Summ_2012_Application_Revisions_technical and substantive

09/07/2010
Summary of Substantive and Technical Changes for All Part D Application Revisions from 2011 Version of Part D Application to
2012 Draft Version

SUBSTANTIVE CHANGES
Clarification

Purpose of the Clarification
PDP

1. Revise general
instructions to indicate
compliance with
attestations is at the point
of the application due
date.
Further clarified this
requirement.
2. Revised retail pharmacy
access section.

3. Revised “Summary of
Sponsor Role and
Responsibilities”.

4.

Amend the instructions
for submitting information

MA-PD

GENERAL INFORMATION and INSTRUCTIONS
Changes the timeframe for compliance
2.4.1;
2.4.1;
with the general attestations to be at the Throughout the
Throughout
time of application submission instead
application
the
2.4.1
of at the time of entering into a contract
application
2.4.1
with CMS. This is to ensure that
applying organizations have the
infrastructure and system capabilities
required to become Part D sponsors.
CMS is streamlining the process for
2.8.1
2.8.1
reviewing retail pharmacy access by
requiring less documentation from the
applicants. This section summarizes at
a high level the change, including
clarifying information about service
areas in HPMS compared to access
reports provided by the applicants.

Application
Cost

PACE

Change in
Burden

2.4.1;
Throughout
the
application
2.4.1

Throughout
the application
2.4.1

N/A

2.8.1

N/A

N/A

N/A

N/A

N/A

N/A

CMS provides additional information
regarding the methodology used in
retail access geo-coding.
Added language regarding discounts 1.5
1.5
1.5
for applicable brand drugs to the
responsibilities for administering the
Part D benefit
APPLICANT EXPERIENCE, CONTRACTS, LICENSURE AND FINANCIAL STABILITY
MANAGEMENT AND OPERATIONS
In an effort to improve the
3.1.1B
3.1.1B
3.1.1B
documentation provided under this

1

09/07/2010
Summary of Substantive and Technical Changes for All Part D Application Revisions from 2011 Version of Part D Application to
2012 Draft Version

SUBSTANTIVE CHANGES
Clarification

about the organization
history and structure.

5. Amend the table for
identifying the first tier,
downstream and related
entities that perform key
Part D functions on behalf
of the Applicant.
6. Added new contract
language required
between applicants and
their first tier, downstream
or related entities that
perform key Part D
functions on the
Applicant’s behalf.

7. Delete the table of
attestations.

8. Delete the requirement to
upload all past and
pending investigations,

Purpose of the Clarification
PDP

MA-PD

Application
Cost

3.1.1C

3.1.1C

New provisions were added to reflect
3.1.1D
3.1.1D
statutory changes from the enactment
of Patient Protection and Affordable
Care Act. Specifically new contract
language is required for network
pharmacies to submit claims on behalf
of enrollees and new language is
required for specific PBM transparency
reporting requirements.
EXPERIENCE AND CAPABILITIES
The specific attestations in this table are 3.1.2
3.1.2
duplicative to the First tier, Downstream
and Related Entities Function Chart
completed in 3.1.1C of the application.
BUSINESS INTEGRITY
The information is no longer required at 3.1.4B
3.1.3B
the time of the application since it is not
used in the determination of whether an

section, CMS has deleted the general
instructions and provided a new
template for Applicants to complete.
This provides applicants with definitive
questions to answer related to the
organization’s history and structure.
Added a column for the applicant to
identify if the first tier, downstream, or
related entity is an offshore
subcontractor.

2

PACE

Change in
Burden

3.1.1C

Management
and
Operations

Increase

3.1.1D

Management
and
Operations

Increase

3.1.2

N/A

Decrease

3.1.3B

Business
Integrity

Decrease

09/07/2010
Summary of Substantive and Technical Changes for All Part D Application Revisions from 2011 Version of Part D Application to
2012 Draft Version

SUBSTANTIVE CHANGES
Clarification

Purpose of the Clarification
PDP

legal actions or matters
subject to arbitration over
the past three years
related to payments from
government entities for
healthcare and/or
prescription drug services.
9. Updated the list of
required Part D contacts.
Additional contact
added.
10. Prohibit the use of PO
Boxes within the mailing
address of the Part D
contacts.

