Download:
pdf |
pdfMedicare Part D Application for New PACE Organizations
2012 Contract Year
Public Reporting Burden
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 information collection contained in this chapter is 0938-0936. The time required to
complete this information collection is estimated to average 18.75 hours per response, including
the time to review instructions, search existing data resources, and gather the data needed, and
complete and review the information collection. If you have any comments concerning the
accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS,
7500 Security Boulevard, C4-26-05, Baltimore, Maryland 21244-1850.
Expiration:
1
1
2
GENERAL INFORMATION ..................................................................................... 4
1.1
Background ....................................................................................................... 4
1.2
Overview ........................................................................................................... 4
1.3
Summary of PACE Organization’s Roles and Responsibilities ......................... 4
1.4
Health Plan Management System (HPMS) ....................................................... 5
1.5
Summary Instructions for Part D Formularies (42 CFR §423.120) .................... 5
1.6
Summary Instructions for Part D Bids (42 CFR §423.265) ............................... 5
1.6.1
CMS Review of Part D Bids ....................................................................... 6
1.6.2
Overview of Part D Bid Negotiation ........................................................... 6
1.7
Standard Contract with PACE Part D Sponsors................................................ 7
1.8
General Enrollment Processing ........................................................................ 7
1.9
Eligibility for the Low Income Subsidy Program ................................................ 7
1.10
Protection of Confidential Information ............................................................... 7
1.11
Payment to PACE Part D Sponsors .................................................................. 8
1.12
Applicability of the National Provider Identifier (NPI) to PACE Organizations ... 8
GENERAL INSTRUCTIONS .................................................................................. 10
2.1
Summary Instructions and Technical Support................................................. 10
2.2
Instructions...................................................................................................... 10
2.3
Format ............................................................................................................ 11
2.4
Part D Waivers ................................................................................................ 12
2.4.1
3
Applicant Requests for Additional Waivers .............................................. 14
APPLICATION FORMS ......................................................................................... 16
3.1
Cover Sheet .................................................................................................... 17
3.2
Management and Operations.......................................................................... 18
3.2.1
Subcontractor (first tier, downstream, and related entities) Function Chart
................................................................................................................. 18
3.2.2
Requirements in Contracts/Administrative Services Agreements ............ 19
3.2.3
Requirements for Long Term Care Pharmacy Access Contracts ............ 25
3.3
HPMS Part D Contacts ................................................................................... 29
3.4
Program Integrity and Compliance Program ................................................... 33
3.5
Health Information Technology ....................................................................... 37
3.6
Enrollment and Eligibility ................................................................................. 37
2
3.7
Complaints Tracking ....................................................................................... 38
3.8
Coordination of Benefits .................................................................................. 39
3.9
Tracking True Out-of-Pocket Costs (TrOOP) .................................................. 40
3.10
Medicare Secondary Payer ............................................................................. 41
3.11
Data Collection and Reporting Requirements ................................................. 42
3.12
Data Exchange between PACE Organizations and CMS ............................... 42
3.13
Health Insurance Portability and Accountability Act of 1996 (HIPAA) ............. 43
3.14
Prohibition on Use of SSN or Medicare ID Number on Enrollee ID Cards ...... 44
3.15
Prescription Drug Event (PDE) Records ......................................................... 45
3.16
Claims Processing .......................................................................................... 45
3.17
Record Retention ............................................................................................ 48
3.18
Electronic Prescription Program...................................................................... 49
3.19
Formulary Submission Requirements ............................................................. 49
3.19.1
Applicability of Formulary Submission Requirements .............................. 49
3.19.2
Formulary/Pharmacy and Therapeutics (P&T) Committee ...................... 50
4
CERTIFICATION ................................................................................................... 55
5
APPENDICES ........................................................................................................ 56
APPENDIX I – Applicant Submission of P&T Committee Member List and
Certification Statement .............................................................................................. 57
3
1 GENERAL INFORMATION
1.1 Background
The Medicare Prescription Drug Benefit program was established by section 101 of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), as
amended by the Patient Protection and Affordable Care Act, as amended, and is
codified in sections 1860D-1 through 1860 D-43 of the Social Security Act (the Act).
1.2 Overview
The Part D benefit constitutes perhaps the most significant change to the Medicare
program since its inception in 1965 by recognizing the vital role of prescription drugs in
our health care delivery system. However, PACE organizations have a longstanding
history of providing statutorily required prescription drugs to all participants. Prior to
Part D, prescription drugs were included as a portion of the Medicaid capitation rate.
However, the MMA mandates that State Medicaid programs may no longer cover Part D
drugs on behalf of dual eligible beneficiaries. PACE organizations may elect to offer a
Part D plan in a similar manner as MA-PD local plans in order to account for this shift in
payer source for prescription drugs.
This chapter of the PACE provider application serves as the Medicare Part D
application.
NOTE: CMS reserves the right to amend or cancel this solicitation at any time. CMS
also reserves the right to revise the Medicare Prescription Drug Benefit program
implementation schedule, including the solicitation and bidding process timelines.
1.3 Summary of PACE Organization’s Roles and Responsibilities
Each PACE Organization should have the ability to:
Submit a formulary each year for CMS approval (as applicable).
Submit a Part D bid each year for CMS approval.
Administer the Part D benefit.
Provide all required prescription drug services as outlined in the PACE statute and
regulation.
Operate quality assurance, drug utilization review, and medication therapy
management programs in accordance with existing PACE requirements.
Protect the privacy of beneficiaries and beneficiary-specific health information.
Develop and/or maintain systems to support enrollment, provide claims-based data
to CMS, accept CMS payment, and support e-prescribing.
Provide necessary data to CMS to support payment, oversight, and quality
improvement activities and otherwise cooperate with CMS oversight responsibilities.
4
Ensure the integrity of the Medicare Trust Fund by eliminating fraud, abuse, and
waste within its organization.
1.4 Health Plan Management System (HPMS)
Completion of the CMS PACE Provider Application and the Part D application (chapter
11) is a significant step towards attaining CMS approval to provide the Part D benefit to
eligible PACE participants. In addition, PACE organizations are required to secure
access to the CMS Health Plan Management System (HPMS) in order to carry out
additional Part D functions including the formulary submission process (as applicable),
the bid submission process, ongoing operations of the Part D program, and reporting
and oversight activities.
PACE organizations must obtain HPMS user ID’s and access to the system only after
being assigned a CMS provider number or ―H-number‖. PACE organizations are
assigned CMS "H-numbers" upon CMS receipt of the PACE provider application. We
note that the PACE provider application is routed to CMS only after it has been
reviewed by the SAA. Once your application has arrived and CMS assigns an ―Hnumber, you will be notified by your CMS PACE team lead. At this point, the PACE
organizations staff must obtain HPMS user ID’s in order to access the system. The
HPMS user ID application may be accessed at:
http://www.cms.gov/AccesstoDataApplication/Downloads/Access.pdf
In addition, instructions to PACE organization for completing this form are located at:
http://www.cms.gov/PACE/Downloads/hpmsconn.pdf
Questions concerning HPMS user IDs should be directed to the HPMS Help Desk at
helpdesk@[email protected]
1.5 Summary Instructions for Part D Formularies (42 CFR §423.120)
Applicants that meet one or more of the definitive criteria for formularies described later
in this document will be required to upload their plan formularies to HPMS using a predefined file format and record layout.
1.6 Summary Instructions for Part D Bids (42 CFR §423.265)
Each PACE applicant must submit to CMS, via HPMS, two Part D bids; 1 for dual
eligible enrollees and 1 for Medicare-only enrollees. Applicants using this solicitation
must apply to offer full risk Part D plans.
The applicants bid will represent the expected monthly cost to be incurred by the
applicant for qualified prescription drug coverage in the plan’s service area for a Part Deligible beneficiary on a standardized basis. The costs represented in each bid should
be those for which the applicant would be responsible. The bid will require the separate
identification, calculation, and reporting of costs assumed to be reimbursed by CMS
through reinsurance. CMS requires that the bid represent a uniform benefit package
among all beneficiaries enrolled in the plan. The benefit packages submitted must be
cross walked appropriately from the formulary (as applicable). Pursuant to 42 CFR
§423.505(k)(4), the CEO, CFO, or an individual delegated with the authority to sign on
5
behalf of one of these officers, and who reports directly to such officer, must certify
(based on best knowledge, information and belief) that the information in the bid
submission is accurate, complete, and truthful, and fully conforms to the requirements in
section 42 CFR §423.265 of the regulations (except section 42 CFR §423.265(b), the
applicability of which is discussed below). In addition, the pricing component of the bid
must be certified by a qualified actuary.
PACE organizations must submit annual Part D bids and receive CMS approval of the
Part D bids prior to providing or continuing to provide Part D benefits. Any PACE
organization that wishes to either continue receiving Part D payment or begin receiving
Part D payment in January of a given year, must submit their Part D bids no later than
the first Monday in June of the year prior. The June bid submission deadline (42 CFR
§423.265(b)) has been waived for newly forming PACE organizations pending the
development of a methodology for accepting mid-year bids.
In order to prepare plan bids, Applicants will use HPMS to define their plan structures
and associated plan service areas and then download the Plan Benefit Package (PBP)
and Bid Pricing Tool (BPT) software. For each plan being offered, Applicants will use
the PBP software to describe the detailed structure of their Part D benefit and the BPT
software to define their bid pricing information. The formulary (as applicable) must
accurately crosswalk to the PBP.
Once the PBP and BPT software has been completed for each plan being offered,
Applicants will upload their bids to HPMS.
1.6.1 CMS Review of Part D Bids
CMS will evaluate the bids based on four broad areas: 1) administrative costs, 2)
aggregate costs, 3) benefit structure, and 4) plan management. CMS will evaluate the
administrative costs for reasonableness in comparison to other PACE bidders. CMS
will also examine aggregate costs to determine whether the revenue requirements for
qualified prescription drug coverage are reasonable and equitable. In addition, CMS will
review the steps the PACE Part D sponsor is taking to control costs, such as through
various programs to encourage use of generic drugs. Finally, CMS will examine
indicators concerning plan management.
CMS is also required to make certain that bids and plan designs meet statutory and
regulatory requirements. We will conduct an actuarial analysis to determine whether
the proposed benefit meets the standard of providing qualified prescription drug
coverage.
1.6.2
Overview of Part D Bid Negotiation
CMS evaluates the reasonableness of bids submitted by PACE Part D sponsors by
means of an actuarial valuation analysis. This requires evaluating assumptions
regarding the expected distribution of costs, including average utilization and cost by
drug coverage tier. CMS could test these assumptions for reasonableness through
actuarial analysis and comparison to industry standards and other comparable bids.
Bid negotiation could take the form of negotiating changes upward or downward in the
utilization and cost per script assumptions underlying the bid’s actuarial basis. We
6
could exercise our authority to deny a bid if we do not believe that the bid and its
underlying drug prices reflect market rates.
1.7 Standard Contract with PACE Part D Sponsors
Successful Applicants will be deemed qualified to enter into a PACE program
agreement that includes Part D coverage. Under this agreement the PACE Part D
sponsor will be authorized to operate the Medicare Part D benefit for all eligible PACE
participants. Only after the qualified Applicant and CMS have reached agreement on
the Applicant’s bid submissions will the Applicant be asked to execute its PACE
program agreement.
1.8 General Enrollment Processing
CMS has developed a system to review an individual’s eligibility for the Part D benefit.
