MEDICARE PRESCRIPTION DRUG BENEFIT
Solicitation for Applications for New Cost Plan Sponsors
Contract Year 2010
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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 Access and Data Transmissions 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 Management and Operations
3.1.2 Experience and Capabilities
3.1.3 Business Integrity
3.1.4 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
3.3 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 Coverage Determinations (Including 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
3.17HIPAA and Related CMS Requirements
3.18 Prohibition on Use of SSN or Medicare ID number on Enrollee ID Cards
3.19 Record Retention
3.20 Claims Processing
3.21 Premium Billing
4. CERTIFICATION
5. APPENDICES
Appendix I Summary of Part D Application Requirements Waived for
Cost Plan Prescription Drug Applicants
Appendix II Crosswalk of Subcontracts submitted as attachments to Section 3.1.1D
Appendix III Crosswalk for Retail Pharmacy Access Contracts
Appendix IV Crosswalk for Mail Order Pharmacy Access Contracts
Appendix V Crosswalk for Home Infusion Pharmacy Access Contracts
Appendix VI Crosswalk for Long-Term Care Pharmacy Access Contracts
Appendix VII Crosswalk for Indian Tribe and Tribal Organization, and Urban Indian Organization (I/T/U) Pharmacy Access Contracts
Appendix VIII Applicant Submission of P&T Committee Member List and Certification Statement
Appendix IX 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 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 1860D-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 predominantly 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, the drug benefit, including the basic Part D 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 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 elect whether to receive their Part D benefits through their Medicare Cost Plan. In the alternative, they may elect to enroll in a PDP to receive prescription drug benefits.
1.4 Schedule
APPLICATION REVIEW PROCESS
|
|
Date |
Milestone |
November 18, 2008 |
Submit Notice of Intent to Apply to CMS
|
December 3, 2008 |
CMS User ID form due to CMS |
January 6,2009 |
Final Applications posted by CMS |
February 26, 2009 |
Applications due
|
March 30,2009 |
Release of Health Plan Management System (HPMS) formulary submissions module. |
March 30-31, 2009 |
Courtesy Cure Period Submissions Due (date subject to change) |
April 10, 2009 |
Plan Creation module, Plan Benefit Package (PBP), and Bid Pricing Tool (BPT) available on HPMS |
April 20,2009 |
Formulary submission due to CMS Transition Policies and Procedures due to CMS |
April 24, 2009 |
Notices of Intent to Deny Issued (date subject to change) |
May 4, 2009 |
Notices of Intent to Deny Submissions Due (date subject to change) |
May 2009 |
CMS sends Part D contract eligibility determination to Applicants, based on review of application. Applicant’s bids must still be negotiated (see below) |
May 15, 2009 |
PBP/BPT Upload Module available on HPMS |
June 1, 2009 |
All bids due. |
July 15, 2009 |
Any contract determination, including an appeal, must be resolved to participate as a Part D sponsor in 2010. |
Early August 2009 |
CMS publishes national average Part D premium |
September 2009 |
CMS completes review and approval of bid data. CMS executes Part D contracts to those organizations who submit an acceptable bid. |
November 15, 2009 |
2010 Annual Coordinated Election Period begins. |
NOTE: This timeline does not represent an all-inclusive list of key dates related to the Medicare-Prescription Drug Benefit 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.
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 February 26, 2009 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 30, 2009, and the bid upload which begins May 15, 2009. 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 ensure valuation of the proposed Part D 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 addendum to their Medicare Cost plan contract with 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 are 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 (HIPAA), are subject to investigation and penalties for findings of violations of the HIPAA Rules as determined by CMS, the Department of Health and Human Services Office for Civil Rights, and the Department of Justice as applicable.)
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, 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 the Part D 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 CMS’ prescription drug event reporting instructions that are posted at www.csscoperations.com and 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 2010. This application is to be submitted to CMS in conjunction with your organization’s attestation to renew your cost contract with CMS in 2010.
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.mscginc.com/Registration/.
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 February 26, 2009. Applicants must use the 2010 solicitation. CMS will not accept or review those submissions using prior versions of the solicitation (e.g., 2009 and earlier).
Instructions
Applicants will complete the entire solicitation via HPMS.
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.
CMS will not accept any information in hard copy. If an Applicant submits the information via hard copy, the application will not be considered received.
CMS will check the application for completeness shortly after its receipt. We will notify Applicants of any deficiencies and afford them a courtesy opportunity to amend their applications. CMS will only review the last submission provided during this courtesy cure period.
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 attest to 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. The end of the 10 day cure period is the last opportunity an Applicant has to provide CMS with clarifications or corrections. CMS will only review the last submission provided during this cure period. Such materials will not be accepted after this 10-day time period.
This solicitation does not commit CMS to pay any cost for the preparation and submission of an application.
CMS will not review applications received after 11:59 P.M. Eastern Standard Time on February 26, 2009. CMS will lock access to application fields within HPMS as of this time. CMS will not review any submissions based on the earlier versions of the solicitation. Applicants must complete the 2010 solicitation in order to be considered for Part D sponsorship.
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 February 26, 2009; 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 plans 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 plans 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 Anders by email at linda.anders@cms.hhs.gov or by phone at 410-786-0459.
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 3, 2009. The deadline for formulary submission to CMS is 11:59PM EDT on April 20, 2009. CMS will use the last successful upload received for an Applicant as the official formulary submission.
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 15, 2009 and the CY 2010 bid deadline of June 1, 2009. 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 2009.
2.6 System Access and Data Transmissions 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.
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 can help 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 20, 2009 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 Submission 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 30- April 20, 2009. 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 1, 2009, 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, consistent with section 423.265(c)(3), 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 that 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 the standards of convenient access to retail pharmacy networks.
Section 3.3.1 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 2010 Pharmacy Access requirements, Applicants may use their contracted PBM’s existing 2009 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 2010. CMS conducts the review of Retail Pharmacy Access based on the service area that the Applicant has provided in HPMS by February 26, 2009. To the extent that the service area is reduced during the application review process, the pharmacy access submission reports must pass a full and complete CMS review, including a review that ensures the access submission matches the service area in HPMS at one of the following points in time:
initial application submission (a fully passing retail access review at this point in the application process will not require a subsequent review even if the service area is later reduced), or
at the time of the courtesy submission window after CMS has issued an interim deficiency notice, if the initial application retail submission is found to contain retail access related deficiencies of any type (a fully passing retail access review at this point in the application process will not require a subsequent review even if the service area is later reduced), or
at the time of the final submission window after CMS has issued a Notice of Intent to Deny (see Section 2.4), if the courtesy retail submission is found to contain retail access related deficiencies of any type.
If none of the submissions includes a service area that perfectly matches HPMS at that exact point in time, CMS will conclude that the Applicant is itself unclear about its service area intentions, will find the submission deficient, and will deny the application for (at a minimum) being unable to demonstrate that it meets the retail access requirements.
