Medicare Part D Application for New PACE Organizations
2010 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 15 hours per response, including the time to review instructions, search existing data resources, 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.
I. GENERAL INFORMATION (§423.1- §423.910)
Background
The Medicare Prescription Drug Benefit program was established by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and is codified in section 1860D-1 through 1860 D-42 of the Social Security Act (the Act). Section 101 of the MMA amended Title XVIII of the Social Security Act by redesignating Part D as Part E and inserting a new Part D, which establishes the Voluntary Prescription Drug Benefit Program (hereinafter referred to as “Part D”).
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.
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.
Ensure the integrity of the Medicare Trust Fund by eliminating fraud, abuse, and waste within its organization.
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 “H-number, 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.hhs.gov/AccesstoDataApplication/Downloads/Access.pdf
In addition, instructions to PACE organization for completing this form are located at:
http://www.cms.hhs.gov/pace/hpmsconn.pdf
Questions concerning HPMS user IDs should be directed to the HPMS Help Desk at helpdesk@[email protected]
Summary Instruction for Part D Formularies (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 pre-defined file format and record layout.
Summary Instruction for Part D Bids (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 D-eligible 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 423.505(k)(4), the CEO, CFO, or a delegee with the authority to sign on 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 423.265 of the regulations (except section 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 (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.
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.
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 could exercise our authority to deny a bid if we do not believe that the bid and its underlying drug prices reflect market rates.
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.
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 dis-enrollments 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 www.cms.hhs.gov website.
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), Specific Low-Income Medicare Beneficiaries (SLMBs), and Qualifying Individuals (QIs). Beneficiaries who are low-income 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.hhs.gov/ website.
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 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.
Payment to PACE Part D Sponsors
Payments will be wired to the organization’s account on the first business 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, and low-income subsidies are also included.
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.”
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.
II. GENERAL INSTRUCTIONS
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 2010. Applicants projecting PACE provider status by 1/1/2010 may submit the Part D application (chapter 11 of the PACE provider application) up until July 1, 2009. Applicants must use the 2010 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:
Eric Nevins by email at: [email protected] or by phone at 410-786-1162.
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.
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.
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 six (5) 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)
Eric Nevins
Mail Stop: C4-21-08
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 five paper copies of the Part D application each applicant must submit five (5) 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:
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.
The following section provides instructions for completing this chapter of the application. The actual application forms are included under section IV.
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.
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 |
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 |
423.162 |
Quality Improvement organization activities |
423.265(b) 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. |
Part D bid submission 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 |
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) 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) |
Conditions necessary to contract as a Part D plan sponsor |
423.505(a-c) and 423.505(e-i) Note: Organizations are required to abide by 423.505(d and j) |
Contract provisions |
423.505(k)(6) Note: Organizations are required to abide by 423.505(k)(1-5) |
Certification for purposes of price compare |
423.506(a)-(b) Note: Organizations are required to abide by 423.506(c)-(e) |
Effective date and term of contract |
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 |
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 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:
The Part D regulation reference;
The appropriate waiver criteria (e.g. duplicative, conflicts, improves benefit coordination);
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 460.26(b) and 460.28 of the PACE regulation.
Please do not submit the previous pages of this chapter in the printed copy of your application.
