Health Law Advisor

On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging for” language in the Anti-Kickback Statute (“AKS”).

The AO involves a proposed arrangement for a medical device company (the “Requestor”) to pay a third-party vendor to access an electronic billing portal operated by the vendor that is used by some of the Requestor’s customers for certain billing operations. In issuing the unfavorable opinion, the OIG said the proposed arrangement “presents anti-competitive risks and risks of inappropriate steering” and characterized the arrangement as being “for the purpose of accessing referrals” from hospital customers that are clients of the vendor.

The Requestor in this AO is a medical device company that supplies "bill-only" products to hospitals. “Bill-only” products are items that are not part of a hospital’s regularly purchased inventory but rather are purchased in real time, such as when a surgeon is selecting the right size or component of a device to use during a surgery. According to the AO, what typically happens with “bill-only” products is that a representative of the medical device company delivers a selection of items to a hospital customer the day before or the day of a patient’s procedure so that the surgeon can select the specific items needed for that specific patient. Some of these “bill-only” items are used in procedures reimbursable by federal health care programs.

On May 9, 2025, the Departments of Labor, Health and Human Services, and Treasury (collectively, “the Departments”) asked the D.C. federal court to suspend a lawsuit to challenge the legality of the 2024 Rule on the Mental Health Parity and Addiction Equity Act (MHPAEA) while the Departments consider whether to rescind or modify the 2024 Rule.^[1] On May 15, 2025, the Departments released a public statement that they will not enforce the 2024 Final Rule prior to a final decision in the litigation, plus an additional 18 months after the decision.

The public statement on May 15 provides further details regarding the scope of the non-enforcement policy, including clarification that the 2013 MHPAEA rules remain in effect, as does plans’ obligation to develop comparative analyses of non-quantitative treatment limits (“NQTLs”). However, the Departments have not yet provided any indication of the timeline for publishing a notice of proposed rulemaking to rescind or modify the 2024 Rule, and most likely it will take some time for the Departments to determine how exactly the new rule should be designed to better implement the statutory requirements.

On August 24, 2023, the U.S. District Court for the Eastern District of Texas issued an opinion and order in Texas Medical Association, et al. v. United States Department of Health and Human Services(“HHS”)(“TMA III”). TMA III challenged certain portions of the July 2021 No Surprises Act (“NSA”) interim final rules proposed by the U.S. Departments of Health and Human Services, Labor, and Treasury, along with the Office of Personnel Management (the “Departments”).  In a decision that significantly levels the field for providers, the District Court ruled in part ...

In this episode of the Diagnosing Health Care Podcast:  In July, the Centers for Medicare & Medicaid Services made significant headway in its implementation of the drug pricing provisions of the Inflation Reduction Act (IRA).

How can stakeholders respond to, implement, and comply with all these new provisions? On this episode, hear from special guest Sylvia Yu, Vice President and Senior Counsel of Federal Programs at PhRMA.

Sylvia and Epstein Becker Green attorneys Connie Wilkinson and Alexis Boaz discuss the recent updates on the quickly moving implementation of the drug pricing provisions under the IRA and the industry’s response.

In this episode of the Diagnosing Health Care Podcast:  The Biden administration has released a series of rules and guidance to implement the No Surprises Act, which went into effect on January 1. All providers and facilities must now provide a good faith estimate to uninsured and self-pay patients scheduling appointments for services or upon request.

In this episode of the Diagnosing Health Care Podcast:  The Departments of Labor, Health and Human Services, and the Treasury jointly released a set of frequently asked questions (“FAQs”) related to recent changes made to the Mental Health Parity and Addiction Equity Act effective as of February 10, 2021, and enacted by the Consolidated Appropriations Act at the end of 2020. Accordingly, health plans and insurers must ensure that they understand, and are prepared to provide regulators with documentation of their compliance with, parity requirements on at least a small ...

In December 2015, we wrote about the many failed health insurance co-ops created under the Affordable Care Act (“ACA”), and the impact of those failures on providers and other creditors, consumers, and taxpayers. At that time, co-ops across the country had more than one million enrollees. As of January 2021, there were roughly 120,000 enrollees in three remaining co-op plans. Nonprofit co-op insurers were intended to increase competition and provide less expensive coverage to consumers. However, low prices, lack of adequate government funding, restrictions on the use of ...