CMS-10185.Supporting Statement_07062012

Supporting Statement for Paperwork Reduction Act Submissions:
Medicare Part D Reporting Requirements and
Supporting Regulations in MMA Title I, Part 423, §423.514
A. Background
Title I, Part 423, §423.514 describes CMS’ regulatory authority to establish reporting
requirements for Part D sponsors. It is noted that each Part D plan sponsor must have an
effective procedure to develop, compile, evaluate, and report to CMS, to its enrollees, and to the
general public, at the times and in the manner that CMS requires, statistics in the following areas:
(1) The cost of its operations.
(2) The patterns of utilization of its services.
(3) The availability, accessibility, and acceptability of its services.
(4) Information demonstrating that the Part D plan sponsor has a fiscally sound operation.
(5) Other matters that CMS may require.
After six years of experience with oversight and monitoring of the Reporting Requirements,
Center for Medicare (CM) has identified the appropriate data needed to effectively monitor plan
performance. Changes to the currently approved data collection instrument reflect new
legislation, as well as recent changes to Agency policy and guidance. We have locked these
data elements and do not expect this collection tool to change. Therefore, we are requesting a
three-year OMB approval.

B. Justification
1. Need and Legal Basis
In accordance with Title I, Part 423, Subpart K (§ 423.514), the Act requires each Part D
Sponsor to have an effective procedure to provide statistics indicating:
the cost of its operations;
the patterns of utilization of its services;
the availability, accessibility, and acceptability of its services;
information demonstrating it has a fiscally sound operation;
and other matters as required by CMS
Subsection 423.505 of the MMA regulation establishes as a contract provision that Part D
Sponsors must comply with the reporting requirements for submitting drug claims and related
information to CMS.

2. Information Users
Data collected via Medicare Part D Reporting Requirements will be an integral resource for
oversight, monitoring, compliance and auditing activities necessary to ensure quality
provision of the Medicare Prescription Drug Benefit to beneficiaries. For all reporting
sections, data are reported electronically to CMS. Each reporting section is reported at one
of the following levels: Contract (data should be entered at the H#, S#, R#, or E# level) or
Plan (data should be entered at the Plan Benefit Package (PBP level, e.g. Plan 001 for

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contract H#, R#, S#, or E). Sponsors should retain documentation and data records related
to their data submissions. Data will be validated, analyzed, and utilized for trend reporting by
the Division of Clinical and Operational Performance (DCOP) within the Medicare Drug
Benefit Group. If outliers or other data anomalies are detected, DCOP will work in
collaboration with other Divisions within CMS for follow-up and resolution.
For CY2013 Reporting Requirements, the following 12 reporting sections will be reported and
collected at the Contract-level or Plan-level:
Enrollment and Disenrollment
Retail, Home Infusion, and Long-Term Care Pharmacy Access
Medication Therapy Management (MTM) Programs
Prompt Payment by Part D Sponsors
Grievances
Pharmacy & Therapeutics (P&T) Committees/Provision of Part D Functions
Coverage Determinations and Exceptions
Redeterminations
LTC Utilization
Fraud, Waste, Abuse (FWA) Compliance Programs
Employer/Union Sponsored Sponsors
Plan Oversight of Agents

3. Use of Information Technology
Part D Sponsors will utilize the Health Plan Management Systems (HPMS) and the Gentran
system to submit or enter data for 100% of data elements listed within these reporting
requirements. The reporting time periods vary for each section of the reporting
requirements, on a quarterly, semi-annually or yearly basis. HPMS is the current conduit by
which Part D Sponsors submit many sources of application materials (e.g. formulary,
transition, exceptions, bids) and other ongoing updates to CMS. CMS and its
subcontractors, in turn, communicate to Sponsors regarding this information, including
approval and denial notices and other related announcements. Gentran is a system used by
Part D contracts to submit beneficiary level data that cannot be submitted via HPMS. HPMS
and Gentran are both familiar tools for Part D Sponsors to navigate through the Part D
reporting requirements. Additionally, as access to HPMS and Gentran must be granted to
each user, and is protected by individual login and password, electronic signatures are
unnecessary.

