Title 42

PART 513

Part 513 - Most Favored Nation (mfn) Model

PART 513 - MOST FAVORED NATION (MFN) MODEL Authority:42 U.S.C. 1302, 1315(a), and 1395hh. Source:85 FR 76250, Nov. 27, 2010, unless otherwise noted.

• Authority: 42 U.S.C. 1302, 1315(a), and 1395hh.
• Source: 85 FR 76250, Nov. 27, 2010, unless otherwise noted.

42:5.0.1.2.16.1	SUBPART A	Subpart A - General Provisions
42:5.0.1.2.16.1.69.1	SECTION 513.1	513.1 Basis, scope, and duration.
42:5.0.1.2.16.1.69.2	SECTION 513.2	513.2 Definitions.
42:5.0.1.2.16.2	SUBPART B	Subpart B - Inclusion in the Model
42:5.0.1.2.16.2.69.1	SECTION 513.100	513.100 MFN Model payments and MFN participants.
42:5.0.1.2.16.2.69.2	SECTION 513.120	513.120 MFN Model geographic area.
42:5.0.1.2.16.2.69.3	SECTION 513.130	513.130 MFN Model drugs, updates, categories and excluded drugs.
42:5.0.1.2.16.2.69.4	SECTION 513.140	513.140 Included international data.
42:5.0.1.2.16.3	SUBPART C	Subpart C - Payment Process and Methodology
42:5.0.1.2.16.3.69.1	SECTION 513.200	513.200 Payment process and beneficiary cost-sharing.
42:5.0.1.2.16.3.69.2	SECTION 513.210	513.210 Model payment methodology for MFN Model drugs.
42:5.0.1.2.16.3.69.3	SECTION 513.220	513.220 Model alternative add-on payment.
42:5.0.1.2.16.3.69.4	SECTION 513.230	513.230 Financial hardship exemptions, request process, and reconciliation payment.
42:5.0.1.2.16.4	SUBPART D	Subpart D [Reserved]
42:5.0.1.2.16.5	SUBPART E	Subpart E - Quality Strategy, Beneficiary Protections, and Compliance Activities
42:5.0.1.2.16.5.69.1	SECTION 513.400	513.400 Quality measures.
42:5.0.1.2.16.5.69.2	SECTION 513.410	513.410 Beneficiary protections.
42:5.0.1.2.16.5.69.3	SECTION 513.420	513.420 Monitoring and compliance activities.
42:5.0.1.2.16.5.69.4	SECTION 513.430	513.430 Audits and record retention.
42:5.0.1.2.16.5.69.5	SECTION 513.440	513.440 Enforcement authority.
42:5.0.1.2.16.5.69.6	SECTION 513.450	513.450 Limitations on review.
42:5.0.1.2.16.6	SUBPART F	Subpart F - Waivers
42:5.0.1.2.16.6.69.1	SECTION 513.500	513.500 Waivers of Medicare program requirements for purposes of testing the MFN Model.
42:5.0.1.2.16.7	SUBPART G	Subparts G through J [Reserved]
42:5.0.1.2.16.8	SUBPART K	Subpart K - Model Termination
42:5.0.1.2.16.8.69.1	SECTION 513.1000	513.1000 Termination of the MFN Model.

---