United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2007_register executive 2010-09-22 article Part V Rules and Regulations D09002ee1c809cad2 D09002ee1c809cb9b United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Centers for Medicare & Medicaid Services originator org United States Government Agency or Subagency This rule with comment period finalizes the Medicare program provisions relating to contract determinations involving Medicare Advantage (MA) organizations and Medicare Part D prescription drug plan sponsors, including eliminating the reconsideration process for review of contract determinations, revising the provisions related to appeals of contract determinations, and clarifying the process for MA organizations and Part D plan sponsors to complete corrective action plans. In this final rule with comment period, we also clarify the intermediate sanction and civil money penalty (CMP) provisions that apply to MA organizations and Medicare Part D prescription drug plan sponsors, modify elements of their compliance plans, retain voluntary self-reporting for Part D sponsors and implement a voluntary self- reporting recommendation for MA organizations, and revise provisions to ensure HHS has access to the books and records of MA organizations and Part D plan sponsors' first tier, downstream, and related entities. Although we have decided not to finalize the mandatory self-reporting provisions that we proposed, CMS remains committed to adopting a mandatory self-reporting requirement. To that end, we are requesting comments that will assist CMS in crafting a future proposed regulation for a mandatory self-reporting requirement. 72 FR 68700 https://www.govinfo.gov/app/details/FR-2007-12-05/07-5946 07-5946 fr05de07-22 RIN 0938-AO78 4120-01-P CMS-4124-FC https://www.govinfo.gov/app/details/FR-2007-12-05/07-5946 https://www.govinfo.gov/content/pkg/FR-2007-12-05/html/07-5946.htm https://www.govinfo.gov/content/pkg/FR-2007-12-05/pdf/07-5946.pdf Administrative Practice and Procedure Grant Programs-Health Health Care Health Insurance Health Maintenance Organizations (Hmo) Loan Programs-Health Medicare Reporting and Recordkeeping Requirements Emergency Medical Services Health Facilities Penalties Privacy Reporting and Recordkeeping 42 p. 68700 68741 72 FR 68700 Title 42 Part 422 42 CFR Part 422 Title 42 Part 423 42 CFR Part 423 RIN 0938-AO78 Medicare Program; Revisions to the Medicare Advantage and Part D Prescription Drug Contract Determinations, Appeals, and Intermediate Sanctions Processes; Federal Register Vol. 72, Issue RULE 07-5946 V DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 2008-01-04 CMS-4124-FC 4120-01-P 07-5946 Final rule with comment period.

This rule with comment period finalizes the Medicare program provisions relating to contract determinations involving Medicare Advantage (MA) organizations and Medicare Part D prescription drug plan sponsors, including eliminating the reconsideration process for review of contract determinations, revising the provisions related to appeals of contract determinations, and clarifying the process for MA organizations and Part D plan sponsors to complete corrective action plans. In this final rule with comment period, we also clarify the intermediate sanction and civil money penalty (CMP) provisions that apply to MA organizations and Medicare Part D prescription drug plan sponsors, modify elements of their compliance plans, retain voluntary self-reporting for Part D sponsors and implement a voluntary self- reporting recommendation for MA organizations, and revise provisions to ensure HHS has access to the books and records of MA organizations and Part D plan sponsors' first tier, downstream, and related entities. Although we have decided not to finalize the mandatory self-reporting provisions that we proposed, CMS remains committed to adopting a mandatory self-reporting requirement. To that end, we are requesting comments that will assist CMS in crafting a future proposed regulation for a mandatory self-reporting requirement.

Effective date: These regulations are effective on January 4, 2008, except for the amendments to Sec. Sec. 422.503, 422.504, 423.504, and 423.505, which are effective January 1, 2009. Christine Reinhard, (410) 786-2987. Administrative Practice and Procedure Grant Programs-Health Health Care Health Insurance Health Maintenance Organizations (Hmo) Loan Programs-Health Medicare Reporting and Recordkeeping Requirements Emergency Medical Services Health Facilities Penalties Privacy Reporting and Recordkeeping Medicare: Medicare Advantage and Part D prescription drug contract determinations, appeals, and intermediate sanctions processes; revisions, carolyn_lovett@omb.eop.gov http://www.cms.gov/PrescriptionDrugCovContra/Downloads/PDBManual_Chapter9_FWA.pdf http://www.cms.hhs.gov/eRulemaking http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/PartDReportingRequirements_CurrentYear.pdf http://www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/PDBManual_Chapter9_FWA.pdf Vol. 72, no. 233 Office of the Federal Register, National Archives and Records Administration 2007-12-05 continuing daily deposited born digital 279 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2007-12-05 P0b002ee180941321 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr05de07 https://www.govinfo.gov/app/details/FR-2007-12-05 https://www.govinfo.gov/content/pkg/FR-2007-12-05/pdf/FR-2007-12-05.pdf https://www.govinfo.gov/content/pkg/FR-2007-12-05/xml/FR-2007-12-05.xml fdlp 68471 68741 DGPO 2010-09-22 2024-06-05 FR-2007-12-05 machine generated eng FR FR-2007-12-05 72 233