Form CMS-10185 CY 2013 Part D Reporting Requirements

MEDICARE PART D
REPORTING REQUIREMENTS

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please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail
Stop C4-26-05, Baltimore, Maryland 21244-1850.

Effective as of January 1, 2013

Table of Contents
Introduction… ................................................................................................................... 3

Section I.

Enrollment and Disenrollment ..................................................................... 5

Section II.

Retail, Home Infusion, and Long-Term Care Pharmacy Access ................. 7

Section III.

Medication Therapy Management Programs............................................. 10

Section IV.

Prompt Payment by Part D Sponsors ........................................................ 12

Section V.

Grievances ................................................................................................ 14

Pharmacy & Therapeutics (P&T) Committees/ Provision of Part D Functions ................ 16
Section VI.

Coverage Determinations and Exceptions ................................................ 17

Section VII. Redeterminations ...................................................................................... 19
Section VIII. Long-Term Care (LTC) Utilization ............................................................. 20
Section IX.

Fraud, Waste and Abuse Compliance Programs ...................................... 22

Section X.

Employer/Union-Sponsored Group Health Plan Sponsors ........................ 24

Section XI.

Plan Oversight of Agents ........................................................................... 26

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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)
2)
3)
4)
5)

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.

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,or the individual contract level. These
requirements 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.
Sponsors are required undergo data validation to have some of their Part D data
audited. Each Part D Sponsor shall provide necessary data to CMS to support payment,
program integrity, program management, and quality improvement activities. Additional
reporting requirements are identified in separate guidance documents throughout the year.
Guidance has been separately released for data validation, 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, guidances, or other documents (e.g. pharmacy access and
formularies) during the annual contract bidding, application, or renewal process.
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Information is also required to be submitted throughout the contract year as allowable
changes are made (e.g. formulary changes).
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. Reporting deadlines may occur in the subsequent
calendar year. Unless otherwise specified, drug utilization data should include all covered*
Part D drugs, including compounded drugs.
PACE Organizations offering Part D coverage are exempt from these Part D reporting
requirements.
MA Organizations and Medicare Cost Plans (1876 plans only) that offer Part D benefits will
be required to comply with all reporting requirements contained herein, with the exception
of the Employer/Union-Sponsored Group Health Plan Sponsors reporting section, and the
Plan Oversight of Agents reporting section.
*Covered Part D drug as defined by Section 1860D-2(e)(2) of the MMA. Drugs offered
under enhanced or supplemental drug benefits by Sponsors are not covered Part D drugs.

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Section I.

Enrollment and Disenrollment

CMS provides guidance for Part D sponsors’ processing of enrollment and
disenrollment requests.
Both Chapter 2 of the Medicare Managed Care Manual and Chapter 3 of the
Medicare Prescription Drug Manual outline the enrollment and disenrollment
periods (Section 30) enrollment (Section 40) and disenrollment procedures
(Section 50) for all Medicare health and prescription drug plans.
CMS will collect data on the elements for these requirements, which are
otherwise not available to CMS, in order to evaluate sponsors’ processing of
enrollment and disenrollment requests in accordance with CMS requirements.
For example, while there are a number of factors that result in an individual’s
eligibility for a Special Enrollment Period (SEP), sponsors are currently unable to
specify each of these factors when submitting enrollment transactions. Sponsors’
reporting of data regarding SEP reasons for which a code is not currently
available will further assist CMS in ensuring sponsors are providing support to
beneficiaries, while complying with CMS policies.
Data elements 1.A-1.O must include all enrollments (code 61 transactions).
Disenrollments must not be included in Section 1 Enrollment.
Section 2 Disenrollment must include all voluntary disenrollment transactions.
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:
1. Enrollment:
A. The total number of enrollment requests received in the specified time
period.
B. Of the total reported in A, the number of enrollment requests complete at
the time of initial receipt (i.e. required no additional information from
applicant or his/her authorized representative).
C. Of the total reported in A, the number of enrollment requests that required
requests for additional information.