CENTERS FOR MEDICARE AND MEDICAID SERVICES MEDICARE PART D APPLICATIONPROGRAM OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
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NAME OF LEGAL ENTITY
TRADE NAME (if different)
PARENT ORGANIZATION (if applicable)
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MAILING ADDRESS |
AREA CODE TELEPHONE NO. EXTENSION
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FAX |
CEO OR EXECUTIVE DIRECTOR:NAME AND TITLE
TELEPHONE NUMBER
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MAILING ADDRESS |
PRIMARY APPLICANT CONTACT PERSON: NAME TITLE ADDRESS
FAX TELEPHONE NUMBER
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SECONDARY APPLICANT CONTACT PERSON: NAME TITLE ADDRESS
FAX TELEPHONE NUMBER
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Management and Operations
Subcontractor (first tier, downstream and related entities) Function Chart
Provide the names of the Part D subcontractors (first tier, downstream and related entities) you will use to carry out each of the functions listed in this chart: (Indicate “APPLICANT” where applicant will perform those functions) |
Function |
Subcontractor(s) (first tier, downstream and related entities) |
A pharmacy benefit program that performs adjudication and processing of pharmacy claims at the point of sale. |
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A pharmacy benefit program that performs negotiation with prescription drug manufacturers and others for rebates, discounts, or other price concessions on prescription drugs |
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A pharmacy benefit program that performs administration and tracking of enrollees’ drug benefits in real time. |
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A pharmacy benefit program that performs coordination with other drug benefit programs, including, for example, Medicaid, state pharmaceutical assistance programs, or other insurance. |
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Develops and maintains a pharmacy network.
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A pharmacy benefit program that operates an enrollee grievance and appeals process |
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A pharmacy benefit program that performs customer service functionality, that includes serving seniors and persons with a disability. |
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A pharmacy benefit program that performs pharmacy technical assistance service functionality. |
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PACE organizations functioning with formularies agree to maintain pharmaceutical and therapeutic committees. |
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Provide as attachments copies of executed contracts with each subcontractor (first tier, downstream and related entities) identified in the above table that:
Clearly identify the parties to the contract (or letter of agreement);
Describe the functions to be performed by the subcontractor (first tier, downstream and related entities);
Describe the reporting requirements the subcontractor (first tier, downstream and related entities) has to the Applicant;
Contain language clearly indicating that the subcontractor (first tier, downstream and related entities) 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);
Contains flow-down clauses requiring their activities be consistent and comply with the Applicant’s contractual obligations as a PACE Part D sponsor;
Describe the payment the subcontractor (first tier, downstream and related entities) will receive for performance under the contract, if applicable;
Are signed by a representative of each party with legal authority to bind the entity;
Contain language obligating the subcontractor (first tier, downstream and related entities) to abide by all applicable Federal laws and regulations and CMS instructions;
Contain language obligating the subcontractor (first tier, downstream and related entities) 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.
10. Contain language ensuring that the subcontractor (first tier, downstream and related entities) 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 PACE 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.
11. Contain language that the subcontractor (first tier, downstream and related entities) will ensure that beneficiaries are not held liable for fees that are the responsibility of the PACE Part D sponsor;
12. Contain language indicating that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees;
13. Contain language that if the Applicant, upon becoming a PACE Part D sponsor, delegates an activity or responsibility to the subcontractor (first tier, downstream and related entities), that such activity or responsibility may be revoked if CMS or the sponsor determines the subcontractor (first tier, downstream and related entities) has not performed satisfactorily. Note: The subcontract may include remedies in lieu of revocation to address this requirement;
14. Contain language specifying that the Applicant, upon becoming a PACE Part D sponsor, will monitor the performance of the (first tier, downstream and related entities) subcontractor on an ongoing basis;
15. If the subcontractor (first tier, downstream and related entities) will establish the pharmacy network or select pharmacies to be included in the network, contain language that the PACE Part D sponsor retains the right to approve, suspend, or terminate any arrangement with a pharmacy.
16. If the subcontractor (first tier, downstream and related entities) 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.
If the subcontractor (first tier, downstream and related entities) will establish the pharmacy network or select pharmacies to be included in the network contain language that if a standard is used for reimbursement, the source used by the Part D sponsor for making any such pricing updates and 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.