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 compliance with our retail pharmacy access requirements. 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 to 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. CMS guidance regarding waivers of the pharmacy access and any willing pharmacy requirements for certain Cost Plans sponsors is contained in sections 50.7 and 50.8.1 of Chapter 5 of the Prescription Drug Benefit Manual. These waivers are described below. 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 would apply.
Waiver of Retail Convenient Access Standards
As described in section 50.7.1 of Chapter 5 of the Prescription Drug Benefit Manual, 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
As described in section 50.8.1 of Chapter 5 of the Prescription Drug Benefit Manual, 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 3.3.1E.
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. 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 FOIA 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. This designation must be in writing. When there is a request for information that is designated by the Applicant as confidential or that could reasonably be considered exempt under Exemption 4, CMS is required by its FOIA regulation at 45 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 might impair the government's ability to obtain necessary information in the future; (2) disclosure of the information would cause substantial harm to the competitive position of the submitter; (3) disclosure would impair other government interests, such as program effectiveness and compliance; or (4) disclosure would impair other private interests, such as an interest in controlling availability of intrinsically valuable records, which are sold in the market. Consistent with our approach under the Medicare Advantage program, we would not release information under the Medicare Part D program that would be considered proprietary in nature.
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 I). 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 because the Part D requirement is duplicative of or conflicts with section 1876 Cost Plan requirements, and granting the waiver would improve 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 upload in HPMS 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 February 26, 2009 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, 2009. 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.
NOTE: All uploads and templates will be accessed in HPMS through the HPMS Contract Management Module. Applicants should refer to the Contract Management – Online Application User’s Guide Version 2.0 for further instructions.
3.1 Applicant Experience, Contracts, Licensure and Financial Stability
3.1.1 Management and Operations 42 CFR 423 Subpart K
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: |
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NO |
Requesting Waiver? Yes or No |
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2. Applicant maintains contracts or other legal arrangements between or among the entities combined to meet the functions identified in subsection 3.1.1C. |
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B. Upload in HPMS a pdf document that provides 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 Part D operations within your organization as well as the reporting structure within your organization.
C. Subcontractor (first tier, downstream and related entities) Function Chart
In HPMS, on the Contract Management/Part D Information/Part D Data Page, complete the Part D functions table and provide the names of the subcontractors (first tier, downstream and related entities) you will use 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 |
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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. In HPMS, upload copies of executed contracts and fully executed letters of agreement (in pdf format) with each subcontractor (first tier, downstream and related entities) identified in the above table (3.1.1C) that:
Clearly identify the parties to the contract (or letter of agreement).
Describe the functions to be performed by the subcontractor (first tier, downstream and related entities).
Describe the reporting requirements the subcontractor (first tier, downstream and related entities) has to the Applicant.
Contain language clearly indicating that the subcontractor (first tier, downstream and related entities) has agreed to participate in your Medicare Prescription Drug Benefit program (except for a network pharmacy if the existing contract would allow participation in this program).
Contains flow-down clauses requiring their activities be consistent and comply with the Applicant’s contractual obligations as a Part D sponsor.
Describe the payment the subcontractor (first tier, downstream and related entities) will receive for performance under the contract, if applicable.
Are for a term of at least the initial one-year contract period (i.e. January 1 through December 31) for which this application is being submitted Where the contract is for services or products to be used in preparation for the next contract year’s Part D operations (e.g., marketing, enrollment), the initial term of such contract must include this period of performance (e.g., contracts for enrollment-related services must have a term beginning no later than November 15 extending through the full contract year ending on December 31 of the next year).
Are signed by a representative of each party with legal authority to bind the entity.
Contain language obligating the subcontractor (first tier, downstream and related entities) to abide by all applicable Federal laws and regulations and CMS instructions.
Contain language obligating the subcontractor (first tier, downstream and related entities) to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for this program at 42 CFR §423.136.
11. Contain language ensuring that the subcontractor (first tier, downstream and related entities) will make its books and other records available in accordance with 42 CFR 423.505(e)(2) and 42 CFR 423.505 (i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to audit, evaluate and inspect any books, contracts, and records, including medical records and documentation involving transactions related to CMS’ contract with the Part D sponsor and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later.
12. Contain language that the subcontractor (first tier, downstream and related entities) will ensure that beneficiaries are not held liable for fees that are the responsibility of the Part D sponsor.
13. Contain language that the subcontractor (first tier, downstream and related entities) indicates clearly that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees.
14. Contain language that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor (first tier, downstream and related entities), that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor (first tier, downstream and related entities) has not performed satisfactorily. Note: The subcontract (first tier, downstream and related entities) may include remedies in lieu of revocation to address this requirement.
15. Contain language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor (first tier, downstream and related entities) on an ongoing basis.
16. If the subcontractor (first tier, downstream and related entities) will establish the pharmacy network or select pharmacies to be included in the network contain language that the Part D sponsor retains the right to approve, suspend, or terminate any arrangement with a pharmacy.
17. If the subcontractor (first tier, downstream and related entities) will establish the pharmacy network or select pharmacies to be included in the network contain language that payment to such pharmacies (excluding long-term care and mail order) shall be issued, mailed, or otherwise transmitted with respect to all clean claims submitted by or on behalf of pharmacies within 14 days for electronic claims and within 30 days for claims submitted otherwise.
18. If the subcontractor (first tier, downstream and related entities) will establish the pharmacy network or select pharmacies to be included in the network contain language that if a standard is used for reimbursement, the source used by the Part D sponsor for making any such pricing updates and a provision that updates to such a standard occur not less frequently than once every 7 days beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug.
E. Upload in HPMS electronic lists of, crosswalks of the subcontract citations demonstrating that the requirements of Section 3.1.1D are included in the subcontracts. Submit these data by downloading the appropriate spreadsheet found in HPMS that mimics the Appendix entitled Crosswalk of Citations of Section 3.1.1D to Location in Subcontracts Submitted as attachments in Section 3.1.1.
3.1.2 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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3.1.3 Business Integrity 2 CFR Part 376; Prescription Drug Benefit Manual, Chapter 9
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 (first tier, downstream and related entities), and subcontractor’s (first tier, downstream and related entities) staff agree that they are bound by 2 CFR Part 376 and attest that they are not excluded by the Department of Health and Human Services Office of 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 has 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) 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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3. Applicant’s Pharmacy Benefit Manager (PBM) (and PBM’s parent firm if applicable) has any past or pending investigations, legal actions, administrative actions, or matters subject to arbitration brought involving the 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 government entities, both federal and state, for healthcare and/or prescription drug services. |
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B. If Applicant answered Yes to 3.1.3A2 and/or 3.1.3A3, upload in HPMS as a pdf document 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 upload a brief explanation of 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.