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D. Of the total reported in A, the number of enrollment requests denied due
to the Sponsor’s determination of the applicant’s ineligibility to elect the
plan (e.g. individual not having a valid enrollment period).
E. Of the total reported in C, the number of incomplete enrollment requests
received that are completed within established timeframes.
F. Of the total reported in C, the number of enrollment requests denied due
to the applicant or his/her authorized representative not providing
information to complete the enrollment request within established
timeframes.
G. Of the total reported in A, the number of paper enrollment requests
received.
H. Of the total reported in A, the number of telephonic enrollment requests
received (if offered).
I. Of the total reported in A, the number of internet enrollment requests
received via plan website (if offered).
J. Of the total reported in A, the number of Online Enrollment Center (OEC)
enrollment requests received.
K. For stand-alone prescription drug plans (PDPs) only: Of the total reported
in A, the number of enrollment requests effectuated by sales persons (as
defined in Chapter 3 of the Medicare Managed Care Manual).
L. Of the total reported in A, the number of enrollment transactions submitted
using the SEP Election Period code "S" related to creditable coverage.
M. Of the total reported in A, the number of enrollment transactions submitted
using the SEP Election Period code "S" related to SPAP.
N. For stand-alone prescription drug plans (PDPs) only: Of the number
reported in A, the total number of enrollment transactions submitted using
the SEP Election Period code "S" that coordinates with the Medicare
Advantage Disenrollment Period.
O. Of the total reported in A, the number of enrollment transactions submitted
using the SEP Election Period Code “S” for individuals affected by a
contract nonrenewal, plan termination or service area reduction.
2. Disenrollment:
A. The total number of voluntary disenrollment requests received in the
specified time period.
B. Of the total reported in A, the number of disenrollment requests complete
at the time of initial receipt (i.e. required no additional information from
enrollee or his/her authorized representative).
C. Of the total reported in A, the number of disenrollment requests denied by
the Sponsor for any reason.

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Section II.

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 for the Part D applications and
will be posted on the Prescription Drug Contracting, Application Guidance section
of CMS’ website in
January(http://www.cms.hhs.gov/PrescriptionDrugCovContra/04_RxContracting_
ApplicationGuidance.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), and adequate access to home
infusion pharmacies as provided in §423.120(a)(4).
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.
Submission of supporting documentation with the data elements below is not
required; however, CMS reserves the right to request appropriate documentation
to support a Part D Sponsor’s submitted pharmacy networks. CMS evaluation of
compliance with pharmacy access standards will be conducted based on point-

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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:
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 Section 1 only:
Period 1
Reporting Period
January 1 - March 31
Data due to CMS/HPMS

May 31

Data files to be uploaded through the HPMS at the Contract level, following
templates provided in HPMS.
1. Network Pharmacy data files, as of the last day of the reporting period
specified above:
A. A list of contracted network retail pharmacies, including preferred/nonpreferred status as applicable to network design;
B. A list of contracted Home Infusion pharmacies, and
C. A list of contracted Long-term Care pharmacies.
Please note that contracts will be required to submit pharmacy data using
only the NPI number.
Reporting timeline for Sections 2 and 3 only:
YTD
Reporting Period

January 1 – December 31

Data due to CMS/HPMS

February 28

Data elements to be entered into the HPMS at the Plan (PBP) level:
2. For MA-PD and cost plans that own and operate their own pharmacies
and have received a waiver of the any willing pharmacy requirement:

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A. Number of prescriptions provided by all pharmacies owned and operated
by the plan.
B. Number of prescriptions provided at all pharmacies contracted by the plan.
3. For 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: (These plans are not exempt from
reporting retail pharmacy data).
A. Number of prescriptions provided by retail pharmacies owned and
operated by the plan.
B. Number of prescriptions provided at all retail pharmacies contracted by the
plan.

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Section III. Medication Therapy Management Programs
The requirements stipulating that Part D Sponsors provide Medication Therapy
Management (MTM) programs 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 MTM program. Data will be
uploaded in a data file.
Reporting timeline:
Reporting Period

YTD
January 1 - December 31

Data due to CMS/HPMS

February 28

Sponsors are required to target beneficiaries for the MTM program who meet
specific criteria as specified by CMS in § 423.153(d). Some sponsors also offer
enrollment in the MTM program to other members who do not meet the specific
CMS targeting criteria.
The following information will be collected for each beneficiary identified as being
eligible for the Part D MTM program, whether based on CMS’ specifications or
other plan-specific targeting criteria within the reporting period. Regardless of
this designation, the corresponding MTM services delivered to each beneficiary
(such as targeted medication review or comprehensive medication review) must
meet CMS definitions. The reported beneficiaries must receive MTM services
that meet or exceed CMS’ MTM program requirements.
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.

