Title 42

Volume 5 CHAPTER IV SUBCHAP H

Subchapter H - Health Care Infrastructure And Model Programs

42:5.0.1.2.13	PART 505	PART 505 - ESTABLISHMENT OF THE HEALTH CARE INFRASTRUCTURE IMPROVEMENT PROGRAM
42:5.0.1.2.13.1	SUBPART A	Subpart A - Loan Criteria
42:5.0.1.2.13.1.41.1	SECTION 505.1	505.1 Basis and scope.
42:5.0.1.2.13.1.41.2	SECTION 505.3	505.3 Definitions.
42:5.0.1.2.13.1.41.3	SECTION 505.5	505.5 Loan criteria.
42:5.0.1.2.13.1.41.4	SECTION 505.7	505.7 Terms of the loan.
42:5.0.1.2.13.1.41.5	SECTION 505.9	505.9 State and local permits.
42:5.0.1.2.13.1.41.6	SECTION 505.11	505.11 Loan application requirements and procedures.
42:5.0.1.2.13.2	SUBPART B	Subpart B - Forgiveness of Indebtedness
42:5.0.1.2.13.2.41.1	SECTION 505.13	505.13 Conditions for loan forgiveness.
42:5.0.1.2.13.2.41.2	SECTION 505.15	505.15 Plan criteria for meeting the conditions for loan forgiveness.
42:5.0.1.2.13.2.41.3	SECTION 505.17	505.17 Reporting requirements for meeting the conditions for loan forgiveness.
42:5.0.1.2.13.2.41.4	SECTION 505.19	505.19 Approval or denial of loan forgiveness.
42:5.0.1.2.14	PART 510	PART 510 - COMPREHENSIVE CARE FOR JOINT REPLACEMENT MODEL
42:5.0.1.2.14.1	SUBPART A	Subpart A - General Provisions
42:5.0.1.2.14.1.41.1	SECTION 510.1	510.1 Basis and scope.
42:5.0.1.2.14.1.41.2	SECTION 510.2	510.2 Definitions.
42:5.0.1.2.14.2	SUBPART B	Subpart B - Comprehensive Care for Joint Replacement Program Participants
42:5.0.1.2.14.2.41.1	SECTION 510.100	510.100 Episodes being tested.
42:5.0.1.2.14.2.41.2	SECTION 510.105	510.105 Geographic areas.
42:5.0.1.2.14.2.41.3	SECTION 510.110	510.110 Access to records and retention.
42:5.0.1.2.14.2.41.4	SECTION 510.115	510.115 Voluntary participation election.
42:5.0.1.2.14.2.41.5	SECTION 510.120	510.120 CJR participant hospital CEHRT track requirements.
42:5.0.1.2.14.3	SUBPART C	Subpart C - Scope of Episodes
42:5.0.1.2.14.3.41.1	SECTION 510.200	510.200 Time periods, included and excluded services, and attribution.
42:5.0.1.2.14.3.41.2	SECTION 510.205	510.205 Beneficiary inclusion criteria.
42:5.0.1.2.14.3.41.3	SECTION 510.210	510.210 Determination of the episode.
42:5.0.1.2.14.4	SUBPART D	Subpart D - Pricing and Payment
42:5.0.1.2.14.4.41.1	SECTION 510.300	510.300 Determination of episode quality-adjusted target prices.
42:5.0.1.2.14.4.41.2	SECTION 510.305	510.305 Determination of the NPRA and reconciliation process.
42:5.0.1.2.14.4.41.3	SECTION 510.310	510.310 Appeals process.
42:5.0.1.2.14.4.41.4	SECTION 510.315	510.315 Composite quality scores for determining reconciliation payment eligibility and quality incentive payments.
42:5.0.1.2.14.4.41.5	SECTION 510.320	510.320 Treatment of incentive programs or add-on payments under existing Medicare payment systems.
42:5.0.1.2.14.4.41.6	SECTION 510.325	510.325 Allocation of payments for services that straddle the episode.
42:5.0.1.2.14.5	SUBPART E	Subpart E - Quality Measures, Beneficiary Protections, and Compliance Enforcement
42:5.0.1.2.14.5.41.1	SECTION 510.400	510.400 Quality measures and reporting.
42:5.0.1.2.14.5.41.2	SECTION 510.405	510.405 Beneficiary choice and beneficiary notification.
42:5.0.1.2.14.5.41.3	SECTION 510.410	510.410 Compliance enforcement.