11. Update attestation
language addressing the
Medicare populations
eligible for transitions.

12. Update attestations related

MA-PD

Application
Cost

PACE

Change in
Burden

HPMS Part D
Contacts

N/A

HPMS Part D
Contacts

N/A

Formulary/Pha
rmacy and
Therapeutics
Committee

N/A

Formulary/Pha

N/A

organization is qualified as a Part D
sponsor.

HPMS PART D CONTACTS
Based on CMS guidance issued during
3.1.5A
3.1.4A
3.1.4A
the 2010 Contract Year, added the new
contact for DIR, and Reconciliation
Contact.
Organizations applying to participate as 3.1.5A
3.1.4A
3.1.4A
a Part D sponsor must have a physical
location, therefore, PO Boxes are not
acceptable.
BENEFIT DESIGN
FORMULARY//PHARMACY AND THERAPEUTICS (P&T) COMMITTEE
Pursuant to CMS-4085-F, (preamble
3.2.1A6
3.2.1A6
3.2.1A6
page 167 and 423.120(B)(3)) this
revision clarifies that transition policies
are for new enrollees, newly eligible
Medicare enrollees from other
coverage, individuals who switch from
one plan to another after the start of the
contract year, and current enrollees
remaining in the plan who are affected
by formulary changes between contract
years.
Based on a March 2010 HPMS memo,
3.2.1A8
3.2.1A8
3.2.1A8

3

09/07/2010
Summary of Substantive and Technical Changes for All Part D Application Revisions from 2011 Version of Part D Application to
2012 Draft Version

SUBSTANTIVE CHANGES
Clarification

Purpose of the Clarification
PDP

to documentation of the
transition policy.
13. Adds a new attestation to
address a P&T committee
requirement.

14. Adds a new attestation
related to waste in LTC
facilities.

15. Update and clarify MTM
attestations to reflect the
issuance of CMS-4085-F.

16. Clarify an existing
attestation related to

MA-PD

Application
Cost

organizations must provide CMS the
transition policies.
As a result of CMS-4085-F a new
3.2.1B6
3.2.1B6
attestation was added that requires P&T
committees to review and approve all
clinical criteria.
QUALITY ASSURANCE AND PATIENT SAFETY
Adds a new attestation to reflect
3.2.3A4
3.2.3A4
Section 3310 of the Affordable Care
Act. The statute requires Part D
sponsors to utilize dispensing
techniques to reduce waste in LTC
facilities.
MEDICATION THERAPY MANAGEMENT (MTM)
Prior to the issuance of CMS-4085-F,
3.2.4
3.2.4
the amount a beneficiary was likely to
incur to be considered for MTM services
was determined by the Secretary
annually. The regulation sets the
amount at $3,000 and accounts for
inflation. Further, attestation language
was updated in relation to beneficiaries
that may be targeted for enrollment.

Based on CMS-4085-F, clarified that
CMS will look at meaningful differences

BIDS
3.2.6A1

4

N/A

PACE

Change in
Burden

3.2.1B6

rmacy and
Therapeutics
Committee
Formulary/Pha
rmacy and
Therapeutics
Committee

Increase

3.2.3A4

N/A

Increase

3.2.4

N/A

N/A

N/A

N/A

N/A

09/07/2010
Summary of Substantive and Technical Changes for All Part D Application Revisions from 2011 Version of Part D Application to
2012 Draft Version

SUBSTANTIVE CHANGES
Clarification

Purpose of the Clarification
PDP

meaningful differences.
Additional clarification
provided.
17. Added a new attestation
related to uniform benefits.

