December 2, 2012
WASHINGTON, DC – Officials at the American Board of Sleep Medicine (ABSM) hoped the Office of Inspector General (OIG) would clear the way for physicians to sell PAP devices. As outlined on page 91 of the OIG’s 92-page Semiannual Report to Congress, the request was essentially denied.
According to Jeffrey S. Baird, JD, the ABSM requested that the OIG publish a “safe harbor” to the Medicare anti-kickback statute that would allow physicians (certified by ABSM) to diagnose obstructive sleep apnea for Medicare patients—and to also sell PAP devices to patients.
“The reasoning behind the request is that allowing physicians to do this would improve the continuum (and quality) of care for OSA patients,” says Baird. “The OIG declined on the basis that safe harbors only pertain to the anti-kickback statute and not to the Stark physician self-referral statute. The ABSM request pertained to Stark, and not the anti-kickback statute.
“Stark prohibits a physician from selling most DME—including PAP devices—to a Medicare patient unless a Stark exception is met,” continues Baird. “If the ABSM desires for certified physicians to sell PAP devices to Medicare patients (diagnosed by the physicians), then the ABSM would need to seek an exception to Stark.”
As to the rationale of allowing physicians to sell PAP devices to Medicare patients (diagnosed by the physicians), Baird believes the practice could lead to abuse. “There is a risk that a physician would order a PAP device not because the patient truly needs it, but because the physician will profit from the sale of the device,” he says. “It is a ‘win’ for the DME industry that the OIG did not act on the ABSM’s request.”
For sleep laboratories, nothing changes as a result of the OIG report. “If a sleep lab is not owned by physicians, then the lab can sell PAP devices to Medicare and commercial patients,” explains Baird. “If the sleep lab is owned by physicians, then the lab can sell PAP devices to commercial patients, unless state law says otherwise. However, it cannot sell PAP devices to Medicare patients who qualify for the device at the lab.”
