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WASHINGTON -- Physician groups are hoping Medicare will change its mind about implementing new prior authorization requirements for two outpatient spinal procedures beginning July 1.

In a published last December announcing the implementation, officials at CMS said that, based on the data they looked at, there appeared to be "unnecessary" increases in the utilization of cervical fusion with disc removal and implanted spinal neurostimulators, and therefore prior authorization was necessary for them.

"For both services [sic] categories, we researched possible causes for the increases in volume that would indicate the services are increasingly necessary, but we did not find any explanations that would cause us to believe the increases were necessary," wrote the authors of the final rule. "CMS has not taken any action that would explain the significant increases identified. We also conducted reviews of clinical and industry-related literature and found no indication of changes that would justify the increases observed. After reviewing all available data, we found no evidence suggesting other plausible reasons for the increases, which we believe means financial motivation is the most likely cause."

For example, "we determined that claims volume for the initial level of spinal fusion of the cervical spine with removal of the corresponding intervertebral disc, CPT code 22551, had increased by 1,538.9% between 2012 and 2018, reflecting a 124.9% average annual increase, a substantially greater increase than the 2.8% average annual increase for all OPD [outpatient department] services," CMS said.

But 40 healthcare groups, including the American Academy of Family Physicians, the American College of Surgeons, the American Academy of Ophthalmology, and the American Association of Neurological Surgeons (AANS), opposed the move. "That action was taken despite evidence that Medicare Administrative Contractors were failing to process prior authorization requests within the time period mandated by the agency, and the fact, as CMS has acknowledged, that the agency has 'minimal data'" to track the success of other prior authorization rules, they wrote in an to CMS. "We continue to have serious concerns that beneficiaries will experience significant barriers to access to medically necessary procedures as a direct result of [this] policy."

Groups signing the letter say they wanted to make sure the Biden administration knew of their concerns and their wish that CMS would not impose any new prior authorization requirements, because there isn't any evidence of need for such rules.

The signatories noted that 50 House members -- including both Republicans and Democrats -- with their concerns about adding prior authorization for the two spinal procedures, which came on top of a published about a year earlier implementing prior authorization for five other procedures: blepharoplasty; botulinum toxin injections; panniculectomy; rhinoplasty; and vein ablation.

"Historically, Medicare has rarely required prior authorization for medically necessary services. It's even rarer for procedures for which there is a national coverage determination, which is the case with implanted spinal neurostimulators," the members of Congress wrote in their letter. "The limited use rightly reflects concerns about the burden placed on providers and potential barrier to beneficiary access to medically necessary procedures and equipment. That is why we are concerned that CMS is proposing to move forward with this expansion of prior authorization without the necessary guardrails to ensure beneficiary access to care is protected."

"Due to all of these concerns, we respectfully ask that CMS does not move forward with any expansion of prior authorization under OPPS [Medicare's Outpatient Prospective Payment System] until it has thoroughly examined its experiences with the five procedures that have recently established prior authorization and shared the results of this audit publicly," the letter concluded. Signers included several physician House members, such as Rep. Roger Marshall, MD (R-Kan.), who is now a senator; Ami Bera, MD (D-Calif.); Andy Harris, MD (R-Md.); and Kim Schrier, MD (D-Calif.).

CMS, which issued both of the final rules during the Trump administration, has remained mum about its plans for the prior authorization procedures. "CMS acknowledges receipt of the letter to the CMS Acting Administrator from health care organizations regarding prior authorization for certain services under the Medicare Outpatient Prospective Payment System," an agency spokesperson wrote in an email in response to a query from 乌鸦传媒. "The letter is currently under review."

In the meantime, providers say they are dealing with the fallout from the prior authorization requirements for the previous five procedures. "Our members report delayed responses from Medicare administrative contractors, incorrect denial decisions, and data transmission errors," wrote Cathy Cohen, vice president of governmental affairs for the American Academy of Ophthalmology, in an email. "The approval process has been extremely rocky, disrupting and delaying scheduled, medically necessary surgeries. As recently as today, members reported incorrect denials."

The groups also dispute the idea that there have been unnecessary increases in the use of some of these procedures. "Generally speaking, any increase in utilization is likely a result from appropriate changes in clinical practice, such as providing non-opioid pain treatment for spinal disabilities," wrote Katie Orrico, director of the AANS's Washington office, in an email.

"Frankly, given the 'Patients Over Paperwork' initiative launched by the previous administration, we are dumbfounded why the agency chose to expand prior authorization in the face of ... that the expanded use of this utilization tool is causing significant administrative burden and delays in medically necessary care -- to the detriment of patients ... In the context of the current policy related to these spine procedures -- these delays could result in patients developing worsening neurological deficits, increased narcotic use, and avoidable patient suffering," she noted.

CMS has other tools at its disposal to discourage excessive billing for particular procedures, such as imposing specific coverage criteria or conducting retrospective audits, she added. "Without a clear rationale, increased volume is not in itself a justifiable reason for imposing prior authorization -- particularly given the severe consequences to patients for delays in care."

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