18. Delete 4 attestations.

19. Delete the attestation
referencing the Medicare
Beneficiary Count File.

20. Delete the requirement to
upload a retail pharmacy
access report.

21. Deleted Puerto Rico from
the list of territories eligible

MA-PD

Application
Cost

PACE

Change in
Burden

N/A

N/A

Increase

3.3A3-A6

N/A

Decrease

3.3.1A3

N/A

Decrease

3.3.1B and
Appendix
entitled Retail
Pharmacy
Network
Access
Instructions
3.3.1E

N/A

Decrease

N/A

Decrease

in benefit packages and plan costs
when evaluating bids.
Based on CMS-4085-F, added an
3.2.6A3
N/A
attestation that Applicants offer plans
with uniform benefits to its beneficiaries.
GENERAL PHARMACY ACCESS
The deleted attestations addressed
3.4A3-A6
3.5A3-A6
required contractual provisions in the
pharmacy contract templates. These
were duplicative of the provisions
provided in the appendices containing
all of the required pharmacy contract
provisions.
RETAIL PHARMACY ACCESS
Removed the attestation that required
3.4.1A3
3.5.1A3
Part D sponsors to use the Beneficiary
Count Data file provided to complete
the retail pharmacy access reports.
See, item 19 for the removal of the retail
access reports.
CMS is automating the retail pharmacy
3.4.1B and
3.5.1B and
access analysis based on the service
Appendix
Appendix
area provided by the applicant and the
entitled Retail
entitled Retail
retail pharmacy list. There will no longer Pharmacy
Pharmacy
be a need for an applicant to submit an
Network Access Network
access report to CMS.
Instructions
Access
Instructions
Part D sponsors can demonstrate
3.4.1D
3.5.1E
convenient access in Puerto Rico, and

5

09/07/2010
Summary of Substantive and Technical Changes for All Part D Application Revisions from 2011 Version of Part D Application to
2012 Draft Version

SUBSTANTIVE CHANGES
Clarification

Purpose of the Clarification
PDP

for a waiver of convenient
access.

22. Added a new attestation
related allowing a
beneficiary to have a 12month absence from a
Part D sponsor’s service
area.
23. Amend an existing
attestation to reflect
ADAPs and IHS as third
party payers that sponsors
must coordinate benefits
with.
24. Adds a new attestation
setting a time limit for
third-party payers to
coordinate benefits.

25. Added a new attestation
that ADAPs and IHS count
toward TrOOP.
26. Added a new attestation
related to disclosing
information related to

MA-PD

Application
Cost

PACE

Change in
Burden

N/A

Increase

3.9A3

Coordination
of Benefits

N/A

3.9A14

Coordination
of Benefits

Increase

3.10A15

TrOOP

Increase

3.12A5

N/A

Increase

therefore Part D sponsors operating in
this territory are not eligible for the
waiver.
ENROLLMENT
CMS-4085-F amended 42 CFR 423.44
3.5A25
to allow beneficiaries to have a 12
month absence from their service area
before a sponsor begins disenrollment
procedures.

N/A

COORDINATION OF BENEFITS
Pursuant to PPACA the Affordable
3.10A3
3.11A3
Care Act Section 3314, ADAPs and
IHS are recognized as third party
payers.

CMS-4085-F amends 423.466 to
provide third-party payers no more than
three years from the date a prescription
is filled to coordinate benefits with the
Part D sponsor.

3.10A14

3.11A14

TrOOP
Pursuant to PPACA the Affordable
3.11A16
3.12A15
Care Act Section 3314, ADAPs and
IHS count towards TrOOP.
MARKETING/BENEFICIARY COMMUNICATION
CMS-4085-F amends 423.128 to
3.13A5
3.14A5
require Part D sponsors disclose, upon
CMS’ request, information concerning

6

N/A

09/07/2010
Summary of Substantive and Technical Changes for All Part D Application Revisions from 2011 Version of Part D Application to
2012 Draft Version

SUBSTANTIVE CHANGES
Clarification

Purpose of the Clarification
PDP

performance and contract
compliance deficiencies.
27. Delete attestation table.

28. Update the compliance
plan crosswalk.

29. Add an attestation related
to data validation.

30. Add an attestation related
to PBM transparency.

31. Added new attestation
related to unique Part D
identifiers.
32. Added a new attestation
related to adjustments and
issuances of refunds or
recoveries.