Crosswalks of Requirements in Subcontracts
INSTRUCTIONS: Applicants must complete the following chart for each subcontractor submitted Applicants must identify in which contract or addendum and where specifically (i.e., section numbers, page numbers, paragraph numbers, etc.) in each subcontract the following elements are found. [E.g., Medicare Part D Addendum, page 14, section 3.2, paragraph 2.] |
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Requirement |
Citation |
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The parties to the contract |
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The functions to be performed by the subcontractor (first tier, downstream and related entities). |
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Describes the reporting requirements the subcontractor (first tier, downstream and related entities) has to the Applicant. |
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Language clearly indicating that the subcontractor (first tier, downstream and related entities) 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). |
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Contains flow-down clauses requiring the subcontractor’s (first tier, downstream and related entities) activities to be consistent and comply with the Applicant’s contractual obligations as a Part D sponsor. |
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The payment the subcontractor (first tier, downstream and related entities) will receive for performance under the contract, if applicable. |
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Are for a term of at least the one-year contract period for which application is submitted. |
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Are signed by a representative of each party with legal authority to bind the entity. |
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Language obligating the subcontractor (first tier, downstream and related entities) to abide by all applicable Federal laws and regulations and CMS instructions. |
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Language obligating the subcontractor (first tier, downstream and related entities) 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. |
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Contain language ensuring that the subcontractor (first tier, downstream and related entities) 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 PACE 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.
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Language stating that the subcontractor will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. |
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Contain language indicating that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees.
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Contain language that if the Applicant, upon becoming a PACE Part D sponsor, delegates an activity or responsibility to the subcontractor (first tier, downstream and related entities), that such activity or responsibility may be revoked if CMS or the sponsor determines the subcontractor (first tier, downstream and related entities) has not performed satisfactorily. Note: The subcontract may include remedies in lieu of revocation to address this requirement.
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Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor (first tier, downstream and related entities) on an ongoing basis. |
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Language that the Part D sponsor retains the right to approve, suspend, or terminate any arrangement with a pharmacy if the subcontractor (first tier, downstream and related entities) will establish the pharmacy network or select pharmacies to be included in the network. |
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Language that if the subcontractor (first tier, downstream and related entities) 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. |
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Language that if the subcontractor (first tier, downstream and related entities) will establish the pharmacy network or select pharmacies to be included in the network contain language that if a standard is used for reimbursement, the source used by the Part D sponsor for making any such pricing updates and 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. |
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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 in which contract or addendum and where specifically (i.e., section numbers, page numbers, paragraph numbers, etc.) in each subcontract the following elements are found. [E.g., Medicare Part D Long-Term Care Pharmacy Addendum, page 14, section 3.2, paragraph 2.] |
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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. |
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The functions to be performed by the subcontractor (first tier, downstream and related entities). |
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Describes the reporting requirements the subcontractor (first tier, downstream and related entities) identified in the application has to the Applicant. |
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Language obligating the subcontractor (first tier, downstream and related entities) to abide by all applicable Federal laws and regulations and CMS instructions. |
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Language obligating the subcontractor (first tier, downstream and related entities) 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. |
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Contain language ensuring that the subcontractor (first tier, downstream and related entities) 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 PACE 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.
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Language stating that the subcontractor (first tier, downstream and related entities) will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. |
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Contain language indicating that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees. |
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Contain language that if the Applicant, upon becoming a PACE Part D sponsor, delegates an activity or responsibility to the subcontractor (first tier, downstream and related entities), that such activity or responsibility may be revoked if CMS or the sponsor determines the subcontractor (first tier, downstream and related entities) has not performed satisfactorily. Note: The subcontract may include remedies in lieu of revocation to address this requirement. |
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Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor (first tier, downstream and related entities) on an ongoing basis. |
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Provisions requiring that the long-term care pharmacy have not less than 30 days (but not more than 90 days) to submit claims to the sponsor for reimbursement under the plan. |
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For those contracts that use a standard for reimbursement, provisions that indicate the source used by the Part D sponsor for making any such pricing updates and 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. |
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Provisions governing submitting claims to a real-time claims adjudication system. 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. |
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Provisions governing providing Part D enrollees access to negotiated prices as defined in 42 CFR 423.100 |
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Provisions regarding charging/applying the correct cost-sharing amount. |
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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 are required to incorporate at a minimum, 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.
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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.
