The procedures described in this subpart constitute the only method by which any individuals or entities can obtain a binding advisory opinion on the subject of a physician's referrals, as described in Sec. 411.370. CMS has not and does not issue a binding advisory opinion on the subject matter in Sec. 411.370, in either oral or written form, except through written opinions it issues in accordance with this subpart. [69 FR 57230, Sept. 24, 2004]