Regulatory Editor

The Centers for Medicare & Medicaid Services (CMS) is hearing from makers of a variety of tests in the yearly public clinical lab fee meeting, which takes place in the last year before CMS starts using private payer rates to calculate Medicare rates, a change that may drastically affect the amounts paid for a number of tests in 2018. Two associations voiced some misgivings about how the agency is collecting data for future fee schedules and about what some see as a lack of clarity regarding a test for hepatitis B.

While there are a number of issues facing test makers where the Medicare clinical lab fee schedule (CLFS) is concerned, issues associated with the proposal to update rates as spelled out under the Protecting Access to Medicare Act of 2014 (PAMA) are still front and center. PAMA stipulated that CMS collect data on rates paid by private payers as part of an update to the CLFS, but the program has encountered several sources of drag. Among these was the difficulty of collecting private payer rates in time to get the new pricing system up and running on time, although stakeholders also had issues with the types of labs that would be reporting private payer rates, and how the agency defined new advanced diagnostic tests. (See BioWorld MedTech, Nov. 21, 2016.)

AMA still concerned about data collection

Shannon Curtis, assistant director of federal affairs for the American Medical Association (AMA), said physicians have encountered difficulty in assembling private payer rate data sufficiently quickly to meet PAMA deadlines, adding that the association is also concerned about data collection integrity because CMS's methodology "is not transparent."

"We have less than six months to price the rest of the CLFS," Curtis said, stating that price data from several types of labs, including physician office-based labs, might not make it into the CMS calculation. As a consequence, the rates set by CMS are likely to be too low for some smaller labs to practice, which in turn could lead to tests not being offered in these settings.

Beneficiary access is the overriding consideration, Curtis said, pointing out that many of the labs in question will again be on the front lines for any disease outbreaks. She stated further, "we're really at the cusp of implementing payment reform under MACRA," a reference to the Medicare Access and CHIP Reauthorization Act of 2015. Curtis said many of the provisions of MACRA will come into force around the time the lab fee overhaul does the same.

The AMA, Curtis said, recommends CMS release at some point in August 2017 a set of data on the labs that have responded to the survey so stakeholders can evaluate whether the data are legitimately reflective of the types of labs that will be affected by the rate changes that will take effect in January 2018.

"Even under this schedule, it will be difficult to make adjustments if there are significant cuts," Curtis said. She said AMA recommends that the agency issue an interim final rule "not to supplant the current PAMA exercise," but to validate the data gathering regime and to determine "whether adjustments are called for." Curtis noted that there are instances in which a lab serves as a sole source for a test, and thus those data are likely reliable. Conversely, she said, some smaller labs were unaware of the reporting obligation under PAMA, and did not know which data points were needed until after the six-month data collection period had expired.

"This is further validated by the fact that the largest labs were reporting difficulty" with the reporting requirement as well, Curtis added, noting that a study has emerged that suggests that tests for dangerous pathogens and conditions might be among those that are adversely affected by an inaccurate rate schedule.

ACLA: MAAAs ready for crosswalk

Paul Sheives of the American Clinical Laboratory Association said there are a number of molecular testing codes are not always used in high volumes by ACLA members, and hence he had no comment on some of these. He said ACLA does not believe it is appropriate to use the gapfill process for a number of genetic tests, suggesting the agency use the crosswalk method to set rates for these tests.

The use of gapfilling for multianalyte assays with algorithmic analyses (MAAAs) was necessary in the past due to lack of similar tests on the fee schedule, Sheives said, although he said there are now 14 such tests on the fee schedule. Sheives stated also that gapfilling might still be an option in some cases, but rates for the MAAA codes for which the association offered comment on could be handled via the crosswalk process.

The rate question for MAAAs has been problematic for several years. CMS had preliminarily announced in 2013 that it would not pay at all for MAAAs in 2014, a proposal that drew widespread opposition. The agency decided to hand the question off to its Medicare administrative contractors, which would be charged with the use of the gapfill process to set rates in 2014 for any covered tests. CMS had proposed to crosswalk a number of MAAAs for CY 2016, a proposal opposed by ACLA at the time.

Sheives said the association has information from members for codes for the Zika virus, noting that this includes both the amplified probe and the igM techniques, and said ACLA is still reviewing the matter. "We may be modifying our recommendations for both those codes," he said.

For the code for hepatitis B (code G0499), Sheives said, "we provided a bifurcated recommendation" due to a lack of clarity from the code's descriptor and AMA materials regarding whether this is a reflex test versus an initial antigen test. He said the ACLA committee could not decide, so the association offered so two different crosswalks "based on how you view that code."

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