The large burden estimate increase was updated after receiving validated plan reporting data in 2011. Prior to this, CMS was using estimates of how many denial notices were being sent. Earlier estimates underestimated the number of denial notices issued by Part D plan sponsors because CMS did not have plan reported data. CMS believes the actual burden will not increase significantly, but rather the estimated burden has become more accurate due to plan reporting.
Inventory as of this Action
Requested
Previously Approved
11/30/2016
36 Months From Approved
11/30/2013
1,497,929
0
290,344
374,527
0
145,172
0
0
0
Pursuant to 42 CFR 423.568(c) and (d), if a Part D plan denies drug coverage it must give the enrollee written notice of the adverse coverage determination. The form and content of the written denial notice must comport with specific requirements, including a description of the appeals process. Pursuant to a 2009 change in regulations at 423.580 and 423.582, a prescriber may now request a standard redetermination (plan level appeal) on behalf of an enrollee. It is necessary to incorporate this change in the description of the appeals process contained on the Notice of Denial of Medicare Prescription Drug Coverage.
The Part D denial notice has been revised for clarity and includes new optional language for Part D plan sponsors to use when explaining their denial rationale. Specifically, CMS has added optional language in the denial rationale section of the notice to allow plans to populate text explaining that a drug denied under Part D may be (or is) covered under a different benefit, such as Part B. The instructions have also been changed to guide plans on when to use this optional text. A Crosswalk of the changes has been added to this package.
There is an increase to the total hourly burden estimate for this collection. When this information collection was approved in November 2010, the estimate for the burden hours was 145,172 hours. The estimated annual hour burden for this package is now 374,482.
Since the last collection was approved, there has been an increase in the number of Part D plan sponsors used to estimate the burden, from 456 to 596. The estimate for the total number of denial notices that will be issued across Part D plan sponsors has increased by 1,207,585 (to a total estimate of 1,497,929) and is based on the most recently validated Part D plan sponsor reported data (2011). The increase in the number of Part D plan sponsors, combined with the availability of validated plan reported data on coverage determinations, results in an increase of $6,684,987 in the total estimated cost burden.
We believe the availability and use of validated plan reported data enhances the accuracy of the burden estimates for the Part D denial notice. Based on these estimates (and as noted in section 12 above), the average annual cost per plan sponsor to notify enrollees of their appeal rights through issuance of this standardized denial notice is $18,146.
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.
Form CMS-10146 Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146 and 10146SP)
Crosswalk- Denial Notice 2013(v2).doc
Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146 and 10146SP)