42:5.0.1.2.14.6	SUBPART F	Subpart F - Financial Arrangements and Beneficiary Incentives
42:5.0.1.2.14.6.41.1	SECTION 510.500	510.500 Sharing arrangements under the CJR model.
42:5.0.1.2.14.6.41.2	SECTION 510.505	510.505 Distribution arrangements.
42:5.0.1.2.14.6.41.3	SECTION 510.506	510.506 Downstream distribution arrangements.
42:5.0.1.2.14.6.41.4	SECTION 510.510	510.510 Enforcement authority.
42:5.0.1.2.14.6.41.5	SECTION 510.515	510.515 Beneficiary incentives under the CJR model.
42:5.0.1.2.14.7	SUBPART G	Subpart G - Waivers
42:5.0.1.2.14.7.41.1	SECTION 510.600	510.600 Waiver of direct supervision requirement for certain post-discharge home visits.
42:5.0.1.2.14.7.41.2	SECTION 510.605	510.605 Waiver of certain telehealth requirements.
42:5.0.1.2.14.7.41.3	SECTION 510.610	510.610 Waiver of SNF 3-day rule.
42:5.0.1.2.14.7.41.4	SECTION 510.615	510.615 Waiver of certain post-operative billing restrictions.
42:5.0.1.2.14.7.41.5	SECTION 510.620	510.620 Waiver of deductible and coinsurance that otherwise apply to reconciliation payments or repayments.
42:5.0.1.2.14.8	SUBPART H	Subparts H-J [Reserved]
42:5.0.1.2.14.9	SUBPART K	Subpart K - Model Termination
42:5.0.1.2.14.9.41.1	SECTION 510.900	510.900 Termination of the CJR model.
42:5.0.1.2.15	PART 512	PART 512 - RADIATION ONCOLOGY MODEL AND END STAGE RENAL DISEASE TREATMENT CHOICES MODEL
42:5.0.1.2.15.1	SUBPART A	Subpart A - General Provisions Related to Innovation Center Models
42:5.0.1.2.15.1.55.1	SECTION 512.100	512.100 Basis and scope.
42:5.0.1.2.15.1.55.2	SECTION 512.110	512.110 Definitions.
42:5.0.1.2.15.1.55.3	SECTION 512.120	512.120 Beneficiary protections.
42:5.0.1.2.15.1.55.4	SECTION 512.130	512.130 Cooperation in model evaluation and monitoring.
42:5.0.1.2.15.1.55.5	SECTION 512.135	512.135 Audits and record retention.
42:5.0.1.2.15.1.55.6	SECTION 512.140	512.140 Rights in data and intellectual property.
42:5.0.1.2.15.1.55.7	SECTION 512.150	512.150 Monitoring and compliance.
42:5.0.1.2.15.1.55.8	SECTION 512.160	512.160 Remedial action.
42:5.0.1.2.15.1.55.9	SECTION 512.165	512.165 Innovation center model termination by CMS.
42:5.0.1.2.15.1.55.10	SECTION 512.170	512.170 Limitations on review.
42:5.0.1.2.15.1.55.11	SECTION 512.180	512.180 Miscellaneous provisions on bankruptcy and other notifications.
42:5.0.1.2.15.2	SUBPART B	Subpart B - Radiation Oncology Model
42:5.0.1.2.15.2.55	SUBJGRP 55	General
42:5.0.1.2.15.2.55.1	SECTION 512.200	512.200 Basis and scope of subpart.
42:5.0.1.2.15.2.55.2	SECTION 512.205	512.205 Definitions.
42:5.0.1.2.15.2.56	SUBJGRP 56	RO Model Participation
42:5.0.1.2.15.2.56.3	SECTION 512.210	512.210 RO participants and geographic areas.
42:5.0.1.2.15.2.56.4	SECTION 512.215	512.215 Beneficiary population.
42:5.0.1.2.15.2.56.5	SECTION 512.217	512.217 Identification of individual practitioners.
42:5.0.1.2.15.2.56.6	SECTION 512.220	512.220 RO participant compliance with RO Model requirements.
42:5.0.1.2.15.2.56.7	SECTION 512.225	512.225 Beneficiary notification.
42:5.0.1.2.15.2.57	SUBJGRP 57	Scope of RO Episodes Being Tested
42:5.0.1.2.15.2.57.8	SECTION 512.230	512.230 Criteria for determining cancer types.
42:5.0.1.2.15.2.57.9	SECTION 512.235	512.235 Included RT services.
