Dive Brief:

• The Medical Device Manufacturers Association has joined 39 other healthcare stakeholders in voicing their strong opposition to expansion of Medicare prior authorization requirements set to go into effect July 1. 
• MDMA and a broad coalition of surgeon groups sent a letter on Wednesday to Acting CMS Director Elizabeth Richter arguing that two new service categories in the 2021 Outpatient Prospective Payment System and Ambulatory Surgical Center final rule — cervical fusion with disc removal and implanted spinal neurostimulators — will delay patient access to medically necessary procedures.
• The medtech lobby wants CMS to delay implementation of the new requirements and "outline a transparent process" for future proposals that includes stakeholder feedback, Mark Leahey, MDMA's president and CEO, said in a written statement. 

Dive Insight:

The letter is the latest in pushback by doctors and industry to various CMS proposals to add an extra layer to get treatment approved and paid for.

It also follows bipartisan correspondence from 50 U.S. lawmakers in October 2020 echoing industry concerns about the two new categories.

The congressional letter to then-CMS Administrator Seema Verma said Medicare has rarely required prior authorization for services deemed medically necessary.

"It’s even rarer for procedures for which there is a national coverage determination, which is the case with implanted spinal neurostimulators," the legislators wrote, warning that pre-approval creates a potential barrier to beneficiary access to medically necessary procedures and equipment for the treatment of pain. 

A late December letter to Verma from the International Society for the Advancement of Spine Surgery similarly opposed pre-authorization for spinal neurostimulator procedures called for in the CY 2021 OPPS/ASC final rule. ISASS said if pre-approval were to be implemented for neurostimulators it would lead to increased opioid use and negative physical and clinical outcomes for Medicare patients.

"We believe it is essential to continue to increase access to non-opioid pain treatment. Spinal cord stimulation and cervical fusion surgery are especially important alternatives to opioid prescriptions," ISASS wrote.

In addition to ISASS, signatories to Wednesday's letter to CMS include the American College of Cardiology, American Association of Neurological Surgeons, American Association of Orthopaedic Surgeons, American College of Surgeons, and American Society of Plastic Surgeons. 

CMS in its CY 2020 OPPS/ASC final rule, which went into effect in July, created a nationwide prior authorization process for five hospital outpatient department services: blepharoplasty, botulinum toxin injections, panniculectomy, rhinoplasty, and vein ablation.

While these five categories of services have cosmetic uses in addition to therapeutic indications, the April 7 letter from the coalition of 40 stakeholder groups expressed its concern that CMS decided to expand prior authorization to spinal neurostimulators and cervical fusion in the CY 2021 OPPS/ASC final rule "despite evidence that Medicare Administrative Contractors (MACs) were failing to process prior authorization requests within the time period mandated by the agency."

CMS has also acknowledged that it has "minimal data to track [the effectiveness of] this issue," according to the stakeholder letter to the agency.

In Wednesday's letter, MDMA and the other groups urged CMS to delay prior authorization requirements for the implanted spinal neurostimulators and cervical fusion with disc removal, and withhold action on any further pre-approval expansion until the agency has conducted a "thorough analysis of the impact of prior authorization for the five procedures for which it was implemented in July 2020."

The CMS analysis should include "the extent to which the MACs have been able to meet the timeframes for processing prior authorization requests" as well as "the cost and other burdens imposed upon providers and beneficiaries relative to the benefit to the Medicare program from reductions in inappropriate utilization," the letter states.