For individuals applying for enrollment in a Part D plan, CMS reviews an individual’s
status as a Medicare beneficiary. CMS tracks enrollments and ensures that the
beneficiary does not enroll in more than one plan. Also, CMS tracks low-income
subsidy status and auto-enrollments of full-benefit dual eligible individuals into Part D
plans and facilitated enrollments for other low-income Medicare beneficiaries. Finally,
CMS tracks disenrollments from Part D plans and will deny new enrollments during any
given year unless the enrollment occurs during an allowable enrollment period. For
additional information regarding enrollment processing, refer to the http://www.cms.gov
website.
1.9 Eligibility for the Low Income Subsidy Program
Low-income Medicare beneficiaries receive full or partial subsidies of premiums and
reductions in cost sharing under the Part D benefit. Certain groups of Medicare
beneficiaries are automatically be eligible for the low-income subsidy program. These
beneficiaries include Medicare beneficiaries who are full-benefit dual eligible individuals
(eligible for full benefits under Medicaid), Medicare beneficiaries who are recipients of
Supplemental Security Income benefits; and participants in Medicare Savings Programs
as Qualified Medicare Beneficiaries (QMBs), Specified Low-Income Medicare
Beneficiaries (SLMBs), and Qualifying Individuals (QIs). Beneficiaries who are lowincome and who do not fall into one of the automatic subsidy eligibility groups apply for
a low-income subsidy and have their eligibility determined by either the state in which
they reside or the Social Security Administration (SSA). CMS has developed a
database to track individuals who are automatically deemed subsidy-eligible or who are
determined subsidy-eligible by states or SSA, and communicates the names and
eligibility category of those individuals to Part D sponsors as part of the enrollment files
from the enrollment processing system described below. For additional information
regarding the low income subsidy program, refer to the www.cms.gov/ website.
1.10 Protection of Confidential Information
Applicants may seek to protect their information from disclosure under the Freedom of
Information Act (FOIA) by claiming that FOIA Exemption 4 applies. The Applicant is
required to label the information in question ―confidential‖ or ―proprietary‖, and explain
7
the applicability of the FOIA exemption it is claiming. This designation must be in
writing. When there is a request for information that is designated by the Applicant as
confidential or that could reasonably be considered exempt under Exemption 4, CMS is
required by its FOIA regulation at 45 C.F.R. §5.65(d) and by Executive Order 12,600 to
give the submitter notice before the information is disclosed. To decide whether the
Applicant’s information is protected by Exemption 4, CMS must determine whether the
Applicant has shown that— (1) disclosure of the information might to impair the
government's ability to obtain necessary information in the future; (2) disclosure of the
information would cause substantial harm to the competitive position of the submitter;
(3) disclosure would impair other government interests, such as program effectiveness
and compliance; or (4) disclosure would impair other private interests, such as an
interest in controlling availability of intrinsically valuable records, which are sold in the
market. Consistent with our approach under the Medicare Advantage program, we
would not release information under the Medicare Part D program that would be
considered proprietary in nature.
1.11 Payment to PACE Part D Sponsors
Payments will be wired to the organization’s account on the first day of each month (or
the last business day of the prior month if the first day of the month is not a business
day). The monthly payment will include premiums that SSA or other agencies are
deducting from beneficiary Social Security payments or other payments as well as those
premiums CMS is paying on behalf of low-income individuals. Estimated monthly
reinsurance subsidies, low-income subsidies, and gap discount amounts are also
included.
1.12 Applicability of the National Provider Identifier (NPI) to PACE
Organizations
The Administrative Simplification provisions of the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) mandated the adoption of standard unique
identifiers for health care providers, as well as the adoption of standard unique
identifiers for health plans. The purpose of these provisions is to improve the efficiency
and effectiveness of the electronic transmission of health information. The NPI has
been adopted as the standard unique identifier for health care providers. The National
Plan and Provider Enumeration System (NPPES) is the entity that assigns these unique
identifiers.
For purposes of HIPAA, PACE organizations may be defined as both health plans and
health care providers. We note that an enumeration system applicable to health plans
is still in the development stages. However, any health care provider, as that term is
defined for purposes of HIPAA that transmits any health information in electronic form in
connection with one of the standard transactions, including electronically billing any
health plan (including Medicare), must obtain an NPI. Health care providers are defined
at 45 CFR §160.103 as ―a provider of services (as defined in section 1861 (u) of the Act,
42 USC 1395x (u)), a provider of medical or health services (as defined in section
1861(s) of the Act, 42 ISC 1395x(s)), and any other person or organization who
furnishes, bills, or is paid for health care in the normal course of business.‖
8
Although PACE organizations may meet the definition or a health care provider, as
described above, only those that transmit health information in electronic form in
connection with one of the standard transactions, including billing any health plan
electronically must obtain an NPI. We note that in some instances, PACE organizations
may elect to provide Medicare services to a beneficiary prior to the beneficiary’s
effective date of PACE enrollment. These services may be billable under Medicare
Fee-For-Service. To the extent a PACE organization that is a HIPAA health care
provider elects to bill Medicare electronically for these non-PACE services, an NPI
would be needed.
In addition, consistent with HIPAA requirements, as health plans, all PACE
organizations (regardless of whether the NPI requirements apply to them as health care
providers) are required to accept and recognize the NPI as the health care provider
identifier in standard transactions that are submitted to them from health care providers
or other health plans.
9
2 GENERAL INSTRUCTIONS
The following section provides instructions for completing this chapter of the application.
The actual application forms are included under section 3.
Note: Nothing in this chapter of the PACE Provider Application is intended to
supersede the regulations at 42 CFR Part 423 or Part 460. Failure to reference a
regulatory requirement in this application does not affect the applicability of such
requirement, and PACE Organizations are required to comply with all applicable
requirements of the regulations in Part 423 or Part 460 of 42 CFR.
2.1 Summary Instructions and Technical Support
This application is to be completed by those newly forming PACE organizations that
intend to provide the Part D benefit to eligible participants beginning in 2013. Applicants
projecting PACE provider status by 1/1/2013 may submit the Part D application (chapter
11 of the PACE provider application) up until July 1, 2012. Applicants must use the
2013 solicitation. CMS will not accept or review in any way those submissions using
prior version of the application.
For technical assistance in the completion of this application, contact:
Jack Healey by email at: [email protected] or by phone at 410-786-3683.
2.2 Instructions
Applicants must include the name of the PACE organization in the heading on each
page of the Part D application submitted to CMS.
In many instances Applicants are directed to affirm that they will meet particular
requirements by indicating ―Yes‖ next to a statement of a particular Part D program
requirement. By providing such attestation, an Applicant is committing its organization
to complying with the relevant requirements as of the date your contract is signed,
unless an alternative date is noted.
Additional supporting documentation is notated in the following manner throughout the
application and is to be submitted as follows:
Forms: documents supplied by CMS that are contained at the end of this application.
They are to be completed by the Applicant and returned to CMS as indicated.
Legal documents such as subcontracts should be provided in hard copy as an
attachment to the application. In addition, all subcontracts and other legal
documents should be provided on the CD or diskette copies of the application. The
CD/diskette identification should include the form number.
CMS will check the Part D application for completeness shortly after its receipt. We will
notify Applicants of any deficiencies and afford them the opportunity to amend their Part
D applications.
CMS may verify a sponsor’s compliance with qualifications it attests it will meet, through
on-site facility visits as well as through other program monitoring techniques.
10
Failure to meet the requirements attested to in the Applicant’s response to this
solicitation and failure to operate its Part D plan(s) consistent with the requirements of
the applicable statutes, regulations, and the Part D contract may disqualify it from
participation in the Part D program.
An individual with legal authority to bind the Applicant shall sign and submit the
certification. CMS reserves the right to request clarifications or corrections to a
submitted application. Failure to provide requested clarifications could result in the
applicant receiving a notice of intent to deny the application, in which case, the
Applicant will then have 10 days to seek to remedy its application.
This solicitation does not commit CMS to pay any cost for the preparation and
submission of a Part D application.
2.3 Format
All responses should be completed in Microsoft Word (in a version that is compatible
with Office 2003). Attachments (such as existing contracts) can be submitted in
Microsoft Word (in a version that is compatible with Windows 2003) or as a PDF file.
At the time you receive notification from CMS that your provider application has been
received from the State, you must submit a cover letter and three (3) hard copies of the
Part D application (Chapter 11) and supporting documentation to CMS. In addition, the
applicant should simultaneously submit one copy to the State Administrating Agency
(SAA).
Centers for Medicare & Medicaid Services (CMS)
Jack Healey
Mail Stop: C4-21-26
Attn: PACE Part D Application
7500 Security Boulevard
Baltimore, Maryland 21244-1850
Each hard copy of the Part D application should include tab indexing identifying all of
the major sections of the Part D application. Page size should be 8 ½ by 11 inches.
Font size should be 12 point.
One Part D application should be clearly marked, ―Original‖ and contain all original
signed certifications requested in the application.
Note: It is important that Applicant provide 2 separate contact persons and applicable
contact information for PACE organization Application submission(s). This will help to
avoid delays in the processing of an application.
Along with three paper copies of the Part D application each applicant must submit
three (3) duplicate CDs or diskettes. This will support the review of the application by
different CMS components.
Each CD or diskette must be clearly labeled with the information in the table below:
11
Applicant’s Organization Name
CD or Diskette Number (Copy 1, Copy 2, Copy 3, etc.)
Note: If multiple CDs or diskettes are required to include written
application, appendices, attachments and other supporting documentation,
label as follows: Copy 1 (1 of 2), Copy 1 (2 of 2), Copy 2 (1 of 2), Copy 2 (2
of 2), etc.
In order for CMS to receive your application in a timely manner, please note that
Federal Express and the US Postal Service possess a CMS security clearance.
Applications mailed through carriers that do not have CMS Security Clearance could be
delayed due to clearance processing.
Failure to submit a Part D application consistent with these instructions may delay its
review by CMS and could result in receipt of a notice of intent to deny.
Bid and formulary (as applicable) submissions are required on an annual basis.
Although CMS will not require resubmission of this chapter on an annual basis, we
expect to be notified of any changes to responses initially provided.
2.4 Part D Waivers
CMS is authorized to grant waivers of Part D program requirements where such a
requirement conflicts with or duplicates a PACE requirement, or where granting such a
waiver would improve the PACE Organization’s coordination of PACE and Part D
benefits. The following waivers are in effect for all PACE organizations.
Summary of Medicare Part D Regulatory Requirements Waived for PACE
Organizations
Part D Regulation
Regulatory Requirement(s)
Description
423.44
Involuntary disenrollment
423.48
Information about Part D
423.50
Approval of marketing materials and
enrollment forms
423.104(g)(1)
Access to negotiated prices
423.112
Establishment of PDP service areas
423.120(a)
Access to covered Part D drugs
12
Part D Regulation
Regulatory Requirement(s)
Description
423.120(c)
Use of standardized technology
423.124
Out-of-network access to covered Part D
drugs at out-of-network pharmacies
423.128
Dissemination of Part D plan information
423.132
Public disclosure of pharmaceutical prices for
equivalent drugs
423.136
Privacy, confidentiality, and accuracy of
enrollee records
423.153(a)-423.153(d)
Drug utilization management, quality
assurance, and medication therapy
management programs (MTMPs)
423.156
Consumer satisfaction surveys
423.159(c), 423.160(a)
Electronic prescribing
423.162
Quality Improvement organization activities
423.265(b)
Part D bid submission deadline
Note: Automatic waiver applies to
new or potential organizations that
are not operational by the June
deadline.
Those organizations with effective
program agreements must submit a
Part D waiver request in the event
they are unable to meet the June
deadline.