4. Duplication of Efforts
This collection does not contain duplication of similar information.

5. Small Businesses
This collection does not impose a significant impact on small businesses and other entities.

6. Less Frequent Collection
In an effort to reduce the burden for Part D Sponsors, each reporting requirement section
varies its reporting timeline to capture data as frequently as necessary without increasing
undue burden for Part D Sponsors. Most data collection are on a biannual or more frequent

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basis. Less frequent collection of the reporting requirement data from Part D Sponsors
would severely limit CMS’ ability to perform accurate and timely oversight, monitoring,
compliance and auditing activities around the Part D prescription drug benefit.

7. Special Circumstances
As mandated by MMA, Part D records are to be retained for 10 years.
CMS could potentially require clarification around submitted data, and therefore CMS
may need to contact Part D Sponsors within 30 days of data submission.

8. Federal Register/Outside Consultation
CM’s proposed timeframe for Federal Register/outside consultation is as follows:
CM has requested the Part D reporting requirement document be posted in the
Federal Registry on April 20, 2012, and the 60-day comment period will end June 19,
2012.
From June 20, 2012 to July 9, 2012 CM staff will review all received comments and
questions, and revise the document appropriately. Also, CM staff will prepare a
response document summarizing all received comments and questions, and their
responses. A revised Part D reporting requirement document will be provided. CM
has requested the Part D reporting requirements be posted in the Federal Registry on
July 13, 2012, and the 30-day comment period will end August 12, 2012.
From August 13, 2012 to September 12, 2012, CM staff will review all received
comments and questions, and revise the document appropriately. Also, CM staff will
prepare a response document summarizing all received comments and questions,
and their responses. A final Part D reporting requirement document will be delivered
for OMB review by September 17, 2012.
Final reporting requirements will be posted on www.cms.gov by December 2012.

9. Payments/Gifts to Respondents
There are no payments/gifts to respondents associated with this information collection
request.

10. Confidentiality
CMS will adhere to all statutes, regulations, and agency policies.

11. Sensitive Questions
CMS will adhere to all statutes, regulations, and agency policies.

12. Burden Estimates (Hours & Wages)
The table below illustrates the estimated hours and costs associated with each section of the
CY2013 Medicare Part D Reporting Requirements.

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CY2013 Estimated Hours and Costs

Reporting
Freq

No. of
Responses
(No. of
Respondents*
Reporting
Freq)

Total Part D
Hour Burden
(No. of Hours
for
Reporting*No.
of Responses)

637

4

2,548

3,822

1

637

1

637

637

Contract

2.5

637

1

637

1,593

Contract

1

637

2

1,274

1,274

Plan

2

3,180

4

12,720

25,440

Contract

1

637

4

2,548

2,548

Plan

2

3,180

4

12,720

25,440

Plan

1

3,180

4

12,720

12,720

LTC Utilization

Contract

1.5

637

2

1,274

1,911

FWA Compliance
Programs

Contract

1

637

1

637

637

Employer/Union
Sponsored
Sponsors

Plan

0.5

421

1

421

211

Plan Oversight of
Agents

Contract

0.5

16

1

16

8

48,152

76,240

Level of
Reporting

No. of
Hours
for
Reportin
g

No. of
Respondents

Enrollment and
Disenrollment

Contract

1.5

Retail, Home
Infusion, and LongTerm Care
Pharmacy Access

Contract

Medication Therapy
Management
Programs
Prompt Payment of
Part D Sponsors

Section

Grievances
Pharmacy &
Therapeutics (P&T)
Committees/Provisi
on of Part D
functions
Coverage
Determinations and
Exceptions
Redeterminations

Total

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No. of
Respondents
Annual
Responses=No.
Respondents*Rep
orting Frequency
Total Hour Burden
Avg. cost/hr
Annualized
hours/respondent
= Total Hour
Burden/No. of
Respondents
Annualized wage
hours = Avg.
cost/hr*Annualize
d
hours/respondent
Total Annual Cost
= Total Hour
Burden*Avg.
cost/hr

3,180

48,152

76,240
$46.73

23.97

1,120..34

$ 3,562,695.20

13. Capital Costs
There is no capital costs associated with this collection.

14. Cost to Federal Government
The cost to the Federal Government will be $300,000 to support electronic data
collection through HPMS.