3.1.4 HPMS Part D Contacts CMS Guidance issued 09/09/2006
A. In HPMS on the Contract Management/Contact Information/Contact Data Page provide the name/title, mailing address, phone number, fax number, and email address for the following Applicant contacts:
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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CAP Report Contact for Public Website |
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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 contact 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 42 CFR423.120 (b); Prescription Drug Benefit Manual Chapter 6
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 |
Requesting Waiver? Yes or No |
1. Applicant will submit a formulary to CMS for the Part D benefit. |
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2. Applicant agrees to comply with formulary guidance that is contained in Chapter 6 of the Prescription Drug Benefit Manual. |
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3. Applicant agrees, where using a formulary, to meet all formulary submission deadlines established by CMS. Applicant further agrees that CMS may discontinue its review of the Applicant’s formulary submission upon the Applicant’s failure to meet any of the formulary submission deadlines. Applicant acknowledges that failure to receive CMS approval of its formulary may prevent CMS from approving the Applicant’s bid(s) and contracting with the Applicant for the following benefit year. |
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4. Applicant agrees that its formulary must include substantially all drugs in the six categories of clinical concern that are available on the CMS-established formulary upload date. Applicant further agrees that any new drugs or newly approved uses for drugs within the six classes that come onto the market after the CMS-established formulary upload date will be subject to an expedited Pharmacy and Therapeutic committee review. The expedited review process requires P&T committees to make a decision within 90 days, rather than the normal 180-day requirement. |
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5. Applicant will provide for an appropriate transition for new enrollees prescribed Part D drugs that are not on its formulary. This transition process must satisfy the requirements specified in Chapter 6 of the Prescription Drug Benefit Manual. |
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6. Applicant agrees to submit to CMS a description of the organization’s approach to transitioning beneficiaries on drug regimens that are not on the plan’s Part D approved formulary by close of business on the CMS-established formulary upload date through HPMS. |
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7. Applicant agrees, where appropriate, to extend transition periods beyond 30 days for enrollees using non-formulary drugs that have not been transitioned to a formulary drug or gone through the plan exception process within 30 days. |
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8. Applicant agrees to ensure that staffs are trained on and information systems are in place to accommodate administration of the transition policy. This includes adoption of necessary information system overrides. |
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9. Applicant will establish an emergency supply of non-formulary Part D drugs (31-day supplies, unless the prescription is written for fewer days) for long-term care residents to allow the plan and/or the enrollee time for the completion of an exception request to maintain coverage of an existing drug based on reasons of medical necessity. |
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10. Applicant will establish appropriate timeframes and “first fill” procedures to non-formulary Part D medications in long-term care and retail settings. |
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11. Applicant will abide by CMS guidance related to vaccine administration reimbursement under Part D. |
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B. 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. |
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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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C. If Applicant is intending for its Part D benefit to include use of a formulary, then the members of the P&T committee must be provided directly by the Applicant or by the Applicant’s PBM. The membership of the P&T Committee must be comprised as described in items B9, 10, 11 and 13 above. If Applicant is providing names of P&T committee directly, then provide the membership in HPMS’ Contract Management/Part D Data page. If the PBM operates under a confidentiality agreement (where the Applicant does not know the membership of the PBM’s P&T Committee) refer to the Appendix entitled Applicant Submission of P&T Committee Member List and Certification Statement for additional instructions.
D. 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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3.2.2 Utilization Management Standards 42 CFR 423.153 (b); Prescription Drug Benefit Manual, Chapters 6 and 7
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 42 CFR 423.153(c); Prescription Drug Benefit Manual Chapter 7
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”. |
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NO |
Requesting Waiver? Yes or No |
1. Applicant establishes a quality assurance program that includes measures and reporting systems such as, but not limited to:
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3.2.4 Medication Therapy Management 42 CFR 423.153(d); Prescription Drug Benefit Manual, Chapter 7
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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11. 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 organization) and will remain in the MTMP program for the remainder of the calendar year. |
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12. 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 organization) regardless of setting (i.e., ambulatory, long term care, etc.) |
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13. 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 42 CFR 423.159; Prescription Drug Benefit Manual, Chapter 7
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: |
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NO |
Requesting Waiver? Yes or No |
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3.3 General Pharmacy Access 42 CFR 423.120(a); Prescription Drug Benefit Manual, Chapter 5
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 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(d) modifies the timing requirement for LTC pharmacies). |
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7. 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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8. Applicant agrees to notify CMS when the Applicant changes its pharmacy benefit management subcontractor. |
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9. Applicant agrees to notify CMS about any substantive change in its pharmacy network that may impact its ability to maintain a Part D pharmacy network that meets CMS’ requirements. |
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B. Upload in HPMS a contract template in pdf format 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 uploaded. 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. Upload in HPMS 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 downloading the Microsoft Excel worksheets from HPMS that are located specifically on the Pharmacy Upload page, complete the worksheets and upload the finished document back into HPMS for each of 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.
3.3.1 Retail Pharmacy 42 CFR 423.120(a); 423.859(c); Prescription Drug Benefit Manual, Chapter 5
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. Upload in HPMS the Pharmacy Network Access Reports as described in the Appendix entitled Retail Pharmacy Network Access Instructions.
C. Upload in HPMS the Retail Pharmacy List:
To submit retail pharmacy listings to CMS, Applicants must download the Microsoft Excel worksheet from HPMS that is located specifically on the Pharmacy Upload page, complete the worksheet and upload the finished document back into HPMS.
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 upload in HPMS, in pdf format, 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. In HPMS, in pdf format, provide the following information:
Explain why your organization cannot demonstrate compliance with the access standards or 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 2008 by retail pharmacies owned and operated by Applicant. |
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Provide the number of prescriptions provided in 2008 at all 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 2008 by all pharmacies owned and operated by Applicant. |
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Provide the number of prescriptions provided in 2008 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 Access 42 CFR 423.124; Prescription Drug Benefit Manual, Chapter 5
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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3.3.3 Mail Order Pharmacy 42 CFR 423.120(a)(10); Prescription Drug Benefit Manual, Chapter 5
A. In HPMS, complete the table below:
APPLICANTS MAY OFFER A MAIL ORDER OPTION IN ADDITION TO THEIR CONTRACTED 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. Mail Order Pharmacy List
To submit mail order pharmacy listings to CMS, Applicants must download the Microsoft Excel worksheet from HPMS that is located specifically on the Pharmacy Upload page, complete the worksheet and upload the finished document back into HPMS.
3.3.4 Home Infusion Pharmacy 42 CFR 423.120(a)(4); Prescription Drug Benefit Manual, Chapter 5
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
To submit home infusion pharmacy listings to CMS, Applicants must download the Microsoft Excel worksheet from HPMS that is located specifically on the Pharmacy Upload page, complete the worksheet and upload the finished document back into HPMS.
3.3.5 Long -Term Care (LTC) Pharmacy 42 CFR.120(a)(5); Prescription Drug Benefit Manual, Chapter 5
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
To submit LTC pharmacy listings to CMS, Applicants must download the Microsoft Excel worksheet from HPMS that is located specifically on the Pharmacy Upload page, complete the worksheet and upload the finished document back into HPMS.
