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AMP Offers Recommendations to CMS, HHS to Prepare for Next Pandemic

NEW YORK – The Association for Molecular Pathology released a report on Tuesday with recommendations for the federal government to prepare for future public health emergencies. 

The "Economics of Clinical Testing during a Public Health Emergency: Lessons Learned from Two Years of COVID-19" report, written by members of AMP's 2021 Economic Affairs Committee, noted that labs were affected during the pandemic by "uncertain and confusing economic policies, especially during the early months of the pandemic." 

"Policy measures addressing coverage, pricing, and funding for clinical laboratory testing were slow to appear, lacked appropriate input, or generally failed to provide the assurance of economic stability needed for laboratories to bring forward solutions with confidence in avoiding financial ruin," the report said.

The organization wrote the report to "share key lessons learned and offer strategic recommendations to improve our nation's awareness and ability to respond to future public health emergencies to protect the well-being of all our patients," Samuel Caughron, chair of the AMP Economic Affairs Committee, said in a statement.

The main recommendation in the report is that the US Department of Health and Human Services and the Centers for Medicare and Medicaid Services should "engage laboratory stakeholders early and across the spectrum of care delivery environments before laboratory policies are implemented." Doing this will "ensure that reactionary policies do not have unintended and negative consequences for laboratories and impede their ability to respond effectively," it said.

The organization specifically cited the importance of coding, coverage, and pricing processes, which are typically time-consuming to develop and require changes during a public health emergency. Such decisions "must be considered in the context of the overall financial impact to both the providers of testing and those who pay for it," the report said. 

For coding, the report focused specifically on codes for RT-PCR testing and recommended CMS coordinate early with the lab community, the American Medical Association's CPT Editorial Panel, and other stakeholders so they can provide feedback on coding decisions. Early in the pandemic, the AMA panel created multiple codes for molecular SARS-CoV-2 tests, which AMP said caused confusion among laboratories about appropriate coding. Deciding which of the codes to use "depended on the payor and their ability [to] process claims with new codes."

AMP also urged CMS to work with those industry stakeholders to develop processes to provide up-to-date coding guidance relative to the pandemic and to rapidly develop interim codes and coding guidance. Those interim codes could stay in place until the AMA panel develops permanent codes, which would help mitigate confusion among labs, it said.

Once AMA set its CPT codes for COVID-19 testing in 2020, CMS directed its Medicare Administrative Contractors to set prices for those codes until Medicare was able to develop national payment rates. That process "lacked transparency," since public comment wasn't available and the agency didn't "appear to take the actual costs of performing these tests into account," AMP said.

The organization recommended that CMS work with stakeholders to gather data on the costs of running tests in emergency situations to improve pricing accuracy. The agency should also work with labs from all sectors, including smaller labs, to set prices and "ensure reimbursement is reflective of the costs of performing these tests in all settings," since some labs will have different needs or require more resources, the report noted.

It added that CMS must make sure test prices align with the resources needed to both develop and facilitate them, as well as increased costs associated with supply chain and staffing issues. The pricing must be done in a timely fashion, albeit with enough time to get input from stakeholders. 

In October 2020, CMS announced that COVID-19 test payments for high-throughput testing would be reduced from $100 to $75, but that there would be an additional add-on payment of $25 if a test was completed in two days or less after a sample was collected. AMP noted that elements out of a lab's control, such as turnaround time, shouldn't be used for pricing or payment considerations, so labs serving rural areas or providing testing for a large community aren't penalized. 

When it comes to reimbursement coverage, both emergency coverage policies and non-emergency policies need to be aligned to make sure emergency coverage isn't more restrictive, AMP said. Medicare must also make sure its policies support the "full range of tests available to appropriately diagnose and guide treatment," such as respiratory panels, and don't add significant burden on labs. The agency should also waive ordering requirements to expand access to testing in an emergency and avoid making ordering requirements overly prescriptive, the organization said.

In April 2020, AMP and five other medical organizations, including the College of American Pathologists, requested CMS create a national coverage policy for multiplex respiratory panel tests, as many labs have used the tests to rule out patients with other respiratory conditions besides COVID-19. Last month, Medicare's MolDx program released a final local coverage determination covering these tests under certain conditions. 

Both the Families First Coronavirus Response Act and the Coronavirus Aid, Relief, and Economic Security act allowed for COVID-19 test coverage without a copay, but there was no guidance on billing for patients without insurance or whose insurance refused to cover testing, AMP said. "It was often unclear whether insurance or the government would cover testing and how laboratories' fees would be covered." There was also confusion over whether tests for asymptomatic or pre-symptomatic patients would be covered, since generally Medicare only covers screening tests in certain circumstances, AMP noted.

Transparent, coordinated guidance from both HHS and CMS on coverage policies for people outside of existing policy is necessary for labs, it said. Any change in policy during an emergency, such as removing copay requirements, needs clear guidance on how established billing and coverage prices are affected. The agencies should also consider relaxing typical coverage requirements during an emergency so labs know they will be reimbursed. 

Private payors will need guidance from HHS on coverage requirements and minimum payment amounts for diagnostic tests, the report said.

AMP also laid out recommendations for genomic sequencing and reporting requirements. The organization said that federal guidance and funding on sequencing should be provided and accessible for all clinical labs. 

In addition, it said that the federal government should ensure funding streams and resources for laboratory reporting exist and are available for labs at the beginning of any future pandemic, since labs were required to report COVID-19 test results to a variety of state and federal agencies, putting a "large financial and operational burden" on labs who had not previously been required to report this info.