The United States’ recent False Claims Act (“FCA”) prosecution in United States v. Prometheus Group, et al., is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of medical devices, even where healthcare providers have decided the use is safe and effective. In Prometheus Group, the government alleges that the defendant medical device manufacturer trained providers to re-use disposable rectal probes against U.S. Food and Drug Administration (“FDA”) recommendations, causing the providers to submit false claims for payment to Medicare for the services mis-using the probes. The complaint alleges that Prometheus put…
Continue Reading The Government Seeks FCA Liability for Off-Label Use of Medical Devices

The Eighth Circuit Court of Appeals recently tossed a $5.5 million jury verdict finding that a physician violated the False Claims Act (“FCA”) by submitting claims for items and services ordered subsequent to a violation of the Federal health care program anti-kickback statute (“AKS”). According to the appellate court, the trial court’s jury instruction “brushed aside causation” and “misinterpreted” a 2010 amendment to the AKS.
Continue Reading Eighth Circuit: In False Claims Act Cases Based On Kickback Violations, the Kickback Violation Must Be the “But For” Cause of the Items and Services Subject to the Claim

On July 20, 2022, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert warning physicians and other practitioners to exercise caution when entering into telemedicine arrangements that have certain suspect characteristics.
Continue Reading OIG Warns Physicians About Entering into Arrangements with Telemedicine Companies

The Centers for Medicare and Medicaid Services (“CMS”) recently announced that it is accepting applications for participation in a new population-based track (“Track 3”) as part of the Maryland Total Cost of Care Model’s Maryland Primary Care Program (“MDPCP”), which will begin on January 1, 2023 and continue through December 31, 2026. Track 3 provides a new option for participants to provide high value primary care services to Medicare beneficiaries within the State of Maryland.
Continue Reading New Population-Based Option for the Maryland Primary Care Program in 2023

Assembly Bill 2080[1] (“AB 2080”), known as the “Health Care Consolidation and Contracting Fairness Act of 2022,” was approved by the California Assembly on May 26, 2022, and if passed by the Senate and signed into law before the August 31st recess, will significantly affect healthcare M&A activity in California for a broad spectrum of healthcare providers, payors and other stakeholders.[2] …
Continue Reading Putting the Brakes on Healthcare M&A and Provider/Payor Contracting: AB 2080 Poised to Dramatically Impact Healthcare Transactions in California

On June 29, 2022, the Centers for Medicare and Medicaid Services (CMS) announced it issued significant changes to surveyor guidance for Long Term Care (LTC) facility health, quality and safety standards.[1] …
Continue Reading CMS Adopts Major Changes to LTC Facility Surveyor Guidance

The AHLA’s Annual Meeting held June 27-29 in Chicago reunited healthcare attorneys across the country. The diverse group of attendees were eager not only to reconnect in-person, but also to process the changes that the now-easing pandemic has brought to all corners of the healthcare industry. The conference presenters grappled in real-time with the transitory nature of the healthcare landscape today, including the significant role that technology has played in driving shifts in care delivery. The panel discussions assessed which changes to healthcare delivery and reimbursement would continue after the pandemic, and in what format.
Continue Reading Recap of AHLA’s Annual Meeting

On June 24, 2022, the United States Supreme Court issued its opinion on Dobbs v. Jackson Women’s Health Organization, No. 19-1392 (2022), holding that the United States Constitution provides no basis for a right to abortion. In its opinion, the Court further states that the right to abortion is not in the text of the Constitution, not a part of this nation’s fundamental history or concept of ordered liberty, that abortion restrictions are subject to rational basis review, and that the authority to regulate abortions lies with the 50 individual states. This decision, which is consistent with the draft …
Continue Reading Supreme Court Decision in Dobbs v. Jackson Women’s Health Organization Overturns 50 Years of Precedent on Abortion Laws and Rights

On June 21, 2022 the Supreme Court granted certiorari in Polansky v. Exec. Health Res., 17 F.4th 376 (3d Cir. 2021), allowing the Court to review the Department of Justice’s (“DOJ”) authority to dismiss qui tam suits brought under the False Claims Act (“FCA”), over objections by the relators. The case invites the high Court to decide two key issues: (1) whether the DOJ has the authority to dismiss qui tam suits where it declined to intervene, and (2) what standard of review applies to such requests for dismissal. …
Continue Reading Supreme Court To Review DOJ’s Authority to Dismiss Qui Tam FCA Suits Over Objections From Relators

Since its passage in late 2018, the Eliminating Kickbacks in Recovery Act (EKRA) (18 U.S.C. § 220) has posed interpretive challenges. Our detailed critical analysis of EKRA is available here. EKRA prohibits, among other things, the exchange of remuneration for referrals of patients or patronage to a clinical laboratory, or an individual’s use of the services of a clinical laboratory. The law, however, leaves key terms undefined, including “referral”, “patronage”, and “use of services.” This ambiguity leaves unclear exactly which forms of conduct are prohibited by EKRA. Further, EKRA contains exceptions that overlap imperfectly with safe harbors under the Anti-Kickback…
Continue Reading California District Court Finds that EKRA Applies to Compensation Methodologies for Labs’ Employed Marketers Who Market to Physicians

In one of the final cases of a tumultuous term at the Supreme Court, the Justices ruled against DOJ in a decision that could have wide ranging effects not just for physicians and other prescribers, but for drug control laws more generally. In Xiulu Ruan v. U.S., No. 20-1410 (Jun. 27, 2022), the Court considered the convictions of two physicians for violating the Controlled Substances Act, 21 U.S.C. § 841 because, DOJ contended, and the respective juries found, that their prescriptions were “not authorized.” (The relevant statute makes it a federal crime to “[e]xcept as authorized[,]….knowingly or intentionally…dispense…a controlled substance.” Id.). One…
Continue Reading Supreme Court Rules for Physicians in Blow to DOJ

On April 25, 2022, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 22-07 which evaluated the risk of fraud and abuse under the federal anti-kickback statute (“AKS”) posed by an arrangement involving physician-ownership of a medical device company. The opinion identified six characteristics of the arrangement which greatly reduced the risk of fraud and abuse.
Continue Reading OIG Issues Favorable Advisory Opinion for Physician-Owned Medical Device Company

As telehealth services surged in response to the COVID-19 pandemic, unique compliance challenges likewise developed in unexpected ways. Recognizing these challenges, the Office of Civil Rights (“OCR”) indicated that it would exercise its enforcement discretion by declining to impose penalties against covered health care providers for instances of good faith noncompliance with the requirements of the Health Insurance Portability and Accountability Act (“HIPAA”) in connection with the provision of telehealth services. In effect, a covered health care provider seeking to use audio or video communication technology to provide telehealth services during the public health emergency could do so with greater…
Continue Reading Office of Civil Rights Publishes Guidance on Use of Audio-Only Telehealth Services