3.3.6 Indian Health Service, Indian Tribe and Tribal Organization, and Urban Indian Organization (I/T/U) Pharmacy 42 CFR 423.120(a)(6); Prescription Drug Benefit Manual, Chapter 5
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 D CONTRACT : |
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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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 must download the Microsoft Excel worksheet from HPMS that is located specifically on the Pharmacy Upload page, complete the worksheet and upload the finished document back into HPMS.
3.3.7 Specialty Pharmacy Prescription Drug Benefit Manual, Chapter 5
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 42 CFR 423.30; Prescription Drug Benefit Manual, Chapters 3 and 4; Plan Communication User Guide Version 3.1
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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3.5 Complaints Tracking Prescription Drug Benefit Manual, Chapter 7
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 in accordance with CMS’ Standard Operating Procedures for Part D sponsors. |
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3. Applicant will maintain Standard Operating Procedures that address how its organization will handle and quickly resolve immediate action cases, as well as, outline the steps the organization intends to take to have enrollees call customer service directly for the prompt resolution of all inquiries. |
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3.6 Medicare Prescription Drug Plan Finder Prescription Drug Benefit Manual, Chapter 7
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 2010 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 42 CFR 423.564; Prescription Drug Benefit Manual, Chapter 18
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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1. Applicant will adopt policies and procedures for beneficiary grievances consistent with 42 CFR § 423 subpart M. |
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2. Applicant agrees to abide by Chapter 18 of the Prescription Drug Benefit Manual. |
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3. Applicant will, consistent with 42 CFR § 423.564 establish policies and procedures for:
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4. Applicant will make enrollees aware of the grievance process through information and outreach materials. |
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5. Applicant will accept grievances from enrollees at least by telephone and in writing (including facsimile) |
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6. Applicant will maintain and provide to CMS upon request, access to records on all grievances received both orally and in writing. At a minimum, such record must track the :
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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 Coverage Determinations (Including Exceptions) and Appeals 42 CFR 423 Subpart M; Prescription Drug Benefit Manual, Chapter 18
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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These requirements also apply to exceptions requests by Medicare eligible children for off-formulary Part D pediatric drugs and doses that are medically appropriate. |
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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 42 CFR 423 Subpart J; Prescription Drug Benefit Manual, Chapter 14
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) 42 CFR 423 Subpart J; Prescription Drug Benefit Manual, Chapter 14
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 42 CFR 423.462; Prescription Drug Benefit Manual, Chapter 14
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 42 CFR 423.128; Prescription Drug Benefit Manual, Chapter 2
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 guidelines, the CMS review process will be integrated in the Part C Review required under 42 CFR 417.428.
3.13 Provider Communications Prescription Drug Benefit Manual, Chapter 2
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 42 CFR 423.504(b)(4)(vi); Prescription Drug Benefit Manual, Chapter 9
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. Provide as an upload via HPMS, in .pdf format, a copy of your organization’s Medicare Part D Compliance Plan and/or compliance policies and procedures that you intend to use for this contract.
The Part D compliance plan and any related policies and procedures must be in accordance with 42 CFR 423.504(b)(4)(vi) and the Part D Program Integrity Manual. In addition, the policies and procedures must demonstrate that all 7 elements in the regulation and in Chapter 9 are being implemented in the Part D compliance plan and are specific to the issues and challenges presented by the Part D program. A general compliance plan applicable to healthcare operations is not acceptable.
Note: Please be advised that the Part D Applicant is ultimately responsible for the implementation and monitoring of the day-to-day operations of its Part D compliance program. Section 40.1 of Chapter 9 of the Prescription Drug Benefit Manual indicates that the compliance officer and compliance committee functions may not be delegated or subcontracted. A compliance plan adopted and operated by a Part D Applicant’s subcontractor is not sufficient to demonstrate that the Part D Applicant meets the compliance program requirement.
In HPMS, complete and upload the table below. Applicant must clearly identify where each requirement can be found in the uploaded documents.
Requirement |
Document Page Number |
1. Written policies, procedures, and standards of conduct addressing Part D issues and articulating your organization’s commitment to abide by all applicable Federal and State standards. |
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2. Designation of an employee as the compliance officer and compliance committee accountable to senior management. (Note: This requirement cannot be delegated to a subcontractor (first tier, downstream and related entities)). |
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3. Effective training and education between the compliance officer and organization employees, contractors, agents and directors. |
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4. Effective lines of communication between the compliance officer and organization employees, contractors, agents and directors and members of the compliance committee. |
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5. Enforcement of standards through disciplinary guidelines that are well-publicized in the organization. |
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6. Procedures for internal monitoring and auditing of operations as they relate to Part D administration. |
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7. Procedures for ensuring prompt response to detected Part D offenses and development of corrective action initiatives, relating to the Applicant’s contract as a Part D sponsor. |
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3.15 Reporting Requirements 42 CFR 423.514; 2008 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(b)(2). |
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3. Applicant will notify CMS of any loans or other special financial arrangements made with contractors, subcontractors (first tier, downstream and related entities), 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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10. The Applicant or the Applicant’s representative, such as a TPA, has data management processes and data systems capable of accomplishing collection of data for dates of service within the coverage period with a 3-month closeout window for the submission of remaining unreported claims data. |
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11. The Applicant or the Applicant’s representative, such as a TPA, has data management processes and data systems capable of accomplishing provision of additional information for the purposes of reconciliation of risk factors, low income subsidy payments, reinsurance payments, and risk corridor as required by CMS. |
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12. Applicant will send and receive claims data for third party payers from the CMS contractor that will serve as the clearinghouse for all Part D beneficiary outpatient drug claims. |
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REBATE DATA |
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13. The Applicant or the Applicant’s representative has accounting systems capable of accomplishing the provision of documentation, as specified by CMS, to support the accuracy and completeness of rebate data. Documentation will be provided to CMS in response to an audit-based request. |
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14. The Applicant will report rebate dollars on a quarterly basis at the manufacturer/drug name level (unique strength and package size not required) in the manner specified by CMS. |
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15. The Applicant or the Applicant’s representative has accounting systems capable of accomplishing the production of financial reports to support rebate accounting. The rebate accounting must allow for step-down cost reporting in which rebates received at the aggregate level may be apportioned down to the level of plan enrollees. |
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16. Applicant will report Long-Term Care pharmacy rebate dollars on a quarterly basis at the manufacturer/brand name level (unique strength and package size not required) in a manner specified by CMS. |
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17. The Applicant will report direct and indirect remuneration (DIR) dollars for payment reconciliation on an annual basis at the Plan Benefit Package (PBP) level/plan in the manner specified by CMS. In addition, the Applicant will maintain records and documentation to verify the DIR data reported to CMS. |
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OTHER DATA |
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18. The Applicant will report at a frequency determined by CMS specified data (pursuant to 42 CFR §423.514(a)) on a variety of measures to support payment, program integrity, program management, and quality improvement activities in a manner prescribed by CMS in the Part D Reporting Requirements.
