CMS-10185 Medicare Part D Reporting Requirements

MEDICARE PART D
REPORTING REQUIREMENTS
Effective January 1, 2009

According to the Paperwork Reduction Act of 1995, no persons are required to respond to
a collection of information unless it displays a valid OMB control number. The valid OMB
control number for this information collection is 0938-0992. The time required to complete
this information collection is estimated to average 54 hours annually per respondent,
including the time to review instructions, search existing data resources, gather the data
needed, and complete and review the information collection. If you have comments
concerning the accuracy of the time estimate(s) or suggestions for improving this form,
please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail
Stop C4-26-05, Baltimore, Maryland 21244-1850.

Table of Contents
Introduction ……………………………………………………………………………………..3
Section I.

Retail, Home Infusion, and Long-Term Care Pharmacy Access ................. 6

Section II.

Access to Extended Day Supplies at Retail Pharmacies............................. 9

Section III.

Vaccines.................................................................................................... 10

Section IV.

Medication Therapy Management Programs............................................. 11

Section V.

Generic Drug Utilization............................................................................. 15

Section VI.

Grievances ................................................................................................ 16

Section VII. Pharmacy & Therapeutics (P&T) Committees/ Provision of Part D
Functions................................................................................................... 18
Section VIII. Transition................................................................................................... 19
Section IX.

Exceptions................................................................................................. 20

Section X.

Appeals ..................................................................................................... 21

Section XI.

Overpayment............................................................................................. 23

Section XII. Pharmaceutical Manufacturer Rebates, Discounts, and Other Price
Concessions.............................................................................................. 24
Section XIII. Long-Term Care (LTC) Rebates................................................................ 27
Section XIV. Licensure and Solvency, Business Transactions and Financial
Requirements ............................................................................................ 30
Section XV. Drug benefit analyses................................................................................ 34
Table 1. Summary of Reporting Elements ..................................................................... 36

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Introduction
In December 2003, Congress passed the Medicare Prescription Drug Benefit,
Improvement and Modernization Act (MMA), allowing coverage of outpatient prescription
drugs under the Medicare Part D benefit. 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:
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 it has a fiscally sound operation; and
5) other matters as required by CMS.
The purpose of this document is to assure a common understanding of reporting
requirements and how these data will be used to monitor the prescription drug benefit
provided to Medicare beneficiaries. CMS will use the following terminology to ensure
consistency in these reporting requirements:
• Part D Sponsor –an organization which has one or more contract(s) with CMS to
provide Part D benefits to Medicare beneficiaries. Each contract is assigned a CMS
contract number (e.g. H# or S#).
• Plan – a plan benefit package (PBP) offered within a Part D contract (e.g. Plan ID
#).
This document lists reporting timeframes and required levels of reporting. Data elements
may be reported at the Plan (PBP) level, the individual contract-level, or Sponsor-level.
These requirements will be in effect beginning January 1, 2009 and are subject to change
at the discretion of CMS. According to Subpart O, sanctions may be imposed on Part D
Sponsors who fail to comply with these reporting requirements.
The following criteria were used in selecting reporting requirements:
1) minimal administrative burden on Part D Sponsors;
2) legislative and regulatory authority;
3) validity, reliability, and utility of data elements requested; and
4) wide acceptance and current utilization within the Industry.
Reporting requirements are described in this document for the following areas: Retail,
Home Infusion, and Long-Term Care Pharmacy Access, Access to Extended Day Supplies
at Retail Pharmacies, Vaccines, Medication Therapy Management Programs, Generic
Drug Utilization, Grievances, Pharmacy & Therapeutics (P&T) Committees/Part D
Activities, Transition, Exceptions, Appeals, Overpayment, Pharmaceutical Manufacturer
Rebates, Discounts, and Other Price Concessions, Long-Term Care (LTC) Rebates,
Licensure and Solvency, Business Transactions and Financial Requirements, and Drug
Benefit Analyses.
Each Part D Sponsor shall provide necessary data to CMS to support payment, program
integrity, program management, and quality improvement activities. Additional reporting
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requirements are identified in separate guidance documents throughout the year.
Guidance has previously been released for formulary, TrOOP, coordination of benefits,
payment and 1/3 audit, and low income subsidy.
Part D Sponsors may also be required to submit other information as defined by
requirements in the application, guidance, or other documents (e.g. pharmacy access and
formularies) during the annual contract bidding, application, or renewal process.
Information is also required to be submitted throughout the contract year as allowable
changes are made (e.g. formulary changes).

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Part D Reporting Requirements
In each of the sections that follow, the method of submission (e.g. entered into or uploaded
via the Health Plan Management System (HPMS)) and the level of reporting are specified
following the reporting timeline. Sections that refer to prescriptions should encompass all
covered Part D drugs, including compounded drugs.
For PACE Organizations offering Part D coverage, reporting requirements will be limited
to: Vaccines; Generic Drug Utilization; Pharmacy & Therapeutics (P&T) Committees (for
PACE Organizations utilizing formularies); Transition (for PACE Organizations utilizing
formularies); Exceptions (for PACE Organizations utilizing formularies); Overpayment;
Pharmaceutical Manufacturer Rebates, Discounts, and Other Price Concessions; and
Long-term Care (LTC) Rebates.
MA Organizations and Medicare Cost Plans that offer Part D benefits will be required to
comply with all reporting requirements contained herein, with the exception of subsections
1, 2 and 3 of the Licensure and Solvency, Business Transactions and Financial
Requirements reporting section.
Data format
Each reporting section provides details regarding data format and calculations pertaining
to specific elements. All data should be reported in whole numbers, rounding to the
nearest whole number (ex. 1.78 should be rounded to 2), with the following exceptions:
• MTM section: The number of covered Part D 30-day equivalent prescriptions should
be entered to two decimal places; and
• Long-Term Care (LTC) Rebates section: Rebate $ per unit received should be
entered to four decimal places.

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Section I.

Retail, Home Infusion, and Long-Term Care Pharmacy Access

As outlined in §423.120, Part D Sponsors are required to maintain a pharmacy network
sufficient for ensuring access to Medicare beneficiaries residing in their service areas.
Part D Sponsors must ensure that they provide convenient access to retail pharmacies, as
provided in §423.120(a)(1); adequate access to home infusion (HI) pharmacies, as
provided in §423.120(a)(4); and convenient access to long-term care (LTC) pharmacies,
as provided in §423.120(a)(5). After their initial pharmacy access submissions are
approved at the time of application, Part D Sponsors are responsible for notifying CMS of
any substantive changes in their pharmacy network that may impact their ability to
maintain a Part D pharmacy network that meets our requirements, as described in section
50 of Chapter 5 of the Prescription Drug Benefit Manual.
Part D Sponsors will be required to submit certain data elements on an annual basis that
will allow CMS to evaluate Part D Sponsors’ continued compliance with pharmacy access
requirements. For purposes of evaluating compliance with the retail pharmacy access
standards, Part D Sponsors should use the CMS reference file that provides counts of
Medicare beneficiaries by State, region, and zip code. This reference file is provided by
CMS with Part D applications and will be posted on the Prescription Drug Contracting
section of CMS’ website in January
(http://www.cms.hhs.gov/PrescriptionDrugCovContra/04_RxContracting_ApplicationGuida
nce.asp#TopOfPage). Note that this file contains total Medicare beneficiary counts, not
plan enrollee counts, and that the total Medicare beneficiary count is the appropriate
number to use for purposes of ensuring compliance with the standards for convenient
access to retail pharmacies as provided in §423.120(a)(1).
For purposes of evaluating compliance with the LTC and home infusion pharmacy access
standards, CMS will use data elements submitted by Part D Sponsors, as well as
information from CMS reference files containing counts of nursing home beds and
Medicare beneficiaries by State, region, and zip code, as detailed in sections 50.4 and
50.5.1 of Chapter 5 of the Prescription Drug Benefit Manual. MA-PD plans or cost plan
sponsors having received waivers of the any willing pharmacy requirement and/or the retail
convenient access requirement after the initial pharmacy access submission will submit
certain data elements (C and/or D) on an annual basis for purposes of determining if those
plans still meet CMS standards for a waiver.
Supporting documentation is not required to be submitted with the data elements below;
however, CMS reserves the right to request appropriate documentation to support a Part D
Sponsor’s submitted pharmacy access data elements (e.g., geo-access reports). This
may include documentation of the access data elements at the plan (PBP level). CMS
evaluation of compliance with pharmacy access standards will be conducted based on
point-in-time information about pharmacy networks submitted by Part D Sponsors once per
year.
Employer/Union Direct contracts and “800 series” plans have the following service area
definitions for this section:

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•

•
•

Part D Sponsors that offer both individual plans and "800 series" plans need only to
demonstrate pharmacy access (retail, home infusion, long term care) for their
individual service area. There are no separate requirements for their EGWP-Only
service area.
Part D Sponsors that offer plans to employer groups only (i.e., "800 Series Only"
contracts) need to demonstrate pharmacy access (retail, home infusion, long
term care) for their entire service area.
Employer/Union Direct contracts need to demonstrate pharmacy access (retail,
home infusion, long term care) for their entire service area.

