On August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a new Interim Final Rule (IFR) that changes existing infection control regulations for nursing homes and mandates weekly reporting of COVID-19 related data.
Testing. CMS states that, in support of national efforts to control the spread of COVID-19, nursing homes will be required to test staff and to offer testing to residents for COVID-19. The testing of “staff” includes employees, individuals providing services under arrangement and volunteers. CMS acknowledges that not all residents and staff will consent or be able to be tested for COVID-19. Regarding these situations, CMS states in the IFR:
“We acknowledge that not all residents and staff will consent to COVID-19 testing. In accordance with the requirements at § 483.10(c)(6),residents have the right to refuse and/or discontinue treatment. In addition, staff retain the right to refuse COVID-19 testing. There may also be instances in which facility residents or staff are not able to be tested, such as the presence of anatomical or other medical contraindications. At § 483.80(h)(5), we are requiring that the facility have procedures for addressing residents and staff, including individuals providing services under arrangement and volunteers, who refuse or are unable to be tested. In these instances, we also expect facilities to take steps to maintain the health and safety of its staff and residents who have not been diagnosed with COVID-19 that may include limiting the staff’s access to the facility and cohorting residents [further described in the IFR].”
The frequency of staff testing will be based on the degree of community spread as an indicator that a facility may be at increased risk for COVID-19 transmission. CMS states that additional guidance on the testing frequency is forthcoming. The IFR’s testing requirement will be formally implemented through a revision of the LTC facility infection control regulations at § 483.80.
Reporting. The IFR also requires nursing homes to submit reports of COVID-19 related facility data to the CDC National Healthcare Safety Network (HNSN) not less than weekly. Noncompliance with the reporting requirement 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,” and will constitute a level “F” deficiency. Civil Monetary Penalties (CMPs) will be imposed for each failure to report with a minimum of $1,000 in CMPs for the first time the facility fails to submit a timely report, and an incremental increase of $500 in the CMPs for each subsequent failure. For example, the first failure to timely report would entail a $1,000 fine and the second failure to timely report would entail a $1,500 fine.
Additional details on the new infection control and reporting regulations are contained in the IFR. CMS is waiving the normal notice-and-comment process for this Interim Final Rule citing the Administrative Procedure Act section related to Public Health Emergencies. The IFR will take effect upon its publication in the Federal Register, which had not occurred as of this writing [August 28, 2020].