Title 42

SECTION 513.400

513.400 Quality measures.

§ 513.400 Quality measures.

(a) General. Quality measures do not adjust model payments to MFN participants and are used for monitoring purposes.

(b) Collection of quality measures. (1) CMS administers a patient experience survey to a sample of beneficiaries who receive an MFN Model drug. A sample of non-MFN beneficiaries may also be surveyed.

(2) If during the MFN Model CMS determines that the quality measures specified in paragraph (b) of this section are not sufficient to adequately monitor the quality of care that MFN beneficiaries are receiving from MFN participants or that MFN participants are providing, CMS may specify additional measures. CMS applies the following criteria when specifying additional quality measures:

(i) Additional measures are among one or more of the following categories:

(A) Patient experience of care.

(B) Patient activation

(C) Shared decision making.

(D) Adherence.

(E) Utilization.

(F) Process measures.

(ii) Additional measures will not add significant burden to MFN participants or beneficiaries.

(iii) Additional measures utilize an instrument that CMS has used previously in a model to adjust payment or for monitoring or evaluation.

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