Contact |
Name/Title |
Mailing Address |
Phone/Fax Numbers |
Email Address |
Corporate Mailing |
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CEO – Sr. Official for Contracting |
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Chief Financial Officer |
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Medicare Compliance Officer |
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Enrollment Contact |
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Medicare Coordinator |
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System Contact |
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Customer Service Operations Contact |
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General Contact |
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User Access Contact |
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Backup User Access Contact |
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Marketing Contact |
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Medical Director |
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Bid Primary Contact |
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Payment Contact |
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Pharmacy Benefit Manager Contact |
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Part D Claims Submission Contact |
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Formulary Contact |
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Pharmacy Network Management Contact |
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Medication Therapy Management Contact |
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Contact |
Name/Title |
Mailing Address |
Phone/Fax Numbers |
Email Address |
Patient Safety Contact |
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Part D Benefits Contact |
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Part D Quality Assurance Contact |
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Part D Application Contact |
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Pharmacy Director |
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HIPAA Security Officer |
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HIPAA Privacy Officer |
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Part D Price File Contact (Primary) |
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Part D Price File Contact (Back-up) |
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Part D Appeals |
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Government Relations Contact |
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Emergency Part D Contact |
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Pharmacy Technical Help Desk Contact |
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Processor Contact |
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CMS Casework Communication Contact |
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Part D Exceptions Contact |
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EOB Transfer Contact |
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Coordination of Benefits Contact |
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CEO – CMS Administrator Contact |
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Plan to Plan Reconciliation Contact |
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CAP Report Contact for Public Website |
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B. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO THE FOLLOWING QUALIFICATION TO BE APPROVED FOR A PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO THE FOLLOWING QUALIFICATION BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? – Yes or 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. |
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Business Integrity
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO THE FOLLOWING QUALIFICATION TO BE APPROVED FOR A PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO THE FOLLOWING QUALIFICATION BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
Yes |
No |
Requesting Waiver? – Yes or No |
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B. If Applicant answered No to Attestation #2 and/or Attestation #3, provide as an attachment, all past or pending, if known, investigations, legal actions, administrative actions, or matters subject to arbitration brought by a government agency (state or federal including CMS over the past three years on matters relating to payments from governmental entities, for healthcare and/or prescription drug services involving the following:
1) Applicant (and Applicant’s parent firm if applicable);
2) PBM (and PBM’s parent firm if applicable);
3) Key management of executive staff.
Provide as part of the attachment a brief explanation of each action, including the following:
1) Legal names of the parties;
2) Circumstances;
3) Status (pending or closed);
4) If closed, provide the details concerning resolution and any monetary payments; and
5) Settlement agreements or corporate integrity agreements.
Compliance Plan
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 PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? – Yes or No |
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Provide as an attachment a copy of your organization’s Medicare Part D Compliance Plan and/or compliance policies and procedures that you intend to use for this contract.
The Part D compliance plan and any related policies and procedures must clearly articulate that the appropriate elements listed at 42 CFR 423.504(b)(4)(vi) and in the Part D Program Integrity Manual are being implemented within the context of the compliance plan and are specific to the issues and challenges presented by the Part D program. A general compliance plan applicable to healthcare operations is not sufficient.
Note: Please be advised that the Part D Sponsor is ultimately responsible for the implementation and monitoring of the day-to-day operations of its Part D compliance program. As applicable, 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. A compliance plan adopted and operated by a Part D Applicant’s subcontractor (first tier, downstream and related entities) is not sufficient to demonstrate that the Part D Applicant meets the compliance program requirement.