MA-PD

the Applicant’s performance and
contractual compliance deficiencies.
COMPLIANCE PLAN
Attestations are duplicative of
3.15A
3.16A
provisions required with the actual
compliance plan submission.
Updated the provisions in the
3.15C
3.16C
compliance plan crosswalk to reflect the
new regulatory language from CMS4085-F.
REPORTING REQUIREMENTS
Regulations require Part D sponsors to
3.16A3
3.17A3
attest that the reporting requirements
data has undergone data validation,
including yearly independent audit.
Pursuant to PPACA the Affordable
3.16A19
3.17A16
Care Act Section 6005, add a general
attestation related to specific reporting
requirements for Part D sponsors and
their PBMs.
CLAIMS PROCESSING
CMS-4085-F requires Applicants to use 3.22A12
3.23A12
unique Part D identifiers for each
individual Part D member.
CMS-4085-F amends 423.464 and 466
3.22A13
3.23A13
that requires the adjustments be made
within 45 days of sponsor’s receipt of
information necessitating the
adjustment.
APPENDICES

7

Application
Cost

PACE

Change in
Burden

3.14A

Compliance
Plan

Decrease

3.14C

Compliance
Plan

N/A

3.15A3

N/A

Increase

3.15A18

N/A

Increase

3.21A12

Claims
Processing

Increase

3.21A13

Claims
Processing

Increase

09/07/2010
Summary of Substantive and Technical Changes for All Part D Application Revisions from 2011 Version of Part D Application to
2012 Draft Version

SUBSTANTIVE CHANGES
Clarification

33. Delete the requirement for
an initial applicant to
complete the DUA
agreement.
34. Add new appendix as a
template for Applicant’s
organization background
and structure.

35. Delete reference to
National Council for
Prescription Drug
Programs (NCPDP)
provider number and
replaced with the
required National
Provider Identifier (NPI)
number.

Purpose of the Clarification
PDP

MA-PD

Application
Cost

PACE

This document is collected as part of
the contracting process for initial
applicants.

3.18B

N/A

N/A

N/A

Change in
Burden
Decrease

Consistent with changes to the
Management and Operations section of
the application, a new template was
created to request specific information
about the applicant’s background and
structure.
Consistent with the January 23, 2004
final rule (69 FR 3434), HIPAA
Administrative Simplification:
Standard Unique Health Identifier for
Health Care Providers

3.1.1B and
Appendix

3.1.1B and
Appendix

3.1.1B and
Appendix III

N/A

N/A

Appendix XIV –
I/T/U
Addendum

Appendix XI
– I/T/U
Addendum

Appendix XI
– I/T/U
Addendum

N/A

N/A

8

09/07/2010
Summary of Substantive and Technical Changes for All Part D Application Revisions from 2011 Version of Part D Application to
2012 Draft Version

TECHNICAL CHANGES
Clarification

Purpose of the Clarification
PDP

1. Updated background information.
Additional change made.

2. Updated dates, websites,
(language where appropriate),
regulatory, Prescription Drug
Benefit Manual citations, and
reference file names as needed.
Additional changes made
throughout the document.

3. Made grammatical changes
throughout the document.
Additional changes made
throughout the document.
4. Clarified attestation language
throughout the document.
5. Clarified Part D application
technical assistance manuals.

GENERAL INFORMATION and INSTRUCTIONS
Added language describing the passage of
1.2
the Patient Protection and Affordable Care
Act as amended by the Health Care and
Education Reconciliation Act of 2010
(together, “the Affordable Care Act”).
Throughout
Updated dates, websites, (language where
document
appropriate), references to statutes,
regulations, Part D guidance, reference file
names and URLs. Changed abbreviation
for the Patient Protection and Affordable
Care Act as amended by the Health Care
and Education Reconciliation Act of 2010
from “PPACA” to “the Affordable Care
Act”. Updated websites’ URLs as
appropriate.

MA-PD

Application
Cost

PACE

1.2

1.2

General
Information

Throughout
document

Throughout
document

Throughout
document

In an effort to make the language tense
consistent throughout the application,
grammatical changes were made.