L.

Contract Number.
HICN or RRB Number.
Beneficiary first name.
Beneficiary middle initial.
Beneficiary last name.
Beneficiary date of birth.
Met the specified targeting criteria per CMS – Part D requirements. (Y
(yes) or N (no)).
Long term care (LTC) facility resident (at any time in period). (Y (yes), N
(no), or U (unknown)).
Beneficiary identified as cognitively impaired. (Y (yes), N (no), or U
(unknown)).
Date of MTM program enrollment.
Date met the specified targeting criteria per CMS – Part D requirements.
Required if met the specified targeting criteria per CMS – Part D
requirements. (May be same as Date of MTM program enrollment)
Date of MTM program opt-out.

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M. Reason participant opted-out of MTM program (Death; Disenrollment from
Plan; Request by beneficiary; or Other). Required if Date of MTM
program opt-out is applicable.
N. Offered annual comprehensive medication review (CMR).(Y (yes), N (no)).
Required if met the specified targeting criteria per CMS – Part D
requirements.
O. If offered, date of (initial) offer.
P. Received annual CMR with written summary in CMS standardized format.
(Y (yes) or N (no)). Required if offered annual CMR.
Q. Number of CMRs received with written summary in CMS standardized
format. Required if received annual CMR.
R. Date(s) of CMR(s) with written summary in CMS standardized format. (If
more than 1 CMR is received, up to 5 dates will be allowed.) Required if
received annual CMR.
S. Method of delivery for the annual CMR. (Face-to-face; Telephone;
Telehealth consultation; or Other). (If more than 1 CMR is received, report
the method of delivery for the initial CMR). Required if received annual
CMR.
T. Qualified Provider who performed the initial CMR. (Physician; Registered
Nurse; Licensed Practical Nurse; Nurse Practitioner; Physician’s
Assistant; Local Pharmacist; LTC Consultant Pharmacist; Plan Sponsor
Pharmacist; Plan Benefit Manager (PBM) Pharmacist; MTM Vendor Local
Pharmacist; MTM Vendor In-house Pharmacist; Hospital Pharmacist;
Pharmacist – Other; or Other). Required if received annual CMR.
U. Recipient of CMR. (Beneficiary, Beneficiary’s prescriber; Caregiver; or
Other authorized individual). Required if received annual CMR.
V. Number of targeted medication reviews. Required if met the specified
targeting criteria per CMS – Part D requirements.
W. Number of drug therapy problem recommendations made as a result of
MTM services. (For reporting purposes, a recommendation is defined as
a suggestion to take a specific course of action related to the beneficiary’s
drug therapy. If the same recommendation is made to multiple prescribers
or repeated on multiple dates, then that recommendation should only be
counted and reported once. Examples include, but are not limited to:
Needs additional therapy; Unnecessary drug therapy; Dosage too high;
Dosage too low; More effective drug available; Adverse drug reaction; or
Medication Non-compliance/Non-adherence).
X. Number of drug therapy problem resolutions made as a result of MTM
recommendations. (For reporting purposes, a resolution is defined as a
change or variation from the beneficiary’s previous drug therapy.
Examples include, but are not limited to: Initiate drug; Change drug
(such as product in different therapeutic class, dose, dosage form,
quantity, or interval); Discontinue or substitute drug (such as discontinue
drug, generic substitution, therapeutic substitution, or formulary
substitution); Medication compliance/adherence).

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Section IV. Prompt Payment by Part D Sponsors
The Medicare Improvements for Patients and Providers Act (MIPPA) of 2008
added requirements with regard to prompt payment by Part D sponsors for all
clean claims submitted by network pharmacies within specified timeframes for
electronic and all other (non-electronically submitted) claims. Mail-order and
long-term care (LTC) pharmacies are excluded from these provisions.
Consistent with section 1860D-12(b)(4)(A)(ii) of the Act, a clean claim is defined
as a claim that has no defect or impropriety – including any lack of any required
substantiating documentation – or particular circumstance requiring special
treatment that prevents timely payment of the claim from being made. Part D
sponsors must make payment for clean claims within 14 calendar days of the
date on which an electronic claim is received and within 30 calendar days of the
date on which non-electronically submitted claims are received. Claims
submitted with 100% beneficiary responsibility, i.e., zero plan payment amount,
are excluded from this requirement (it is not possible for a Sponsor to pay a
pharmacy late for a $0.00 dollar due claim).
Receipt of an electronic claim is defined as the date on which the claim is
transferred, and receipt of a non-electronically submitted claim as the 5th
calendar day after the postmark day of the claim or the date specified in the time
stamp of the transmission, whichever is sooner.
A claim will be deemed to be a clean claim to the extent that the Part D sponsor
that receives the claim does not issue notice to the submitting network pharmacy
of any deficiency in the claim within 10 calendar days after an electronic claim is
received and within 15 calendar days after a non-electronically submitted claim is
received. A claim deemed to be a clean claim must be paid by the sponsor
within 14 calendar days (for an electronic claim) or 30 calendar days (for a nonelectronic claim) of the date on which the claim is received.
Reporting timeline:
Reporting Period