Electronic Prescription Program
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO THE FOLLOWING QUALIFICATION TO BE APPROVED FOR A PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO THE FOLLOWING QUALIFICATION BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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Enrollment and Eligibility
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 PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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Complaints Tracking
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 PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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Coordination of Benefits
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 PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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Tracking Out-of-Pocket Costs (TrOOP)
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 PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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NOTE: For information regarding the TrOOP facilitator, Applicant may link to http://medifacd.ndchealth.com/
Medicare Secondary Payer
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 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 423.180(d) |
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2. Applicant will adhere to MSP laws and any other Federal and State laws in establishing payers of last resort. |
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3. Applicant will follow the Rules for Coordination of Benefits adopted in the most current National Association of Insurance Commissioner Coordination of Benefits Model Regulation as applicable. |
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4. Applicant will collect mistaken primary payment from insurers, group health plans, employer sponsors, enrollees and other entities. |
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5. Applicant agrees that in situations involving workers’ compensation claims, the Applicant makes an effort to determine which Part D drugs will be included as part of workers’ compensation future medical payments (i.e., those services and items provided after the final settlement) and ensures that it does not make (or recover) payment for such drugs. |
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Data Collection and Reporting Requirements
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 PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
REBATE DATA |
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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 PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
HPMS |
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ENROLLMENT & PAYMENT |
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report availability.
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7. Applicant will participate in connectivity testing and other system testing measures as provided to the Applicants prior to contract execution to validate system setup. |
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8. Applicant will establish system(s) to process enrollment and payment transactions as exchanged with CMS in accordance with system development lifecycle standards. |
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9. Applicant will ensure appropriate security safeguards and protocols are in place to protect the protected health information in the system(s). |
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10. Applicant will maintain all pertinent system security and disaster recovery plans and procedures. |
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Health Insurance Portability and Accountability Act of 1996 (HIPAA)
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 PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
1. Applicant will comply with any applicable standards, implementation specifications, and requirements in the Standards for Privacy of Individually Identifiable Health Information under 45 CFR Parts 160 and 164 subparts A and E. |
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2. Applicant will comply with any applicable standards, implementation specifications, and requirements in the Security Standards under 45 CFR Parts 160, 162 and 164 |
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3. Applicant agrees to encrypt all hard drives or other storage media within the device as well as all removable media. |
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4. Applicant agrees to develop and implement a policy addressing the handling of portable media that is accessed or used outside of the organization's physical purview. |
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5. Applicant will comply with any applicable standards, implementation specifications, and requirements in the Standard Unique Health Identifier for Health Care Providers under 45 CFR Part 160 and 162. |
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6. Applicant agrees that when its organization received a National Provider Identifier (NPI) in prescription drug event data, that the organization must report an NPI. |
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7. Applicant agrees that when its organization received a National Provider Identifier (NPI) it will implement a contingency plan related to compliance with the NPI provisions. |
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8. Applicant will comply with any applicable standards, implementation specifications, and requirements in the Standards for Electronic Transactions under 45 CFR Parts 160 and 162 subparts I et seq. |
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9. Applicant agrees to submit the Offshore Subcontract Information and Attestation for each offshore subcontractor (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 of the upcoming contract year.
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Prohibition on Use of SSN or Medicare ID number on Enrollee ID Cards
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 PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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Claims Processing
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 PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
Note: In preparation for implementation CMS (except for scheduled down time and disasters) will conduct testing and otherwise monitor for the impact of TrOOP system interfaces with plan claims processing systems, and adjust these standards as appropriate if necessary. OR (b) Have internal procedures in a place to ensure accurate and timely payment of all claims submitted by network pharmacies.
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Note: This is in contrast to paper claims submitted by beneficiaries per the regulations at 42 CFR §423.568(b). |
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3. Applicant will develop and have available for CMS inspection a complete description of your claims adjudication system including:
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4. Applicant will develop and have available to CMS upon request policies and procedures that include a complete description and flow chart detailing the claims adjudication process for each:
Manual claim entry (e.g. for processing direct member reimbursement) |
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5. Applicant will develop and will make available to CMS upon request policies and procedures that include a complete description of claim detail management, including:
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6. Applicant will develop and have 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:
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7. Applicant will develop and have available to CMS upon request policies and procedures that include a description of how overpayments and underpayments to pharmacies, and/or enrollees (including other payers who have paid on behalf of the enrollee) are processed, including recovery procedures. |
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8. In accordance with sections 460.122 and 460.124 of the PACE regulation, applicant will develop and have available to CMS upon request policies and procedures that include a complete description of procedures surrounding disputed claims, including:
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9. Applicant will have a robust testing process that will identify and correct any plan configuration errors prior to implementation. |
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10. Applicant will accept from eligibility files and any prior claims data electronically in NCPDP format. |
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11. Applicant will document the manner and extent to which it has tested benefit designs such as drugs excluded or quantity limitations and plan parameters such as the dual eligible plan vs. the Medicare-only plan.
