On September 2, 2020, CMS issued an interim final rule with comment period enacting regulations related to, among other things, COVID-19 reporting and testing by Medicare and Medicaid healthcare providers and related enforcement of those requirements. The regulations are effective as of September 2, 2020 and are, with one exception, applicable for the duration of the COVID-19 public health emergency. The deadline for comments to be submitted to CMS is November 2, 2020.

Hospital Reporting and Enforcement

Beginning September 2, the rule requires every hospital that is a Medicare and/or Medicaid provider to report COVID-19 incidences and related data as a condition of participation in Medicare and Medicaid in accordance with the instructions provided by the Secretary of the U.S. Department of Health and Human Services (“Secretary”). This requirement applies to short-term acute care hospitals, long-term care hospitals, rehabilitation hospitals, psychiatric hospitals, cancer hospitals, children’s hospitals, and critical access hospitals that are Medicare and/or Medicaid providers. Guidance, which was issued by CMS on July 29, 2020, includes a current list of the data that must be reported. The data that must be reported includes, but is not limited to, the total number of staffed beds in a hospital and the number of those beds that are occupied, information about the hospital’s supplies, and the number of patients currently hospitalized who have laboratory-confirmed COVID-19.

If a hospital fails to report the required data, the hospital will be non-compliant with the Medicare conditions of participation and the hospital’s participation agreement with CMS will be subject to termination in accordance with 42 C.F.R. § 489.53(a)(3). While CMS currently lacks statutory authority to impose civil monetary penalties against hospitals for noncompliance with this new requirement, CMS stated that it will utilize all enforcement and payment authorities available to ensure compliance with this new requirement.

Clinical Laboratory Reporting and Enforcement

The rule also requires all clinical laboratories to report test results for any test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 to the Secretary for the duration of the COVID-19 public health emergency. This regulation implements laboratory reporting requirements in accordance with the Coronavirus Aid, Relief, and Economic Security Act. All clinical laboratories should develop a mechanism to track and collect test results to comply with this new requirement and update their policies and procedures as needed.

If a laboratory fails to submit the required data, the laboratory will be in violation of Clinical Laboratory Improvement Amendments reporting requirements resulting in condition level deficiencies for which civil monetary penalties and other penalties may apply. CMS will impose civil monetary penalties in the amount of $1,000 for the first day of noncompliance and $500 for each subsequent day of noncompliance.

Long-Term Care Facility Reporting and Enforcement

In addition, the rule includes enforcement provisions which apply if Medicare and/or Medicaid long-term care facilities that are subject to the weekly COVID-19 reporting requirements at 42 C.F.R. § 483.80(g)(1) and (2) do not comply with those requirements.

CMS will determine each week if any long-term care facilities did not comply with the reporting requirements through a retrospective review. Any noncompliance will be cited as a level “F” deficiency. In addition, each time a long-term care facility fails to report the required data, the facility will be subject to civil monetary penalties for its failure to report. CMS will impose a minimum penalty of $1,000 for the first instance of noncompliance and will increase the penalty by a minimum of $500 for each subsequent instance of noncompliance. The maximum civil monetary penalty that CMS will impose will be $6,500. The enforcement provisions will continue to be in effect for up to one year beyond the end of the COVID-19 public health emergency.

COVID-19 Diagnostic Tests and Related Tests

The rule also establishes that on and after September 2, Medicare beneficiaries may only receive one COVID-19 diagnostic test and one of each other related test (as listed in the interim final rule with comment period issued May 8, 2020 by CMS) without an order from a physician or other practitioner.