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.

Continue Reading Physician Loses Rare Criminal E/M Fraud Trial

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.

Continue Reading It’s a Long Way From Here to There: Advanced Healthcare Practitioners, EMTALA’s Call Coverage Requirements, and Rural Hospitals

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.

Continue Reading DOJ Continues Enforcement Efforts Against Provider-Owned Managed Care Plans

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.

Continue Reading Healthcare Industry Faces Heightened Antitrust Scrutiny Under New Merger Guidelines, HSR Rules

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.

Continue Reading New Regulations on Health Care Transactions in California
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.

Continue Reading False Claims Act Update: A Mid-Year Review (2023)

On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions. The guidance document applies to clinical trials that will be conducted under investigational new drug applications, including clinical trials that are not intended to support marketing applications. Notably, the use of the term “psychedelic” in the guidance document is intended to encompass “classic psychedelics” that are understood to be 5-HT2 agonists (e.g., psilocybin and lysergic acid diethylamide (LSD)) as well as entactogens or empathogens (e.g., methylenedioxymethamphetamine (MDMA)). This is the first FDA draft guidance that discusses designing clinical trials for psychedelic drugs.

Continue Reading Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs
Provider Relief Fund Update

In his article The Shield Becomes a Sword, Nick Healey discusses Article I, Section 38 of the Wyoming Constitution, which guarantees the right of every competent adult to make their own healthcare decisions and was passed in 2012 in response to concerns over the Patient Protection and Affordable Care Act (ACA) and its potential limitations on patient choice. Recently, the Wyoming Legislature’s attempts to restrict certain healthcare decisions, such as abortion and gender-affirming medical care, have been challenged in court under the argument that they violate Section 38. The article explores the tension between the right to make healthcare decisions and the possibility of reasonable restrictions on those rights, ultimately leaving the interpretation of Section 38 up to the courts.

On June 14, 2023, a federal jury found that a Georgia physician knowingly violated the False Claims Act following a two-week trial on allegations that he made false claims to the Medicare Program. Now, despite just $1.1 million in improper payments stemming from false claims, a federal court is likely to impose a judgment that exceeds $27 million after adding statutory per-claim penalties and trebling the amount determined by the jury to be false.

Continue Reading Georgia Physician Awaits $27+ Million Judgment Following False Claims Act Trial Loss