Contract ID Number: _____
MEDICARE PRESCRIPTION DRUG BENEFIT
Solicitation for Applications for New Cost Plan Sponsors
January 16, 2007
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Table of Contents
1. GENERAL INFORMATION
1.1 Purpose of Solicitation
1.2 Background
1.3 Objectives and Structure
1.4 Schedule
1.5 Summary of Cost Plan Sponsor Role and Responsibilities
1.6 Summary of CMS Role and Responsibilities
2. INSTRUCTIONS
2.1 Overview
2.2 Other Technical Support
2.3 HPMS Data Entry
2.4 Instructions and Format of Qualifications
2.5 Submission Software Training
2.6 System and Data Testing with CMS
2.7 Summary Instruction and Format for Bids
2.7.1 Format of Bids
2.7.2 CMS Review of Bids
2.7.3 Overview of Bid Negotiation
2.8 Pharmacy Access
2.8.1 Retail Pharmacy Access
2.8.2 Home Infusion Pharmacy Access
2.8.3 Long-Term Care Pharmacy Access
2.8.4 Waivers Related to Pharmacy Access
2.9 Standard Contract with Cost Plan Sponsors
2.10 Protection of Confidential Information
2.11 Waivers
3. APPLICATION
3.1 Applicant Experience, Contracts, Licensure and Financial Stability
3.1.1 Contracts
3.1.2 Management and Operations
3.1.3 Experience and Capabilities
3.1.4 Business Integrity
3.1.5 HPMS Part D Data Entry
3.2 Benefit Design
3.2.1 Formulary/Pharmacy and Therapeutics (P&T) Committee
3.2.2 Utilization Management Standards
3.2.3 Quality Assurance and Patient Safety
3.2.4 Medication Therapy Management
3.2.5 Electronic Prescription Program
3.2.6 Bids
3.3 Pharmacy Access
3.3.1 Retail Pharmacy
3.3.2 Out of Network Pharmacy
3.3.3 Mail Order Pharmacy
3.3.4 Home Infusion Pharmacy
3.3.5 Long Term Care (LTC) Pharmacy
3.3.6 Indian Health Service, Indian Tribe and Tribal Organization, and Urban Indian Organization I/T/U Pharmacy
3.3.7 Specialty Pharmacy
3.4 Enrollment and Eligibility
3.5 Complaints Tracking
3.6 Medicare Prescription Drug Plan Finder
3.7 Grievances
3.8 Exceptions and Appeals
3.9 Coordination of Benefits
3.10 Tracking Out-of-Pocket Costs (TrOOP)
3.11 Medicare Secondary Payer
3.12 Marketing/Beneficiary Communications
3.13 Provider Communication
3.14 Compliance Plan
3.15 Reporting Requirements
3.16 Data Exchange between Cost Plan and CMS
3.17 Upgrades of Health Information Technology--REMOVED
3.18Health Insurance Portability and Accountability Act of 1996 HIPAA
3.19 Prohibition on Use of SSN or Medicare ID number on Enrollee ID Cards
3.20 Record Retention
3.21 Claims Processing
4. CERTIFICATION
5. APPENDICES
Appendix I Banking Information Form
Appendix II Summary of Part D Application Requirements Waived for
Cost Plan Prescription Drug Applicants
Appendix III Certification of Monthly Enrollment and Payment Data Relating to CMS Payment to a Cost Plan
Appendix IV Certification that Subcontracts Meet the requirements of Section 3.1.2D
Appendix V Crosswalk of Subcontracts submitted as attachments to Section 3.1.2D
Appendix VI Crosswalk for Retail Pharmacy Access Contracts
Appendix VII Crosswalk for Mail Order Pharmacy Access Contracts
Appendix VIII Crosswalk for Home Infusion Pharmacy Access Contracts
Appendix IX Crosswalk for Long-Term Care Pharmacy Access Contracts
Appendix X Crosswalk for Indian Tribe and Tribal Organization, and Urban Indian Organization (I/T/U) Pharmacy Access Contracts
Appendix XI Applicant Submission of P&T Committee Member List and Certification Statement
Appendix XII Pharmacy Network Access Instructions
1. GENERAL INFORMATION
1.1 Purpose of Solicitation
The Centers for Medicare & Medicaid Services (CMS) is seeking applications from qualified entities to enter into cost contracts under section 1876 of the Social Security Act (referred to here as “Cost Plan sponsors” or “Cost Plan Applicants”) to enter into contracts to offer Medicare Prescription Drug Plans (PDPs) as described in the Medicare Prescription Drug Benefit Final Rule, published in the Federal Register, on January 28, 2005 (70 Fed. Reg. 4194) Please submit your applications according to the process described in Section 2.0.
If your organization, or your parent or affiliated organization already has a Cost Plan contract with CMS to offer the Part D benefit, and you are expanding your service area, please refer to the www.cms.hhs.gov website for the Part D Service Area Expansion Application for instructions to complete an application for Service Area Expansion. If your organization, or your parent or affiliated organization already has a MA-PD or Cost Plan contract with CMS to offer the Part D benefit, and you are seeking a contract as a Prescription Drug Plan (PDP), you are required to complete the PDP application.
1.2 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 sections 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”).
1.3 Objectives and Structure
The Part D benefit constitutes perhaps the most significant change to the Medicare program since its inception in 1965. The addition of outpatient drugs to the Medicare program reflects Congress’ recognition of the fundamental change in recent years in how medical care is delivered in the U.S. It recognizes the vital role of prescription drugs in our health care delivery system, and the need to modernize Medicare to assure their availability to Medicare beneficiaries. Effective January 1, 2006, the MMA established an optional prescription drug benefit, known as the Part D program, for individuals who are entitled to Medicare Part A and/or enrolled in Part B.
In general, coverage for the prescription drug benefit is provided predominately through Prescription drug plans (PDPs) that offer drug-only coverage, or through Medicare Advantage (MA) sponsors that offer integrated prescription drug and health care coverage (MA-PD plans). If the MA-PD sponsor meets the basic requirement, then it may also offer supplemental benefits through enhanced alternative drug coverage for an additional premium. MA-PD sponsors must offer either a basic benefit or broader coverage for no additional cost. Medicare Cost Plans may, at their election, offer a Part D drug plan as an optional supplemental benefit, subject to the same rules that apply to a MA-PD plan. PACE organizations may elect to offer a Part D plan in a similar manner as MA-PD local sponsors in order to account for the shift in payer source from the Medicaid capitation rate to private Part D Sponsors. If the MA-PD plan meets the basic requirement, the MA-PD may also offer supplemental benefits through enhanced alternative coverage for an additional premium. For Cost Plans, even for the basic Part D benefit, the drug benefit will be an optional supplemental benefit.
Applicants who offer either a PDP or MA-PD plan may offer national plans (with coverage in every region) or regional plans. MA-PD plan Applicants may also offer local plans. CMS has identified 26 MA Regions and 34 PDP Regions; in addition, each territory is its own PDP region. Additional information about the regions can be found on the www.cms.hhs.gov website Cost Plans are local plans and are not required to provide regional coverage.
This solicitation is only for entities seeking to offer a Part D supplemental benefit in addition to their Cost Plan. Separate Part D solicitations are also posted on the CMS website for entities offering MA Plans with a Part D Drug benefit at the local or regional levels, for entities offering Employer Group Plans with a Part D benefit, and for entities offering a stand-alone PDP. Through out this solicitation reference is made to a Part D Sponsor which is meant to encompass stand-alone PDPs, MA plans, with a Part D benefit and Cost Plans with a Part D benefit.
Medicare reasonable cost plans (as defined under Section 1876 of the Social Security Act), Program of All Inclusive Care for the Elderly (PACE) organizations (as defined in section 1894 of the Social Security Act), and employer groups may also offer prescription benefits under the MMA. Those entities must not complete this Part D qualification application, but should refer to the separate applications posted on the CMS website.
Part D sponsors have flexibility in terms of benefit design. This flexibility includes, but is not limited to, authority to establish a formulary that designates specific drugs that will be available within each therapeutic class of drugs and the ability to have a cost-sharing structure other than the statutorily defined structure (subject to certain actuarial tests). (Sponsors are still required to follow CMS formulary guidance. See Section 2.7.1 of this application). The plans also may include supplemental benefits coverage such that the total value of the coverage exceeds the value of basic prescription benefit coverage.
CMS payment for qualified drug benefits is separate from interim and settlement cost payments Cost Plans sponsors receive for Part A and/or Part B services under their cost contract agreements. CMS provides payment to Cost Plans sponsors in the form of advance monthly payments, reinsurance subsidies (when incurred), and low-income subsidies. Further detail on payment for Part D services is provided in Section 2.6 of this document.
As stated above, Section 1876 cost contractors are not required to offer a Part D benefit to their enrollees. Section 1876 cost contractors may offer qualified prescription drug coverage as an optional supplemental benefit under 42 CFR 417.440(b)(2). Further, Section 1876 cost contractors may offer enhanced prescription drug coverage, but only if they offer the basic Part D benefit to their enrollees as well. Section 1876 Cost Plan enrollees may or may not choose to elect to receive their Part D benefits through their Medicare Cost Plan. They may instead elect to enroll in a PDP to receive prescription drug benefits.
1.4 Schedule
APPLICATION REVIEW PROCESS
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|
Date |
Milestone |
December 1, 2006 |
1. Submit Notice of Intent to Apply, to CMS 2. Request HPMS Access (Includes User ID and Password Request) 3. Request CMS Connectivity |
January 16, 2007 |
Final Applications posted by CMS |
March 12, 2007 |
Applications due
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March 26, 2007 |
Release of Health Plan Management System (HPMS) formulary submissions module. |
April 7, 2007 |
Plan Creation module, Plan Benefit Package (PBP), and Bid Pricing Tool (BPT) available on HPMS |
April 16, 2007 |
Formulary submission due to CMS |
May 2007 |
CMS sends Part D contract eligibility determination to Applicants, based on review of application. Applicant’s bids must still be negotiated (see below) |
May 18, 2007 |
PBP/BPT Upload Module available on HPMS |
June 4, 2007 |
All bids due. |
Early August 2007 |
CMS publishes national average Part D premium |
September 2007 |
CMS completes review and approval of bid data. CMS executes Part D contracts to those organizations who submit an acceptable bid. |
November 15, 2007 |
2008 Annual Coordinated Election Period begins. |
NOTE: This timeline does not represent an all-inclusive list of key dates related to the Medicare-Prescription Drug Program. 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.
1.5 Summary of Cost Plan Sponsor Role and Responsibilities
Key aspects of each Cost Plan sponsor shall include the ability to:
Submit a formulary each year for CMS approval.
Submit a Part D Sponsor plan bid each year for CMS approval.
Enroll all eligible Medicare beneficiaries who apply and reside within the Cost Plan sponsor’s approved service area. A sponsor must serve at least on entire region.
Administer the Part D benefit, including providing coverage for drugs included in a CMS-approved formulary, administering appropriate deductibles and co-payments, managing the benefit using appropriate pharmacy benefit managerial tools, and operating effective oversight of that benefit.
Provide access to negotiated prices on covered Part D drugs, with different strengths and doses available for those drugs, including a broad selection of generic drugs.
Ensure that records are maintained in accordance with CMS rules and regulations and that both records and facilities are available for CMS inspection and audit.
Disclose the information necessary for CMS to oversee the program and ensure appropriate payments.
Offer a contracted retail pharmacy network, providing convenient access to retail pharmacies.
Process claims at the point of sale.
Operate quality assurance, drug utilization review, and medication therapy management programs.
Administer a coverage determinations, grievances, exceptions, and appeals process consistent with CMS requirements.
Provide customer service to beneficiaries, including enrollment assistance, toll-free telephone customer service help, and education about the Part D benefit.
Protect the privacy of beneficiaries and beneficiary-specific health information.
Develop marketing materials and conduct outreach activities consistent with CMS standards.
Develop and/or maintain systems to support enrollment, provide claims-based data to CMS, accept CMS payment (including subsidies for low-income beneficiaries), track true out-of-pocket costs, coordinate benefits with secondary insurers (or primary insurers when Medicare is secondary), and support e-prescribing.
Provide necessary data to CMS to support payment, oversight, and quality improvement activities and otherwise cooperate with CMS oversight responsibilities.
1.6 Summary of CMS Role and Responsibilities
There are three distinct phases to the overall review to determine whether CMS will enter into a contract with an Applicant. The first phase is the application review process. CMS reviews all applications submitted on or by March 12, 2007 to determine whether the Applicant meets the qualifications we have established to enter into a Part D addendum to the Applicant’s cost contract.
The second phase has two steps – the formulary upload, which begins March 26, 2007, and the bid upload which begins May 18, 2007. The formulary review entails determining that the proposed formulary (if one is used) has at least two drugs in every therapeutic category and class (unless special circumstances exist that would allow only one drug); does not substantially discourage enrollment by certain types of Part D eligible individuals; includes adequate coverage of the types of drugs most commonly needed by Part D enrollees; and includes an appropriate transition policy. CMS contacts Applicants if any issues are identified during the review for discussion and resolution. The intent is to provide an opportunity for Applicants to make any necessary corrections prior to Part D bid submission, which is on the first Monday in June each year. The second step involves the bid review and negotiations with Applicants to assure valuation of the proposed benefits are reasonable and actuarially equivalent.
The third phase involves contracting. Applicants judged qualified to enter into a Part D contract as a result of successfully completing phase one and two will be offered a Part D contract by CMS.
