Response to Comments

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Overview

Substantive Comments
Clarification Comments

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Sheet 1: Substantive Comments

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW:

This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law

Comment Number

Entity Submitting Comments

Subject Matter

Summary of Comment

Accept/Deny Change

Substantive Comments

Instructions

1

CMS

Review standards

Reference to final rule: applicants must demonstrate that they meet all (not substantially all) Part D program requirements to qualify as a Part D sponsor.

Accept

Format of Bids

2

CMS OGC

Bid Submissions

Reference to final rule: multiple bid submissions must reflect differences in benefit packages or plan costs that CMS determines represent substantial differences.

Accept

Pharmacy Access

3

AHIP

Retail Pharmacy Access Review

Defines the methodology for the retail pharmacy review, which involves generating access percentages (rural, suburban, urban) for all applicants and eliminating the applicants from uploading their own geo reports.

Accept

HPMS Part D Contacts

4

CMS OGC

Contacts

Add "Reconciliation Contact" per the 1/25/2010 HPMS memo

Accept

Claims Processing

5

CMS OGC

Discount in coverage gap

Add language to summary of Part D Sponsor Role and Responsibilities to include offering discounts for applicable brand name drugs at POS.

Accept

Reporting Requirements

6

CMS OGC

Guidance

Language change to attestation to better align with new requirement for yearly independent audit.

Accept

Pharmacy Access Contracts

7

CMS

I/T/U Addendum

Clarify that CMS requires use of NPI numbers and will not longer accept NCPDP numbers.

Accept

Appendices

8

CMS OGC

Financial Solvency & Captital Adequacy Documentation

Clarify CMS' considerations for determining sufficient cash flow to meet financial obligations (what comprises the "current ratio").

Not applicable - the current ratio is a standard accounting term and does not need definition by CMS.

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Sheet 2: Clarification Comments

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW:
This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.
Comment Number	Entity Submitting Comments	Subject Matter	Summary of Comment	Accept/Deny Change
Clarification Comments (comments not on substantive information within the application; CMS will clarify directly with commenters)
1	Coventry	Attestations	Coventry requests further explanation of what CMS means by "dispensing techniques".	Not applicable - Attestation currently provides examples of dispensing techniques (e.g., weekly, daily, or automated dose dispensing)
2	Coventry	Attestations	Coventry requests clarification on purpose of the "meaningful bid" attestation, and proposes that this be removed.	Not applicable - Attestation is not new for 2011.
3	Coventry	Attestations	Coventry requests that CMS provide the technical specifications for data validation accurately and timely.	Not applicable - request for timely requirements will be shared with appropriate DCOP staff
4	United	Instructions/ Attestations	Requested clarification on the commitment applicants make when attesting "Yes" in case where the applicant cannot be in compliance with the element as of the date the application is submitted to CMS.	Accept with comment - a qualifier shall be added to the sentence and will read, "By providing such attestation, an Applicant is committing that its organization complies with the relevant requirements as of the date your application is submitted to CMS, unless a different date is stated by CMS."
5	CMS OGC	Attestations	Clarify attestation regarding systems for processing COB file, notification to enrollees of other drug coverage in system, and request for concurrence.	Accept
6	TTAG	I/T/U Addendum	General technical edits adding citations to the Affordable Care Act	Accept
7	TTAG	I/T/U Addendum	Language provided by TTAG states that the Part D Sponsor is required to pay the Provider reasonable charges billed.	Defered to the Indian Health Service general counsel, who in turn deferred to the IHCIA implementation committee. In conference call with CMS' Triabl Affairs staff and IHS general counsel, CMS emphasized the short time frame for providing CMS with a final recommendation for the I/T/U addendum language.
8	CMS OGC	Throughout application	General technical edits, including adding citations to the Affordable Care Act, and new Part D regulations.	Accept
9	CMS	Throughout application	General technical edits and clarifications to ensure citations and references are accurate.	Accept
10	CMS	Contracting	Added clarifying language that each first tier and down stream contract must meet all the contract provisions when read on its own.	Accept