423.401(a)(1)
Licensure
423.420
Solvency standards for non-licensed entities
423.462
Medicare secondary payer procedures
423.464(c)
Coordination of benefits and user fees
13
Part D Regulation
Regulatory Requirement(s)
Description
423.464(f)(2) and 423.464(f)(4)
Coordination with other prescription drug
coverage
423.502(b)(1)(i-ii)
Documentation of State licensure or Federal
waiver
423.504(b)(2-3), 423.504(b)(4)(i-v) and
(vi)(A-E), and 423.504(d)
Conditions necessary to contract as a Part D
plan sponsor
Note: Organizations are required to
abide by 423.504(b)(4)(vi)(F-H),
423.504(b)(5), 423.504(c), and
423.504(e)
423.505(a-c) and 423.505(e-i)
Contract provisions
Note: Organizations are required to
abide by 423.505(d and j)
423.505(k)(6)
Certification for purposes of price compare
Note: Organizations are required to
abide by 423.505(k)(1-5)
423.506(a)-(b)
Effective date and term of contract
Note: Organizations are required to
abide by 423.506(c)-(e)
423.512 – 423.514
Contracting terms
423.551-423.552
Change of ownership or leasing of facilities
during term of contract
423.560-423.638
Grievances, coverage determinations, and
appeals
N/A
A PDP sponsor is required to be a
nongovernmental entity
2.4.1 Applicant Requests for Additional Waivers
CMS may grant additional waivers upon a PACE Organization’s request, provided that
the waivers may be justified because the Part D requirement is duplicative of or
conflicting with PACE requirements, or the waiver will improve the coordination of PACE
14
and Part D benefits. Any waiver granted by CMS will apply to all similarly situated
PACE Organizations.
PACE Organizations that identify the need for additional Part D waivers must submit a
separate Part D waiver request package that includes:
1. The Part D regulation reference;
2. The appropriate waiver criteria (e.g. duplicative, conflicts, improves benefit
coordination);
3. A discussion of how the requested waiver meets at least one of the three waiver
criteria.
Four copies of these requests should be submitted to the following address:
Centers for Medicare and Medicaid Services (CMS)
Janet Samen
Attn: Part D PACE Waiver Request
Mail Stop: C5-05-27
7500 Security Boulevard
Baltimore, MD 21244-1850
Finally, the PACE Organization should also copy their State Administering Agency on
the request as well as their CMS PACE Team Lead.
Determinations will be coordinated between Part D and PACE policy staff and issued to
applicants following a comprehensive review of the request in a similar manner as
PACE BIPA 903 waivers are evaluated in accordance with sections 42 CFR §460.26(b)
and 42 CFR §460.28 of the PACE regulation.
15
3 APPLICATION FORMS
Please do not submit the previous pages of this chapter in the printed copy of your
application.
16
3.1 Cover Sheet
CENTERS FOR MEDICARE AND MEDICAID SERVICES
MEDICARE PART D APPLICATION
PROGRAM OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
NAME OF LEGAL ENTITY
MAILING ADDRESS
TRADE NAME (if different)
PARENT ORGANIZATION (if applicable)
AREA CODE TELEPHONE NO. EXTENSION
FAX
CEO OR EXECUTIVE DIRECTOR:
MAILING ADDRESS
NAME AND TITLE
TELEPHONE NUMBER
PRIMARY APPLICANT CONTACT PERSON:
NAME
TITLE
ADDRESS
E-MAIL
FAX
TELEPHONE NUMBER
SECONDARY APPLICANT CONTACT:
NAME
TITLE
ADDRESS
E-MAIL
FAX
TELEPHONE NUMBER
17
3.2 Management and Operations
3.2.1 Subcontractor (first tier, downstream, and related entities) Function
Chart
In HPMS, on the
Contract and
Management/Part D
Information/Part D
Data Page, provide
the names of the first
tier, downstream and
related entities you
will use to carry out
each of the functions
listed in this chart
and whether the first
tier, downstream and
related entities are
off-shore:
(Indicate
―APPLICANT‖ where
applicant will perform
those functions)
Function
Subcontractor(s) (first
tier, downstream and
related entities)
Off-Shore
Yes/No
A pharmacy benefit
program that
performs adjudication
and processing of
pharmacy claims at
the point of sale.
A pharmacy benefit
program that
performs negotiation
with prescription drug
manufacturers and
others for rebates,
discounts, or other
price concessions on
prescription drugs
A pharmacy benefit
program that
performs
administration and
tracking of enrollees’
drug benefits in real
time, including TrOOP
balance processing.
A pharmacy benefit
program that
performs coordination
with other drug
benefit programs,
including, for
example, Medicaid,
state pharmaceutical
assistance programs,
or other insurance.
18
A pharmacy benefit
program that
develops and
maintains a pharmacy
network.
A pharmacy benefit
program that operates
an enrollee grievance
and appeals process
A pharmacy benefit
program that
performs customer
service functionality,
that includes serving
seniors and persons
with a disability.
A pharmacy benefit
program that
performs pharmacy
technical assistance
service functionality.
PACE organizations
functioning with
formularies agree to
maintain
pharmaceutical and
therapeutic
committees.
3.2.2 Requirements in Contracts/Administrative Services Agreements
A. Provide as attachments copies of executed contracts, fully executed letters of
agreement, or administrative services agreements with each (first tier,
downstream and related entities identified in the above table and with any first
tier, downstream, or related entity that contracts with any of the identified
entities on the applicant’s behalf. All contracts must:
1. Clearly identify the parties to the contract (or letter of agreement). If the applicant is
not a direct party to the contract (e.g., if one of the contracting entities is entering
into the contract on the applicant’s behalf), the applicant must be identified as an
entity that will benefit from the services described in the contract.
2. Describe the functions to be performed by the first tier, downstream or related entity,
and the reporting requirements the first tier, downstream, or related entity has to the
Applicant. 42 CFR §423.505(i)(4)(i)
19
3. Contain language clearly indicating that the first tier, downstream, or related entity
has agreed to participate in your Medicare Prescription Drug Benefit program
(except for a network pharmacy if the existing contract would allow participation in
this program).
4. Contain flow-down clauses requiring that their activities be consistent and comply
with the Applicant’s contractual obligations as a Part D sponsor. 42 CFR
§423.505(i)(3)(iii)
5. Describe the payment the first tier, downstream, or related entity will receive for
performance under the contract, if applicable.
6. Be signed by a representative of each party with legal authority to bind the entity.
7. Contain language obligating the first tier, downstream, or related entity to abide by
all applicable Federal laws and regulations and CMS instructions. 42 CFR
§423.505(i)(4)(iv)
8. Contain language obligating the first tier, downstream, or related entity to abide by
State and Federal privacy and security requirements, including the confidentiality
and security provisions stated in the regulations for this program at 42 CFR
§423.136.
9. Contain language ensuring that the first tier, downstream, or related entity will make
its books and other records available in accordance with 42 CFR §423.505(e)(2) and
42 CFR §423.505(i)(2). Generally stated these regulations give HHS, the
Comptroller General, or their designees the right to audit, evaluate and inspect any
books, contracts, records, including medical records and documentation involving
transactions related to CMS’ contract with the Part D sponsor and that these rights
continue for a period of 10 years from the final date of the contract period or the date
of audit completion, whichever is later. 42 CFR §423.505(e)(2) and (i)(2)
10. Contain language that the first tier, downstream, or related entity will ensure that
beneficiaries are not held liable for fees that are the responsibility of the Part D
sponsor. 42 CFR §423.505(i)(3)(i)
11. Contain language that if the Applicant, upon becoming a Part D sponsor, delegates
an activity or responsibility to the first tier, downstream, or related entity, that such
activity or responsibility may be revoked if CMS or the Part D sponsor determines
the first tier, downstream, or related entity has not performed satisfactorily. Note:
The contract/administrative services agreement may include remedies in lieu of
revocation to address this requirement. 42 CFR § 423.505(i)(4)(ii)
12. Contain language specifying that the Applicant, upon becoming a Part D sponsor,
will monitor the performance of the first tier, downstream, or related entity on an
ongoing basis. 42 CFR §423.505(i)(4)(iii)
13. If the first tier, downstream, or related entity will establish the pharmacy network or
select pharmacies to be included in the network contain language that the Part D
sponsor retains the right to approve, suspend, or terminate any arrangement with a
pharmacy. 42 CFR §423.505(i)(5)
20
14. If the first tier, downstream, or related entity will establish the pharmacy network or
select pharmacies to be included in the network contain language that payment to
such pharmacies (excluding long-term care and mail order) shall be issued, mailed,
or otherwise transmitted with respect to all clean claims submitted by or on behalf of
pharmacies within 14 days for electronic claims and within 30 days for claims
submitted otherwise. 42 CFR §§423.505(i)(3)(vi) and 423.520
15. If the first tier, downstream, or related entity will establish the pharmacy network or
select pharmacies to be included in the network contain language that if a
prescription drug pricing standard is used for reimbursement, identify the source
used by the Part D sponsor for the standard of reimbursement. 42 CFR
§§423.505(b)(21) and 423.505(i)(3)(viii)(B)
16. If the first tier, downstream, or related entity will establish the pharmacy network or
select pharmacies to be included in the network and a prescription drug pricing
standard is used for reimbursement, contain a provision that updates to such a
prescription drug pricing standard occur not less frequently than once every 7 days
beginning with an initial update on January 1 of each year, to accurately reflect the
market price of acquiring the drug. 42 CFR §423.505(b)(21) and (i)(3)(viii)(A)
17. If the first tier, downstream, or related entity will establish the pharmacy network or
select pharmacies to be included in the network contain language requiring the
network pharmacies to submit claims to the Part D sponsor or first tier, downstream
or related entity whenever the membership ID card is presented or on file at the
pharmacy unless the enrollee expressly requests that a particular claim not be
submitted. 42 CFR § 423.120(c)(3)
18. If the first tier, downstream, or related entity will adjudicate and process claims at the
point of sale and/or negotiate with prescription drug manufacturers and others for
rebates, discounts, or other price concessions on prescription drugs contain
language that the first tier, downstream, or related entity will comply with the
reporting requirements established in Section 6005 of the Affordable Care Act.
21
B. Crosswalk of Requirements in Contracts/Administrative Services Agreements
INSTRUCTIONS: Applicants must complete and upload in HPMS the following chart for
each contract/administrative services agreement submitted under Section 3.1.1D.
Applicants must identify where specifically (i.e., the pdf page number) in each
contract/administrative services agreement the following elements are found.
Requirement
Location in
Subcontract by
Page number
and Section
1. The parties to the contract
2. The functions to be performed by the first tier, downstream, or
related entity. Describe the reporting requirements the first tier,
downstream, or related entity identified in Section 3.1.1C of the
application has to the applicant. 42 CFR §423.505(i)(4)(i)
3. Language clearly indicating that the first tier, downstream, or related
entity has agreed to participate in your Medicare Prescription Drug
Benefit program (except for a network pharmacy if the existing
contract would allow participation in this program).
4. Contains flow-down clauses requiring the first tier, downstream, or
related entity’s activities to be consistent and comply with the
Applicant’s contractual obligations as a Part D sponsor. 42 CFR
§423.505(i)(3)(iii)
5. The payment the first tier, downstream, or related entity will receive
for performance under the contract, if applicable.
6. Are signed by a representative of each party with legal authority to
bind the entity.
7. Language obligating the first tier, downstream, or related entity to
abide by all applicable Federal laws and regulations and CMS
instructions. 42 CFR §423.505(i)(4)(iv)
8. Language obligating the first tier, downstream, or related entity to
abide by State and Federal privacy and security requirements,
including the confidentiality and security provisions stated in the
regulations for the program at 42 CFR §423.136.