CMS has developed a Medicare Prescription Drug Benefit program monitoring system to ensure that the Part D sponsors deliver good value through defined benefits and are compliant with program requirements. We focus on several operational areas critical to the value of the benefit, including beneficiary access to and satisfaction with their Part D benefit and protection of the financial integrity of the program. Specific areas include pharmacy access, adequacy and value of the benefit, benefit management, enrollment and disenrollment, marketing, program safeguard activities, customer service, confidentiality and security of enrollee information, and effectiveness of tracking true out-of-pocket costs. The types of the reporting that CMS requires of Part D sponsors is presented in the application. For additional information on reporting requirements, refer to the www.cms.hhs.gov/ website (NOTE: Part D sponsors, as covered entities under the Health Insurance Portability and Accountability Act of 1996 (HIPPA), are subject to investigation and penalties for findings of HIPPA Privacy Rule violations as determined by the Department of Health and Human Services Office for Civil Rights and the Department of Justice.)
We monitor compliance, through the analysis of data we collect from Part D sponsors, CMS contractors, and our own systems. The types of data we collect from sponsors include: certain benefit data, prescription drug event (PDE) claims data, cost data, benefit management data, marketing review information, and customer satisfaction and complaints data, and information used to determine low-income subsidy (LIS) match rates.
To monitor plan performance we : 1) conduct beneficiary satisfaction surveys and operate a complaints tracking system to monitor and manage complaints brought to our attention that are not satisfactorily resolved through PDP sponsors’ grievance processes and 2) conduct periodic site visits to verify Part D sponsor compliance with Part D program requirements. We use information from all the specified sources to analyze the appropriateness and value of the benefit delivered, and to evaluate the opportunity for additional value and quality improvement.
If any trends we identify indicate less than satisfactory performance, contract violations, significant departures from the marketed Part D offering, fraud, or other violations of State or Federal laws, appropriate action is taken ranging from requests for corrective action plans to all categories of sanctions consistent with 42 CFR 423.509 and Part 423, Subpart O. We also make referrals, if appropriate, to the Office of Inspector General or to Federal and State authorities where violations of laws under the jurisdictions of these agencies are in question.
CMS is committed to educating Medicare beneficiaries about the Part D program. CMS plans to continue to educate beneficiary and consumer groups, health care providers, States, and other interested groups about the Part D program. Among the topics to be discussed with these groups is the identification and reporting of possible fraud and/or abuse. CMS also engages in activities that publicize or educate beneficiaries about the program. For example, the Medicare Prescription Drug Plan Finder assists beneficiaries in finding a plan to meet their specific needs. Refer to the www.Medicare.gov/MPDPF/ website.
Marketing Guidelines and Review
Marketing guidelines are posted on the www.cms.hhs.gov/ website. Part D sponsors are required to adhere to these guidelines in developing their marketing materials and marketing strategy. Cost Plan sponsors are required to submit materials to CMS based on the Medicare Marketing Guidelines.
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 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 (SSI) 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 will apply for a low-income subsidy and have their eligibility determined by either the states 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. The database 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.
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 beneficiaries in Part D plans and facilitated enrollments for other low-income Medicare beneficiaries. Full-benefit dual eligible beneficiaries who do not enroll in Part D plans are automatically enrolled into a plan and other low-income beneficiaries are enrolled through “facilitated enrollment.” 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.
Payment to Cost Plan Sponsors
CMS provides payment to Cost Plan sponsors in the form of advance monthly payments (consisting of the Cost Plan sponsor’s Part D standardized bid, risk adjusted for health status, minus the beneficiary monthly premium), estimated reinsurance subsidies, and estimated low-income subsidies. After the end of the payment year, CMS reconciles the correct amounts of low-income subsidies and reinsurance amounts against the amount paid as a part of the prospective monthly payments. Risk sharing amounts (if applicable) are determined after all other reconciliations have been completed. For a more complete description refer to Prescription Drug Event Data that is posted at on the www.cms.hhs.gov/ website.
2. INSTRUCTIONS
2.1 Overview
This application is to be completed only by section 1876 Cost Plan contractors that intend to offer a new Part D benefit to their Cost Plan enrollees during 2008. This application is to be submitted to CMS in conjunction with your organization’s attestation to renew your cost contract with CMS in 2008.
2.2 Other Technical Support
CMS conducts technical support calls, also known as User Group calls, for Applicants and existing Part D sponsors. . CMS operational experts (e.g., from areas such as enrollment, information systems, marketing, bidding, formulary design, and coordination of benefits) are available to discuss and answer questions regarding the agenda items for each meeting. Registration for the technical support calls and for the list serve to get updates on CMS guidance can be found at www.aspenxnet.com/partd/usergroups. CMS also conducts special training sessions, including user group calls, for sponsors that are new to the Part D program.
2.3 Health Plan Management System (HPMS) Data Entry
Cost Plan organizations that submit a Notice of Intent to Apply form are assigned a pending contract number (H number) to use throughout the application and subsequent operational processes. Once the contract number is assigned, Cost Plan Applicants receive their CMS User ID(s) and password(s) for HPMS access and need to input contact and other related information into HPMS. Applicants are required to provide prompt entry and ongoing maintenance of data in HPMS. By keeping the information in HPMS current, the Applicant facilitates the tracking of their application throughout the review process and ensures that CMS has the most current information for application updates, guidance and other types of correspondence.
In the event that an Applicant is awarded a contract, this information will also be used for frequent communications during implementation. Therefore, it is important that this information be accurate at all times.
2.4 Instructions and Format of Qualifications
Applications may be submitted up until March 12, 2007. Applicants must use the 2008 solicitation. CMS will not accept or review those submissions using prior versions of the solicitation (e.g., 2007 and earlier).the 2007 solicitation.
Instructions
Applicants will complete most of this solicitation via HPMS. Throughout the solicitation, reference is made to submitting further documentation to CMS. In such instances, Applicants must include the contract ID number in the heading on each page of any attachments to be submitted to CMS.
In preparing your application in response to the prompts in Section 3.0 of this solicitation, please mark “Yes” or “No” or “Not Applicable” in sections organized with that format within HPMS.
In many instances Applicants are directed to affirm within HPMS 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 in Section 3.0.
Information that is required to be entered into HPMS will not be accepted in hard copy. If HPMS entry is required and an Applicant submits the information via hard copy, the application will be considered incomplete.
Additional supporting documentation is notated in the following manner throughout the solicitation and is to be submitted as follows:
Appendices: documents supplied by CMS that are contained at the end of this solicitation. They are to be completed by the Applicant and returned to CMS as indicated.
Attachments – documents that are to be created and/or supplied by the Applicant and sent to CMS with the application. Attachments are to be used only when the application does not indicate to respond directly within HPMS (i.e., subcontracts, letters of agreement, etc.)
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 copies of the application. The CD identification should include the appendix number.
CMS will check the application for completeness shortly after its receipt. A complete application consists of properly completing the appropriate sections within HPMS and CMS receipt of all appropriate attachments. We will notify Applicants of any deficiencies and afford them an opportunity to amend their applications.
CMS has established that all aspects of the program that the Applicant attests to must be ready for operation by the contract signature date. As with all aspects of a Part D sponsor’s operations under its contract with CMS, we may verify a sponsor’s compliance with qualifications it attests it will meet, through on-site visits at the Part D sponsor’s facilities 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, call letter, and the Part D contract may delay a Part D sponsor’s marketing and enrollment activities, or, if corrections cannot be made timely, the Part D sponsor will be disqualified from participation in the Part D program.
An individual with legal authority to bind the Applicant shall sign and submit the certification found in Section 4.0. CMS reserves the right to request clarifications or corrections to a submitted application. Failure to provide requested clarifications within a 2-day period 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 an application.
Format
To assure that each CMS review panelist receives the application in the manner intended by the Applicant, Applicants should deliver a total of two (2) hard copies of the supporting documentation (i.e., attachments and appendices.
Applicant must include a cover letter with the supporting documentation that includes the following elements:
Organization Name
Parent Organization (if any)
Organization Address
Organization Phone Number
Contract ID Number (or #s if applicable)
Contact Person
Contact Person Phone Number
Contact Person Email Address
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.
Both hard copies should be in separate 3-ring binders. Tab indexing should be used to identify all of the major sections of the supporting documentation. Page size should be 8 ½ by 11 inches and the pages should be numbered. Font size should be 12 point.
One set of supporting documentation should be clearly marked, “Original” and contain all original signed certifications requested in the application.
Additionally, the Applicant must submit the cover letter, appendices, attachments and all supporting documentation electronically on four (4) duplicate CDs. The CDs may have the files zipped. This will support the review of the application by different CMS components.
Each CD must be clearly labeled with the information in the table below:
Applicant’s Organization Name
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CMS Identification Number (Contract ID #s)
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CD Number (Copy 1, Copy 2, Copy 3, Copy 4)
Note: If multiple CDs are required to include appendices, attachments and other supporting documentation, label the CDs as follows: Copy 1 (1 of 2), Copy 1 (2 of 2); Copy 2 (1 of 2), Copy 2 (2 of 2), etc.
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Failure to submit application supporting documentation consistent with these instructions may delay its review by CMS and could result in the Applicant receiving a notice of intent to deny.
Applications Supporting Documentation must be sent to:
Centers for Medicare & Medicaid Services (CMS)
Mail Stop: C1-26-12
Attn: Cost Plan - Part D Application Supporting Documentation
7500 Security Boulevard
Baltimore, Maryland 21244-1850
In order for CMS to receive your application supporting documentation in a timely manner, please note that Federal Express and the US Postal Service possess a CMS Security Clearance. Application supporting documentation mailed through carriers that do not have CMS Security Clearance could be delayed due to clearance processing.
CMS will not review applications received after 5:00 P.M. EST on March 12, 2007. CMS will lock access to application fields within HPMS as of 5:00 P.M. EST on March 12, 2007. CMS will not review any submissions based on the earlier versions of the solicitation. Applicants must complete the 2008 solicitation in order to be considered for Part D sponsorship.
Single Application Representing Multiple Plans
Separate entries MUST be submitted through HPMS for each pending contract number/application. However, Part D plans of the same type, offered by the same legal entity, regardless of their service areas may be represented in a single submission of supporting attachments. The Applicant must complete the table in 3.1.1 indicating that multiple contracts are represented in the application’s supporting attachment documentation.
If a subsidiary, parent, or otherwise related organization is also applying to offer Part D benefits, these entities MUST submit separate applications. There are four types of Part D solicitations for which applications are due on March 12, 2007; they are PDP, MA-PD, Cost Plan solicitations, and the Service Area Expansion Application. Organizations that intend to offer a combination of these types of Part D contracts must submit a separate application for each type. (Employer and PACE sponsors will also have separate solicitations.) For example, a MA-PD and PDP product may not be represented in the same application. Entities intending to have both local MA-PD and Regional PPO contracts must submit separate MA-PD applications.
Applicant Entity Same as Contracting Entity
The legal entity that submits this application must be the same entity with which CMS enters into a Part D contract, or in the case of a MA-PD and Cost Plan sponsor, the same legal entity seeking an addendum to an MA or Cost Plan contract. An entity that qualifies for a Part D contract, or for an addendum to an MA or Cost Plan contract, may offer multiple plans of the same type (e.g. PDP, MA-PD, or Cost Plan) in the service area described in the application.
Technical Assistance
For technical assistance in the completion of this application, contact:
Marla Rothouse by email at marla.rothouse@cms.hhs.gov or by phone at 410-786-8063; or Linda Gousis by email at linda.gousis@cms.hhs.gov or by phone at 410-786-8616.
2.5 Submission Software Training
Applicants use the CMS Health Plan Management System (HPMS) during the application, formulary, and bid processes. Applicants are required to enter contact and other information collected in HPMS in order to facilitate the application review process.
Applicants are required to upload their plan formularies to HPMS using a pre-defined file format and record layout. The formulary upload functionality will be available on March 26, 2007. The deadline for formulary submission to CMS is by close of business on April 16, 2007.
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 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. Applicants will be able to submit bid uploads to HPMS on their PBP or BPT one or more times between May 18, 2007 and the CY 2008 bid deadline of June 4, 2007. CMS will use the last successful upload received for a plan as the official bid submission.
CMS will provide technical instructions and guidance upon release of the HPMS formulary and bid functionality as well as the PBP and BPT software. In addition, systems training will be available at the Bid Training in April 2007.
2.6 System and Data Testing with CMS
Cost Plan sponsors will use 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. Cost Plan sponsors are required to secure access to HPMS in order to carry out these functions. .
All Cost Plan sponsors must submit information about their membership to CMS electronically and have the capability to download files or receive electronic information directly. Prior to the approval of your contract, Cost Plan sponsors must contact the MMA Help Desk at 1-800-927-8069 for specific guidance on establishing connectivity and the electronic submission of files. Instructions are also on the MMA Help Desk webpage, www.cms.hhs.gov/mmahelp, in the Plan Reference Guide for CMS Part C/D System link. The MMA Help Desk will be the primary contact for all issues related to the physical submission of transaction files to CMS. Cost Plan sponsors that enter into a Part D addendum to their Cost Plan contract with CMS must also submit the Banking Information Form (Appendix I) so that payments can be transmitted to your account.
Each month, CMS provides reports to each Cost Plan sponsor for each of their plans with member and plan-level information by CMS. Cost Plan sponsors must compare the membership and payment information in those reports on a monthly basis with their records and report any discrepancies to the Division of Payment Operations within thirty (30) days. An analyst or group of analysts in that office is responsible for your geographic area and helping sponsors to resolve enrollment and payment issues. The Division of Payment Operations also approves any retroactive actions that your plans may need to submit to correct member records. Contact Angela Wright at (410) 786-1125 for the name of the analyst for your geographic area. Definitive information about the format and submission of files can also be found in the Plan Communications User’s Guide produced by the Division of Payment Operations (available at www.cms.hhs.gov/MedicareMangCareSys/). The MMA Help Desk also provides additional system and technical information at www.cms.hhs.gov/mmahelp.
