Congressional Members Lobby CMS on PAMA Regulations

Forty-four members of House of Representatives last month asked the Centers for Medicare & Medicaid Services (CMS) to make significant changes in how the Protecting Access to Medicare Act (PAMA) regulations would be implemented in the coming year—changes that echo demands being made by the laboratory sector as a whole.

CMS issued proposed regulations for the implementation of PAMA in the second half of last year, and the laboratory sector vigorously lobbied to make significant changes in the final regulations. The Dec. 16 letter to acting CMS Administrator Andy Slavitt presumably will keep up the pressure on the agency to relent.

Final PAMA rules were initially expected to be issued by CMS late last year, but it has yet to issue them. The agency issued proposed rules in October, and accepted more than 1,000 comments during the public comment period. CMS is legally required to finalize the rules by June 30.

The letter, which was signed by both Republican and Democratic lawmakers—many of whom receive substantial contributions from health care companies and related political action committees—noted that a "number of laboratories are prohibited from participating in the reporting process. We are deeply concerned that this prohibition will skew the market data, resulting in Medicare rates that are not reflective of true market prices."

The letter did not provide more specifics about which labs are being excluded, but the laboratory sector has expressed concern to CMS that the exclusion of hospital-based laboratories—which tend to be paid at higher rates than standalone labs—would dramatically ratchet down Medicare reimbursements. Under PAMA, laboratories receiving at least $50,000 annually in payments through the Clinical Laboratory Fee Schedule would have to submit payment data for evaluation.

The House members also asked CMS to expand its definition of an advanced diagnostic laboratory test (ADLT) to include protein biomarkers, which it said had been inexplicably excluded from the proposed regulations. Laboratory lobbies have also asked that protein biomarkers be included. "Protein-based diagnostics are being used to make clinical decisions regarding patient care today, and encouraging further development in this area is crucial," the letter said.

In addition to expressing this concern, the members of Congress also asked for more flexibility regarding the reporting deadlines for data, which under the proposed guidelines could begin as soon as this month. "The proposed timeline presents a significant challenge to the laboratory community as it provides little time to prepare, certify and submit upwards of millions of data points based on a yet-to-be released set of agency requirements," they wrote. The lab sector has also asked that deadlines for gathering and reporting data be set back, possibly into 2017.

"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," American Clinical Laboratory Association President Alan Mertz said in a statement. "This strong, bipartisan statement is in alignment with the position of clinical lab community, strongly urging CMS to delay implementation of the PAMA CLFS reforms until improvements can be made, not only to protect access to clinical laboratory services for Medicare beneficiaries, but also to ensure continued diagnostic innovation." The House Members letter is similar to one sent by 19 members of the U.S. Senate.

Takeaway: Members of Congress have been adding their voices to the concerns of the laboratory sector to CMS regarding the proposed PAMA regulations.