15. Changes to Burden
Data included in Part D Reporting Requirements are already available to Part D Sponsors.
CMS does not expect compliance to these reporting requirements would result in additional
start-up costs. Anticipated staff performing these data collection would be data analysts,
and/or IT analysts. An average competitive hourly wage rate of $46.73 was used to calculate
estimated wages. Please refer to table listed under #12 for details on estimated burden
hours and costs.
There was an overall increase in respondents and burden estimates associated with this
reporting.
For CY2013, to determine the total number of annual responses, we summed the number of

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responses for each section. This is indicated in the Supporting Statement in the chart under
#12.
We removed and/ or added data elements for the Prompt Payment by Part D Sponsors,
Grievances, Fraud, Waste, and Abuse Compliance Programs, and Plan Oversight of Agents
reporting sections; however, these changes resulted in no changes to the burden for these
sections. In addition, we added data elements and revised data elements for the Medication
Therapy Management Programs and the Coverage Determinations and Exceptions reporting
sections, which resulted in an increase in burden hours for both sections. Lastly, we
removed the following reporting sections and decreased burden estimates associated with
these sections because these data are no longer necessary for monitoring through these
reporting requirements:
Access to Extended Day Supplies at Retail Pharmacies
Pharmacy Support of E-prescribing

This is a revised data collection in comparison to the CY2012 Medicare Part D Reporting
requirements. The following table illustrates the change in burden hours per reporting
section from CY2012 to CY2013:

No. of Hours for
CY2012 Reporting

No. of Hours for
CY2013 Reporting

Increase/(Decrease)

1.5

1.5

-

Retail, Home Infusion, and LongTerm Care Pharmacy Access

1

1

-

Medication Therapy Management
Programs

2

2.5

.5

Prompt Payment by Part D
Sponsors

1

1

-

Grievances

2

2

-

Pharmacy & Therapeutics (P&T)
Committees/Provision of Part D
Functions

1

1

-

1.5

2

.5

1

1

-

1.5

1.5

-

Section

Enrollment and Disenrollment

Coverage Determinations and
Exceptions
Redeterminations
LTC Utilization

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No. of Hours for
CY2012 Reporting

No. of Hours for
CY2013 Reporting

Increase/(Decrease)

FWA Compliance Programs

1

1

-

Employer/Union Sponsored
Sponsors

0.5

0.5

-

Plan Oversight of Agents

0.5

0.5

-

Section

There was an overall increase of 1,124 responses, and an overall increase of 9,742 burden hours
associated with this revised data collection. In addition, the annualized burden per respondent
increased from 22 hours to 24 hours. The increase in responses, burden hours and annualized
burden associated with this data collection is attributed to: (1) an increase in the estimated
number of new plans for CY2013, (2) a change in the most common reporting frequency from biannual to quarterly, and (3) the addition of data elements included in two reporting sections.
These changes are reflected in the revised Reporting Requirements document. The following
table illustrates the changes in burden from CY2012 to CY2013:

CY2012

CY2013

Differential

Annual Responses

47,028

48,152

1,124

Annual Hour Burden

66,498

76,240

9,742

22

24

2

Annualized Burden per
Respondent

16. Publication/Tabulation Dates
Collection of these data will commence in January 1, 2013, and the first reporting deadline
will be May 31, 2013. Since this is a coverage benefit for Medicare beneficiaries, the
collection of these data from PDPs and MA-PDs will continue indefinitely.
17. Expiration Date
This collection does not lend itself to the displaying of an expiration date.

18. Certification Statement
There are no exceptions.

C. Collections of Information Employing Statistical Methods
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This information collection does not employ any statistical analyses.

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