Contract ID Number: E________
2008
MEDICARE PRESCRIPTION DRUG BENEFIT
Solicitation for Applications for New
Employer/Union Direct Contract Medicare Advantage Prescription Drug Plan (MA-PD) Sponsors
January ??, 2007
PUBLIC REPORTING BURDEN: According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-0936. The time required to complete this information collection is estimated to average 54 hours per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have any comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS/EPOG, 7500 Security Boulevard, C1-22-06, Baltimore, Maryland 21244-1850.
Table of Contents
1. GENERAL INFORMATION
1.1 Purpose of Solicitation
1.2 Background
1.3 Objectives and Structure
1.4 Part D Schedule
1.5 Summary of Part D Sponsor Role and Responsibilities
1.6 Summary of CMS Role and Responsibilities
2. INSTRUCTIONS
2.1 Overview
2.2 Other Technical Support
2.3 HPMS Data Entry
2.4 Instructions and Format of Qualifications
2.5 Submission Software Training
2.6 System and Data Testing with CMS
2.7 Summary Instruction and Format for Part D Bids
2.7.1 Format of Part D Bids
2.7.2 CMS Review of Part D Bids
2.7.3 Overview of Part D 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 Direct Contract MA-PD Sponsors
2.10 Protection of Confidential Information
2.11 Waivers
3. APPLICATION
3.1 Applicant Experience, Contracts, Licensure and Financial Stability
3.1.1 Contracts
3.1.1 Management and Operations
3.1.3 Experience and Capabilities
3.1.4 Business Integrity
3.1.5 HPMS Part D Contacts
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 Service Area/Regions
3.4 Pharmacy Access
3.4.1 Retail Pharmacy
3.4.2 Out-of-Network Pharmacy
3.4.3 Mail Order Pharmacy
3.4.4 Home Infusion Pharmacy
3.4.5 Long Term Care (LTC) Pharmacy
3.4.6 Indian Health Service, Indian Tribe and Tribal Organization, and Urban Indian Organization I/T/U Pharmacy
3.4.7 Specialty Pharmacy
3.5 Enrollment and Eligibility
3.6 Complaints Tracking
3.7 Grievances
3.8 Exceptions and Appeals
3.9 Coordination of Benefits
3.10 Tracking Out-of-Pocket Costs (TrOOP)
3.11 Medicare Secondary Payer
3.12 Marketing/Beneficiary Communications
3.13 Provider Communication
3.14 Compliance Plan
3.15 Reporting Requirements
3.16 Data Exchange between Part D Sponsor and CMS
3.17 Upgrades of Health Information Technology
3.18 HIPAA
3.19 Prohibition on Use of SSN or Medicare number on Enrollee Cards
3.20 Record Retention
3.21 Claims Processing
4. CERTIFICATION
5. APPENDICES
Appendix I CMS Connectivity Request Form
Appendix II Banking Information Form
Appendix III Summary of Part D Application Requirements Fulfilled under Part C for Medicare Advantage Prescription Drug (MA-PD) Applicants
Appendix IV Financial Solvency Documentation
Appendix V Certification of Monthly Enrollment and Payment Data Relating to CMS
Payment
Appendix VI Certification that Subcontractors Meet the Requirements of Section 3.1.1F
Appendix VII Crosswalk of Section 3.1.1F Requirements on Subcontracts submitted as attachments to Section 3.1.1F
Appendix VIII Crosswalk for Retail Pharmacy Access Contracts
Appendix IX Crosswalk for Mail Order Pharmacy Access Contracts
Appendix X Crosswalk for Home Infusion Pharmacy Access Contracts
Appendix XI Crosswalk for Long-Term Care Pharmacy Access Contracts
Appendix XII Crosswalk for Indian Tribe and Tribal Organizations, and Urban Indian Organization (I/T/U) Pharmacy Access Contracts
Appendix XIII Applicant Submission of P&T Committee Member List and Certification Statement
Appendix XIV Pharmacy Network Access Instructions
Appendix XV Instructions for Additional Employer/Union-Only Group Waiver/Modification Requests
1. GENERAL INFORMATION
1.1 Purpose of Solicitation
The Centers for Medicare & Medicaid Services(CMS) is seeking applications from entities that meet the requirements of Section 1857(i) to enter into Medicare Advantage Prescription Drug (MA-PD) contracts to offer qualified prescription drug coverage as described in the Medicare Prescription Drug Benefit Final Rule, published in the Federal Register, on January 28, 2005 (70 Fed. Reg. 4194). Hereinafter, these entities will be referred to as “Direct Contract MA-PDs” or “Direct Contract MA-PD Sponsors”). Please submit your applications according to the process described in Section 2.0. If your organization already has a MA contract with CMS, you must complete a renewal application for 2007.
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 sections1860D-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 re-designating 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 its availability to Medicare beneficiaries. Effective January 1, 2006, 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.
The MMA provides employers and unions with a number of options for providing prescription drug coverage to their Medicare-eligible actives and retirees. Under the MMA, those options include making special arrangements with Medicare Advantage Organizations (MAOs) and Section 1876 Cost Plans to purchase customized benefits, including drug benefits, for their actives and retirees; purchasing benefits from sponsors of prescription drug-only plans (PDPs); and directly contracting with CMS to become Part D plan sponsors themselves. Each of these approaches involves the use of CMS waivers authorized under Sections 1857(i) or 1860D-22(b) of the Social Security Act (SSA). Under this authority, CMS may waive or modify requirements that “hinder the design of, the offering of, or the enrollment in” employer-sponsored group plans.
This Solicitation applies to only the last option, the Direct Contract MA-PD employer or union sponsor who directly contracts with CMS to offer a MA-PD to its actives and retirees. Please note, this Solicitation is only to be used for Direct Contract MA-PDs.
CMS is authorized to grant two types of waivers for Direct Contract MA-PD Sponsors. First, CMS is authorized to grant waivers of Part D program requirements where such a requirement conflicts with or duplicates a Part C requirement, or where granting such a waiver would improve the MA-PD sponsors coordination of Part C and Part D benefits. Second, CMS may grant additional waivers or modifications of additional requirements under Part 423 that hinder the design of, the offering of, or the enrollment in the employer/union group-sponsored MA-PD. (See Section 2.11 and Appendix XVIII of the Solicitation.)
CMS payment to MA organizations for provision of Part C services to their enrollees is calculated separately from the payment for the Part D benefit. Like PDP sponsors, MA-PD 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) (MA-PD sponsors are required to follow CMS formulary guidance. See Section 2.7.1 of the Solicitation.)
1.4 Part D Schedule
APPLICATION REVIEW PROCESS |
|
Date |
Milestone |
December 1, 2006 |
New MA organizations: 1. Submit notice of intent to apply to CMS 2. Request HPMS Access (Includes User ID and Password Request) 3. Request CMS Connectivity |
January 14, 2007 |
Final Applications Posted by CMS |
March 12, 2007 |
Applications due
|
March 26, 2007 |
Release of Health Plan Management System (HPMS) formulary submissions module. |
April ??, 2007 |
Plan Creation module, Plan Benefit Package (PBP) and Bid Pricing Tool (BPT) available on HPMS |
April 16, 2007 |
Formulary Submissions due to CMS |
May 2007 |
CMS sends Part D contract eligibility determination to Applicants, based on review of application. Applicant’s bids must still be negotiated (see below) |
May 18, 2007 |
PBP/BPT Upload Module available on HPMS |
June 4, 2007 |
All bids due. |
Early August 2007 |
CMS publishes national average Part D premium
|
September 2007 |
CMS completes review and approval of bid data. CMS executes Part D addenda to MA contract with MA-PD organizations who submit an acceptable bid. |
November 15, 2007 |
2008 Annual Coordinated Election Period begins |
NOTE: CMS reserves the right to amend or cancel this Solicitation at any time. CMS also reserves the right to revise the Medicare Prescription Drug Benefit program implementation schedule, including the solicitation and bidding process timelines.
1.5 Summary of Direct Contract MA-PD Sponsor’s Role and Responsibilities
Key aspects of each MA-PD shall include the ability to:
Submit a formulary each year for CMS approval.
Submit a MA-PD plan bid each year for CMS approval.
Restrict enrollment in the MA-PD to those Part D eligible individuals eligible for the employer’s/union’s employment-based group coverage.
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.
MA-PDs (except Medicare private fee for service plans) must feature a contracted retail pharmacy network, providing enrollees convenient access to retail pharmacies as specified in 42 CFR §423.120
Process claims at the point of sale.
All MA-PDs must operate quality assurance programs. MA-PDs, except Medicare Private Fee-for-Service plans meeting specific requirements, must also provide drug utilization review, and medication therapy management programs.
Administer 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 beneficiary dissemination 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, coordinated 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 enters into a contract with an Applicant. The first phase is the Part D application review process. CMS reviews the application submitted on or by March 12, 2007 to determine whether the Applicant meets the qualifications we have established to enter into a Part D addendum to the Applicant’s Part C contract.
The second phase has two steps – the formulary upload which begins March 26, 2007 and the Part D bid upload which begins May 18, 2007. The formulary review entails determining that the proposed formulary (if one is used) has at least two drugs in every therapeutic category and class (unless special circumstances exist that would allow only one drug); does not substantially discourage enrollment by certain types of Part D eligible individuals; includes adequate coverage of the types of drugs most commonly needed by Part D enrollees; and includes an appropriate transition policy. CMS contacts applicants if any issues are identified during the review for discussion and resolution. The intent is to provide an opportunity for applicants to make any necessary corrections prior to Part D bid submission on June 4, 2007. The second step involves the bid review and negotiations with applicants to assure 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 addendum as a result of successfully completing phase one and two are offered a Part D addendum to their Medicare managed care contract by CMS.
CMS has developed a Medicare Prescription Drug Benefit program monitoring system to ensure that the Part D sponsors deliver good value through defined benefits and are compliant with program requirements. This monitoring system was developed in coordination with the CMS personnel responsible for oversight of the Medicare Advantage program to minimize duplication of effort. 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, beneficiary dissemination, program safeguard activities, customer service, confidentiality and security of enrollee information, and effectiveness of tracking true out-of-pocket costs. The types of reporting that CMS requires of Part D sponsors is presented in the application. For additional information on reporting requirements, refer to the www.cms.hhs.gov/ website. (NOTE: Part D sponsors, as covered entities under the Health Insurance Portability and Accountability Act Privacy Rule, are subject to investigation and penalties for findings of Health Insurance Portability and Accountability Act Privacy Rule violations as determined by the Department of Health and Human Services Office for Civil Rights and the Department of Justice.) We monitor compliance, through the analysis of data we collect from Part D sponsors, CMS contractors, and our own systems. The types of data we collect from sponsors include: certain benefit data, PDE claims data, cost data, benefit management data, beneficiary dissemination information, and complaints data.
To monitor plan performance in the areas we have identified, we: 1) operate a complaints tracking system to monitor and manage complaints brought to our attention that are not satisfactorily resolved through the Direct Contract MA-PD sponsors’ grievance processes; and 2) conduct periodic site visits to verify Direct Contract MA-PD sponsor’s 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, significant departures from the marketed Part D offering, or fraud or other violations of State or Federal laws, appropriate action is taken ranging from request 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 Services Office of the 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 other activities that publicize or otherwise educate beneficiaries about the program.
Marketing Guidelines and Review
Marketing guidelines are posted on the www.cms.hhs.gov/ website, and will be updated on a quarterly basis. Direct Contract MA-PD Sponsors will be required to adhere to all CMS requirements concerning marketing and beneficiary dissemination unless these requirements have been specifically waived and/or modified for Direct Contract MA-PD sponsors. Specific marketing requirements that are eligible for waiver are reflected in this application. Beneficiary dissemination requirements relevant to this Solicitation are incorporated herein. (See Section 3.9 of the Solicitation.)
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 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, and communicate 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 how low income subsidy eligibility determinations are made, refer to the www.cms.hhs.gov/ website .
CMS has developed a system to review an individual’s eligibility for the Part D benefit. Beneficiaries enrolled in a Direct Contract MA–PD plan must obtain qualified prescription drug coverage through that plan (42 CFR 423.30 (b)) or they are enrolled in a MSA plan (42 CFR 423.30 (b)).
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. Finally, CMS tracks disenrollments from Part D plans and will deny new enrollments during any given year unless the enrollment occurs during an allowable enrollment period. For additional information regarding enrollment processing, refer to the www.cms.hhs.gov/ website
Under Section 1857(i) of the Social Security Act, Direct Contract MA-PD Sponsors may only offer “employment based retiree health coverage.” Therefore, Direct Contract MA-PD Sponsors will be required to restrict enrollment to those Part D eligible individuals eligible for their employment-based group coverage.
Direct Contract MA-PD Sponsors may enroll those Part D eligible individuals eligible for the employer’s/union’s employment-based group coverage using a group enrollment process that includes providing CMS with any information it has on other insurance coverage for the purposes of coordination of benefits. Also, special enrollment periods exist for individuals enrolling in employer/union group-sponsored Part D plans, for individuals to disenroll from a Part D plan to take employer/union group-sponsored coverage of any kind, and for individuals disenrolling from employer/union group-sponsored coverage to enroll in a Part D plan. These special enrollment rules apply to Direct Contract MA-PD Sponsors. For additional information regarding enrollment and eligibility, refer to www.cms.hhs.gov/States/Downloads/CMSOperationalGuidanceforPDPEnrollment.pdf.
Payment to Direct Contract MA-PD Sponsors
Generally, CMS provides payment to Direct Contract MA-PD Sponsors in the form of advance monthly payments (consisting of the MA-PD plan’s Part D standardized bid, risk adjusted for health status, minus the beneficiary monthly premium), and estimated low-income subsidies. After the end of the payment year, CMS reconciles the correct amounts of low-income subsidies against the amount paid as a part of the prospective monthly payments. A complete description of the bidding and payment process for Direct Contract MA-PD Sponsors will be included in future CMS guidance. For a more complete description refer to Prescription Drug Event Data that is posted on the www.cms.hhs.gov website.
2. INSTRUCTIONS
2.1 Overview
This application is to be completed by those qualified employer/union entities that intend to offer an MA-PD plan during 2008. This application is to be submitted to CMS in conjunction with the documents required for participation in the Part C program during 2008 (e.g., a new MA application). Please refer to the guidance for MA and Cost Plan sponsors posted on the CMS web site for instructions on the type of MA documentation your organization must provide to CMS to qualify to operate an MA plan during 2008.
