and civil penalties against executives of private equity firms and health care entities that are found to have contributed to the death or injury of a patient through a triggering event. Additionally, the bill imposes certain requirements that impact real estate investments funds (REITs) and would require annual reporting requirements for change of control transactions.

New from the Diagnosing Health Care Podcast: Laboratories in the United States are facing a major regulatory landscape shift.

The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory developed tests (LDTs). What does this mean for labs going forward?

On this episode, Epstein Becker Green attorneys James Boiani, Rob Wanerman, and Megan Robertson lay out the new landscape, analyze existing and potential challenges, and identify key developments to watch for as this new regulatory era unfolds.