Payments to Cost Plan sponsors for their Part D services will be wired to sponsor accounts 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 includes premiums that SSA or other agencies are deducting from beneficiary Social Security or other payments as well as those premiums CMS is paying on behalf of low-income individuals. Estimated monthly reinsurance subsidies (reinsurance being paid in the early years based on an estimate of reinsurance included in the bid), and low-income subsidies are included.
2.7 Summary Instruction and Format for Part D Bids
Cost Plan sponsors must submit to CMS a bid for each prescription drug plan it intends to offer. Applicants using this solicitation may apply to offer full risk Part D plans only. Applicants must submit their formularies to HPMS on or before April 16, 2007 and the PBPs and BPTs on or before the bid submission date.
2.7.1 Format of Bids
Bid- Related Submission Sections Due Prior to Bid Submissions Date
To facilitate the timely review of all the bid submissions, CMS requires Applicants to submit the portion of their bid related to formulary and covered drugs from March 26- April 16, 2007. CMS reviews areas of each proposed drug plan formulary by tier and drug availability and evaluates each element against evidence-based standards such as widely accepted treatment guidelines. Elements include, but may not be limited to the list of drugs, the categories and classes, tier structures (not cost sharing), and utilization management tools such as quantity limits, step therapy, and prior authorization. CMS makes the review criteria available to Applicants well in advance of the date Applicants must submit this information to CMS. Outliers are selected for further evaluation during the formulary review process prior to CMS approval of the bid. CMS makes reasonable efforts to inform Applicants of their outliers so that they may substantiate their offering. If such substantiation is not satisfactory to CMS, the Applicant is given the opportunity to modify the formulary. CMS intends to complete as much of this work as possible before the June 4, 2007, PBP and BPT submissions so that any modification may be reflected in those documents.
Bid Submissions
The Applicant’s bid represents the expected monthly cost to be incurred by the Applicant for qualified prescription drug coverage in the approved 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. These costs would not include payments made by the plan enrollee for deductible, coinsurance, co-payments, or payments for the difference between the plan’s allowance and an out-of-network pharmacy’s usual and customary charge. The bid requires 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 based upon a uniform level of premium and cost sharing among all beneficiaries enrolled in the plan. The benefit packages submitted must be cross walked appropriately from the formulary. 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, and assumptions related to projected reinsurance and low-income cost sharing subsidies, is accurate, complete, and truthful, and fully conforms to the requirements in section 423.265 of the regulations. In addition, the pricing component of the bid must also be certified by a qualified actuary.
In order to encourage successful bid submissions, CMS limits multiple bids to ensure that each bid submitted represents a meaningful variation based on the plan characteristics that will provide beneficiaries with substantially different options. CMS expects that more than two (2) bids from a sponsoring organization would not provide meaningful variation, unless one of the bids is an enhanced alternative plan that provides coverage in the coverage gap. CMS reviews multiple bids received from a Part D Applicant as a whole and applies a reasonableness test to determine examples of a strong likelihood of incompetence and/or ‘gaming’, including, but not limited to: a) multiple bid submissions that would fail a reasonableness test; b) multiple bid submissions based on different formulary drug lists; c) multiple bid submissions based on different levels of utilization management control; and d) multiple bid submissions that reflect a significant unexplained variation in costs between the plans, particularly between plans offered to the group versus the individual market.
2.7.2 CMS Review of Bids
CMS evaluates the bids based on four broad areas: 1) administrative costs, 2) aggregate costs, 3) benefit structure, and 4) plan management. CMS evaluates the administrative costs for reasonableness in comparison to other bidders. CMS also examines aggregate costs to determine whether the revenue requirements for qualified prescription drug coverage are reasonable and equitable. In addition, CMS reviews the steps the Part D sponsor is taking to control costs, such as through various programs to encourage use of generic drugs. Finally, CMS examines indicators concerning plan management, such as customer service.
CMS is also required to make certain that bids and plan designs meet statutory and regulatory requirements. We conduct actuarial analysis to determine whether the proposed benefit meets the standard of providing qualified prescription drug coverage. Also, CMS reviews the structure of the premiums, deductibles, co-payments, and coinsurance charged to beneficiaries and other features of the benefit plan design to ensure that it is not discriminatory (that is, that it does not substantially discourage enrollment by certain Part D eligible individuals).
2.7.3 Overview of Bid Negotiation
CMS evaluates the reasonableness of bids submitted by Cost Plan 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. CMS could exercise its authority to deny a bid if we do not believe that the bid and its underlying drug prices reflect market rates.
2.8 Pharmacy Access
An integral component of this Solicitation concerns the pharmacy access standards established under section 1860D-4(b)(1)(c) of the Social Security Act. The standards require in part that each Part D sponsor must secure the participation in their pharmacy networks of a sufficient number of pharmacies to dispense drugs directly to patients (other than by mail order) to ensure convenient access to covered Part D drugs by Part D plan enrollees. To implement this requirement, specific access rules consistent with the TRICARE standards were developed and are delineated in 42 CFR §423.120. Furthermore, 42 CFR §423.120 mandates that the Part D sponsors must provide adequate access to home infusion and convenient access to long-term care, and Indian Health Service, Indian Tribe and Tribal Organization, and Urban Indian Organization (I/T/U) pharmacies in accordance with 42 CFR § 423.120 and related CMS instructions and guidance.
Retail Pharmacy Access
Applicants must ensure that their retail pharmacy network meets the criteria established under 42 CFR §423.120. Applicants must ensure the pharmacy network has a sufficient number of pharmacies that dispense drugs directly to patients (other than by mail order) to ensure convenient access to Part D drugs. CMS rules require Applicants establish retail pharmacy networks in which:
In urban areas, at least 90 percent of Medicare beneficiaries in the Applicant’s service area, on average, live within 2 miles of a retail pharmacy participating in the Applicant’s network;
In suburban areas, at least 90 percent of Medicare beneficiaries in the Applicant’s service area, on average, live within 5 miles of a retail pharmacy participating in the Applicant’s network; and
In rural areas, at least 70 percent of Medicare beneficiaries in the Applicant’s service area, on average, live within 15 miles of a retail pharmacy participating in the Applicant’s network
Applicants may count I/T/U pharmacies and pharmacies operated by Federally Qualified Health Centers and Rural Health Centers towards that standard of convenient access to retail pharmacy networks.
Section 3.3 of this Solicitation includes a reference to the Appendix entitled Retail Pharmacy Network Access Instructions that provides Applicants with detailed instructions to complete the retail pharmacy network access portion of this submission. For purposes of meeting the 2008 Pharmacy Access requirements, Applicants may use their contracted PBM’s existing 2007 Part D network to demonstrate compliance. If an Applicant is creating a new Part D network, the submission must be based on executed contracts for Year 2008. While Applicants are required to demonstrate that they meet the Part D pharmacy access requirements at the time this solicitation is submitted to CMS, CMS expects that pharmacy network contracting will be ongoing in order to maintain access to Part D drugs. See the Appendix entitled Retail Pharmacy Network Access Instructions for detailed instructions for the retail pharmacy network analysis.
Home Infusion Pharmacy Access
Applicants must demonstrate that their contracted pharmacy network provides adequate access to home infusion pharmacies. In order to demonstrate adequate access to home infusion pharmacies, Applicants must provide a list of all contracted home infusion pharmacies (see section 3.3.4). CMS uses this pharmacy listing to develop a ratio for the number of contracted home infusion pharmacies in each State/Territory in the proposed service area compared to the number of Medicare beneficiaries in each State/Territory in the proposed service area and identify outliers amongst all Applicants.
Long-Term Care Pharmacy Access
Applicants must demonstrate that their contracted pharmacy network provides convenient access to long-term care pharmacies. In order to demonstrate convenient access to long-term care pharmacies, Applicants must provide a list of all contracted long-term care pharmacies (see section 3.3.5). CMS uses this pharmacy listing to develop a ratio for the number of contracted long-term care pharmacies in each State/Territory in the proposed service area compared to the number of nursing home beds in each State/Territory in the proposed service area and identify outliers amongst all Applicants.
Waivers Related to Pharmacy Access
Waivers for MA-PD Plans. On June 3, 2005, CMS issued special guidance related to Medicare Advantage Prescription Drug Plan and Cost Plan waiver requests located on the www.cms.hhs.gov website. CMS has waived for MA-PDs provisions (described below) related to the pharmacy access and any willing pharmacy standards. If an Applicant believes that any waiver described below applies to a specific contract/plan number then please complete the documentation identified. These waivers do not apply to any PDPs regardless of whether Applicant is also seeking to offer MA-PDs or cost plans to which the waivers to apply.
Waiver of Retail Convenient Access Standards
The requirement that Applicants must offer their Part D plan benefit through a contracted retail pharmacy network that meets CMS convenient access standards is waived for Applicants that operate their own pharmacies. Applicants must demonstrate at the plan level that a majority (50%) of the prescriptions are filled at retail pharmacies owned and operated by the organization in order to be granted the waiver.
Waiver of Any Willing Pharmacy Requirements
The requirement that Applicants must offer a network pharmacy contract to any willing pharmacy that agrees to accept Applicant’s standard terms and conditions is waived for Applicants that own and operate the pharmacies in their network. Applicants must demonstrate at the plan level that at least 98% of prescriptions are filled through pharmacies that are owned and operated by plan sponsor in order to be granted the waiver.
Waivers for Plans in the Territories
To ensure access to coverage in the territories, §1860D-42(a) of the MMA grants CMS the authority to waive the necessary requirements to secure access to qualified prescription drug coverage for Part D eligible individuals residing in the territories. The regulations for the MMA under §423.859(c) allow access to coverage in the territories to be waived or modified either through an Applicant’s request or at CMS’s own determination. Under that authority, CMS will consider waiving the convenient access requirements for a plan’s Part D contracted retail pharmacy network, found in §423.120(a)(1) of the Part D Final Regulation for the territories, if Applicant requests such a waiver, and demonstrates that it has made a good faith effort to meet the requirements described in Section 3.3E.
2.9 Standard Contract with Cost Plan Sponsors
Successful Applicants will be deemed qualified to enter into a Part D addendum to their section 1876 Cost Plan contract allowing the Applicant to offer a Medicare prescription drug plan(s) as an optional supplemental benefit after CMS has reviewed the Applicant’s entire submission. It is only after the qualified Applicant and CMS have reached agreement on the Applicant’s bid submissions will the Applicant be asked to execute its Part D addendum.
2.10 Protection of Confidential Information
Applicants may always seek to protect their information from disclosure under the Freedom of Information Act (FOIA) by claiming that FIOA Exemption 4 applies. Applicant is required to label the information in question “confidential” or “proprietary,” and explain the applicability of the FOIA exemption it is claiming. 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 CFR §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— (1) disclosure of the information is likely to impair the government's ability to obtain necessary information in the future; (2) disclosure of the information is likely to cause substantial harm to the competitive position of the submitter; or (3) the records are considered valuable commodities in the marketplace which, once released through the FOIA, would result in a substantial loss of their market value. 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.
2.11
Waivers
CMS is authorized to grant waivers of Part D program requirements otherwise applicable to Cost Plans, where such a requirement conflicts with or duplicates a requirement under Section 1876 (or 42 CFR Part 417), or where granting such a waiver would improve the Cost Plan sponsor’s coordination of Part A, B, and Part D benefits. Accordingly, CMS has identified the waivers it is granting to all Cost Plan sponsors in the chart shown in Summary of PDP Application Requirements Waived for Cost Plan Prescription Drug Applicants (Appendix II). As a result of the CMS-granted waivers, the Cost Plan sponsor application is less comprehensive than the PDP sponsor application. These waivers will be reflected in each Cost Plan sponsor’s Part D addendum.
Applicant Requests for Additional Waivers: CMS may grant additional waivers upon an Cost Plan sponsor’s request, provided that the waivers may be justified as duplicative of or conflicting with section 1876 Cost Plan requirements, or improving the coordination of Part A and/or Part B benefits with Part D benefits. Any waiver granted by CMS will apply to all similarly situated Cost Plan sponsors.
For each waiver request, the Applicant must provide, as an attachment per instructions in Section 2.4, a statement 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.
CMS will notify Applicants whether their requests were approved via a CMS web posting of all approved waivers. As noted above, waivers granted will be reflected in each Cost Plan sponsor’s Part D addenda.
Where this application directs the Applicant to attest that it will meet a particular Part D requirement for which the Applicant has requested a waiver, the Applicant should check both the “Yes” box and the “Waiver Requested” box within HPMS. In the event that CMS does not approve a particular waiver, the Applicant will still have attested that it will meet all the applicable Part D program requirements and remain eligible to enter into a Part D addendum upon approval of its bids. This process will prevent Applicants from having to submit additional application responses after the original March 12, 2007 deadline. If, as a result of CMS’ denial of its waiver request, the Applicant no longer intends to offer a Part D benefit plan, the Applicant must notify CMS in writing on or before June 30, 2007. CMS will not execute a Part D addendum with Applicants that submit such a notice. The notice of withdrawal should be sent to:
Centers for Medicare & Medicaid Services (CMS)
Center for Beneficiary Choices
Attention: Application Withdrawal
7500 Security Boulevard
Mail Stop C1-26-12
Baltimore, Maryland 21244-1850
3. APPLICATION
Note: Nothing in this application is intended to supersede the regulations at 42 CFR Part 423. Failure to reference a regulatory requirement in this application does not affect the applicability of such requirement, and Cost Plan sponsors and/or Applicants are required to comply with all applicable requirements of the regulations in Part 423 of 42 CFR.
