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).

“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.

On November 6, 2023, the Office of Inspector General (“OIG”) issued its long-awaited General Compliance Program Guidance (“Guidance”) “to help advance the industry’s voluntary compliance efforts in preventing fraud, waste, and abuse in the health care system.” Although the Guidance is nonbinding, it reflects the OIG’s expectation that compliance programs become increasingly sophisticated in their approach to identifying and managing compliance risks as healthcare delivery and payment models continue to evolve.

Large managed care plans have been squarely in DOJ’s crosshairs for years, but a late July 2023 Justice Department settlement agreement with one regional healthcare provider’s Medicare Advantage Plan offers a glimpse into an issue health systems and providers with their own managed care plans need to track.

This post examines the recent DOJ settlement, analyzes the trend towards enforcement of provider-owned managed care plans, and offers a prediction on what might be coming on the enforcement side.

Consistent with the Biden Administration’s whole-of-government approach to address perceived consolidation in a variety of industries, including in the healthcare industry, the Federal Trade Commission (FTC) and U.S. Department of Justice (DOJ) Antitrust Division (collectively, the Agencies) are continuing to make good on their promise to increase scrutiny of mergers and acquisitions through newly proposed HSR rules and revised merger guidelines.

A medical school applicant recently filed suit, alleging that several Texas medical schools improperly rejected him by basing their admissions decisions on race and gender. The complaint asserts that these schools (along with “nearly every school and university in the United States”) participate in the practice known as affirmative action, giving preference to women and non-Asian minorities rather than candidates with more impressive academic accomplishments.

On February 23, 2022, Judge Jeremy Kernodle of the Eastern District of Texas ruled that certain parts of the Interim Final Rule Part II (the Rule) implementing the No Surprises Act are invalid. Specifically, the provisions of the Rule governing the methodology for how arbitrators determine the amount of payments insurers and self-funded health plans

There were no major surprises when the Medicare hospital outpatient prospective payment system (OPPS) and physician fee schedule (PFS) Final Rules were released on November 2, 2021, but there are still several financial and compliance areas that healthcare providers must prepare for as we head into 2022. Today’s update provides a brief summary of the

On February 25, 2021, the Wisconsin Legislature enacted 2021 Wisconsin Act 4 (the “Act”), which, in part, grants immunity to business entities from civil liability related to COVID-19 exposure, with certain exceptions.

Specifically, the Act immunizes certain entities from civil liability for any act or omission in the course of performance or provision of the entity’s function or services, that leads to death or injury to an individual or damages caused by an act or omission resulting from or relating to exposure directly or indirectly to COVID-19 (or its variants), or conditions associated with the infectious disease.  However, civil immunity does not extend to acts or omissions that are reckless, wanton conduct, or intentional misconduct.

Effective on January 1, 2021, the Price Transparency Rule (the “Rule”) requires all hospitals operating within the United States to make public a list of their standard charges for items and services via the Internet in a machine-readable format. Hospitals must also provide prices for a list of 300 shoppable services that must be made publicly available in a searchable, consumer-friendly format. This requirement is being enforced with the intent to enable healthcare consumers to make more informed decisions based on cost, increase market competition, and ultimately drive down the cost of healthcare services, making them more affordable for all patients.  Many hospitals are spending time now to determine which “items and services” require price disclosure under the Rule, and some have found that the Rule does not provide sufficient guidance in all situations.