Pathology/Lab Coding Alert

PAMA Update:

Await CMS Final Rule Before Reporting Your Lab's Data

CLFS repricing on hold for now.

With the proposed-rule deadline upon us for reporting lab test volume and pricing data, you may be wondering if you’re facing penalties for non-compliance.

The answer is “no.” Although CMS’s proposed rule established the March 31, 2016 deadline for reporting clinical lab payment data for dates of service July 1 to Dec. 31, 2015, a final rule never materialized.

Without posting an official statement, CMS replied to queries from professional organizations such as the American Society for Clinical Pathology (ASCP), stating that clinical laboratories aren’t currently required to provide test volume and payment rate data as outlined in the Protecting Access to Medicare Act of 2014 (PAMA) Section 216.

Wait: In the CMS response, the agency noted that it does “not have a projected completion date for the Medicare Clinical Laboratory Fee Schedule (CLFS) Final Rule at this time. Therefore, no data are to be submitted by laboratories until the regulations are finalized.”

‘Representative’ Data Questioned

Based on an exchange logged in the Congressional Record, Sen. Richard Burr (R-NC) and Sen. Orrin Hatch (R-UT) concurred that “the intent of [Section 216 of PAMA] is to ensure that Medicare rates reflect true market rates for laboratory services, and as such, that all sectors of the laboratory market should be represented in the reporting system, including independent laboratories and hospital outreach laboratories that receive payment on a fee-for-service basis under the fee schedule [CLFS].”

However, the proposed rule “excludes hospital laboratories, 94 percent of physician office laboratories, and 52 percent of independent laboratories,” said David N.B. Lewin, MD, FASCP, president, ASCP, in an open letter to Andrew M. Slavitt, CMS acting administrator.

Concern: Industry analysts express alarm that collecting such non-representative data would allow CMS to base future CLFS payments on values skewed towards large reference labs, which operate with larger economies of scale that often result in lower rates. 

Bottom line: Hold your lab data reporting for now, and hope for a better offer when CMS finally issues the final rule for re-valuing clinical lab tests.


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