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.

In July of this year, the California Office of Health Care Affordability (“OHCA”) released draft regulations requiring the advance reporting of certain healthcare transactions that could affect the cost of healthcare or adversely impact the healthcare market in California. These reporting requirements implement provisions of amendments to the California Health and Safety Code enacted in 2022, which authorized OHCA to review proposed transactions and, if appropriate, undertake a detailed cost and market impact review (“CMIR”) to determine the potential impact on the health care economy of California.

Many long-term care residents live in Missouri nursing homes for years. But occasionally circumstances may change such that it is no longer appropriate for the resident to continue to reside at the facility. In certain cases, nursing homes may discharge or transfer a resident even if the resident does not consent to the discharge or transfer – this is known as an “involuntary discharge” or an “involuntary transfer.” In this case, the resident has the right to appeal the involuntary discharge or transfer.

Evaluation and management (E/M) services have been called “the core” of healthcare billing.[1] E/M is a catch-all claim, allowing medical professionals to bill for diagnosing or treating nearly any illness or injury. E/M is also divided into fairly subjective levels depending on complexity, and the differences between levels is often merely a difference of opinion. While the DOJ has brought cases based on disputes over E/M services before, those cases are typically civil and part of a more complex upcoding or unbundling scheme.[2] This is because nearly everything involving some effort expended by a physician could arguably justify that physician believing the E/M service was proper, and therefore criminal cases requiring scienter evidence that proves the case beyond a reasonable doubt are incredibly rare.

Yet one of those rare cases went to trial this month.

Distances in rural health care can be hard to fathom. A 2018 study found it took rural Americans, on average, 17 minutes to get to a hospital, but only 10 minutes in an urban center.[i] The distance between rural hospitals can be vastly further – in 2019, a National Institutes of Health study noted that hospitals in one rural state were generally at least 50 miles apart.[ii] These areas have been described (without meaning to be pejorative) as “health deserts.”[iii] Small populations, and a growing shortage of physicians in rural areas,[iv] often lead to hospitals in these areas having only one or two physicians in a particular specialty. Advanced health practitioners (AHP’s) with specialty training, such as psychiatric nurse practitioners or certified nurse midwives, can be an excellent way to preserve access to specialty care, particularly when lack of physician coverage would otherwise mean the hospital must divert or transfer emergency patients.

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.

On July 31, 2023, the California Office of Health Care Affordability (“OHCA”) released draft regulations concerning pre-transaction review of so-called “Material Change Transactions” as part of its legislative mandate to review transactions which could have potential impacts on the costs of health care in the State of California.  When approved, final regulations would be effective January 1, 2024. The draft regulations contemplate a dramatic expansion of state review of transactions affecting health care services.  The draft regulations are to be discussed at a public regulatory workshop to be convened by OHCA on August 15, 2023, at its Sacramento offices. OHCA will accept public comments on the draft regulations through August 31, 2023, submitted to CMIR@HCAI.CA.GOV.

Supreme Court Sunrise

The Supreme Court issued a number of headline-grabbing decisions this term on topics like religious accommodation, LGBTQ protections, and consideration of race in college admissions. These decisions are wide-reaching and impact individuals, employers, and higher education institutions. Though not nearly as wide-reaching, the Supreme Court also issued two important decisions this year dealing with the False Claims Act (FCA) that could have dramatic impact nonetheless for those ensnared in an FCA action.