Important: CMS Issues Interim Final Rule on COVID-19 Testing of NF Staff & Residents – Routine Testing to Start August 28, 2020

On August 25, 2020, the Centers for Medicare and Medicaid Services (CMS) issued an Interim Final Rule, impacting COVID-19 testing of nursing facility staff and residents, NHSN weekly data reporting, the reporting of COVID-19 tests conducted by nursing homes, the ordering of COVID-19 tests, and the SNF Value-Based Purchasing (VBP) Program. While the Interim Final Rule was released on August 25, 2020, it is not final until published in the Federal Register.  It is expected to be published on Wednesday, September 2, 2020 and at that time the regulation and guidance becomes effective.  Details of the Interim Final Rule are as follows:

COVID-19 Testing of NF Staff and Residents

The Interim Final Rule amends the current infection control requirements for nursing facilities at §483.80, making it a requirement of participation that nursing facilities test their staff and residents for COVID-19, based on parameters set by the Secretary of the U.S. Department of Health and Human Services (HHS).  On August 26, 2020, CMS issued QSO-20-38, providing guidance on the Interim Final Rule and its requirements for COVID-19 testing of nursing home staff and residents.  Under the QSO memorandum, all nursing facilities will be required to test staff at least once a month and up to twice a week, depending on the facility’s county positivity rate in the past week, based on data to be displayed on the following website.

For more about QSO-20-38 and its requirements for COVID-19 testing for nursing staff and residents based on three triggers, please click here. 

Nursing facilities that do not comply with the new testing requirements may face enforcement sanctions based on the severity of the noncompliance, such as civil money penalties of $400 per day, or $8,000 per instance.

Under the Interim Final Rule, “staff” are considered any individuals employed by the facility, any individuals that have arrangements to provide services for the facility (i.e., hospice), and any individuals volunteering at the facility.  Only individuals who work onsite at the facility will be subject to the testing requirements.  Nursing facilities will be required to document each instance of staff or resident COVID-19 testing.

CMS acknowledged that not all residents and staff will consent to COVID-19 testing.  At §483.80(h)(5), CMS is therefore requiring that nursing facilities have procedures for addressing staff and residents who refuse or are unable to be tested.  In these instance, CMS expects facilities to take steps to maintain the health and safety of its staff and residents who have not been diagnosed with COVID-19, which may include limiting staff access to the facility and cohorting residents.

In a separate call today, CMS announced that all CLIA waived nursing facilities should receive a point of care testing machine by the end of September with enough testing supplies for testing of all staff twice.  Beyond that initial supply nursing facilities will have to purchase testing supplies for the machines.  CMS expects nursing facilities to use money from the next CARES distribution to pay for these testing supplies.  The next CARES distribution is expected to be made this week, the week of August 24.  CMS recently updated the point of care testing distribution list and 521 nursing facilities in Indiana are on that list (click here to download).

The interim final rule also states that nursing facilities are free to use whatever testing methods that are “consistent with current professional standards of practice is important to ensure accurate and effective testing.” CMS goes on to state that turnaround time of results is a key factor in the effectiveness of the testing method selected. CMS states that “[T]here are many different tests available and facilities have the flexibility and discretion to select the test that best suits their needs so long as the tests are conducted in accordance with nationally recognized standards and meet the response time for test results as specified by the Secretary.” Nursing facilities should consider this language and flexibility in designing their testing protocol, laboratory relationships, and in working in the point of care testing machines once received.

NSHN Weekly Data Reporting

Currently, nursing facilities are required to report COVID-related data to NHSN on a weekly basis.  Under the Interim Final Rule, noncompliance with this requirement for each weekly reporting cycle 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 civil monetary penalty in the amount of $1,000 for the first week, and $500 for each subsequent week.  These enforcement policies will continue to be in effect for up to one year beyond the end of the public health emergency, while the rest of the provisions described here are effective only for the duration of the public health emergency.

Reporting COVID-19 Test Results

The Interim Final Rule implements a CARES Act requirement that laboratories report COVID-19 test results daily to the HHS Secretary.  All laboratories conducting COVID-19 testing and reporting patient-specific results, including hospital labs, nursing homes, and other facilities conducting testing for COVID-19, will be required to comply in the manner prescribed by the HHS Secretary.  If a laboratory does not report the required information, CMS will impose a civil monetary penalty in the amount of $1,000 a day for the first day, and $500 for each subsequent day.  Laboratories will be provided a three (3) week grace period to begin reporting required test data.  IHCA/INCAL will update you as soon as further guidance is available.

Limits on Ordering COVID-19 Tests

The Interim Final Rules revises CMS’s previous policy that covered repeated COVID-19 testing for Medicare beneficiaries without practitioner orders.  The Interim Final Rule specifies that each Medicare beneficiary may receive one COVID-19 test without the order of a physician or other health practitioner, but Medicare will require such an order for all further COVID-19 tests.  CMS stated this change helps ensure that beneficiaries receive appropriate medical attention if they need multiple tests and is designed to prevent fraudulent billing related to unnecessary add-on testing as well.  Tests conducted prior to the Interim Final Rule do not count toward the first test a Medicare beneficiary can receive without practitioner orders.

To help ensure that Medicare beneficiaries have broad access to testing, CMS is also paying for tests when ordered by a pharmacist or other healthcare professional authorized under applicable state law to order diagnostic laboratory tests for the duration of the public health emergency.

SNF Value-Based Purchasing Program

The Interim Final Rule revises the performance period for the FY 2022 SNF VBP Program, which will cover the following time period:  April 1, 2019 through December 31, 2019 and July 1, 2020 through September 30, 2020.  The FY 2022 SNF VBP Program will not include the six (6) months of data that CMS excepted for the SNF VBP Program under the Extraordinary Circumstances Exception for the public health emergency.