The 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). The MMA specifies that the prescription drug benefit program will be available to beneficiaries on January 1, 2006. Coverage for the prescription drug benefit will be provided under private prescription drug plans, or through Medicare Advantage prescription drug plans. Organizations offering drug plans will have flexibility in the design of the prescription drug benefit.
While there are no program changes, this is a revised collection. Overall, the annual hour burden has decreased 28,010,378 hr (from 35,582,601 to 7,572,223 hr). The differences in the burden estimate are due to factors such as decreases in the number of Part D contracts and in the number of new Part D enrollees. Our additional experience with the program as well as data reported by the Part D sponsors have also enabled us to refine our previous estimates, resulting in a number of significant changes to the burden.
More specifically, in ?? 423.120, 423.128, 423.153, and 423.505, the decreased burden is due to decreases in the number of Part D sponsors. Other changes were based on additional program experience that permitted a refinement of our previous estimates of burden hours or number of responses. In ?? 423.32, 423.44, 423.56, 423.564, 423.568, 423.570, 423.572, and 423.578, the decreased burden occurred because of decreases in the number of people newly enrolling in Part D and in the number of Part D sponsors. Other changes to burden requirements were due to the correction of errors in previous calculations, new regulatory requirements associated with Part D IRMAA and additional experience with the program that permitted a refinement of the estimates. Finally, in ?? 423.329, 423.336, 423.343, and 423.892 the increase in burden occurred because of adjustments made to the number of sponsors included in the estimates.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.