Health Law Daily New rules regulate COVID testing, reporting for nursing homes, other providers
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Friday, August 28, 2020

New rules regulate COVID testing, reporting for nursing homes, other providers

By Anthony H. Nguyen, J.D.

Interim final rule requires nursing homes to test staff and offer COVID-19 testing for residents.

CMS will require nursing homes to test staff and offer testing to residents for the novel coronavirus disease 2019 (COVID-19). According to an interim final rule set to publish in the Federal Register on September 2, 2020, laboratories and nursing homes using point-of-care testing devices will be required to report diagnostic test results as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The interim final rule also require hospitals to provide COVID-19 cases and related data to HHS.

Hospital reporting data. Hospitals and critical access hospitals must report daily important data critical to support the fight against COVID-19, including, but not limited to elements such as the number of confirmed or suspected COVID-19 positive patients, ICU beds occupied, and availability of essential supplies and equipment such as ventilators and personal protective equipment (PPE). According to CMS, this reporting is essential for planning, monitoring, and resource allocation to support the broader surveillance of COVID-19. The agency noted that while many hospitals are voluntarily reporting this information now, not all are doing so. Under the interim final rule, this hospital data reporting is a requirement for continuing participation in the Medicare and Medicaid programs.

Nursing home staff testing requirements. CMS is revising its infection-control regulations for long-term care facilities to require nursing homes to test their staff for COVID-19. The change is designed to increase testing in nursing homes. CMS recommendations for the frequency of staff testing will be based on the degree of community spread that indicate the facility may be at increased risk for COVID-19 transmission (see New guidance, revised survey tool for long-term care facility COVID-19 testing, August 26, 2020).

As such, nursing homes are accountable for the testing requirement by directing surveyors to inspect nursing homes for adherence to the new testing requirements. In addition to citations for non-compliance, facilities may be subject to enforcement sanctions, including civil money penalties in excess of $400 per day or over $8000 per instance of noncompliance.

Clinical labs test reporting. The interim final rule also 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 must report, including hospital labs, nursing homes, and other facilities conducting testing for COVID-19. Failure to report test results to HHS will result in a civil monetary penalty in the amount of $1,000 a day for the first day, and $500 for each subsequent day. Labs will have a one-time, three-week grace period to begin reporting required test data.

Physician, pharmacist test ordering. CMS also changed its previous policy that covered repeated COVID-19 testing for Medicare beneficiaries without practitioner orders. The revised policy allows a beneficiary to receive one COVID-19 test without the order of a physician or other health practitioner, but will require such a physician’s order for all further COVID-19 tests that is to be paid by Medicare. CMS noted that the change is to help ensure that beneficiaries receive appropriate medical attention if multiple tests are needed and also designed to stop fraud associated with performing or billing for unnecessary tests.

CMS will also pay for tests when ordered by a pharmacist or other healthcare professional authorized under applicable state law to order diagnostic laboratory tests. Medicare makes payment for these services only when they have an arrangement with a physician or other billing practitioner. The regulation change will allow Medicare to continue to pay for COVID-19 tests when ordered by pharmacists and other healthcare professionals without such an arrangement.

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