The Healthcare Reform Act Section 6003 adds an additional requirement to the Medicare in-office ancillary exception under the Stark law and regulations that requires the referring physician to inform the patient in writing that the patient may obtain the specified service (magnetic resonance imaging, computed tomography, and positron emission tomography) from a person other than the referring physician or the referring physician’s group. Although this statutory requirement went into effect on January 1, 2010, CMS stated in its July proposed regulations implementing this requirement that disclosure will only be required for services furnished after the regulation takes effect on January 1, 2011.
The proposed regulation is as follows:
42 CFR 411.355 General exceptions to the referral prohibition related to both ownership/investment and compensation.
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(b) * * *
(7) Disclosure requirement for certain imaging services.
(i) With respect to magnetic resonance imaging, computed tomography, and positron emission tomography, the referring physician shall provide written notice to the patient at the time of the referral that the patient may receive the same services from a person other than one described in paragraph (b)(1) of this section. Except as set forth in paragraph (b)(7)(ii) of this section, the written notice shall include a list of at least 10 other suppliers (as defined in Sec. 400.202 of this chapter) that provide the services for which the individual is being referred and which are located within a 25-mile radius of the referring physician’s office location at the time of the referral. The notice should be written in a manner sufficient to be reasonably understood by all patients and should include for each supplier on the list, at a minimum, the supplier’s name, address, telephone number, and distance from the referring physician’s office location. A record of the disclosure notification, signed by the patient, shall be maintained as a part of the patient’s medical record.
(ii) If there are fewer than 10 other suppliers located within a 25-mile radius of the physician’s office location at the time of the referral, the physician shall list all of the other suppliers of the imaging service that are present within a 25-mile radius of the referring physician’s office location, including up to 10 suppliers. Provision of the written list of alternate suppliers will not be required if no other suppliers provide the services for which the individual is being referred within the 25-mile radius.
The government’s commentary on this new regulation can be found here.
CMS provides a 38 page pdf on all the provisions in the Healthcare Reform Act and the status of regulations that have proposed or finalized — at least as of September 24, 2010. That pdf can be found and downloaded (including links to regulations) at