Reporting timeline for Sections A and B only:
Period 1
January 1 - March 31
Reporting
Period
May 31
Data due to
CMS/HPMS
A. Data elements to be entered into the HPMS at the CMS Contract level:
1. Percentage of Medicare beneficiaries living within 2 miles of a retail network
pharmacy in urban areas of a Plan’s service area (by State for PDPs and
regional PPOs, and by service area for local MA-PD plans) as of the last day of
the reporting period specified above.
2. Percentage of Medicare beneficiaries living within 5 miles of a retail network
pharmacy in suburban areas (by State for PDPs and regional PPOs, and by
service area for local MA-PD plans) as of the last day of the reporting period
specified above.
3. Percentage of Medicare beneficiaries living within 15 miles of a retail network
pharmacy in rural areas (by State for PDPs and regional PPOs, and by service
area for local MA-PD plans) as of the last day of the reporting period specified
above.
4. The number of contracted retail pharmacies in a Plan’s service area (by State for
PDPs and regional PPOs, and by service area for local MA-PD plans) as of the
last day of the reporting period specified above.
B. Data files to be uploaded through the HPMS at the CMS Part D Contract level. Part D
Sponsors will provide an excel file
(filename=Pharmacies_(CONTRACTNAME)_(CONTRACTYEAR).xls replacing
‘(CONTRACTNAME)’ with the Part D Contract’s name (CONTRACTYEAR).xls and
‘(CONTRACTYEAR) ’ with the appropriate contract year containing the following fields:
1. A list of contracted HI network pharmacies into HPMS as of the last day of the
reporting period specified above.
2. A list of contracted LTC network pharmacies into HPMS as of the last day of the
reporting period specified above.
Part D Sponsors will use the templates provided in HPMS for upload of their HI and LTC
pharmacy networks.

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Reporting timeline for Sections C and D only:
Period 1
January 1 – December 31
Reporting
Period
February 28
Data due to
CMS/HPMS
C. Data elements to be entered into the HPMS at the Plan (PBP) level for only those MAPD and cost plans that own and operate their own pharmacies and have received a
waiver of the any willing pharmacy requirement.
1. Number of prescriptions provided by all pharmacies owned and operated.
2. Number of prescriptions provided at all pharmacies contracted
D. Data elements to be entered into the HPMS at the Plan (PBP) level for only those MAPD and cost plans that own and operate their own retail pharmacies and have received
a waiver of the retail pharmacy convenient access standards. MA-PD and cost plans
that have received a waiver of the retail pharmacy convenient access standards are not
required to submit data elements A1-A4 above.
1. Number of prescriptions provided by retail pharmacies owned and operated.
2. Number of prescriptions provided at all retail pharmacies contracted.

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Section II. Access to Extended Day Supplies at Retail Pharmacies
NOTE: This reporting requirement applies only to those Part D Plans that include in their
networks mail-order pharmacies offering extended day supplies of covered Part D drugs.
As provided in §423.120 and section 50.10 of Chapter 5 of the Prescription Drug Benefit
Manual, Part D Sponsors that include mail-order pharmacies in their networks must permit
enrollees to receive benefits, which may include an extended day supply of covered Part D
drugs (for example, a 90-day supply), through a network retail pharmacy rather than a
network mail-order pharmacy. Part D Sponsors must contract with a sufficient number of
retail pharmacies so as to ensure that enrollees have reasonable access to the same
extended day supply benefits at retail that are available at mail-order pharmacies. Part D
Sponsors must submit data annually that will allow CMS to evaluate access to extended
day supplies at retail pharmacies.
Reporting timeline:
Reporting
Period
Data due to
CMS/HPMS

Period 1
January 1 - March 31
May 31

Data elements to be entered into the HPMS at the CMS Contract level:
A. The number of contracted retail pharmacies that are contracted to dispense an
extended day supply of covered Part D drugs as of the last day of the reporting period
specified above.

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Section III.

Vaccines

For monitoring purposes, Part D Sponsors will be responsible for reporting several data
elements related to their reimbursement of vaccines, demonstrating their implementation
of CMS requirements regarding vaccine access detailed in section 60.2 of Chapter 5 of the
Prescription Drug Benefit Manual. For this section, Sponsors are required to report on the
vaccine itself, or ingredient cost. Sponsors do not need to report or include vaccine
administration claims as part of this reporting requirement.
Data element A should be a sum of data elements B-F; claims should not be reported
more than once in data elements B-F. Additionally, elements B through F below intend to
capture a number of different methods to provide vaccines to enrollees. This does not
imply that each method must be implemented; it is acceptable to submit zero values.
Reporting timeline:
Reporting
Period
Data due to
CMS/HPMS

Quarter 1
January 1 March 31
May 31

Quarter 2
April 1 June 30
August 31

Quarter 3
July 1 September 30
November 30

Quarter 4
October 1 December 31
February 28

Data elements to be entered into the HPMS at the Contract level:
A. The total number of Part D vaccines processed during the time period specified
above, regardless of the method used to process the claim as described in B
through F below.
B. The number of Part D vaccines provided in any out-of-network setting where a state
recognized immunizer dispenses a Part D vaccine (e.g. physician’s office) where
the beneficiary retrospectively files paper receipts for reimbursement of the vaccine
during the time period specified above.
C. The number of vaccines adjudicated through network pharmacies during the time
specified above. (Including those vaccines processed by the pharmacy and
submitted electronically).
D. The number of vaccines processed through a paper enhanced process, where the
provider used or navigated a process that facilitated out-of-network access during
the time period specified above.
E. The number of vaccines processed through an internet based web tool.
F. The number of vaccines processed during the time period specified above through
a process not described in data elements B through E.

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Section IV. Medication Therapy Management Programs
The requirements stipulating that Part D Sponsors provide Medication Therapy
Management Programs (MTMP) are described in Title I, Part 423, Subpart D, § 423.153.
For monitoring purposes, Part D Sponsors will be responsible for reporting several data
elements related to their MTMP. Data will be manually submitted in HPMS, or uploaded
in a data file.
I.

Data elements to be entered into the HPMS at the Contract level.

Data related to the identification and participation in the MTMP will be submitted according
to the following timeline (note: Period 2 encompasses one full year):
Reporting timeline:
Reporting
Period
Data due to
CMS/HPMS

Period 1
January 1 June 30
August 31

YTD
January 1 December 31
February 28

A. The method used to enroll beneficiaries into the MTMP. Method of enrollment may be
opt-in, opt-out, a combination of opt-in and opt-out, or other. This will be selection from
a drop-down box. If “other” is selected, a description will be required as a text field.
B. The number of beneficiaries who met the eligibility criteria for the MTMP in the
specified time period above.
C. The total number of beneficiaries who participated in the MTMP at any point during the
time period specified above. This should be a longitudinally cumulative total, and be a
subset of the number of beneficiaries who met the criteria for the MTMP in the specified
time period.
D. The total number of beneficiaries who discontinued participation from the MTMP at any
time during the specified time period above. This should be a subset of the total
number of beneficiaries who participated in the MTMP in the specified time period.
E. The number of beneficiaries who discontinued participation from the MTMP due to
death at any time during the specified time period above. This should be a subset of
the total number of beneficiaries who discontinued participation from the MTMP in the
specified time period.
F. The number of beneficiaries who discontinued participation from the MTMP due to
disenrollment from the Plan at any time during the specified time period above. This
should be a subset of the total number of beneficiaries who discontinued participation
from the MTMP in the specified time period.
G. The number of beneficiaries who discontinued participation from the MTMP at their
request at any time during the specified time period above. This should be a subset of
the total number of beneficiaries who discontinued participation from the MTMP in the
specified time period.
H. The number of beneficiaries who discontinued participation from the MTMP for a
reason not specified in data elements E-G during the specified time period above. This
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should be a subset of the total number of beneficiaries who discontinued participation
from the MTMP in the specified time period.
I. The number of beneficiaries who declined to participate in the MTMP during the
specified time period above. This should be a subset of the number of beneficiaries
who met the criteria for the MTMP in the specified time period.
J. The number of beneficiaries whose participation status in the MTMP is pending during
the specified time period above. This should be a subset of the number of beneficiaries
who met the criteria for the MTMP in the specified time period and should only apply to
period 1. A value of zero will be accepted.
K. For beneficiaries participating in the MTMP as of the last day of the reporting period
specified, provide the prescription cost of all covered Part D medications on a per
MTMP beneficiary per month basis. This should be a currency field, rounded to the
nearest dollar. The numerator represents the total prescription drug costs. The total
prescription cost should be limited to covered Part D medications and be calculated
using gross drug cost as follows: (Ingredient Cost Paid + Dispensing Fee + Sales Tax).
This is based on the sum of all Part D covered prescriptions that were dispensed within
the reporting period specified for each beneficiary participating in the MTMP as of the
last day of the reporting period. This includes both MTMP beneficiary cost sharing and
Part D costs paid. The denominator represents the total number of member months for
the MTMP participating beneficiaries. These member months should include all
months the beneficiary was enrolled in the plan during the reporting period specified,
not only the months that the beneficiary enrolled in the MTMP. The following equation
also describes this calculation.
Figure 1: Calculating total prescription cost per MTMP beneficiary per month.
n ⎛m
⎞
⎡Total prescription cost ⎤
∑ ⎜ ∑ Gross Drug Cost ⎟
i ⎝ j
⎠
⎢ per MTMP beneficiary ⎥ =
⎥ n
⎢
⎥⎦ ∑ (Member Months in Part D Contract during Reporting Period)
⎢⎣ per month
i
{Gross Drug Cost = (Ingredient Cost Paid + Dispensing Fee + Sales Tax).

