On August 26, 2024, the United States Attorney’s Office for the District of Montana filed a False Claims Act (FCA) complaint against a Montana oncologist, alleging that the oncologist’s busy schedule led to excessive claims that violated the FCA. The complaint is unusual in that its chief theory is the amount of time the oncologist ..read more

Engaging in management and investor conversations about maintaining and growing a business is critical, no matter the industry. Whether you’re discussing normal business sustainability, organic growth, or contemplating a sale, these discussions become more complex when practicing physicians are the business’s revenue generators. These conversations must be handled carefully to comply with the spirit and ..read more

On July 3, 2024, Judge Louis Guirola, Jr. of the federal district court in Mississippi issued a nationwide preliminary injunction prohibiting the U.S. Department of Health and Human Services (HHS) from “enforcing, relying on, implementing, or otherwise acting on” the gender identity provisions of a HHS Final Rule that purported to implement Section 1557 of ..read more

In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning interpretations of ambiguous laws, as long as those interpretations were reasonable. This doctrine has been a cornerstone of administrative law, significantly impacting the way federal agencies operate and implement regulations. Chief Justice John Roberts, writing for the 6-3 majority, described the framework as “unworkable,” arguing that it allowed federal agencies to cha ..read more

In their recent article in Missouri Medicine, Trecia Moore and Mary-Ann Czak discuss the NLRA’s protection of private sector employees’ rights to join unions and note the decline in union membership since the 1950s. Despite this decline, there is a resurgence in union activity and public approval, especially among physicians, driven by changes in employment structures, autonomy issues, and burnout. Learn more in their full article, “Physician Organizing: Trends and Takeaways.” This article appears in Missouri Medicine: The Journal of the Missouri State Medical Association a ..read more

On June 13, 2024, the Justice Department announced arrests in what it called the nation’s first criminal case against digital health company executives over allegations that those executives caused illegal prescriptions for controlled substances to be ordered by way of telehealth visits. While the Justice Department has previously brought charges in telehealth cases involving things like orthotic braces or genetic testing, a case against digital health executives involving telehealth-prescribed controlled substances is a first. According to the Justice Department, two executives of a company c ..read more

This post is the first in a series dedicated to Colorado’s Medicaid finance and payment systems, challenges faced by those programs, and opportunities for expansion. The Colorado Healthcare Affordability and Sustainability Enterprise (CHASE) oversees Colorado’s hospital provider tax and the use of those taxes to support Medicaid supplemental payments. CHASE uses the largest portion of those taxes to generate payments targeting the cost shortfalls from treating Medicaid and uninsured patients. Broadly speaking, federal regulations (see 42 C.F.R. §§ 447.272, 447.321) allow each class of institut ..read more

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 ..read more

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. The proposed regulations include provisions that will require reporting of transactions that were not covered ..read more

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 per ..read more