Orforglipron OSA in JAMA / OIG Flags MA DME Gaps / AADSM Presses FDA on Mail-Order Oral Appliances

Good morning. This is Heartstrong Sleep Daily — your briefing on sleep medicine news, DME industry updates, and clinical research. Here's what's new today. First, clinical research. JAMA has published the ATTAIN-OSA program, two randomized trials of Eli Lilly's oral GLP-1 agonist orforglipron in adults with moderate-to-severe obstructive sleep apnea and obesity or overweight. In the first trial, the treatment-regimen analysis showed a mean AHI reduction of 17.8 events per hour on orforglipron, versus 4.5 on placebo, a between-group difference of 13.2 at 52 weeks. The PAP angle matters for DME providers. In the trial enrolling participants already on positive airway pressure, 19.6 percent on orforglipron reached remission or mild disease, compared with 31.5 percent in the non-PAP trial. Lilly says it plans to submit to the FDA for this indication by the end of 2026. Second, DME industry. The HHS Office of Inspector General has released a report finding gaps in how Medicare Advantage organizations and CMS screen DME suppliers for fraud. According to the report, out-of-network suppliers that aren't enrolled in Medicare receive the least screening, and carry the highest fraud risk. OIG notes limits in the CMS Preclusion List, and recommends that CMS require stronger checks, and require all DMEPOS suppliers billing Medicare Advantage to enroll in Medicare, or seek statutory authority to do so. For CPAP suppliers, that points toward more verification scrutiny on plan networks. Third, sleep medicine news. The American Academy of Dental Sleep Medicine has sent a letter to the FDA urging consumer protections for oral appliances used for snoring and sleep apnea. As reported by Dentistry IQ, the Academy is raising concerns about direct-to-consumer and mail-order devices, citing faulty products and potential patient harm. It asks the FDA to publish a dedicated web page warning consumers, and to emphasize prescription-based, professionally supervised care. For sleep physicians and referral partners, it's a signal that oversight of the oral appliance channel is getting attention. That's your Heartstrong Sleep Daily briefing. For patient care solutions and DME support, contact Heartstrong Sleep at 877-815-7300 or heartstrongsleep.com. We'll see you tomorrow.