2.2 Other Technical Support
CMS conducts technical support calls, also known as User Group calls, for Applicants. CMS operational experts (e.g., enrollment, information systems, marketing, bidding, formulary design, and coordination of benefits) are available to discuss and answer questions on the agenda items for each meeting. Registration for the technical support calls and to join the list serve to get updates on CMS guidance can be found at www.aspenxnet.com/partd/usergroups
2.3 Health Plan Management System (HPMS) Data Entry
MA-PD and/or RPPO organizations that submit a Notice of Intent to Apply form are assigned a pending contract number (H/R number) to use throughout the application and subsequent operational processes. Once the contract number is assigned, MA-PD and/or RPPO Applicants receive their CMS User ID(s) and password(s) for HPMS access and need to input contact and other related information into the Health Plan Management System (HPMS). Applicants are required to provide prompt entry and ongoing maintenance of data in HPMS. By keeping the information in HPMS current, the Applicant facilitates the tracking of their application throughout the review process and ensures that CMS has the most current information for application updates, guidance and other types of correspondence.
In the event that an Applicant is awarded a contract, this information will also be used for frequent communications during implementation. Therefore, it is important that this information be accurate at all times.
2.4 Instructions and Format of Qualifications
Applications may be submitted up until March 12, 2007. Applicants must use the 2008 solicitation. CMS will not accept or review in anyway those submissions using the 2007 solicitation.
Instructions
Applicants must include the contract ID number in the heading on each page of the application submitted to CMS.
In preparing your application in response to the prompts in Section 3.0 of this solicitation, please mark “Yes” or “No” in sections organized with that format.
In many instances Applicants are directed to affirm that they will meet particular requirements by indicating “Yes” next to a statement of a particular Part D program requirement. By providing such attestation, an Applicant is committing its organization to complying with the relevant requirements as of the date your contract is signed, unless an alternative date is noted in Section 3.0.
Additional supporting documentation is notated in the following manner throughout the application and is to be submitted as follows:
Appendices: documents supplied by CMS that are contained at the end of this application. They are to be completed by the Applicant and returned to CMS as indicated.
Attachments: documents that are to be created and/or supplied by the Applicant and sent to CMS with the application. Attachments are to be used only when the application does not indicate to respond directly below the question. (i.e. subcontracts, letters of agreement, etc.)
Legal documents such as subcontracts should be provided in hard copy as an attachment to the application. In addition, all subcontracts and other legal documents should be provided on the CD copies of the application. The CD identification should include the appendix number.
CMS has established that all aspects of the program that the Direct Contract MA-PD Sponsor attests to must be ready for operation by the contract signature date. As with all aspects of a Direct Contract MA-PD 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 Direct Contract MA-PD Sponsor’s facilities as well as through other program monitoring techniques. Consequences of a failure to meet the requirements attested to in this Solicitation and failure to operate a Part D plan consistent with the requirements of the applicable statutes, regulations, call letter, and the Part D contract may delay the Direct Contract MA-PD’s enrollment activities or, if corrections cannot be made in a timely manner, the Direct Contract MA-PD Sponsor may be disqualified from participation in the Part D program.
An individual with legal authority to bind the Applicant shall sign and submit the certification found in Section 4.0. CMS reserves the right to request clarifications or corrections to a submitted application. Failure to provide requested clarifications within a 2-day period could result in the applicant receiving a notice of intent to deny the application, in which case, the Applicant will then have 10 days to seek to remedy its application.
This Solicitation does not commit CMS to pay any cost for the preparation and submission of an application.
Format
To assure that each CMS review panelist receives the application in the manner intended by the applicant, Applicants should deliver a total of two (2) hard copies of the supporting documentation.
Applicant must include a cover letter with the supporting documentation that includes the following elements:
Organization Name
Parent Organization if any
Organization Address
Organization Phone #
Contract ID # (or #s if applicable)
Contact Person(s)
Contact Person(s) Phone Number(s)
Contact Person(s) Email Address(es)
Note: It is important that Applicant provides 2 separate contact persons and applicable contact information for MA-PD Application submission(s). This will help to avoid delays in the processing of an application.
All responses must be completed in Microsoft Word, Microsoft Excel, or PDF (in a version that is compatible with Office 2003).
Both hard copies must be in separate 3-ring binders. Tab indexing must be used to identify all of the major sections of the application. Page size must be 8 ½ by 11 inches and the pages must be numbered. Font size must be 12 point.
One application must be clearly marked, “Original” and contain all original signed certifications requested in the application.
Additionally, the Applicant must submit the cover letter, written application, appendices, attachments and all supporting documentation electronically on 2 duplicate (CDs). This will support the review of the application by different CMS components.
Each CD must be clearly labeled with the information in the table below:
Applicant’s Organization Name |
CMS Identification Number (Contract ID #s) |
CD Number (Copy 1, Copy 2)
NOTE: If all of the application materials will not fit on a single CD, Applicant must submit multiple CDs and label them as follows: Copy 1 (1 of 2), Copy 1 (2 of 2); Copy 2 (1 of 2), Copy 2 (2 of 2), etc. |
Failure to submit an application consistent with these instructions may delay its review by CMS and could result in receipt of a notice of intent to deny.
Applications must be sent to:
Centers for Medicare & Medicaid Services (CMS)
Mail Stop: C1-22-06
Attn: Direct Contract MA-PD Application
7500 Security Boulevard
Baltimore, Maryland 21244-1850
In order for CMS to receive your application in a timely manner, please note that Federal Express and the US Postal Service possess a CMS Security Clearance. Applications mailed through carriers that do not have CMS Security Clearance could be delayed due to clearance processing.
CMS will not review applications received after 5:00 P.M. EST on March 12, 2007.
Applicant Entity Same as Contracting Entity
The legal entity that submits this application must be the same entity that signs a MA contract with CMS and seeks an addendum for the Part D benefit.
Technical Assistance
For technical assistance in the completion of this Application, contact:
Marye Isaacs by email at Marye.Isaacs@cms.hhs.gov or by phone at 410-786-3276 or Julian Nadolny by email at Julian.Nadolny@cms.hhs.gov or by phone at 410-786-2274.
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 related information collected in HPMS in order to facilitate the application review process.
Applicants are required to upload their plan formularies to HPMS using a pre-defined file format and record layout. The formulary upload functionality will be available on March 26, 2007. The deadline for formulary submission to CMS is by close of business on April 16, 2007.
In order to prepare plan bids, Applicants will use HPMS to define their plan structures and associated plan service areas and then download the Plan Benefit Package (PBP) and Bid Pricing Tool (BPT) software. For each plan being offered, Applicants will use the PBP software to describe the detailed structure of their Part D benefit and the BPT software to define their bid pricing information. The formulary must accurately crosswalk to the PBP.
Once the PBP and BPT software has been completed for each plan being offered, Applicants will upload their bids to HPMS. Applicants will be able to submit bid uploads to HPMS on their PBP or BPT one or more times between May 18, 2007 and the CY 2008 bid deadline of June 4, 2007. CMS will use the last successful upload received for a plan as the official bid submission.
CMS will provide technical instructions and guidance upon release of the HPMS formulary and bid functionality as well as the PBP and BPT software. In addition, systems training will be available at the Bid Training in April 2007.
2.6 System and Data Testing with CMS
MA-PD organizations 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. MA-PD sponsors are required to secure access to HPMS in order to carry out these functions. Transitioning MA organizations have HPMS connectivity and are not required to re-establish their HPMS connectivity.
All Direct Contract MA-PD 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, MA-PD sponsors must contact the MMA Helpdesk at 1-800-927-4736 for specific guidance on establishing connectivity and the electronic submission of files. The MMA Helpdesk will be the primary contact for all issues related to the physical submission of transaction files to CMS. MA-PDs that enter into a contract with CMS must also submit the Banking Information Form (Appendix??) so that payments can be transmitted to your account.
Each month, CMS will provide reports to each Direct Contract MA-PD sponsor for each of their plans with member and plan-level information by CMS. MA-PD 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 days. An analyst or group of analysts in that office will be responsible for your geographic area and will 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 Helpdesk also provides additional information at that site regarding frequent questions and answers from MA-PD sponsors.
Payments 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 will include premiums and subsidies CMS is paying on behalf of low-income individuals qualifying for the full and partial low-income subsidies. Estimated low-income subsidies will also be included.
The monthly payment will include premiums and subsidies CMS is paying on behalf of low-income individuals.
2.7 Summary Instruction and Format for Part D Bids
Each Direct Contract MA-PD Sponsor must submit to CMS a bid for each prescription drug plan it intends to offer. Further guidance for Direct Contract MA-PD Sponsors on bidding for 2007 contract year will be provided by DMS. Applicants must submit their formularies to HPMS on or before April 16, 2007 and the PBPs and BPTs on or before June 4, 2007.
2.7.1 Format of Part D Bids
Bid Submission Sections Due Prior to June 4, 2007
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 by April 16, 2007. CMS reviews areas of each proposed drug plan formulary by tier and drug availability and evaluate 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 review of the formulary development process prior to CMS approval of the bid. CMS makes reasonable efforts to inform Applicants of their outliers so that they may substantiate their offering. If such substantiation is not satisfactory to CMS, the Applicant is given the opportunity to modify the formulary. CMS intends to complete as much of this work as possible before the June 4, 2007, PBP and BPT submissions so that any modification may be reflected in those documents.
Bid Submission Due June 4, 2007
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. Generally, 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 42 CFR 423.505(k)(4), the CEO, CFO, or a delegee with the authority to sign on behalf of one of these officers, and who reports directly to such officer, must certify (based on best knowledge, information and belief) that the information in the bid submission, and assumptions related to projected reinsurance and low-income cost sharing subsidies, is accurate, complete, and truthful, and fully conforms to the requirements in Section 423.265 of the regulations. In addition, the pricing component of the bid must also be certified by a qualified actuary.
2.7.2 CMS Review of Part D 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 MA-PD 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 Part D Bid Negotiation
CMS evaluates the reasonableness of bids submitted by MA-PD applicants 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 our authority to deny a bid if we do not believe that the bid and its underlying drug prices reflect market rates.
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. 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
CMS waived the specific Part D retail pharmacy access standards in 423.120(a)(1) (“TriCare” standards) for Employer/Union Direct Contract PDPs. Direct PDPs must agree that its retail pharmacy access will be sufficient to meet the needs of its population, including situations involving emergency access. CMS may review the adequacy of the plan’s pharmacy networks and potentially require expanded access in the event of beneficiary complaints or for other reasons it determines in order to ensure that the plan’s network is sufficient to meet the needs of its retiree population.
Section 3.4 of this Solicitation includes a reference to Appendix XIII that provides Applicants with detailed instructions to complete the retail pharmacy network access portion of this submission. For purposes of meeting the 2008 Pharmacy Access requirements, Applicants may use their contracted PBM’s existing 2007 Part D network to demonstrate compliance. If an Applicant is creating a new Part D network, the submission must be based on executed contracts for Year 2008. See Appendix XIII 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 3.4.4). CMS uses this pharmacy listing to develop a ratio for the number of contracted home infusion pharmacies in each State/Territory in the proposed service area compared to the number of Medicare beneficiaries in each State/Territory in the proposed service area and identify outliers amongst all Applicants.
Long-Term Care Pharmacy Access
Applicants must demonstrate that their contracted pharmacy network provides convenient access to long-term care pharmacies. In order to demonstrate convenient access to long-term care pharmacies, Applicants must provide a list of all contracted long-term care pharmacies (see section 3.4.5). CMS uses this pharmacy listing to develop a ratio for the number of contracted long-term care pharmacies in each State/Territory in the proposed service area compared to the number of nursing home beds in each State/Territory in the proposed service area and identify outliers amongst all Applicants.
Waivers Related to Pharmacy Access
Waivers for MA-PD Plans. On June 3, 2005, CMS issued special guidance related to Medicare Advantage Prescription Drug Plan and Cost Plan waiver requests located at: www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/10_RxContracting_SpecialGuidance.
CMS has waived for MA-PDs provisions (described below) related to the pharmacy access and any willing pharmacy standards. If an Applicant believes that any waiver described below applies to a specific contract/plan number then please complete the documentation identified. These waivers do not apply to any PDPs regardless of whether Applicant is also seeking to offer MA-PDs or cost plans to which the waivers to apply.
Waiver of Convenient Access Standards for MA-PFFS
The requirement that Applicants must offer Part D plan benefits through a contracted pharmacy network that meets CMS convenient access standards is waived for MA-PFFS plans that meet the criteria in table 3.4A.
Waiver of Any Willing Pharmacy Requirements for MA-PD
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.
2.9 Standard Contract with Direct Contract MA-PD Sponsors
Successful Applicants will be deemed qualified to enter into a Part D addendum to their Medicare Advantage contract after CMS has reviewed the Applicant’s entire submission. Under this addendum the MA-PD sponsor will be authorized to operate one or more Medicare prescription drug plans. It is only after the qualified Applicant and CMS have reached agreement on the Applicant’s bid submissions will the Applicant be asked to execute its Part D addendum.
2.10 Protection of Confidential Information
Applicants can always seek to protect their information from disclosure under the Freedom of Information Act (FOIA) by claiming that FOIA Exemption 4 applies. The Applicant is required to label the information in question "confidential" or "proprietary", and explain the applicability of the FOIA exemption it is claiming. When there is a request for information that is designated by the Applicant as confidential or that could reasonably be considered exempt under Exemption 4, CMS is required by its FOIA regulation at 45 C.F.R. 5.65(d) and by Executive Order 12,600 to give the submitter notice before the information is disclosed. To decide whether the Applicant’s information is protected by Exemption 4, CMS must determine whether the Applicant has shown that— (1) disclosure of the information is likely to impair the government's ability to obtain necessary information in the future; (2) disclosure of the information is likely to cause substantial harm to the competitive position of the submitter; or (3) the records are considered valuable commodities in the marketplace which, once released through the FOIA, would result in a substantial loss of their market value. Consistent with our approach under the Medicare Advantage program, we would not release information under the Medicare Part D program that would be considered proprietary in nature.
