PAMA Laboratory Reporting Delay a Win for AAFP

Time Could Allow Fixes to Flawed Clinical Diagnostic Test Payment System

January 14, 2020 04:25 pm News Staff

Outside sports, stopping the clock is rarely the best strategy. Inside the labs running clinical diagnostics for Medicare beneficiaries, though, a one-year delay on a data reporting deadline is exactly what the Academy wanted.

[scientist inspecting sample vials]

Earlier this month, CMS announced(www.cms.gov) that it would delay until 2021 this year's private payer data reporting for its Clinical Diagnostic Test Payment System.

Crucially, it's a victory for millions of Medicare beneficiaries who rely on access to clinical laboratory services but have been subject to a fee system governed by faulty, incomplete data collection and a consequent diminishment of lab benefits.

It's also a win for the Academy, one of the 26 physician, medical and patient organizations that signed a July 17 letter asking congressional leaders to call a time-out on the data reporting so the process can be fixed.

"Over the past two years, more than 53 million seniors who depend on clinical diagnostics for early prevention and effective treatment of chronic diseases have faced significant cuts to these laboratory tests," said the letter.(2 page PDF) It was sent to the chairs and ranking members of the Senate Finance Committee, the House Ways and Means Committee, and the House Energy and Finance Committee.

The data reporting is a requirement of 2014's Protecting Access to Medicare Act,(www.cms.gov) in which Congress directed CMS to create a market-based fee schedule for clinical laboratory services.

But CMS has so far based its rates on data collected from less than 1% of labs nationwide, resulting in severe cuts that threaten health care for seniors and other vulnerable populations.

Citing a survey of laboratories conducted by the Infectious Diseases Society of America, the letter noted that the fallout has been problematic:

  • 79% of survey respondents said they would be unable to provide the full range of testing needed to rapidly diagnose infectious diseases,
  • more than 32% changed their test menu and
  • nearly 40% now refer more tests to other labs.

Referring testing out to other laboratories "can cause life-threatening delays in diagnosis and care," said the letter.

The newly announced delay was dictated by the December spending package that extended funding for federal programs through fiscal year 2020 (a package that otherwise largely disappointed the AAFP).

Hospital outreach and other laboratories governed by PAMA that would have owed data during the first quarter of this year will now report that data between Jan. 1 and March 31, 2021.

Starting in 2024, data reporting will resume on a three-year cycle.

CMS also has ruled out reducing 2020 payment rates by more than 10% for clinical diagnostic laboratory tests that are not advanced or new; for 2021, 2022 and 2023, these rates will be reduced by no more than 15%.

Related AAFP News Coverage
AAFP Letter Cites Concerns With CMS' Proposed Lab Rule
(4/9/2019)