Barclay Damon’s Health Care Controversies Team has seen a recent increase in investigations, compliance, and enforcement activities involving health care facilities conducted by the NYS Department of Health (DOH) and the Office of the Attorney General (OAG).
In a prior alert about exceptions to New York State’s newly enacted COVID-19 immunity statute, we discussed Governor Cuomo’s announcement that the state planned to launch a joint investigation by the DOH and the OAG into whether nursing homes were complying with state and federal safety orders during the pandemic. Since that announcement, investigators have approached health care facilities for inspection and sent letters questioning facilities’ compliance with newly issued notification rules and shifting standards related to admitting COVID-19 patients and testing employees.
Following the governor’s announcement into the investigation of nursing homes on April 23, a DOH-operated nursing home for veterans in Queens was reported to have been in violation of several safety protocols amid the public health crisis. Some violations include not separating roommates when one was suspected of having contracted the virus, failing to isolate those infected in a separate section of the facility with a dedicated team of staff members, and failing to keep families apprised of developments concerning their loved ones. As of May 3, the state-run nursing home reported a total of 33 COVID-19 deaths.
In addition to the state immunities afforded to health care providers, the secretary for the US Department of Health and Human Services (HHS) authorized the temporary waiver of certain Medicare, Medicaid, and HIPAA requirements under Section 1135 of the Social Security Act. These waivers allow providers such as nursing homes and others to provide timely, quality care to as many individuals as possible.1
Among other things, Section 1135 waivers seek to ensure sufficient staffing levels, efficient treatment of patients, and control of the spread of COVID-19. While these blanket waivers allow for adjustments to operations governed by federal law, some of these adjustments come at the cost of certain patient rights and, as a result, have led to an increase in regulatory complaints and investigations by applicable state and federal authorities.
As we see a surge in regulatory activity, health care facilities are well advised to avoid exposure of liability for, among other things, violations of state and federal non-discrimination laws and anti-fraud statutes, including the False Claims Act, as well as applicable state laws and regulations governing the health care delivery system.
Unfortunately, some facilities have already been subjected to federal claims of non-discrimination during the pandemic. On May 4, residents of Queens Adult Care Center filed a class-action lawsuit in the Eastern District of New York alleging violations of the Americans With Disabilities Act for the operators’ failure to take proper precautions against COVID-19, including proper screening and testing of employees and residents.
In a similar vein, health care facilities and other organizations are advised to take documented and measured steps to avoid federal or state anti-fraud or anti-discrimination liability. Further, from a compliance standpoint, and given the sudden and recent uptick in governmental investigations, facilities should thoroughly and extensively document case management and other services received by each resident and have robust policies and procedures in place governing each aspect of their operations.
1 Centers for Medicare and Medicaid Services, “1135 Waivers”
If you have any questions regarding the content of this alert, please contact Linda Clark, Health Care Controversies Team leader, at lclark@barclaydamon.com; Mary Connolly, associate, at mconnolly@barclaydamon.com; or another member of the firm’s Health Care Controversies Team.
We also have a specific team of Barclay Damon attorneys who are actively working on assessing regulatory, legislative, and other governmental updates related to COVID-19 and who are prepared to assist clients. Please contact Yvonne Hennessey, COVID-19 Response Team leader, at yhennessey@barclaydamon.com or any member of the COVID-19 Response Team at COVID-19ResponseTeam@barclaydamon.com.