For beneficiaries i to n, and prescriptions j to m from the i th beneficiary}

L. For beneficiaries participating in the MTMP as of the last day of the reporting period
specified, provide the number of covered Part D 30-day equivalent prescriptions on a
per MTMP beneficiary per month basis. This should be a numeric field.
This numerator should be calculated by first summing days supply of all covered Part D
prescriptions dispensed for beneficiaries participating in MTMP as of the last day of the
reporting period, and dividing by 30 to determine the number of 30 day equivalent
prescriptions dispensed. The denominator represents the total number of member
months for the MTMP participating beneficiaries. These member months should
include all months enrolled the beneficiary was enrolled in the plan during the reporting
period specified, not only the months that the beneficiary enrolled in the MTMP. The
following equation also describes this calculation.

Page 12 of 46

Figure 2: Calculating total number of 30-day prescription equivalents per MTMP
beneficiary per month.
n ⎛ m ⎛ Days Supply ⎞ ⎞
⎟ ⎟⎟
∑ ⎜⎜ ∑ ⎜
i ⎝ j ⎝
30
⎡Total number of 30 - day prescription equivalent s⎤
⎠⎠
=
⎢
⎥
n
per MTMP beneficiar y per month
⎛ Member Months in Part D Contract
⎣
⎦
∑ ⎜⎜
i ⎝
during Reporting Period
{For beneficiar ies i to n, and prescriptions j to m from the i th beneficiar y }

II.

Data file to be uploaded using Gentran or Connect Direct at the Contract level.

Reporting timeline:
Reporting Period
Data due to
CMS/HPMS

YTD
January 1 December 31
February 28

The file will contain the following fields for beneficiaries identified as being eligible for the
Medication Therapy Management Program:
Beneficiaries Eligible for MTMP Record Layout:
Field Name

Field Type

Field
Length
5

Contract
Number
HICN or RRB
Number

CHAR
REQUIRED
CHAR
REQUIRED

Beneficiary first
name

CHAR
REQUIRED

30

Beneficiary
middle initial

CHAR
OPTIONAL

1

Beneficiary last
name

CHAR
REQUIRED

30

20

Field Description
The organization’s contract number
(e.g. H1234, S1234).
For each beneficiary identified to be
eligible for MTMP in the reporting
period, provide the unique number
that the Social Security Administration
assigns to every Medicare beneficiary
which is the Health Insurance Claim
number (HICN). For Railroad
Retirement Board (RRB) beneficiaries,
provide the RRB number in this field
instead of the HICN.
The first name of each beneficiary
identified to be eligible for MTMP in
the reporting period.
The middle initial of each beneficiary
identified to be eligible for MTMP in
the reporting period.
The last name of each beneficiary
identified to be eligible for MTMP in

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⎞
⎟⎟
⎠

Field Name

Field Type

Field
Length

Field Description
the reporting period.

Beneficiary date
of birth

DATE
REQUIRED

8

LTC Enrollment

CHAR
REQUIRED

1

Date of MTMP
enrollment

DATE
OPTIONAL

8

Date MTMP
participation was
declined
Date participant
discontinued
MTMP

DATE
OPTIONAL

8

DATE
OPTIONAL

8

Reason
participant
discontinued
MTMP

CHAR
Conditionally
REQUIRED

2

The date of birth of each beneficiary
identified to be eligible for MTMP in
the reporting period. (CCYYMMDD,
e.g. 19400101).
For each beneficiary enrolled in
MTMP, indicate if the beneficiary was
a long-term care (LTC) resident for the
entire time they were enrolled in
MTMP. This should be Y (yes), N
(no), or U (unknown).
For each beneficiary identified to be
eligible for the MTMP in the reporting
period, who enrolled in MTMP, the
date MTMP enrollment began.
(CCYYMMDD, e.g. 19400101).
This should be a date field
(CCYYMMDD, e.g. 19400101).
For each beneficiary who enrolled in
MTMP and then discontinued
participation, the date their
participation ended. This should be a
date field (CCYYMMDD, e.g.
19400101).
For each beneficiary with a MTMP
disposition status of discontinued
participation, the reason for
discontinuation must be provided.
Reasons for discontinuation must be
one of the following:
01 - Death;
02 - Disenrollment from Plan;
03 - Request by beneficiary; or
04 - Other.
Note: If Date Participant Discontinued
MTMP provided, then Reason
participant discontinued MTMP is
required.

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Section V.

Generic Drug Utilization

Cost control requirements for Part D Sponsors are presented in Title I, Part 423, Subpart
D. Accordingly, Part D Sponsors will be responsible for reporting data elements needed to
monitor utilization of generic drugs (defined by Title I, Part 423, Sub-Part A, § 423.4).
Reporting timeline:
Reporting
Period
Data due to
CMS/HPMS

Quarter 1
January 1 March 31
May 31

Quarter 2
April 1 June 30
August 31

Quarter 3
July 1 September 30
November 30

Quarter 4
October 1 December 31
February 28

Data elements to be entered into the HPMS at the Plan (PBP) level:
A. The total number of paid claims for Part D generic drugs (regardless of days supply)
with dates of service during the specified reporting period identified above. First
DataBank or Medispan generic drug classifications will be used to identify generic
drugs.
B. The total number of Part D paid claims (regardless of days supply) with dates of service
during the specified reporting period identified above.

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Section VI. Grievances
Title I, Part 423, Subpart M of the regulation includes regulations that require Part D
Sponsors to maintain grievance information. All plans (PBPs) will be responsible for
reporting data related to grievances received.
A grievance is defined as any complaint or dispute, other than one that involves a
coverage determination, expressing dissatisfaction with any aspect of the operations,
activities, or behavior of a Part D organization, regardless of whether remedial action is
requested. Examples of subjects of a grievance provided in the solicitation for applications
include, but are not limited to, timeliness, appropriateness, access to, and/or setting of
services provided by the PDP, concerns about waiting times, demeanor of pharmacy or
customer service staff, a dispute concerning the timeliness of filling a prescription, the
accuracy of filling the prescription or enrollment/disenrollment issues or recognition of low
income subsidy (LIS) eligibility problems.
Part D Sponsors are required by the regulations to track and maintain records on all
grievances received orally and in writing. Grievance data, requested herein by CMS,
should be reported based on the date the grievance was received by the Plan (PBP), not
the date the event or incident that precipitated the grievance occurred. Multiple grievances
by a single complainant should be tracked and followed as separate grievances. Plans
may report grievances in the categories as determined by the Plans after initial
investigation. Plans should not dismiss or exclude any grievances filed by beneficiaries or
their appointed representatives from this reporting section.
Reporting timeline:
Reporting
Period
Data due to
CMS/HPMS

Quarter 1
January 1 March 31

Quarter 2
April 1 June 30

May 31

August 31

Quarter 3
July 1 September
30
November
30

Quarter 4
October 1 December
31
February 28

Data elements to be entered into the HPMS at the Plan (PBP) level:
A. For the time period identified above, the number of fraud and abuse grievances
received related to Part D. A fraud grievance is a statement, oral or written, alleging
that a provider, pharmacy, pharmacist, PBM, Plan, Plan Agent or broker, or beneficiary
engaged in the intentional deception or misrepresentation that the individual knows to
be false or does not believe to be true, and the individual makes knowing that the
deception could result in some unauthorized benefit to himself/herself or some other
person. An abuse grievance is a statement, oral or written, alleging that a provider,
pharmacy, pharmacist, PBM, Plan, Plan Agent or broker or beneficiary engaged in
behavior that the individual should have known to be false, and the individual should
have known that the deception could result in some unauthorized benefit to
himself/herself or some other person.

