(1) Whether the services are or were reasonable and medically necessary for the diagnosis and treatment of illness or injury or to improve functioning of a malformed body member, or (with respect to pneumococcal vaccine) for prevention of illness or (in the case of hospice care) for the palliation and management of terminal illness;

(2) Whether the quality of the services meets professionally recognized standards of health care, as determined through the resolution of oral beneficiary complaints as specified in § 476.110, written beneficiary complaints as specified in § 476.120, or the completion of general quality of care reviews as specified in § 476.160.

(3) Whether those services furnished or proposed to be furnished on an inpatient basis could, consistent with the provisions of appropriate medical care, be effectively furnished more economically on an outpatient basis or in an inpatient health care facility of a different type;

(4) Through DRG validation, the validity of diagnostic and procedural information supplied by the hospital;

(5) The completeness, adequacy and quality of hospital care provided;

(6) The medical necessity, reasonableness and appropriateness of hospital admissions and discharges;

(7) The medical necessity, reasonableness and appropriateness of inpatient hospital care for which additional payment is sought under the outlier provisions of §§ 412.82 and 412.84 of this chapter; and

(8) Whether a hospital has misrepresented admission or discharge information or has taken an action that results in—

(9) Hospital reclassification of a beneficiary's inpatient admission status to that of an outpatient receiving observation services when a beneficiary meets the eligibility criteria at §§ 405.1210 through 405.1212 of this chapter. Appeals of determinations are available as specified in § 405.1212 of this chapter.

(1) The QIO must review at least a random sample of hospital discharges each quarter and submit new diagnostic and procedural information to the Medicare administrative contractor, fiscal intermediary, or carrier if it determines that the information submitted by the hospital was incorrect.

(2) As directed by CMS, the QIO must review changes in DRG and LTC-DRG assignments made by the intermediary under the provisions of §§ 412.60(d) and 412.513(c) of this chapter that result in the assignment of a higher-weighted DRG or a different LTC-DRG. The QIO's review must verify that the diagnostic and procedural information supplied by the hospital is substantiated by the information in the medical record.

(1) Provide, to each health care facility scheduled to come under review, a timely written notice that specifies the date and manner in which the QIO proposes to implement review, and the information to be furnished by the facility to each Medicare beneficiary upon admission as specified in § 476.78(b)(3) of this part.

(2) Publish, in at least one local newspaper of general circulation in the QIO area, a notice that states the date the QIO will assume review responsibilities and lists each area health care facility to be under review. The QIO must indicate that its plan for the review of health care services as approved in its contract with CMS is available for public inspection in the QIO's business office and give the address, telephone number and usual hours of business.

(1) A copy of each agreement with Medicare administrative contractors, fiscal intermediaries, and carriers;

(2) A copy of its currently approved review plan that includes the QIO's method for implementing review; and

(3) Copies of all subcontracts for the conduct of review.

(1) Providers must allocate adequate space to the QIO for its conduct of review at the times the QIO is conducting review.

(2) Providers and practitioners must provide patient care data and other pertinent data to the QIO at the time the QIO is collecting review information that is required for the QIO to make its determinations. When the QIO does postadmission, preprocedure review, the provider must provide the necessary information before the procedure is performed, unless it must be performed on an emergency basis. Providers and practitioners must—

(3) Providers must inform Medicare beneficiaries at the time of admission, in writing, that the care for which Medicare payment is sought will be subject to QIO review and indicate the potential outcomes of that review. Furnishing this information to the patient does not constitute notice, under § 411.402(a) of this chapter, that can support a finding that the beneficiary knew the services were not covered.

(4) When the provider has issued a written determination in accordance with § 412.42(c)(3) of this chapter that a beneficiary no longer requires inpatient hospital care, it must submit a copy of its determination to the QIO within 3 working days.

(5) Providers must assure, in accordance with the provisions of their agreements with the QIO, that each case subject to preadmission review has been reviewed and approved by the QIO before admission to the hospital or a timely request has been made for QIO review.

(6)

(7) Hospitals must agree that, if the hospital admits a case subject to preadmission review without certification, the case must receive retrospective prepayment review, according to the review priority established by the QIO.

(1) A provider or practitioner that lacks the capability to submit requested patient records to the requesting QIO in an electronic format may request a waiver from the requirements in paragraph (c) of this section.

(2) Providers and practitioners that are not required to execute a written agreement with the QIO may request a waiver to be exempted from submitting patient records in an electronic format.

(2) A QIO may reimburse a provider or practitioner for requested patient records submitted in an electronic format, at the rate of $3.00 per patient record.

(3) For a provider or practitioner that has an approved waiver under paragraph (d) of this section, a QIO may reimburse the provider or practitioner for requested records submitted by—

(4) A QIO may only reimburse a provider or practitioner once for each patient record submitted, per request, even if a patient record is submitted using multiple formats, in fragments, or more than once in response to a single request by the QIO.

(f) Appeals. Reimbursement for the costs of submitting requested patient records to the QIO in electronic format, by facsimile or by photocopying and mailing is an additional payment to providers under the prospective payment system, as specified in §§ 412.115, 413.355, and 484.265 of this chapter. Appeals concerning these costs are subject to the review process specified in part 405, subpart R, of this chapter.

(c) Submission of patient records in electronic format. Except as specified in paragraph (d) of this section, a provider or practitioner must deliver patient records requested by a QIO for the purpose of fulfilling one or more QIO functions, in an electronic format, using the mechanism specified by the QIO. In the absence of any mechanism specified by the requesting QIO, the requested patient records must be submitted using any CMS-approved mechanism.

(1) A provider or practitioner that lacks the capability to submit requested patient records to the requesting QIO in an electronic format may request a waiver from the requirements in paragraph (c) of this section.

(2) Providers and practitioners that are not required to execute a written agreement with the QIO may request a waiver to be exempted from submitting patient records in an electronic format.

(1) For purposes of this paragraph (e), a patient record means all patient care data and other pertinent data or information relating to care or services provided to an individual patient in the possession of the provider or practitioner, as requested by a QIO for the purpose of performing one or more QIO functions.

(2) A QIO may reimburse a provider or practitioner for requested patient records submitted in an electronic format, at the rate of $3.00 per patient record.

(3) For a provider or practitioner that has an approved waiver under paragraph (d) of this section, a QIO may reimburse the provider or practitioner for requested records submitted by—

(4) A QIO may only reimburse a provider or practitioner once for each patient record submitted, per request, even if a patient record is submitted using multiple formats, in fragments, or more than once in response to a single request by the QIO.

(1) The QIO and the Medicare administrative contractor, 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 Medicare administrative contractor, fiscal intermediary, or carrier and obtain approval from CMS, before it makes conclusive determinations for the Medicare program, unless CMS finds that the Medicare administrative contractor, fiscal intermediary, or carrier has—

(1) Informing the appropriate Medicare administrative contractors, fiscal intermediaries, and carriers of—

(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.

(1) Within the time specified in its contract, the QIO must submit to CMS for approval its agreement with the Medicare administrative contractors, fiscal intermediaries, and carriers, or if an agreement has not been established, the QIO's proposed administrative procedures, including any comments by the Medicare administrative contractors, 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—

(1) Through a revised agreement with the Medicare administrative contractor, fiscal intermediary, or carrier, or

(2) In the case of procedures, by the QIO, after providing opportunity for comment by the Medicare administrative contractor, fiscal intermediary, or carrier.

(1) The Medicare administrative contractor or 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 Medicare administrative contractor or fiscal intermediary. Medicare coverage requirements must also be applied.