Noridian’s LCD Proposal Stirs Controversy

The MAC is proposing an LCD for vertebral augmentation procedures.

The controversy over the vertebral augmentation procedures kyphoplasty and vertebroplasty continues with a just-released proposed Local Coverage Determination (LCD) from Noridian, a Medicare Administrative Contractor (MAC).

In this LCD, for which comments are now being accepted, Noridian is proposing to cover such procedures for hospitalized patients who have an acute vertebral compression fracture as confirmed by advanced imaging (CT or MRI) with severe pain, if there is a consensus among the treating team.

The number of kyphoplasties and vertebroplasties being performed has dropped recently, as large controlled trials have called into question the efficacy of these procedures, according to healthcare experts. Because of the controversy, however, the MACs recently held a Contractor Advisory Committee meeting to discuss the topic (a transcript is available online at https://tinyurl.com/y4v5hqpt).

Less than two months after this meeting, however, this new proposed LCD was released.

Noridian has a current LCD for these procedures, and the proposed LCD differs in several ways. If adopted, there will be a requirement for advanced imaging to document the compression fracture and the presence of edema. But unlike the current LCD, the proposal requires no trial of conservative measures prior to proceeding with the procedure, but simply requires the hospitalized patient to have the pain of eight or more on the visual analog scale, plus the consensus of the treating team.

“The absence of a requirement for a trial of conservative care seems baffling,” said Ronald Hirsch, MD, vice president of R1 RCM. “Perhaps it was an oversight that will be addressed in the final LCD.”          

In the proposal, Noridian does review the current literature and evidence, concluding that “the preponderance of evidence (studies, national and society guidelines, systematic reviews, multispecialty panel clinical care pathways, and Medicare claims data) favors consideration of early PVA in select patients.”

Others are not so confident. UpToDate, a nationally recognized source for evidence-based medical decisions, recommends reserving these procedures “for patients with incapacitating pain from acute and subacute fractures who are unable to taper parenteral opioids or transition to oral opioids within seven days of admission, or have intolerable side effects from opioid therapy.”

“It appeared Noridian gave great weight to a multi-specialty expert panel that published a care pathway that appears to be based more on personal opinion than an objective review of the medical literature,” Hirsch said.

Noridian is accepting comments on the proposed LCD at policydraft@noridian.com.

Programming Note:

Listen to Dr. Ronald Hirsch every Monday on Monitor Mondays, 10-10:30 a.m. EST.

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