SEVERAL IMPORTANT clinical laboratory associations are concerned that the lab test price reporting under the Patient Access to Medicare Act of 2014 will have a negative effect on diagnostic innovation and on Medicare beneficiaries’ access to lab testing services.
The American Clinical Laboratory Association wants to ensure that the new Medicare Part B clinical laboratory fee schedule rates established by the Centers for Medicare & Medicaid Services under PAMA do not threaten access to laboratory services for Medicare beneficiaries. ACLA also wants Congress to ensure that the new rates do not limit innovation among diagnostic testing laboratories, Julie Khani, ACLA‘s Executive Vice President, told THE DARK REPORT. ACLA is concerned about how the regu- lations under PAMA define “applicable labs” that must report lab test price data to CMS.
“While the ‘applicable lab’ definition in the final rule is an improvement from the proposed rule, we are monitoring implementation closely to ensure that PAMA results in market-based rates,” Khani said. “We urge Congress to exercise its oversight authority to ensure that the new reimbursement rates do not limit diagnostic innovation or threaten Medicare beneficiary access to clinical laboratory services.”
In addition, ACLA is concerned about the challenges clinical laboratories face as they prepare to report their price and volume data to CMS starting in January.
“Collecting and certifying private payer data to submit to CMS is very challenging, especially since labs are going through it for the first time,” Khani said. “Challenges include determining those codes for which applicable information is to be reported, reviewing the large amounts of data that will be reported, pulling the necessary data from laboratory systems, and collecting and reporting information on automated multi-channel chemistry tests. We are also still awaiting guidance from CMS on the advanced diagnostic laboratory test (ADLT) application process.
“We continue to work closely with Congress and CMS on PAMA implementation,” she added.
how Will New Congress act?
One factor that adds uncertainty to the implementation of PAMA market price reporting is the effect a new president and new Congress will have when they take office in January. New members of the executive and legislative branches may be receptive to arguments from the clinical laboratory industry about how CMS has interpreted the PAMA statute and is implementing the market price reporting section of the law. TDR
Contact Julie Khani at 202-637-9466 or jkhani@ACLA.com.