Period 1
January 1 - June 30

Period 2
July 1 - December 31

Data due to CMS/HPMS

August 31

February 28

Data elements to be entered into the HPMS at the Contract level:
A. Total number of paid claims.
B. Total number of paid electronic claims.
C. Total number of paid non-electronic (e.g. paper) claims.
D. Total number of paid electronic claims which were not paid timely,
according to appropriate time-periods.

12

E. Total number of paid non-electronic claims which were not paid timely,
according to appropriate time-periods.

13

Section V.

Grievances

According to MMA statute, a grievance is 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. Part D Sponsors are
required to notify enrollees of its decisions no later than 30 days after receiving
their grievance. An extension up to 14 days is allowed if it is requested by the
enrollee, or if the Part D Sponsor needs additional information and documents
that this extension is in the interest of the enrollee. A grievance that involves
refusal by a Part D Sponsor to process an expedited coverage determination or
redetermination requires a response from the Part D Sponsor within 24 hours.
When categorizing grievances into core categories, Plans may report based on
their investigations subsequent to the enrollees’ filing of the grievances.
For reporting, Plans should:
Report data based on the date the grievance decision was made.
Track multiple grievances by a single complainant and report as separate
grievances.
Report grievances, regardless if they are also reported in the Complaints
Tracking Module (CTM).
For reporting, Plans should not:
Report requests for coverage determinations, exceptions, or redeterminations
as grievances.
Report their CTM records to CMS as their grievance logs.
Report general inquiries or questions as grievances.
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
May 31

Quarter 2
April 1 June 30
August 31

14

Quarter 3
July 1 September 30
November 30

Quarter 4
October 1 December 31
February 28

Data to be reported at the Plan (PBP) level:
Total number
of grievances
Enrollment, plan benefits, or
pharmacy access
Customer service
Coverage determinations and
Redeterminations process (e.g.
untimely decisions)
CMS issues
Other

15

Number of grievances in which
timely notification was given

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. Part D Sponsors must
attest if changes have occurred, and if they have been communicated to CMS.
Reporting timeline for Section 1:
Reporting Period

YTD
January 1 - December 31

Data due to CMS/HPMS

February 28

Data elements to be entered into the HPMS at the Contract level:
1. P&T Committee:
A. Indicate if there have been changes in P&T committee membership during
the time period specified above.
B. 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.
Reporting timeline for Section 2:
Quarter 1
Reporting
January 1 Period
March 31
Data due to
May 31
CMS/HPMS

Quarter 2
April 1 June 30
August 31

Quarter 3
July 1 September 30
November 30

Quarter 4
October 1 December 31
February 28

2. Provision of Part D Functions:
A. Indicate if there have been changes to the organizations providing Part D
functions during the reporting period.
B. 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.

16

Section VI. Coverage Determinations and Exceptions
Title I, Part 423, Subpart M describes Part D Sponsors’ requirements for coverage
determinations, formulary and tier exceptions, and exceptions to established drug
utilization management programs including timeframes for standard and expedited
requests. Prior authorization (PA) 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 total number of pharmacy transactions in the time period above.
B. Of the total reported in A, the number of pharmacy transactions rejected due to nonformulary status.
C. Of the total reported in A, the number of pharmacy transactions rejected due to prior
authorization (PA) requirements.
D. Of the total reported in A, the number of pharmacy transactions rejected due to step
therapy requirements.
E. Of the total reported in A, the number of pharmacy transactions rejected due to
quantity limits (QL) requirements based on CMS approved formulary. Safety edits
and rejections due to early refills should be excluded.
F. Did the plan have high cost edits for compounds in place during the time period
above? ((Y (yes) or N (no)).
G. If yes to element F, the cost threshold used.
H. Did the plan have high cost edits for non-compounds in place during the time period
above? ((Y (yes) or N (no)).
I. If yes to element H, the cost threshold used.
J. Of the total reported in A, the total number of claims rejected due to high cost edits
for compounds.
K. Of the total reported in A, the total number of claims rejected due to high cost edits
for non-compounds.
Prior authorizations:
L. Total number of PA
decisions made in the
reporting period

