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 2005_register executive 2010-09-23 article Part II Rules and Regulations D09002ee1c8120e99 D09002ee1c8120ffd 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 final rule implements the provisions of the Social Security Act (the Act) establishing and regulating the Medicare Prescription Drug Benefit. The new voluntary prescription drug benefit program was enacted into law on December 8, 2003 in section 101 of Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). Although this final rule specifies most of the requirements for implementing the new prescription drug program, readers should note that we are also issuing a closely related rule that concerns Medicare Advantage organizations, which, if they offer coordinated care plans, must offer at least one plan that combines medical coverage under Parts A and B with prescription drug coverage. Readers should also note that separate CMS guidance on many operational details appears or will soon appear on the CMS website, such as materials on formulary review criteria, risk plan and fallback plan solicitations, bid instructions, solvency standards and pricing tools, plan benefit packages. The addition of a prescription drug benefit to Medicare represents a landmark change to the Medicare program that will significantly improve the health care coverage available to millions of Medicare beneficiaries. The MMA specifies that the prescription drug benefit program will become available to beneficiaries beginning on January 1, 2006. Generally, coverage for the prescription drug benefit will be provided under private prescription drug plans (PDPs), which will offer only prescription drug coverage, or through Medicare Advantage prescription drug plans (MA PDs), which will offer prescription drug coverage that is integrated with the health care coverage they provide to Medicare beneficiaries under Part C of Medicare. PDPs must offer a basic prescription drug benefit. MA-PDs must offer either a basic benefit or broader coverage for no additional cost. If this required level of coverage is offered, MA-PDs or PDPs, but not fallback PDPs may also offer supplemental benefits through enhanced alternative coverage for an additional premium. All organizations offering drug plans will have flexibility in the design of the prescription drug benefit. Consistent with the MMA, this final rule also provides for subsidy payments to sponsors of qualified retiree prescription drug plans to encourage retention of employer-sponsored benefits. We are implementing the drug benefit in a way that permits and encourages a range of options for Medicare beneficiaries to augment the standard Medicare coverage. These options include facilitating additional coverage through employer plans, MA-PD plans and high-option PDPs, and through charity organizations and State pharmaceutical assistance programs. See sections II.C, II.J, and II.P, and II.R of this preamble for further details on these issues. The proposed rule identified options and alternatives to the provisions we proposed and we strongly encouraged comments and ideas on our approach and on alternatives to help us design the Medicare Prescription Drug Benefit Program to operate as effectively and efficiently as possible in meeting the needs of Medicare beneficiaries. 70 FR 4194 https://www.govinfo.gov/app/details/FR-2005-01-28/05-1321 05-1321 fr28ja05-21 RIN 0938-AN08 4120-01-S CMS-4068-F https://www.govinfo.gov/app/details/FR-2005-01-28/05-1321 https://www.govinfo.gov/content/pkg/FR-2005-01-28/html/05-1321.htm https://www.govinfo.gov/content/pkg/FR-2005-01-28/pdf/05-1321.pdf Kidney Diseases Medicare Reporting and Recordkeeping Requirements Administrative Practice and Procedure Grant Programs-Health Health Care Health Insurance Health Maintenance Organizations (Hmo) Loan Programs-Health 392 p. 4194 4585 70 FR 4194 Title 42 Part 400 42 CFR Part 400 Title 42 Part 403 42 CFR Part 403 Title 42 Part 411 42 CFR Part 411 Title 42 Part 417 42 CFR Part 417 Title 42 Part 423 42 CFR Part 423 RIN 0938-AN08 Medicare Program; Medicare Prescription Drug Benefit; Federal Register Vol. 70, Issue RULE 05-1321 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 2005-03-22 CMS-4068-F 4120-01-S 05-1321 Final rule.

