Critical Changes to Stark II and the Federal Anti-Kickback Statute

April 28, 2010

in Health Care Now! | Blalock Walters Health Care Blog, News

By Brent T. Hoard, Esq.  

Ancillary Services Exception:

Does your practice rely on the Stark II exception and rule, in order to self-refer Medicare patients for CT, MRI, or PET scans?  If so, absent additional clarification from Congress or CMS, effective January 1, 2010 (i.e., immediately), the referring physician must inform the patient in writing at the time of the referral that the patient may obtain the imaging services from someone other than the referring physician, and provide the patient with a written list of suppliers who furnish such services in the area in which such patient resides.  That being said, there is continued debate as to the intended effective date of compliance, but we believe the conservative approach is for affected providers to provide notice.

Although this provision defies common sense, and is particularly troubling given Florida’s large population of “snowbirds” (note that the list is of suppliers in the “area in which such patient resides”), such notification is now required by law.  Attached to this newsletter is a sample Notification of Alternate Suppliers to assist with your practice’s compliance with this requirement.  With this communication now mandatory, your practice may wish to use it as an opportunity for marketing to patients.  For instance, consider adding to the notice positive statements about the practice’s dedication to patient service and positive experience.

B. Federal Anti-Kickback Statute:

Prior to the enactment of the reform, the federal Anti-Kickback Statute, codified at 42 U.S.C. § 1320a-7(b) (the “Federal AKS”), required the federal government to prove a provider’s specific intent to violate the statute before criminal penalties could be imposed.  The Federal AKS has now been amended to provide that “a person need not have actual knowledge of this section or specific intent to commit a violation of this section.”  This revision is particularly onerous because the Federal AKS is a criminal statute.  Accordingly, if your practice is involved in any business transaction that may implicate the Federal AKS (e.g., a merger, purchase, sale, lease arrangement, or physician recruitment efforts just to name a few), we strongly recommend that you seek the assistance of competent health care counsel to assist with navigating the new Federal AKS minefield.

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