2.11 Waivers
2.11.1 Waivers for All MA-PD Sponsors
CMS is authorized to grant waivers of Part D program requirements where such a requirement conflicts with or duplicates a Part C requirement, or where granting such a waiver would improve the MA-PD sponsor’s coordination of Part C and Part D benefits. Accordingly, CMS has identified the waivers it is granting to all MA-PD sponsors in the chart shown in Summary of Medicare Part D Regulatory Requirements Fulfilled under Part C for Medicare Advantage Prescription Drug (MA-PD) Applicants (Appendix III). As a result of these CMS-granted waivers, the MA-PD sponsor application is less comprehensive than the PDP sponsor application. These waivers will be reflected in each MA-PD sponsor’s Part D addendum.
Applicant Requests for Additional Waivers: CMS may grant additional waivers upon an MA-PD sponsor’s request, provided that the waivers may be justified as duplicative of or conflicting with Part C requirements, or improving the coordination of Part C and Part D benefits. Any waiver granted by CMS will apply to all similarly situated MA-PD sponsors.
For each waiver request, the Applicant must provide, as an attachment to its MA-PD application and on a CD per instructions in Section 2.4, a statement that includes:
The Part D regulation reference;
The appropriate waiver criteria (e.g., duplicative, conflicts, improves benefit coordination);
A discussion of how the requested waiver meets at least one of the three waiver criteria.
CMS will notify Applicants whether their requests were approved via a CMS web posting of all approved waivers. As noted above, waivers granted will be reflected in each MA-PD sponsor’s Part D addendum.
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 must check both the “Yes” box and the “Waiver Requested” box. 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 at the end of the summer of 2006. This process will prevent Applicants from having to submit additional application responses after the original March 12, 2007 deadline. If, as a result of CMS’ denial of its waiver request, the Applicant no longer intends to offer a Part D benefit plan, the Applicant must notify CMS in writing on or before June 30, 2007. CMS will not execute a Part D addendum with Applicants that submit such a notice. This 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 C1-22-06
Baltimore, Maryland 21244-1850
2.11.2 Waivers for Direct Contract MA-PD Sponsors
Direct Contract MA-PD Waiver Information: In general, Part D plans can only cover beneficiaries in the service areas in which they operate. However, under CMS waiver authority, employers/unions which directly contract with CMS to sponsor their own MA-PD plans, can extend coverage to all of their beneficiaries, regardless of whether they reside in one or more other MA regions in the nation.
Also, Part D plans must meet minimum enrollment standards (42 CFR 423.512(a)). CMS has waived this requirement for all Direct Contract MA-PD Sponsors.
In general, a MA organization must be organized and licensed under State law as a risk-bearing entity eligible to offer health insurance or health benefits coverage in each State in which it offers its coverage. (42 CFR 423.504(b)(2), 422.400 and 422.501.) However, CMS has waived the state licensing requirement for all Direct Contract MA-PD Sponsors. However, CMS will require such entities to meet the financial solvency standards identified in Appendix VI of the Solicitation.
Additional relevant waivers that CMS has granted to Direct Contract MA-PD Sponsors are incorporated into this Solicitation.
Applicant Requests for Additional Waivers: CMS may grant additional waivers or modifications of additional requirements under 42 CFR Parts 422 and 423 that hinder the design of, the offering of, or the enrollment in the employer/union group-sponsored MA-PD.
There are certain attestations to which all applicants must attest ‘Yes’ in the Solicitation. However, in addition to attesting ‘Yes,’ an Applicant may request in writing a waiver or modification of additional requirements under this Part that hinder the design of, the offering of, or the enrollment in the Direct Contract MA-PD. Applicants who wish to request waivers in addition to those specified in the Solicitation must satisfy the requirements of Appendix XVIII.
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 must check both the “Yes” box and the “Waiver Requested” box. 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 at the end of the summer of 2006. Waivers or modifications approved by CMS apply to any similarly situated entity seeking to offer, sponsor, or administer a Direct Contract MA-PD meeting the conditions of the waiver or modification. 42 CFR 422.106(d).
If, as a result of CMS’ denial of its waiver request, the Applicant no longer intends to offer a Part D benefit as part of their MA plan, the Applicant must notify CMS in writing. CMS will not execute a Part D addendum with Applicants that submit such a notice. This 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 C1-22-06
Baltimore, Maryland 21244-1850
Note: Nothing in this application is intended to supersede the regulations at 42 CFR Part 423, except to the extent waivers and/or modifications to these requirements have been granted by CMS. Failure to reference a regulatory requirement in this application does not affect the applicability of such requirement, and MA-PD Sponsors are required to comply with all applicable requirements of the regulations in 42 CFR Part 423.
For several of the Part D program requirements described in this Solicitation, CMS has issued operational policy guidance that provides more detailed instructions to Part D sponsors. Organizations submitting an application in response to this Solicitation acknowledge that in making the attestations stated below, they are also representing to CMS that they have reviewed the associated guidance materials posted on the CMS web site and will comply with such guidance should they be approved for a Part D contract. Applicants must visit the CMS web site periodically to stay informed about new or revised guidance documents.
3.1 Applicant Experience, Contracts, Licensure and Financial Stability
3.1.1 Management and Operations
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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B. Complete the form below inserting ‘N/A’ if a line is not applicable:
IDENTIFY YOUR ORGANIZATION BY PROVIDING THE FOLLOWING INFORMATION |
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Full Legal Organization’s Name: |
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Full Address of Your Organization’s Headquarters (Street, City, State, Zip):
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Name of Chief Executive Officer/Trustee(s)/Equivalent Official: |
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Name of Chief Operating Officer/Trustee(s)/Equivalent Official: |
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Name of Chief Financial Officer: |
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Type of Entity (place a checkmark in all applicable boxes): Employer Trust established by one or more employers or labor organizations Union Governmental Church Group Not-for-Profit Publicly-Traded Corporation Privately- Held Corporation Other (list type) ___________________ |
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Name of Your Organization’s Parent Organization, if any: |
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Is Applicant subject to ERISA? Yes No |
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State in Which your Organization is Incorporated or Otherwise Organized to do Business: |
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Federal Taxpayer Identification Number: |
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PROVIDE NAME AND TITLE OF INDIVIDUAL WHO WILL SIGN THE MA-PD CONTRACT, IF APPLICATION AND BID ARE SUCCESSFUL. PLEASE SEE 42 CFR §423.502(b). THIS PERSON MUST BE AUTHORIZED TO ACT FOR THE ENTITY |
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Name of Individual: |
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PROVIDE YOUR COMPANY’S CONTACT INFORMATION FOR AN INDIVIDUAL WHO CAN ANSWER QUESTIONS REGARDING YOUR ORGANIZATION’S APPLICATION |
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Name of Individual: |
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Telephone Number: |
Fax Number: |
Email Address: |
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C. Provide as an attachment, a brief summary of the background, history, structure and ownership of Applicant’s organization. Include a chart showing the structure of ownership, subsidiaries, and business affiliations. The organizational chart should depict the placement of the MA-PD operations within Applicant’s organization as well as who within Applicant’s organization will be managing/administering the MA-PD.
If Applicant is a state agency, instrumentality or subdivision, the organizational chart should indicate the relationship between the entity that is named as the MA-PD Applicant and the state or commonwealth with respect to which Applicant is an agency, instrumentality or subdivision. The organizational chart also should indicate the source of Applicant’s revenues including whether Applicant receives appropriations and/or have the authority to issue debt.
If Applicant is a labor organization including a fund or trust, the organizational chart should indicate the relationship (if any) between Applicant and any other related labor organizations such as regional, local or international unions, or welfare funds sponsored by such related labor organizations. If Applicant is a jointly trusteed Taft-Hartley fund, please include the names and titles of labor-appointed and management-appointed trustees.
If Applicant is a trust such as a voluntary employee beneficiary association under Sec. 501(c)(9) of the Internal Revenue Code, the organizational chart should include the names of the individual trustees and the bank, trust company or other financial institution that has custody of Applicant’s assets.
D. Complete the form(s) below to identify the names of each of the entities with which you subcontract or will subcontract to serve the functions identified in Subsection 3.1.1 E.
IDENTIFY YOUR SUBCONTRACTOR BY PROVIDING THE FOLLOWING INFORMATION |
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Full Legal Organization’s Name of Subcontractor: |
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Full Address of Subcontractor’s Headquarters (Street, City, State, Zip): |
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Name of Chief Operating Officer: |
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Name of Chief Financial Officer: |
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Type of Ownership: Sole Proprietorship Partnership Publicly-Traded Corporation Privately- Held Corporation Other (list type)___ _______
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Name of Subcontractor’s Parent Organization, if any: |
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State in Which Your Subcontractor is Incorporated or Otherwise Organized to do Business: |
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Federal Taxpayer Identification Number: |
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PROVIDE INDIVIDUAL WHO WILL SIGN THE MEDICARE CONTRACT WITH THE MA-PD APPLICANT. THIS PERSON MUST BE AUTHORIZED TO ACT FOR THE SUBCONTRACTOR ENTITY: |
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Name of Individual: |
Title: |
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E. Subcontractor Function Chart
Identify the names of the sub-contractors you will use to serve these functions. (Indicate “APPLICANT” where applicant will perform those functions). NOTE: Information for each identified subcontractor must be provided in 3.1.1D. |
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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, 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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F. Provide as attachments (as instructed in Section 2.4) copies of executed contracts or executed letters of agreement with each subcontractor identified in 3.1.1D that contain each of the elements listed below.
Clearly identify the parties to the contract (or letter of agreement);
Describe the functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant;
Contain language clearly indicating that the subcontractor has agreed to participate in your Medicare Prescription Drug Benefit program (except for a network pharmacy if the existing contract would allow participation in this program), and flow-down clauses requiring their activities be consistent and comply with the Applicant’s contractual obligations as a Direct Contract MA-PD Sponsor;
Contain language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Benefit program;
Describe the payment the subcontractor will receive for performance under the contract, if applicable;
Are for a term of at least the one-year contract period (e.g., January 1 through December 31) for which this application is being submitted.
Are signed by a representative of each party with legal authority to bind the entity;
Contain language obligating the subcontractor to abide by all applicable Federal and State laws and regulations and CMS instructions;
Contain language obligating the subcontractor to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for this program at 42 CFR 423.136;
Contain language ensuring that the subcontractor will make its books and other records available in accordance with 42 CFR 423.505(i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to inspect, evaluate and audit books and other records and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later.
Contain language that the subcontractor will ensure that beneficiaries are not held liable for fees that are the responsibility of the Direct Contract MA-PD Sponsor;
Contain language that if the Applicant, upon becoming a Direct Contract MA-PD Sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement;
Contain language specifying that the Applicant, upon becoming a MA-PD sponsor, will monitor the performance of the subcontractor on an ongoing basis; and
Contain language specifying that if the subcontractor will establish the pharmacy network or select the pharmacies to be included in the network, the Direct Contract MA-PD Sponsor retains the right to approve, suspend, or terminate any arrangement with a pharmacy.
15. Contain language to ensure PBM reporting 100% of the manufacturer rebates paid for drugs provided under the sponsor’s Part D plan, including the portion of such rebates retained by the PBM as part of the price concession for the PBM’s services. (e.g. clause that provides for 100% reporting requirement with an auditing clause in any contract).
G. Provide as an attachment, as instructed in section 2.4, the signed certification in Appendix V. The certification allows the Applicant to verify that the subcontracts meet all of the requirements identified in 3.1.1F.
H. Provide as an attachment, crosswalks of the subcontract citations demonstrating that the requirements of Section 3.1.2D are included in the subcontracts. Submit this data by creating a spreadsheet in Microsoft Excel that mimics Appendix VI. Provide this attachment as instructed in Section 2.4.
3.1.2 Experience and Capabilities
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN. |
YES |
NO |
Requesting Waiver? Yes or No |
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3.1.3 Financial Solvency
A MA-PD generally must be licensed by at least one state as a risk-bearing entity. (42 CFR 423.401(a)(1), 422.400 and 422.501.) CMS has waived the requirement for Direct Contract MA-PD Sponsors. Direct Contract MA-PD Sponsors are not required to be licensed, but must demonstrate financial solvency through other CMS requirements. Each Direct Contract MA-PD Sponsor applicant must comply with the requirements set forth at Appendix VI and provide all required information.
3.1.4 Business Integrity
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO THE FOLLOWING QUALIFICATION TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO THE FOLLOWING QUALIFICATION BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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B If Applicant answered No to 3.1.4A2, provide as an attachment, all past or pending, if known, investigations, legal actions, or matters subject to arbitration brought by a government agency (state or federal including CMS) over the past three years relating to payments from government entities, for healthcare and/or prescription drug services involving the following:
1. Applicant (and Applicant’s parent firm if applicable;
2. PBM (and PBM’s parent firm if applicable); and
3. Key management or executive staff
Provide as part of the attachment a brief explanation of each action, including the following:
1) Legal names of the parties;
2) Circumstances;
3) Status (pending or closed);
4) If closed, provide the details concerning resolution and any monetary payments;
and
5) Settlement agreements or corporate integrity agreements.
3.1.5 HPMS Part D Contacts
A. Complete the table below: 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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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 |
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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
A. 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’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN IN HPMS. |
YES |
NO |
1. Applicant will submit a formulary to CMS for the Part D benefit. |
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B. Complete the table below:
IF APPLICANT IS SUBMITTING A FORMULARY, THEN APPLICANT MUST ALSO PROVIDE A P&T COMMITTEE MEMBER LIST EITHER DIRECTLY OR THROUGH ITS PHARMACY BENEFIT MANAGER (PBM). APPLICANT MUST ATTEST ‘YES’ OR ‘NO’ THAT IT IS USING ITS PHARMACY BENEFIT MANAGER’S P&T COMMITTEE, IN ORDER TO BE APPROVED FOR AN ADDENDUM TO ITS MA CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO THE FOLLOWING QUALIFICATION BY PLACING A CHECKMARK IN THE RELEVANT COLUMN. |
YES |
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 A9, 10, 11 and 13 above. If Applicant is providing names of P&T Committee directly, then complete the form below. If PBM is providing the P&T Committee, refer to Appendix XII for additional instructions.
