Advocacy Update

Read the Latest Issue of Advocacy Update

June 9, 2020

In this Issue:

New COVID-19 Test Data Reporting Requirements for Laboratories: HHS

The Department of Health and Human Services (HHS) released guidance on June 4 detailing the additional data for COVID-19 tests that laboratories must report to the federal government. Laboratories are required by a newly enacted law to report results from each COVID-19 test they provide to patients to the HHS as part of surveillance activities for the disease. 

The CAP has reviewed the new HHS guidance and is engaged with administrative officials on how the government can reduce the burden and support laboratories so they can more easily comply with its requirements. Required data elements are:

  • Test ordered – use harmonized LOINC codes provided by the Centers for Disease Control and Prevention (CDC)
  • Device identifier
  • Test result – use appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by the CDC
  • Test result date (date format)
  • Accession number/specimen ID
  • Patient age
  • Patient race
  • Patient ethnicity
  • Patient sex
  • Patient residence ZIP code
  • Patient residence county
  • Ordering provider name and NPI (as applicable)
  • Ordering provider ZIP
  • Performing facility name and/or CLIA number, if known
  • Performing facility ZIP code
  • Specimen source - use appropriate LOINC, SNOMED-CT, or SPM4 codes, or equivalently detailed alternative codes
  • Date test ordered (date format)
  • Date specimen collected (date format)

Patient demographic and ordering provider information also must be reported to state and local public health departments, but these data will not be collected by the CDC. 

The HHS guidance also provided additional information on methods for submission, data reporting and transmission requirements, and laboratory data reporting and electronic health records.

Paycheck Protection Program Flexibility Legislation Passes in Congress

On June 5, President Donald J. Trump signed into law CAP–backed legislation that increases flexibility in the Paycheck Protection Program (PPP) for small businesses like pathology practices.

The CAP was pleased that the Senate passed the Paycheck Protection Program Flexibility Act on June 3 to modify the PPP's specific provisions, including making it easier for PPP loan recipients to qualify for loan forgiveness. The House passed their version of the legislation on May 28, and the CAP released a statement on May 27 supporting this legislation as it would be vital to pathology practices nationwide.

Specifically, the law provides small businesses with more time to use loans under the program by extending the eight-week period in which they must use the money to qualify for loan forgiveness to 24 weeks after the loan is issued, or through December 30, 2020, whichever comes first. The law also allows small businesses to spend more of the loans on non-payroll costs by lowering the required percentage of forgiven loan amounts that must come from payroll expenses from 75% to 60%. Additionally, the law extends the date by which businesses must restore staffing and salary levels to have the full loan amount forgiven from June 30, 2020, to December 31, 2020.

The law also repeals a Coronavirus Aid, Relief, and Economic Security (CARES) Act provision that barred companies with forgiven PPP loans from deferring their payroll tax payments. The law also extends the repayment period to five years for loans issued after June 5, while existing PPP loans can be extended to five years if the lender and the borrower agree. The deadline to apply for these loans is June 30.

For more information and resources on financial assistance programs for pathology practices, visit the CAP’s COVID-19 resources.

CAP Leads Efforts for Critical Coverage of Respiratory Viral Panel Tests

On June 4, the CAP, the Association for Molecular Pathology (AMP) and the Infectious Diseases Society of America (IDSA), met with the Centers for Medicare & Medicaid Services (CMS) to advocate for coverage of respiratory viral panels (RVPs) during the COVID-19 pandemic. The CAP, AMP, and IDSA requested clarifying regulatory language that would remove the treating physician ordering requirement for additional diagnostic laboratory tests, including respiratory viral panels, for influenza and respiratory viruses.

Additionally, the group asked the CMS to allow for broader coverage of RVPs during the pandemic as a means of identifying other pathogens in order to help manage patient care.

The group made three recommendations to the CMS to increase coverage for RVPs:

  • Allow for RVP testing in coexistence with testing for COVID-19
  • Remove the treating physician requirement for RVP testing even with it is not done at the same time
  • Allow for broader coverage of RVPs during the COVID-19 pandemic to diagnose and manage patients.

