On June 25, the Centers for Medicare & Medicaid Services (CMS) published a request for information (RFI) in the Federal Register about how to address any undue regulatory impact and burden of the physician self-referral law, commonly referred to as the “Stark Law”. The deadline for comments is August 24. CMS says the reason for the RFI is “To inform our efforts to assess and address the impact and burden of the physician self-referral law, including whether and, if so, how it may prevent or inhibit care coordination…”

Sleep Review magazine—which is owned by Medqor and is a sister publication of The Hearing Review—recently published an article about Stark Law reform and the possibility that CMS may soon address unnecessary burdens arising from the law. Sleep Review Editor Sree Roy writes:

Over the past year, [CMS] has discussed regulatory burden issues with the provider community. A top area of burden—identified in the 2,600-plus comments CMS received when it solicited feedback on the topic—is compliance with the Stark Law and its accompanying regulations.

Although false-starts have already occurred in Stark Law reform, the article addresses how CMS may issue a proposed regulation by the end of the year with regard to self-referrals, and how the American Academy of Sleep Medicine (AASM) is targeting some specific exemptions and the prospects for a change to the Stark Law. Specifically, for the sleep industry, patients receive their positive airway pressure (PAP) equipment from third-party durable medical equipment (DME) companies, not from prescribing clinicians, which can lead to physicians being unaware about when or if patients receive the equipment or the appropriate training to use it.

The Stark Law, which was passed by Congress in 1989, prohibits physicians from referring Medicare and Medicaid patients to services and providers in which they have a financial interest. The law was designed to fight corruption and discourage self-referrals across the medical industry which can lead to over-utilization of services and inhibition of competition—widely thought to be major drivers in high healthcare costs.

However, since its passage, the Stark Law has evolved into a complex set of regulations, which some say impede efforts to transition away from a fee-for-service to a value-based healthcare model (see HR‘s special report, Hearing and Value-based Healthcare). Even the Congress member for whom the bill is named, Fortney “Pete” Stark, has spoken out in favor of repealing the version of the bill that was ultimately passed. Instead, he endorses a return to his bill’s original intent: to punish anyone who accepts a bribe, splits commissions, or accepts a kickback in exchange for referring services.

Although Stark Laws are generally not applicable for non-physicians like audiologists or hearing aid specialists, certain anti-kickback aspects of the law do apply. Examples might include an exchange of money, office space, substantial gifts, etc, for referrals, or a fee-splitting arrangement that offers reimbursement to the referrer (also see ASHA’s “Issues in Ethics”). Additionally, many dispensing professionals are employed by ENTs or physician-affiliated groups that are affected by the law.

To read the Sleep Review article, click here.