On April 29, 2024, the Food and Drug Administration (FDA) announced a Final Rule amending regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory. Under the new rule, the FDA will phase out its laboratory developed test (LDT) enforcement discretion policy over a four-year period. The phaseout policy “applies to IVDs that are manufactured and offered as LDTs by laboratories that are certified under CLIA[1] and that meet the regulatory requirements under CLIA to perform high complexity testing, and used within such laboratories, even if those IVDs do not fall within FDA’s traditional understanding of an LDT because they are not designed, manufactured, and used within a single laboratory.”

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Section 1557 of the Affordable Care Act prohibits discrimination in healthcare based on a number of characteristics including race, color, national origin, sex, age, and disability. On April 26, 2024, the Department of Health and Human Services (HHS) issued a Final Rule that according to HHS provides clarity on Section 1557 with a goal of ensuring nondiscriminatory access to care for all, including women, people with disabilities, LGBTQI+ people, people with limited English proficiency (LEP), people of color, and people regardless of age. The first Section 1557 final rule was published in 2016 followed by a second final rule in 2020 that rescinded large sections of the 2016 rule. The 2024 Final Rule restores those provisions and enhances them.

On February 8, 2024, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) finalized long-awaited modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 C.F.R. Part 2, which requires individuals or entities that receive federal funding and provide SUD treatment to implement additional privacy protections and obtain specific consent before using and disclosing SUD treatment records (see 42 C.F.R. § 2.11).

While Monty Hall (or for the current generation, Wayne Brady) was nowhere in sight, it was difficult not to think about the show “Let’s Make a Deal” while sitting in the audience at the American Bar Association’s 39th National Institute on White Collar Crime. During the Institute, one of the featured speakers, Deputy Attorney General Lisa Monaco, announced a new DOJ-led whistleblower rewards program.

“Incident to” billing is widely practiced, and its regulations are generally well-known. But one Arizona physician recently found himself pleading guilty in federal court on April 3, 2024, to a criminal healthcare fraud charge over improperly billing Medicare and private payors for healthcare services that failed to abide by the rules over “incident to” billing. This blog post explores how this lack of compliance resulted in such a serious criminal consequence.

So, you’ve received a third-party subpoena. Now what? A third-party subpoena is the procedural mechanism that allows parties in litigation to obtain evidence from non-party individuals and/or entities. For federal cases, Federal Rule of Civil Procedure 45 governs this process. Rule 45 outlines specific procedures that litigants must follow to serve a subpoena seeking documents and/or testimony properly. The Rule also provides protections non-parties can use to alleviate their burden in producing responsive documents. Most states have their own rules that govern non-party discovery that often, but not always, mirror Rule 45.

On October 8, 2023, Governor Gavin Newsom signed Assembly Bill 1286 (AB 1286), a sweeping pharmacy measure with several components aimed at promoting patient safety. Chief among AB 1286’s mandates is a new law requiring that community pharmacies report outpatient medication errors to the California Board of Pharmacy. But beyond the mandatory reporting requirement, AB 1286 contains various other important provisions governing the practice of pharmacy in California.

Most experienced False Claims Act (FCA) practitioners are all too familiar with the statutory provision requiring defendants to pay whistleblowers’ attorneys’ fees at the end of FCA cases. What is less commonly known is the provision that grants defendants their attorneys’ fees in certain circumstances.

One whistleblower learned about that provision the hard way, when on March 14, 2024, a Mississippi federal judge ordered that he pay over $1 million to cover the defendants’ attorneys’ fees, following grant of summary judgment to defendants in what the judge labeled a “frivolous” qui tam. This blog post looks at the case that led to such a large attorneys’ fees award and considers the types of cases in which these efforts are wise.

U.S. Senators Angus King (I-ME) and Marco Rubio (R-FL) recently introduced a bill addressing cybersecurity protections and oversight in the healthcare industry. The Strengthening Cybersecurity in Health Care Act, introduced on February 8, 2024, aims to bolster a vulnerable and often-targeted industry against cyberattacks. The proposal follows a number of significant cyberattacks on healthcare organizations in recent years; Senator King noted that approximately 133 million people, or nearly one in three Americans, had their personal information compromised in 2023 alone.