Health Law Scan

Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals’ relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior counsel, neurology & immunology at EMD Serono, and Morgan Lewis partner Scott Memmott, who highlighted specific compliance risk areas for healthcare professionals (HCPs), as well as permissible interactions with pharmaceutical and medical device manufacturers and contracting/risk mitigation best practices.

The US Department of Health and Human Services, Office of Inspector General (OIG) recently transmitted a memorandum to the Center for Medicaid and CHIP Services detailing the findings of the Massachusetts state auditor's report on the commonwealth’s controls around dual-eligible hospice patients and weaknesses related to election statements and potential MassHealth overpayments for curative items and services related to hospice patients that should have been covered by the hospices.

The Centers for Medicare and Medicaid Services (CMS) announced that it had restarted the Targeted Probe and Educate (TPE) audit process, effective September 1, 2021. More recently, the Medicare Administrative Contractors for hospice have targeted “claims with revenue code 0656 [General Inpatient Care] greater than or equal to 7 days submitted with dates of service on or after January 1, 2020” for active, pre-pay medical review.

We hope you were able to join us for our July Fast Break on the US Court of Appeals for the Fourth Circuit's recently affirmed $114 million judgment in United States v. Mallory. If not, you missed a great session, featuring Katie McDermott and Howard Young analyzing this protracted suit filed under the qui tam provisions of the False Claims Act (FCA) against the owners of two specialty clinical laboratories and a contracted sales and marketing company.

We hope you were able to join us for last month's Fast Break on the Regulatory Sprint to Coordinated Care, which has been a longstanding initiative of the Centers for Medicare and Medicaid Services, US Department of Health and Human Services (HHS), and Office of the Inspector General to navigate a path to value-based payment models, culminating in the December 2020 final rules. If not, you missed a conversational session featuring Katie McDermott, Al Shay, and Jake Harper diving a bit deeper into this topic.

The US Department of Health and Human Services Office of Inspector General (OIG), the Department of Justice (DOJ), and other federal regulators have grown increasingly concerned about the use of telehealth technologies by perpetrators of various fraud schemes. While this is in part due to the meteoric rise in use of telehealth services during the past year and the need to quickly formalize permanent policy around the technology, the federal government’s concern extends well before the COVID-19 public health emergency (PHE).

Members of our healthcare industry team have published two LawFlashes that may be of particular interest to hospice clients and friends of Health Law Scan, referring to recent Anti-Kickback Safe Harbor Revisions and the Consolidated Appropriations Act, 2021.

Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized rules that will alter critical healthcare fraud and abuse regulations to remove or diminish obstacles to value-based enterprises that meaningfully embrace patient care coordination.

We invite you to join us on Tuesday, August 25 for our next installment of the Fast Break series, this time focused on fraud enforcement following the coronavirus (COVID-19) pandemic.

In managing the quickly evolving healthcare landscape during this current crisis, healthcare companies should be wary of fraudsters who attempt to divert critical resources.