PROVIDE THE NAMES OF THE MEMBERS OF YOUR ORGANIZATION’S P&T COMMITTEE. INDICATE WHICH MEMBERS ARE PRACTICING PHYSICIANS OR PRACTICING PHARMACISTS. FURTHER, INDICATE WHICH MEMBERS ARE EXPERTS IN THE CARE OF THE ELDERLY OR DISABLED, AND FREE OF ANY CONFLICT OF INTEREST WITH YOUR ORGANIZATION AND PHARMACEUTICAL MANUFACTURERS. (APPLICANTS SHOULD MARK THE INFORMATION AS PROPRIETARY.) SUBMIT THE DATA BY CREATING A SPREADSHEET IN MICROSOFT EXCEL THAT MIMICS THE TABLE BELOW. PROVIDE THIS ATTACHMENT ON A CD AS INSTRUCTED IN SECTION 2.5. |
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Practice/Expertise Mark an ‘X’ in Appropriate Column |
Free of Any Conflict of Interest Type Yes or No Type Yes if the member has no conflict of interest and NO if there is a conflict of interest. Please complete for each member of the P&T Committee. |
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Full Name of Member Start Date and End Date |
Practicing Physician |
Practicing Pharmacist |
Elderly/Disabled Expert |
With Your Organization? |
With Pharmaceutical Manufacturers? |
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3.2.2 Utilization Management Standards
If the Applicant is an MA Private Fee for Service (MA-PFFS) organization, as described in 42 CFR 422.4 (a) (3), the utilization management requirements used as the basis for this subsection of the application do not apply. (See 42 CFR 423.153 (e).) The Applicant should proceed to subsection 3.2.3 “Quality Assurance and Patient Safety” of the application.
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN. |
YES |
NO |
Requesting Waiver? Yes or No |
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3.2.3 Quality Assurance and Patient Safety
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN. |
YES |
NO |
Requesting Waiver? Yes or No |
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6. Applicant will report to CMS data for QA standards in the manner prescribed by CMS. (See Section 3.16 Reporting Requirements) |
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7. Applicant will establish appropriate transition policies and procedures for beneficiaries on drug regimens that are not on the plan’s Part D formulary. These policies and procedures must address all the elements specified in current formulary transition guidance and the description is not due in March. |
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8 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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9. The 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 formulary by close of business on April 16, 2007 to PartDformularies@cms.hhs.gov. |
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10. Applicant will establish policies and procedures for P&T Committee involvement in reviewing non-formulary drug request to ensure Utilization Management tools are appropriate in situations in which a new enrollee is already stabilized on a drug and the description is not due in March. |
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11. Applicant will establish an emergency supply of non-formulary Part D drugs 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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12. Applicant will establish appropriate timeframes and “first fill” procedures to non-formulary Part D medications in long term care and retail setting. |
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3.2.4 Medication Therapy Management
If the Applicant is a MA Private Fee for Service (MA-PFFS) organization, as described in 42 CFR 422.4(a)(3), the medication management standards used as the basis for this sub-section of the application do not apply (See 42 CFR 423.153 (e)). The Applicant should proceed to sub-section 3.2.5 “Electronic Prescription Program” of the application.
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN. |
YES |
NO |
Requesting Waiver? Yes or No |
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8. Applicant will provide drug claims data to Chronic Care Improvement Programs (CCIP) for those beneficiaries that are enrolled in CCIPs in a manner specified by CMS. |
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9. Applicant will report to CMS specified data on MTM programs in the manner prescribed by CMS. (See Section 3.16 Reporting Requirements) |
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10. Applicant will establish an appropriate policy on how they will set MTM fees to pharmacists or others providing MTM services for covered Part D drugs. The policy will explain how the Applicant’s fee or payment structure takes into account the resources used and the time required for by those providing MTM services. |
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11. The Applicant agrees to submit a description on how they will set MTM fees to pharmacists or others providing MTM services for covered Part D drugs. The policy will explain how the Applicant’s fee or payment structure takes into account the resources used and the time required for by those providing MTM services. Note: Instructions to submit a description of MTM fees with a description of your MTM program will be forthcoming in future guidance from CMS and is not due in March. |
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12. Applicant will establish an appropriate MTM enrollment policy in which once enrolled, beneficiaries will not be disenrolled from the MTMP program if they no longer meet one or more of the MTMP eligibility criteria (as determined by the plan) and will remain in the MTMP program for the remainder of the calendar year. |
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13. Applicant will establish and maintain appropriate interventions for its MTM program for all enrollees who meet all three of the required criteria (as determined by the plan) regardless of setting (i.e. ambulatory, long term care, etc.) |
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14. Applicant will establish and maintain safeguards against discrimination based on the nature of their MTM interventions (i.e. TTY if phone based, Braille if mail based, etc.) |
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3.2.5 Electronic Prescription Program
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO THE FOLLOWING QUALIFICATION TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO THE FOLLOWING QUALIFICATION BY PLACING A CHECKMARK IN THE RELEVANT COLUMN. |
YES |
NO |
Requesting Waiver? Yes or No |
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3.3 Service Area/Regions
In general, Part D plans can only enroll beneficiaries residing in the service areas in which they operate. CMS has waived this requirement for Direct Contract MA-PD Sponsors. Direct Contract MA-PD Sponsors can extend to all of their retirees, regardless of whether they reside in one or more other MA regions in the nation.
3.4 Pharmacy Access
A. Complete the table below ONLY if you are a Private Fee For Service Applicant. Otherwise, proceed directly to 3.4B.
APPLICANT MUST ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
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Note: Only if Applicant attests No to 3.4A1, and Yes to 3.4A2-4, Applicant may move directly to Section 3.5 and will be granted a waiver of convenient access.
B. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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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) the lowest-priced, generically equivalent drug, if one exists for the beneficiary’s prescription, as well as any associated differential in price. (Note: 42 CFR 423.132(a) modifies the timing requirement for LTC pharmacies) |
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7. Applicant agrees to maintain a contract log as specified in forthcoming CMS guidance. |
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8. Applicant agrees that each of the contract provisions referenced in Appendices VII-XI will be included in the respective downstream pharmacy network contracts. |
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9. Applicant agrees to notify CMS when the Applicant changes its pharmaceutical benefit management subcontractor. |
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10. Applicant agrees to notify CMS about any substantive change in your organization’s pharmacy network that may impact your organization’s ability to maintain a Part D pharmacy network that meets CMS’ requirements. |
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Note: While CMS realizes that contracts with Indian Health Services (IHS), Indian Tribes and Tribal organizations and Urban Indian Organization (I/T/U), Federally Qualified Health Centers (FQHC) and Rural Health Centers (RHC) may be counted for purposes of meeting the pharmacy access standards, it should be noted that contracts with these pharmacies may not be used as a substitute for including retail pharmacies in plan networks.
C. Provide as an attachment a contract template containing the unsigned standard terms and conditions (including all provisions listed in Appendices VII through XI offered in the contract (or addenda to the contract) for each of the following types of pharmacies: Retail, Mail Order, Home Infusion, Long-Term Care and I/T/U. The mail order contract template is only necessary if the plan is offering mail order. If Applicant has contracted with a Pharmacy Benefit Management entity to provide a pharmacy network, those downstream contract templates must also be submitted. If there are several different types of standard terms and conditions for the same type of pharmacy, please provide a contract template for all versions and label according to type of pharmacy. For example, if different terms for retail pharmacies apply depending upon geographic location, all standard terms must be provided. Each contract template type must contain the unsigned standard terms and conditions, including the provisions listed in Appendices VII-XI.
D. Provide 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 the applicable requirements cited in Appendix VII through Appendix XI are included in such contracts. Submit this data by creating separate spreadsheets in Microsoft Excel that mimic Appendix VII through Appendix XI. Provide these attachments on each of the 4 CDs as instructed in Section 2.4. If the Applicant is a joint enterprise, this information must be clearly labeled to indicate to which party of the joint enterprise the information pertains.
3.4.1 Retail Pharmacy
CMS has waived the “Tricare” retail pharmacy access requirements set forth in 42 CFR 423.120(a)(1); they will not apply when the plan’s pharmacy network is sufficient to meet the needs of its enrollee population, as determined by CMS. CMS may periodically review the adequacy of the plan’s pharmacy network and require the plan to expand access if CMS determines that such expansion is necessary in order to ensure that the plan’s network is sufficient to meet the needs of its enrollee population.
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
1. Applicant agrees that its retail pharmacy access will be sufficient to meet the needs of its plan population, including situations involving emergency access. |
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2. Applicant acknowledges that CMS may review the adequacy of the plan’s pharmacy networks and potentially require expanded access in the event of beneficiary complaints or for other reasons it determines in order to ensure that the plan’s network is sufficient to meet the needs of its plan population. |
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3. Applicant agrees that when Applicant is offering extended supplies via mail order, it also has to contract with a sufficient number of network retail pharmacies so as to ensure that enrollees have reasonable access to the same extended day supply benefits at retail that are available at mail-order. |
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4. Applicant agrees to use the CMS beneficiary counts in the data file “Medicare Beneficiaries by State, Region, Zip DATE” to prepare the retail network analyses. |
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5. Applicant seeks to obtain a pharmacy access waiver of any willing pharmacy requirements. If YES, complete table C. |
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B.. Complete the table below:
Waiver of Any Willing Pharmacy Requirements for MA-PDs
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Provide the number of prescriptions provided in 2006 by all pharmacies owned and operated by Applicant. |
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Provide the number of prescriptions provided in 2006 at all pharmacies contracted by Applicant. |
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NOTE: CMS will determine the percentage of prescriptions at provided at all pharmacies owned and operated by Applicant over total prescriptions provided at all pharmacies by Applicant.
F. Provide as attachments the Geo-Access Reports as described in Appendix XIII.
G. Provide as attachments the Retail Pharmacy List:
To submit retail pharmacy listings to CMS, Applicants must complete, at a minimum, two worksheets within the Excel file labeled and “Retail Pharmacy List” (see file templates “Retail Pharmacy List” for reference).
1. Assuming that Applicant has only one unique retail pharmacy network, they must complete the following:
Complete the worksheet labeled “Retail List – A”.
Complete all columns with the information indicated in each column heading.
Complete all appropriate cells (columns) for every record (row) for which you are listing a pharmacy.
We recognize that in some instances, networks may exceed a single worksheet and ask that you label each worksheet properly. For instance, label multiple sheets for a single pharmacy list as “Retail List - A”, “Retail List - A2”, “Retail List - A3”, etc. Only designate a worksheet as “Retail List – B” if you are referencing an alternate or separate retail pharmacy listing. In the event Applicant is representing more than one unique retail pharmacy network, create as many worksheets as may be necessary to provide your complete network. Label additional worksheets as “Retail List – B”, “Retail List – C”, etc.
While the documentation that Applicant provides will represent the pharmacy networks for the service area where Applicant’s current retirees reside, Direct Contract PDPs must ensure that they have adequate Part D pharmacy access sufficient to meet the needs of their retiree population wherever retirees may reside. This includes retail/mail order, home infusion, long-term care and I/T/U pharmacy access. These pharmacy access requirements will be included as terms in the CMS contract that will be made available to qualified applicants in September 2007. One way to ensure convenient access in service areas that you may cover but where your retirees presently do not reside would be to subcontract with a pharmacy benefit manager (PBM) that offers a national Part D pharmacy network.
3.4.2 Out-of-Network Pharmacy
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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3.4.3 Mail Order Pharmacy
A. 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. |
YES |
NO |
Requesting Waiver? Yes or No |
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B. Mail Order Pharmacy List
Provide as an attachment the following information:
To submit mail order pharmacy listings to CMS, Applicants must complete, at a minimum, two worksheets within the Excel file labeled and “Mail Order Pharmacy List” (see file templates “Mail Order Pharmacy List” for reference).
1. Assuming that Applicant has only one unique mail order pharmacy network, they must complete the following:
Complete the worksheet labeled “Mail List – A”.
Complete all columns with the information indicated in each column heading.
Complete all appropriate cells (columns) for every record (row) for which you are listing a pharmacy.
We recognize that in some instances, networks may exceed a single worksheet and ask that you label each worksheet properly. For instance, label multiple sheets for a single pharmacy list as “Mail List - A”, “Mail List - A2”, “Mail List - A3”, etc. Only designate a worksheet as “Mail List – B” if you are referencing an alternate or separate mail order pharmacy listing. In the event Applicant is representing more than one unique mail order pharmacy network, create as many worksheets as may be necessary to provide your complete network. Label additional worksheets as “Mail List – B”, “Mail List – C”, etc.
The “Contract ID List” worksheet should list all of the contract numbers and the legal entity name(s) (as it appears in HPMS), that are represented by the mail order list provided in the worksheet labeled “Mail List - A”. For many, if not all, contract numbers, the mail order pharmacy list may be the same. For those contract numbers associated with “Mail List – A”, you will complete the “Contract ID List” worksheet by populating the “List Identifier”, column C, with an “A”. If there are any circumstances, where there are contract numbers that have an alternate mail order pharmacy listing, you will populate the “List Identifier” column with the appropriate letter identifier (i.e. B, C, etc.).
3.4.4 Home Infusion Pharmacy
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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B. Home Infusion Pharmacy List
Within HPMS, Applicants will need to complete at a minimum, two worksheets within an Excel file labeled “Home Infusion Pharmacy List”. (Appendix XIII contains the template “Home Infusion Pharmacy List”).
Assuming that Applicant has only one unique home infusion pharmacy network, do the following:
Complete the worksheet labeled “H_I List – A”. All columns should be completed with the information indicated in each column heading. Please be sure to complete all appropriate cells (columns) for every record (row) for which Applicant is listing a pharmacy. CMS recognizes that in some instances, networks may exceed a single worksheet and ask that Applicant label each worksheet properly. For instance, label multiple sheets for a single pharmacy list as “H_I List - A”, “H_I List - A2”, “H_I List - A3”, etc. Only designate a worksheet as “H_I List – B” if Applicant is referencing an alternate or separate home infusion pharmacy listing.
In the event Applicant is representing more than one unique home infusion pharmacy network, create as many worksheets as may be necessary to provide all the unique networks. Label additional worksheets as “H_I List – B”, “H_I List – C”, etc.
The “Contract ID List” worksheet should list all of the contract numbers and the legal entity name(s) (as it appears in HPMS), that are represented by the home infusion list provided in the worksheet labeled “H_I List - A”. For many, if not all, contract numbers, the home infusion pharmacy list may be the same. For those contract numbers associated with “H_I List – A”, Applicant will complete the “Contract ID List” worksheet by populating the “List Identifier”, column C, with an “A”. If there are any circumstances, where there are contract numbers that have an alternate home infusion pharmacy listing, Applicant will populate the “List Identifier” column with the appropriate letter identifier (i.e. B, C, etc.).