This final rule implements the provisions of the Social Security Act (the Act) establishing and regulating the Medicare Prescription Drug Benefit. The new voluntary prescription drug benefit program was enacted into law on December 8, 2003 in section 101 of Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). Although this final rule specifies most of the requirements for implementing the new prescription drug program, readers should note that we are also issuing a closely related rule that concerns Medicare Advantage organizations, which, if they offer coordinated care plans, must offer at least one plan that combines medical coverage under Parts A and B with prescription drug coverage. Readers should also note that separate CMS guidance on many operational details appears or will soon appear on the CMS website, such as materials on formulary review criteria, risk plan and fallback plan solicitations, bid instructions, solvency standards and pricing tools, plan benefit packages. The addition of a prescription drug benefit to Medicare represents a landmark change to the Medicare program that will significantly improve the health care coverage available to millions of Medicare beneficiaries. The MMA specifies that the prescription drug benefit program will become available to beneficiaries beginning on January 1, 2006. Generally, coverage for the prescription drug benefit will be provided under private prescription drug plans (PDPs), which will offer only prescription drug coverage, or through Medicare Advantage prescription drug plans (MA PDs), which will offer prescription drug coverage that is integrated with the health care coverage they provide to Medicare beneficiaries under Part C of Medicare. PDPs must offer a basic prescription drug benefit. MA-PDs must offer either a basic benefit or broader coverage for no additional cost. If this required level of coverage is offered, MA-PDs or PDPs, but not fallback PDPs may also offer supplemental benefits through enhanced alternative coverage for an additional premium. All organizations offering drug plans will have flexibility in the design of the prescription drug benefit. Consistent with the MMA, this final rule also provides for subsidy payments to sponsors of qualified retiree prescription drug plans to encourage retention of employer-sponsored benefits. We are implementing the drug benefit in a way that permits and encourages a range of options for Medicare beneficiaries to augment the standard Medicare coverage. These options include facilitating additional coverage through employer plans, MA-PD plans and high-option PDPs, and through charity organizations and State pharmaceutical assistance programs. See sections II.C, II.J, and II.P, and II.R of this preamble for further details on these issues. The proposed rule identified options and alternatives to the provisions we proposed and we strongly encouraged comments and ideas on our approach and on alternatives to help us design the Medicare Prescription Drug Benefit Program to operate as effectively and efficiently as possible in meeting the needs of Medicare beneficiaries.

These regulations are effective on March 22, 2005. Lynn Orlosky (410) 786-9064 or Randy Brauer (410)786-1618 (for issues related to eligibility, elections, enrollment, including auto-enrollment of dual eligible beneficiaries, and creditable coverage). Kidney Diseases Medicare Reporting and Recordkeeping Requirements Administrative Practice and Procedure Grant Programs-Health Health Care Health Insurance Health Maintenance Organizations (Hmo) Loan Programs-Health Medicare and medicaid: Medicare Prescription Drug Benefit, christopher_martin@omb.eop.gov http://content.healthaffairs.org/cgi/reprint/hlthaff.w2.253v1.pdf http://hhs.gov/ocr/hipaa http://research.aarp.org/health/2004_13_rx.pdf http://www.access.gpo.gov/fr/index.html http://www.ansi.org http://www.census.gov/epcd/www/smallbus.htm#EmpSize http://www.cms.hhs.gov/medicare/cob/employers/emp_vdsa.asp http://www.cms.hhs.gov/medicarereform/mmaregions/ http://www.cms.hhs.gov/pdps/ http://www.cms.hhs.gov/pdps/default.asp http://www.cms.hhs.gov/publications/trusteesreport/ http://www.cms.hhs.gov/statistics/nhe/projections-2003/t11.asp http://www.dol.gov/ebsa/faqs/faq_claims_proc_reg.html http://www.eeoc.gov/policy/regs/retiree_benefits/ http://www.gasb.org/news/index.html http://www.kff.org http://www.medpac.gov/public_meetings/transcripts/1104_allcombined_transc.pdf http://www.usp.org/drugInformation/mmg/ www.cbo.gov www.cms.hhs.gov/pdps/riskad.zip www.cms.hhs.gov/review/default.asp www.ebri.org www.employersandmedicare.org www.fasb.org www.fasb.org/pdf/fas106.pdf www.gao.gov www.healthaffairs.org www.iom.edu www.kff.org www.medicare.gov www.mercerhr.com www.nap.edu www.sba.gov www.uschamber.com www.wsj.com Vol. 70, no. 18 Office of the Federal Register, National Archives and Records Administration 2005-01-28 continuing daily deposited born digital 750 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2005-01-28 P0b002ee18099a4ed 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28ja05 https://www.govinfo.gov/app/details/FR-2005-01-28 https://www.govinfo.gov/content/pkg/FR-2005-01-28/pdf/FR-2005-01-28.pdf https://www.govinfo.gov/content/pkg/FR-2005-01-28/xml/FR-2005-01-28.xml fdlp 4003 4741 DGPO 2010-09-23 2024-06-06 FR-2005-01-28 machine generated eng FR FR-2005-01-28 70 18