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HHS/CMS RIN: 0938-AN08 Publication ID: Fall 2004 
Title: Medicare Drug Benefit Effective Calendar Year 2006--Title I (CMS-4068-F)  
Abstract: This final rule implements title I of the Medicare Modernization Act, which establishes a new voluntary outpatient prescription drug benefit under a new Medicare part D, beginning January 1, 2006. Coverage for the drug benefit will be provided by private prescription drug plans (PDPs) that offer drug only coverage, or through Medicare Advantage plans or preferred provider plans (PPOs) that will offer prescription drug and non-drug coverage. Plans will offer a standard drug benefit but have the flexibility to vary the drug benefit within actuarial equivalency parameters. Assistance with premiums and cost sharing will be provided to eligible low-income beneficiaries. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 42 CFR 417    42 CFR 423   
Legal Authority: PL 108-173, MMA   
Legal Deadline:  None

Statement of Need: Implementation of the Medicare Prescription Drug Benefit is required by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). 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.

Summary of the Legal Basis: Section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173).

Alternatives: None.

Anticipated Costs and Benefits: The Prescription Drug benefit will have a positive impact on beneficiaries. All Medicare beneficiaries will have access to a voluntary drug benefit. A typical beneficiary--not eligible for additional low-income benefits--with no coverage today will see their total spending on drugs drop by 53 percent. In addition, it is estimated that nearly 11 million beneficiaries with limited means will participate in the low-income subsidy, receiving substantial additional help from Medicare. Beneficiaries will see lower drug costs as a result of price negotiation and coordination of health services by the prescription drug plans and Medicare Advantage plans.

Risks: Risks include not publishing the final regulation in time to allow prospective prescription drug plans (PDPs) to participate. Prospective PDPs need to apply to become a Medicare PDP and prepare bids in the spring of 2005. This is a particular concern since this is a brand new program and benefit. If plans choose not to participate due to a delay in publishing the final regulation, there is the risk of low participation in the part D program for 2006 and beneficiaries will be without the drug benefit. Because the drug benefit is the cornerstone of the MMA legislation, this is a big risk.

Timetable:
Action Date FR Cite
NPRM  08/03/2004  69 FR 46632   
NPRM Comment Period End  10/04/2004    
Notice  07/30/2004  69 FR 45822   
Final Action  01/00/2005    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal, State, Tribal 
Small Entities Affected: Businesses, Governmental Jurisdictions  Federalism: Yes 
Included in the Regulatory Plan: Yes 
Related RINs: Related to 0938-AN07 
Agency Contact:
Tracey McCutcheon
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Beneficiary Services, 7500 Security Boulevard, C4-25-02,
Baltimore, MD 21244
Phone:410 786-6715
Email: tmccutcheon@cms.hhs.gov