Bennett Bigelow & Leedom

CLIENT ALERT, July 12, 2010

CMS Seeks Public Comment on Rule Clarifying Physician Disclosure Requirements for Imaging Services

On June 25, 2010, the Centers for Medicare and Medicaid Services ("CMS") published its pre-publication version of a proposed rule clarifying the new physician disclosure requirements of Section 6003 of the Patient Protection and Affordable Care Act (P.L. 111-148). Section 6003 amended the Stark law “in-office ancillary services” exception to require a group practice that makes a referral under this exception for MRI, CT, or PET services to inform the patient in writing that the patient may obtain the same service from another supplier outside the group practice. Key aspects of the proposed rule include:

CMS clarified that the new disclosure obligations will not take effect until the effective date of a final rule (expected to be January 1, 2011). Previously, the disclosure requirement appeared to be effective on March 23, 2010, when the Act was signed into law. CMS is “not inclined” at this time to expand the disclosure requirements beyond the services mentioned in the Act (i.e., MRI, CT, and PET).
CMS is "not inclined" at this time to expand the disclosure requirements beyond the services mentioned in the Act (i.e., MRI, CT, and PET).
CMS proposes that the disclosure include at least ten alternative suppliers with each supplier’s name, address, phone number, and distance from the referring physician’s office. All of the alternative supplies must be located within a twenty-five-mile radius of the referring physician’s office.
Hospitals and critical access hospitals cannot be listed as alternative suppliers.
The patient must sign the notification form, which will be maintained in patient’s medical record as documentation that the notice was given.

Notably, the new disclosure requirement parallels existing requirements in Washington’s so-called Anti-Rebating Statute, RCW 19.68.010, which provides an exception for a physician’s financial interest in a facility that furnishes diagnostic services where “the referring practitioner affirmatively discloses to the patient in writing” the fact he or she has a financial interest and provides the patient with a list of alternative facilities, with a statement that the patient has a choice of facilities and will not be treated differently if the patient chooses one of the alternative facilities.

The proposed rule will be published in the Federal Register on July 13, 2010. Comments are due by 5 PM EST August 24, 2010, and can be sent electronically at www.regulations.gov (enter file code CMS-1503-P), or via regular mail to CMS, DHHS, Attention: CMS-1503-P, P.O. Box 8013, Baltimore, MD 21244-8013.

If you have any questions regarding this Client Alert or would like assistance with the submission of comments to CMS, please contact Renee Howard or Anne Redman at 206-622-5511.