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B. For the time period identified above, the number of enrollment/disenrollment grievances
received related to Part D. Examples include, but are not limited to, discrimination in
the enrollment process, enrollment information and/or identification cards not being
received by beneficiaries in a timely manner, and disenrollment requests not being
processed in a timely manner.
C. For the time period identified above, the number of benefit package grievances
received related to Part D. Examples include, but are not limited to, beneficiary cost
sharing, pricing co-insurance issues and issues related to coverage during the
coverage gap period.
D. For the time period identified above, the number of pharmacy access/network
grievances received related to Part D. Examples include, but are not limited to,
network pharmacy refusing to accept a beneficiary’s card and network/non-network
pharmacy concerns.
E. For the time period identified above, the number of marketing grievances received
related to Part D. Examples include, but are not limited to, marketing materials or
promotional messages by sales representatives that include misrepresentations or
false/misleading information about plans and benefits, overly aggressive marketing
practices, and discriminatory practices identified in marketing materials or through
oral/written promotional messages.
F. For the time period identified above, the number of customer service grievances
received related to Part D. Examples include, but are not limited to, grievances
regarding services provided by the pharmacist/pharmacy staff, plan or subcontractor
representatives, or customer service representatives.
G. For the time period identified above, the number of confidentiality/privacy grievances
received related to Part D. Examples include, but are not limited to, potential violations
of medical information privacy standards by the plan or pharmacy.
H. For the time period identified above, the number of quality of care grievances received
related to Part D. Examples include, but are not limited to, grievances received from
beneficiaries or Quality Improvement Organizations (QIOs) regarding quality of care.
I. For the time period identified above, the number of exception grievances received
related to Part D. An example of an exception grievance is one which is filed because
an enrollee’s request to have their coverage determination expedited was denied.
J. For the time period identified above, the number of appeal grievances received related
to Part D. An example of an appeal grievance is one which is filed because an
enrollee’s request to have a redetermination expedited was denied.
K. For the time period identified above, the number of other grievances received related to
Part D not falling into one of the categories described above.
L. For the time period identified above, the total number of grievances received related to
Part D.
M. For the time period identified above, the total number of LIS grievances received
related to Part D. This number should be based on the beneficiary’s LIS status at the
time of filing the grievance.

Page 17 of 46

Section VII. Pharmacy & Therapeutics (P&T) Committees/ Provision of Part D
Functions
In addition to satisfying and maintaining P&T committee requirements described in
§423.120, Part D Sponsors will be responsible for providing information to CMS relating to
changes made during a contract year to their P&T committees on a periodic basis. CMS
recognizes the importance of maintaining confidentiality of these records. Additionally,
CMS will provide methods other than HPMS data submission for those Part D Sponsors
with contractual limitations in providing these data.
Part D Sponsors are also responsible for providing information to CMS relating to the
organizations responsible for providing specific functions. This information must be
updated on a timely manner if changes occur. On a quarterly basis, Part D Sponsors must
attest if changes have occurred, and if they have been communicated to CMS.
Reporting timeline:
Reporting
Period
Data due to
CMS/HPMS

Quarter 1
January 1 March 31
May 31

Quarter 2
April 1 June 30
August 31

Quarter 3
July 1 September 30
November 30

Quarter 4
October 1 December 31
February 28

A. Data elements to be entered into the HPMS at the Contract level:
1. Indicate if there have been changes in P&T committee membership during the
time period specified above.
2. If changes have occurred, indicate if these changes have been reflected within
the Contract Management module. For those Sponsors operating under
confidentiality agreements, indicate if these changes have been sent to CMS per
those agreements.
B. Data elements to be entered into the HPMS at the Contract level:
1. Indicate if there have been changes to the organizations providing Part D
functions during the reporting period.
2. If changes have occurred, indicate if these changes have been reflected within
the Contract Management module on the Part D Data page within the
Organizations Providing Part D Functions table.

Page 18 of 46

Section VIII. Transition
As described in §423.120(a)(3) and section 30.4 of Chapter 6 of the Prescription Drug
Benefit Manual, Part D Plans must provide for an appropriate transition process for new
enrollees who were prescribed non-formulary Part D drugs. For purposes of CMS
oversight, Plans (PBPs) will be responsible for reporting various data elements related to
minimum plan transition process timeframes on an annual basis.
Reporting timeline:
Quarter 1*
Reporting Period
January 1- March 31
Data due to
May 31
CMS/HPMS
*Note: Only one quarter of data will be collected annually
Data elements to be entered into HPMS at the Plan (PBP) level:
A. The minimum number of days supply the Plan’s transition policy provides for its onetime, temporary fill for enrollees in the retail setting. (NOTE: This must be at least 30
days, unless the enrollee presents a prescription written for less than 30 days).
B. The minimum number of days, beginning on the enrollee’s effective date of coverage,
in a plan’s transition process for enrollees in the retail setting. (NOTE: This must be at
least 90 days.)
C. The minimum number of days supply the Plan’s transition policy provides for its
temporary fill (with multiple refills as necessary) for enrollees in the LTC setting.
(NOTE: This must be at least 31 days, unless the enrollee presents a prescription
written for less than 31 days).
D. The minimum number of days, beginning on the enrollee’s effective date of coverage,
in a plan’s transition process for enrollees in the LTC setting. (NOTE: This must be at
least 90 days.)
E. After the minimum transition period has expired, the minimum number of days supply
the Plan provides to LTC enrollees for an emergency supply of non-formulary Part D
drugs while an exception is being processed (NOTE: This must be at least 31 days,
unless the enrollee presents a prescription written for less than 31 days).
F. The maximum number of business days after a temporary transition fill within which the
Plan will send a written transition notice via U.S. first class mail. (NOTE: This must be
3 business days or less.)

Page 19 of 46

Section IX. Exceptions
Title I, Part 423, Subpart D includes regulations regarding formulary and tier exceptions,
and exceptions to established drug utilization management programs. Plans (PBPs) that
utilize prior authorization or step therapy edits as utilization management tools (including
for non-formulary exceptions) will be responsible for reporting several data elements
related to these activities. Prior authorization requests/approvals that relate to Part B
versus Part D coverage should be included in this reporting.
Reporting timeline:
Reporting
Period
Data due to
CMS/HPMS

Quarter 1
January 1 March 31
May 31

Quarter 2
April 1 June 30
August 31

Quarter 3
July 1 September 30
November 30

Quarter 4
October 1 December 31
February 28

Data elements to be entered into the HPMS at the Plan (PBP) level:
A. The number of pharmacy transactions rejected due to failure to complete step therapy
edit requirements in the time period specified above.
B. The number of pharmacy transactions rejected due to need for prior authorization (not
including first pass step therapy edits or early refills) in the time period specified above.
C. The number of pharmacy transactions rejected due to quantity limits in the time period
specified above.
D. The number of prior authorizations requested for formulary medications in the time
period specified above (not including first pass step therapy edits, early refills, or
quantity limits).
E. The number of prior authorizations approved for formulary medications, of those
submitted in the time period specified above (not including first pass step therapy edits,
early refills, or quantity limits).
F. The number of exceptions requested for non-formulary medications in the time period
specified above (not including early refills).
G. The number of exceptions approved for non-formulary medications, of those submitted
in the time period specified above (not including early refills).
H. The number of tier exceptions requested in the time period specified above (not
including first pass step therapy edits or early refills).
I. The number of tier exceptions approved, of those submitted in the time period specified
above (not including first pass step therapy edits or early refills).
J. The number of quantity limit exceptions requested in the time period specified above
(not including early refills).
K. The number of quantity limit exceptions approved, of those submitted in the time period
specified above (not including early refills).

Page 20 of 46

Section X.

Appeals

Title I, Part 423, Subpart M includes regulations regarding coverage determinations and
appeals under Part D. As defined in §423.560, an appeal is any of the procedures that
deal with the review of adverse coverage determinations made by the Plan on the benefits
the enrollee believes he or she is entitled to receive, including a delay in providing or
approving the drug coverage (when a delay would adversely affect the health of the
enrollee), or on any amounts the enrollee must pay for the drug coverage. These
procedures include redeterminations by the Plan and reconsiderations by the independent
review entity (IRE). Redeterminations or reconsiderations may result in reversal or partial
reversal of the original decision.
• Example of a full reversal of an original decision: Non-formulary exception request
approved upon redetermination for drug and quantity prescribed.
• Example of a partial reversal of an original decision: Non-formulary exception
request approved upon redetermination for drug, but full quantity prescribed is not
approved.
CMS will request appeal data as part of the monitoring of a Plan’s availability, accessibility,
and acceptability of its services.
Reporting timeline:
Reporting
Period
Data due to
CMS/HPMS

Quarter 1
January 1 March 31
May 31

Quarter 2
April 1 June 30
August 31

Quarter 3
July 1 September 30
November 30

Quarter 4
October 1 December 31
February 28

Data elements to be entered into the HPMS at the Plan (PBP) level:
A. The number of appeals submitted for standard redetermination in the time period
specified above. (Do not include those appeals that were submitted as expedited
redeterminations and were not granted expedited status. )
B. The number of appeals submitted for expedited redetermination in the time period
specified above.
C. The number of appeals submitted for expedited redetermination that were granted
expedited status in the time period specified above.
D. The number of appeals submitted for standard redetermination withdrawn by the
enrollee in the time period specified above.
E. The number of appeals submitted for expedited redetermination withdrawn by the
enrollee in the time period specified above.
F. The number of redeterminations in the time period specified above resulting in full
reversal of original decision.
G. The number of redeterminations in the time period specified above resulting in partial
reversal of original decision.
H. The number of adverse redeterminations in the time period specified above due to
insufficient evidence of medical necessity from enrollee’s prescribing physician.
Examples of insufficient evidence of medical necessity may include, but are not limited
Page 21 of 46

I.
J.
K.
L.
M.
N.
O.
P.

to, when the plan does not receive the information, or the information received does not
support medical necessity.
The number of appeals submitted for IRE reconsideration in the time period specified
above due to inability to meet timeframe for coverage determination.
The number of appeals submitted for IRE reconsideration in the time period specified
above due to inability to meet timeframe for redetermination.
The number of IRE decisions for standard reconsideration in the time period specified
above resulting in full reversal of original coverage determination or redetermination.
The number of IRE decisions for standard reconsideration in the time period specified
above resulting in partial reversal of original coverage determination or redetermination.
The number of IRE decisions for expedited reconsideration in the time period specified
above resulting in full reversal of original coverage determination or redetermination.
The number of IRE decisions for expedited reconsideration in the time period specified
above resulting in partial reversal of original coverage determination or redetermination.
The number of IRE decisions for standard reconsideration in the time period specified
above resulting in upholding of original coverage determination or redetermination.
The number of IRE decisions for expedited reconsideration in the time period specified
above resulting in upholding of original coverage determination or redetermination.