C. Home Infusion Discussion
Provide as an attachment a discussion about how your organization’s contracted home infusion network assures adequate access to Medicare beneficiaries.
3.4.5 Long -Term Care (LTC) Pharmacy
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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6. Applicant agrees that it will contract with a sufficient number of LTC pharmacies to provide the entire plan’s institutionalized enrollees’ convenient access to their Part D benefit. |
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7. Applicant will ensure that, in contracting with LTC pharmacies, it does not agree to particular contracting terms and conditions containing provisions that have the net result of creating a non-uniform benefit for plan enrollees residing in LTC facilities serviced by network LTC pharmacies whose contracts with the Applicant may not include the same provisions. |
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B. LTC Pharmacy List
Within HPMS, Applicants will need to complete, at a minimum, two worksheets within an Excel file labeled “Long Term Care Pharmacy List” (see file template “Long Term Care Pharmacy List” for reference).
Assuming that Applicant has only one unique long term care pharmacy network, do the following:
Complete the worksheet labeled “LTC List – A”. All columns should be completed with the information indicated in each column heading. Please be sure to complete all appropriate cells (columns) for every record (row) for which you are listing a pharmacy. CMS recognizes that in some instances, networks may exceed a single worksheet and ask that Applicant label each worksheet properly. For instance, label multiple sheets for a single pharmacy list as “LTC List - A”, “LTC List - A2”, “LTC List - A3”, etc. Only designate a worksheet as “LTC List – B” if you are referencing an alternate or separate long-term care pharmacy listing.
In the event Applicant is representing more than one unique long term care pharmacy network, create as many worksheets as may be necessary to provide all the unique networks. Label additional worksheets as “LTC List – B”, “LTC List – C”, etc.
The “Contract ID List” worksheet should list all of the contract numbers and the legal entity name(s) (as it appears in HPMS), that are represented by the long-term care list provided in the worksheet labeled “LTC List - A”. For many, if not all, contract numbers, the long-term care pharmacy list may be the same. For those contract numbers associated with “LTC List – A”, Applicant will complete the “Contract ID List” worksheet by populating the “List Identifier”, column C, with an “A”. If there are any circumstances, where there are contract numbers that have an alternate long term care pharmacy listing, Applicant will populate the “List Identifier” column with the appropriate letter identifier (i.e. B, C, etc.).
C. LTC Discussion
Provide as an attachment a discussion about how your organization’s contracted long-term care network assures convenient access to Medicare beneficiaries.
3.4.6 Indian Health Service, Indian Tribe and Tribal Organization, and Urban Indian Organization (I/T/U) Pharmacy
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT : |
YES |
NO |
N/A |
Requesting Waiver? Yes or No |
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NOT ALL MA-PD 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 MA-PD 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 AN MA-PD 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: |
YES |
NO |
N/A |
Requesting Waiver? Yes or No |
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Note: Information for Part D Sponsors on Contracting with Indian Health Care Providers is posted on the www.cms.hhs.gov/PrescriptionDrugCovContra/ website.
ITU Pharmacy List
In order to demonstrate that a Part D Applicant meets these requirements Applicants must submit, as an attachment, a list of ALL I/T/U pharmacies (using the list of I/T/U pharmacies provided by CMS that reside in their service area. This information must be submitted at the county-level and CMS designated contract level and include contracting status with each of the I/T/U pharmacies in the Applicant’s service area.
To submit I/T/U pharmacy listings to CMS, Applicants will need to complete at a minimum, two worksheets within an Excel file labeled “ITU Pharmacy List” (see file template “ITU Pharmacy List” for reference).
Assuming that Applicant has only one unique I/T/U pharmacy network, do the following:
Complete the worksheet labeled “ITU List - A”. All columns should be completed with the information indicated in each column heading. Please be sure to complete all appropriate cells (columns) for every record (row) for which Applicant is listing a pharmacy. Only designate a worksheet as “ITU List – B” if Applicant is referencing an alternate or separate I/T/U pharmacy listing.
In the event Applicant is representing more than one unique I/T/U pharmacy network, create as many worksheets as may be necessary to provide all the unique networks. Label additional worksheets as “ITU List – B”, “ITU List – C”, etc.
The “Contract ID List” worksheet should list all of the contract numbers and the legal entity name(s) (as it appears in HPMS), that are represented by the I/T/U list provided in the worksheet labeled “ITU List - A”. For many, if not all, contract numbers, the I/T/U pharmacy list may be the same. For those contract numbers associated with “ITU List – A”, Applicant will complete the “Contract ID List” worksheet by populating the “List Identifier”, column C, with an “A”. If there are any circumstances, where there are contract numbers that have an alternate I/T/U pharmacy listing, Applicant will populate the “List Identifier” column with the appropriate letter identifier (i.e. B, C, etc.).
3.4.7 Specialty Pharmacy
Complete the table below.
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PDP CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO E ACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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3.5 Enrollment and Eligibility
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PDP CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN. |
YES |
NO |
Requesting Waiver? Yes or No |
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3.6 Complaints Tracking
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PDP CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN. |
YES |
NO |
Requesting Waiver? Yes or No |
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2. Applicant will continue to monitor and document complaint resolutions for complaints attributed to their contracts in the CMS’ Complaint Tracking Module. |
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3. Applicant will maintain Standard Operating Procedures that address how your organization will handle and quickly resolve immediate action cases, as well as, outline the steps your organization intends to take to have enrollees call your customer service directly for the prompt resolution of all inquiries. |
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3.7 Grievances
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS (AS THEY WOULD APPLY TO THE OPERATION OF YOUR ORGANIZATION’S PART D BENEFIT) TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN. |
YES |
NO |
Requesting Waiver?
Yes or No |
1. Applicant will establish and maintain a process designed to track and address enrollees’ grievances and assures that they will adopt appropriate timelines, policies and procedures and train the relevant staff and subcontractors on such policies and procedures in accordance with 42 CFR 423.564. |
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2. Applicant agrees to abide by Chapter 18 of the Prescription Drug Benefit Manual and the Part D QIC Reconsideration Procedures Manual. |
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3. Applicant will make enrollees aware of the grievance process through information and outreach materials. |
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4. Applicant will accept grievances from enrollees at least by telephone and in writing (including facsimile) |
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5. Applicant will maintain, and provides upon request by CMS access to records on all grievances received both orally and in writing, that includes, at a minimum:
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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 MA-PD 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 MA-PD sponsor
Concerns about waiting times, demeanor of pharmacy or customer service staff
A dispute concerning the timeliness of filling a prescription or the accuracy of filling the prescription.
3.8 Exceptions, Appeals
Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A MA-PD CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN. |
YES |
NO |
Requesting Waiver? Yes or No |
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Note: Appeals policies and procedures for Part D are separate and distinct from appeals policies and procedures required for Part C.
3.7 Coordination of Benefits
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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3.8 Tracking Out-of Pocket Costs (TrOOP)
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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Please identify the other governing standards:
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Please identify the other governing standards:
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7. Applicant will retroactively adjust claims and recalculates TrOOP balances based on N1 transactions received from the TrOOP Facilitation Contractor that were created based on other than real-time TrOOP-eligible claims. |
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8. Applicant will retroactively adjust claims and recalculate TrOOP balances based on receipts received from its Medicare enrollees that reflect amounts the enrollee paid on other than real-time TrOOP-eligible claims. |
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9. Applicant agrees that when it receives an N1 transaction, but has no supplemental payer information on file to identify the payer, the Applicant contacts the beneficiary to identify the payer and sends the payer information to the COB Contractor via ECRS verification. |
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10. Applicant agrees to retroactively adjust claims, recalculate TrOOP balances, and reimburse other payers (when applicable) whenever it receives information indicating that errors were made in the order of payment and there are multiple other payers on a beneficiary record. |
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11. Applicant will count other payer paid amounts as satisfying the Part D deductible whether or not the entire amount counts toward TrOOP. |
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12. Applicant will establish and identify in the Health Plan Management System (HPMS) a COB contact who can be contacted by CMS, the States and other payers to resolve COB issues. |
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13. Applicant will establish an EOB Transfer contact who can be contacted by CMS, the States and other payers to resolve EOB transfer issues. |
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14. Applicant agrees that when they receive notice that a beneficiary has disenrolled from the Applicant’s Part D plan due to reenrollment in another Part D plan during the coverage year, the Applicant ill send the beneficiary’s TrOOP balance and gross covered drug spending amount to the other Part D Sponsor’s EOB Transfer Contact, and update these amounts when applicable. |
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NOTE: For information regarding the TrOOP facilitator, Applicant may link to http://medeifacd.ndchealth.com/home/medifacd_home.htm
3.9 Medicare Secondary Payer
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PDP CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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3.10 Marketing/Beneficiary Communications
CMS will waive the disclosure requirements set forth in 42 CFR 423.128 and in subregulatory marketing guidelines when a Direct Contract MA-PD Sponsor is subject to alternative disclosure requirements (e.g., the Employee Retirement Income Security Act of 1974 (“ERISA”)) and fully complies with such alternative requirements.
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C 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 |
Please identify the other governing standards: ____________________________________________________________
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Applicant further agrees to provide general coverage information, as well as information concerning utilization, grievances, quality assurance, and sponsor financial information to any beneficiary upon request; OR
Please identify the other governing standards: ____________________________________________________________
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Please identify the other governing standards: ____________________________________________________________
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Please identify the other governing standards: ____________________________________________________________
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Please identify the other governing standards: ____________________________________________________________
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3.11 Provider Communications
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
1. Applicant will operate a toll-free call center (i.e. pharmacy tech help desk center) to respond to inquiries from pharmacies and providers regarding the Applicant’s Medicare prescription drug benefit. Inquiries will concern such operational areas as claims processing, benefit coverage, claims submission, and claims payment. |
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2. Applicant agrees that it will have a “one-stop” area on their website that provides needed information on the procedures, the forms and the contact information for their prior authorization and exceptions processes. |
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3. Applicant will operate a toll-free call center to respond to physicians and other providers for information related to exceptions and prior authorizations as well as beneficiary appeals. The call center must operate during normal business hours and never less than 8:00 a.m. to 6:00 p.m., Monday through Friday according to the time zones for the regions in which they operate. |
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3.12 Compliance Plan
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? – Yes or No |
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Note: Please be advised that the Part D Sponsor is ultimately responsible for the implementation and monitoring of the day-to-day operations of its Part D compliance program. A compliance plan adopted and operated by a Part D Sponsor’s subcontractor is not sufficient to demonstrate that the Part D Sponsor meets the compliance program requirement.
B. Provide as an attachment a copy of your organization’s Compliance Plan that you intend to use for this contract.
3.13 Reporting Requirements
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C 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 |
REPORTING REQUIREMENTS GUIDANCE
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1. Applicant agrees to comply with applicable Reporting Requirements Guidance that is posted on the www.cms.hhs.gov/ website.
NOTE: CMS has modified the reporting requirements under 42 CFR 423.514(a) to require information regarding such direct contract arrangements be reported to enrollees and to the general public to the extent required by other law (including ERISA or securities laws) or by contract. |
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CLAIMS DATA |
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2. The Applicant or the Applicant’s representative, such as a third party administrator (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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3. The Applicant or the Applicant’s representative, such as a third party administrator (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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4. The Applicant or the Applicant’s representative, such as a third party administrator (TPA), has data management processes and data systems capable of accomplishing submission of data to CMS via the Medicare Data Communications Network (MDCN) as referenced in Section 2.6. |
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5. The Applicant or the Applicant’s representative, such as a third party administrator (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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6. The Applicant or the Applicant’s representative, such as a third party administrator (TPA), has data management processes and data systems capable of accomplishing Correction of all data errors identified by CMS. |
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7. The Applicant or the Applicant’s representative, such as a third party administrator (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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8. The Applicant or the Applicant’s representative, such as a third party administrator (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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9. 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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UTILIZATION MANAGEMENT DATA |
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EXCEPTIONS AND APPEALS
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MEDICATION THERAPY MANAGEMENT DATA |
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OTHER DATA |
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CONFLICT OF INTEREST
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Note: Further detail on our approach to monitoring and oversight, including the updated exact reporting measures will be posted on the CMS website not later than May 2007
3.14 Data Exchange Between MA-PD and CMS
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
HPMS |
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ENROLLMENT & PAYMENT |
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3.15 Upgrades of Health Information Technology
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PDP CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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3.16 Health Insurance Portability and Accountability Act of 1996 (HIPAA)
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A MA-PD CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
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3.17 Prohibition on Use of SSN or Medicare ID Number on Enrollee ID Cards
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATION TO BE APPROVED FOR A MA-PD CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
1. Applicant agrees not to use an enrollee’s Social Security Number (SSN) or Medicare ID Number on the enrollee’s identification card. |
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3.18 Record Retention
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
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2. Applicant agrees to have pharmacies, contracted for the Part D benefit, maintain prescription records in their original format for the greater of 3 years or the period required by State law and allow those records to be transferred to an electronic format that replicated the original prescription for the remaining 7 years of the 10 year record retention requirement. |
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3. Applicant agrees to keep all other records—except prescription records—that must be retained for Medicare under Part C and Part D in the format(s) required by State law. |
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3.19 Claims Processing
A. Complete the table below:
APPLICANT MUST ATTEST ‘YES’ TO EACH OF THE FOLLOWING QUALIFICATIONS TO BE APPROVED FOR A PART D ADDENDUM TO THE PART C CONTRACT. ATTEST ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING QUALIFICATIONS BY PLACING A CHECKMARK IN THE RELEVANT COLUMN: |
YES |
NO |
Requesting Waiver? Yes or No |
Note: In preparation for implementation CMS (except for scheduled down time and disasters) will conduct testing and otherwise monitor for the impact of TrOOP system interfaces with plan claims processing systems, and adjust these standards as appropriate if necessary. |
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4.0 CERTIFICATION
I, the undersigned, certify to the following:
I have read the contents of the completed application and the information contained herein is true, correct, and complete. If I become aware that any information in this application is not true, correct, or complete, I agree to notify the Centers for Medicare & Medicaid Services (CMS) immediately and in writing.
I authorize CMS to verify the information contained herein. I agree to notify CMS in writing of any changes that may jeopardize my ability to meet the qualifications stated in this application prior to such change or within 30 days of the effective date of such change. I understand that such a change may result in termination of the approval.