For most 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 in making the attestations stated below, 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.
3.1 Applicant Experience, Contracts, Licensure and Financial Stability
3.1.1 Contracts
A. Provide as an attachment per the instructions in Section 2.4 the table below if submitting one set of supporting documentation for multiple contracts.
PROVIDE THE NEW CONTRACT NUMBER THAT WILL BE USED TO IDENTIFY ALL NEW CONTRACT NUMBERS DURING APPLICATION PROCESS : ____________________(Do not use existing CMS contract numbers): |
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PROVIDE THE ADDITIONAL NEW CONTRACT NUMBERS THAT ARE TO BE ASSOCIATED WITH THIS APPLICATION. (ADD ADDITIONAL ROWS AS NECESSARY) |
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NOTE: Only Cost Plan contract numbers may be associated with other Cost Plan contract numbers. Only PDP contract numbers may be associated with other PDP contract numbers. Only Regional Preferred Provider Organization ( RPPO) contract numbers may be associated with other RPPO contract numbers.
3.1.2 Management and Operations
A. 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 PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
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B. Provide as an attachment a brief summary of the history, structure and ownership of your organization. Include a chart showing the structure of ownership, subsidiaries, and business affiliations. The organizational chart should depict the placement of the Medicare PDP operations within your organization as well as the reporting structure within your organization.
C. Subcontractor Function Chart
In HPMS, on the Contractor Management/Part D Information/Data Page, complete the Part D functions table and provide the names of the sub-contractors you will use to serve the functions identified to carry out each of the functions listed in this chart: (Indicate with “Name of Applicant’s Organization” where applicant will perform those functions) |
Function |
Subcontractor(s) |
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, Medigap, 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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Maintains a pharmaceutical and therapeutic committee. |
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D. Provide as attachments (as instructed in Section 2.4) copies of executed contracts and fully executed letters of agreement with each subcontractor identified in the above tables (3.1.2 C) that:
Clearly identify the parties to the contract (or letter of agreement).
Describe the functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant.
Contain language clearly indicating that the subcontractor 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), and flow-down clauses requiring their activities be consistent and comply with the Applicant’s contractual obligations as a Part D sponsor.
Contain language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Benefit program.
Describe the payment the subcontractor will receive for performance under the contract, if applicable.
Are for a term of at least the one-year contract period (i.e. January 1 through December 31) for which this application is being submitted.
Are signed by a representative of each party with legal authority to bind the entity.
Contain language obligating the subcontractor to abide by all applicable Federal and State laws and regulations and CMS instructions.
Contain language obligating the subcontractor 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.
Contain language ensuring that the subcontractor will make its books and other records available in accordance with 42 CFR 423.505 (i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to inspect, evaluate and audit books and other records 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.
Contain language that the subcontractor will ensure that beneficiaries are not held liable for fees that are the responsibility of the Part D sponsor.
Contain language that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement.
Contain language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor on an ongoing basis.
If the subcontractor 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.
E. Provide as an attachment, as instructed in section 2.4, the signed certification in the Appendix entitled Certification that Subcontracts meet the requirements of Section 3.1.2D. The certification allows the Applicant to verify the subcontracts submitted under 3.1.2D meet all of the requirements identified in 3.1.2D.
F. Provide electronic lists of, crosswalks of the subcontract citations demonstrating that the requirements of Section 3.1.2D are included in the subcontracts. Submit these data by creating a spreadsheet in Microsoft Excel that mimics the Appendix entitled Crosswalk of Citations of Section 3.1.2D to Location in Subcontracts Submitted as attachments in Section 3.1.2. Provide this attachment as instructed in Section 2.4
3.1.3 Experience and Capabilities
A. 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 PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
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3.1.4 Business Integrity
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ OR ‘NO’ TO THE FOLLOWING QUALIFICATION TO BE APROVED FOR A PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO THE FOLLOWING QUALIFICATION BY PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
1. Applicant, applicant’s staff, applicant’s affiliated companies, subsidiaries, subcontractors, and subcontractor’s staff agree that they are bound by 45 CFR Part 76 and attest that they are not excluded by the Department of Health and Human Services Office of Inspector General or by the General Services Administration. Please note that this includes any member of its board of directors, and any key management, executive staff, or any major stockholder. |
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2. Applicant agrees it does not have any past or pending investigations, legal actions, administrative actions, or matters subject to arbitration brought involving the Applicant (and Applicant’s parent firm if applicable) and its Pharmaceutical Benefit Manager (PBM) (and PBM’s parent firm if applicable), including any key management or executive staff, by a government agency (state or federal including CMS) over the past three years on matters relating to payments from governmental entities, both federal and state, for healthcare and/or prescription drug services. |
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B. If Applicant answered No to 3.1.4A2, provide as an attachment, all past or pending, if known, investigations, legal actions, or matters subject to arbitration brought by a government agency (state or federal including CMS) over the past three years relating to payments from government 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); and
3. Key management or executive staff
Provide as part of the attachment a brief explanation or each action, including the following:
Legal names of the parties;
Circumstances;
Status (pending or closed);
d) If closed, provide the details concerning resolution and any monetary payments; and
e) Settlement agreements or corporate integrity agreements.
3.1.5 HPMS Part D Contacts
A. In HPMS on the Contract Management/Contract Information/Contract Data Page provide the name/title, mailing address, phone number, fax number, and email address for the following Applicant contacts:
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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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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B. In HPMS, 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 IN HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
1. Applicant agrees that CMS may release contract information to States, SPAPs, providers, Part D sponsors, and others who need the contact information for legitimate purposes. |
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3.2 Benefit Design
3.2.1 Formulary/Pharmacy and Therapeutics (P&T) Committee
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ OR ‘NO’ TO THE FOLLOWING QUALIFICATION TO BE APPROVED FOR A PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ 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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B. In HPMS, 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’ IF IT IS USING ITS PBM’S P&T COMMITTEE TO BE APPROVED FOR A PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ BY PLACINIG A CHECKMARK IN THE RELEVANT COLUMN IN HPMS. |
YES |
NO |
Requesting Waiver? Yes or No |
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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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B. 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 in items B9, 10, 11 and 13 above. If Applicant is providing names of P&T Committee directly, then complete the form below. If PBM is providing the P&T Committee, refer to the Appendix entitled, Applicant Submission of P & T Committee Member List and Certification Statement for additional instructions.
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 THIS INFORMATION AS PROPRIETARY. SUBMIT THIS DATA BY CREATING A SPREADSHEET IN MICROSOFT EXCEL THAT MIMICS THE TABLE BELOW. PROVIDE THIS ATTACHMENT ON A CD AS INSTRUCTED IN SECTION 2.4) |
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Practice/Expertise Mark an ‘X’ in Appropriate Column |
Free of Any Conflict of Interest Type ‘Yes’ or ‘No’ Type ‘Yes’ if the member has no conflict of interest and ‘No’ if there is a conflict of interest. Please complete for each member of the P&T Committee. |
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Full Name of Member Start Date and End Date |
Practicing Physician |
Practicing Pharmacist |
Elderly/Disabled Expert |
With Your Organization? |
With Pharmaceutical Manufacturers? |
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3.2.2 Utilization Management Standards
A. 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 PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
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3.2.3 Quality Assurance and Patient Safety
A. 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 PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS”. |
YES |
NO |
Requesting Waiver? Yes or No |
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3.2.4 Medication Therapy Management
A. 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 PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
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12. Applicant will establish an appropriate MTM enrollment policy in which once enrolled, beneficiaries will not be disenrolled from the MTMP program if they no longer meet one or more of the MTMP eligibility criteria (as determined by the plan) and will remain in the MTMP program for the remainder of the calendar year. |
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13. Applicant will establish and maintain appropriate interventions for its MTM program for all enrollees who meet all three of the required criteria (as determined by the plan) regardless of setting (i.e., ambulatory, long term care, etc.) |
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14. Applicant will establish and maintain safeguards against discrimination based on the nature of their MTM interventions (i.e., TTY if phone based, Braille if mail based, etc.) |
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3.2.5 Electronic Prescription Program
A. In HPMS, 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 EACH OF THE FOLLOWING QUALIFICATION BY PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
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Bids
A. In HPMS, 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 IN HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
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3.3 General Pharmacy Access
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APROVED 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 |
Requesting Waiver? Yes or No |
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3. Where applicable, Applicant’s network pharmacy contracts contain provisions governing the submission of claims to a real-time adjudication system, except in the limited case of pharmacies for which only batch processing is feasible (e.g., some I/T/U pharmacies and certain pharmacies that are allowed to submit claims in the X12 format). |
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4. Applicant’s network pharmacy contracts contain provisions governing providing Part D enrollees access to negotiated prices as defined in 42 CFR 423.100.
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5. Applicant’s network pharmacy contracts contain provisions regarding charging/ applying the correct cost-sharing amount, including that which applies to individuals qualifying for the low-income subsidy. |
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6. Where applicable, Applicant’s network pharmacy contracts contain provisions governing informing (i.e., web posting) 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. (NOTE: 42 CFR 423.132(a) modifies the timing requirement for LTC pharmacies). |
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7. Applicant agrees to maintain a contract log as specified in forthcoming CMS guidance. |
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8. Applicant agrees that each of the contract provisions referenced in the Appendices entitled,
will be included in the respective downstream pharmacy network contracts. |
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9. Applicant agrees to notify CMS when the Applicant changes its pharmaceutical benefit management subcontractor. |
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10. Applicant agrees to notify CMS about any substantive change in your organization’s pharmacy network that may impact your organization’s ability to maintain a Part D pharmacy network that meets CMS’ requirements. |
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B. Provide as an attachment a contract for each of the following types of pharmacies: Retail, Mail Order, Home Infusion, Long-Term Care, and I/T/U. The mail order contract template is only necessary if the plan is offering mail order. The I/T/U template is only necessary if the plan’s projected service area includes I/T/U pharmacies. If Applicant has contracted with a Pharmacy Benefit Management entity to provide a pharmacy network, those downstream contract templates must also be submitted. If there are several different types of standard terms and conditions for the same type of pharmacy, please provide a contract template for all versions and label according to type of pharmacy. For example, if different terms for retail pharmacies apply depending upon geographic location, all standard terms must be provided. Each contract template must contain the unsigned standard terms and conditions, including the provisions listed in the Appendices entitled
Crosswalk for Retail Pharmacy Access Contracts
Crosswalk for Mail Order Pharmacy Access Contracts
Crosswalk for Home Infusion Pharmacy Access Contracts
Crosswalk for Long-Term Care Pharmacy Access Contracts
Crosswalk for I/T/U Pharmacy Access Contracts
C. Provide as attachments crosswalks of the Pharmacy Access Contract Citations (for Retail, Mail Order (if offered), Home Infusion, Long-Term Care and I/T/U Pharmacy networks) demonstrating that all applicable requirements are included in such contracts. Submit this data by creating separate spreadsheets in Microsoft Excel that mimics the Appendices entitled
Crosswalk for Retail Pharmacy Access Contracts
Crosswalk for Mail Order Pharmacy Access Contracts
Crosswalk for Home Infusion Pharmacy Access Contracts
Crosswalk for Long-Term Pharmacy Access Contracts
Crosswalk for I/T/U Pharmacy Access Contracts
Provide these attachments on each of the 4 CDs as instructed in Section 2.4.
3.3.1 Retail Pharmacy
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APROVED 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 |
Retail Pharmacy Network Access Instructions). |
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B. Provide as attachments the Geo-Access Reports as described in the Appendix entitled Retail Pharmacy Network Access Instructions.
C. Provide as attachments the Retail Pharmacy List:
To submit retail pharmacy listings to CMS, Applicants must complete, at a minimum, two worksheets within the Excel file labeled and “Retail Pharmacy List” (see reference document entitled “Retail Pharmacy List”
1. Assuming that Applicant has only one unique retail pharmacy network, they must complete the following:
Complete the worksheet labeled “Retail List – A”.
Complete all columns with the information indicated in each column heading.
Complete all appropriate cells (columns) for every record (row) for which you are listing a pharmacy.
We recognize that in some instances, networks may exceed a single worksheet and ask that you label each worksheet properly. For instance, label multiple sheets for a single pharmacy list as “Retail List - A”, “Retail List - A2”, “Retail List - A3”, etc. Only designate a worksheet as “Retail List – B” if you are referencing an alternate or separate retail pharmacy listing. In the event Applicant is representing more than one unique retail pharmacy network, create as many worksheets as may be necessary to provide your complete network. Label additional worksheets as “Retail List – B”, “Retail List – C”, etc.
The “Contract ID List” worksheet should list all of the contract numbers and the legal entity name(s) (as it appears in HPMS), that are represented by the retail list provided in the worksheet labeled “Retail List - A”. For many, if not all, contract numbers, the retail pharmacy list may be the same. For those contract numbers associated with “Retail List – A”, you will complete the “Contract ID List” worksheet by populating the “List Identifier”, column C, with an “A”. If there are any circumstances, where there are contract numbers that have an alternate retail pharmacy listing, you will populate the “List Identifier” column with the appropriate letter identifier (i.e., B, C, etc.).
D. Submission of Supporting Discussion in Areas Failing to Meet Access Standards
CMS will consider supporting discussion provided by an Applicant in evaluating the Applicant’s Part D network to determine if the Applicant is qualified to be a Part D Sponsor. While you have the opportunity to provide this discussion, CMS’ expectation is that your organization will meet the required access standards in all cases. Providing the discussion below does not mean CMS will allow you to fail the access standards, but in extreme or unusual circumstances, we may consider this information.
Provide as an attachment the following information to demonstrate that meeting the access standard within the service area is not practical or impossible.
