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.

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