The Centers for Medicare & Medicaid Services’ wide-ranging rule bolstering its regulatory authority to address issues relating to the COVID-19 public health emergency contains two notable directives for federally regulated long-term care facilities: (1) an increase in civil monetary penalties for failure to timely report information relating to COVID-19; and (2) a new requirement for LTC facilities to conduct COVID-19 testing of residents and staff.
The directive regarding civil monetary penalties is applicable for one year beyond the expiration of the public health emergency. CMS believes the urgency of the pandemic constitutes good cause to waive the normal notice-and-comment process, and the agency has already issued some guidance to LTC facilities and surveyors describing the implementation of the testing provision.
At Baker Donelson, we are assisting nursing homes in implementing the coming rule as efficiently and as effectively as possible. While the federal government is setting standards under the rule regarding testing frequency, we note that individual states may also require more frequent testing.
New enforcement requirements for long-term care facilities
CMS is strengthening its ability to enforce recent LTC requirements, previously published in its May COVID-19 interim final rule, that require facilities to report COVID-19 and infection control-related data to the Centers for Disease Control and Prevention National Healthcare Safety Network. The required weekly data includes suspected and confirmed COVID-19 infections among residents and staff, including residents previously treated for COVID-19; total deaths attributable to COVID-19 among residents and staff; and personal protective equipment and hand hygiene supplies.
The new regulations specify penalties that may be imposed for a facility’s failure to electronically report the required data each week. Noncompliance will be cited at a scope of widespread, and a severity of no actual harm with potential for more than minimal harm that is not immediate jeopardy, which constitutes a level “F” deficiency.
CMS will impose a minimum initial penalty of $1,000 for the first week of noncompliance, with an incremental increase of $500 per additional week the facility is out of compliance and a maximum of $6,500 per infraction.
After each penalty, CMS will place the facility back into compliance without requiring a plan of correction. Facilities will also be offered an opportunity for Independent Informal Dispute Resolution under 42 C.F.R. § 488.431 to address any technical issues or other legitimate reasons why the data could not be timely updated. Facilities should take care to adequately document any circumstances that prevent timely submission of COVID-19 data to challenge the assessment of these increased CMP amounts.
Requirement for LTC Facilities to Test Facility Residents and Staff for COVID-19
CMS is revising the LTC facility infection control regulations by adding a new section at 42 C.F.R. § 483.80(h) that establishes six provisions to support the LTC facility testing mandate. CMS’s definition of “staff” under the new rule is expansive in that it includes not only any individuals employed by the facility, but any on-site facility volunteers and any individuals who have arrangements to provide on-site services to the facility. Thus, facilities should immediately identify all individuals who qualify as “staff” to arrange for testing as soon as possible.
Although the parameters for conducting resident and staff testing have not yet been provided, facilities can expect to receive this information in upcoming CMS memoranda, in addition to posts on the CMS and CDC websites. CMS plans to include parameters such as the frequency of testing; the identification of any facility resident or staff diagnosed with, who has symptoms consistent with, or with known or suspected exposure to COVID-19; the criteria for testing asymptomatic facility residents and staff, such as the county’s COVID-19 positivity rate; the response time for test results; and any other factors that help identify and prevent the transmission of COVID-19.
The agency is not limiting its parameters to items already identified and is soliciting comments on other considerations. All comments on the interim final rule must be received no later than 5 p.m. ET on November 1.
CMS is requiring that all resident and staff testing be conducted in a manner that is consistent with “current professional standards of practice.” To accommodate evolving testing practices, CMS has defined “current professional standards of practice” to mean “those professional standards that apply at the time that the care or service is delivered.”
Thus, tests must be conducted in accordance with standards recognized nationally at the time the service is delivered and must meet the turnaround time for results that will ensure effectiveness.
CMS advises that LTC facilities must coordinate with state and local health departments to ensure availability of sufficient testing supplies and processing test results when necessary, also coordinating with their local certified CLIA laboratories where appropriate. The facility’s infection prevention and control plan must include considerations regarding access to adequate testing supplies and arrangements for acquiring testing supplies.
In addition, the testing plan must include arrangements necessary to conduct, process and receive test results. Facilities should also maintain documentation of resident and staff testing in the medical and staff personnel records. For staff that are providing on-site services under arrangement, CMS expects an agreement for services would include a process for documenting test results.
Additionally, CMS expects LTC facilities to continue taking actions to prevent the spread of COVID-19 by reducing the interaction of facility staff and residents with symptoms consistent with COVID-19 or who test positive for the virus with other staff and residents in the facility. Facilities should restrict access for any staff member who presents with symptoms of or a positive test for COVID-19 until the staff member meets specified return-to-work criteria established in forthcoming guidelines.
Similarly, each facility is expected to have procedures for addressing residents and staff who refuse or are unable to be tested by taking steps, including limiting staff access to the facility and cohorting residents, to maintain the health and safety of its staff and residents who have not been diagnosed with COVID-19.
Lastly, the rule also reminds facilities they are expected to assess their ability to replace workers who can no longer work with trained personnel, and to maintain appropriate staffing levels. CMS expects facilities to make adjustments to work and time off schedules, use volunteers, and contact federal, state and local healthcare partners to assist with staffing shortages.
Amy Wilmot Schrader and Stefanie J. Doyle are attorneys with Baker Donelson. Schrader focuses her practice on assisting companies and individuals in their dealings and engagements with Florida administrative agencies, while Doyle represents clients in the healthcare industry, concentrating on fraud and abuse, public and private financing, and transactions.