Indicate the geographic areas in which the applicant cannot demonstrate that it meets the retail pharmacy convenient access standards as defined in Appendix entitled “Retail Pharmacy Network Access Instructions.”
Explain why these standards cannot be met. Include in the discussion relevant information such as geographic barriers, pharmacy infrastructure barriers, and/or market barriers.
Describe how the pharmacies in the Applicant’s retail contracted network will provide access to all eligible Part D individuals enrolled in the Applicant’s plan(s) in each of the geographic areas defined in item 1 above.
E. In HPMS, complete the table below if your pending service area includes any of the U.S. Territories:
Request for a Waiver of Convenient Access Standards for the Territories
YES NO N/A |
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Region 35 – American Samoa |
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Region 36 – Guam |
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Region 37 – Northern Mariana Islands |
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Region 38 – Puerto Rico |
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Region 39 – US Virgin Islands |
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F. Complete the following if Applicant marked YES to requesting a waiver of convenient access standards for any of the territories in 3.3.1E. Provide the following information as an attachment per the instructions in Section 2.4:
Explain why these standards cannot be met.
Describe the Applicant’s efforts to identify and contract with all of the retail pharmacies in each of the applicable territories.
Describe how the pharmacies in the Applicant’s contracted network demonstrate convenient access to all eligible Part D individuals enrolled in the Applicant’s plan(s) in each of the territories listed above as not meeting the standards in §423.120(a)(1).
G. In HPMS complete the table below:
Waiver of Retail Convenient Access Standards
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Provide the number of prescriptions provided in 2006 by retail pharmacies owned and operated by Applicant. |
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Provide the number of prescriptions provided in 2006 at retail pharmacies contracted by Applicant. |
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NOTE: CMS will determine the percentage of prescriptions at provided at retail pharmacies owned and operated by Applicant over total prescriptions provided at all retail pharmacies contracted by Applicant.
H. In HPMS complete the table below:
Waiver of Any Willing Pharmacy Requirements
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Provide the number of prescriptions provided in 2006 by all pharmacies owned and operated by Applicant. |
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Provide the number of prescriptions provided in 2006 at all pharmacies contracted by Applicant. |
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NOTE: CMS will determine the percentage of prescriptions at provided at all pharmacies owned and operated by Applicant over total prescriptions provided at all pharmacies contracted by Applicant.
3.3.2 Out of Network Pharmacy
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APROVED 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 |
Requesting Waiver? Yes or No |
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3.3.3 Mail Order Pharmacy
A. In HPMS, complete the table below:
APPLICANTS MAY OFFER A MAIL ORDER OPTION IN ADDITION TO THEIR CONTRACTED OPTIONAL SUPPLEMENTAL PART D PHARMACY NETWORK BUT MAIL ORDER PHARMACIES DO NOT COUNT IN MEETING NETWORK ADEQUACY STANDARDS. INDICATE ‘YES’ OR ‘NO’ WHETHER SUCH MAIL ORDER PHARMACY IS OFFERED IN HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
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B. Provide as an attachment the Mail Order Pharmacy List
To submit mail order pharmacy listings to CMS, Applicants must complete, at a minimum, two worksheets within the Excel file labeled and “Mail Order Pharmacy List” (see reference document entitled “Mail Order Pharmacy List.”
1. Assuming that Applicant has only one unique mail order pharmacy network, they must complete the following:
2. Complete the worksheet labeled “Mail List – A”.
Complete all columns with the information indicated in each column heading.
Complete all appropriate cells (columns) for every record (row) for which you are listing a pharmacy.
We recognize that in some instances, networks may exceed a single worksheet and ask that you label each worksheet properly. For instance, label multiple sheets for a single pharmacy list as “Mail List - A”, “Mail List - A2”, “Mail List - A3”, etc. Only designate a worksheet as “Mail List – B” if you are referencing an alternate or separate mail order pharmacy listing. In the event Applicant is representing more than one unique mail order pharmacy network, create as many worksheets as may be necessary to provide your complete network. Label additional worksheets as “Mail List – B”, “Mail List – C”, etc.
The “Contract ID List” worksheet should list all of the contract numbers and the legal entity name(s) (as it appears in HPMS), that are represented by the mail order list provided in the worksheet labeled “Mail List - A”. For many, if not all, contract numbers, the mail order pharmacy list may be the same. For those contract numbers associated with “Mail List – A”, you will complete the “Contract ID List” worksheet by populating the “List Identifier”, column C, with an “A”. If there are any circumstances, where there are contract numbers that have an alternate mail order pharmacy listing, you will populate the “List Identifier” column with the appropriate letter identifier (i.e. B, C, etc.).
3.3.4 Home Infusion Pharmacy
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APROVED 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 |
Requesting Waiver? Yes or No |
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B. Home Infusion Pharmacy List
Within HPMS, Applicants will need to complete at a minimum, two worksheets within an Excel file labeled “Home Infusion Pharmacy List”. (See reference document entitled “Home Infusion Pharmacy List” ).
Assuming that Applicant has only one unique home infusion pharmacy network, do the following:
Complete the worksheet labeled “H_I List – A”. All columns should be completed with the information indicated in each column heading. Please be sure to complete all appropriate cells (columns) for every record (row) for which Applicant is listing a pharmacy. CMS recognizes that in some instances, networks may exceed a single worksheet and ask that Applicant label each worksheet properly. For instance, label multiple sheets for a single pharmacy list as “H_I List - A”, “H_I List - A2”, “H_I List - A3”, etc. Only designate a worksheet as “H_I List – B” if Applicant is referencing an alternate or separate home infusion pharmacy listing.
In the event Applicant is representing more than one unique home infusion pharmacy network, create as many worksheets as may be necessary to provide all the unique networks. Label additional worksheets as “H_I List – B”, “H_I List – C”, etc.
The “Contract ID List” worksheet should list all of the contract numbers and the legal entity name(s) (as it appears in HPMS), that are represented by the home infusion list provided in the worksheet labeled “H_I List - A”. For many, if not all, contract numbers, the home infusion pharmacy list may be the same. For those contract numbers associated with “H_I List – A”, Applicant will complete the “Contract ID List” worksheet by populating the “List Identifier”, column C, with an “A”. If there are any circumstances, where there are contract numbers that have an alternate home infusion pharmacy listing, Applicant will populate the “List Identifier” column with the appropriate letter identifier (i.e., B, C, etc.).
C. Home Infusion Discussion
Provide as an attachment a discussion about how your organization’s contracted home infusion network assures adequate access to Medicare beneficiaries.
3.3.5 Long -Term Care (LTC) Pharmacy
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APROVED 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 |
Requesting Waiver? Yes or No |
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B. LTC Pharmacy List
Within HPMS, Applicants will need to complete, at a minimum, two worksheets within an Excel file labeled “Long Term Care Pharmacy List” (see reference document entitled “Long Term Care Pharmacy List”).
Assuming that Applicant has only one unique long term care pharmacy network, do the following:
Complete the worksheet labeled “LTC List – A”. All columns should be completed with the information indicated in each column heading. Please be sure to complete all appropriate cells (columns) for every record (row) for which you are listing a pharmacy. CMS recognizes that in some instances, networks may exceed a single worksheet and ask that Applicant label each worksheet properly. For instance, label multiple sheets for a single pharmacy list as “LTC List - A”, “LTC List - A2”, “LTC List - A3”, etc. Only designate a worksheet as “LTC List – B” if you are referencing an alternate or separate long-term care pharmacy listing.
In the event Applicant is representing more than one unique long term care pharmacy network, create as many worksheets as may be necessary to provide all the unique networks. Label additional worksheets as “LTC List – B”, “LTC List – C”, etc.
The “Contract ID List” worksheet should list all of the contract numbers and the legal entity name(s) (as it appears in HPMS), that are represented by the long-term care list provided in the worksheet labeled “LTC List - A”. For many, if not all, contract numbers, the long-term care pharmacy list may be the same. For those contract numbers associated with “LTC List – A”, Applicant will complete the “Contract ID List” worksheet by populating the “List Identifier”, column C, with an “A”. If there are any circumstances, where there are contract numbers that have an alternate long term care pharmacy listing, Applicant will populate the “List Identifier” column with the appropriate letter identifier (i.e. B, C, etc.).
C. LTC Discussion
Provide as an attachment a discussion about how your organization’s contracted long-term care network assures convenient access to Medicare beneficiaries.
3.3.6 Indian Health Service, Indian Tribe and Tribal Organization, and Urban Indian Organization (I/T/U) Pharmacy
In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS TO BE APPROVED FOR A PART DCONTRACT : |
YES |
NO |
N/A |
Requesting Waiver? Yes or No |
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NOT ALL PART D REGIONS HAVE I/T/U PHARMACIES. IF THE APPLICANT’S SERVICE AREA COVERS ANY REGION THAT INCLUDES I/T/U PHARMACIES, THEN THE APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D CONTRACT. IF ALL OF THE APPLICANT’S SERVICE AREA DOES NOT INCLUDE I/T/U PHARMACIES, THEN THE APPLICANT MAY ANSWER ‘NO’ OR ‘N/A’ AND STILL BE APPROVED FOR A PART D CONTRACT SINCE THESE REQUIREMENTS DO NOT APPLY. ATTEST ‘YES’, ‘NO,’ OR ‘N/A’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS: |
YES |
NO |
N/A |
Requesting Waiver? Yes or No |
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Provide as an attachment the I/T/U Pharmacy List
In order to demonstrate that a Part D Applicant meets these requirements Applicants must submit, as an attachment, a list of ALL I/T/U pharmacies (using the list of I/T/U pharmacies provided by CMS that reside in their service area. This information must be submitted at the county-level and CMS designated contract level and include contracting status with each of the I/T/U pharmacies in the Applicant’s service area.
To submit I/T/U pharmacy listings to CMS, Applicants will need to complete at a minimum, two worksheets within an Excel file labeled “I/T/U Pharmacy List” (see reference document entitled “I/T/U Pharmacy List”).
Assuming that Applicant has only one unique I/T/U pharmacy network, do the following:
Complete the worksheet labeled “I/T/U List - A”. All columns should be completed with the information indicated in each column heading. Please be sure to complete all appropriate cells (columns) for every record (row) for which Applicant is listing a pharmacy. Only designate a worksheet as “I/T/U List – B” if Applicant is referencing an alternate or separate I/T/U pharmacy listing.
In the event Applicant is representing more than one unique I/T/U pharmacy network, create as many worksheets as may be necessary to provide all the unique networks. Label additional worksheets as “I/T/U List – B”, “I/T/U List – C”, etc.
The “Contract ID List” worksheet should list all of the contract numbers and the legal entity name(s) (as it appears in HPMS), that are represented by the I/T/U list provided in the worksheet labeled “I/T/U List - A”. For many, if not all, contract numbers, the I/T/U pharmacy list may be the same. For those contract numbers associated with “I/T/U List – A”, Applicant will complete the “Contract ID List” worksheet by populating the “List Identifier”, column C, with an “A”. If there are any circumstances, where there are contract numbers that have an alternate I/T/U pharmacy listing, Applicant will populate the “List Identifier” column with the appropriate letter identifier (i.e., B, C, etc.).
3.3.7 Specialty Pharmacy
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 E ACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
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3.4 Enrollment and Eligibility
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APROVED 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 |
Requesting Waiver? Yes or No |
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(a) Verification of Medicare Eligibility (b)The end date of the beneficiary’s Part D IEP, (c) Periods of enrollment in a Medicare plan that provides prescription drug coverage, and (d) Periods of enrollment in a retiree prescription drug plan whose sponsor receives a retiree drug subsidy from Medicare |
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3.5 Complaints Tracking
A. 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 PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
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2. Applicant will continue to monitor and document complaint resolutions for complaints attributed to their contracts in the CMS’ Complaint Tracking Module. |
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3. Applicant will maintain Standard Operating Procedures that address how your organization will handle and quickly resolve immediate action cases, as well as, outline the steps your organization intends to take to have enrollees call your customer service directly for the prompt resolution of all inquiries. |
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Medicare Prescription Drug Plan Finder
A. 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 PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS:. |
YES |
NO |
Requesting Waiver? Yes or No |
1. Applicant agrees to provide its CY 2008 drug pricing and pharmacy network data for publishing on the “Medicare Prescription Drug Plan Finder (MPDPF)” in the format and on a schedule required by CMS |
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2. Applicant agrees to perform quality checks for data submitted to CMS for display on the MPDPF and agrees that failure to conduct quality checks may result in suppression of the Applicant’s pricing data from the website. |
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3. Applicant agrees that errors or omissions identified by CMS during analyses of the data will also result in the suppression of the Applicant’s pricing data from the website. |
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3.7 Grievances
A. 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 PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS: |
YES |
NO |
Requesting Wavier? Yes or No
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1. Applicant will establish and maintain a process designed to track and address enrollees’ grievances and assures that they will adopt appropriate timelines, policies and procedures and train the relevant staff and subcontractors on such policies and procedures in accordance with 42 CFR 423.564. |
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Note: A grievance is any complaint or dispute, other than one that involves a coverage determination, expressing dissatisfaction with any aspect of a Part D sponsor’s operations, activities, or behavior, regardless of whether remedial action is requested. Examples of subjects of a grievance include, but are not limited to:
Timeliness, appropriateness, access to, and/or setting of services provided by the Part D sponsor
Concerns about waiting times, demeanor of pharmacy or customer service staff
A dispute concerning the timeliness of filling a prescription or the accuracy of filling the prescription.
3.8 Exceptions, Appeals
A. 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 PLACING A CHECKMARK IN THE RELEVANT COLUMN In HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
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Note: Appeals policies and procedures for Part D are separate and distinct from appeals policies and procedures required for Part C.
