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AACC Coalition Calls for Harmonization Funding

Federal Insider: May 2021

AACC Coalition Calls for Harmonization Funding

Twenty associations, clinical laboratories, and in vitro diagnostics companies joined an AACC-led coalition calling on Congress to increase funding for the Centers for Disease Control and Prevention (CDC) to continue its efforts to harmonize the reporting of clinical laboratory test results. The coalition is asking Congress to appropriate an additional $7.2 million for harmonization activities directed by CDC’s Environment Health Laboratory in the fiscal year 2022 budget.

In a letter to legislators, AACC notes that past funding for harmonization has resulted in expanded harmonization and standardization activities that improve detection and management of hormone disorders, kidney disease, cancer, and heart disease. Using the funds AACC has advocated for in past years, CDC has distributed free reference/harmonization materials for clinical standardization programs for chronic disease biomarkers; developed reference methods for biomarkers used in the diagnosis of multiple diseases, including bone, kidney, cardiovascular, and endocrine disorders, as well as diabetes and cancers; expanded outreach of harmonization/standardization programming to non-traditional markers, point-of-care-testing devices, and patient and payor organizations; and conducted method performance evaluations for laboratories and manufacturers.

“The undersigned organizations believe that every patient should have access to dependable and accurate clinical laboratory test results and that those test results should be harmonized,” the coalition wrote in a letter to lawmakers.

Federal Advisors Explore PAMA Data Collection Changes

A preliminary report at the April 2 meeting of the Medicare Payment Advisory Commission (MedPac) suggests ways that the Centers for Medicare and Medicaid Services (CMS) could change how it implements the Protecting Access to Medicare Act (PAMA), a law that initiated significant cuts to most routine laboratory tests on Medicare’s Clinical Laboratory Fee Schedule (CLFS). In the 2020 Further Consolidated Appropriations Act, Congress mandated that MedPac study CMS’s methodology for collecting private payer rates.

PAMA requires that CMS use a weighted median of private rates for CLFS payments. The law’s critics have complained that CMS’s method of collecting this private payer price data gives too much weight to large, independent laboratories that generally negotiate the lowest rates with insurers.

In the MedPac meeting, policy analysts said that their study showed independent laboratories were indeed “overrepresented” in CMS’s first round of data reporting—90% of the private payer data reported to CMS came from independent labs, even though these labs only perform 48% of the tests billed to Medicare.

Further illustrating the discrepancy, MedPac’s analysis showed that, compared to independent laboratories, private payer rates were on average 45% higher at hospital outpatient laboratories and 53% higher at physician office laboratories.

The MedPac analysts presented a proposal to collect a more representative sample through a survey instead of the data collection method CMS currently uses.

The MedPac study also found that CMS spending on laboratory testing increased from 2017 through 2019, despite cuts to reimbursement for most tests and even though overall utilization remained about the same. The increase in overall cost was the result of new, high-cost tests, they said. MedPac will issue a final report on the CLFS in June.

Biden Administration’s Approach Boosts Insurance Enrollment

The Department of Health and Human Services (HHS) announced that more than half a million consumers have already signed up for health insurance through HealthCare.gov as a result of the administration’s special enrollment period (SEP) for the COVID-19 public health emergency and the additional financial assistance from the American Rescue Plan. According to HHS, the new financial assistance has resulted in significantly reduced premiums for consumers using the federal health insurance marketplace.

HHS data also show gains in enrollment among historically uninsured communities, including Blacks and Americans near the poverty level. Of applicants who identified a race, 17% identified as Black, compared to about 11% in both 2020 and 2019. Among consumers requesting financial assistance, 41% reported being at or slightly above the federal poverty level, compared to 38% in 2020 and 33% in 2019.

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