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CAP Calls for LCD Transparency Legislation to Prevent 'Rubber Stamping'


NEW YORK (360Dx) – The College of American Pathologists is calling for legislators to retain language in a local coverage determination transparency bill that would prevent coverage determinations from being "rubber stamped" by other jurisdictions.

CAP and dozens of state pathology associations are among the 100 medical groups supporting the Local Coverage Determination Clarification Act aimed at increasing transparency in the LCD process. LCDs are policies issued by Medicare administrative contractors establishing whether Medicare will cover specific medical devices, lab tests, or services in a specific jurisdiction.

The LCD Clarification Act is intended to address medical community concerns that the current LCD process is secretive, and provides insufficient insight into how coverage decisions are made. But the version of the LCD Clarification Act passed in the House of Representatives last week (H.R. 3635) eliminated language requiring Medicare administrative contractors (MAC) to make independent assessments and solicit comments from members of the local medical community before adopting a different jurisdiction's coverage determination. The rule, which was intended to prevent a local decision from expanding across the country without proper review, is considered critical by CAP.

"We are disappointed that the committee, at the request of the Centers for Medicare & Medicaid Services, has removed one of the bill's cornerstone provisions to stop Medicare contractors from rubberstamping coverage decisions and using the LCD program to circumvent the more rigorous requirements of the National Coverage Determination process," CAP President R. Bruce Williams, said in a statement following the House Ways and Means Committee's markup of the legislation.

The NCD process is much more transparent by law than the current LCD process, said Donald Karcher chair of the pathology department and director of laboratories at George Washington University Medical School, and chair of the CAP committee of government and professional affairs. But there are several LCDs that have been rolled out in more than one jurisdiction through the process that CAP refers to as rubber stamping, and one LCD has now been rolled out to 29 states, he said.

"That is more than half the states in the US. That's a national coverage determination, yet it has never been through that very transparent NCD process," Karcher said.

A senate version of the bill, S. 794, has been referred to the Senate Finance Committee but has not yet been debated in committee. CAP has been communicating with sponsors of that bill to stress the importance of the provision that was removed from the House bill, according to Karcher.

"The LCD process should not lead to a de facto NCD, so we are hopeful that the Senate will hold onto the original language," he said.

The House Ways and Means Committee removed the provision requiring MACs to independently review another MAC's evidence before making an LCD at the request of CMS and some legislators out of concern that it could slow the process, according to a CAP spokesperson. CMS declined to comment on pending legislation.

The bills introduced in both the House and the Senate last year by Rep. Lynn Jenkins (R-Kan.) and Sen. Johnny Isakson (R-Ga.) respectively, are aimed at bringing clarity to a process that pathologists and other medical groups have long criticized for being secretive and flawed.

"Medicare administrative contractors are responsible for decisions that impact millions of Medicare beneficiaries, determining which technologies, procedures, and services are available to them. Unfortunately, the local coverage determination process MACs use lacks transparency and does not provide meaningful opportunity for stakeholder input or appeals," said Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker in a statement after the House Ways and Means Committee favorably reported out the legislation.

In addition to CAP and AdvaMed, a coalition of approximately 100 organizations are backing the legislation, including 39 state pathology associations, and dozens of other medical specialty and patient advocacy groups, according to Karcher.

Provisions that remain in the bill that passed the house would bring transparency to the LCD process by requiring the Carrier Advisory Committee meetings in which MACs make their decisions to be open, public, and on the record, with minutes taken and posted to the MAC's website for public inspection, according to a CAP issue brief. The bill would also require MACs to include, at the beginning of the process, a description of the evidence that will be taken into account when forming an LCD, as well as the rationale for denying coverage.

"If this information is not provided until the final LCD, it hinders meaningful stakeholder exchange and can make a MAC's decision to deny coverage a fait accompli," the issue brief stated.

The bill also addresses current frustration with the appeals process for non-coverage determinations, Karcher noted.

"If an LCD is flawed, and we have found that there are quite a few in our opinion that have been flawed, they become payment policy and there is almost no recourse within that jurisdiction to have that reversed," he said. "The legislation would lead to an appropriate appeal process so that if the decision still appears incorrect or inappropriate, then there would be a more meaningful appeals process that would involve more than just the original MAC making that decision."

Specifically, HR 3635 gives providers and suppliers an opportunity to have a qualified third party make a decision about the validity of their reconsideration requests in limited circumstances. It also would not prevent an "eligible aggrieved party" from working through an administrative law judge to appeal a decision, according to CAP's issue brief.

It is unclear when the Senate will take up its version of bill, but CAP continues to stress the importance of restoring the so-called rubber-stamping provision in the bill in its final form.

"The rubber-stamping provision we feel very strongly needs to be added back. We really feel that protects the process," Karcher said. "Without it, we worry that flawed LCDs will prevent pathologists and other physicians from using our clinical judgement and being able to perform needed services for patients. If [the legislation] stays largely intact, we think the process would be much better for Medicare beneficiaries and for providers."