3.9 Coordination of Benefits
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APROVED 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 |
Requesting Waiver? Yes or No |
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3.10 Tracking Out-of Pocket Costs (TrOOP)
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APROVED 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 |
Requesting Waiver? Yes or No |
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NOTE: For information regarding the TrOOP facilitator, Applicant may link to http://medifacd.ndchealth.com/home/medifacd_home.htm
3.11 Medicare Secondary Payer
A. 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 PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
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3.12 Marketing/Beneficiary Communications
A. 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 PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS. |
YES |
NO |
Requesting Waiver? Yes or No |
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Note: While Cost Plan sponsors have to meet the Part D marketing guideline, the CMS review process will be integrated in the Part C Review required under 42 CFR 417.428.
3.13 Provider Communications
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APROVED 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 |
Requesting Waiver? Yes or No |
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3.14 Compliance Plan
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APROVED 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 |
Requesting Waiver? Yes or No |
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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. Section 40.9 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 Sponsor’s subcontractor is not sufficient to demonstrate that the Part D Sponsor meets the compliance program requirement.
B. Provide as an attachment a copy of your organization’s Compliance Plan that you intend to use for this contract.
3.15 Reporting Requirements
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APROVED 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 |
Requesting Waiver? Yes or No |
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REPORTING REQUIREMENTS GUIDANCE |
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1. Applicant agrees to comply with the Reporting Requirements Guidance that is posted on the www.cms.hhs.gov/ website. |
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BUSINESS TRANSACTIONS AND FINANCIAL REQUIREMENTS |
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2. Applicant will report, consistent with 42 CFR §423.514(b), information related to significant business transactions between the Part D plan sponsor and a party in interest within 120 days of the end of each fiscal year. This qualification includes combined financial statements, where required under 42 CFR §423.514(c). |
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3. Applicant will notify CMS of any loans or other special financial arrangements made with contractors, subcontractors, and related entities as that term is defined in 42 CFR §423.501. |
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4. Applicant will submit audited financial statements to CMS annually.
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CLAIMS DATA |
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5. The Applicant or the Applicant’s representative, such as a TPA, has data management processes and data systems capable of accomplishing collection of data in either an NCPDP or X12 format in a batch mode. Data to be collected will encompass quantity, type, and costs of pharmaceutical prescriptions filled for enrollees. The plan must link this information to Medicare beneficiary identification numbers (HIC#s). |
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6. The Applicant or the Applicant’s representative, such as a TPA, has data management processes and data systems capable of accomplishing submission of prescription drug claims information for Medicare enrollees for every Part D drug prescription in the format required by CMS, using batch submission processes. Data to be submitted will encompass quantity, type and costs of pharmaceutical prescriptions filled for enrollees. The plan must link this information to Medicare beneficiary identification numbers (HIC#s). |
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7. The Applicant or the Applicant’s representative, such as a TPA, has data management processes and data systems capable of accomplishing submission of data to CMS via the Medicare Data Communications Network (MDCN) . |
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8. The Applicant or the Applicant’s representative, such as a TPA, has data management processes and data systems capable of accomplishing performance of data edit and quality control procedures to ensure accurate and complete prescription drug data. |
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9. The Applicant or the Applicant’s representative, such as a TPA, has data management processes and data systems capable of accomplishing correction of all data errors identified by CMS. |
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REBATE DATA |
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OTHER DATA |
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SUPPORTING WWW.MEDICARE.GOV |
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CONFLICT OF INTEREST |
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Note: Further detail on our approach to monitoring and oversight, including the updated reporting measures will be posted on the CMS website not later than May 2007.
3.16 Data Exchange Between Cost Plans and CMS
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APROVED 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 |
Requesting Waiver? Yes or No |
HPMS |
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ENROLLMENT & PAYMENT |
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3.17 Upgrades of Health Information Technology--REMOVED
3.18 Health Insurance Portability and Accountability Act of 1996 (HIPAA)
A. 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 PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
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5. Applicant agrees to transmit payment and remittance consistent with the HIPAA-adopted ACS X12N 835, Version 4010/4010A1: Health Care Claim Payment and Remittance Advice Implementation Guide (“835”). |
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6. Applicant agrees that it and its subcontractors shall not perform any activities under its Part D sponsor contract at a location outside of the United States without the prior written approval of CMS. In making a decision to authorize the performance of work outside of the United States, CMS will consider the following factors, including but not limited to:
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3.19 Prohibition on Use of SSN or Medicare ID number on Enrollee ID Cards
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATION TO BE APPROVED FOR A PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATION BY PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
1. Applicant agrees not to use an enrollee’s the Social Security Number (SSN) or Medicare ID Number on the enrollees’ identification card. |
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3.20 Record Retention
A. 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 PLACING A CHECKMARK IN THE RELEVANT COLUMNIN HPMS: |
YES |
NO |
Requesting Waiver? Yes or No |
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3.21 Claims Processing
A. In HPMS, complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APROVED 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 |
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. |
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Submit as an attachment, per the instructions in Section 2.4, the following certification:
4.0 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 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.
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, 2008 with the requirement stated here in this application as well as in 42 CFR § 423 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.
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 addendum to my organization’s Medicare Cost Plan contract with CMS.
7) I acknowledge that I am aware that there is operational policy guidance including the forthcoming 2008 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 l comply with such guidance should they be approved for a Part D contract.
__________________________________ ___________________
Authorized Representative Name (printed) Title
__________________________________ ___________________
Authorized Representative Signature Date (MM/DD/YYYY)
5. 0
APPENDICES
APPENDIX I
Banking Information Form
As Government vendors, organizations with Medicare contracts are paid by the Department of Treasury through an Electronic Funds Transfer (EFT) program using the Automated Clearing House Network (ACH). Government vendor payments are directly deposited into corporate accounts at financial institutions on the expected payment date. Additionally, CMS must have the EIN/TIN and associated name as registered with the IRS.
Please provide the following information to assist the Centers for Medicare & Medicaid Services in establishing payment arrangements for your organization. Mail the completed chart to the following address by March 12, 2007.
Centers for Medicaid & Medicare Services
Attention: Yvonne Rice
Mail Stop C1-05-17
7500 Security Blvd.
Baltimore, MD 21244
Name of Organization:
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DBA, if any: |
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Full Address of Organization (Street, City, Zip):
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Contact Person Name:
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Telephone Number: |
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Contract Numbers, if known:
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Employer/Tax Identification Number (EIN/TIN):
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EIN/TIN Name (Name of Business for tax purposes as registered with the IRS): A W-9 may be required |
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Full Address for 1099 Tax Form (Street, City, Zip):
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Name of Bank:
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Full Address of Bank (Street, City, Zip):
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ACH/EFT Coordinator Name:
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Telephone Number: |
Nine Digit Routing Transit (ABA Number):
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Depositor Account Title:
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Depositor Account Number:
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Check Account Type: (Please Attach a Copy of A Voided Check)
Checking Savings
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SIGNATURE & TITLE OF ORGANIZATION’S AUTHORIZED REPRESENTATIVE
Signature: _________________________________
Date: ________________
Title: _____________________________________
Print Name: _______________________________
Phone Number: ____________________________
APPENDIX II
Summary of PDP Application Requirements Fulfilled under Part C for
Cost Plan Prescription Drug Applicants
Part D Regulation Waived |
Regulatory Requirement(s) Description |
Basis and Rationale |
42 CFR 423 Subpart I, excepting 42 CFR 423.440 ( which concerns Federal preemption of State law and prohibition of State premium taxes) |
Licensure and Solvency – Applicant must be licensed to bear risk in the State in which it intends to operate or apply for a licensure waiver and meet CMS solvency standards. |
Duplicative of Cost Plan requirements for licensure and solvency under 42 CFR §417.404 (General requirements) and 42 CFR 417.407 (Requirements for a Competitive Medical Plan (CMP)). All Cost Plans are State licensed in some manner or have authority to offer a Cost Plan in all states in which they operate. |
42 CFR 423.112 (a) |
Service Area – Applicant must offer a Part D plan that serves at least an entire PDP region. |
Conflicts with Cost Plan regulations (42 CFR 417.1) defining the service area for HMOs and CMPs offering Medicare reasonable Cost Plans. |
42 CFR 423.120(a)(3) Waiver applies only to Cost contractors that operate their own pharmacies |
Pharmacy Network – Applicant must offer its Part D plan benefit through a contracted retail pharmacy network that meets CMS standards for convenient access. |
Waiver stated in regulations at 42 CFR 423.120(a)(7)(i) excuses from the CMS standards for convenient access those Cost contractors that administer their Part D benefit through pharmacies owned by the Cost contractor if that organization’s pharmacy network access is comparable to the CMS convenient access standards . {Note: Applicants will be expected to provide comparable information in the application for organizational pharmacies} |
42 CFR 423.120(a)(8)(i) Waiver applies only to Cost contractors that operate their own pharmacies |
Pharmacy Network – Applicant must offer its Part D benefit through any willing pharmacy that agrees to meet reasonable and relevant standard network terms and conditions. |
Waiver promotes the coordination of Parts C and D benefits. Excuses from CMS any willing pharmacy requirement those Cost contractors that administer their Part D benefit through pharmacies owned by the Cost contractor and dispense at least 98% of all prescriptions through pharmacies owned and operated by Applicant. |
APPENDIX III
CERTIFICATION OF MONTHLY ENROLLMENT AND PAYMENT DATA
RELATING TO CMS PAYMENT TO A MEDICARE COST PLAN
Pursuant to the contract(s) between the Centers for Medicare & Medicaid Services (CMS), and ______________________________ (name of Cost Plan Applicant) hereafter referred to as the “Cost Plan” governing the operation of the following Cost Plans _____________________________ (plan identification numbers), the Cost Plan hereby requests payment under the contract, and in doing so, makes the following certifications concerning CMS payments to the Cost Plan. The Cost Plan acknowledges that the information described below directly affects the calculation of CMS payments to the Cost Plan and that misrepresentations to CMS about the accuracy of such information may result in Federal civil action and/or criminal prosecution. This certification shall not be considered a waiver of the Cost Plan’s right to seek payment adjustments from CMS based on information or data that does not become available until after the date the Cost Plan submits this certification.
1. The Cost Plan has reported to CMS for applications received in the month of______________
(month and year) all new enrollments, disenrollments, and changes in Plan Benefit Packages with respect to the above-stated Cost Plans. Based on best knowledge, information, and belief, all information submitted to CMS in this report is accurate, complete, and truthful.
2. The Cost Plan has reviewed the CMS monthly membership transaction report and reply (TRR) listing for the month of ______________ (month and year) for the above-stated Cost Plans and has submitted requests to IntegriGuard, under separate cover, for retroactive adjustments to correct payment data when the Cost Plan has more accurate information. This may include enrollment status and State and County Code related to a specific beneficiary. For those portions of the monthly membership report and the reply listing to which the Cost Plan raises no objection, the Cost Plan, through the certifying CEO/CFO, will be deemed to have attested, based on best knowledge, information, and belief, to their accuracy, completeness, and truthfulness.
NAME: __________________________________________________
TITLE: ___________________________________________________
On behalf of: ______________________________________________ (Cost Plan)
NOTE: The person signing this form must be the CEO, CFO, or an individual delegated the authority to sign on behalf of on of the CEO or CFO and who reports to the CEO or CFO. Otherwise the certification will be considered invalid, per
42 CFR 423.505(k).
Appendix IV
CERTIFICATION BY COST PLAN THAT SUBCONTRACTS MEET THE REQUIREMENTS OF SECTION 3.1.2D
A. I, the undersigned, certify, on behalf of NAME OF LEGAL ENTITY CONTRACTING AS A MEDICARE ADVANTAGE ORGANIZATION, to the following:
The contracts submitted as attachments to Section 3.1.2:
Clearly identify the parties to the contract (or letter of agreement).
Describe the functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant identified in Section 3.1.2C of the application.
Contain language clearly indicating that the subcontractor has agreed to perform functions required under the Applicant’s Medicare Cost Plan Contract (except for a network pharmacy if the existing contract would allow participation in this program), and flow-down clauses requiring the subcontractor’s activities to be consistent with and comply with the Applicant’s contractual obligations as a Cost Plan that sponsors a Part D Plan.
Contain language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Plan contract.
Describe the payment the subcontractor will receive for performance under the contract, if applicable;
Are for a term of at least a year (i.e., January 1, 2008 through December 31, 2008).
Are signed by a representative of each party with legal authority to bind the entity.
Contain language obligating the subcontractor to comply with all applicable Federal and State laws and regulations and CMS instructions.
Contain language obligating the subcontractor 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.
Contain language that specifies all of the requirements set forth in 42 CFR §423.505(i), including:
Requiring that the subcontractor agree to make its books and other records available to HHS, the Comptroller General, or their designees in accordance with 42 CFR §423.505(i)(2), including the right to inspect, evaluate and audit books and other records 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.
Contain language stating that the subcontractor will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant.
Contain language stating that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement.
Contain language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor on an ongoing basis.
Contain language that the Part D sponsor retains the right to approve, suspend, or terminate any arrangement with a pharmacy if the subcontractor will establish the pharmacy network or select pharmacies to be included in the network.
I certify that I am authorized to sign on behalf of the Applicant.
I understand that CMS will review the submitted contracts to ensure that they comply with the contracting requirements stated in Section 3.1.2D of the Solicitation for Applications from Cost Plan Sponsors. When a submitted contract does not meet a requirement, CMS will ask the Applicant to resubmit the contract in question. I understand the Applicant’s failure to provide in a timely manner fully executed contracts that meet CMS requirements may affect CMS’ decision to allow the Applicant to accept enrollment into its Part D plan(s) on November 15, 2007.