M. Number of timely PA
decisions in the reporting
period

17

N. Number of favorable
PA decisions(PA
requirements
satisfied) in the
reporting period

Exceptions to prior authorization (PA) requirements:
O. Total number of decisions
P. Number of timely PA
for PA exceptions made in
exception decisions in the
the reporting period
reporting period

Exceptions to step therapy requirements:
R. Total number of decisions
S. Number of timely step
for exceptions to step
therapy exception
therapy requirements made
decisions in the reporting
in the reporting period
period

Exceptions to quantity limits (QL) requirements:
U. Total number of decisions
V. Number of timely QL
for exceptions to QL
exception decisions in the
requirements made in the
reporting period
reporting period

Q. Number of favorable
PA exception
decisions in the
reporting period

T. Number of favorable
step therapy
exception decisions
in the reporting
period

W. Number of
favorable QL
exception decisions
in the reporting
period

Tier exceptions:
X. Total number of decisions
for tier exceptions made in
the reporting period

Y. Number of timely tier
exception decisions in the
reporting period

Z. Number of
favorable tier
exception decisions
in the reporting
period

Formulary exceptions:
AA. Total number of
decisions for formulary
exceptions made in the
reporting period

BB. Number of timely
formulary exception
decisions in the reporting
period

CC. Number of
favorable formulary
exception decisions
in the reporting
period

18

Section VII. Redeterminations
Title I, Part 423, Subpart M includes regulations regarding 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. Redeterminations may result in reversal or partial reversal
of the original decision. Part B vs. Part D redeterminations should be included in this
reporting. Sponsors should report data based on the date the redetermination decision
was made.
Example of an approved redetermination: Non-formulary exception request
approved upon redetermination for drug and quantity prescribed.
Example of a partially approved redetermination: Non-formulary exception request
approved upon redetermination for drug, but full quantity prescribed not approved.
CMS will request redeterminations 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. Total number of
B. Of the total
C. Of the total
D. Of the total
redetermination
reported in A, the
reported in A, the
reported in A, the
decisions made
number of
number of
number of fully
in the reporting
redetermination
partially
favorable
period
decisions made
favorable
redetermination
within required
redetermination
decisions made
timeframes
decisions made

19

Section VIII. Long-Term Care (LTC) Utilization
LTC network pharmacies receive access/performance rebates that may create financial
incentives that conflict with Part D sponsors’ formularies or drug utilization management
(DUM) programs. These incentives can negatively impact formulary adherence as well
as overall drug costs associated with beneficiaries served by LTC pharmacies. CMS will
collect data for LTC pharmacies’ formulary and non-formulary cost and utilization, for
comparison to retail pharmacies’ cost and utilization patterns.
Sponsors will report the number of 31-day equivalent prescriptions dispensed by each
LTC pharmacy, and the aggregate number of 30-day equivalent prescriptions dispensed
by network retail pharmacies. These are calculated by summing days supply of all
covered Part D prescriptions dispensed by the respective pharmacy or group of
pharmacies, and then dividing by either 31 or 30 days. Prescription cost is defined as
the sum of ingredient cost, dispensing fee, and sales tax; the ingredient cost should
reflect the Sponsor’s negotiated price. A network LTC pharmacy is a network pharmacy
owned by or under contract with a LTC facility to provide prescription drugs to the
facility’s residents.
Reporting timeline:
Reporting Period

