On July 16, 2019, the Centers for Medicare & Medicaid Services (CMS) announced its final rule updating regulations pertaining to the use of arbitration agreements by long-term care facilities. Significantly, the final rule reversed CMS’s prior ban on pre-dispute arbitration agreements, imposed in CMS’s October, 2016 “Reforms of Requirements for Long-Term Care Facilities” final rule. Despite the repeal of the ban, the final rule continues to prohibit long-term care facilities from requiring a resident to…

On February 22, 2019, the federal Environmental Protection Agency (EPA) issued a final version of the hazardous waste pharmaceuticals rule. The new rule was promulgated under the federal Resource Conservation and Recovery Act (“RCRA”), that provides for significant civil and criminal penalties for violation. According to the EPA, the new rule is a “better fit” for healthcare organizations managing hazardous waste pharmaceuticals (HWPs) because it reduces overlapping regulation by the FDA and the DEA, and…

In January 2019, CMS amended its subregulatory program integrity guidance to Medicare contractors with more specific instructions on when and how to use statistical sampling and extrapolation to report and return overpayments (“Transmittal 828”). A subsequent February 2019 Report in Brief from the U.S. Department of Health & Human Services, Office of Inspector General (“OIG”) offers insight into this guidance in the context of an audit of inpatient rehabilitation facility claims (“Report”). Notably, the Report…

The False Claims Act grants the government the authority to dismiss qui tam actions over the objections of the relator if “the court has provided the person with an opportunity for a hearing on the motion.”  31 USCS § 3730. However, what constitutes a “hearing” under the Act and the extent of the government’s authority to unilaterally dismiss qui tam actions has been the subject of dispute amongst the Courts of Appeals. Recently, in United…

NEW MAPS Capabilities. The Michigan Department of Licensing and Regulatory Affairs (“LARA”) announced the launch of two new communication capabilities in MAPS, available on July 18, 2019: Clinician to Clinician Messaging–enables providers to send communications and share information about mutual patients in a secure fashion through an inbox attached to the provider’s MAPS account (similar to email). The inbox will be visible only to the communicating providers, and not to the providers’ registered delegates, other providers…

New Hospice Exceptions. Motivated by concerns that the requirements of Michigan controlled substance (“CS”) laws might result in hospice patients being denied timely access to necessary pain control drugs in their final days, the Michigan legislature amended the CS laws to benefit hospice patients, effective July 8, 2019. Two new exceptions give providers more flexibility under the bona fide prescriber-patient relationship requirement and the Michigan Automated Prescription System (“MAPS”) query requirement, both explained below, for meeting…

When the Supreme Court accepted the cert petition to resolve a Circuit split regarding the False Claims Act’s statute of limitations when the government does not intervene, it created the potential that the Court would extend the limitations period for private relators’ FCA actions. That is exactly what happened. The Supreme Court unanimously ruled that a relator can bring suit within three years after a government official knows, or should know, about a potential FCA…