CMS clarifies the new lab reporting requirement

Last month, we highlighted a new rule from Medicare that requires certain clinical labs to report how much they receive from private insurers for lab tests. Now, the Centers for Medicare & Medicaid Services (CMS) has issued guidance to help labs meet the new requirements by clarifying some of the who, what, and when related to the new rule.

With respect to “who,” labs can use a four-question test to determine if the new rule applies to them:

• Is the lab certified under the Clinical Laboratory Improvement Amendments (CLIA)?
• Does the CLIA-certified lab bill Medicare Part B under its own national provider identifier?
• Does the lab meet the majority of Medicare revenues threshold?
• Does the lab meet the low expenditure threshold?

To answer “what,” CMS lays out the three major types of information that affected labs must collect and report:

• The specific billing code associated with a test
• The private payer rate for each test for which final payment has been made during the data collection period
• The associated volume for each test

Finally, in terms of “when,” the guidance defines the first data collection and reporting periods:

• Labs affected by the rule must collect applicable information from all claims for which the lab received final payment between Jan. 1 and June 30 of this year.
• Labs must submit that information to CMS between Jan. 1 and March 31 of next year.

During the six-month window between the end of the data collection period and the beginning of the data reporting period, CMS expects laboratories and reporting entities to assess whether the applicable laboratory thresholds are met.

As noted in our original post, CMS estimates this new rule will include only 5 percent of physician office labs and about half of independent labs. For those that fall in that category, the new guidance is essential reading.

– Kent Moore, Senior Strategist for Physician Payment for the American Academy of Family Physicians