42:5.0.1.2.15.2.57.10	SECTION 512.240	512.240 Included modalities.
42:5.0.1.2.15.2.57.11	SECTION 512.245	512.245 Included RO episodes.
42:5.0.1.2.15.2.58	SUBJGRP 58	Pricing Methodology
42:5.0.1.2.15.2.58.12	SECTION 512.250	512.250 Determination of national base rates.
42:5.0.1.2.15.2.58.13	SECTION 512.255	512.255 Determination of participant-specific professional episode payment and participant-specific technical episode payment amounts.
42:5.0.1.2.15.2.59	SUBJGRP 59	Billing and Payment
42:5.0.1.2.15.2.59.14	SECTION 512.260	512.260 Billing.
42:5.0.1.2.15.2.59.15	SECTION 512.265	512.265 Payment.
42:5.0.1.2.15.2.59.16	SECTION 512.270	512.270 Treatment of add-on payments under existing Medicare payment systems.
42:5.0.1.2.15.2.60	SUBJGRP 60	Data Reporting
42:5.0.1.2.15.2.60.17	SECTION 512.275	512.275 Quality measures, clinical data, and reporting.
42:5.0.1.2.15.2.61	SUBJGRP 61	Medicare Program Waivers
42:5.0.1.2.15.2.61.18	SECTION 512.280	512.280 RO Model Medicare program waivers.
42:5.0.1.2.15.2.62	SUBJGRP 62	Reconciliation and Review Process
42:5.0.1.2.15.2.62.19	SECTION 512.285	512.285 Reconciliation process.
42:5.0.1.2.15.2.62.20	SECTION 512.290	512.290 Timely error notice and reconsideration review process.
42:5.0.1.2.15.3	SUBPART C	Subpart C - ESRD Treatment Choices Model
42:5.0.1.2.15.3.63	SUBJGRP 63	General
42:5.0.1.2.15.3.63.1	SECTION 512.300	512.300 Basis and scope.
42:5.0.1.2.15.3.63.2	SECTION 512.310	512.310 Definitions.
42:5.0.1.2.15.3.64	SUBJGRP 64	ESRD Treatment Choices Model Scope and Participants
42:5.0.1.2.15.3.64.3	SECTION 512.320	512.320 Duration.
42:5.0.1.2.15.3.64.4	SECTION 512.325	512.325 Participant selection and geographic areas.
42:5.0.1.2.15.3.64.5	SECTION 512.330	512.330 Beneficiary notification.
42:5.0.1.2.15.3.65	SUBJGRP 65	Home Dialysis Payment Adjustment
42:5.0.1.2.15.3.65.6	SECTION 512.340	512.340 Payments subject to the Facility HDPA.
42:5.0.1.2.15.3.65.7	SECTION 512.345	512.345 Payments subject to the Clinician HDPA.
42:5.0.1.2.15.3.65.8	SECTION 512.350	512.350 Schedule of home dialysis payment adjustments.
42:5.0.1.2.15.3.66	SUBJGRP 66	Performance Payment Adjustment
42:5.0.1.2.15.3.66.9	SECTION 512.355	512.355 Schedule of performance assessment and performance payment adjustment.
42:5.0.1.2.15.3.66.10	SECTION 512.360	512.360 Beneficiary population and attribution.
42:5.0.1.2.15.3.66.11	SECTION 512.365	512.365 Performance assessment.
42:5.0.1.2.15.3.66.12	SECTION 512.370	512.370 Benchmarking and scoring.
42:5.0.1.2.15.3.66.13	SECTION 512.375	512.375 Payments subject to adjustment.
42:5.0.1.2.15.3.66.14	SECTION 512.380	512.380 PPA Amounts and schedules.
42:5.0.1.2.15.3.66.15	SECTION 512.385	512.385 PPA exclusions.
42:5.0.1.2.15.3.66.16	SECTION 512.390	512.390 Notification and targeted review.
42:5.0.1.2.15.3.67	SUBJGRP 67	Quality Monitoring
42:5.0.1.2.15.3.67.17	SECTION 512.395	512.395 Quality measures.
42:5.0.1.2.15.3.68	SUBJGRP 68	Medicare Program Waivers
42:5.0.1.2.15.3.68.18	SECTION 512.397	512.397 ETC Model Medicare program waivers.
42:5.0.1.2.16	PART 513	PART 513 - MOST FAVORED NATION (MFN) MODEL
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.

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