A key element of the ASCLS Mission and Vision is serving as the voice of all clinical laboratory professionals. Keeping abreast of and influencing the formulation of appropriate public (governmental) policy on health care issues vital to the profession and the public is a crucial component of serving as the voice.



ALERT! We need to take action now! Please tell CMS your concerns about their proposed rule to modify the Clinical Laboratory Fee Schedule


CMS has published a proposed rule describing how the agency plans to recalculate the Clinical Laboratory Fee Schedule (CLFS) per the PAMA law passed by Congress. ASCLS and the Government Affairs Committee are very concerned about a number of portions of the proposed rule and will be submitting comments to CMS outlining our concerns. However, it is very important that CMS hear concerns from as many others in the laboratory community as possible.


  Here is a sample of the points and letter you should send:


I am a (insert position or level of professional) at (facility), a (describe whether a hospital doing outreach l, independent or physician laboratory, etc.) in (State). The following comments are for CMS’s Proposed Rule file code CMS-1621-P which sets out a process to reform the Clinical Laboratory Fee Schedule (CLFS). I feel these issues must be addressed if this process is going to achieve Congress’s intent to ensure that Medicare beneficiaries have access to laboratory services for a reasonable cost.

  • The publication of the proposed rule violates the deadline set in the statute; the late publication will adversely affect the implementation of this process
    • Therefore, the timeline now being proposed does not provide adequate time for data collection and reporting
      • In fact payments for testing performed in Q4 2015 are likely to not have yet been received before the beginning of the data submission period so, with the timeline in this rule, there may be no or little data to report.
    • The effective date for the new rates should be extended to January 1, 2018, to reflect the delay in rulemaking by CMS and the additional time needed for data collection and reporting. This timeframe would then be consistent with the PAMA statute, which required CMS to implement a final rule by June 30, 2015 to enable an effective date for new rates by January 1, 2017, thereby contemplating an 18-month period from the date of the final rule to the effective date of the new rates.


  • We believe that the interpretation of the percent decreases of laboratory fees as described in the proposed rule will jeopardize patient access to quality timely laboratory services especially Medicare beneficiaries in skilled nursing and assisted living facilities. We believe that it was not the intent of Congress to decrease reimbursement to the point of risking access. The intent was to match the payments of private payors so that Medicare was not overpaying for laboratory services. 


  • The proposed rule would also implement provisions relating to advanced diagnostic laboratory tests (ADLTs) in a manner that is not consistent with the statute.
    • The statute creates a new category of diagnostic test, advanced diagnostic laboratory tests (ADLTs). These tests are defined in the law as "an analysis of multiple biomarkers of DNA, RNA or proteins combined with a unique algorithm to yield a single patient-specific result." However, the proposed rule states an ADLT must analyze "at a minimum, biomarkers of DNA or RNA." This interpretation improperly excludes tests that are solely comprised of proteins. The final rule should be revised to include tests that are solely comprised of proteins in the definition of ADLTs.
  •  PAMA requires the reporting of private payor rate and volume data of applicable laboratories so CMS can calculate a weighted median price for each test code.
    • As Senators Orrin Hatch and Richard Burr have stated, the intent of the PAMA definition of "applicable laboratory" was to ensure true market-based pricing, and therefore that laboratories reporting data should be representative of the broad scope of the laboratory market, including hospital outreach labs.
    • The statute refers to laboratories that derive a majority of their Medicare revenue from the Physician Fee Schedule and the Clinical Laboratory Fee Schedule. In contrast, the proposed rule defines "applicable laboratory" as an entity with a Taxpayer Identification Number, that may or may not itself be a laboratory, and looks at the percentage of Medicare revenue of the entire entity instead of the Medicare revenue derived from a laboratory.
    • As a result, the proposed rule ignores the intent of Congress by excluding virtually all hospital laboratories and physician office laboratories, as well as over 50% of independent laboratories.
    • CMS should revise the definition of applicable laboratory in the final rule to mean a facility identified by a CLIA number, not the parent organization’s TIN, so that true market-based reimbursement rates will be calculated as intended by Congress
  • The proposed rule does not describe how the data is to be reported
    • Reimbursement rates will be reported for a three month window:
      • What date will be used to determine if the reimbursement qualifies for reporting? Date of service? Date of order? Date of reimbursement?
    • There is no proposed format in the rule and therefore no opportunity for laboratories’ billing systems to create or modify their reporting in time to comply