Page 22 of 46

Section XI. Overpayment
Part D Sponsors will be responsible for reporting data related to overpayments associated
with Part D benefits. An overpayment occurs when a Part D Sponsor erroneously makes a
payment in excess of the amount due and payable under the Part D drug benefit.
Examples would include overpayments a plan makes to pharmacies, sub-contractors, or
PBMs for claims payment. This information is necessary to ensure that overpayments are
being identified and recouped appropriately.
Reporting timeline:
Reporting
Period
Data due to
CMS/HPMS

Period 1
January 1 June 30
August 31

Period 2
July 1 –
December 31
February 28

Data elements to be entered into the HPMS at the Contract level:
A. For the time period identified above, the total overpayment dollars identified to be
recouped by the Contract (i.e., any funds recovered from any entity it has overpaid,
including, pharmacies, providers, Pharmaceutical Benefit Managers, etc.)
B. For the time period identified above, the total overpayment dollars recouped by the
Contract.

Page 23 of 46

Section XII. Pharmaceutical Manufacturer Rebates, Discounts, and Other Price
Concessions
Part D Sponsors will be responsible for reporting multiple data elements related to rebates.
These data will be monitored as components of a Part D Sponsor’s operational costs.
CMS recognizes the importance of maintaining confidentiality of these records.
Rebates, discounts, and other price concessions will be reported at either the CMS Part D
Sponsor or Contract level. Reporting will not be combined by the subcontractor PBM to
include multiple Part D Sponsors’ data. For example: (1) national Part D sponsors with
multiple regional plans contracting independently or through a PBM will report rebates from
the level of the national Part D sponsor; (2) regional or local Part D sponsor whether
utilizing subcontractor PBM or not report at the Part D sponsor specific level; (3) PBM
providing Part D coverage outside of a subcontractor role will report rebates at the PBM
level. Rebate information should be summarized for each drug, rolled up to include
multiple strengths, package sizes, dosage formulations, or combinations. The quarterly
reported totals are not cumulative YTD totals.
Reporting timeline:
Reporting
Period

Quarter 1
January 1 March 31

Quarter 2
April 1 June 30

Data due to
CMS/HPMS

September
30

December
31

Quarter 3
July 1 September
30
March 31

Quarter 4
October 1 December
31
June 30

Data files to be uploaded through the HPMS at the CMS Part D Sponsor or Contract level
as specified below. HPMS will provide an option to report “No Data to Report” for Part D
Sponsors or Contracts that have no rebate or discount/price concessions data; those
Sponsors will not upload data files.
A. Part D Sponsors/Contracts will provide a tab delimited text file
(filename=REBATES_(SPONSORNAME)_(CONTRACTYEAR).txt, replacing
‘(SPONSORNAME)’ with the Part D Sponsor’s name and ‘(CONTRACTYEAR)’ with the
appropriate contract year following the below file layout.
Pharmaceutical Manufacturer Rebate File Record Layout:
Field Name

Field Type

Manufacturer
Name

CHAR
REQUIRED

Drug Name

CHAR
REQUIRED

Field
Length
100

100

Field Description
For each rebate, provide the
contracting manufacturer name.
This should be a character field.
For each rebate, provide the drug
name. This should be a
character field.

Page 24 of 46

Field Name

Field Type

Field
Length
12

Rebates
Received

NUM
REQUIRED

Pending
Rebates

NUM
REQUIRED

12

Prior Rebates

NUM
REQUIRED

12

Field Description
For each unique
manufacturer/drug combination,
provide the rebate amount
received in the reporting period
specified.
- Limit to 999999999999, no
decimals, can be a negative
number.
- Zero should be entered in the
fields if no rebate was received in
the reporting period specified.
For each unique
manufacturer/brand name
combination, provide the rebate
amount requested for the
reporting period specified but not
yet received (if applicable).
- Limit to 999999999999, no
decimals, can be a negative
number
- Zero should be entered in the
fields if no rebate was requested
but not received for the reporting
period specified.
For each unique
manufacturer/brand name
combination, provide the rebate
amount received that is
associated with a prior reporting
period (if applicable).
- Limit to 999999999999, no
decimals, can be a negative
number
- Zero should be entered in the
fields if no rebate was received
that is associated with a prior
reporting period.

B. It is expected that the file specified above will summarize most rebate information.
However, for all non-rebate discounts, price concessions, or other value adds such as
gift-in-kind or other programs (e.g., coupons or disease management programs specific
to a Part D Sponsor), Part D Sponsors will provide an additional tab delimited text file
(filename=DISCOUNTS_( SPONSORNAME)_(CONTRACTYEAR).txt, replacing
‘(SPONSORNAME)’ with the Part D Sponsor’s name and ‘(CONTRACTYEAR)’ with the
appropriate contract year following the below file layout.
Page 25 of 46

Discounts and Other Price Concessions File Record Layout:
Field Name

Field Type

Manufacturer/
Company
Name
Description

CHAR
REQUIRED

Value

Justification

Field
Length
100

CHAR
REQUIRED
NUM
REQUIRED

250

CHAR
OPTIONAL

4000

12

Field Description
List the name of each manufacturer for
whom there is an associated discount,
price concession, or other value add.
Describe the discount, price concession,
or other value adds.
Provide the value of the discount, price
concession, or other value adds.
-Zero is not an allowable value.
For each discount, price concession, or
value add, provide a justification for
receipt.

Page 26 of 46

Section XIII. Long-Term Care (LTC) Rebates
Part D Sponsors must require disclosure of access/performance rebates or other price
concessions received by their long-term care (LTC) network pharmacies designed to or
likely to influence or impact utilization of Part D drugs. The term “access/performance
rebates” refers to rebates manufacturers provide to pharmacies that are designed to
prefer, protect, or maintain that manufacturer’s product selection by the pharmacy or to
increase the volume of that manufacturer’s products that are dispensed by the pharmacy
under its formulary (referred to as “moving market share”). As evidence that they are
managing and monitoring drug utilization, Part D Sponsors must report these data to CMS
for oversight. CMS recognizes the importance of maintaining confidentiality of these
records.
Access/performance rebates received and reported by pharmacies will be reported at
either the CMS Part D Sponsor or Contract level. Data should include rebates received for
all Part D drugs, not limited to formulary/covered drugs. Rebate information should be
reported for each applicable NDC. The quarterly reported totals are not cumulative YTD
totals.
Special reporting cases:
• LTC pharmacy not required to report rebates: Sponsors may exercise discretion for
requiring rebate reporting from LTC pharmacies that serve less than 5% of LTC
beds in an area (“area” is defined as the state in which the LTC pharmacy is
licensed.). For this reporting exemption, the term pharmacy represents a pharmacy
organization at its highest level rather than the discrete NCPDP number or location.
A pharmacy organization that includes multiple pharmacy locations should be
considered in its entirety by a Plan to determine if that chain serves less than 5% of
the LTC beds in the respective area. For reporting purposes, however, these LTC
pharmacies must still be listed in the rebate report to CMS.
• For an individual pharmacy, that is not part of a pharmacy chain and serves
less than 5% of the LTC beds in the area, the sponsor should list the LTC
pharmacy NCPDP # in the report, leave the Manufacturer, Drug name and
Rebate unit fields blank, and enter "Not required to report" in the Technical
Notes field.
• For a pharmacy chain serving less than 5% of LTC beds of a state in which
any of its pharmacies are licensed, the sponsor should list all pharmacies by
NCPDP #, leave the Manufacturer, Drug name and Rebate unit fields blank,
and enter "Not required to report" in the Technical Notes field.
• For a pharmacy chain with multiple pharmacies serving more than 5% of LTC
beds in a state, a sponsor must list all of the chain’s pharmacies licensed in
that state and their rebates received. Any pharmacies that did not receive
rebates should be reported by listing NCPDP #, leaving the Manufacturer,
Drug name and Rebate unit fields blank, and entering "Not required to report"
in the Technical Notes field.