I agree that if my organization meets the minimum qualifications and is Medicare-approved, and my organization enters into a Part D contract with CMS, I will abide by the requirements contained in Section 3.0 of this Application as well as Parts 422 and 423 of 42 CFR and all other applicable Federal statutes, regulations, and policies, including employer/union-only group waiver guidance, and provide the services outlined in my application.
I agree that CMS may inspect any and all information necessary including inspecting of the premises of the Applicant’s organization or plan to ensure compliance with stated Federal requirements including specific provisions for which I have attested. I further agree to immediately notify CMS if despite these attestations I become aware of circumstances which preclude full compliance by January 1, 2008 with the requirement stated here in this application as well as in Parts 422 and 423 of 42 CFR of the regulation.
I understand that in accordance with 18 U.S.C. § 1001, any omission, misrepresentation or falsification of any information contained in this application or contained in any communication supplying information to CMS to complete or clarify this application may be punishable by criminal, civil, or other administrative actions including revocation of approval, fines, and/or imprisonment under Federal law.
I further certify that I am an authorized representative, officer, chief executive officer, or general partner of the business organization that is applying for qualification to enter into a Part D addendum to my organization’s Medicare Advantage contract with CMS.
7) I acknowledge that I am aware that there is operational policy guidance, including the forthcoming 2008 Call Letter, relevant to this application that is posted on the CMS website and that it is continually updated. Organizations submitting an application in response to this solicitation acknowledge that they are also representing to CMS that they will 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
Return Form to: MMAHelp@CMS.HHS.GOV by January 17, 2006
Subject: CMS Connectivity Request Form
APPENDIX I
CMS
CONNECTIVITY REQUEST FORM
Prescription Drug Plan
THE FOLLOWING ORGANIZATION IS REQUESTING CONNECTIVITY TO CMS FOR THE PRESCRIPTION DRUG PLAN |
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Name of Organization:
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Primary Contact Name:
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Primary Contact Telephone Number: |
Address (Street, City, State, Zip):
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Telecommunications Contact Name:
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Telecommunications Contact Email:
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Physical Site Address (Must be the physical location for the T1 installation):
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1.
Does your site have leased line IP connectivity into the MDCN
(Medicare Data Communications Network) via AGNS (AT&T Global
Network Services)? Yes. Please answer questions 2-13. No. Please answer questions 4-13.
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2.
What are the AGNS account names; i.e. BXKY, BXSC, CWF3,
associated with the physical location to be used for
transactions? (For example, the AGNS account for the IP
connectivity into the CMS central office is HCFA).
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3. Are there other locations networked to the physical site?
Yes No
If yes please list the city and state below.
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4. What are the IP networks/sub-network masks that will be communicating with CMS? (This is required for both ends of the connectivity so routing can be put in place over the new PVC built across the AGNS.) Please note you may need to contact your network administrator for this information NOTE: If the AGNS router is placed on a ring/segment upstream from the origination network(s), CMS will need to know what the next hop will be out of the AGNS router to get to the cascaded network(s).
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5. Do you currently have Connect: Direct that you will use for the Medicare Prescription Drug Program within your system infrastructure?
Yes. Please answer question a below. No. Please answer questions b and c below.
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a. Which version of Connect: Direct do you currently have within your infrastructure; i.e. enterprise, workstation (runs on PC) or satellite (LAN/Server based)? |
b. Please provide the following information for Connect: Direct software installation on the hardware resident within your infrastructure.
Make & Model of Hardware Where Software Will Reside: Number of Processors Associated with this Hardware: Operating System Used on the Hardware:
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c. Who is the contact person(s) who will be responsible for the Connect: Direct Software? Name: Phone Number: Email Address:
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6. For T1 installation, what type of LAN will connect to the CMS router; i.e. ethernet, token ring? |
7. Will this new site require non-portable registered IP addresses from AGNS? Yes No.
If yes, how many?
If no, what addresses will be used at this site (sub-network/mask) and what IP address/sub-network mask should be used as the LAN interface address on the AGNS router?
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8. What protocols will need to be enabled for this site; i.e. IP, SNA?
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9. Will this site require the use of a dynamic routing protocol to advertise/learn routes to/from the AT&T Business Services network; i.e. IGRP, EIGRP, OSPF, BGP?
Yes No
If no, CMS will assume static routes should be used on the router placed at the new site.
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10.
What IP network(s) or host(s) at this site, including sub-network
mask(s), will need to be able to communicate with what IP
network(s) or host(s) at other sites and vice versa? Please
include subnetwork masks for the destination network(s) as
well NOTE:
If the AGNS router is placed on a ring/segment upstream from the
origination network(s), CMS will need to know what the next hop
will be out of the AGNS router to get to the cascaded network(s).
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11. Does this site have connectivity out to the Internet?
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12. If there is connectivity out to the Internet, please describe the firewall used at the site for which this is applicable.
Socks or proxy: Firewall software/hardware:
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13. Is there any unsolicited inbound traffic permitted from the Internet through the firewall?
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14. Will AGNS MDCN WAN be connected to the secure side of the firewall?
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15. Are there any dial-up connectivity requirements to the sub-network(s) at this site?
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Questions about completing the CMS Connectivity Request form should be direct to the MMAHelp Desk at
MMAHelp@CMS.HHS.GOV with Part D Benefit as the subject line or call 1-800-927-8069.
APPENDIX II
Banking Information Form
As Government vendors, organizations with Medicare contracts are paid by the Department of Treasury through an Electronic Funds Transfer (EFT) program. Government vendor payments are directly deposited into corporate accounts at financial institutions on the expected payment date. Additionally, CMS must have the EIN/TIN and associated name as registered with the IRS.
Please provide the following information to assist the Centers for Medicare & Medicaid Services in establishing payment arrangements for your organization. Mail the completed chart to the following address by March 12, 2007:
Centers for Medicaid and Medicare Services
Attention: Yvonne Rice
Mail Stop C1-05-17
7500 Security Blvd.
Baltimore, MD 21244
Name of Organization:
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DBA, if any: |
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Full Address of Organization (Street, City, Zip):
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Contact Person Name:
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Telephone Number: |
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Contract Numbers, if known:
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Employer/Tax Identification Number (EIN/TIN):
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EIN/TIN Name (Name of Business for tax purposes as registered with the IRS): A W-9 may be required |
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Full Address for 1099 Tax Form (Street, City, Zip):
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Name of Bank:
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Full Address of Bank (Street, City, Zip):
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ACH/EFT Coordinator Name:
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Telephone Number: |
Nine Digit Routing Transit (ABA Number):
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Depositor Account Title:
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Depositor Account Number:
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Check Account Type: (Please Attach a Copy of A Voided Check)
Checking Savings
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SIGNATURE & TITLE OF ORGANIZATION’S AUTHORIZED REPRESENTATIVE
Signature: _________________________________
Date: ____ ____________
Title: _____ ____________________________
Print Name: __ _____________________________
Phone Number: ______ ______________________
APPENDIX III
Summary of Medicare Part D Regulatory Requirements Fulfilled under Part C for
Medicare Advantage Prescription Drug (MA-PD) Applicants
Part D Regulation |
Regulatory Requirement(s) Description |
Basis for Waiver |
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42 CFR 423.153(b) &(d) Waiver applies to MA-PFFS only |
Utilization Management - Applicant must have a cost effective utilization management system. |
Waiver stated in regulations at 42 CFR 423.153 (e) excuses MA PFFS organizations from meeting the utilization management requirements specified in 423.153(b). |
42 CFR 423.153(b) &(d) Waiver applies to MA-PFFS only |
Medication Therapy Management Program – Applicant must have a program to manage medication therapy to optimize outcomes, reduce adverse drug interactions. |
Waiver stated in regulations at 42 CFR §423.153 (e) excuses MA PFFS organizations from meeting Medication Therapy Management Program requirements specified in 42 CFR 423.155.
|
42 CFR 423.120 (a)(7)(i) Waiver applies only to MA-PDs that operate their own pharmacies |
Pharmacy Network – Applicant must offer its Part D plan benefit through a contracted retail pharmacy network that meets CMS convenient access standards. |
Waiver stated in regulations at 42 CFR 423.120(a)(7) (i) excuses from the CMS convenient access standards those MA organizations that administer their Part D benefit through pharmacies owned by the MA organization if that organization’s pharmacy network access is comparable to the CMS convenient access standards. |
42 CFR 423.120(a)(7)(ii) Waiver applies to MA-PFFS plan that provides access through all pharmacies. |
Pharmacy Network – Applicant must offer its Part D plan benefit through a contracted retail pharmacy network that meets CMS convenient access standards |
Waiver stated in regulations at 42 CFR 423.120 (a) (7) (ii). excuses from the CMS convenient access standards those MA-PFFS organizations that offer a qualified prescription drug coverage, and provide plan enrollees with access to covered Part D drugs dispensed at all pharmacies, without regard to whether they are contracted network pharmacies and without charging cost-sharing in excess of the requirements for qualified prescription drug coverage. |
42 CFR 423.120(a)(8)(i) Waiver applies only to MA-PDs 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 MA organizations that administer their Part D benefit through pharmacies owned by the MA organization and dispense at least 98% of all prescriptions through pharmacies owned and operated by Applicant. |
42 CFR 423.36 42 CFR 423.38 42 CFR 423.40 42 CFR 423.44 |
Enrollment and Eligibility – Applicant agrees to accept Part D plan enrollments and determine Part D plan eligibility consistent with Part D program requirements. |
Duplicative of MA requirements under 42 CFR 422 Subpart B - Eligibility, Election, and Enrollment. MA organizations will conduct enrollment and determine eligibility consistent with MA program requirements. These requirements mirror those stated in the Part D regulation
|
42 CFR 423.514(b) and (c) |
Reporting Requirements – Applicant must report information concerning significant business transactions. |
Duplicative of MA requirements for reporting significant transactions under 42 CFR 422.500 and 42 CFR 422.516(b) and (c) and requirements for providing annual financial statements.
|
42 CFR 423.514(e) |
Reporting Requirements – Applicant must notify CMS of any loans or any other special arrangements it makes with contractors, subcontractors, and related entities. |
Duplicative of MA requirement for reporting loans or special arrangements under 42 CFR 422.516(e). |
APPENDIX IV
Financial Solvency Documentation
For Direct Contract MA-PD Sponsor Applicants
Documentation of Minimum Net Worth
The Direct Contract MA-PD Sponsor must demonstrate financial solvency through furnishing two years of independently audited financial statements to CMS. If the potential Direct Contract MA-PD Sponsor has not been in operation at least twelve months, it may choose to: 1) obtain independently audited financial statements for a shorter time period; or 2) demonstrate that it has the minimum net worth through presentation of un-audited financial statements that contain sufficient detail to allow CMS to verify the validity of the financial presentation. The un-audited financial statement must be accompanied by an actuarial opinion from a qualified actuary regarding the assumptions and methods used in determining loss reserves, actuarial liabilities and related items.
A “qualified actuary” for purposes of this application means a member in good standing of the American Academy of Actuaries, a person recognized by the Academy as qualified for membership, or a person who has otherwise demonstrated competency in the field of actuarial science and is satisfactory to CMS.
If the potential Direct Contract MA-PD Sponsor’s auditor is not one of the 10 largest national accounting firms in accordance with the list of the 100 largest public accounting firms published by the CCH Public Accounting Report, the applicant should enclose proof of the auditor’s good standing from the relevant state board of accountancy.
The Direct Contract MA-PD Sponsor must have sufficient cash flow to meet its financial obligations as they become due. The amount of the minimum net worth requirement to be met by cash or cash equivalents is $750,000. Cash equivalents are short-term highly liquid investments that can be readily converted to cash. To be classified as cash equivalents, investments must have a maturity date not longer than 3 months from the date of purchase.
In determining the ability of a Direct Contract MA-PD Sponsor to meet this requirement, CMS will consider the following:
The timeliness of payment,
The extent to which the current ratio is maintained at 1:1 or greater, or whether there is a change in the current ratio over a period of time; and
The availability of outside financial resources.
CMS may apply the following corresponding corrective remedies:
If a Part D Sponsor fails to pay obligations as they become due, CMS will require the Part D Sponsor to initiate corrective action to pay all overdue obligations.
CMS may require the Part D Sponsor to initiate corrective action if any of the following are evident:
If there is a change in the availability of outside resources, CMS will require the Part D Sponsor to obtain funding from alternative financial resources.
The Direct Contract MA-PD Sponsor generally must use the standards of Generally Accepted Accounting Principles (GAAP). Generally Accepted Accounting Principles (GAAP) are those accounting principles or practices prescribed or permitted by the Financial Accounting Standards Board. However, a Part D Sponsor whose audited financial statements are prepared using accounting principles or practices other than GAAP, such as a governmental entity that reports in accordance with the principles promulgated by the Governmental Accounting Standards Board (GASB), may utilize such alternative standard.
A Direct Contract MA-PD Sponsor may request a waiver in writing of the bonding and/or insurance requirements set forth at 42 CFR 423.504(b)(4)(iv) and (v) in accordance with Appendix XVIII to this application. Relevant considerations will include demonstration that either or both of the foregoing requirements are unnecessary based on the entity’s individualized circumstances, including maintenance of similar coverage pursuant to other law, such as the bonding requirement at ERISA Sec. 412.
A potential Direct Contract MA-PD Sponsor must furnish the following financial information to CMS to the extent applicable:
Self-Insurance/Self Funding- If the potential Direct Contract MA-PD Sponsor’s health plan(s) are self-insured or self-funded, it must forward proof of stop-loss coverage (if any) through copies of policy declarations.
Trust- If the potential Direct Contract MA-PD Sponsor maintains one or more trusts with respect to its health plan(s), a copy of the trust documents, and if the trust is intended to meet the requirements of Section 501(c)(9) of the Internal Revenue Code, the most recent IRS approval letter.
Forms 5500 and M-1- The two most recent annual reports on Forms 5500 and M-1 (to the extent applicable) for the potential Direct Contract MA-PD Sponsor’s health plans that cover prescription drugs for retirees that are Part D eligible individuals.