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19. The Applicant will provide CMS with routine administrative reports (pursuant to 42 CFR 423.514 (a)) on a variety of measures that concern the Applicant’s performance in the administration of the Part D benefit. Such reports shall be submitted according to instructions issued with timely notice by CMS. |
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SUPPORTING WWW.MEDICARE.GOV |
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20. The Applicant will submit pricing and pharmacy network information to be publicly reported on www.medicare.gov in order to provide Medicare beneficiaries with necessary information regarding prescription drug costs under the respective plans. Details regarding this data requirement will be posted on www.cms.hhs.gov by April 2008. |
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CONFLICT OF INTEREST |
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21. The Applicant will provide financial and organizational conflict of interest reports to CMS, pursuant to instructions to be issued by CMS.
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3.16 Data Exchange Between Cost Plans and CMS 42 CFR 423.505(c) and (k)
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 Health Insurance Portability and Accountability Act of 1996 (HIPAA) 45 CFR Parts 160, 162, and 164; CMS issued guidance 08/15/2006 and 07/23/2007
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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9. 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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10. Applicant agrees for each offshore subcontractor (first tier, downstream and related entities) (including downstream offshore subcontractors) that receive, process, transfer, handle, store, or access Medicare beneficiary protected health information (PHI) by the last Friday in September for the upcoming contract year. |
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3.18 Prohibition on Use of SSN or Medicare ID number on Enrollee ID Cards Prescription Drug Benefit Manual, Chapter 2
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 |
1. Applicant agrees not to use an enrollee’s Social Security Number (SSN) or Medicare ID Number on the enrollees’ identification card. |
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3.19 Record Retention 42 CFR 423.505 (d)
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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3.20 Claims Processing CMS issued guidance 4/26/2006
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: This is in contrast to paper claims submitted by beneficiaries per the regulations at 42 CFR §423.568(b). |
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3.21 Premium Billing 42 CFR 423.293, CMS issued guidance 03/08/2007
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 it will take steps to ensure that members are not over billed or double billed for their monthly premiums. The Applicant will promptly refund members when billing errors occur. |
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2. Applicant agrees it cannot prevent excessive billing when a member exercises their right to have Social Security withholding and has a secondary payer (e.g., SPAP) paying part of their premium. In such cases the Applicant agrees it will promptly reimburse members for overpayments. |
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3. Applicant agrees it will not direct bill a member when the member is already in Premium Withholding status until the status change with both CMS and SSA has been confirmed. |
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4. Applicant agrees that when a member is in Premium Withholding status and the withheld amount has not been issued by CMS in the monthly plan payments, the Applicant will resolve the matter with CMS not with the member. |
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Upload in HPMS, in .pdf format, the following certification:
4.0 CERTIFICATION
I, NAME, TITLE, attest 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, 2009 with the requirements stated here in this application as well as in 42 CFR Part 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 2010 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
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 and operated by the Cost contractor if that organization’s pharmacy network access meets 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 and operated by the Cost contractor and dispense at least 98% of all prescriptions through pharmacies owned and operated by Applicant. |
Appendix II
Crosswalk of Section 3.1.1D Requirements in Subcontracts Submitted as Attachments to Section 3.1.1
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APPENDIX
III
Crosswalk for Retail Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete and upload in HPMS the following chart (which contains applicable Section 3.1.1D requirements AND additional requirements specific to Pharmacy Access) for each Retail pharmacy contract template submitted under Section 3.3. Applicants must identify in which contract or addendum and where specifically (i.e., section numbers, page numbers, paragraph numbers, etc.) in each subcontract the following elements are found. [Eg. Medicare Part D Retail Pharmacy Addendum, page 14, section 3.2, paragraph 2]. |
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The provisions listed below must be in all pharmacy contracts if contracts reference policies and procedures with which the pharmacy must comply. Provide the relevant documentation as evidence and cite this documentation accordingly. |
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Section |
Requirement |
Citation |
3.1.1D2 |
The functions to be performed by the subcontractor (first tier, downstream and related entities). |
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3.1.1D3 |
Describes the reporting requirements the subcontractor (first tier, downstream and related entities) identified in Section 3.1.1C of the application has to the Applicant. |
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3.1.1D8 |
Language obligating the subcontractor (first tier, downstream and related entities) to abide by all applicable Federal laws and regulations and CMS instructions. |
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3.1.1D9 |
Language obligating the subcontractor (first tier, downstream and related entities) to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
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3.1.1D10 |
Language ensuring that the subcontractor (first tier, downstream and related entities) will make its books and other records available in accordance with 42 CFR 423.505(e)(2) and 42 CFR 423.505(i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to audit, evaluate and inspect any books, contracts, records, including medical records and documentation involving transactions related to CMS’ contract with the Part D sponsor and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later. |
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3.1.1D11 |
Language stating that the subcontractor (first tier, downstream and related entities) will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. |
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3.1.1D12 |
Language indicating that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees. |
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3.1.1D13 |
Language ensuring that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor (first tier, downstream and related entities), that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor (first tier, downstream and related entities) has not performed satisfactorily. Note: The subcontract may include remedies in lieu of revocation to address this requirement |
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3.1.1D14 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor (first tier, downstream and related entities) on an ongoing basis. |
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MIPPA Section 171 |
Provisions requiring that payment shall be issued, mailed or otherwise transmitted with respect to all clean claims submitted by or on behalf of pharmacies within 14 days for electronic claims and within 30 days for claims submitted otherwise.
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MIPPA Section 173 |
For those contracts that use a standard for reimbursement, provisions indicating the source used by the Part D sponsor for making any such price updates and that updates to such a standard occur not less frequently than once every 7 days beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug. |
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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 IV
Crosswalk for Mail Order Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete and upload in HPMS the following chart (which contains applicable Section 3.1.1D requirements AND additional requirements specific to Pharmacy Access) for each Mail Order pharmacy contract template submitted under Section 3.3. Applicants must identify in which contract or addendum and where specifically (i.e., section numbers, page numbers, paragraph numbers, etc.) in each subcontract the following elements are found. [Eg. Medicare Part D Mail Order Pharmacy Addendum, page 14, section 3.2, paragraph 2]. |
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The provisions listed below must be in all pharmacy contracts. If contracts reference policies and procedures with which the pharmacy must comply, provide the relevant documentation as evidence and cite this documentation accordingly. |
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Section |
Requirement |
Citation |
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3.1.1D2 |
The functions to be performed by the subcontractor (first tier, downstream and related entities). |
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3.1.1D3 |
Describes the reporting requirements the subcontractor (first tier, downstream and related entities) identified in Section 3.1.1C of the application has to the Applicant. |
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3.1.1D8 |
Language obligating the subcontractor (first tier, downstream and related entities) to abide by all applicable Federal laws and regulations and CMS instructions. |
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3.1.1D9 |
Language obligating the subcontractor (first tier, downstream and related entities) to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
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3.1.1D10 |
Language ensuring that the subcontractor (first tier, downstream and related entities) will make its books and other records available in accordance with 42 CFR 423.505(e)(2) and 42 CFR 423.505(i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to audit, evaluate and inspect any books, contracts, records, including medical records and documentation involving transactions related to CMS’ contract with the Part D sponsor and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later. |
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3.1.1D11 |
Language stating that the subcontractor (first tier, downstream and related entities) will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. |
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3.1.1D12 |
Language indicating that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees. |
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3.1.1D13 |
Language ensuring that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor (first tier, downstream and related entities), that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor (first tier, downstream and related entities) has not performed satisfactorily. Note: The subcontract may include remedies in lieu of revocation to address this requirement. |
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3.1.1D14 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor (first tier, downstream and related entities) on an ongoing basis. |
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MIPPA Section 173 |
For those contracts that use a standard for reimbursement, provisions indicating the source used by the Part D sponsor for making any such price updates and that updates to such a standard occur not less frequently than once every 7 days beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug.
