CMS Issues Interim Final Rule Requiring Regular Testing of Nursing Home Staff; Sweeping Regulatory Changes that Could Mean CMPs for Non-Compliance Topping $400 Per Day

The Centers for Medicare & Medicaid Services (CMS) announced sweeping regulatory changes that require nursing homes to test staff and offer COVID-19 testing to residents for. 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 new rules also require hospitals to provide COVID-19 cases and related data to the U.S. Department of Health and Human Services (HHS).

 “These new rules represent a dramatic acceleration of our efforts to track and control the spread of COVID-19,” said CMS Administrator Seema Verma. “Reporting of test results and other data are vitally important tools for controlling the spread of the virus and give providers on the front lines what they need to fight it.”

New testing requirements for nursing homes

CMS now requires that nursing homes will offer tests to residents when there is an outbreak or residents show symptoms.

Facilities that do not comply with the new requirements will be cited for non-compliance and may face enforcement sanctions based on the severity of the noncompliance, such as civil money penalties in excess of $400 per day, or over $8,000 for an instance of noncompliance.

The administration announced that the agency is helping facilities offset the cost of testing through new funding from the Provider Relief Fund, authorized under the CARES Act.

The extensive rule includes the following provisions impacting PALTC professionals:

• Establish a new requirement for LTC facilities to test facility residents and staff for COVID-19; this is a Requirement of Participation (RoP) in Medicare and Medicaid. The frequency of staff testing will be based on the degree of community spread and will be announced shortly through guidance.
• Establish new requirements in the hospital and critical access hospital (CAH) Conditions of Participation (CoPs) for tracking the incidence and impact of COVID-19 to assist public health officials in detecting outbreaks and saving lives.
• Establish requirements for all laboratories—this includes labs and nursing homes using  point-of-care (POC) testing instruments to perform COVID testing with a CLIA certificate—to report COVID-19 test results. This requirement stems from the CARES Act. If a laboratory does not report the required information, CMS will impose a civil monetary penalty (CMP) 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. This requirement complements existing HHS guidance requiring laboratories to report test results and additional information, such as demographic data.
• Revise the FY 2022 performance period under the Skilled Nursing Facility (SNF) Value Based Purchasing (VBP) program as a result of the COVID-19 public health emergency (PHE).
• If CMS does not have enough data to reliably compare national performance on measures, CMS may propose to not score facilities, hospitals, or SNFs based on such limited data or make the associated payment adjustments for the affected program year in the VBP.
• Will not enforce certain procedural volume requirements for four national coverage determinations.
• Revise the previous policy outlined in the May 8, 2020, COVID-19 IFC by establishing that one single COVID-19 diagnostic test and one of each other applicable related tests without an order from a treating physician or other practitioner is reasonable and necessary.
• Establish a policy whereby the orders of pharmacists and other practitioners that are allowed to order laboratory tests in accordance with state scope of practice and other pertinent laws can fulfill the requirements related to orders for covered COVID-19 and related tests for Medicare patients.

The comment period will end in mid-October or 60 days after the rule is officially published in the Federal Register.