_________________________ ________________________
Authorized Representative Name (printed) Title
_______________________________ ________________________
Authorized Representative Signature Date (MM/DD/YYYY
Appendix V
Crosswalk of Section 3.1.2D Requirements in Subcontracts Submitted as Attachments to Section 3.1.2
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APPENDIX
VI
Crosswalk for Retail Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete the following chart (which contains applicable Section 3.1.2D requirements AND additional requirements specific to Pharmacy Access) for each Retail pharmacy contract template submitted under Section 3.3. Applicants must identify where, in each contract template, the following elements reside. If multiple retail contract templates exist, applicant must provide a ‘Crosswalk for Retail Pharmacy Access Contracts’ document (Appendix VI) for each contract template. |
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The provisions listed below must be in all pharmacy contracts if contracts reference policies and procedures to which the pharmacy must comply, provide the relevant documentation as evidence and cite this documentation accordingly. |
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Section |
Requirement |
Citation |
3.1.2D2 |
The functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant identified in Section 3.1.2C of the application. |
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3.1.2D4 |
Language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Benefit program. |
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3.1.2D8 |
Language obligating the subcontractor to abide by all applicable Federal and State laws and regulations and CMS instructions. |
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3.1.2D9 |
Language obligating the subcontractor 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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3.1.2D10 |
Language ensuring that the subcontractor will make their books and other records available in accordance with 42 CFR §423.505(i)(2), which generally states these regulations give HHS, the Comptroller General, or their designees the right to inspect. |
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3.1.2D11 |
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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3.1.2D12 |
Language stating that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement. |
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3.1.2D13 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor on an ongoing basis. |
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3.3A3 |
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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3.3A4 |
Provisions governing providing Part D enrollees access to negotiated prices as defined in 42 CFR 423.100 |
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3.3A5 |
Provisions regarding charging/applying the correct cost-sharing amount. |
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3.3A6 |
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. |
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APPENDIX VII
Crosswalk for Mail Order Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete the following chart (which contains applicable Section 3.1.2D requirements AND additional requirements specific to Pharmacy Access) for each Mail Order pharmacy contract template submitted under Section 3.3. Applicants must identify where, in each contract template, the following elements reside. If multiple retail contract templates exist, applicant must provide a ‘Crosswalk for Mail Order Pharmacy Access Contracts’ document (Appendix VII) for each contract template. |
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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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Section |
Requirement |
Citation |
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3.1.2D2 |
The functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant identified in Section 3.1.2C of the application. |
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3.1.2D4 |
Language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Benefit program. |
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3.1.2D8 |
Language obligating the subcontractor to abide by all applicable Federal and State laws and regulations and CMS instructions. |
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3.1.2D9 |
Language obligating the subcontractor 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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3.1.2D10 |
Language ensuring that the subcontractor will make their books and other records available in accordance with 42 CFR §423.505(i)(2), which generally states these regulations give HHS, the Comptroller General, or their designees the right to inspect. |
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3.1.2D11 |
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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3.1.2D12 |
Language stating that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement. |
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3.1.2D13 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor on an ongoing basis. |
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3.3A3 |
Provisions governing submitting claims to a real-time claims adjudication system.
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3.3A4 |
Provisions governing providing Part D enrollees access to negotiated prices as defined in 42 CFR 423.100 |
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3.3A5 |
Provisions regarding charging/applying the correct cost-sharing amount. |
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3.3A6 |
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. |
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APPENDIX VIII
Crosswalk for Home Infusion Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete the following chart (which contains applicable Section 3.1.2D requirements AND additional requirements specific to Pharmacy Access) for each Home Infusion pharmacy contract template submitted under Section 3.3. Applicants must identify where, in each contract template, the following elements reside. If multiple retail contract templates exist, applicant must provide a ‘Citations for Home Infusion Pharmacy Access Contracts’ document (Appendix VIII) for each contract template. |
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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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Section |
Requirement |
Citation |
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3.1.2D2 |
The functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant identified in Section 3.1.2C of the application. |
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3.1.2D4 |
Language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Benefit program. |
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3.1.2D8 |
Language obligating the subcontractor to abide by all applicable Federal and State laws and regulations and CMS instructions. |
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3.1.2D9 |
Language obligating the subcontractor 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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3.1.2D10 |
Language ensuring that the subcontractor will make their books and other records available in accordance with 42 CFR §423.505(i)(2), which generally states these regulations give HHS, the Comptroller General, or their designees the right to inspect. |
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3.1.2D11 |
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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3.1.2D12 |
Language stating that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement. |
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3.1.2D13 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor on an ongoing basis. |
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3.3A3 |
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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3.3A4 |
Provisions governing providing Part D enrollees access to negotiated prices as defined in 42 CFR 423.100 |
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3.3A5 |
Provisions regarding charging/applying the correct cost-sharing amount. |
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3.3A6 |
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. |
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3.3.4A5 |
Provisions ensuring that before dispensing home infusion drugs, pharmacy ensures that the professional services and ancillary supplies are in place. |
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APPENDIX IX
Crosswalk for Long-Term Care Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete the following chart (which contains applicable Section 3.1.2D requirements AND additional requirements specific to Pharmacy Access) for each Long-Term Care pharmacy contract template submitted under Section 3.3. Applicants must identify where, in each contract template, the following elements reside. If multiple retail contract templates exist, applicant must provide a ‘Citations for Long-Term Care Pharmacy Access Contracts’ document (Appendix IX) for each contract template. |
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The provisions listed below must be in all pharmacy contracts. If contracts reference policies and procedures to which the pharmacy must comply, provide the relevant documentation as evidence and cite this documentation accordingly. |
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Section |
Requirement |
Citation |
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|
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3.1.2D2 |
The functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant identified in Section 3.1.2C of the application. |
|
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3.1.2D4 |
Language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Benefit program. |
|
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3.1.2D8 |
Language obligating the subcontractor to abide by all applicable Federal and State laws and regulations and CMS instructions. |
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3.1.2D9 |
Language obligating the subcontractor 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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3.1.2D10 |
Language ensuring that the subcontractor will make their books and other records available in accordance with 42 CFR §423.505(i)(2), which generally states these regulations give HHS, the Comptroller General, or their designees the right to inspect. |
|
|
3.1.2D11 |
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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3.1.2D12 |
Language stating that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement. |
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|
3.1.2D13 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor on an ongoing basis. |
|
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3.3A3 |
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. |
|
|
3.3A4 |
Provisions governing providing Part D enrollees access to negotiated prices as defined in 42 CFR 423.100 |
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3.3A5 |
Provisions regarding charging/applying the correct cost-sharing amount. |
|
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Elements Specific to Long-Term Care Contracts
Note: CMS released Long-Term Care Guidance in early March 2005 that can be found at www.cms.hhs.gov/pdps/LTC_guidance.pdf . This document contains an updated list of performance and service criteria for contracting with long-term care pharmacies. Applicants should, at a minimum, to 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.
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Performance and Service Criteria |
Citation |
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APPENDIX X
Crosswalk for Indian Tribe and Tribal Organization, and Urban Indian Organization (I/T/U) Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete the following chart (which contains applicable Section 3.1.2D requirements AND additional requirements specific to Pharmacy Access) for each I/T/U pharmacy contract template submitted under Section 3.3. Applicants must identify where, in each contract template, the following elements reside. If multiple I/T/U contract templates exist, applicant must provide a ‘Citations Crosswalk for I/T/U Pharmacy Access Contracts’ document (Appendix X) for each contract template. |
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The provisions listed below must be in all pharmacy contracts. If contracts reference policies and procedures to which the pharmacy must abide, provide the relevant documentation as evidence and cite this documentation accordingly. |
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Section |
Requirement |
Citation |
|
|
|
3.1.2D2 |
The functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant identified in Section 3.1.2C of the application. |
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3.1.2D4 |
Language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Benefit program. |
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3.1.2D8 |
Language obligating the subcontractor to abide by all applicable Federal and State laws and regulations and CMS instructions. |
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3.1.2D9 |
Language obligating the subcontractor 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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3.1.2D10 |
Language ensuring that the subcontractor will make their books and other records available in accordance with 42 CFR §423.505(i)(2), which generally states these regulations give HHS, the Comptroller General, or their designees the right to inspect. |
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3.1.2D11 |
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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3.1.2D12 |
Language stating that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement. |
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3.1.2D13 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor on an ongoing basis. |
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3.3A3 |
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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3.3A4 |
Provisions governing providing Part D enrollees access to negotiated prices as defined in 42 CFR 423.100 |
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3.3A5 |
Provisions regarding charging/applying the correct cost-sharing amount. |
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3.3A6 |
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. |
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Elements Specific to Indian Tribe and Tribal Organization, and Urban Indian Organization (I/T/U) Pharmacy Contracts
Note: Provisions listed below are in the model I/T/U Addenda, located at www.cms.hhs.gov/10Rx Contracting Specific Guidelines.asp and all I/T/U Contracts must contain language consistent with the model addendum that address the following: |
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Item 1 |
Suppression of the addendum from underlying agreement. |
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Item 3 |
The description of the provider. |
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Item 4 |
Counting of costs paid for by provider toward any deductibles. |
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Item 5 |
Persons eligible for services of the provider. |
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Item 6 |
The applicability of certain Federal law. |
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Item 7 |
The non-taxable status of the provider. |
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Item 8 |
Insurance and indemnification. |
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Item 9 |
Applicability of state licensing law to provider’s employees. |
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Item 10 |
Provider eligibility for payments |
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Item 11 |
Dispute resolution. |
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Item 12 |
Federal law as the governing law. |
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Item 13 |
The contract will apply to all pharmacies and dispensaries operated by the provider. |
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Item 14 |
The contract will not affect the provider’s acquisition of pharmaceuticals. |
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Item 15 |
The provider’s point of sale processing capabilities. |
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Item 16 |
Claims processing. |
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Item 17
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Reasonable and appropriate payment rates. |
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Item 18 |
Any information, outreach or enrollment materials prepared by the Applicant will be supplied at no cost to the provider. |
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Item 19 |
The provider determines the hours of service for the pharmacies or dispensaries of the provider. |
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Item 20 |
Endorsement |
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Item 21 |
Term and Termination of Pharmacy Agreement |
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APPENDIX XI
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).
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.
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 sub-contracted PBM and direct the PBM to submit the form to CMS by March 12, 2007. 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 will 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 4 CDs 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 2 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 CDs and hard copy material via courier to:
Centers for Medicare & Medicaid Services
ATTN: P&T Member List and/or P&T Certification
Mail Stop C1-26-12
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: _____________________________________________
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. PROVIDE THIS ATTACHMENT ON A CD AS INSTRUCTED IN SECTION 2.4. |
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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 Start Date and End Date |
Practicing Physician |
Practicing Pharmacist |
Elderly/Disabled Expert |
With Your Organization? |
With Pharmaceutical Manufacturers? |
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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 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 PBM’s P&T Committee, member 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 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 Applicant’s Contract Number: _____________________
__________________________________ _____________________________
Authorized Representative Name (printed) Title
__________________________________ _______________________________
Authorized Representative Signature Date (MM/DD/YYYY)
Appendix XII
Retail Pharmacy Network Access Instructions
By contract, Part D sponsors are required to meet the access standards in 42 CFR §423.120(a)(1). Applicants should note that the Retail access standard requirement is applied at the Plan Benefit Package (PBP) level. It is important to note the reference to plan (and not contract ID) in the requirements defined in 42 CFR §423.120 (a)(1). As part of routine monitoring and audit processes, CMS will review retail pharmacy access at the PBP level.
Note: While CMS realizes that contracts with Indian Health Services, Indian Tribes and Tribal organizations and Urban Indian Organization (I/T/U), Federally Qualified Health Centers (FQHC) and Rural Health Centers (RHC) may be counted for purposes of meeting the pharmacy access standards, it should be noted that contracts with these pharmacies may not be used as a substitute for including retail pharmacies in plan networks.
Information Required to Qualify As Part D Sponsor
CMS recognizes that the deadline for submission of the Part D application (March) precedes the plan bidding and finalization process (June). Further CMS recognizes that many (if not most) Part D sponsors continue work on defining their PBP service areas throughout their Bid formulation process. Therefore, it is difficult for applicants to submit final pharmacy accessibility analyses for each PBP, and we will only require a contract-level submission at this time. This circumstance is especially problematic for MA-PD sponsors that may choose to offer a PBP to a subset of their Contract Service Area. The impact on PDPs, RPPOs, and Cost Plans is minimal since those types of contracts must offer all PBPs with Part D throughout each specific PDP Region (PDPs), MA Region (RPPOs) or geographic area (Cost Plans).
Geographic Accessibility Analysis Instructions
All Applicants are strongly encouraged to use GeoNetworks® to compile the reports as outlined in this appendix. If this is not possible then Applicant must contact Dennis Hodges, at dennis.hodges@cms.hhs.gov (410.786.3048), no later than February 1, 2007 to determine if analyses provided by an alternative method are acceptable. Please note that alternative methods must produce analyses that will result in data directly comparable to the results produced by GeoNetworks®. Applicants that wish to use alternative methods will be required to demonstrate how their analysis is comparable to results produced by GeoNetworks®.
Though in many instances CMS provides specific instructions for formatting and compiling plan accessibility reports, this appendix is not intended to provide step-by-step instructions for the use of GeoNetworks®. The instructions and examples provided here were developed using GeoNetworks version 7.5.2.1 It is the responsibility of Applicant to ensure that their submission provides adequate information for CMS to determine if each of their offerings meets the retail pharmacy access submission requirements. Detailed descriptions of the information needed by CMS are provided below.