22
9. Language ensuring that the first tier, downstream, or related entity
will make its books and other records available in accordance with
42 CFR 423.505(e)(2) and 42 CFR 423.505(i)(2). Generally stated
these regulations give HHS, the Comptroller General, or their
designees the right to audit, evaluate and inspect any books,
contracts, records, including medical records and documentation
involving transactions related to CMS’ contract with the Part D
sponsor and that these rights continue for a period of 10 years from
the final date of the contract period or the date of audit completion,
whichever is later. 42 CFR §423.505
10. Language stating that the first tier, downstream, or related entity will
ensure that beneficiaries are not held liable for fees that are the
responsibility of the Applicant. 42 CFR §423.505(i)(3)(i)
11. Language ensuring that if the Applicant, upon becoming a Part D
sponsor, delegates an activity or responsibility to the first tier,
downstream, or related entity, that such activity or responsibility may
be revoked if CMS or the Part D sponsor determines the first tier,
downstream, or related entity has not performed satisfactorily. Note:
The contract/administrative services agreement may include
remedies in lieu of revocation to address this requirement. 42 CFR
§423.505(i)(4)(ii)
12. Language specifying that the Applicant, upon becoming a Part D
sponsor, will monitor the performance of the first tier, downstream, or
related entity on an ongoing basis. 42 CFR §423.505(i)(4)(iii)
13. Language that the Part D sponsor retains the right to approve,
suspend, or terminate any arrangement with a pharmacy if the first
tier, downstream, or related entity will establish the pharmacy
network or select pharmacies to be included in the network. 42 CFR
§423.505(i)(5)
14. Language that if the first tier, downstream, or related entity will
establish the pharmacy network or select pharmacies to be included
in the network contain language that payment to such pharmacies
(excluding long-term care and mail order) shall be issued, mailed, or
otherwise transmitted with respect to all clean claims submitted by or
on behalf of pharmacies within 14 days for electronic claims and
within 30 days for claims submitted otherwise. 42 CFR
§423.505(i)(3)(vi)
23
15. Language that if the first tier, downstream, or related entity will
establish the pharmacy network or select pharmacies to be included
in the network and a prescription drug pricing standard is used for
reimbursement,identifies the source used by the Part D sponsor for
the prescription drug pricing standard of reimbursement. 42 CFR
§423.505(i)(3)(viii)(B)
16. If the first tier, downstream, or related entity will establish the
pharmacy network or select pharmacies to be included in the
network and a prescription drug pricing standard is used for
reimbursement, a provision requiring that updates to such a standard
occur not less frequently than once every 7 days beginning with an
initial update on January 1 of each year, to accurately reflect the
market price of acquiring the drug. 42 CFR §423.505(i)(3)(viii)(A)
17. If the first tier, downstream, or related entity will establish the
pharmacy network or select pharmacies to be included in the
network language requiring the network pharmacies to submit claims
to the Part D sponsor or first tier, downstream or related entity
whenever the membership ID card is presented or on file at the
pharmacy unless the enrollee expressly requests that a particular
claim not be submitted. 42 CFR §423.120(c)(3)
18. Language that if the first tier, downstream, or related entity will
adjudicate and process claims at the point of sale and/or negotiate
with prescription drug manufacturers and others for rebates,
discounts, or other price concessions on prescription drugs contain
language requiring that the first tier, downstream, or related entity will
comply with the reporting requirements established in Section 6005
of the Affordable Care Act.
24
3.2.3 Requirements for Long Term Care Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete the following chart (which contains applicable
requirements from above AND additional requirements specific to Pharmacy Access) for
each long term care pharmacy contract template submitted. Applicants must identify
where specifically (i.e., section numbers, page numbers, paragraph numbers, etc.) in each
contract template the following elements are found. [E.g., Medicare Part D Long-Term
Care Pharmacy Addendum, page 14, section 3.2, paragraph 2.]
The provisions listed below must be in all pharmacy contracts. If contracts reference
policies and procedures with which the pharmacy must comply, provide the relevant
documentation as evidence and cite this documentation accordingly.
Requirement
Citation
1. The functions to be performed by the first tier, downstream, or related
entity. Describes the reporting requirements the first tier,
downstream, or related entity identified in Section 3.1.1C of the
application has to the Applicant. 42 CFR §423.505(i)(4)(i)
2. Language obligating the first tier, downstream, or related entity to
abide by all applicable Federal laws and regulations and CMS
instructions. 42 CFR §423.505(i)(4)(iv)
3. Language obligating the first tier, downstream, or related entity to
abide by State and Federal privacy and security requirements,
including the confidentiality and security provisions stated in the
regulations for the program at 42 CFR §423.136.
4. Language ensuring that the first tier, downstream, or related entity will make its books and other
records available in accordance with 42 CFR 423.505(e)(2) and 42 CFR 423.505(i)(2). Generally stated
these regulations give HHS, the Comptroller General, or their designees the right to audit, evaluate and
inspect any books, contracts, records, including medical records and documentation involving
transactions related to CMS’ contract with the Part D sponsor and that these rights continue for a period
of 10 years from the final date of the contract period or the date of audit completion, whichever is later.
42 CFR §423.505
5. Language stating that the first tier, downstream, or related entity will
ensure that beneficiaries are not held liable for fees that are the
responsibility of the Applicant. 42 CFR §423.505(i)(3)(i)
25
6. Language ensuring that if the Applicant, upon becoming a Part D
sponsor, delegates an activity or responsibility to the first tier,
downstream, or related entity, that such activity or responsibility may
be revoked if CMS or the Part D sponsor determines the first tier,
downstream, or related entity has not performed satisfactorily. Note:
The contract may include remedies in lieu of revocation to address
this requirement. 42 CFR §423.505(i)(4)(ii)
7. Language specifying that the Applicant, upon becoming a Part D
sponsor, will monitor the performance of the first tier, downstream, or
related entity on an ongoing basis. 42 CFR §423.505(i)(4)(iii)
8. Provisions requiring that payment shall be issued, mailed or otherwise
transmitted with respect to all clean claims submitted by or on behalf
of pharmacies within 14 days for electronic claims and within 30 days
for claims submitted otherwise. 42 CFR §423.505(i)(3)(vi)
9. For those contracts that use a prescription drug pricing standard for
reimbursement, a provision indicating the source used by the Part D
sponsor for the prescription drug pricing standard of reimbursement.
42 CFR §423.505(i)(3)(viii)(B)
10. For those contracts that use a prescription drug pricing standard for
reimbursement, a provision that updates to such a standard occur not
less frequently than once every 7 days beginning with an initial
update on January 1 of each year, to accurately reflect the market
price of acquiring the drug.42 CFR §423.505(i)(3)(viii)(A)
11. Language requiring the network pharmacy to submit claims to the
Part D sponsor or first tier, downstream or related entity whenever the
membership ID card is presented or on file at the pharmacy unless
the enrollee expressly requests that a particular claim not be
submitted. 42 CFR §423.120(c)(3)
12. Provisions governing submitting claims to a real-time claims
adjudication system. 42 CFR §423.505(j) and §423.505(b)(17)
13. Note: Applicant may indicate for I/T/U pharmacies and for certain
pharmacies that are allowed to submit claims in the X 12 format that
these may be batch processed.
14. Provisions governing providing Part D enrollees access to negotiated
prices as defined in 42 CFR 423.100. 42 CFR §423.104(g)
15. Provisions regarding charging/applying the correct cost-sharing
amount. 42 CFR §423.104
26
16. Provisions governing informing the Part D enrollee at the point of sale
(or at the point of delivery for mail order drugs) of the lowest-priced,
generically equivalent drug, if one exists for the beneficiary's
prescription, as well as any associated differential in price. 42 CFR
§423.132
Elements Specific to Long-Term Care Contracts
Note: CMS Long-Term Care Guidance included in Chapter 5 of the Prescription Drug
Benefit Manual contains an updated list of performance and service criteria for
contracting with long-term care pharmacies. Applicants should, at a minimum,
incorporate these criteria in ALL LTC pharmacy network contracts. Applicant must
list the criteria below, and then identify where the elements reside in the contract
template(s) submitted.
Performance and Service Criteria
Citation
Comprehensive Inventory and Inventory Capacity – Network Long Term
Care Pharmacies [NLTCPs] must provide a comprehensive inventory of
Plan formulary drugs commonly used in the long term care setting. In
addition, NLTCPs must provide a secured area for physical storage of
drugs, with necessary added security as required by federal and state
law for controlled substances. This is not to be interpreted that the
pharmacy will have inventory or security measures outside of the normal
business setting.
Pharmacy Operations and Prescription Orders -- NLTCPs must provide
services of a dispensing pharmacist to meet the requirements of
pharmacy practice for dispensing prescription drugs to LTC residents,
including but not limited to the performance of drug utilization review
(DUR). In addition, the NLTCP pharmacist must conduct DUR to
routinely screen for allergies and drug interactions, to identify potential
adverse drug reactions, to identify inappropriate drug usage in the LTC
population, and to promote cost effective therapy in the LTC setting. The
NLTCP must also be equipped with pharmacy software and systems
sufficient to meet the needs of prescription drug ordering and distribution
to an LTC facility. Further, the NLTCP must provide written copies of the
NLTCP’s pharmacy procedures manual and said manual must be
available at each LTC facility nurses’ unit. NLTCPs are also required to
provide ongoing in-service training to assure that LTC facility staff is
proficient in the NLTCP’s processes for ordering and receiving of
medications. NLTCP must be responsible for return and/or disposal of
unused medications following discontinuance, transfer, discharge, or
death as permitted by State Boards of Pharmacy. Controlled substances
and out of date substances must be disposed of within State and Federal
guidelines.
27
Special Packaging -- NLTCPs must have the capacity to provide specific
drugs in Unit of Use Packaging, Bingo Cards, Cassettes, Unit Dose or
other special packaging commonly required by LTC facilities. NLTCPs
must have access to, or arrangements with, a vendor to furnish supplies
and equipment including but not limited to labels, auxiliary labels, and
packing machines for furnishing drugs in such special packaging required
by the LTC setting.
IV Medications -- NLTCPs must have the capacity to provide IV
medications to the LTC resident as ordered by a qualified medical
professional. NLTCPs must have access to specialized facilities for the
preparation of IV prescriptions (clean room). Additionally, NLTCPs must
have access to or arrangements with a vendor to furnish special
equipment and supplies as well as IV trained pharmacists and
technicians as required to safely provide IV medications.
Compounding /Alternative Forms of Drug Composition -- NLTCPs must
be capable of providing specialized drug delivery formulations as
required for some LTC residents. Specifically, residents unable to
swallow or ingest medications through normal routes may require tablets
split or crushed or provided in suspensions or gel forms, to facilitate
effective drug delivery.
Pharmacist On-call Service -- NLTCP must provide on-call, 24 hours a
day, 7 days a week service with a qualified pharmacist available for
handling calls after hours and to provide medication dispensing available
for emergencies, holidays and after hours of normal operations.
Delivery Service -- NLTCP must provide for delivery of medications to the
LTC facility up to seven days each week (up to three times per day) and
in-between regularly scheduled visits. Emergency delivery service must
be available 24 hours a day, 7 days a week. Specific delivery
arrangements will be determined through an agreement between the
NLTCP and the LTC facility. NLTCPs must provide safe and secure
exchange systems for delivery of medication to the LTC facility. In
addition, NLTCP must provide medication cassettes, or other standard
delivery systems, that may be exchanged on a routine basis for
automatic restocking. The NLTCP delivery of medication to carts is a
part of routine ―dispensing‖.
