Regulatory advocacy for regional sleep lab and sleep therapy equipment suppliers

In 2008 Medicare published for comment the proposed “Affiliation Rule” which would prohibit all affiliations among Medicare providers of sleep tests with the Medicare supplier of CPAP therapy. A consortium of regional sleep lab and sleep therapy equipment suppliers asked for leadership in seeking redress from the proposed to rule. We gave structure to the consortium, prepared written comments and met with the Medicare policy chiefs tasked with oversight of the proposed rule along with other leaders of the Department of Health and Human Services. When the Centers for Medicare and Medicaid Services issued the final text of the rule later that year, CMS acknowledged the value of the integrated care model used by consortium members. 73 Fed. Reg 69855 (Nov. 19, 2008). The final rule, promulgated at 42 CFR 424.57(f), modified the proposed rule to permit affiliations in many situations. These modifications permitted consortium members to maintain and expand their business sleep medicine business models.