On August 27, 2020, the Centers for Medicare & Medicaid Services (“CMS”) filed an interim final rule with comment period (“IFC”), detailing new long-term care (“LTC”) facility COVID-19 testing requirements and strengthening enforcement of existing related facility reporting requirements.  According to CMS, the IFC represents the agency’s latest effort in an ongoing initiative to control COVID-19 transmission during the continuing public health emergency (“PHE”).

New LTC Resident and Staff COVID-19 Testing Requirements

The IFC’s key LTC regulatory revision involves the amendment of existing infection control requirements to require COVID-19 testing for all facility residents and staff.  Applicable facilities must also electronically report COVID-19 information, including suspected and confirmed resident and staff infections, in a standardized format specified by the HHS Secretary.  Below are additional details regarding the IFC’s new testing requirements:

  • Individuals Subject to Testing. The new COVID-19 testing requirements apply to all residents and staff that physically work on-site at an applicable LTC factility.  “Staff,” for the purposes of the IFC, includes “any individuals employed by the facility, any individuals that have arrangements to provide services for the facility, and any individuals volunteering at the facility.”  CMS indicated that the new testing mandate may implicate individuals providing services for a facility “under arrangement,” including, for example, a hospice with an agreement to provide care for LTC facility residents.
  • Testing Parameters.  LTC facilities must conduct the newly required testing in accordance with forthcoming Secretary-implemented parameters, which may include testing frequency, result response timing, identification of symptoms, and asymptomatic testing guidelines.  CMS is also requiring all resident and staff COVID-19 testing to be conducted in a manner consistent with current professional standards of practice.  The IFC provides little guidance regarding what constitutes “professional standards of practice,” other than to confirm that the applicable standards are those that exist at the time the care or service is delivered.  CMS is soliciting comments regarding any other appropriate testing parameters that the Secretary should consider for implementation.
  • Testing Documentation and Policies.  CMS is also requiring that the completion and results of each resident and staff COVID-19 test be appropriately documented in staff personnel records, resident medical records, or other individual files, as applicable.  LTC facilities must also maintain appropriate policies and procedures, including those addressing instances where residents and staff refuse or are unable to be tested, access to and acquisition of testing supplies, and emergency staffing strategies.
  • Transmission Prevention.  CMS expects that LTC facilities will take action to prevent transmission when a resident or staff member presents with COVID-19 symptoms or a positive test result.  Specifically, CMS transmission prevention recommendations include restricting facility access for an affected staff member until the applicable individual is deemed safe to return to work, or, in the case of facility residents, the implementation of “cohorting” procedures, which involve the confinement of residents who are known or suspected to have COVID-19 to a specified area of the facility and not sharing staff beyond those residents’ “cohort.”

New CMPs for LTC Data Reporting Violations

The IFC also strengthens CMS’s ability to enforce recently imposed LTC facility reporting requirements, which were established on May 8, 2020, in an effort to support ongoing COVID-19 surveillance.  Specifically, these recently implemented reporting regulations require nursing homes to report COVID-19 and infection control data to the CDC National Healthcare Safety Network (“NHSN”) at least weekly.  The IFC’s enhanced enforcement mechanisms center on the imposition of civil monetary penalties (“CMPs”) for each week that a facility fails to electronically report required COVID-19 data through the NHSN system.

As set forth under the IFC, LTC facilities must pay a $1,000 CMP for the first instance of reporting noncompliance, a figure that will increase by $500 for each subsequent weekly reporting failure.  For example, an LTC that fails to meet the data reporting requirements will receive a $1,000 CMP for the first week of reporting violations, $1,500 for the second week, and $2,000 for the third week.  This weekly $500 penalty escalation process will continue until the penalty amount reaches a $6,500 cap after 12 weeks of noncompliance.  Subsequent violations occurring beyond that 12-week period will continue to be assessed at $6,500 per week.  If a facility is unable to meet reporting requirements and/or experiences financial hardship, that facility may dispute the findings under an independent informal dispute resolution process set forth under 42 C.F.R. Part 488.431, and the facility may submit a financial hardship request to CMS.  The foregoing CMP enforcement policies will continue in effect for up to one year beyond the end of the PHE.

The IFC’s changes become effective as of the rule’s anticipated September 2, 2020, Federal Register publication, and unless otherwise noted, the changes will remain in effect only for the duration of the PHE.  Any comments must be received within 60 days of the September 2 Federal Register publication to be considered.