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CMS Relaxes Medicare and Medicaid Ordering Requirements for COVID-19 Testing and Finalizes Coverage of Antibody Testing

In an effort to increase access to COVID-19 testing for Medicare and Medicaid beneficiaries, the Centers for Medicare & Medicaid Services (CMS) has issued a second round of regulatory waivers that includes relaxed Medicare requirements for ordering COVID-19 diagnostic laboratory tests, flexibility for Medicaid coverage requirements of COVID-19 tests, and Medicare coverage of COVID-19 serology tests to identify antibodies.

Waiver of Medicare’s Treating Physician Rule

Under current regulations, Medicare covers diagnostic laboratory tests, such as COVID-19 testing, only if ordered by a physician or other non-physician practitioner (NPP) who is treating the patient and who uses the results of the test in managing the patient’s specific medical condition.  This regulation is known in the laboratory industry as the “treating physician rule.”  To combat the pandemic, CMS anticipates the need to test many Medicare beneficiaries quickly but is concerned that not all Medicare beneficiaries have access to a physician who can order the testing.  Further, given that community testing sites operated by large clinical diagnostic laboratories and pharmacies are a key component in expanding the availability of testing, CMS believes that states will increasingly look to pharmacists and other qualified healthcare professionals to order COVID-19 testing.  However, if a Medicare beneficiary visits a testing site without a physician order, or if a health care professional who is not the beneficiary’s treating physician or NPP orders the testing, Medicare likely would not cover the test.  

CMS thus is amending the treating physician rule by allowing Medicare coverage for COVID-19 testing even if a physician or NPP does not order the testing.  In addition, because the symptoms for influenza and COVID-19 are similar, CMS is also waiving the ordering requirement for diagnostic laboratory tests for influenza virus and respiratory syncytial virus ordered in conjunction with COVID-19 testing to rule out influenza virus or a related diagnosis.  The waiver of the ordering requirement for diagnostic laboratory tests is limited to the CPT/HCPCS codes listed on CMS’s website.  The waiver is retroactively effective March 1, 2020, through the end of the COVID-19 public health emergency.

What the amended regulation does not say – but which CMS makes clear in the preamble to the interim final rule – is that the testing will be covered only when ordered by “any healthcare professional authorized to do so under state law” and when ordered to establish or rule out a COVID-19 diagnosis or to identify patients with an adaptive immune response to SARS-CoV-2 indicating a recent or prior infection.  Laboratories therefore will need to screen ordering healthcare professionals on an individual, state-by-state basis, which could be burdensome given the need to keep up with the patchwork of relevant state executive orders and other actions issued in response to the COVID-19 public health emergency.  Further, while CMS is eager to have pharmacists collect specimens for COVID-19 testing, as well as order and even perform such testing, a pharmacist’s scope of practice type requires physician or NPP supervision.  And if a pharmacy intends to perform such testing, it would need to obtain a CLIA certificate.

The amended regulation exempts COVID-19 and related testing from documentation and recordkeeping that would not be relevant in the absence of a treating physician’s or NPP’s order. CMS nevertheless states that it expects the laboratory submitting the claim to include “the ordering or referring NPI information on the claim form” when an order is written for the test, consistent with current billing instructions.  CMS did not explain how a laboratory would meet the claims submission requirement that the ordering supplier must be PECOS-enrolled.

Finally, if COVID-19 testing is furnished without an order from a physician or NPP, CMS notes that the performing laboratory must “directly notify the patient of the results consistent with other applicable laws, as well as meet other applicable test result reporting requirements,” such as reporting to local public health officials.  While some laboratories operate a patient portal for this purpose, smaller laboratories may find it difficult to quickly adapt to the need to deliver results to patients, especially patients who do not have a treating physician or NPP. 

Flexibilities for Medicaid Coverage of Laboratory Services

CMS has also implemented flexibility for Medicaid coverage of COVID-19 laboratory services.  Under current Medicaid regulations, diagnostic laboratory tests are covered only if they are (1) performed in an office or similar facility setting, and (2) ordered and provided by a physician or other licensed practitioner or ordered by a physician but provided by a referral laboratory.  Under the modified requirements, CMS is now permitting coverage of COVID-19 tests administered in non-office settings, such as parking lots or other temporary testing sites set up to minimize transmission of COVID-19.  Additionally, CMS is waiving the requirement that laboratory tests be ordered and provided by a physician or other licensed practitioner or ordered by a physician and provided by a referral laboratory to allow for Medicaid coverage of self-collected, FDA-authorized COVID-19 tests, which allow patients to collect specimens at home to send in to laboratories. 

These Medicaid coverage flexibilities are also retroactively effective March 1, 2020. Interestingly, CMS is not limiting these flexibilities to the duration of the COVID-19 public health emergency.  The flexibilities will apply during any future public health emergency formally declared by CMS and during any subsequent “period of active surveillance.” CMS defines a period of active surveillance as “an outbreak of communicable disease during which no approved treatment or vaccine is widely available,” which would end upon termination by the Department of Health and Human Services (HHS), or the date that is two incubation periods after the last known case of the communicable disease, whichever is sooner.  CMS seeks comments on this definition of a period of active surveillance. 

Medicare Coverage of COVID-19 Serology Testing to Detect Antibodies

Blood-based serology tests can be used to detect if individuals may have previously been infected with the virus that causes COVID-19 by identifying whether the individual has antibodies specific to the virus.  CMS is finalizing coverage of COVID-19 serology tests, which are now Medicare-covered diagnostic laboratory tests.  CMS notes that it typically would use the National Coverage Determination (NCD) process to establish a benefit category and establish that an item or service is reasonable and necessary.  An NCD generally outlines the conditions under which a service or item is considered covered, and providers rely on them to ensure items and services will be paid by Medicare.  However, CMS is bypassing the NCD process because there is no time for the notice and comment period given the need to immediately establish national coverage for serology tests during the public health emergency. Without an NCD, providers have limited guidance on whether a serology test will be considered reasonable and necessary, and thus covered by Medicare.  CMS merely notes that it expects to be billed only once per sample, and that the serology tests should only be performed and billed if clinically indicated. CMS does not provide any guidance on when a serology test would be clinically indicated, although coverage is limited to tests performed on patients with known or suspected prior or current COVID-19 infections.

CMS has published several provider-specific fact sheets on new waivers and flexibilities during the COVID-19 public health emergency, including fact sheets for laboratories, physicians and other practitioners, and hospitals.  These fact sheets as well as additional information about CMS’s COVID-19 waivers are available online and are updated by CMS as new actions are taken.  The health care industry should keep an eye out for more COVID-19-related announcements from CMS.  We will continue to monitor future developments and provide updates.


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Karen S. Lovitch

Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice

Karen advises industry clients on regulatory, transactional, operational, and enforcement matters. She has deep experience handling FCA investigations and qui tam litigation for laboratories and diagnostics companies.
Rachel Yount is a Mintz attorney who focuses her practice on health care industry transactions. Her clients include hospitals, health systems and plans, physician organizations, and pharmacy benefit managers.