The CMS meeting followed an April 28 letter to CMS Administrator Seema Verma calling for coverage of the tests.

The CAP will continue to work with the CMS to advocate for coverage of RVPs.

CDC Guidance on COVID-19 Serology Testing Follows Statements by CAP, AMA

On May 26, the Centers for Disease Control & Prevention (CDC) released interim guidelines on the use of COVID-19 antibody tests in clinical and public health laboratories. The CDC interim guidelines follow a statement by the CAP articulating concerns about serology testing and recommendations from other medical groups such as the American Medical Association (AMA).

In the guidance, the CDC asked laboratories to limit the risk of false COVID-19 antibody positives, including testing people twice to mitigate the imperfect specificity of the tests. The Food and Drug Administration (FDA) had initially issued a serology testing policy where commercial manufacturers could submit emergency use authorization requests, including their validation data.

The CDC guidance also stated that to minimize false-positive COVID-19 test results, laboratories should choose an assay with high specificity and test populations and individuals with an elevated likelihood of previous exposure to COVID-19. The CDC remains concerned about the poor performance among many serology tests currently available on the market. The CDC guidance also stated that COVID-19 antibodies most commonly become detectable about one to three weeks after symptom onset. Evidence suggests that infectiousness likely is significantly decreased and that some degree of immunity from future infection has developed.

In its statement, the CAP said serology (or antibody) tests are designed to determine if a person was exposed to or infected with SARS-CoV-2 at some point. SARS-CoV-2 antibodies will be produced if a person had COVID-19 or if an individual had an asymptomatic or mild infection with SARS-CoV-2. Interestingly, several studies suggest that not all individuals will mount an antibody response post-infection. Serologic testing alone should not be relied upon to detect the active infection as antibodies can take days to weeks to develop, and testing too soon following infection may lead to a false-negative result.

AMA Holds First Virtual Annual Meeting, Elects New President

In a historic meeting, the AMA had its first virtual annual meeting on June 7, with the CAP participating in the AMA’s elections and a town hall on COVID-19.

During the virtual meeting, the AMA House of Delegates discussed pay parity, telemedicine in the time of COVID-19, World Health Organization funding, and physician wellness. Due to the impact of COVID-19, physician wellness was a topic of interest. Physicians had to stop care, were isolated, or took significant pay cuts (especially those physicians who have independent practices). The impact of caring for COVID-19 patients for front line physicians was devastating, sounding the alarm for physicians' mental health services. The AMA has COVID-19 resources for its members, including caring for caregivers and tips on managing mental health. The AMA will soon launch a clinical health web resource to survey the medical workforce's mental well-being.

The AMA also noted the many federal relief programs available for physicians and their practices during COVID-19. During the meeting, delegates learned that many AMA members could benefit from the Payment Protection Programs, the Advance Medicare Payments. Still, AMA members called for improvements in the execution of that program. Additionally, the members discussed the benefits of the direct Provider Relief Fund payment. Other topics addressed were health equity, medical education during COVID-19, and how the pandemic change training, among other issues.

Susan Bailey, M.D, gets sworn in as the 175 President of the AMA

During the virtual meeting, the AMA House of Delegates elected Susan Bailey, M.D., an allergist from Fort Worth, Texas as the 175 President of AMA. Dr. Bailey is the third consecutive woman to hold the office. Outgoing AMA president Patrice Harris, MD, spoke about the unprecedented challenges the medical community faced this past year.

Outgoing AMA President Patrice Harris, MD

The CAP is an active member of the AMA House of Delegates and encourages pathologists to join the AMA or renew their AMA membership. A robust CAP delegation at the AMA can shape a health care system that best utilizes pathologists to deliver high-quality care and meet the evolving demands of patient care. The CAP and AMA work together on many of the health and medical policies that affect the way you practice and your reimbursements. Join or renew your AMA membership today.

Test Your Advocacy News Knowledge

It’s June, and it’s time to test your CAP Advocacy News Quiz. Last month, over 100 pathologists took the quiz. See how you compare against your fellow CAP members’ in the June News Quiz. Take the June news quiz.