Three Medicare Administrative Contractors (MACs) have announced the effective release date of March 15, 2020, for their final local coverage determinations (LCD) policies covering Inspire Medical Systems Inc’s Inspire upper airway stimulation therapy for obstructive sleep apnea. In addition, the Wisconsin Physician Services (WPS) Government Health Administrators issued their draft LCD proposing coverage of Inspire therapy.
“Following the standard public comment periods and formal review meetings, we are excited to announce that the first three LCD policies will be formally issued during the first quarter,” says Tim Herbert, president and CEO of Inspire Medical Systems, in a release. “Secondly, the draft LCD from WPS will provide coverage for the remaining six states, and once issued, will signify 100% Medicare coverage across the United States for Inspire therapy.”
The effective release dates for First Coast Service Options Inc, Noridian Healthcare Solutions LLC, and Novitas Solutions Inc were announced to be March 15, 2020. First Coast covers Medicare patients in Florida. Noridian covers Medicare patients in Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, and Wyoming. Novitas covers Medicare patients in Colorado, New Mexico, Arkansas, Delaware, Louisiana, Maryland, Mississippi, New Jersey, Oklahoma, Pennsylvania, Texas, and the District of Columbia.
WPS covers Medicare patients in Indiana, Iowa, Kansas, Michigan, Missouri, and Nebraska, and their draft LCD proposing coverage of Inspire therapy was published on January 30, 2020. Inspire expects the review process will require several months prior to formal release, as with the other six MACs.
The three final LCDs, as well as the draft LCD from WPS, are consistent with the criteria for medical necessity. Specifically, the policies state that U.S. Food and Drug Administration-approved hypoglossal nerve neurostimulation is considered medically reasonable and necessary for the treatment of moderate to severe OSA when the following criteria are met:
- Beneficiary is 22 years of age or older;
- Body mass index is less than 35 kg/m2;
- A sleep study is performed within 24 months of first consultation for an Inspire implant;
- Beneficiary has predominantly obstructive events (defined as central and mixed apneas less than 25% of the total apnea-hypopnea index (AHI);
- AHI is 15 to 65 events per hour;
- Beneficiary has documentation that demonstrates CPAP failure or intolerance; and
- Absence of complete concentric collapse at the soft palate level as seen on a drug-induced sleep endoscopy procedure.
The other three additional MACs—National Government Services Inc, CGS Administrators LLC and Palmetto GBA LLC, which collectively represent 19 states—are completing their respective review processes and Inspire expects these formal release dates to be announced in the near future.