Period 1
January 1 - June 30

Period 2
July 1 – December 31

Data due to CMS/HPMS

August 31

February 28

Data file to be uploaded through the HPMS at the Contract level as specified below:
A. The total number of network LTC pharmacies in the service area (PDPs and
regional PPOs will report for each state, MA-PDs will report for the service area).
B. The total number of network retail pharmacies in the service area (PDPs and
regional PPOs will report for each state, MA-PDs will report for the service area).
C. The total number of beneficiaries in LTC facilities for whom Part D drugs have
been provided under the Contract.
D. For each network LTC pharmacy in the service area:
1. LTC pharmacy name;
2. LTC pharmacy NPI;
3. Contract entity name of LTC pharmacy;
4. Chain code of LTC pharmacy;
5. Number of 31-day equivalent formulary prescriptions dispensed;
6. Number of 31-day equivalent non-formulary prescriptions dispensed;
7. Cost of formulary prescriptions;
8. Cost of non-formulary prescriptions.
E. In aggregate, for all retail pharmacies in the service area:
1. Number of 30-day equivalent formulary prescriptions dispensed;
2. Number of 30-day equivalent non-formulary prescriptions dispensed;
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3. Cost of formulary prescriptions;
4. Cost of non-formulary prescriptions.

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Section IX. Fraud, Waste and Abuse Compliance Programs
Note: Employer Direct plan sponsors are exempt from this reporting section.
Compliance plan requirements for Part D Sponsors are described in 42 C.F.R.
§423.504 (b)(4)(vi)(G), including procedures to voluntarily self-report potential
fraud or misconduct related to the Part D program to CMS or its designees.
Chapter 9 of the Prescription Drug Benefit Manual, “Part D Compliance Plan to
Control Fraud, Waste and Abuse”, provides interpretive rules and guidelines to
Part D Sponsors for implementing the regulatory requirements to have a
compliance plan under 42 C.F.R. §423.504(b)(4)(vi)(A-G), and the requirement
mandated by Congress in section 1860D-4(c)(1)(D) of the Act that Part D
Sponsors have a “program to control fraud, waste and abuse”.
Part D Sponsors may voluntarily report aggregate data related to their anti-fraud,
waste and abuse activities. Aggregate reporting will allow CMS to monitor
Sponsors’ fraud, waste and abuse programs. These data will measure the types
of incidents, the sources by which incidents are identified to Sponsors, as well as
the activities taken by sponsors to respond to the incidents. Sponsors should
refer to §423.504(b)(4)(vi)(G)(1) and § 423.504(b)(4)(vi)(G)(2) for sponsors’
requirements to conduct inquiries and to design corrective actions to prevent
future misconduct as well as address underlying problems.
For this data collection, the following definitions will apply:
A fraud incident/complaint is defined as 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 incident/complaint 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.
Closed incidents include, but are not limited to, incidents with corrective
action(s) initiated and completed, and incidents referred to appropriate
authorities and accepted.
Reporting timeline:
Reporting Period

YTD
January 1 - December 31

Data due to CMS/HPMS

February 28
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Data elements to be entered into the HPMS at the Contract level:
A. The number of potential fraud and abuse incidents related to inappropriate
billing. Inappropriate billing by pharmacies should be included.
B. The number of potential fraud and abuse incidents related to providing
false information.
C. The number of potential fraud and abuse incidents related to doctor
shopping/drug seeking beneficiary.
D. The number of potential fraud and abuse incidents related to attempting to
steal identity/money.
E. The number of potential fraud and abuse incidents related to other areas
not listed above (e.g. OIG exclusion list, and broker/agent complaints).
F. The total number of potential fraud and abuse incidents identified.
G. Of the total reported in F, the number identified through internal efforts.
H. Of the total reported in F, the number of incidents received from external
sources. Incidents reported through the Complaints Tracking Module
(CTM) or as grievances should be included.
I. Of the total reported in F, the number of potential fraud and abuse
incidents that were closed.
J. The number of inquiries initiated by the Sponsor as a result of potential
fraud and abuse incidents.
K. The number of corrective actions initiated by the Sponsor as a result of
potential fraud and abuse incidents.
L. The number of potential fraud and abuse incidents referred to CMS for
action; includes referrals to CMS staff, MEDICs, or other CMS designated
program safeguard contractor.
M. The number of potential fraud and abuse incidents referred to federal law
enforcement for action. This includes referrals to the OIG, FBI, DEA, and
FDA.
N. The number of potential fraud and abuse incidents referred to local law
enforcement for action; this includes but is not limited to referrals to state,
county, township, or province police.
O. The number of potential fraud and abuse incidents referred to State
Insurance Commissioners (SICs) or state licensing authorities.

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Section X.