Emergency Boxes -- NLTCPs must provide ―emergency‖ supply of
medications as required by the facility in compliance with State
requirements.
28
Emergency Log Books -- NLTCP must provide a system for logging and
charging medication used from emergency/first dose stock. Further, the
pharmacy must maintain a comprehensive record of a resident’s
medication order and drug administration.
Miscellaneous Reports, Forms and Prescription Ordering Supplies -NLTCP must provide reports, forms and prescription ordering supplies
necessary for the delivery of quality pharmacy care in the LTC setting.
Such reports, forms and prescription ordering supplies may include, but
will not necessarily be limited to, provider order forms, monthly
management reports to assist the LTC facility in managing orders,
medication administration records, treatment administration records,
interim order forms for new prescription orders, and boxes/folders for
order storage and reconciliation in the facility.
Provide that long-term care pharmacies must have not less than 30 days,
nor more than 90 days, to submit to the Part D Sponsor claims for
reimbursement under the plan. 42 CFR § 423.504(b)(20)
Provisions requiring that long-term care pharmacies dispense drugs and
report information as required by 42 CFR §423.154.
3.3 HPMS Part D Contacts
A. In HPMS, on the Contract Management/Contact Information/Contact Data Page
provide the name/title, mailing address, phone number, fax number, and email
address for the following Applicant contacts. We recognize that due to the
many PACE Part D waivers, several of the requested contacts bear no
relevance for PACE organizations. However, for systems purposes all
sections must be populated. Therefore, in instances where a contact does not
apply, please list the Application Contact.
Note: The same individual should not be identified for each of these contacts. If a
general phone number is given then CMS requires specific extensions for the
individual identified. Under no circumstances should these numbers merely lead to a
company’s general automated phone response system. Further, Applicants must
provide specific email addresses for the individuals named.
Note: Contact definitions are provided in HPMS in the Contract
Management/Contact Information/Contact Data/Documentation link entitled Contact
Definitions.
29
Contact
Name/Title
Mailing
Phone/Fax
Address (PO Numbers
Boxes may
not be used)
Email Address
Corporate Mailing
CEO – Sr. Official for
Contracting
Chief Financial Officer
Medicare Compliance
Officer
Enrollment Contact
Medicare Coordinator
System Contact
Customer Service
Operations Contact
General Contact
User Access Contact
Backup User Access
Contact
Marketing Contact
Medical Director
Bid Primary Contact
Payment Contact
Part D Claims
Submission Contact
Formulary Contact
Pharmacy Network
Management Contact
30
Medication Therapy
Management Contact
Part D Benefits
Contact
Part D Quality
Assurance Contact
Part D Application
Contact
Pharmacy Director
HIPAA Security
Officer
HIPAA Privacy Officer
Part D Price File
Contact (Primary)
Part D Price File
Contact (Back-up)
Part D Appeals
Government Relations
Contact
Emergency Part D
Contact
Pharmacy Technical
Help Desk Contact
Processor Contact
CMS Casework
Communication
Contact
Part D Exceptions
Contact
Coordination of
Benefits Contact
31
CEO – CMS
Administrator Contact
Plan to Plan
Reconciliation Contact
Bid Audit Contact
Plan Directory
Contact for Public
Website
CAP Report Contact
for Public Website
Financial Reporting
Contact
Best Available
Evidence Contact
Automated TrOOP
Balance Transfer
Contact
Agent/Broker
Compensation Data
Contact
Complaint Tracking
Module (CTM)
Contact
Part D Reporting
Requirement Contact
Fraud Investigations
Contact
Reconciliation Contact
DIR Contact
32
B. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to
be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the
following qualifications by clicking on the appropriate response in
HPMS:
Yes
No
Yes
No
1. Applicant agrees that CMS may release contact information to States,
SPAPs, providers, Part D sponsors, and others who need the contact
information for legitimate purposes.
3.4 Program Integrity and Compliance Program
A. In HPMS, complete the table below:
Applicant must attest ‘yes’ or ‘no’ to each of the following
qualifications to be approved for a Part D contract. Attest ‘yes’ or
‘no’ to each of the following qualifications by clicking on the
appropriate response in HPMS:
1. Applicant, applicant staff, and its affiliated companies, subsidiaries or
first tier, downstream and related entities, and staff of the first tier,
downstream and related entities agree that they are bound by 2 CFR
Part 376 and attest that they are not excluded by the Department of
Health and Human Services Office of the Inspector General or by the
General Services Administration exclusion lists. Please note that this
includes any member of its board of directors, and any key
management or executive staff or any major stockholder.
Additionally, given Medicare payment may not be made for items or
services furnished by an excluded provider or entity, applicant should
follow the guidance provided in the January 13, 2010 HPMS memo
entitled Claims for Drugs Prescribed or Dispensed by Excluded
Providers.
B. Provide as an upload via HPMS, in a .pdf format, a copy of your organization’s
Medicare Part D Compliance Program that you intend to use for this contract.
The Part D compliance program must be in accordance with 42 CFR 423.504(b)(4)(vi).
The compliance program must explicitly include the name of the applicant. (The name
of a parent organization is insufficient.) The Part D compliance program must include
all 7 elements in the regulation and in Chapter 9 and are specific to the issues and
challenges presented by the Part D program. The compliance plan must explicitly state
that it encompasses Medicare Part D. A general compliance program applicable to
healthcare operations is not acceptable.
Please be advised that the Applicant is ultimately responsible for the implementation
and monitoring of the day-to-day operations of its Part D compliance program. 42 CFR
33
§ 423.504(b)(vi)(B)(1) and section 40.1 of Chapter 9 of the Prescription Drug Benefit
Manual indicates that the compliance officer and compliance committee functions may
not be delegated or subcontracted. This means that the Medicare Compliance Officer
identified in HPMS contacts (see section entitled HPMS Part D Contacts) must be an
employee of the Applicant, the Applicant’s parent organization, or a corporate affiliate of
the Applicant. A compliance program adopted and operated by an Applicant’s first tier,
downstream, and related entities is not sufficient to demonstrate that the Applicant
meets the compliance program requirement.
C. In HPMS, complete and upload the table below for the Compliance Plan.
Applicant must clearly identify where each requirement can be found in the
uploaded documents.
Compliance Plan Elements
A. Written policies, procedures, and standards of conduct must
include the following seven components:
Page, paragraph
here element
located
§ 423.504(b)
(4)(vi)(A)
1. Articulate the applicant’s commitment to comply with all applicable
Federal and State standards.
2. Describe compliance expectations as embodied in the standards of
conduct.
3. Describe the implementation and operation of the compliance
program.
4. Provide guidance to employees and others on dealing with potential
compliance issues.
5. Identify how to communicate compliance issues to appropriate
compliance personnel.
6. Describe how potential compliance issues will be investigated and
resolved by the applicant.
7. Include a policy of non-intimidation and non-retaliation for good faith
participation in the compliance program, including, but not limited to,
reporting potential issues, investigating issues, conducting selfevaluations, audits and remedial actions, and reporting to
appropriate officials.
34
B. Designation of a compliance officer and a compliance
committee who report directly to and are accountable to
applicant’s chief executive or senior management and include the
following three components:
§ 423.504(b)
(4)(vi)(B)
1. The compliance officer, vested with the day-to-day operations of the
compliance program, must be an employee of the MA applicant,
parent organization or corporate affiliate. The compliance officer
may not be an employee of the MA applicant’s first tier, downstream
or related entity.
2. The compliance officer and the compliance committee must
periodically report directly to the governing body of the MA applicant
on the activities and status of the compliance program, including
issues identified, investigated, and resolved by the compliance
program.
3. The governing body of the MA applicant must be knowledgeable
about the content and operation of the compliance program and
must exercise reasonable oversight with respect to the
implementation and effectiveness of the compliance programs.
C. Establish, implement and provide effective training and
education for employees including the chief executive and senior
administrators or managers, governing body members, first tier,
downstream, and related entities must include the following
components:
§ 423.504(b)
(4)(vi)(C)
1. Training and education must occur at least annually and must be
part of the orientation for new employees, new first tier, downstream
and related entities, and new appointments to chief executive,
senior administrator, or governing body member.
2. An indication that first tier, downstream, and related entities who
have met the fraud, waste, and abuse certification requirements
through enrollment into the Medicare program or accreditation as a
Durable Medical Equipment, Prosthetics, Orthotics, and supplies
(DMEPOS) are deemed to have met the training and educational
requirements for fraud, waste, and abuse.
D. Establishment and implementation of effective lines of
communication, ensuring confidentiality, between:
§ 423.504(b)
(4)(vi)(D)
1. The compliance officer, members of the compliance committee, the
MA applicant’s employees, managers and governing body.
35
2. The MA applicant’s first tier, downstream, and related entities.
3. Such lines of communication must be accessible to all.
4. Allow compliance issues to be reported, including a method for
anonymous and confidential good faith reporting of potential
compliance issues, as they are identified.
E. Well-publicize disciplinary standards and implementation of
procedures, which encourage good faith participation in the
compliance program by all affected individuals, that are enforced
and include the following three policies:
§ 423.504(b)
(4)(vi)(E)
1. Articulate expectations for reporting compliance issues and assist in
their resolution.
2. Identify non-compliance or unethical behavior.
3. Provide for timely, consistent, and effective enforcement of the
standards when noncompliance or unethical behavior is determined.
F. Establish and implementation of an effective system for routine
monitoring and identification of compliance risks. The system
should include: internal monitoring and audits and, as
appropriate, external audits, to evaluate the MA applicant,
including first tier entities’, compliance with CMS requirements
and the overall effectiveness of the compliance program.
§ 423.504(b)
(4)(vi)(F)
G. Establishment and implementation of procedures and a system
for promptly responding to compliance issues as they are raised,
investigating potential compliance problems identified in the
course of self-evaluations and audits, correcting such problems
promptly and thoroughly to reduce the potential for recurrence,
and ensure ongoing compliance with CMS requirements. The
procedures must include the following components:
§ 423.504(b)
(4)(vi)(G)
1. If the MA applicant discovers evidence of misconduct related to
payment or delivery of items or services under the contract, it must
conduct a timely, reasonable inquiry into that conduct.
2. The MA applicant must conduct appropriate corrective actions (e.g.,
repayment of overpayments and disciplinary actions against
responsible individuals) in response to the potential violation.
3. The MA applicant should have procedures to voluntarily self-report
potential fraud or misconduct related to the MA program to CMS or
its designee.
36
3.5 Health Information Technology
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE
FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A
PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH
OF THE FOLLOWING QUALIFICATIONS BY PLACING A
CHECKMARK IN THE RELEVANT COLUMN:
YES
NO
Requesting
Waiver?
Yes or No
1. Applicant agrees that as it implements, acquires, or
upgrades health information technology (HIT) systems,
where available, the HIT systems and products meet
standards and implementation specifications adopted
under section 3004 of the Public Health Services Act as
added by section 13101 of the American Recovery and
Reinvestment Act of 2009, P.L. 111-5.
3.6 Enrollment and Eligibility
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE
FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A
PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH
OF THE FOLLOWING QUALIFICATIONS BY PLACING A
CHECKMARK IN THE RELEVANT COLUMN:
YES
NO
Requesting
Waiver?
Yes or No
1. Applicant complies with CMS operational guidance on
Creditable Coverage and the Late Enrollment Penalty.
