[Code of Federal Regulations] [Title 42, Volume 4] [Revised as of October 1, 2006] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR476.80] [Page 470] TITLE 42--PUBLIC HEALTH CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 476_UTILIZATION AND QUALITY CONTROL REVIEW--Table of Contents Subpart C_Review Responsibilities of Utilization and Quality Control Quality Improvement Organizations (QIOs) Sec. 476.80 Coordination with Medicare fiscal intermediaries and carriers. (a) Procedures for agreements. The Medicare fiscal intermediary or carrier must have a written agreement with the QIO. The QIO must take the initiative with the fiscal intermediary or carrier in developing the agreement. The following steps must be taken in developing the agreement. (1) The QIO and the fiscal intermediary or carrier must negotiate in good faith in an effort to reach written agreement. If they cannot reach agreement, CMS will assist them in resolving matters in dispute. (2) The QIO must incorporate its administrative procedures into an agreement with the fiscal intermediary or carrier and obtain approval from CMS, before it makes conclusive determinations for the Medicare program, unless CMS finds that the fiscal intermediary or carrier has-- (i) Refused to negotiate in good faith or in a timely manner, or (ii) Insisted on including in the agreement, provisions that are outside the scope of its authority under the Act. (b) Content of agreement. The agreement must include procedures for-- (1) Informing the appropriate Medicare fiscal intermediaries and carriers of-- (i) Changes as a result of DRG validations and revisions as a result of the review of these changes; and (ii) Initial denial determinations and revisions of these determinations as a result of reconsideration, or reopening all approvals and denials with respect to cases subject to preadmission review, and outlier claims in hospitals under a prospective payment system for health care services and items; (2) Exchanging data or information; (3) Modifying the procedures when additional review responsibility is authorized by CMS; and (4) Any other matters that are necessary for the coordination of functions. (c) Action by CMS. (1) Within the time specified in its contract, the QIO must submit to CMS for approval its agreement with the Medicare fiscal intermediaries and carriers, or if an agreement has not been established, the QIO's proposed administrative procedures, including any comments by the Medicare fiscal intermediaries and carriers. (2) If CMS approves the agreement or the administrative procedures (after a finding by CMS as specified in paragraph (a)(2) of this section), the QIO may begin to make determinations under its contract with CMS. (3) If CMS disapproves the agreement or procedures, it will-- (i) Notify the QIO and the appropriate fiscal agents in writing, stating the reasons for disapproval; and (ii) Require the QIO and fiscal intermediary or carrier to revise its agreements or procedures. (d) Modification of agreements. Agreements or procedures may be modified, with CMS's approval-- (1) Through a revised agreement with the fiscal intermediary or carrier, or (2) In the case of procedures, by the QIO, after providing opportunity for comment by the fiscal intermediary or carrier. (e) Role of the fiscal intermediary. (1) The fiscal intermediary will not pay any claims for those cases which are subject to preadmission review by the QIO, until it receives notice that the QIO has approved the admission after preadmission or retrospective review. (2) A QIO's determination that an admission is medically necessary is not a guarantee of payment by the fiscal intermediary. Medicare coverage requirements must also be applied. [50 FR 15330, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999]