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Key Revenue Cycle Takeaways from CMS’ August 25, 2020 COVID-19 Interim Final Rule


Key Revenue Cycle Takeaways from CMS’ August 25, 2020 COVID-19 Interim Final Rule


On August 25, 2020 CMS released its third COVID-19 Interim Final Rule entitled, “Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency”. The rule can be read in its entirety at the link provided below. It is important to note that CMS-3401-IFC has not yet been published to the Federal Register. CMS is waiving the 30-day delay of implementation for the rule, meaning all policy changes outlined in the IFC will be effective the date the rule is formally published.

Data Reporting Requirements

Hospital Reporting Requirements of COVID-19 Data:

On March 4, 2020, CMS issued guidance that encouraged hospitals to report persons under investigation for COVID-19 within their facility to local and state public health authorities as well as other appropriate agencies. With the August 25 IFC, CMS is now making these data reporting requirements mandatory. Per CMS, hospitals should report relevant COVID-19 data in the format and frequency outlined by the Secretary of the Department of Health and Human Services (HHS). These reporting requirements are outlined within the HHS document, “COVID-19 Guidance for Hospital Reporting and FAQs For Hospitals, Hospital Laboratory, and Acute Care Facility Data Reporting Updated July 29, 2020”, linked below. Per CMS, if a hospital should fail to consistently report these required data elements, the hospital would be considered non-compliant with the Medicare Conditions of Participations (CoPs) and therefore could be subject to termination of its Medicare contract.

Laboratory Reporting Requirements of COVID-19 Test Results:

The CARES Act created legislation that requires every laboratory that performs or analyzes a test that is intended to either detect SARS-CoV-2 or diagnose a possible case of COVID-19 to report the results from each test performed to the Secretary of HHS until the end of the declared public health emergency (PHE). On June 4, 2020, HHS outlined the required data elements, frequency of reporting and reporting channels for this laboratory data in the document, “COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115”, linked below. Within the August 25 IFC, CMS announced that labs that fail to report SARS-CoV-2 test results in the manner prescribed by HHS will be considered in violation of CLIA reporting requirements and therefore may be subject to civil monetary penalties (CMPs). Per CMS, the CMPs for failing to report SARS-CoV-2 test results will be $1,000 for the first day of non-compliance and $500 for each subsequent day – up to a penalty cap of $10,000 per violation. Within the rule, CMS notes that it will rely on CMS-deemed Accreditation Organizations (AOs), State Licensure Programs and Exempt States (ES) to identify non-compliant laboratories

Limits to COVID-19 and Related Testing Performed Without a Physician Order

Within its May 8, 2020 COVID-19 IFC, CMS announced that it would allow COVID-19 testing to be covered without an order from a physician or other qualified non-physician practitioner (NPP). Within the May 8 rule, CMS applied the same leeway to influenza and respiratory syncytial virus (RSV) testing when performed in conjunction with a COVID-19 test. With its August 25 IFC, CMS is revising its coverage policy for COVID-19, flu and RSV tests performed without a corresponding physician order. CMS states it will now consider one single COVID-19, flu and/or RSV test as reasonable and necessary when performed without a physician’s order. Per CMS, any COVID, flu or RSV tests performed without a physician’s order prior to the effective date of the August 25 IFC will not count towards the beneficiary’s one test limit. Absent from the rule is an explanation of how MACs will keep tally of these tests or how claims will be processed should the beneficiary exceed the one test limit (i.e., will the allowed amount be applied to patient responsibility, would an ABN be required, etc.). We have submitted these questions to the CMS COVID-19 inbox and will provide an update if and when a response is received.

Expansion of Testing Order Authority

Within the August 25 IFC, CMS announced an interim ordering policy that expands the eligible practitioners allowed to order COVID-19, flu and RSV tests for Medicare beneficiaries. Per CMS, for the duration of the declared PHE, COVID-19 and related lab tests may be ordered by pharmacists and other healthcare professionals who are authorized to order such tests per their individual state scope of practices and/or other pertinent laws. However, CMS does remind providers in the rule that pharmacists are not considered physicians or practitioners under Medicare statute. Therefore, if pharmacists render services other than writing an order for a COVID test (i.e., performance of specimen collection, symptom assessment, etc.) these supportive services would still need to be performed incident-to the services of a qualifying physician and must be billed under the supervising physician’s NPI number.

NCD Procedural Volume Requirements

Certain NCDs include procedural volume requirements that facilities must satisfy in order for the specific items and services noted in the NCD to be covered by Medicare. In the August 25 IFC, CMS announced that that for the duration of the declared PHE it will not be enforcing the procedural volume requirements outlined in the following NCDs:

  • NCD 20.34 Percutaneous Left Atrial Appendage Closure (LAAC)
  • NCD 20.32 Transcatheter Aortic Valve Replacement (TAVR)
  • NCD 20.33 Transcatheter Mitral Valve Repair (TMVR)
  • NCD 20.9.1 Ventricular Assist Devices (VADs)