2. For each enrollment request received, Applicant queries
the Batch Eligibility Query (BEQ) or the User Interface (UI)
prior to the submission of an enrollment transaction to the
MARx system to receive:
Verification of Medicare Entitlement and Part D Eligibility,
Periods of enrollment in a Medicare plan that provides
prescription drug coverage,
Periods of enrollment in a retiree prescription drug plan
whose sponsor receives a retiree drug subsidy from
Medicare, and
Information regarding the Low Income Subsidy applicable
to each new enrollee.
37
3. Applicant collects, reviews, and transmits creditable
coverage information in accordance with CMS operational
guidance and policies.
4. Applicant uses the information provided by CMS,
including the Low-Income Subsidy/Part D Premium Report
Data File to determine match rates of their information to
that of CMS within 72 hours of receipt. Applicant further
agrees that their match rate should achieve 95 percent
and that non-matches are resolved within 72 hours.
5. Applicant does not disenroll members for failure to pay
premiums (or notify them of impending disenrollment) in
cases where the individual is considered to be in premium
withhold status by CMS as provided in CMS Enrollment
and Disenrollment Guidance and Premium Payment
policies.
6. Applicant does not disenroll a member or initiate the
disenrollment process if the organization has been notified
that a State Pharmaceutical Assistance Program (SPAP)
or other payer intends to pay the entire Part D premium on
behalf of an individual.
3.7 Complaints Tracking
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE
FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A
PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH
OF THE FOLLOWING QUALIFICATIONS BY PLACING A
CHECKMARK IN THE RELEVANT COLUMN:
YES
NO
Requesting
Waiver?
Yes or No
1. Applicant resolves 95% of complaints designated as
immediate needs complaints via the CMS Complaints
Tracking Module within 2 calendar days.
2. Applicant is expected to resolve at least 95% of complaints
designated as ―urgent‖ via the CMS Complaints Tracking
Module in accordance with CMS issued guidance.
3. Applicant is expected to resolve at least 95% of complaints
without an issue level via the CMS Complaints Tracking
Module in accordance with CMS issued guidance.
38
4. Applicant monitors and documents complaint resolutions
for complaints attributed to their contracts in the CMS’
Complaint Tracking Module in accordance with CMS’
Standard Operating Procedures for Part D sponsors.
5. Applicant maintains Standard Operating Procedures that
address how its organization will handle and quickly
resolve immediate action cases, as well as, outline the
steps the organization intends to take to have enrollees
call your customer service directly for the prompt resolution
of all inquiries.
3.8 Coordination of Benefits
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE
FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A
PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF
THE FOLLOWING QUALIFICATIONS BY PLACING A
CHECKMARK IN THE RELEVANT COLUMN:
YES
NO
Requesting
Waiver?
Yes or No
1. Applicant complies with Chapter 14 of the Prescription
Drug Benefit Manual.
2. Applicant has a system for notifying enrollees when CMS’
systems indicate other prescription drug coverage, and
requesting enrollees to concur with new/changed
information.
3. Applicant permits SPAPs, ADAPs, IHS, and other third
party payers to coordinate benefits as required by the
regulations in 42 CFR Part 423, Subpart J, and Chapter 14
of the Prescription Drug Benefit Manual. For example, an
SPAP may require agreements be signed in order for the
state to pay premiums on behalf of a beneficiary. CMS
expects Part D sponsors to execute these trading partner
agreements within a reasonable timeframe.
4. Applicant does not impose fees on SPAPs or other thirdparty insurers that are unreasonable and/or unrelated to
the cost of coordination of benefits.
39
5. Applicant coordinates benefits with SPAPs, other
entities providing prescription drug coverage,
beneficiaries, and others paying on the beneficiaries’
behalf for a period not to exceed three years from the
date on which the prescription for a covered Part D
drug was filled.
3.9 Tracking True Out-of-Pocket Costs (TrOOP)
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE
FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A
PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF
THE FOLLOWING QUALIFICATIONS BY PLACING A
CHECKMARK IN THE RELEVANT COLUMN:
YES
NO
Requesting
Waiver?
Yes or No
1. Applicant tracks each enrollee’s true out of pocket
(TrOOP) costs reflecting the amount the enrollee has
spent out of pocket during a program year on covered Part
D drugs.
2. Applicant accepts data concerning third party payers in a
format specified by CMS and uses these data in the
Applicant’s TrOOP calculation process.
3. In the event of disenrollment, Applicant provides the
TrOOP status of the beneficiary as of the effective date of
the disenrollment to the beneficiary, if there has been a
change in these data since the last report to the
beneficiary.
4. Applicant agrees that, when an exception to the ATBT
process is required, the Applicant sends TrOOP-related
data manually for disenrolling Part D beneficiaries as well
as receives these data manually for newly enrolling Part D
beneficiaries transferring mid-year from another plan.
5. Applicant treats costs incurred by AIDS Drug Assistance
Programs and Indian Health Services in providing
prescription drugs toward the annual out-of-pocket
threshold.
NOTE: For information regarding the TrOOP facilitator, Applicant may link to
http://medifacd.ndchealth.com/
40
3.10 Medicare Secondary Payer
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE
FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A
PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH
OF THE FOLLOWING QUALIFICATIONS BY PLACING A
CHECKMARK IN THE RELEVANT COLUMN:
YES
NO
Requesting
Waiver?
Yes or No
1. Applicant is familiar with rules that determine when other
payers are primary or secondary to Medicare as
referenced in 42 CFR §423.462.
2. Applicant adheres to MSP laws and any other Federal and
State laws in establishing payers of last resort.
3. Applicant follows the Rules for Coordination of Benefits
adopted in the most current National Association of
Insurance Commissioner Coordination of Benefits Model
Regulation.
4. Applicant collects mistaken primary payment from insurers,
group health plans, employer sponsors, enrollees and
other entities.
5. Applicant agrees that in situations involving workers’
compensation, Black Lung, No-Fault, or Liability coverage
to make conditional primary payment and recover any
mistaken payments, unless the Applicant is already aware
that the enrollee has workers’ compensation, Black Lung,
No-Fault, or Liability coverage and has previously
established that a certain drug is being used exclusively to
treat a related injury.
41
3.11 Data Collection and Reporting Requirements
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE
FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A
PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH
OF THE FOLLOWING QUALIFICATIONS BY PLACING A
CHECKMARK IN THE RELEVANT COLUMN:
REBATE DATA
YES
NO
Requesting
Waiver?
Yes or No
1. The Applicant reports direct and indirect remuneration
(DIR) dollars for payment reconciliation on an annual basis
at the Plan Benefit Package (PBP) level/plan level in the
manner specified by CMS. In addition, the Applicant
maintains records and documentation to verify the DIR
data reported to CMS.
3.12 Data Exchange between PACE Organizations and CMS
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE
FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A
PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH
OF THE FOLLOWING QUALIFICATIONS BY PLACING A
CHECKMARK IN THE RELEVANT COLUMN:
YES
NO
Requesting
Waiver?
Yes or No
HPMS
1. Applicant uses HPMS to communicate with CMS in
support of the application process, formulary submission
process, bid submission process, ongoing operations of
the Part D program, and reporting and oversight activities.
Part D sponsors are required to secure access to HPMS in
order to carry out these functions.
ENROLLMENT & PAYMENT
2. Applicant establishes connectivity to CMS as noted in the
instructions provided by the MAPD Help Desk at 1-800927-8069 or via the MAPD HelpDesk webpage,
www.cms.gov/mapdhelpdesk, in the Plan Reference Guide
for CMS Part C/D system link.
3. Applicant obtains CMS User ID and Password.
42
4. Applicant submits enrollment, disenrollment and change
transactions to communicate membership information to
CMS within the timeframes provided by CMS.
5. Applicant reconciles Part D data to CMS
enrollment/payment reports received daily, weekly and
monthly.
6. Applicant completes the review of monthly reports,
including submitting all requests for discrepancy
corrections, and submits the CEO Certification of
enrollment data for plan payment within 45 days of CMS
monthly membership payment report availability.
7. Applicant participates in connectivity testing and other
system testing measures as provided to the Applicants
prior to contract execution to validate system setup.
8. Applicant has system(s) to process enrollment and
payment transactions as exchanged with CMS in
accordance with system development lifecycle
standards.
9. Applicant ensures appropriate security safeguards and
protocols are in place to protect the protected health
information in the system(s).
10. Applicant maintains all pertinent system security and
disaster recovery plans and procedures.
3.13 Health Insurance Portability and Accountability Act of 1996
(HIPAA)
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE
FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A
PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH
OF THE FOLLOWING QUALIFICATIONS BY PLACING A
CHECKMARK IN THE RELEVANT COLUMN:
YES
NO
Requesting
Waiver?
Yes or No
1. Applicant complies with all applicable standards,
implementation specifications, and requirements in the
Standards for Privacy of Individually Identifiable Health
Information, and Security Standards under 45 CFR Parts
160, 162, and 164.
43
2. Applicant encrypts all hard drives or other storage media
within the device as well as all removable media.
3. Applicant has policies addressing the secure handling of
portable media that is accessed or used by the
organization.
4. Applicant complies with all applicable standards,
implementation specifications, and requirements in the
Standard Unique Health Identifier for Health Care
Providers final rule under 45 CFR Parts 160 and 162.
5. Applicant agrees that when its organization receives a
National Provider Identifier (NPI) in prescription drug event
data, that the organization must report an NPI.
6. Applicant agrees to implement a contingency plan related
to compliance with the NPI provisions.
7. Applicant complies with all applicable standards,
implementation specifications, and requirements in the
Standards for Electronic Transactions under 45 CFR Parts
160 and 162.
8. Applicant submits the Offshore Subcontract Information
and Attestation via HPMS for each offshore subcontractor
(first tier, downstream and related entities) (including
downstream offshore subcontractors’ first tier, downstream
and related entities) that receive, process, transfer, handle,
store, or access Medicare beneficiary protected health
information (PHI) by the last Friday in September for the
upcoming contract year.
3.14 Prohibition on Use of SSN or Medicare ID Number on Enrollee ID
Cards
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE
FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A
PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH
OF THE FOLLOWING QUALIFICATIONS BY PLACING A
CHECKMARK IN THE RELEVANT COLUMN:
YES
NO
Requesting
Waiver?
Yes or No
1. Applicant does not use an enrollee’s Social Security
Number (SSN) or Medicare ID Number on the enrollee’s
identification card.
44
3.15 Prescription Drug Event (PDE) Records
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE
FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A
PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH
OF THE FOLLOWING QUALIFICATIONS BY CLICKING ON
THE APPROPRIATE RESPONSE IN HPMS:
YES
NO
YE
NO
Requesting
Waiver?
Yes or No
2. Applicant abides by CMS guidance related to PDE data.
Such guidance includes the 2008 Regional Prescription
Drug Event Data Participant Training Guide and Technical
Assistance Resource Guide which can be found at
www.csscoperations.com/new/pdic/pdd-training/pddtraining.html.
3. Applicant submits data and information necessary for CMS
to carry out payment provisions.
4. Applicant submits PDE data on the schedule required by
applicable regulations and CMS guidance.
5. Applicant provides diagnosis data for risk adjustment as
required by CMS.
6. Applicant submits the PDE data in the format described by
CMS and in accordance with the National Council for
Prescription Drug Programs (NCPDP) industry standard
format.
7. Applicant meets all data submission deadlines.
8. Applicant pays all Plan-to-Plan payables on time.
9. Applicant complies with Medicare Coverage Gap Discount
Program requirements.
10. Applicant complies with timely response requirements for
PDE Data Quality Reviews posted on the Data Quality
Validation website.