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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 V
Crosswalk for Home Infusion Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete and upload in HPMS the following chart (which contains applicable Section 3.1.1D requirements AND additional requirements specific to Pharmacy Access) for each Home Infusion pharmacy contract template submitted under Section 3.3. Applicants must identify in which contract or addendum and where specifically (i.e., section numbers, page numbers, paragraph numbers, etc.) in each subcontract the following elements are found. [Eg. Medicare Part D Home Infusion Pharmacy Addendum, page 14, section 3.2, paragraph 2]. |
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The provisions listed below must be in all pharmacy contracts. If contracts reference policies and procedures with which the pharmacy must comply, provide the relevant documentation as evidence and cite this documentation accordingly. |
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Section |
Requirement |
Citation |
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3.1.1D2 |
The functions to be performed by the subcontractor (first tier, downstream and related entities). |
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3.1.1D3 |
Describes the reporting requirements the subcontractor (first tier, downstream and related entities) identified in Section 3.1.1C of the application has to the Applicant. |
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3.1.1D8 |
Language obligating the subcontractor (first tier, downstream and related entities) to abide by all applicable Federal laws and regulations and CMS instructions. |
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3.1.1D9 |
Language obligating the subcontractor (first tier, downstream and related entities) to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
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3.1.1D10 |
Language ensuring that the subcontractor (first tier, downstream and related entities) will make its books and other records available in accordance with 42 CFR 423.505(e)(2) and 42 CFR 423.505(i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to audit, evaluate and inspect any books, contracts, records, including medical records and documentation involving transactions related to CMS’ contract with the Part D sponsor and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later. |
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3.1.1D11 |
Language stating that the subcontractor (first tier, downstream and related entities) will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. |
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3.1.1D12 |
Language indicating that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees. |
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3.1.1D13 |
Language ensuring that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor (first tier, downstream and related entities), that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor (first tier, downstream and related entities) has not performed satisfactorily. Note: The subcontract may include remedies in lieu of revocation to address this requirement. |
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3.1.1D14 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor (first tier, downstream and related entities) on an ongoing basis. |
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MIPPA Section 171 |
Provisions requiring that payment shall be issued, mailed or otherwise transmitted with respect to all clean claims submitted by or on behalf of pharmacies within 14 days for electronic claims and within 30 days for claims submitted otherwise. |
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MIPPA Section 173 |
For those contracts that use a standard for reimbursement, provisions indicating the source used by the Part D sponsor for making any such price updates and that updates to such a standard occur not less frequently than once every 7 days beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug.
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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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Provision ensuring that pharmacy that delivers home infusion drugs provides delivery of home infusion drugs within 24 hours of discharge from an acute care setting, or later if so prescribed. |
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APPENDIX VI
Crosswalk for Long-Term Care Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete and upload in HPMS the following chart (which contains applicable Section 3.1.1D requirements AND additional requirements specific to Pharmacy Access) for each Long-Term Care pharmacy contract template submitted under Section 3.3. Applicants must identify in which contract or addendum and where specifically (i.e., section numbers, page numbers, paragraph numbers, etc.) in each subcontract the following elements are found. [Eg. Medicare Part D Long-Term Care Pharmacy Addendum, page 14, section 3.2, paragraph 2]. |
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The provisions listed below must be in all pharmacy contracts. If contracts reference policies and procedures 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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3.1.1D2 |
The functions to be performed by the subcontractor (first tier, downstream and related entities). |
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3.1.1D3 |
Descries the reporting requirements the subcontractor (first tier, downstream and related entities) has identified in 3.1.1C of the application has to the Applicant. |
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3.1.1D8 |
Language obligating the subcontractor to abide by all applicable Federal laws and regulations and CMS instructions. |
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3.1.1D9 |
Language obligating the subcontractor (first tier, downstream and related entities) to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
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3.1.1D10 |
Language ensuring that the subcontractor (first tier, downstream and related entities) will make its books and other records available in accordance with 42 CFR 423.505(e)(2) and 42 CFR 423.505(i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to audit, evaluate and inspect any books, contracts, records, including medical records and documentation involving transactions related to CMS’ contract with the Part D sponsor and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later. |
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3.1.1D11 |
Language stating that the subcontractor (first tier, downstream and related entities) will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. |
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3.1.1D12 |
Language indicating that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees. |
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3.1.1D13 |
Language ensuring that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor (first tier, downstream and related entities), that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor (first tier, downstream and related entities) has not performed satisfactorily. Note: The subcontract may include remedies in lieu of revocation to address this requirement. |
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3.1.1D14 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the (first tier, downstream and related entities) subcontractor on an ongoing basis. |
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MIPPA Section 172 |
Provisions requiring that the long-term care pharmacy have not less than 30 days (but not more than 90 days) to submit claims to the sponsor for reimbursement under the plan. |
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MIPPA Section 173 |
For those contracts that use a standard for reimbursement, provisions indicating the source used by the Part D sponsor for making any such price updates and that updates to such a standard occur not less frequently than once every 7 days beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug. |
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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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Elements Specific to Long-Term Care Contracts
Note: CMS included in Chapter 5 of the Prescription Drug Benefit Manual Long-Term Care Guidance contains a 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 VII
Crosswalk for Indian Tribe and Tribal Organization, and Urban Indian Organization (I/T/U) Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete and upload in HPMS the following chart (which contains applicable Section 3.1.1D requirements AND additional requirements specific to Pharmacy Access) for each I/T/U pharmacy contract template submitted under Section 3.3. Applicants must identify in which contract or addendum and where specifically (i.e., section numbers, page numbers, paragraph numbers, etc.) in each subcontract the following elements are found. [Eg. Medicare Part D I/T/U Pharmacy Addendum, page 14, section 3.2, paragraph 2]. |
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The provisions listed below must be in all pharmacy contracts. If contracts reference policies and procedures with which the pharmacy must comply, provide the relevant documentation as evidence and cite this documentation accordingly. |
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Section |
Requirement |
Citation |
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3.11D2 |
The functions to be performed by the subcontractor (first tier, downstream and related entities). |
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3.1.1D3 |
Describes the reporting requirements the subcontractor (first tier, downstream and related entities) identified in Section 3.1.1C of the application has to the Applicant. |
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3.1.1D8 |
Language obligating the subcontractor (first tier, downstream and related entities) to abide by all applicable Federal laws and regulations and CMS instructions. |
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3.1.1D9 |
Language obligating the subcontractor (first tier, downstream and related entities) to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
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3.1.1D10 |
Language ensuring that the subcontractor (first tier, downstream and related entities) will make its books and other records available in accordance with 42 CFR 423.505(e)(2) and 42 CFR 423.505(i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to audit, evaluate and inspect any books, contracts, records, including medical records and documentation involving transactions related to CMS’ contract with the Part D sponsor and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later. |
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3.1.1D11 |
Language stating that the subcontractor (first tier, downstream and related entities) will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. |
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3.1.1D12 |
Language indicating that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees. |
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3.1.1D13 |
Language ensuring that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor (first tier, downstream and related entities), that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor (first tier, downstream and related entities) has not performed satisfactorily. Note: The subcontract may include remedies in lieu of revocation to address this requirement |
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3.1.1D14 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor (first tier, downstream and related entities) on an ongoing basis. |
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MIPPA Section 171 |
Provisions requiring that payment shall be issued, mailed or otherwise transmitted with respect to all clean claims submitted by or on behalf of pharmacies within 14 days for electronic claims and within 30 days for claims submitted otherwise.