Throughout
document

Throughout
document

Throughout
document

Throughout
document

Language was edited in attestations
throughout the document to better clarify
CMS policy.
Added description of the two technical
assistance manuals available to Part D
applicants: Basic Contract Management
User’s Manual and the Online Application
User’s Manual, both available in HPMS.

Throughout
document

Throughout
document

Throughout
document

Throughout
document

2.2

2.2

2.2

N/A

9

09/07/2010
Summary of Substantive and Technical Changes for All Part D Application Revisions from 2011 Version of Part D Application to
2012 Draft Version

TECHNICAL CHANGES
Clarification

6. Updated contact for application
technical assistance.
7. Updated name for the Medicare
Plan Finder.

8.

9.

10.

11.

12.

Purpose of the Clarification

New contact is Linda Anders.

PDP

MA-PD

2.4.8

2.4.8

Application
Cost

PACE

2.4.5

Changed name from “Medicare
Throughout
Throughout
Throughout
N/A
Prescription Drug Plan Finder” to
document
document
document
“Medicare Plan Finder.”
EXECUTED CONTRACTS, FULLY EXTECUTED LETTERS OF AGREEMENT, ADMINISTRATIVE SERVICES AGREEMENTS, OR INTERCOMPANY
AGREEMENTS WITH EACH FIRST TIER, DOWNSTREAM AND RELATED ENTITIES
Clarified CMS’ expectations.
Provided expectation that each contract
3.1.1.D
3.1.1.D
3.1.1.D
Management
meets all requirements when read on its
and
own.
Operations
TROOP
Deleted two attestations related to
Deleted the attestations because they were
3.11A12
3.12A12
3.10A12
TrOOP
TrOOP related Part D contacts.
duplicative of information collected in the
3.11A13
3.12A13
3.10A13
HPMS Contacts section of the application.
MEDICARE SECONDARY PAYER
Deleted an attestation related to
Based on the prior attestation in the table,
3.12A7
3.13A7
3.11A7
Medicare
workers’ compensation Medicare
this attestation is duplicative of CMS policy.
Secondary
set asides.
Payer
MARKETING/BENEFICIARY COMMUNICATION
Based on the Affordable Care Act, the
Changed the date when the
3.13A12
3.14A12
3.12A12
ANOC/SB must be received by
annual enrollment period for 2012 will begin
th
beneficiaries.
October 15 . Beneficiaries must receive the
Changed “two weeks” to “15
ANOC/SB no later than 15 days two weeks
days” per updated guidance.
prior to the start of the annual election
st
period. As a result, the October 31 date has
been changed in the attestation.
HIPAA
Consolidated two attestations into
Consolidated the attestations requiring
3.18A1 and A2
3.19A1 and A2
3.17A1 and A2
HIPAA
one.
Applicants comply with the Standards for
Privacy of Individually Identifiable Health

10

09/07/2010
Summary of Substantive and Technical Changes for All Part D Application Revisions from 2011 Version of Part D Application to
2012 Draft Version

TECHNICAL CHANGES
Clarification

Purpose of the Clarification
PDP

MA-PD

Application
Cost

Information and Security Standards.
The regulations from HiTech implementing
3.18A11
3.19A11
the privacy and security provisions of ARRA
amend sections 160 and 164 of HIPAA,
which is addressed in another attestation in
this section of the application.
APPENDICES
14. Updated the contract crosswalks to Based on PPACA the Affordable Care Act
Appendices
Appendices IVreflect language requirements
and CMS-4085-F, new provisions are
VIII-XII
IX
based on new regulation or
required between the Part D sponsor and its
statute.
first tier, downstream, and related entities.
Each crosswalk was updated to reflect these
new requirements and are also reflected
within the respective sections of the
application.
NOTE 1: Nothing in the technical changes table increases burden on the applicant.
NOTE 2: The Service Area Expansion Application is a condensed version of the initial application.
NOTE 3: Red Bolded language represents changes made following the 60-day comment period.
13. Deleted an attestation related to
privacy and security provisions
from ARRA.

11

PACE

3.17A11

HIPAA

Appendices IVIX

N/A