3.16 Claims Processing
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE
FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A
Requesting
45
PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH
OF THE FOLLOWING QUALIFICATIONS BY PLACING A
CHECKMARK IN THE RELEVANT COLUMN:
S
Waiver?
Yes or No
1. Applicant has an on-line claims processing system that
operates in real time to ensure accurate and timely
payment of all claims submitted by network pharmacies on
behalf of Part D plan enrollees. System operates
according to the following standards:
98% response within 4 seconds;
99% of all claims paid with no errors;
99% system availability.
2. Applicant has a system designed to:
Pay non-electronic claims submissions from network
pharmacies in accordance with 42 CFR §423.520; and
Pay requests for reimbursement from beneficiaries in
accordance with 42 CFR §423.568(b).
3. Applicant has available for CMS inspection a complete
description of your claims adjudication system including:
Hardware and software;
Operating system;
Commercial organization from which Applicant receives
pricing files, including file revision history;
Number of sites processing claims (including disaster
recovery back-up system);
System volume in covered lives, including the number of
transactions the system can support per day and per hour.
4. Applicant has available to CMS upon request policies and
procedures that include a complete description and flow
chart detailing the claims adjudication process for each:
Contracted network pharmacies;
Paper claims;
Out-of-network pharmacy claims submitted by
beneficiaries;
Non-electronic claims submitted by network pharmacies,
46
and other payers seeking to coordinate benefits;
Batch-processed claims; and
Manual claim entry (e.g. for processing direct member
reimbursement).
5. Applicant has available to CMS upon request policies and
procedures that include a complete description of claim
detail management, including:
The length of time that detailed claim information is
maintained online (not less than 12 months);
The data storage process after it is no longer online; and
The length of time that detailed claim information is stored
when it is no longer online (not less than 10 years).
6. Applicant has available to CMS upon request policies and
procedures that include a complete description of the
accessibility of this information for data capture purposes
and flow chart of the claims data retrieval process for each:
Entire claims history file;
File claims adjustments including records of
reimbursements and recoveries due to network
pharmacies and beneficiaries; and
Deductible files/ TrOOP/ and gross covered prescription
drug cost accumulator.
7. Applicant has a robust testing process that will identify and
correct any plan configuration errors prior to
implementation.
8. Applicant uses HIPAA compliant transactions where
applicable.
9. Applicant documents the manner and extent to which it
has tested benefit designs such as drug exclusions or
quantity limitations and plan parameters such as copayments and benefit intervals (phases).
47
10. Applicant rapidly adopts any new messaging approved by
the NCPDP Workgroup to adjudicate a Part D claim and
appropriately coordinate benefits in real time.
11. Applicant regularly updates their systems with the most
current information on sanctioned providers and has
processes in place to identify and prevent payment of Part
D claims at point-of-sale when such claims have been
prescribed by excluded providers.
12. Applicant assigns and exclusively uses unique Part D
identifiers (RxBin or RxBin/RxPCN) for each individual Part
D member.
13. Applicant agrees when it receives information that
necessitates a retroactive claims adjustment, the applicant
processes the adjustment and issues refunds or recovery
notices within 45 days of the applicant’s receipt of
complete information regarding the claims adjustment.
3.17 Record Retention
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE
FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A
PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF
THE FOLLOWING QUALIFICATIONS BY PLACING A
CHECKMARK IN THE RELEVANT COLUMN:
YES
NO
Requesting
Waiver?
Yes or No
1. The Applicant maintains books, records, documents, and
other evidence of accounting procedures and practices
consistent with 42 CFR §423.505(d).
2. Applicant has pharmacies, contracted for the Part D
benefit, maintain prescription records in their original
format for the greater of 3 years or the period required by
State law and allow those records to be transferred to an
electronic format that replicates the original prescription for
the remaining 7 years of the 10 year record retention
requirement.
3. Applicant keeps all other records—except prescription
records—that must be retained for Medicare under Part C
and Part D in the format(s) required by State law or at the
Applicant’s discretion.
48
3.18 Electronic Prescription Program
Complete the table below. Only those applicants that attest ―yes‖ to item 1 in the table
below must complete items 2 and 3 and will be required to adhere to electronic
prescription program requirements specified in 42 CFR §§ 423.159 and 160. All
applicants must complete item 4.
APPLICANT MUST ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D
CONTRACT. ATTEST ‘YES’ OR ‘NO’ BY CHECKING THE
APPROPRIATE BOX
YES
NO
1. Applicant establishes an electronic prescription program.
2. Applicant supports and complies with electronic prescription
standards relating to covered Part D drugs for Part D enrollees.
3. Applicant has an electronic prescription drug program that complies
with final Part D standards for transmitting, directly or through an
intermediary, prescriptions and prescription-related information using
electronic media for covered Part D drugs for Part D eligible
individuals.
4. Applicant obtains the Prescription Origin Code on original
prescriptions submitted via the NCPDP 5.1 option field 419 DJ and
reports this code on their PDE submissions.
3.19 Formulary Submission Requirements
3.19.1
Applicability of Formulary Submission Requirements
For purposes of formulary submission and review, the following paragraphs describe
the definition of a formulary.
Cost sharing tiers: Any coverage list that utilizes more than one cost sharing tier
with differential co-pay or coinsurance, is considered a formulary.
Prior authorization: Any coverage list that contains one or more drugs that must
undergo prior authorization before dispensing is considered a formulary. If in the
normal course of clinical practice, the prescribing physician uses FDA-approved
indications and use criteria to determine appropriateness of therapy, this is not
considered prior authorization.
Step therapy: Any coverage list that contains one or more drugs that are part of a
step therapy management program is considered a formulary. This includes any
program that requires a certain drug to be used first, before a different drug can be
dispensed. Step therapy can apply to certain drug classes or among brand and
generic drug combinations.
49
Quantity limitations: Any coverage list that contains one or more drugs with
quantity limits is considered a formulary. Quantity limits are often used in cases
where FDA-approved prescribing instructions state that only a certain number of
doses should be used in a certain time period.
Steerage: Any coverage list that contains one or more drugs that are considered
preferred or drugs that are steered towards is considered a formulary. Common
prescribing patterns are not considered steerage as long as there are no adverse
consequences to physicians or patients if a particular drug is not chosen.
If a plan meets any of the five criteria referenced above, then their coverage list is
considered a formulary and needs to be submitted to CMS for review and approval.
Only those applicants that have a coverage list that includes one of the items
listed above will be required to adhere to formulary requirements specified in 42
CFR §423.120(b) and complete the application sections that follow.
3.19.2
Formulary/Pharmacy and Therapeutics (P&T) Committee
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING
QUALIFICATIONS TO BE APPROVED FOR A PART D CONTRACT.
ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
QUALIFICATIONS BY CHECKING THE APPROPRIATE BOX
YES
NO
1. Applicant will submit a formulary to CMS for the Part D benefit by the
CMS specified dates.
2. Applicant will link all associated contracts to an initial formulary
submission on or before the formulary submission deadline;
otherwise, Applicant will be considered to have missed the formulary
submission deadline.
3. Applicant complies with formulary guidance that is contained in
Chapter 6 of the Prescription Drug Benefit Manual, the HPMS
Formulary Submission Module and Reports Technical Manual, and all
other formulary instructions.
4. Applicant agrees, when using a formulary, to meet all formulary
submission deadlines established by CMS. Applicant further agrees
that CMS may discontinue its review of the Applicant’s formulary
submission upon the Applicant’s failure to meet any of the formulary
submission deadlines. Applicant acknowledges that failure to receive
CMS approval of its formulary may prevent CMS from approving the
Applicant’s bid(s) and contracting with the Applicant for the following
benefit year.
50
5. Applicant agrees that its formulary includes substantially all drugs in
the protected classes that are specified as of the CMS-established
formulary submission deadline. Applicant further agrees that any new
drugs or newly approved uses for drugs within the protected classes
that come onto the market after a CMS-established formulary
submission deadline will be subject to an expedited P&T committee
review. The expedited review process requires P&T committees to
make a decision within 90 days, rather than the normal 180-day
requirement.
6. Applicant provides for an appropriate transition for new enrollees into
Part D plans following the annual coordinated election period, 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 affected by formulary
changes prescribed Part D drugs that are not on its formulary. This
transition process satisfies the requirements specified in Chapter 6 of
the Prescription Drug Benefit Manual.
7. Applicant attests that its organization’s approach to transitioning
beneficiaries on drug regimens that are not on the plan’s Part D
approved formulary meets CMS criteria. The transition policy
attestation will be completed in HPMS by close of business on the
CMS-established formulary submission deadline in section 1.4.
8. Applicant agrees to submit its organization’s transition policy and a
description of how the transition policy will be implemented within the
applicant’s claims adjudication system, including pharmacy
notification via email to [email protected] by close of
business on the CMS-established formulary submission deadline in
section 1.4.
9. Applicant extends, where appropriate, transition periods beyond 30
days for enrollees using non-formulary drugs that have not been
transitioned to a formulary drug or gone through the plan exception
process within 30 days.
10. Applicant ensures that staff is trained and information systems are in
place to accommodate administration of the transition policy. This
includes adoption of necessary information system overrides.
11. Applicant provides an emergency supply of non-formulary Part D
drugs (31-day supplies, unless the prescription is written for fewer
days) for long-term care residents to allow the plan and/or the
enrollee time for the completion of an exception request to maintain
coverage of an existing drug based on reasons of medical necessity.
51
12. Applicant has appropriate timeframes and ―first fill‖ procedures for
non-formulary Part D medications in long-term care and retail
settings.
13. Applicant abides by CMS guidance related to vaccine administration
reimbursement under Part D.
B. Complete the table below:
If Applicant is intending for its Part D benefit to include the use of a
formulary, then Applicant must also provide a P&T committee
member list either directly or through its pharmacy benefit manager
(PBM). Applicant must attest ‘yes’ or ‘no’ that it is using its PBM’s
P&T committee, in order to be approved for a Part D contract. Attest
‘yes’ or ‘no’ by checking the appropriate box.
Yes
No
1. Applicant is using the P&T Committee of its PBM for purposes of the
Part D benefit.
2. If answered yes to B1, Applicant’s PBM is operating under a
confidentiality agreement for purposes of the P&T Committee (meaning
Applicant has no knowledge of the membership of the PBM’s P&T
Committee). (If not applicable, check ―NO.‖) Note: If answer is YES,
then Applicant must complete P&T Committee Certification Statement
and PBM must complete the P&T Committee Member List located in
the Appendix entitled Applicant Submission of P&T Committee Member
List and Certification Statement.
3. Applicant develops and uses a P&T committee to develop and review
the formulary and to ensure that the formulary is appropriately revised
to adapt to both the number and types of drugs on the market.
4. Note: While the P&T committee may be involved in providing
recommendations regarding the placement of a particular Part D drug
on a formulary cost-sharing tier, the ultimate decision maker on such
formulary design issues is the Part D plan sponsor, and that decision
weighs both clinical and non-clinical factors.
5. Applicant’s P&T committee first looks at medications that are clinically
effective. When two or more drugs have the same therapeutic
advantages in terms of safety and efficacy, the committee may review
economic factors that achieve appropriate, safe, and cost-effective drug
therapy.
52
6. Applicant assures that the P&T committee uses appropriate scientific
and economic considerations to consider utilization management
activities that affect access to drugs, such as access to non-formulary
drugs, prior authorization, step therapy, generic substitution, and
therapeutic interchange protocols.
7. Applicant’s P&T committee reviews and approves all clinical prior
authorization criteria, step therapy protocols, and quantity limit
restrictions applied to each covered Part D drug.