Page 27 of 46

•

•

If a pharmacy is licensed in multiple states and meets the criteria of 5% of
the LTC beds served in at least one state, the rebates received by that
pharmacy must be reported.
LTC pharmacy is noncompliant in reporting rebates: Sponsor should list that LTC
pharmacy NCPDP in the report, leave the Manufacturer, Drug name and Rebate
unit fields blank, and in the Technical Notes field, enter "Noncompliant".

Reporting timeline:
Reporting
Period
Data due to
CMS/HPMS

Quarter 1
January 1 March 31
September
30

Quarter 2
April 1 June 30
December
31

Quarter 3
July 1 September 30
March 31

Quarter 4
October 1 December 31
June 30

Data files to be uploaded through the HPMS at the Part D Sponsor or Contract level as
specified above.
Part D Sponsors/Contracts will provide a tab delimited text file (filename=REBATES_LTC
PHARMACIES_(CONTRACTNAME)_( CONTRACTYEAR).txt, replacing
‘(CONTRACTNAME)’ with the Part D Sponsor’s name and ‘with the appropriate contract
year containing the following fields.
LTC Rebates File Record Layout:
Field Name

Field Type

Field
Length
100

LTC Pharmacy
Name
NCPDP #

CHAR
REQUIRED
CHAR
REQUIRED

NPI Number

CHAR
OPTIONAL

10

NDC

CHAR
REQUIRED

11

Manufacturer
Name

CHAR
REQUIRED

100

Drug Name

CHAR
REQUIRED

100

7

Field Description
For each rebate, provide the
name of the LTC pharmacy.
Indicate the contracted LTC
pharmacy NCPDP number.
This field should be a 7
character long string using 0
– 9.
Indicate the contracted LTC
pharmacy NPI (National
Provider Identifier) number.
Provide the 11-digit NDC
associated with this rebate.
For each rebate, provide the
contracting manufacturer
name.
For each rebate, provide the
brand name.

Page 28 of 46

Rebate $ / Unit

NUM
REQUIRED

17

Provide the contractual per
unit rebates received during
the reporting period (cash
basis) associated with the
listed drug.
• Limit to
999999999999.9999
• Can be a negative
number.

Technical Notes

CHAR
OPTIONAL

4000

Provide any technical notes
regarding the LTC pharmacy
rebate calculations.

Page 29 of 46

Section XIV. Licensure and Solvency, Business Transactions and Financial
Requirements
Title I, Part 423, Subpart I includes regulations regarding Licensure and Solvency. Part D
Sponsors and will be responsible for reporting multiple data elements and documentation
related to their licensure and solvency and other financial requirements. Employer/Union
Direct Contract PDPs (Direct Contract PDP) will be responsible for reporting multiple data
elements and documentation related to their solvency and other financial requirements.
Direct Contract PDPs are employers or unions that directly contract with CMS to offer a
Part D plan exclusively to the employer’s/union’s retirees. Documentation required in
Subsections l and ll will be uploaded into the Fiscal Soundness Module in HPMS. Data
elements required under Subsection lll will be entered into the Fiscal Soundness Module in
HPMS. Thus, documentation will no longer be mailed to CMS, nor will data will entered
into the Part D Reporting Module in HPMS. Documentation requirements are listed
separately for Part D PDPs and Direct Contract PDPs. These data will be used to ensure
Part D PDPs and Direct Contract PDPs continue to be fiscally solvent entities.
•
•
•

Subsection I. Financial and Solvency Requirements Documentation - Part D PDPs
Subsection II. Financial and Solvency Requirements Documentation – Direct
Contract PDPs
Subsection III. Financial and Solvency Requirements HPMS data– Part D PDPs
and Direct Contract PDPs

Reporting timeline:
Quarter 1 Quarter 2
YTD
YTD
Reporting
Period
Data due to
CMS/HPMS

January 1
March 31
May 15

Quarter 3
YTD

January 1 January 1 September 30
June 30
August 15 November 15

Annual

January 1 December 31
120 days after the end of the
calendar year or within 10
days of the receipt of the
Annual Audited F/S whichever
is earlier.

I. Financial and Solvency Requirements Documentation for Part D PDP Contracts:
A. According to the quarterly time periods specified above, Part D PDP Contracts that are
licensed will submit the following completed Health Blank form pages directly to CMS:
• Jurat;
• Assets;
• Liabilities, Capital and Surplus;
• Statement of Revenue and Expenses;
• Capital and Surplus Account; and
• Cash Flow;

Page 30 of 46

B.

C.

D.

E.

F.

G.

H.

Note: CMS will accept a copy of the Health Blank form submitted to the state in
its entirety.
According to the quarterly time periods specified above, non-licensed Part D PDP
Contracts will submit un-audited financial statements, which convey the same
information contained in the Health Blank form, directly to CMS. An alternative for nonlicensed Part D PDP Contracts would be to complete the Health Blank pages as
prescribed in A. above.
According to the quarterly time periods specified above, non-licensed Part D PDP
Contracts will submit documentation showing that an insolvency deposit of $100,000 is
being held in accordance with CMS requirements by a qualified financial institution.
According to the quarterly time periods specified above, Part D PDP Sponsors not
licensed in any state must submit documentation that demonstrates they possess the
allowable sources of funding to cover projected losses for the greater of 7.5% of the
aggregated projected target amount for a given year or resources to cover 100% of any
projected losses in a given year. This documentation should include a worksheet
indicating how they arrived at the aggregated projected target amount. Pro-forma
financial statements including the balance sheet, income statement and statement of
cash flows projecting through the next 12 months by quarter. Enrollment projections
through the next 12 months by quarter. Guarantees, letters of credit and other
documents essential to demonstrating that the funding for projected losses requirement
has been met must also be included.
All Part D PDP contracts will submit a copy of their independently audited financial
statements (which are statutory based or GAAP based) with a management letter
within one hundred twenty days following their fiscal year end or within 10 days of
receipt of those statements, whichever is earlier directly to CMS. Licensed entities may
not report under GAAP for a period longer than 36 months.
All Part D PDP Contracts will submit a copy of an Actuarial Opinion by a qualified
actuary within one hundred twenty days following their fiscal year end directly to CMS.
The opinion should address the assumptions and methods used in determining loss
revenues, actuarial liabilities, and related items.
According to the quarterly time periods specified above, Part D PDP sponsors with any
state licensure waivers must submit an update on the status of obtaining licensure for
each waived state.
Per § 423.514 each Part D sponsor must report to CMS annually, within 120 days of
the end of the fiscal year, significant business transactions, between the Part D
sponsor and a party in interest.
Documentation submitted should include the following:
1. A description of the transaction or transactions taking place with the party in
interest.
2. Identification of the party in interest and an explanation of how that party meets
the definition of a party in interest.
3. The costs incurred during the fiscal year relating to the transactions between the
party in interest and the Part D sponsor and what those costs would have been if
incurred at fair market value. If the costs incurred exceed fair market value,
provide an explanation justifying that the costs are consistent with prudent
management and fiscal soundness requirements.
4. Combined financial statements for the Part D plan sponsor and a party in
interest if 35% or more of the costs of operation of the Part D sponsor go to a
Page 31 of 46

party in interest, or 35% or more of the revenue of a party in interest is from the
Part D sponsor.

II. Financial and Solvency Requirements Documentation for Direct Contract PDPs:
A. According to the quarterly time periods specified above, Direct Contract PDPs will
submit un-audited financial statements directly to CMS.
B. According to the quarterly time periods specified above, Direct Contract PDPs will
submit documentation showing that an insolvency deposit of $100,000 is being held in
accordance with CMS requirements by a qualified financial institution (unless CMS
waived this requirement in writing with respect to the sponsor).
C. Direct Contract PDPs will submit a copy of their independently audited financial
statements with a management letter within one hundred twenty days following their
fiscal year end or within 10 days of receipt of those statements, whichever is earlier
directly to CMS.
D. All Direct Contract PDPs will submit a copy of their credit rating (or, if they have no
credit rating, a Dun & Bradstreet report) on a quarterly basis directly to CMS as follows:
For Quarter 1:
May 15th
For Quarter 2:
Aug. 15th
For Quarter 3:
Nov. 15th
For Quarter 4:
Feb. 15th
E. All Direct Contract PDPs will submit an ERISA Sec. 411(a) attestation directly to CMS
by February 15th.