ERISA Sec. 411(a) Attestation- Each applicant (including an applicant that is exempt from ERISA) must provide a signed attestation that no person serves as a fiduciary, administrator, trustee, custodian, counsel, agent, employee, consultant, adviser or in any capacity that involves decision-making authority, custody, or control of the assets or property of any employee benefit plan sponsored by the potential Direct Contract MA-PD Sponsor if he or she has been convicted of, or has been imprisoned as a result of his or her conviction of, one of the felonies set forth in ERISA Sec. 411(a), for 13 years after such conviction or imprisonment (whichever is later).
II. INSOLVENCY REQUIREMENTS
A. Hold Harmless and Continuation of Coverage/Benefits
A Direct Contract MA-PD Sponsor shall be subject to the same hold harmless and continuation of coverage/benefit requirements as Medicare Advantage contractors.
B. Insolvency Deposit
A Direct Contract MA-PD Sponsor generally must forward confirmation of its establishment and maintenance of an insolvency deposit of at least $100,000, to be held in accordance with CMS requirements by a qualified U. S. Financial Institution. A “qualified financial institution” means an institution that:
A Direct Contract MA-PD Sponsor may request a waiver in writing of this requirement in accordance with Appendix XVIII to this application.
III. GUARANTEES (this Section only applies to an Applicant that utilizes a Guarantor)
A Direct Contract MA-PD Sponsor, or the legal entity of which the Direct Contract MA-PD Sponsor is a component, may apply to CMS to use the financial resources of a Guarantor for the purpose of meeting the requirements of a Direct Contract MA-PD Sponsor set forth above. CMS has the sole discretion to approve or deny the use of a Guarantor.
To apply to use the financial resources of a Guarantor, a Direct Contract MA-PD Sponsor must submit to CMS:
To serve as a Guarantor, an organization must meet the following requirements:
Is a legal entity authorized to conduct business within a State of the United States.
Not be under Federal or State bankruptcy or rehabilitation proceedings.
Have a net worth (not including other guarantees, intangibles and restricted reserves) equal to three times the amount of the Part D Sponsor guarantee.
If a State insurance commissioner or other State official with authority for risk-bearing entities regulates the Guarantor, it must meet the net worth requirement in Section I.A above with all guarantees and all investments in and loans to organizations covered by guarantees excluded from its assets.
If the Guarantor is not regulated by a State insurance commissioner or other similar State official, it must meet the net worth requirement in Section I.A above with all guarantees and all investments in and loans to organizations covered by a guarantee and to related parties (subsidiaries and affiliates) excluded from its assets.
If the guarantee request is approved, a Direct Contract MA-PD Sponsor must submit to CMS a written guarantee document signed by an appropriate Guarantor. The guarantee document must:
A Direct Contract MA-PD Sponsor must submit to CMS the current internal financial statements and annual audited financial statements of the Guarantor according to the schedule, manner, and form that CMS requires.
A Direct Contract MA-PD Sponsor cannot modify, substitute or terminate a guarantee unless the Direct Contract MA-PD Sponsor:
Requests CMS's approval at least 90 days before the proposed effective date of the modification, substitution, or termination;
Demonstrates to CMS's satisfaction that the modification, substitution, or termination will not result in insolvency of the Direct Contract MA-PD Sponsor; and
Demonstrates how the Direct Contract MA-PD Sponsor will meet the requirements of this section.
If at any time the Guarantor or the guarantee ceases to meet the requirements of this section, CMS will notify the Direct Contract MA-PD Sponsor that it ceases to recognize the guarantee document. In the event of this nullification, a Direct Contract MA-PD Sponsor must:
Meet the applicable requirements of this section within 15 business days; and
If required by CMS, meet a portion of the applicable requirements in less than the 15 business days in paragraph (G.1.) of this section.
IV. ONGOING REPORTING REQUIREMENTS
An approved Direct Contract MA-PD Sponsor is required to update financial information set forth in Sections I and II above to CMS on an ongoing basis. The schedule, manner, and form of reporting will be in accordance with CMS requirements.
APPENDIX V
CERTIFICATION OF MONTHLY ENROLLMENT AND PAYMENT DATA
RELATING TO CMS PAYMENT TO A MEDICARE ADVANTAGE THAT SPONSOR AN MA-PD PLAN
Pursuant to the contract(s) between the Centers for Medicare and Medicaid Services (CMS), and __________ ____________ (name of MA Organization) hereafter referred to as the “Organization” governing the operation of the following MA-PD plans _________ ____________ (plan identification numbers), the Organization hereby requests payment under the contract, and in doing so, makes the following certifications concerning CMS payments to the Organization. The Organization acknowledges that the information described below directly affects the calculation of CMS payments to the Organization and that misrepresentations to CMS about the accuracy of such information may result in Federal civil action and/or criminal prosecution. This certification shall not be considered a waiver of the Organization’s right to seek payment adjustments from CMS based on information or data that does not become available until after the date the Organization submits this certification.
1. The Organization has reported to CMS for applications received in the month of__ ___
(month and year) all new enrollments, disenrollments, and changes in Plan Benefit Packages with respect to the above-stated plans. Based on best knowledge, information, and belief, all information submitted to CMS in this report is accurate, complete, and truthful.
2. The Organization has reviewed the CMS monthly membership report and reply listing for the month of __ __ (month and year) for the above-stated MA-PD plans and has submitted requests to the IntegriGuard, under separate cover, for retroactive adjustments to correct payment data when the Organization has more accurate information. This may include enrollment status and State and County Code related to specific beneficiary. For those portions of the monthly membership report and the reply listing to which the Organization raises no objection, the Organization, through the certifying CEO/CFO will be deemed to have attested, based on best knowledge, information, and belief, to their accuracy, completeness, and truthfulness.
NAME: __ ________________________________________________
TITLE: _____ _______________________________________
On behalf of: _____ __________________________________ (Organization)
NOTE: The person signing this form must be the CEO, CFO, or an individual delegated the authority to sign on behalf of on of the CEO or CFO and who reports to the CEO or CFO. Otherwise the certification will be considered invalid, per CFR 423.505 (k).
APPENDIX VI
CERTIFICATION BY MEDICARE ADVANTAGE ORGANIZATION THAT SUBCONTRACTORS MEET THE REQUIREMENTS OF SECTION 3.1.1F
A. I, the undersigned, certify, on behalf of__ __ (Legal Name of Organization), to the following:
The contracts submitted as attachments to Section 3.1.1:
Clearly identify the parties to the contract (or letter of agreement);
Describe the functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant identified in Section 3.1.11B of the application;
Contain language clearly indicating that the subcontractor has agreed to perform functions required under the Applicant’s Medicare Advantage-Prescription Drug (MA-PD) contract (except for a network pharmacy if the existing contract would allow participation in this program), and flow-down clauses requiring the subcontractor’s activities to be consistent with and comply with the Applicant’s contractual obligations as a Medicare Advantage Organization that sponsors an MA-PD plan;
Contain language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Benefit program;
Describe the payment the subcontractor will receive for performance under the contract, if applicable;
Are for a term of at least a year (i.e., January 1, 2007 through December 31, 2007);
Are signed by a representative of each party with legal authority to bind the entity;
Contain language obligating the subcontractor to comply with all applicable Federal and State laws and regulations and CMS instructions;
Contain language obligating the subcontractor to comply with State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations at 42 CFR §423.136;
Contain language that specifies all of the requirements set forth in 42 CFR 423.505(i), including:
Requiring the subcontractor to agree to make its books and other records available to HHS, the Comptroller General, or their designees in accordance with 42 CFR 423.505(i)(2), including the right to inspect, evaluate and audit books and other records and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later;
b. Contain language stating that the subcontractor will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant;
c. Contain language stating that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement;
d. Contain language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor on an ongoing basis; and
e. Contain language that the Part D sponsor retains the right to approve, suspend, or terminate any arrangement with a pharmacy if the subcontractor will establish the pharmacy network or select pharmacies to be included in the network.
I certify that I am authorized to sign on behalf of the Applicant.
I understand that CMS will review the submitted contracts to ensure that they comply with the contracting requirements stated in Section 3.1.1F of the Solicitation for Applications from Prescription Drug Plans (PDPs)/Medicare Advantage Prescription Drug Plan Sponsors/Cost Plan Sponsors. When a submitted contract does not meet a requirement, CMS will ask the Applicant to resubmit the contract in question. I understand the Applicant’s failure to provide in a timely manner fully executed contracts that meet CMS requirements may affect CMS’ decision to allow the Applicant to accept enrollment into its Part D plan(s) on November 15, 2006.
____________ ________________ _________ __________
Authorized Representative Name (printed) Title
_________________________________ ________ ___________
Authorized Representative Signature Date (MM/DD/YYYY
Appendix VII
Certification that Subcontracts Meet the Requirements of 3.1.1F
INSTRUCTIONS: Applicants must complete the following chart for each subcontractor submitted under Section 3.1.1D. Applicants must identify where in each contract the following elements may be found. |
||
Section |
Requirement |
Citation |
3.1.1F1 |
The parties to the contract |
|
3.1.1F2 |
The functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant identified in Section 3.1.1B of the application. |
|
3.1.1F3 |
Language clearly indicating that the subcontractor has agreed to participate in your Medicare Prescription Drug Benefit program (except for a network pharmacy if the existing contract would allow participation in this program), and flow-down clause. |
|
3.1.1F4 |
Language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Benefit program. |
|
3.1.1F5 |
The payment the subcontractor will receive for performance under the contract, if applicable. |
|
3.1.1F6 |
Are for a term of at least the first year of the program. |
|
3.1.1F7 |
Are signed by a representative of each party with legal authority to bind the entity. |
|
3.1.1F8 |
Language obligating the subcontractor to abide by all applicable Federal and State laws and regulations and CMS instructions. |
|
3.1.1F9 |
Language obligating the subcontractor to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
|
3.1.1F10 |
Language ensuring that the subcontractor will make their books and other records available in accordance with 42 CFR §423.505(i)(2), which generally states these regulations give HHS, the Comptroller General, or their designees the right to inspect. |
|
3.1.1F11 |
Language stating that the subcontractor will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. |
|
3.1.1F12 |
Language stating that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement. |
|
3.1.1F13 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor on an ongoing basis. |
|
3.1.1F14 |
Language that the Part D sponsor retains the right to approve, suspend, or terminate any arrangement with a pharmacy if the subcontractor will establish the pharmacy network or select pharmacies to be included in the network. |
|
3.1.1F15 |
Language to ensure that subcontractor reports 100% of any manufacturer rebates paid for drugs provided under the Applicant’s Part D plan. |
|
APPENDIX VIII
Crosswalk
for Retail Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete the following chart (which contains applicable Section 3.1.1 F requirements AND additional requirements specific to Pharmacy Access) for each Retail pharmacy contract template submitted under Section 3.4. Applicants must identify where, in each contract template, the following elements reside. If multiple retail contract templates exist, applicant must provide a ‘Crosswalk for Retail Pharmacy Access Contracts’ document (Appendix X) for each contract template. |
||
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. |
||
Section |
Requirement |
Citation |
|
|
|
3.1.1F2 |
The functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant identified in Section 3.1.1B of the application. |
|
3.1.1F4 |
Language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Benefit program. |
|
3.1.1F8 |
Language obligating the subcontractor to abide by all applicable Federal and State laws and regulations and CMS instructions. |
|
3.1.1F9 |
Language obligating the subcontractor to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
|
3.1.1F10 |
Language ensuring that the subcontractor will make their books and other records available in accordance with 42 CFR §423.505(i)(2), which generally states these regulations give HHS, the Comptroller General, or their designees the right to inspect. |
|
3.1.1F11 |
Language stating that the subcontractor will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. |
|
3.1.1F12 |
Language stating that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement. |
|
3.1.1F13 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor on an ongoing basis. |
|
3.4A3 |
Provisions governing submitting claims to a real-time claims adjudication system. Note: Applicant may indicate for I/T/U pharmacies and for certain pharmacies that are allowed to submit claims in the X 12 format that these may be batch processed. |
|
3.4A4 |
Provisions governing providing Part D enrollees access to negotiated prices as defined in 42 CFR 423.100 |
|
3.4A5 |
Provisions regarding charging/applying the correct cost-sharing amount. |
|
3.4A6 |
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. |
|
APPENDIX IX
Crosswalk for Mail Order Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete the following chart (which contains applicable Section 3.1.1F requirements AND additional requirements specific to Pharmacy Access) for each Mail Order pharmacy contract template submitted under Section 3.4. Applicants must identify where, in each contract template, the following elements reside. If multiple retail contract templates exist, applicant must provide a ‘Crosswalk for Mail Order Pharmacy Access Contracts’ document (Appendix XI) for each contract template. |
||
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. |
||
Section |
Requirement |
Citation |
|
|
|
3.1.1F2 |
The functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant identified in Section 3.1.1B of the application. |
|
3.1.1F4 |
Language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Benefit program. |
|
3.1.1F8 |
Language obligating the subcontractor to abide by all applicable Federal and State laws and regulations and CMS instructions. |
|
3.1.1F9 |
Language obligating the subcontractor to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
|
3.1.1F10 |
Language ensuring that the subcontractor will make their books and other records available in accordance with 42 CFR §423.505(i)(2), which generally states these regulations give HHS, the Comptroller General, or their designees the right to inspect. |
|
3.1.1F11 |
Language stating that the subcontractor will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. |
|
3.1.1F12 |
Language stating that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement. |
|
3.1.1F13 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor on an ongoing basis. |
|
3.4A3 |
Provisions governing submitting claims to a real-time claims adjudication system.