8. Applicant adheres to P&T guidelines that will, from time to time, be
promulgated with regard to such subject areas as membership, conflict
of interest, meeting schedule, meeting minutes, therapeutic classes,
drug review and inclusion, formulary management, utilization
management and review, formulary exceptions, and educational
programs for providers.
9. Applicant’s P&T committee makes a reasonable effort to review a new
FDA approved drug product within 90 days, and will make a decision
on each new drug product within 180 days of its release onto the
market, or a clinical justification will be provided if this timeframe is not
met. These timeframes also include the review of products for which
new FDA indications have been approved.
10. Applicant’s P&T committee approves inclusion or exclusion of the
therapeutic classes in the formulary on an annual basis.
11. The majority of the membership of the Applicant’s P&T committee are
practicing physicians and/or practicing pharmacists.
12. The membership of the Applicant’s P&T committee includes at least
one practicing physician and at least one practicing pharmacist who are
both free of conflict with respect to the Applicant organization and
pharmaceutical manufacturers.
13. The membership of the Applicant’s P&T committee includes at least
one practicing physician and at least one practicing pharmacist who are
experts in the care of the elderly or disabled persons.
14. Applicant’s P&T committee recommends protocols and procedures for
the timely use of and access to both formulary and non-formulary drug
products.
15. Applicant verifies that their P&T Committee members (listed in 3.2.1 C)
do not appear on the HHS Office of Inspector General’s Exclusion List.
This list can be found at http://exclusions.oig.hhs.gov/search.html
53
C. If Applicant is intending for its Part D benefit to include use of a formulary,
then the members of the P&T committee must be provided either directly by
the Applicant or by the Applicant’s PBM. The membership of the P&T
committee must be comprised as described in items B, 10, 11 and 13 above. If
Applicant is providing names of P&T committee directly, then provide the
membership in HPMS’ Contract Management/Part D Data page. If the PBM
operates under a confidentiality agreement (where the Applicant does not
know the membership of the PBM’s P&T Committee) refer to the Appendix
entitled Applicant Submission of P & T Committee Member List and
Certification Statement for additional instructions.
54
Upload in HPMS, in a .pdf format, the following certification:
4 CERTIFICATION
I,
, attest to the following:
(NAME & TITLE)
1. I have read the contents of the completed application and the information contained
herein is true, correct, and complete. If I become aware that any information in this
application is not true, correct, or complete, I agree to notify the Centers for
Medicare & Medicaid Services (CMS) immediately and in writing.
2. I authorize CMS to verify the information contained herein. I agree to notify CMS in
writing of any changes that may jeopardize my ability to meet the qualifications
stated in this application prior to such change or within 30 days of the effective date
of such change. I understand that such a change may result in termination of the
approval.
3. I agree that if my organization meets the minimum qualifications and is Medicareapproved, and my organization enters into a Part D contract with CMS, I will abide
by the requirements contained in Section 3.0 of this Application and provide the
services outlined in my application.
4. I agree that CMS may inspect any and all information necessary including inspecting
of the premises of the Applicant’s organization or plan to ensure compliance with
stated Federal requirements including specific provisions for which I have attested. I
further agree to immediately notify CMS if despite these attestations I become aware
of circumstances which preclude full compliance by January 1 of the upcoming
contract year with the requirements stated here in this application as well as in Part
423 of 42 CFR of the regulation.
5. I understand that in accordance with 18 U.S.C. §1001, any omission,
misrepresentation or falsification of any information contained in this application or
contained in any communication supplying information to CMS to complete or clarify
this application may be punishable by criminal, civil, or other administrative actions
including revocation of approval, fines, and/or imprisonment under Federal law.
6. I further certify that I am an authorized representative, officer, chief executive officer,
or general partner of the business organization that is applying for qualification to
enter into a Part D contract with CMS.
7. I acknowledge that I am aware that there is operational policy guidance, including
the forthcoming Call Letter, relevant to this application that is posted on the CMS
website and that it is continually updated. Organizations submitting an application in
response to this solicitation acknowledge that they will comply with such guidance
should they be approved for a Part D contract.
Authorized Representative Name (printed)
Authorized Representative Signature
Title
Date (MM/DD/YYYY)
55
5 APPENDICES
56
APPENDIX I – Applicant Submission of P&T Committee Member List and
Certification Statement
This appendix summarizes CMS policy on Part D Applicant/Sponsor and PBM
submission of P&T Committee membership, and the accountability that each Part D
Applicant/Sponsor holds regarding the integrity of the P&T Committee whose
membership is submitted either directly by the Part D Applicant/Sponsor or by the
applicant/sponsor’s PBM. This appendix also instructs Part D Applicants (or their
PBM’s) on how to submit the Applicant’s P&T Committee membership list, and a
Certification of P&T Integrity and Quality in the event the Applicant is planning to
operate under a confidentiality agreement with its PBM (such that the PBM does not
disclose the membership to the Applicant).
I. P&T Committee Member Disclosure to CMS
As provided in the regulation at CFR 423.120 (b)(1), a Part D Sponsor’s P&T
Committee list must contain a majority of members who are practicing physicians and/or
pharmacists, include at least one practicing physician and one practicing pharmacist
who are experts regarding care of the elderly or disabled individuals, and includes at
least one practicing physician and one practicing pharmacist who are independent and
free of conflict relative to the Part D Sponsor or Plan and pharmaceutical
manufacturers.
In the event the Part D Applicant/Sponsor has entered into a confidential agreement
such that the PBM will not disclose its P&T Committee membership to the Part D
Applicant/Sponsor, then it is the Part D Sponsor’s responsibility to notify CMS that this
information will be submitted by the Sponsor’s PBM. Moreover, the Part D
Applicant/Sponsor must ensure that the PBM notifies CMS of the P&T Committee
membership. Also, the Part D Applicant/Sponsor should ensure that the PBM notifies
the Sponsor that this information has been successfully submitted to CMS.
II. Instructions to Plans and PBMs
A. If the Part D Applicant sub-contracts with a PBM for its P&T Committee and
operates under a Confidentiality Agreement (such that its members are not
disclosed to the Part D Applicant) then the Applicant must (1) complete the attached
Certification in HPMS, and (2) forward the attached P&T Committee Member
Disclosure form to the sub-contracted PBM and direct the PBM to submit the form to
CMS by February 21, 2012. The PBM should email the P&T Committee Member
Disclosure form to the following email box: [email protected].
B. In the event of any future changes to the membership of the Part D Sponsor’s P&T
Committee or the PBM’s P&T Committee, Part D Sponsors must (or in the case of a
confidential agreement the Part D Sponsor) assure that the PBM will notify the
appropriate CMS account manager (to be assigned at a future date) and make the
57
correct changes in HPMS on the Contract Management/Part D Data page within 30
days of the effective date of such change.
III. PHARMACY AND THERAPEUTICS COMMITTEE MEMBER DISCLOSURE
PBM must email the following form to [email protected] by February 21,
2012.
Name of Part D Plan or PBM: ______________________________________
If Part D Plan, provide Part D Contract number(s):_________________
Contact Person: ______________________________________
Phone Number: ______________________________________
Email: _____________________________________________
A. Complete the table below.
PROVIDE THE NAMES OF THE MEMBERS OF YOUR ORGANIZATION’S P&T
COMMITTEE. INDICATE WHICH MEMBERS ARE PRACTICING PHYSICIANS OR
PRACTICING PHARMACISTS. FURTHER, INDICATE WHICH MEMBERS ARE
EXPERTS IN THE CARE OF THE ELDERLY OR DISABLED, AND FREE OF ANY
CONFLICT OF INTEREST WITH YOUR ORGANIZATION AND PHARMACEUTICAL
MANUFACTURERS. (APPLICANTS SHOULD MARK THE INFORMATION AS
PROPRIETARY.) SUBMIT THIS DATA BY CREATING A SPREADSHEET IN
MICROSOFT EXCEL THAT MIMICS THE TABLE BELOW.
Full Name
of Member
Start Date
and End
Date
Practice/Expertise
Free of Any Conflict of Interest
Mark an ‘X’ in Appropriate Column
Type Yes or No
Practicing
Physician
Practicing
Elderly/Disabled With
With
Expert
Pharmaceutical
Pharmacist
Your
Organization? Manufacturers?
B. Complete the table below if a PBM submitting on behalf of Part D plan.
PROVIDE THE NAMES OF THOSE APPLICANTS FOR THE PART D BENEFIT FOR
WHICH YOUR ORGANIZATION IS PROVIDING PHARMACY BENEFIT MANAGEMENT
SERVICES, THE TYPE OF APPLICATION, AND THE CONTRACT NUMBER(S). ADD
58
ADDITIONAL ROWS AS NECESSARY.
Organization Name
Type of Application
Contract Number(s)
59
Applicant must upload in HPMS:
CERTIFICATION FOR PART D SPONSORS USING A PHARMACY BENEFIT
MANAGER’S PHARMACY& THERAPEUTICS COMMITTEE UNDER A
CONFIDENTIALITY AGREEMENT
I, attest, on behalf of LEGAL NAME OF PART D SPONSOR APPLICANT (―Applicant‖),
to the following:
I certify that APPLICANT has entered into a contract with LEGAL NAME OF PBM
(―PBM‖) to perform pharmacy benefit management services related to the operation of a
Medicare Part D benefit plan(s) on behalf of APPLICANT.
I agree, to the best of my knowledge, that ―PBM,‖ has a Pharmacy and Therapeutics
(P&T) Committee that contains a majority of members who are practicing physicians
and/or pharmacists, includes at least one practicing physician and one practicing
pharmacist who are experts regarding the care of the elderly or disabled individuals,
and includes at least one practicing physician and one practicing pharmacist who are
independent and free of conflict relative to my plan and organization and
pharmaceutical manufacturers.
I agree that the PBM will supply to CMS the following information, including but not
limited to, the full legal name of each member of its P&T Committee designated as a
practicing physician or pharmacist specializing in elderly and/or disabled care. Each
member must also disclose any conflict of interest with my organization, and/or
pharmaceutical manufacturers.
I agree that my organization has policies and procedures to ensure and confirm the
ongoing integrity, qualifications and expertise of the PBM’s P&T Committee.
I agree that in the event CMS identifies a PBM’s P&T Committee member is listed on
the OIG exclusion list, my organization will be notified by CMS of such a problem. In
such an instance, my organization must assure that the PBM takes appropriate steps to
correct the problem or my organization will be at risk of being subject to a corrective
action plan and sanctions, depending on the nature of the problem.
I agree that CMS may inspect the records and premises of my organization or my
subcontractor (first tier, downstream and related entities) to ensure compliance with
the statements to which I have attested above.
I certify that I am authorized to sign on behalf of the Applicant.
60
Part D Applicant’s Contract Number: _____________________
__________________________
___________________________
Authorized Representative Name (printed)
__________________________________
Authorized Representative Signature
Title
___________________________
Date (MM/DD/YYYY)
Mailing Instructions
8. Provide a signed cover sheet indicating that the information being sent to CMS is an
addendum to the Plan’s Part D Application.
9. Please mail 3 hard copies, including one original, of both the completed Certification
for Part D Sponsors Using a Pharmacy Benefit Manager’s Pharmacy and
Therapeutics Committee under a Confidentiality Agreement form to:
ATTN: Jack Healey
Mail Stop: C4-21-26
7500 Security Boulevard
Baltimore, MD 21244-1850
61
| File Type | application/pdf |
| File Title | MEDICARE PRESCRIPTION DRUG BENEFIT |
| Author | Marla Rothouse |
| File Modified | 2011-09-23 |
| File Created | 2011-09-23 |