The Medicare Beneficiary File “Medicare Beneficiaries by State, Region, ZIP 09302006.xls” is provided by CMS.
The Medicare Beneficiary File referenced above contains ZIP Codes and beneficiary counts for Applicants as of September 30, 2006. Use of this file is required for the accessibility analysis submission. Applicants should download this census file and create a sub-file(s) specific to their service area and/or region(s) and/or state as needed to support the level of analyses required (specified below). Applicants may not use beneficiary counts from other sources in their accessibility analyses.
Applicants should import the data sub-file to create a geo-coded population file based on the Census data sub-file. A population file is created by navigating to Data > Populate > From File> “select and open the file”. Applicants may geocode by selecting the “geocode after populate” check box during this step, or they may geocode the population file in a later step outlined below.
Quality Check: Applicant should verify that the beneficiary (employee) count in the population file is consistent with the total beneficiary census for the sub-file used as the basis for the analyses. CMS will check the count of beneficiaries provided in the reports against the count of beneficiaries residing in the plan’s service area.
Applicants should assign an Urban, Suburban, or Rural indicator to each Medicare beneficiary record in the Population file using the GeoNetworks® function, “Assign Place Names.” Place names may be assigned by navigating to Data > Assign Place Names > Selecting and open the file. The Input field should be set to “ZIP”. The default place name classification “STD_CLASS” will assign a Urban (U), Suburban (S), or Rural (R) designation to ZIP codes consistent with the definitions specified in 42 CFR § 423.100.
If geocodes are not assigned when the population file is created, Applicant may assign geocodes by navigating to Data > Assign Geocodes > Select and open file > Click OK. Applicants must use “representative” geocoding as the method to assign locations to each record in the Population file. This is the default GeoNetworks® method of assignment of geocodes when no address information is provided in the file (i.e., in this instance).
Applicants must define one employer group for all beneficiaries using the Medicare Beneficiary File Extract used in their analyses. The all beneficiaries file is used in the service area report.
To define all beneficiaries, navigate to Define > Employee Groups > Add > on the Connection tab, select the data source > on the Filter Tab no tests should be set > Under the Options tab, enter the label of “All Beneficiaries” in the Description field and specify that Service Area Restriction is set to “inside”> click OK.
Applicants must define three subsets of the Medicare Beneficiary File Extract used in their analyses. These subsets are based on filtering on the designation of urban/suburban/rural assigned in the step above. These three subsets are used in the accessibility reports.
To define the subset of Urban beneficiaries, navigate to Define > Employee Groups > Add > on the Connection tab, select the data source > on the Filter Tab, select “filename.STD_CLASS” as the field > “Test” should be “=” (equal to) > Value should be ‘U’ (Note: the single quotes signify a text field) > Under the Options tab, enter the label of “Urban Beneficiaries” in the Description field and specify that Service Area Restriction is set to “inside”> click OK.
To define the subset of Suburban beneficiaries, navigate to Define > Employee Groups > Add > on the Connection tab, select the data source > on the Filter Tab, select “filename.STD_CLASS” as the field > “Test” should be “= “ (equal to) > Value should be ‘S’ (Note: the single quotes signify a text field) > Under the Options tab, enter the label of “Suburban Beneficiaries” in the Description field and specify that Service Area Restriction is set to “inside”> click OK.
To define the subset of Rural beneficiaries, navigate to Define > Employee Groups > Add > on the Connection tab, select the data source > on the Filter Tab, select “filename.STD_CLASS” as the field > Test should be “= “ (equal to) > Value should be ‘R’ (Note: the single quotes signify a text field) > Under the Options tab, enter the label of “Rural Beneficiaries” in the Description field and specify that Service Area Restriction is set to “inside”> click OK.
Quality Check: Applicant should verify that the urban, suburban, and rural definitions are defined appropriately for each page of the report. These (filtered) sub-populations are used to verify access compliance. CMS will compare the total of urban, suburban, and rural beneficiaries for specific counties to totals derived from the Medicare Beneficiary File. Additionally, Applicant should verify that only beneficiaries within their service area are included in the report. This setting can be checked under the Options tab, in the Service Area Restriction box. The “within” radio button should be selected.
Applicants must use their listing of contracted Part D retail pharmacies. The listing used in these analyses must be consistent with the pharmacy listing provided under the instructions in Section 3.3.1C of this solicitation that includes address information to define their provider file. If an Applicant used more than one retail pharmacy network to provide the Part D benefit, the network must be combined in the GeoNetworks® analysis (and the submission provided under Section 3.3.1B of this solicitation to represent one complete Part D network).
Applicant may use representative ZIP Geocoding or the more precise geocoding methods (i.e., the ZIP+ 4 Centroid Method, the ZIP+2 Centroid Method, or address-based geocoding). CMS strongly encourages the use of more precise methods for geocoding. Use of address-based geocoding will prevent, in some market areas, false indications that access standards are not met.
Applicant must define Geocodes for their provider file by navigating to Data > Assign Geocodes > Select and open the provider file > Click OK. To the extent possible, CMS recommends that Applicants use “address-based” geocoding as to assign locations to pharmacies, as it is more precise. If this function is not available on your version of GeoNetworks®, the default, representative geocoding, methodology is acceptable.
Next, Applicant shall define the Provider Group by navigating to Define > Provider Groups > Add > on the Connection tab, select the data source > on the Options tab, enter the label of “Part D Retail Pharmacy Network” in the Description field > Select OK.
Quality Check: Applicant should verify that the total counts for pharmacy providers match the counts in the Part D contracted retail pharmacy listing that must also be provided to CMS in accordance with the instructions in Section 3.3.1C of this solicitation. CMS will check total counts of pharmacies provided in the service area against the record count from submitted pharmacy listings.
CMS recognizes that some local MA-PDPs contract with PBMs to provide national networks. CMS also recognizes that these PBM contracts are to the benefit or the beneficiary. Our review testing will reject instances where the total number of pharmacies in the GeoNetworks® analysis is greater than the number of retail pharmacies provided in the retail Pharmacy listing provided in Section 3.3.1C of this solicitation.
Applicant must define access standards in accordance with the Part D standards, as defined in 42 CFR § 423.120 (a)(1).
To define the Urban access standard, navigate to Define > Access Standards > Add > in the Description field, type “Urban: 1 provider within 2 miles” > Ensure that the Number of Providers is 1, the Test is within, and Miles is 2 > Click OK.
To define the Suburban access standard, navigate to Define > Access Standards > Add > in the Description field, type “Suburban: 1 provider within 5 miles” > Ensure that the Number of Providers is 1, the Test is within, and Miles is 5 > Click OK.
To define the Rural access standard, navigate to Define > Access Standards > Add > in the Description field, type “Rural: 1 provider within 15 miles” > Ensure that the Number of Providers is 1, the Test is within, and Miles is 15 > Click OK.
The following two sections provide instructions specific to the type of Part D Sponsor. Section 4.a. should be referenced by Cost Plan Applicants.
a. Cost Applicants
Service Areas may be defined in GeoNetworks® by navigating to Define > Service Areas > Add > Use buttons on right to select your service area.
Within each contract number, Cost Plan Applicants must define their service areas. As specified in 42 CFR 423.120(a), access standards must be met at the plan level. However, as discussed in this appendix, New MA-PD or Cost Plan applicants or MA-PDs or Cost Plan Applicants seeking Service Area Expansions for Part D should submit their pharmacy access analyses at the contract level, including the entire service area for the contract. GeoNetworks® reports provided at the contract level must include detail on the number of beneficiaries and the number of contracted pharmacies at the county level. New MA-PD or Cost Plan applicants or MA-PDs or Cost Plan applicants seeking Service Area Expansions for Part are not required to submit separate geographic accessibility analyses for each unique PBP service area or each unique combination of PBPs offered in the same service area.
Table I Example Cost Plan Contractor PBP Offerings |
||
Contract |
Contract Geographic Area |
Pharmacy Network |
H0000 – Cost Plan of the Greater Baltimore Area |
Anne Arundel County Baltimore County Carroll County Frederick County |
Part D Pharmacy Network 1 |
In this example, the Cost Plan Applicant should define one service area (labeled H0000) in the description field that includes the counties in the Cost Plan geographic area.
Quality Check: Applicants must verify that the contract and its service area are represented appropriately. CMS will verify the service area of plans using data submitted to the Health Plan Management System (HPMS). Inconsistencies between the Contract’s Part D service area specified in HPMS and the Contract Service Area specified in the GeoNetworks Analysis will cause delays in review and, potentially, denial of the Applicants Part D application.
The following provides instructions for Cost Plans for completion of the Cost Plan reports.
Cost Plan Reports
Applicant reports must include a title page and a table of contents. To add a title page navigate to Page > Add > Title Page. To add a table of contents navigate to Page > Add > Table of Contents. Double click on the new Table of Contents page. Under the Options tab select Tab leaders, Page specifications, and Roman page numbers to be included in the report.
Accessibility Detail pages should be generated to represent urban/suburban/rural beneficiaries with and without access in each of the service areas defined. There should be six reports for each unique combination of a plan service area(s) and pharmacy network(s).
As stated earlier in this appendix, for a given contract number Cost Plans must provide separate retail pharmacy accessibility analyses for beneficiaries classified as Urban, Suburban, and Rural for each unique combination of contractor service area and pharmacy network (i.e., preferred only; preferred and non-preferred). The title of the accessibility detail report should specify the network represented in the pharmacy list. The network reference should match the “List Identifier” entry in your submission of the “Retail Pharmacy List.xls” file. As specified in the instructions below, statistics for each county within the service area individually, and statistics for the entire contract service area in total must be provided.
Using the example outlined in part 4.a the steps to define the accessibility detail report for urban beneficiaries in the service area of H0000 are as follows:
Navigate to Page > Add > Accessibility Detail > Double click on the page that appears
Under the Specifications tab for the new Accessibility Detail Page set Employee Group to be your urban beneficiaries, set Provider Group to be “Part D Pharmacy Network 1”, set Access Standard to be “Urban: 1 provider within 2 miles”, set Access filter to “all”, and set Service Area to “H0000”.
Under the Options tab for the new Accessibility Detail Page, select to summarize by county, and under show, ensure that the following options are checked: state, percent in filter, number in filter, number of providers, subtotals and totals.
Under the Titles Page, uncheck the default Title 1 and specify a title that describes the unique service area. In this instance the title would be “H0000”
The steps above are repeated, with appropriate modifications, for suburban and rural beneficiaries.
The steps to define the service area report for all beneficiaries with access in the service area of H0000 are as follows:
Navigate to Page > Add > Service Area Detail> Double click on the page that appears
Under the Specifications tab for the new Service Area Detail Page set Employee Group to be all beneficiaries, set Provider Group to be “Part D Pharmacy Network 1”, set Service Area to H0000.
Under the Options tab for the new Service Area Detail Page, select to summarize by county, set service area filter to inside, ensure that the following options are checked: state, number of employees, number of providers, and totals.
Under the Titles tab, uncheck the default Title 1 and specify a title that describes the unique service area. In this instance the title would be “H0000”
Ensure that no specifications are indicated under the Include tab.
Under the Sort tab ensure that sort order is State (ascending), then County (ascending).
Including the title and table of contents, six page report will be generated using the CMS example for H0000, and following all of the specifications including: (1) use of the appropriate employee group, (2) correct definition of the access standards, (3) correct definition of the service area; and (4) generation of analyses with “all” beneficiary specification. An overview of this report is specified in Table II. An example of the Cost Plan GeoAccess ® report with the file name “Example Cost Plan GeoNetworks Analysis.tif” accompanies this document.
Table II Example H0000 Report Pages Specification |
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Rpt # |
Page |
Summarized by |
Employee Group |
Provider Group |
Access Standard |
Service Area / Title 1 |
Access Filter |
1 |
Title |
|
|
|
|
|
|
2 |
Table of Contents |
|
|
|
|
|
|
3 |
Accessibility Detail |
County |
Urban Beneficiaries |
Part D Retail Pharmacy Network 1 |
Urban: 1 provider within 2 miles |
H0000 |
All |
4 |
Accessibility Detail |
County |
Suburban Beneficiaries |
Part D Retail Pharmacy Network 1 |
Suburban: 1 provider within 5 miles |
H0000 |
All |
5 |
Accessibility Detail |
County |
Rural Beneficiaries |
Part D Retail Pharmacy Network 1 |
Rural: 1 provider within 15 miles |
H0000 |
All |
6 |
Service Area |
County |
All Beneficiaries |
Part D Retail Pharmacy Network 1 |
|
H0000 |
|
7 |
GeoNetworks Report (auto generated summary information to be included in submission) |
|
|
|
|
|
|
As part of the submission for each contract report Applicants should include the “Report Information” page. This page is generated automatically when the GeoNetworks® report is run.
An example of the Cost Plan GeoAccess® report with the file name “Example Cost Plan GeoNetworks Analysis.tif” accompanies this document.
Quality Check: Applicants must verify that accessibility detail reports are provided for each unique combination of service area and pharmacy network consistent with the example table above. Additionally, each submission should include the report information page for each report.
Applicants must provide both a single hardcopy of their GeoNetworks® reports as well as Adobe Acrobat readable (*.pdf) versions of the reports. These reports must be submitted as attachments pursuant to the instructions in Section 2.4 of this solicitation.
1 Systems files for CDF, DPF, PPF, RPF, ZDF are version 6.20. System file for Qms is version 17.00.
| File Type | application/msword |
| File Title | Medicare Prescription Drug Benefit |
| Author | CMS |
| Last Modified By | CMS |
| File Modified | 2007-03-07 |
| File Created | 2007-02-05 |