Beginning Jan. 1, 2011, a physician who refers a patient for MRI, CT, or PET scans offered by the physician’s practice under the in-office ancillary exception to the Stark Law must provide notice to the patient of alternative area suppliers for the imaging services. The notices are mandated by the Patient Protection and Affordable Care Act (PPACA) and follow rules promulgated by the Centers for Medicare & Medicaid Services (CMS).

This month, physician practices that bill for MRI, CT, and PET scans should be (1) determining whether they offer these imaging services pursuant to the Stark Law in-office ancillary exception and, if so, (2) developing procedures and forms to make the appropriate disclosures to their patients, beginning Jan. 1. A failure to make appropriate disclosure can lead to a violation of the federal Stark Law and, with that, the potential for significant legal and financial risk.

Specific disclosure requirements

When:

  • The written disclosure must be made to the patient by the referring physician at the time of referral for each imaging service.  

Content:

  • No specific form is required by CMS.
  • Notification to the patient that he or she may obtain the imaging service somewhere other than from the physician.
  • A list of suppliers (MRI, CT, and PET) within a 25-mile radius of the physician’s office location. The number of suppliers listed must be at least five, except where fewer than five exist within that geographic range. Physicians may add to this list (but not substitute other suppliers) by including providers, such as nearby hospitals. If no alternative suppliers exist within the 25-mile radius, a physician must still disclose to the patient that he or she may receive the service elsewhere.
  • The name, address, and phone number of each supplier must be listed. CMS advises physicians to annually update the list of alternative suppliers to make sure it is reasonably current and accurate.  

Style:

  • The disclosure notice should be written in a manner sufficient to be “reasonably understood by all patients[.]”  

Documentation:

  • Although physicians need not obtain the patient’s signature on the written disclosure form, they must be able to demonstrate compliance with the disclosure rule. If a signature is not obtained, physicians should carefully consider what evidence they can present to CMS to prove that notice was given for a particular referral. If a signature is not obtained, one approach might be to include a checklist in the medical record, along with the disclosure form, where the physician checks a box indicating that the disclosure form was given to the patient at the time of the referral.

CMS’s final rules were published on Nov. 29, 2010, and can be found at 75 Fed. Reg. at 73586-7, 73616 (Nov. 29, 2010).