III. Financial and Solvency Requirements data elements to be entered into HPMS –
For Part D PDP Contracts / Direct Contract PDPs:
The following data is to be entered into HPMS. For Part D PDP Contracts, the following is
to be entered at the Part D Contract level per the NAIC #. Each Contract-NAIC# entity will
be listed under each contract.
A. Total assets as of the end of the quarterly reporting period identified above. This
should be a currency field.
B. Total liabilities as of the end of the quarterly reporting period identified above. This
should be a currency field.
C. Cash from operations as of the end of the quarterly reporting period identified above.
This should be a currency field.
D. Cash and short term investments as of the end of the reporting period identified above.
This should be a currency field.
E. Total current assets as of the end of the quarterly reporting period identified above.
This should be a currency field.
F. Total current liabilities as of the end of the quarterly reporting period identified above.
This should be a currency field.
G. Total revenue as of the end of the quarterly reporting period identified above. This
should be a currency field.
H. Total expenses as of the end of the quarterly reporting period identified above. This
should be a currency field.
Page 32 of 46

I. Total administrative expense as of the end of the quarterly reporting period identified
above. This should be a currency field. NOTE: Direct Contract PDPs are waived from
this element
J. Total net income as of the end of the quarterly reporting period identified above. This
should be a currency field.
K. Drug benefit expenses (excluding administrative expenses) as of the end of the
quarterly reporting time period. Drug benefit expenses are paid claims costs which
would be comprised of negotiated costs and dispensing fees less member share. This
should be a currency field.
L. Drug benefit revenues as of the end of the quarterly reporting period. Drug benefit
revenues would include premiums, CMS subsidies, rebates and other reinsurance.
This should be a currency field.

Page 33 of 46

Section XV. Drug benefit analyses
Part D Sponsors must provide enrollees with coverage of benefits as described within
§423.104. For the purposes of CMS review, Plans (PBPs) will be required to report
multiple data elements related to their provision of Part D benefits. HPMS will display each
Plan’s benefit design for integration with the data reported by Part D Sponsors. If a
Plan does not have a coverage gap, the Plan should list the number of people who are
pre-catastrophic in the data element D (non-LIS) and E (LIS) fields, and then indicate zero
in the data element F (non-LIS) or G (LIS) fields. If a PBP does not have a deductible,
HPMS will not display data fields B or C.
Reporting timeline: Part D Sponsors will provide data on a monthly basis to CMS.
Quarter 1
Quarter 2
Quarter 3
Quarter 4
2/1
3/1
4/1
5/1
6/1
7/1 8/1 – 9/1 – 10/1
11/1 12/1
Reporting 1/1
–
–
–
–
–
–
–
8/31
9/30
–
–
–
Period
1/31 2/28 3/31 4/30 5/31 6/30 7/31
10/31 11/30 12/3
1
3/31 4/30 5/31 6/30 7/31 8/31 9/30 10/31 11/30 12/31 1/31 2/28
Data due
to CMS/
HPMS
Data elements to be entered into the HPMS at the Plan (PBP) level:
A. HPMS will display each Plan’s benefit design (e.g. defined standard, enhanced
alternative)
B. The total number of non-LIS enrollees in the deductible phase as of the last day of the
month.
C. The total number of LIS enrollees in the deductible phase as of the last day of the
month. [List all LIS beneficiaries for all subsidy levels.]
D. The total number of non-LIS enrollees in the pre-initial coverage limit phase as of the
last day of the month. (If a Plan does not have a coverage gap, the Plan should list the
number of people who are pre-catastrophic in this field, and then indicate zero in
the data element F.)
E. The total number of LIS enrollees in the pre-initial coverage limit phase as of the last
day of the month. (If a Plan does not have a coverage gap, the Plan should list the
number of people who are pre-catastrophic in this field, and then indicate zero in
the data element G.) [List all LIS beneficiaries for all subsidy levels.]
F. The total number of non-LIS enrollees in the coverage gap as of the last day of the
month. (If a Plan does not have a coverage gap, the Plan should list the number of
people who are pre-catastrophic in data element D, and then indicate zero in this field.)
G. The total number of LIS enrollees in the coverage gap as of the last day of the month.
(If a Plan does not have a coverage gap, the Plan should list the number of people who
are pre-catastrophic in data element E, and then indicate zero in this field.) [List all LIS
beneficiaries for all subsidy levels.]
H. The total number of non-LIS enrollees in the catastrophic coverage level as of the last
day of the month.

Page 34 of 46

I. The total number of LIS enrollees in the catastrophic coverage level as of the last day
of the month. [List all LIS beneficiaries for all subsidy levels.]

Page 35 of 46

Table 1. Summary of Reporting Elements
Note: this summary table is for quick reference use only. Please refer to the respective
detailed sections for full definitions, timelines, reporting level, and submission procedures.
Section Section
Element
Format
Frequency HPMS
I.
Retail, Home
Percentage of Medicare
Numeric Annually
Yes
Infusion, and
beneficiaries living within 2
Long-Term
miles of a retail network
Care Pharmacy pharmacy in urban areas of
Access
a Plan’s service area (by
State for PDPs and regional
PPOs, and by service area
for local MA-PD plans)
Percentage of Medicare
Numeric Annually
Yes
beneficiaries living within 5
miles of a retail network
pharmacy in suburban
areas (by State for PDPs
and regional PPOs, and by
service area for local MAPD plans)
Percentage of Medicare
Numeric Annually
Yes
beneficiaries living within 15
miles of a retail network
pharmacy in rural areas (by
State for PDPs and regional
PPOs, and by service area
for local MA-PD plans)
The number of contracted
Numeric Annually
Yes
retail pharmacies in a Plan’s
service area (by State for
PDPs and regional PPOs,
and by service area for local
MA-PD plans)
Pharmacies_(CONTRACTN Excel file Annually
Yes
AME)_(CONTRACTYEAR).
xls
Numeric Annually
Yes
For only those MA-PD and
cost plans that own and
operate their own retail
pharmacies and have
received a waiver of the any
willing pharmacy
requirement - Number of
Prescriptions provided by all
retail pharmacies owned
and operated
Page 36 of 46

Section

II.

III.

Section

Access to
Extended Day
Supplies at
Retail
Pharmacies
Vaccines

Element
For only those MA-PD and
cost plans that own and
operate their own retail
pharmacies and have
received a waiver of the any
willing pharmacy
requirement - Number of
prescriptions provided at all
retail pharmacies contracted
For only those MA-PD and
cost plans that own and
operate their own retail
pharmacies and have
received a waiver of the
retail pharmacy convenient
access standards - Number
of prescriptions provided by
retail pharmacies owned
and operated
For only those MA-PD and
cost plans that own and
operate their own retail
pharmacies and have
received a waiver of the
retail pharmacy convenient
access standards - Number
of prescriptions provided at
all retail pharmacies
contracted
The number of contracted
retail pharmacies that are
contracted to dispense an
extended day supply of
covered Part D drugs
The total number of Part D
vaccines processed
regardless of the method
used to process the claim

Page 37 of 46

Format
Numeric

Frequency
Annually

HPMS
Yes

Numeric

Annually

Yes

Numeric

Annually

Yes

Numeric

One Quarter Yes
will be
collected
Annually

Numeric

Quarterly

Yes

Section

IV.

Section

Medication
Therapy
Management
Programs
(MTMP)

Element
The number of Part D
vaccines provided in any
out-of-network setting
where a state recognized
immunizer dispenses a Part
D vaccine (e.g. physician’s
office) where the beneficiary
retrospectively files paper
receipts for reimbursement
of the vaccine
The number of vaccines
adjudicated through network
pharmacies. (Including
those vaccines processed
by the pharmacy and
submitted electronically)
The number of vaccines
processed through a paper
enhanced process, where
the provider used or
navigated a process that
facilitated out-of-network
access
The number of vaccines
processed through an
internet based web tool
The number of vaccines
through a process not
described in data elements
B through E
The method used to enroll
beneficiaries into the MTMP
Number of beneficiaries
who met the eligibility
criteria for the MTMP
Number of beneficiaries
who participated in the
MTMP
Number of beneficiaries
who discontinued
participation from the MTMP
Number of beneficiaries
who discontinued
participation from the MTMP
due to death

Page 38 of 46

Format
Numeric

Frequency
Quarterly

HPMS
Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Text

Semiannually
Semiannually

Yes

Numeric

Semiannually

Yes

Numeric

Semiannually

Yes

Numeric

Semiannually

Yes

Numeric

Yes

Section

Section

V.

Generic Drug
Utilization

VI.

Grievances

Element
Number of beneficiaries
who discontinued
participation from the MTMP
due to disenrollment from
the Plan
Number of beneficiaries
who discontinued
participation from the MTMP
at their request
Number of beneficiaries
who discontinued
participation from the MTMP
for a reason not specified in
data elements E-G
Number of beneficiaries
who declined to participate
in the MTMP
Number of beneficiaries
whose participation status in
the MTMP is pending
Prescription cost of all
medications for all
beneficiaries participating in
the MTMP (as of the last
day of the reporting period
specified) on a per MTMP
beneficiary per month basis
Number of covered Part D
30-day equivalent
prescriptions on a per
MTMP beneficiary per
month basis
Data file containing various
data fields for beneficiaries
identified as being eligible
for the Medication Therapy
Management Program
Total number of paid claims
for generic drugs
Total number of paid claims
Number of fraud and abuse
grievances received
Number of
enrollment/disenrollment
grievances received

Page 39 of 46

Format
Numeric

Frequency
Semiannually

HPMS
Yes

Numeric

Semiannually

Yes

Numeric

Semiannually

Yes

Numeric

Semiannually

Yes

Numeric

Semiannually

Yes

Currency Semiannually

Yes

Numeric

Semiannually

Yes

Tab
delimited
text file

Annually

No

Numeric

Quarterly

Yes

Numeric
Numeric

Quarterly
Quarterly

Yes
Yes

Numeric

Quarterly

Yes

Section

VII.

