As part of a broader Trump administration announcement made on August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued sweeping oversight changes in the form of an Interim Final Rule with Comment Period (IFC) designed to address COVID-19 infections in long-term care facilities. The new measures supersede prior CMS guidance and constitute the agency’s most significant and decisive recommendations with respect to skilled nursing care providers since the beginning of the coronavirus pandemic.

Notably, operators must now routinely perform testing of nursing home staff or risk losing their eligibility to participate in Medicare and Medicaid. The frequency of the required testing depends on the rate of spread in the surrounding area—the higher the overall case count in the community, the more frequent the testing—up to twice weekly. The cost of testing will be funded as part of the nearly $10 billion in Provider Relief Funds provided under the CARES Act.

The new mandates also include:

• Hospital Data Reporting Requirements – Hospitals and critical access hospitals must report daily data, such as the number of confirmed/suspected COVID-19 positive patients, occupied ICU beds, and PPE availability. This requirement is mandatory for Medicare/Medicaid program participation. If the rules are not followed, hospitals face a potential loss of Medicare/Medicaid reimbursements.
• New Reporting Requirements for Labs – Every day, laboratories are required to report COVID-19 test results to the Secretary of Health and Human Services. This includes all labs that test in hospitals, nursing homes, and other healthcare facilities. If the lab fails to follow the requirement, a $1,000 first day penalty will be assessed and $500 for additional days.
• Limits on Medicare Coverage of COVID-19 Tests Without Orders: The “One-Test Rule” – To combat fraud, CMS is now limiting the number of COVID-19 tests (and related tests) that can be ordered without a physician or non-physician practitioner order. Pursuant to this updated interim final rule, Medicare will now reimburse only one COVID-19 diagnostic test and one of each other related diagnostic tests (e.g., tests for influenza virus and respiratory syncytial virus) without a qualified practitioner order. Tests performed without an order before this IFC will not count toward the one test rule.

Facilities that do not comply with the new requirements may be cited for noncompliance and may face enforcement sanctions based on the severity of the noncompliance, including civil monetary penalties in excess of $400 per day, or over $8,000 per instance of noncompliance.

The new CMS rule can be found here. A full list of CDC guidance to nursing homes can be found here.

In conjunction with the updated rule, CMS also issued guidance to state survey agencies that provides further detail regarding LTC facility testing requirements. Providers and stakeholders seeking assistance or more information on the interim final rule and the comment period may visit CMS’ Coronavirus Waivers & Flexibilities page for additional information, including fact sheets for changes for each provider type.