Responses_OMBsummary_122007

Memo

To: Carolyn Leavitt, Office of Management and Budget

From: Alice Lee-Martin, Division of Clinical and Economic Performance,

MDBG, CBC

CC: Bonnie Harkless, OSORA

Date: February 5, 2021

Re: Responses to public comments on CMS-10185, 2007 Part D Reporting Requirements

In response to the Federal Register posting of document CMS-10185 2007 Part D Reporting Requirements on October 12, 2007, we received 16 sets of public comments by the November 13, 2007 deadline. Each set of comments may have addressed multiple reporting sections. The comments may be tabulated as follows:

• 21 comments to Retail, Home Infusion and Long-term Care Pharmacy Access

• 18 comments to Vaccines

• 16 comments to Medication Therapy Management Programs

• 14 comments to Home Infusion

• 9 comments to Drug Benefit Analyses

• 6 comments to Access to Extended Day Supplies at Retail Pharmacies

• 5 comments to Grievances

• 3 comments to P&T Committees/Provision of Part D Functions

• 3 comments to Long-term Care Rebates

• 3 General comments

• 2 comments to Pharmaceutical Manufacturer Rebates, Discounts, and Other Price Concessions

• 1 comment each to Transition, Exceptions, Appeals, Overpayment, and Reversals

Please see the attached document, Responses_2008 Part D Reporting Requirements_122007, which provides a summary of comments and our responses. Additionally, please see the attached document, CY2008_Part D reporting requirements, which reflects the changes made as a result of these comments. The net impact of these changes is a decrease in reporting burden associated with CY2008 reporting requirements.

Reporting section	Change	Effect to Reporting Burden
Retail, Home Infusion, and Long-Term Care Pharmacy Access	Reporting level changed from Plan (PBP) to Contract.	Decrease
Access to Extended Day Supplies at Retail Pharmacies	Reporting changed from biannual reporting of 6 mo data to annual reporting of 3 mo data. Reporting level changed from Plan (PBP) to Contract.	Decrease
Vaccines	Data elements clarified.	None
Reversals	Section deleted	Decrease
Home Infusion Utilization	Proposed section deleted	Decrease
Medication Therapy Management Programs	Some data elements in the MTM beneficiary file revised from required to optional.	Decrease
Long-term Care Rebates	Exemption of collecting rebates from LTC pharmacies serving less than 5% of LTC beds in the area is clarified that the term pharmacy represents a pharmacy organization at its highest level rather than the discrete NCPDP number or location.	None

Please contact me at [email protected] or 410 786-1103 if you have any questions. Thank you for your assistance.

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