VIII.

Section

Pharmacy &
Therapeutics
Committees/
Provision of
Part D
Functions

Transition

Element
Number of benefit package
grievances received
Number of pharmacy
access/network grievances
received
Number of marketing
grievances received
Number of customer service
grievances received
Number of
confidentiality/privacy
grievances received
Number of quality of care
grievances received
Number of exception
grievances received
Number of appeal
grievances received
Number of other grievances
received
Total number of grievances
Total number of LIS
grievances
Indicate if changes in P&T
Committee membership.
If changes, indicate if these
are reflected within Contract
Management module.
Indicate if changes have
occurred in organizations
providing Part D functions.
If changes, indicate if these
are reflected within Contract
Management module.
Minimum number of days
supply the Plan’s transition
policy provides for its onetime, temporary fill for
enrollees in the retail
setting.
Minimum number of days,
beginning on the enrollee’s
effective date of coverage,
in a plan’s transition
process for enrollees in the
retail setting
Page 40 of 46

Format
Numeric

Frequency
Quarterly

HPMS
Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric
Numeric

Quarterly
Quarterly

Yes
Yes

Text

Quarterly

Yes

Text

Quarterly

Yes

Text

Quarterly

Yes

Text

Quarterly

Yes

Numeric

One Quarter Yes
will be
collected
Annually

Numeric

One Quarter Yes
will be
collected
Annually

Section

IX.

Section

Exceptions

Element
Minimum number of days
supply the Plan’s transition
policy provides for its
temporary fill (with multiple
refills as necessary) for
enrollees in the LTC setting.
Minimum number of days,
beginning on the enrollee’s
effective date of coverage,
in a plan’s transition
process for enrollees in the
LTC setting
Minimum transition period
has expired, the minimum
number of days supply the
Plan provides to LTC
enrollees for an emergency
supply of non-formulary Part
D drugs while an exception
is being processed
Maximum number of
business days after a
temporary transition fill
within which the Plan will
send a written transition
notice via U.S. first class
mail
Number of pharmacy
transactions rejected due to
failure to complete step edit
requirements
Number of pharmacy
transactions rejected due to
need for prior authorization
(not including first pass step
therapy edits or early refills)
Number of pharmacy
transactions rejected due to
quantity limits in the time
period specified above.
Number of prior
authorizations requested for
formulary medications (not
including first pass step
therapy edits or early refills)

Page 41 of 46

Format
Numeric

Frequency HPMS
One Quarter Yes
will be
collected
Annually

Numeric

One Quarter Yes
will be
collected
Annually

Numeric

One Quarter Yes
will be
collected
Annually

Numeric

One Quarter Yes
will be
collected
Annually

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Section

X.

Section

Appeals

Element
Number of prior
authorizations approved for
formulary medications (not
including first pass step
therapy edits or early refills)
Number of exceptions
requested for non-formulary
medications (not including
early refills)
Number of exceptions
approved for non-formulary
medications (not including
early refills)
Number of exceptions
requested for tier
exceptions (not including
first pass step therapy edits
or early refills)
Number of exceptions
approved for tier exceptions
(not including first pass step
therapy edits or early refills)
Number of exceptions
requested for quantity limits
(not including early refills)
Number of exceptions
approved for quantity limits
(not including early refills)
Number of appeals
submitted for standard
redetermination
Number of appeals
submitted for expedited
redetermination
Number of appeals
submitted for expedited
redetermination that were
granted expedited status
Number of appeals
submitted for standard
redetermination withdrawn
by the enrollee
Number of appeals
submitted for expedited
redetermination withdrawn
by the enrollee
Page 42 of 46

Format
Numeric

Frequency
Quarterly

HPMS
Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Section

Section

Element
Number of redeterminations
resulting in full reversal of
original decision
Number of redeterminations
resulting in partial reversal
of original decision
Number of adverse
redeterminations due to
insufficient evidence of
medical necessity from
enrollee’s prescribing
physician
Number of appeals
submitted for IRE
reconsideration due to
inability to meet timeframe
for coverage
determination
Number of appeals
submitted for IRE
reconsideration due to
inability to meet timeframe
for redetermination
Number of IRE decisions for
standard reconsideration
resulting in full reversal of
original coverage
determination or
redetermination
Number of IRE decisions for
standard reconsideration
resulting in partial reversal
of original coverage
determination or
redetermination
Number of IRE decisions for
expedited reconsideration
resulting in full reversal of
original coverage
determination or
redetermination

Page 43 of 46

Format
Numeric

Frequency
Quarterly

HPMS
Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Section

XI.

XII.

XIII.

XIV.

Section

Element
Number of IRE decisions for
expedited reconsideration
resulting in partial reversal
of original coverage
determination or
redetermination
Number of IRE decisions for
standard reconsideration
resulting in upholding of
original coverage
determination or
redetermination
Number of IRE decisions for
expedited reconsideration
resulting in upholding of
original coverage
determination or
redetermination
Overpayment
Total overpayment dollars
identified to be recouped
Total overpayment dollars
recouped
Pharmaceutical REBATES_(SPONSORNA
Manufacturer
ME)_(CONTRACTYEAR).tx
Rebates,
t
Discounts, and DISCOUNTS_(SPONSORN
Other Price
AME)_(CONTRACTYEAR).t
Concessions
xt
Long-term Care REBATES_LTCPHARMACI
(LTC) Rebates ES_(CONTRACT)_(CONTR
ACTYEAR).txt
Licensure and
Licensed Part D PDP
Solvency,
Contracts will submit
Business
Completed Health Blank
Transactions
form pages: Jurat, Assets,
and Financial
Liabilities, Capital and
Requirements
Surplus, Statement of
Revenue and Expenses,
Capital and Surplus
Account, and Cash Flow
OR
Non-licensed Part D PDP
Contracts will submit unaudited financial statements

Page 44 of 46

Format
Numeric

Frequency
Quarterly

HPMS
Yes

Numeric

Quarterly

Yes

Numeric

Quarterly

Yes

Currency SemiAnnually
Currency SemiAnnually
Tab
Quarterly
delimited
text file
Tab
Quarterly
delimited
text file
Tab
Quarterly
delimited
text file
Mailed to Quarterly
CMS

Yes
Yes
Yes

Yes

Yes

No

Section

Section

Element
Documentation showing
that an insolvency deposit
of $100,000 is being held
(for non-licensed Part D
PDP Contracts and Direct
Contract PDPs)
Funding for projected losses
worksheet (for non-licensed
Part D PDP Contracts only)
Independently audited
financial statement with a
management letter for Part
D PDPs and Direct Contract
PDPs
Copy of an Actuarial
Opinion by a qualified
actuary for the Part D PDP
Documentation on the
status of obtaining licensure
for each waived state (for
Part D PDP Contracts with
any state licensure waivers
only)
Documentation of significant
business transactions
Un-audited financial
statements for Direct
Contract PDPs
Copy of credit rating for
Direct Contract PDPs
ERISA Sec. 411(a)
attestation for Direct
Contract PDPs s
Total assets
Total liabilities
Total cash
Total cash equivalents
Total current assets
Total current liabilities
Total revenue
Total expenses
Total administrative
expense
Total net income

Page 45 of 46

Format
Frequency
Mailed to Quarterly
CMS

HPMS
No

Mailed to Quarterly
CMS

No

Mailed to Yearly
CMS
(fiscal)

No

Mailed to Yearly
CMS
(fiscal)

No

Mailed to Quarterly
CMS

No

Mailed to Yearly
CMS
(fiscal)
Mailed to Quarterly
CMS

No
No

Mailed to Quarterly
CMS
Mailed to Yearly
CMS

No

Currency
Currency
Currency
Currency
Currency
Currency
Currency
Currency
Currency

Quarterly
Quarterly
Quarterly
Quarterly
Quarterly
Quarterly
Quarterly
Quarterly
Quarterly

Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes

Currency Quarterly

Yes

No

Section

Section

XV.

Part D Benefit
Analyses

Element
Drug benefit expenses
(excluding administrative
expenses)
Drug benefit revenues
Total number of non-LIS
enrollees in the deductible
phase
Total number of LIS
enrollees in the deductible
phase
Total number of non-LIS
enrollees in the pre-initial
coverage limit phase
Total number of LIS
enrollees in the pre-initial
coverage limit phase
Total number of non-LIS
enrollees in the coverage
gap
Total number of LIS
enrollees in the coverage
gap
Total number of non-LIS
enrollees in the catastrophic
coverage level
Total number of non-LIS
enrollees in the catastrophic
coverage level

Page 46 of 46

Format
Frequency
Currency Quarterly

HPMS
Yes

Currency Quarterly
Numeric Monthly

Yes
Yes

Numeric

Monthly

Yes

Numeric

Monthly

Yes

Numeric

Monthly

Yes

Numeric

Monthly

Yes

Numeric

Monthly

Yes

Numeric

Monthly

Yes

Numeric

Monthly

Yes