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12. Applicant agrees to rapidly adopt any new messaging approved by the NCPDP Workgroup to adjudicate a Part D claim and appropriately coordinate benefits in real time. |
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Record Retention
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 PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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CERTIFICATION
I, the undersigned, certify to the following:
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.
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.
I agree that if my organization meets the minimum qualifications and is Medicare-approved, and my organization enters into a Part D Addendum with CMS, I will abide by the requirements contained in this Application and provide all required services outlined in this application and in accordance with sections 1894 and 1934 of the Act.
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, 2010 with the requirements stated here in this application as well as in Part 423 of 42 CFR of the regulation.
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.
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 Addendum with CMS.
For several of the Part D program requirements described in this solicitation, CMS has issued operational policy guidance that provides more detailed instructions to Part D sponsors. Organizations submitting an application in response to this solicitation acknowledge that they are also representing to CMS that they have reviewed the associated guidance materials posted on the CMS web site and will comply with such guidance should they be approved for a Part D contract. Applicants must visit the CMS web site periodically to stay informed about new or revised guidance documents.
__________________________________ ___________________
Authorized Representative Name (printed) Title
__________________________________________ ________________________
Authorized Representative Signature Date (MM/DD/YYYY)
Applicability of Formulary Submission Requirements
For purposes of formulary submission and review, the following paragraphs describe the definition of a formulary.
Any coverage list that utilizes more than one cost sharing tier with differential co-pay or coinsurance, is considered a formulary.
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.
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.
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.
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 answer yes to 1 or more of items 1-5 listed above will be required to adhere to formulary requirements specified in section 423.120(b) and complete the forms that follow.
Formulary/Pharmacy and Therapeutics (P&T) Committee
A. Complete the form below:
APPLICANT MUST ATTEST ‘YES’ OR ‘NO’ TO THE FOLLOWING QUALIFICATION 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 IN HPMS. |
YES |
NO |
1. Applicant will submit a formulary to CMS for the Part D benefit. |
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2. Applicant agrees to comply with formulary guidance that is contained in Chapter 6 of the Prescription Drug Benefit Manual. |
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3. Applicant agrees, where 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. |
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4. Applicant agrees that its formulary must include substantially all drugs in the six categories of clinical concern that are available on the CMS-established formulary upload date. Applicant further agrees that any new drugs or newly approved uses for drugs within the six classes that come onto the market after the CMS-established formulary upload date will be subject to an expedited Pharmacy and Therapeutic committee review. The expedited review process requires P&T committees to make a decision within 90 days, rather than the normal 180-day requirement. |
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5. Applicant will provide for an appropriate transition for new enrollees prescribed Part D drugs that are not on its formulary. This transition process must satisfy the requirements specified in Chapter 6 of the Prescription Drug Benefit Manual. |
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6. Applicant agrees to submit to CMS a description of the organization’s approach to transitioning beneficiaries on drug regimens that are not on the plan’s Part D approved formulary by close of business on the CMS-established formulary upload date to [email protected]. |
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7. Applicant agrees, where appropriate, to extend 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. |
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8. Applicant agrees to ensure that staffs are trained on and information systems are in place to accommodate administration of the transition policy. This includes adoption of necessary information system overrides. |
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9. Applicant will establish an emergency supply of non-formulary Part D drugs (31-day supplies, unless the prescription if 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. |
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10. Applicant will establish appropriate timeframes and “first fill” procedures to non-formulary Part D medications in long-term care and retail settings. |
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11. Applicant will abide by CMS guidance related to vaccine administration reimbursement under Part D. |
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B. Complete the form 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, TO BE APPROVED FOR A PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ BY PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS. |
YES |
NO |
Requesting Waiver? Yes or No |
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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. |
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3. Applicant will develop and use 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.
