To that end, the Centers for Medicare & Medicaid Services has proposed a “master list” of prosthetic limbs that are prone to “unnecessary utilization.” Devices on the list would be subject to “prior authorization” to determine reimbursement, meaning additional documentation would be required. A final rule is expected in a few months.
Devices on the master list include CPAP devices to treat sleep apnea, power wheel chairs, and various prostheses for the foot, knee, ankle and hip, according to the proposed rule in the Federal Register. And under so-called local coverage determination guidelines, prostheses must “provide the appearance of a natural gait” and could be denied coverage if the beneficiary does not have “sufficient cardio-pulmonary capacity to effectively use the prosthesis at the determined functional level.”
In addition, The Wall Street Journal reports that private insurers could adopt Medicare’s coverage decisions, as they have done in the past. Already UnitedHealth Group has said it will no longer reimburse a prosthetic device, in line with the Medicare proposal, because the company says it doesn’t work any better than an alternative.
Opponents of the proposed changes held a rally in August 2015 outside the Washington headquarters of the Department of Health and Human Services (DHHS) to protest the potential changes, which haven’t yet been finalized. Participants included veterans, who are among the 1.6 million Americans missing limbs.
CMS cites a report by the Office of the Inspector General, which found that Medicare spent $43 million on lower-limb prostheses that didn’t meet coverage requirements, and spent $61 million over 5 years to reimburse patients for whom proof of a physician referral was lacking. Annual Medicare spending on artificial legs was $655 million in 2009, an increase of 25% over 2005, the reports says, according to The Washington Post.
“CMS believes that Medicare beneficiaries will continue to have access to lower-limb prosthetics that are appropriate, and the intent of this proposed local coverage determination is not meant to restrict any medically necessary prosthesis,” the agency told the media in a prepared statement. “We welcome comments from the public and stakeholders on how to improve the proposal so that Medicare beneficiaries are able to get the lower-limb prosthetics they need.”
The Agency’s formal public comment deadline has passed, but that doesn’t mean opponents (or proponents) can stop giving feedback through other means, including legislation. “I’ve heard from a number of constituents, along with patient groups, that have raised serious concerns regarding this proposed CMS policy,” Rep. Erik Paulsen (R-MN) said in a statement to the Minneapolis StarTribune. “I share their apprehension on what this rule would mean for patient access to prosthetic care and will be engaging with the agency to encourage them to pursue a different path.”
REFERENCE: Fierce Medical Devices; 21 SEP 2015; Varun Saxena