Healthcare Providers

For years, law enforcement has bypassed traditional means of securing evidence by informal requests for documents from witnesses of crimes. At some point, that practice bled over into informal requests for healthcare providers’ documents, including documents reflecting protected health information (PHI). Healthcare providers, for the most part, have complied with these informal requests because, as the logic goes, law enforcement couldn’t possibly prosecute me for complying with law enforcement, right? Isn’t that entrapment?

This cooperative, well-intentioned practice by healthcare providers now appears to be drawing scrutiny from Congress. On December 12, 2023, members of Congress sent a letter to Health & Human Services Secretary Xavier Becerra announcing the results of a Congressional inquiry into the practice of pharmacies handing over patient information without legal process. In the face of that new scrutiny, which is sure to extend beyond pharmacies to all healthcare providers, what are healthcare providers to do when asked for PHI through informal means?

The Rise of Ketamine Clinics and Ketamine-Assisted Therapy

Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the utilization of pharmaceutical drugs for, among other factors, unapproved indications. An approved indication occurs when the Food and Drug Administration (FDA) formally approves a given drug for a named medical condition.

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.

On February 27, 2023, a jury in Minnesota federal court rendered a verdict in favor of the United States and against a surgical product distributor following a False Claims Act jury trial that lasted six weeks.[1] The jury identified $43 million in Medicare payments flowing from 64,575 kickback-procured claims.

OSHA is currently considering a possible “Prevention of Workplace Violence in Healthcare and Social Assistance” rule. If passed, the Rule would apply to employers whose employees face an increased risk of workplace violence from their patients, clients, residents and/or facility visitors. Such employees include those who work in hospitals, ambulatory medical care or substance abuse…

Executive Order GA-40

On July 26, 2022, Judge Jeremy Kernodle of the Eastern District of Texas affirmed that certain parts of the Interim Final Rule Part II implementing the No Surprises Act (the Act) were invalid. This ruling is nearly identical to Judge Kernodle’s February decision in Texas Medical Association & Corley v. US Dept. of Health and Human Services. This decision vacated a portion of the Interim Final Rule that required arbitrators to give more weight to the out-of-network rate, including what is called the Qualified Payment Amount (QPA), over other permissible factors. The rule’s requirement ultimately contradicted the Act’s direction that arbitrators consider various factors, and not weight any one more heavily than another.

On June 27, 2022, the United States Supreme Court, by a vote of 9-0, overturned the lower circuit courts’ rulings affirming the convictions of two physicians of the unlawful distribution of controlled substances. In Ruan v. United States (Case No. 20-1410), consolidated with Kahn v. United States (Case No. 21-5261), the Supreme Court was asked to determine whether a physician may be convicted of unlawful distribution of controlled substances under 21 U.S.C. § 841(a)(1) without regard to whether, in good faith, the physician “reasonably believed” or “subjectively intended” that his or her prescriptions fall within that course of professional practice. The Controlled Substances Act makes it unlawful for “any person knowingly or intentionally … to manufacture, distribute, or dispense” a controlled substance, “except as authorized.” A prescription is authorized when it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a). The “vague and highly general regulatory language” left open the question of what conduct would fall under the statute’s exception and thus be considered legal.

Health insurance aid cardiogram care chain check

As the health care industry shifts from fee-for-service to value-based arrangements, providers are facing a lot of challenges. A provider’s relationship with payers is often strained by the new business model, and a provider’s ability to collaborate with payers has never been more important.

On this episode of Value-Based Care Insights, host Daniel J. Marino…