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MIPPA Section 173 |
For those contracts that use a standard for reimbursement, provisions indicating the source used by the Part D sponsor for making any such price updates and that updates to such a standard occur not less frequently than once every 7 days beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug.
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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 |
Supersession 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 VIII
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 in HPMS, and (2) forward the attached P&T Committee Member Disclosure form to the sub-contracted PBM and direct the PBM to submit the form to CMS by February 26, 2009. The PBM should email the P&T Committee Member Disclosure form to the following email box: drugbenefitimpl@cms.hhs.gov.
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) and make the correct changes in HPMS on the Contract Management/Part D Data page within 30 days of the effective date of such change.
PHARMACY AND THERAPEUTICS COMMITTEE MEMBER DISCLOSURE
PBM must email the following form to drugbenefitimpl@cms.hhs.gov by February 26, 2009.
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. |
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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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Applicant must upload in HPMS:
CERTIFICATION FOR PART D SPONSORS USING A PHARMACY BENEFIT MANAGER’S PHARMACY& THERAPEUTICS COMMITTEE UNDER A CONFIDENTIALITY AGREEMENT
I, attest, on behalf of LEGAL NAME OF PART D SPONSOR APPLICANT (“Applicant”), to the following:
I certify that APPLICANT has entered into a contract with LEGAL NAME OF PBM (“PBM”) to perform pharmacy benefit management services related to the operation of a Medicare Part D benefit plan(s) on behalf of APPLICANT.
I agree, to the best of my knowledge, that “PBM,” has a Pharmacy and Therapeutics (P&T) Committee that contains a majority of members who are practicing physicians and/or pharmacists, includes at least one practicing physician and one practicing pharmacist who are experts regarding the care of the elderly or disabled individuals, and includes at least one practicing physician and one practicing pharmacist who are independent and free of conflict relative to my plan and organization and pharmaceutical manufacturers.
I agree that the PBM will supply to CMS the following information, including but not limited to, the full legal name of each member of its P&T Committee designated as a practicing physician or pharmacist specializing in elderly and/or disabled care. Each member must also disclose any conflict of interest with my organization, and/or pharmaceutical manufacturers.
I agree that my organization 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 (first tier, downstream and related entities) to ensure compliance with the statements to which I have attested above.
I certify that I am authorized to sign on behalf of the Applicant.
Part D Applicant’s Contract Number: _____________________
__________________________ ______________________________
Authorized Representative Name (printed) Title
_____________________________ ______________________________
Authorized Representative Signature Date (MM/DD/YYYY)
Appendix IX
Retail Pharmacy Network Access Instructions
Part D Applicants are strongly encouraged to use The Quest Analytics Suite™ or GeoNetworks® software to compile the reports as outlined in this appendix. If this is not possible, the Applicant must contact Dennis Hodges at dennis.hodges@cms.hhs.gov (410.786.3048) no later than February 4, 2009 to determine if analyses provided by an alternative method are acceptable. Alternative methods must produce analyses that will result in data directly comparable to the results produced by The Quest Analytics Suite™ or GeoNetworks®. Applicants that wish to use alternative methods will be required to demonstrate how their analysis is comparable to results produced by either The Quest Analytics Suite™ or 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 either software. The instructions and examples provided here were developed using The Quest Analytics Suite version 2007.3 and 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. Please note that these retail pharmacy access reports will be uploaded into HPMS on the appropriate Pharmacy Access Upload page.
I. Instructions for Part D Applicants using The Quest Analytics Suite™
The Medicare Beneficiary File “Medicare Beneficiaries by State, Region, ZIP 10082008.xls” is provided by CMS and can be accessed at the following URL: www.cms.hhs.gov\PrescriptionDrugCovContra\. The Medicare Beneficiary File referenced above contains ZIP Codes and beneficiary counts for Applicants as of September, 2008. Use of this file is required for the accessibility analysis submission.
Download this 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.
Open the Quest Analytics Project file you downloaded and link to the data sub-file in The Quest Analytics Suite by adding an Employee Group and name it “All Beneficiaries”. Applicants may geocode by selecting the “Geocoding Tab” and select “Geocode Now” during this step, or they may defer geocoding the population file until run time.
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.
The most recent version of The Quest Analytics Suite™ automatically assigns an Urban, Suburban, or Rural classification for each Medicare beneficiary record consistent with the definitions specified in 42 CFR §423.100. Select the appropriate options under project preferences.
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 Employee Groups resource and Copy the All Beneficiaries group. Change the name to “Urban Beneficiaries” and on the zip code filter, turn off the suburban and rural check boxes.
To define the subset of Suburban beneficiaries, navigate to Employee Groups resource and Copy the All Beneficiaries group. Change the name to “Suburban Beneficiaries” and on the zip code filter, turn off the urban and rural check boxes.
To define the subset of Rural beneficiaries, navigate to Employee Groups resource and Copy the All Beneficiaries group. Change the name to “Rural Beneficiaries” and on the zip code filter, turn off the urban and suburban check boxes.
Verify that the urban, suburban, and rural definitions are defined appropriately for each page of the report. CMS will compare the total of urban, suburban, and rural beneficiaries for specific counties to totals derived from the Medicare Beneficiary File.
The Quest Analytics Suite™ default restricts beneficiaries inside your service area.
Applicants may specify that contracted providers outside their service area (e.g., across state or county lines) be included in their accessibility analyses. The most recent release of The Quest Analytics Suite™ allows for the inclusion of providers outside the specified service area under the report area options.
2. Defining the Provider File
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 3.4.1C 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 analysis (and the submission provided under Section 3.4.1B of this solicitation to represent one complete Part D network).