Employer/Union-Sponsored Group Health Plan Sponsors

NOTE: This reporting requirement applies only to individual PDPs and “800
series” PDPs offered to employers. MA-PD plans already report these data as
part of the Part C reporting requirements and are therefore exempt from this Part
D reporting section.
CMS has statutory authority to waive or modify requirements that hinder the
design of, the offering of, or the enrollment in, employer/union sponsored PDPs,
as set forth in section 1860D-22(b) of the Social Security Act. Under the abovereferenced statutory authority, PDPs are permitted to utilize these waivers to
contract with employer and union group sponsors to facilitate the enrollment of
their Medicare-eligible retirees into PDPs. (Please note that in addition to these
“indirect contract” arrangements, CMS also has separate statutory authority to
directly contract with employers and union group plan sponsors to offer a
prescription drug benefits to their retirees). When exercising our discretion to
grant these statutory waivers or modifications to PDPs offering these plans,
these waivers and/or modifications are conditioned upon the PDP meeting a set
of conditions and complying with certain requirements, which may include these
kinds of reporting requirements.
The information requested is necessary for CMS to fulfill its affirmative oversight
obligation to ensure PDPs and the employer groups that contract with the PDPs
are properly utilizing these waivers and modifications and that CMS’ statutory
waiver authority is being implemented in accordance with the requirements of
section 1860D-22(b) of the Act.
The Tax Identification Number (TIN) is the standard unique employer identifier.
The Medicare program uses the TIN to identify employers and businesses in
other areas of the program. For example, insurers are required to report TIN
information in order to comply with the mandatory Medicare Secondary Payer
insurer reporting requirements of Section 111 of the Medicare, Medicaid, and
SCHIP Extensions Act of 2007 (Public Law 110-173). Thus, some of these same
entities (such as employer/union sponsors) affected by our reporting
requirements will similarly be required by law to collect and report TIN
information to CMS for Medicare secondary payment purposes.
Collection of TINs from the employer/union sponsors as outlined above may be a
challenge for PDP sponsors. Employer/union sponsors unable or unwilling to
provide TINs or other required information should be notified by PDP sponsors
that they will be unable to utilize the waivers available to employer/union group
health plans and should work with them to explore other Medicare options for
their retirees.

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Reporting timeline:
Reporting Period

YTD
January 1 – December 31

Data due to CMS/HPMS

February 28

Data file to be uploaded through the HPMS at the Plan (PBP) level:
A. Employer Legal Name.
B. Employer DBA Name.
C. Employer Federal Tax ID.
D. Employer Address.
E. Type of Group Sponsor (employer, union, trustees of a fund).
F. Organization Type (state government, local government, publicly traded
organization, privately held corporation, non-profit, church group, other).
G. Type of Contract (insured, ASO, other).
H. Employer Plan Year Start Date.
I. Current/Anticipated enrollment.

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Section XI. Plan Oversight of Agents
NOTE: This section applies only to Sponsors of stand-alone prescription drug
plans, which do not also have MA-PD plans. Sponsors of MA-PD plans already
report these data as part of the Part C reporting requirements and are therefore
exempt from this Part D reporting section. Employer/union group plans are
exempt from this reporting section.
Sponsors are required to comply with State requests for information about the
performance of licensed agents or brokers as part of a state investigation into the
individual’s conduct. Plans are responsible for monitoring the conduct of their
agents. While the states oversee agent licensing, CMS will monitor agent
complaints to determine if Sponsors are investigating identified complaints and
imposing disciplinary actions as well as reporting poor conduct to the state.
Complaints include both complaints from the Complaint Tracking Module (CTM)
and other complaints or grievances made directly to the Sponsor. Complaints
may result in various disciplinary actions, ranging from verbal warning to
termination of employment or contract.
Reporting timeline:
Reporting Period

YTD
January 1 - December 31

Data due to CMS/HPMS

February 28

Data elements to be entered into the HPMS at the Contract level:
A. Total number of agents.
B. Total number of employed/captive agents.
C. Total number of independent agents.
D. Number of complaints concerning employed/captive agents.
E. Number of complaints concerning independent agents.
F. Number of employed/captive agent for cause terminations reported to
State.
G. Number of independent agent for cause terminations reported to State.
H. Number of employed/captive agent assisted enrollments.
I. Number of independent agent assisted enrollments.
J. Total number of enrollments.

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