What Are the Changes?

On April 26, 2024, the U.S. Department of Health and Human Services (“HHS”) issued a final rule (the “Final Rule”) along with guidance updating the Health Insurance Portability and Accountability Act (“HIPAA”) regulations at 45 C.F.R. Parts 160 and 164 (the “Privacy Rule”). The Final Rule prohibits the use or disclosure of protected health information (“PHI”) for the purpose of (1) conducting criminal, civil, or administrative investigations into, or (2) imposing criminal, civil, or administrative liability on any person for the mere act of seeking, obtaining, providing, or facilitating reproductive health care that is legal when provided. The Final Rule also prohibits the use or disclosure of PHI in order to (3) identify any person for any of those purposes (the “Prohibition”).[1]

Continue Reading HHS Changes HIPAA Privacy Rule to Restrict the Disclosure of Reproductive Health Care Information

On May 16, 2024, the California Office of Health Care Affordability (“OHCA”) released proposed emergency regulations to update its existing rules for the reporting of certain health care transactions to OHCA for consideration of whether a Cost and Market Impact Review (“CMIR”) is warranted under the California Health Care Quality and Affordability Act. The current CMIR regulations became effective January 1, 2024, for transactions with a proposed closing date on or after April 1, 2024.

Continue Reading Update on California Health Care: Cost and Market Impact Regulations

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.”

Continue Reading Discretion No More: FDA’s New Final Rule Regulating Laboratory Developed Tests

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.

Continue Reading Nondiscrimination in Healthcare: HHS’s New Final Rule Under Section 1557 of the Affordable Care Act

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).

Continue Reading Confidentiality of Substance Use Disorder Records: HHS Finalizes Changes to Part 2 Rule

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.

Continue Reading Let’s Make a Deal with DOJ: The Impact of the DOJ’s New Whistleblower Reward Program on Corporate Compliance

“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.

Continue Reading Arizona Physician Pleads Guilty to Healthcare Fraud over Improper “Incident To” Billings

We are proud to announce a much-needed addition to Husch Blackwell’s lineup of podcasts. Last week, we launched False Claims Act Insights, a new podcast devoted to exploring issues relating to False Claims Act (FCA) investigations and litigation. The show is hosted by Jonathan Porter—a partner in our firm’s White Collar, Internal Investigations & Compliance practice group and former Assistant U.S. Attorney for the Southern District of Georgia—and will feature prominent guests who dive into the complexities of FCA enforcement and compliance.

The U.S. Department of Justice recently published its annual release of FCA-related information, boasting that its 2023 results were the “Highest Number of Settlements and Judgements in History.” In sum, the Department achieved settlements and judgments exceeding $2.68 billion during the last fiscal year. As FCA enforcement continues to increase, we are pleased to provide subscribers to Healthcare Law Insights a go-to resource for perspectives on FCA-related news and developments.

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.

Continue Reading Five Important Things to Consider When You Receive a Third-Party Subpoena

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.

Continue Reading California Enacts First-in-Nation Pharmacy Medication Error Reporting Law