CLINICAL LABORATORY ASSOCIATIONS are using a letter-writing campaign to members of Congress as a last-minute Hail Mary attempt to head off the controversial lab price market reporting rule that CMS intends to implement after January 1.
Both Democrats and Republicans in the U.S. House of Representatives and the U.S. Senate have signed a letter to the acting administrator of the federal Centers for Medicare & Medicaid Services asking for a delay of the rules to implement the Protecting Access to Medicare Act.
Copies of the letter, dated December 14, circulated in both houses of Congress. The letter asks CMS Acting Administrator Andrew Slavitt to delay implementing the Medicare Clinical Diagnostic Laboratory Tests Payment System Proposed Rule. CMS published the proposed rule in the Federal Register on October 1.
Fears of Skewed Data
Alan Mertz, President of the American Clinical Laboratory Association, said, “This Dear Colleague letter vigorously illustrates that the proposed timeline for reporting data and pricing will result in skewed data and Medicare rates that do not reflect the market.”
The letters signed by senators and representatives explain the biggest problems labs have with PAMA since the Act was signed into law in 2014. In the letter, members of Congress say they are concerned about several specific provisions of the proposed rule. First, the letter says CMS should, “…provide clinical laboratories with sufficient time to implement these important changes, and preserve market competition to ensure continued access to laboratory services.”
The timeline calls for CMS to set rates for clinical laboratory tests starting January 1, 2017, based on lab-pricing data to be collected starting January 1, 2016. Clinical labs have no idea how to comply with CMS’ data collection system as outlined in the Medicare Clinical Diagnostic Laboratory Tests Payment System Proposed Rule, published October 1, 2015. Under the proposal, some labs are prohibited from participating in the reporting process CMS recommends, the letter said.
“We are deeply concerned that this prohibition will skew market data, resulting in Medicare rates that are not reflective of true market prices,” the letter said.
Another concern involved CMS’ definition of a new category of tests— advanced diagnostic laboratory tests (ADLTs). Language in the PAMA statute says that an ADLT must analyze multiple biomarkers of DNA, RNA, and proteins. But the CMS definition leaves proteins out of the definition, a critical factor because pathologists look for protein-based diagnostic markers to help them make clinical decisions regarding patient care, the letter says.