Applicant may use representative ZIP Geocoding or the more precise geocoding methods for pharmacy providers (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.
The Quest Analytics Suite™ will automatically geocode your provider file using an “address-based” method (if licensed). If this function is not available on your version of Quest Analytics Suite™, the default, distributive geocoding methodology, is acceptable.
Define the Provider Group by navigating to Add Provider Groups. Select the data source on the Source Table button. On the Name enter the label of “Part D Retail Pharmacy Network”, select OK.
Verify that the total counts for pharmacy providers in the report do not exceed the count of pharmacies in your Part D contracted retail pharmacy listing that must also be provided using the retail listing template provided in HPMS.
3. Defining Access Criteria
The Applicant must define access standards in accordance with the Part D standards, as defined in 42 CFR § 423.120(a)(1).
The Urban access standard of 1 provider within 2 miles is predefined within the Quest project file that you downloaded.
The Suburban access standard of 1 provider within 5 miles is predefined within the Quest project file that you downloaded.
The Rural access standard of 1 provider within 15 miles is predefined within the Quest project file that you downloaded.
4. Defining the Plan Service Area
Applicants should define their service area based on the service area for the entire contract. The service area defined in your report must EXACTLY match the service area you have specified in HPMS.
PDP Applicants
PDPs and RPPOs are required to demonstrate the accessibility standards at the state level. Applicants must also present access statistics at the county level. Please note that it is not a requirement for PDP (or RPPO) Applicants to provide summary statistics related to the accessibility standards at the region level.
Define the service area by navigating to Service Area and Add and select your service area.
Verify that the service area in your report EXACTLY matches the service area you have entered in HPMS. New Applicants must include all regional (and their component States) in their report. SAE applicants MUST include only new regions (and their component States) in their report.
Verify that the reports provided to CMS include subtotals for each individual state and grand total summary statistics encompassing all states in the service area. For SAE applicants the reports provided to CMS should include subtotals for each individual state and grand total summary statistics encompassing all states in the expansion area.
5. Generating the Accessibility Analyses Reports
A report template is included in the Quest Analytics project file that you downloaded. This includes all the report pages and access standards along with the applicable sorting options.
6. Providing copies of the Analysis to CMS for review
Applicants must upload their report in Adobe Acrobat readable (*.pdf) format into HPMS.
The Medicare Beneficiary File “Medicare Beneficiaries by State, Region, ZIP 10082008.xls” is provided by CMS and can be accessed at the following URL: www.cms.hhs.gov\PrescriptionDrugCovContra\. The Medicare Beneficiary File referenced above contains ZIP Codes and beneficiary counts for Applicants as of September, 2008. Use of this file is required for the accessibility analysis submission.
Download this 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.
Import the data sub-file into GeoNetworks® 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.
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.
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 opening 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, Applicants 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 employee 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.
Define a single “all beneficiaries file” by navigating 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.
Verify that the urban, suburban, and rural definitions are defined appropriately for each page of the report. CMS will compare the total of urban, suburban, and rural beneficiaries for specific counties to totals derived from the Medicare Beneficiary File.
Verify that only beneficiaries within your 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 3.4.1C 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 3.4.1B of this solicitation to represent one complete Part D network).
Applicant may use representative ZIP Geocoding or the more precise geocoding methods for pharmacy providers (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.
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.
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.
Verify that the total counts for pharmacy providers in the GeoNetworks® report do not exceed the count of pharmacies in your Part D contracted retail pharmacy listing that must also be provided using the retail listing template provided in HPMS
The 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.
Applicants should define their service area based on the service area for the entire contract. The service area defined in your GeoNetworks® report must EXACTLY match the service area you have specified in HPMS.
Cost Plan Applicants
Cost Plans are required to demonstrate the accessibility standards at the service area level,. Applicants must also present access statistics at the county level.
Define the service area by navigating to Define > Service Areas > Add > Use buttons on right to select your service area.
Verify that the service area defined in your GeoNetworks® report EXACTLY matches the service area you have entered in HPMS. Service Area Expansion Applicants MUST include both existing and new Counties in their GeoNetworks® report.
Verify that the reports provided to CMS include subtotals for each individual county and grand total summary statistics encompassing all counties in the service area.
Reports for multi-state MA-PFFS applications should also include subtotals for each state.
Cost Plan Reports
Including the title, the table of contents, and the GeoNetworks run report,, a seven (7) item report will be generated. The following set of instructions references the CMS example for H0000 and, following all of the report development specifications, should result in the items listed in Table II. Applicants should ensure that they: (1) use the appropriate employee group (i.e. the Beneficiary Count file you derived from the CMS provided reference file), (2) use the correct definition of the access standards, (3) use the correct definition of your service area (including both current and SAE areas for SAE Applicants); and (4) provide analyses with “all” beneficiary specification in order to provide CMS with a summary of the service area included in your report. (5) CMS also requests the inclusion of the summary report that provides information about the set-up and run date of the analysis. This summary report is automatically generated by GeoNetworks®. An example of the Cost Plan GeoAccess reports with the file name, “Example Cost Plan GeoNetworks Analysis.tif” accompanies this document
Table II Example H0000 Report Pages Specification |
|||||||
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 Pharmacy Network 1 |
Urban: 1 provider within 2 miles |
H0000 |
All |
4 |
Accessibility Detail |
County |
Suburban Beneficiaries |
Part D Pharmacy Network 1 |
Suburban: 1 provider within 5 miles |
H0000 |
All |
5 |
Accessibility Detail |
County |
Rural Beneficiaries |
Part D Pharmacy Network 1 |
Rural: 1 provider within 15 miles |
H0000 |
All |
6 |
Service Area |
County |
All Beneficiaries |
Part D Pharmacy Network 1 |
|
H0000 |
|
7 |
GeoNetworks Report (auto generated summary information to be included in submission) |
|
|
|
|
|
|
Title Page
To add a title page, navigate to Page > Add > Title Page.
Table of Contents
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 the service area defined. There should be three Accessibility Detail reports. The title in the accessibility detail report should specify the network represented in the pharmacy list. For each accessibility analysis, a report is created that provides the percentage of beneficiaries with access and the percentage of beneficiaries without access. Both the with and without access statistics should appear together on each of the urban/suburban/rural reports. Statistics for each individual county within the service area and statistics for the entire service area (in total) must be provided.
Define the accessibility detail report for urban beneficiaries in the service area for H0000 requires the following steps:
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 for 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 Retail Network 1”, set Service Area to H0000.
Under the Options tab for the new Service Area Detail Page, select to summarize by state, set service area filter to inside, ensure that the following options are checked: number of employees, number of providers, and totals.
Under the Titles tab, uncheck the default Title 1 and specify a title that describes the 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).
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.
Applicants must upload their GeoNetworks® report in Adobe Acrobat readable (*.pdf) format into HPMS.
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 | Marla Rothouse |
| File Modified | 2008-11-07 |
| File Created | 2008-11-07 |