For the fifth time since March 30, the AAFP has appealed to CMS Administrator Seema Verma, M.P.H., to rethink the agency's planned revision of the Medicare payment methodology for certain clinical diagnostic lab tests paid under the clinical laboratory fee schedule (CLFS).
The lab payment issue is directly related to passage of the the Protecting Access to Medicare Act of 2014 (PAMA).
In an Oct. 19 letter(2 page PDF) signed by AAFP Board Chair John Meigs, M.D., of Centerville, Ala., the Academy pointed out that according to the agency's own estimates, the use of private payer rate-based CLFS payment amounts beginning Jan. 1, 2018, will "slash CLFS payment rates by about $670 million in 2018."
Cuts of this severity would be a significant blow to primary care practices already operating on slim financial margins, said the AAFP.
In fact, these cuts, approaching 10 percent annually across the board for the next three years, "threaten to shutter physician office-based laboratories (POLs), which provide essential and rapid point-of-care testing to their patients," said the letter.
To prove the point, the AAFP included in the letter real stories that have been relayed to the Academy by family physicians. The first, from a member in rural North Carolina, told of a new patient who presented on a Friday afternoon, seemingly healthy but complaining of black stools. The physician reported no physical findings other than the patient being pale and slightly tachycardic.
However, "His point-of-care testing revealed his hemoglobin to be 4.1, which means he had lost two-thirds of his blood volume. Without this point-of-care test within my POL, he would have gone through the weekend with an actively bleeding peptic ulcer and probably would have died," said the physician quoted in the letter.
The letter also quoted a family physician in rural Kansas who related an encounter with a 16-year old patient who presented with fatigue. The physician used point-of-care testing in his office lab.
"I quickly found out her hemoglobin was 7 and appropriately sent her to the emergency department. Without this testing, the patient likely would have been sent home, with potentially disastrous consequences."
The AAFP charged that CMS is basing the payment cuts on flawed data, because the agency issued its final CLFS regulation based on a data collection period of Jan. 1 to June 30, 2016 -- meaning that all but one week of data was collected before the final rule was even issued on June 23, 2016.
Further, "the data collected by CMS is based on large laboratory corporations, which does not accurately translate to smaller or rural POLs," said the letter.
The Academy urged CMS to extend the data reporting period deadline to March 30, 2018, and to "conduct market segment surveys" to include reference labs, POLs, independent labs and hospital community labs.
The AAFP predicted "pronounced" patient consequences if the $670 million cut is implemented and called on CMS to
- issue an interim final rule to modify existing regulation and conduct the market segment surveys described above;
- allow pricing to proceed as planed on Jan. 1, 2018, based on the existing rule but only for sole-source clinical tests and any additional clinical tests for which factors "establish high data integrity and transparency of private payer payment calculation"; and
- delay pricing changes for all other clinical tests until the market segment surveys are complete.
The AAFP reminded CMS that "relief from overly burdensome regulation" is a top priority of the Trump administration and that proper implementation of PAMA could further those efforts.