Health Law Advisor

On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the ten (10) Medicare Part D drugs selected for the first round of negotiations of the Medicare Drug Price Negotiation Program (Program)—a few days before the September 1, 2023, statutory deadline imposed by the Inflation Reduction Act (IRA). The negotiated pricing will go into effect in 2026.

In its announcement, CMS included details about upcoming opportunities for public input regarding the Program, including a series of patient-focused listening sessions CMS plans to hold for each ...

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 ...

It is axiomatic that New York State requires every Medicaid provider to have an “effective” compliance program.  New York Social Services Law § 363-d.  In July 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) proposed extensive modifications to the regulatory requirements governing compliance programs for entities receiving “significant” Medicaid revenue (increased by these regulations from a threshold of $500,000 to $1 million).  These regulations were proposed to implement portions of the New York State 2020-2021 Budget Bill ...

New York State cannabis agencies and related individuals were served with a lawsuit from four New York veterans (Carmine Fiore, William Norgard, Steve Mejia, and Dominic Spaccio, collectively, the “Plaintiffs”) related to the cannabis market and licensing structure on August 2, 2023. The Plaintiffs are alleging that under the Conditional Adult-Use Retail Dispensary (“CAURD”) licenses, state officials have been favoring “Justice Involved” individuals over disabled veterans in the application process. Their lawsuit has thus far led to the issuance of a ...

On June 1, 2023, the U.S. Supreme Court unanimously settled a long-standing dispute over a subjective versus objective standard for scienter under the False Claims Act (FCA), holding that a defendant’s own subjective belief is relevant to scienter, rather than what an “objectively reasonable” person may have known or believed.

The case in question, U.S. ex rel. Schutte v. SuperValu Inc., consolidated from two lower court decisions, involved allegations that the defendants, two retail pharmacy chains, overcharged the government for prescription drugs in violation of ...

Due diligence is a standard phase of any corporate transaction, whether structured as an asset or stock sale or joint venture, and sellers are often surprised, and even overwhelmed, by the comprehensiveness of the diligence investigation.  Preparing prior to soliciting bids or looking for a buyer can ease the burden of diligence and allow the seller to focus on other areas of the transaction, such as negotiating important terms and documents.

On August 3, 2023, the U.S. Department of Health & Human Services (“HHS”), the Department of Labor, and the Department of Treasury (collectively, the “Departments”) temporarily suspended the federal Independent Dispute Resolution (“IDR”) process immediately following the issuance of a decision by the U.S. District Court for the Eastern District of Texas (the “Court”) that vacated certain regulations and guidance the Departments issued to implement the No Surprises Act (“NSA”).

The Court’s ruling in Texas Medical Association, et al. v. HHS (“TMA IV”)—which addressed claim “batching” and the $350 administrative fee required to initiate the IDR process—represents the Department’s third significant loss in legal challenges against the Departments’ implementation of the NSA’s IDR process that providers, facilities, air ambulance providers, and plans may use to determine the correct payment amounts for certain out-of-network services. On August 11, 2023, the Departments issued a “Frequently Asked Questions” guidance document to detail their intended approach to address the administrative fee. The Departments plan to issue additional updates on the NSA IDR process after further analysis of the TMA IV decision.

When the COVID-19 Public Health Emergency (“PHE”) ended on May 11, 2023, many physician groups furnishing certain medical equipment, devices, and/or supplies to their Medicare patients became in violation of the federal Physician Self-Referral Law (the “Stark Law”), which has draconian penalties, such as clawback of Medicare payments plus additional stiff monetary penalties and possible exclusion from participation in federal health care programs. 

During the COVID-19 PHE, CMS issued temporary waivers, including a waiver of the “location requirement” of the In-Office Ancillary Services (“IOAS”) exception. That waiver allowed physician groups that furnish certain durable medical equipment, orthotics, prosthetic devices – including intermittent urinary catheters (“IUCs”) – and other medical supplies (collectively referred to here as “DME”) to provide home delivery of such DME to their Medicare patients without facing sanctions for violating the Stark Law.[1] With the end of the PHE having occurred over three months ago, that temporary waiver of sanctions ended and can no longer be relied upon for legal compliance with the Stark Law.[2]     

Introduction

Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is obvious. But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI?

In a previous blog, we discussed the Federal Trade Commission’s (“FTC”) proposed changes to its Guides Concerning the Use of Endorsements and Testimonials in Advertising (the “Endorsement Guides”). The Endorsement Guides are intended to help businesses ensure that their endorsement and testimonial advertising conforms with Section 5 of the FTC Act, which prohibits “unfair or deceptive acts or practices in or affecting commerce,” including false advertising. We specifically highlighted the FTC’s proposed changes related to social media platforms and their users, deceptive endorsements by online “influencers,” businesses’ use of consumer reviews, and the impact of advertising on children. Now, approximately one year later, and after receiving and considering public comments on its proposed changes, the FTC has issued its final rule adopting revisions to the Endorsement Guides. See Guides Concerning the Use of Endorsements and Testimonials in Advertising, 88 Fed. Reg. 48092 (July 26, 2023) (to be codified at 16 C.F.R. pt. 255). In issuing its final revised Endorsement Guides, the FTC stated that the changes are intended to “reflect the ways advertisers now reach consumers to promote products and services, including through social media and reviews.” We summarize below the FTC’s final revisions to the same sections of the Endorsement Guides covered in our earlier blog.