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, and that decision weighs both clinical and non-clinical factors. |
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12. Applicant’s P&T committee will recommend protocols and procedures for the timely use of and access to both formulary and non-formulary drug products. |
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13. Applicant will verify 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 |
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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 directly by the Applicant or by the Applicant’s PBM. The membership of the P&T Committee must be comprised as described below. If Applicant is providing names of P&T Committee directly, then complete the table below in HPMS on the Contract Management/Part D Data page.
Pharmacy and Therapeutics (P&T) Committee
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.) ADD ADDITIONAL ROWS AS NECESSARY. |
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Practice/Expertise Mark an ‘X’ in Appropriate Column |
Free of Any Conflict of Interest Type Yes or No |
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Full Name of Member |
Practicing Physician |
Practicing Pharmacist |
Elderly/Disabled Expert |
With Your Organization? |
With Pharmaceutical Manufacturers? |
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Applicant Submission of P&T Committee Member List and Certification Statement
This 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).
P&T Committee Member Disclosure to CMS
As provided in 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.
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, and (2) forward the attached P&T Committee Member Disclosure Form to the subcontracted PBM and direct the PBM to submit the form to CMS. The PBM should follow the mailing instructions below.
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 must assure that the PBM) notify the appropriate CMS account manager (to be assigned at a future date) within 30 days of the effective date of such change.
Mailing Instructions
1. Provide a signed cover sheet indicating that the information being sent to CMS is an addendum to the Plan’s Part D Application.
2. Please mail 5 CD’s or diskettes containing both the completed P&T Committee Member Disclosure form and the completed Certification for Part D Sponsors Using a Pharmacy Benefit Manager’s Pharmacy and Therapeutics Committee under a Confidentiality Agreement form.
3. Please mail 5 hard copies, including one original, of both the completed P&T Committee Member Disclosure form and the completed Certification for Part D Sponsors Using a Pharmacy Benefit Manager’s Pharmacy and Therapeutics Committee under a Confidentiality Agreement form.
Mail the 5 CD’s or diskettes and hard copy material via courier to:
Centers for Medicare and Medicaid Services
ATTN: Eric Nevins
Mail Stop: C4-21-08 Location:
7500 Security Boulevard
Baltimore, MD 21244-1850
PHARMACY AND THERAPEUTICS COMMITTEE MEMBER DISCLOSURE
Name of Part D Plan or PBM:
If Part D Plan, provide Part D Contract number(s):
Contact Person:
Phone Number:
Email:
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 THAT YOUR ORGANIZATION IS PROVIDING PHARMACY BENEFIT MANAGEMENT SERVICES, THE TYPE OF APPLICATION, AND THE CONTRACT NUMBER(S). ADD ADDITIONAL ROWS AS NECESSARY. |
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Organization Name
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Type of Application |
Contract Number(s) |
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CERTIFICATION FOR PART D SPONSORS USING A PHARMACY BENEFIT MANAGER’S PHARMACY& THERAPEUTICS COMMITTEE UNDER A CONFIDENTIALITY AGREEMENT
I, the undersigned, certify, 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 will establish, 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 problem with a member of the PBM’s P&T Committee, 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 risk 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.
Part D Plan Contract Number:
__________________________________ _____________________________
Authorized Representative Name (printed) Title
__________________________________ _______________________________
Authorized Representative Signature Date (MM/DD/YYYY)
| File Type | application/msword |
| Author | Warren Rothouse |
| Last Modified By | Marla Rothouse |
| File Modified | 2008-08-25 |
| File Created | 2008-08-11 |