|
|
3.4A4 |
Provisions governing providing Part D enrollees access to negotiated prices as defined in 42 CFR 423.100 |
|
3.4A5 |
Provisions regarding charging/applying the correct cost-sharing amount . |
|
3.4A6 |
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. |
|
APPENDIX X
Crosswalk for Home Infusion Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete the following chart (which contains applicable Section 3.1.1F requirements AND additional requirements specific to Pharmacy Access) for each Home Infusion pharmacy contract template submitted under Section 3.4. Applicants must identify where, in each contract template, the following elements reside. If multiple retail contract templates exist, applicant must provide a ‘Crosswalk for Home Infusion Pharmacy Access Contracts’ document (Appendix XII) for each contract template. |
||
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. |
||
Section |
Requirement |
Citation |
|
|
|
3.1.1F2 |
The functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant identified in Section 3.1.1B of the application. |
|
3.1.1F4 |
Language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Benefit program. |
|
3.1.1F8 |
Language obligating the subcontractor to abide by all applicable Federal and State laws and regulations and CMS instructions. |
|
3.1.1F9 |
Language obligating the subcontractor to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
|
3.1.1F10 |
Language ensuring that the subcontractor will make their books and other records available in accordance with 42 CFR §423.505(i)(2), which generally states these regulations give HHS, the Comptroller General, or their designees the right to inspect. |
|
3.1.1F11 |
Language stating that the subcontractor will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. |
|
3.1.1F12 |
Language stating that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement. |
|
3.1.1F13 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor on an ongoing basis. |
|
3.4A3 |
Provisions governing submitting claims to a real-time claims adjudication system. Note: Applicant may indicate for I/T/U pharmacies and for certain pharmacies that are allowed to submit claims in the X 12 format that these may be batch processed. |
|
3.4A4 |
Provisions governing providing Part D enrollees access to negotiated prices as defined in 42 CFR 423.100 |
|
3.4A5 |
Provisions regarding charging/applying the correct cost-sharing amount. |
|
3.4A6 |
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. |
|
|
Provisions ensuring that before dispensing home infusion drugs, pharmacy ensures that the professional services and ancillary supplies are in place. |
|
APPENDIX XI
Crosswalk for Long-Term Care Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete the following chart (which contains applicable Section 3.1.1F requirements AND additional requirements specific to Pharmacy Access) for each Long-Term Care pharmacy contract template submitted under Section 3.4. Applicants must identify where, in each contract template, the following elements reside. If multiple retail contract templates exist, applicant must provide a ‘Crosswalk for Long-Term Care Pharmacy Access Contracts’ document (Appendix XIII) for each contract template. |
|||
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. |
|||
Section |
Requirement |
Citation |
|
|
|
|
|
3.1.1F2 |
The functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant identified in Section 3.1.1B of the application. |
|
|
3.1.1F4 |
Language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Benefit program. |
|
|
3.1.1F8 |
Language obligating the subcontractor to abide by all applicable Federal and State laws and regulations and CMS instructions. |
|
|
3.1.1F9 |
Language obligating the subcontractor to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
|
|
3.1.1F10 |
Language ensuring that the subcontractor will make their books and other records available in accordance with 42 CFR §423.505(i)(2), which generally states these regulations give HHS, the Comptroller General, or their designees the right to inspect. |
|
|
3.1.1F11 |
Language stating that the subcontractor will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. |
|
|
3.1.1F12 |
Language stating that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement. |
|
|
3.1.1F13 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor on an ongoing basis. |
|
|
3.4A3 |
Provisions governing submitting claims to a real-time claims adjudication system. Note: Applicant may indicate for I/T/U pharmacies and for certain pharmacies that are allowed to submit claims in the X 12 format that these may be batch processed. |
|
|
3.4A4 |
Provisions governing providing Part D enrollees access to negotiated prices as defined in 42 CFR 423.100 |
|
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3.4A5 |
Provisions regarding charging/applying the correct cost-sharing amount. |
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Elements Specific to Long-Term Care Contracts
Note: CMS released Long-Term Care Guidance in early March 2005 that can be found on the www.cms.hhs.gov/ website. This document contains an updated list of performance and service criteria for contracting with long-term care pharmacies. Applicants are required to incorporate at a minimum, these criteria in ALL LTC pharmacy network contracts. Applicant must list the criteria below, and then identify where the elements reside in the contract template(s) submitted.
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Performance and Service Criteria |
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APPENDIX XII
Crosswalk for Indian Tribe and Tribal Organization, and Urban Indian Organization (I/T/U) Pharmacy Access Contracts
INSTRUCTIONS: Applicants must complete the following chart (which contains applicable Section 3.1.1F requirements AND additional requirements specific to Pharmacy Access) for each I/T/U pharmacy contract template submitted under Section 3.4. Applicants must identify where, in each contract template, the following elements reside. If multiple I/T/U contract templates exist, applicant must provide a ‘Crosswalk for I/T/U Pharmacy Access Contracts’ document (Appendix XII) for each contract template. |
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The provisions listed below must be in all pharmacy contracts. If contracts reference policies and procedures with which the pharmacy must comply, provide the relevant documentation as evidence and cite this documentation accordingly. |
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Section |
Requirement |
Citation |
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3.1.1F2 |
The functions to be performed by the subcontractor, as well as any reporting requirements the subcontractor has to the Applicant identified in Section 3.1.1B of the application. |
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3.1.1F4 |
Language describing the services to be performed in a manner that encompasses the services required to support the Medicare Prescription Drug Benefit program. |
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3.1.1F8 |
Language obligating the subcontractor to abide by all applicable Federal and State laws and regulations and CMS instructions. |
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3.1.1F9 |
Language obligating the subcontractor to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
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3.1.1F10 |
Language ensuring that the subcontractor will make their books and other records available in accordance with 42 CFR §423.505(i)(2), which generally states these regulations give HHS, the Comptroller General, or their designees the right to inspect. |
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3.1.1F11 |
Language stating that the subcontractor will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. |
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3.1.1F12 |
Language stating that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the subcontractor, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the subcontractor has not performed satisfactorily. The subcontract may include remedies in lieu of revocation to address this requirement. |
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3.1.1F13 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor on an ongoing basis. |
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3.4A3 |
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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3.4A4 |
Provisions governing providing Part D enrollees access to negotiated prices as defined in 42 CFR 423.100 |
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3.4A5 |
Provisions regarding charging/applying the correct cost-sharing amount. |
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3.4A6 |
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, that is posted on the www.cms.hhs.gov/ website.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 XIII
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 regulation at CFR 423.120 (b)(1), a Part D Sponsor’s P&T Committee list must contain a majority of members who are practicing physicians and/or pharmacists, include at least one practicing physician and one practicing pharmacist who are experts regarding care of the elderly or disabled individuals, and includes at least one practicing physician and one practicing pharmacist who are independent and free of conflict relative to the Part D Sponsor or Plan and pharmaceutical manufacturers.
In the event the Part D Applicant/Sponsor has entered into a confidential agreement such that the PBM will not disclose its P&T Committee membership to the Part D Applicant/Sponsor, then it is the Part D Sponsor’s responsibility to notify CMS that this information will be submitted by the Sponsor’s PBM. Moreover, the Part D Applicant/Sponsor must ensure that the PBM notifies CMS of the P&T Committee membership. Also, the Part D Applicant/Sponsor should ensure that the PBM notifies the Sponsor that this information has been successfully submitted to CMS.
Instructions to Plans and PBMs
A. If the Part D Applicant sub-contracts with a PBM for its P&T Committee and operates under a Confidentiality Agreement (such that its members are not disclosed to the Part D Applicant) then the Applicant must (1) complete the attached Certification, and (2) forward the attached P&T Committee Member Disclosure Form to the subcontracted PBM and direct the PBM to submit the form to CMS by March 12, 2007. The PBM should follow the mailing instructions below.
B. In the event of any future changes to the membership of the Part D Sponsor’s P&T Committee or the PBM’s P&T Committee, Part D Sponsors must (or in the case of a confidential agreement the Part D Sponsor must assure that the PBM) notify the appropriate CMS account manager (to be assigned at a future date) within 30 days of the effective date of such change.
Mailing Instructions
1. Provide a signed cover sheet indicating that the information being sent to CMS is an addendum to the Plan’s Part D Application.
2. Please mail 4 CD’s containing both the completed P&T Committee Member Disclosure form and the completed Certification for Part D Sponsors Using a Pharmacy Benefit Manager’s Pharmacy and Therapeutics Committee under a Confidentiality Agreement form.
3. Please mail 2 hard copies, including one original, of both the completed P&T Committee Member Disclosure form and the completed Certification for Part D Sponsors Using a Pharmacy Benefit Manager’s Pharmacy and Therapeutics Committee under a Confidentiality Agreement form.
Mail the CD’s and hard copy material via courier to:
Centers for Medicare and Medicaid Services
ATTN: Kimberly Spurgeon/Addendum to Generalist Review Section/ (P&T Member List) and/or (P&T Certification)
Mail Stop C1-22-06
7500 Security Boulevard
Baltimore, MD 21244-1850
PHARMACY AND THERAPEUTICS COMMITTEE MEMBER DISCLOSURE
Name of Part D Plan or PBM: __ ____________________
If Part D Plan, provide Part D Contract number(s):___ _________
Contact Person: __ _______________________________
Phone Number: ___ ______________________________
Email: __ ______________________________________
A. Complete the table below.
PROVIDE THE NAMES OF THE MEMBERS OF YOUR ORGANIZATION’S P&T COMMITTEE. INDICATE WHICH MEMBERS ARE PRACTICING PHYSICIANS OR PRACTICING PHARMACISTS. FURTHER, INDICATE WHICH MEMBERS ARE EXPERTS IN THE CARE OF THE ELDERLY OR DISABLED, AND FREE OF ANY CONFLICT OF INTEREST WITH YOUR ORGANIZATION AND PHARMACEUTICAL MANUFACTURERS. (APPLICANTS SHOULD MARK THE INFORMATION AS PROPRIETARY.) SUBMIT THIS DATA BY CREATING A SPREADSHEET IN MICROSOFT EXCEL THAT MIMICS THE TABLE BELOW. PROVIDE THIS ATTACHMENT ON A CD AS INSTRUCTED IN SECTION 2.4. |
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Practice/Expertise Mark an ‘X’ in Appropriate Column |
Free of Any Conflict of Interest Type Yes or No |
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Full Name of Member |
Practicing Physician |
Practicing Pharmacist |
Elderly/Disabled Expert |
With You’re 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 THAT YOUR ORGANIZATION IS PROVIDING PHARMACY BENEFIT MANAGEMENT SERVICES, THE TYPE OF APPLICATION, AND THE CONTRACT NUMBER(S). ADD ADDITIONAL ROWS AS NECESSARY. |
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Organization Name
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Type of Application |
Contract Number(s) |
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CERTIFICATION FOR PART D SPONSORS USING A PHARMACY BENEFIT MANAGER’S PHARMACY& THERAPEUTICS COMMITTEE UNDER A CONFIDENTIALITY AGREEMENT
I, the undersigned, certify, on behalf of LEGAL NAME OF PART D SPONSOR APPLICANT (“Applicant”), to the following:
I certify that APPLICANT has entered into a contract with LEGAL NAME OF PBM (“PBM”) to perform pharmacy benefit management services related to the operation of a Medicare Part D benefit plan(s) on behalf of APPLICANT.
I agree, to the best of my knowledge, that “PBM,” has a Pharmacy and Therapeutics (P&T) Committee that contains a majority of members who are practicing physicians and/or pharmacists, includes at least one practicing physician and one practicing pharmacist who are experts regarding the care of the elderly or disabled individuals, and includes at least one practicing physician and one practicing pharmacist who are independent and free of conflict relative to my plan and organization and pharmaceutical manufacturers.
I agree that the PBM will supply to CMS the following information, including but not limited to, the full legal name of each member of its P&T Committee designated as a practicing physician or pharmacist specializing in elderly and/or disabled care. Each member must also disclose any conflict of interest with my organization, and/or pharmaceutical manufacturers.
I agree that my organization will establish policies and procedures to ensure and confirm the ongoing integrity, qualifications and expertise of the PBM’s P&T Committee.
I agree that in the event CMS identifies a PBM’s P&T Committee member is listed on the OIG exclusion list, my organization will be notified by CMS of such a problem. In such an instance, my organization must assure that the PBM takes appropriate steps to correct the problem or my organization will be at risk of being subject to a corrective action plan and sanctions, depending on the nature of the problem.
I agree that CMS may inspect the records and premises of my organization or
my subcontractor 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 XIV
Retail Pharmacy Network Access Instructions
By contract, Part D sponsors are required to meet the access standards in 42 CFR §423.120 (a)(1). Applicants should note that the Retail access standard requirement is applied at the Plan Benefit Package (PBP) level. It is important to note the reference to plan (and not contract ID) in the requirements defined in 42 CFR §423.120 (a)(1). As part of routine monitoring and audit processes, CMS will review retail pharmacy access at the PBP level.
Information Required to Qualify As Part D Sponsor
CMS recognizes that the deadline for submission of the Part D application (March) precedes the plan bidding and finalization process (June). Further CMS recognizes that many (if not most) Part D sponsors continue work on defining their PBP service areas throughout their Bid formulation process. Therefore, it is difficult for applicants to submit final pharmacy accessibility analyses for each PBP. This circumstance is especially problematic for MA-PD sponsors that may choose to offer a PBP to a subset of their Contract Service Area. The impact on PDPs, RPPOs, and Cost Plans is minimal since those types of contracts must offer all PBPs with Part D throughout each specific PDP Region ( PDPs), MA Region (RPPOs) or geographic area (Cost Plans).
Geographic Accessibility Analysis Instructions
All Applicants are strongly encouraged to use GeoNetworks® to compile the reports as outlined in this appendix. If this is not possible then Applicant must contact Dennis Hodges at dennis.hodges@cms.hhs.gov (410.786.3048) by no later than _____________to determine if analyses provided by an alternative method are acceptable. Please note that alternative methods must produce analyses that will result in data directly comparable to the results produced by GeoNetworks®. Applicants that wish to use alternative methods will be required to demonstrate how their analysis is comparable to results produced by GeoNetworks®.
Though in many instances CMS provides specific instructions for formatting and compiling plan accessibility reports, this part of the chapter is not intended to provide step-by-step instructions for the use of GeoNetworks®. It is the responsibility of Applicant to ensure that their submission provides adequate information for CMS to determine if each of their plan offerings meets the retail pharmacy access submission requirements.
The Medicare Beneficiary File (“Medicare Beneficiaries by State, Region, ZIP __________” ) is provided by CMS.
The Medicare Beneficiary File referenced above contains ZIP Codes and beneficiary counts for Applicants as of______________. Use of this file is required for the _____________ accessibility analysis submission. Applicants should download this census file and create a sub-file(s) specific to their service area and/or region(s) and/or state as needed to support the level of analyses required. Applicants may not use beneficiary counts from other sources in their accessibility analyses.
Applicants should import the data sub-file to create a geo-coded population file based on the Census data sub-file. A population file is created by navigating to Data > Populate > From File> “select and open the file”. Applicants may geocode by selecting the “geocode after populate” check box during this step, or they may geocode the population file in a later step outlined below.
Quality Check: Applicant should verify that the beneficiary (employee) count in the population file is consistent with the total beneficiary census for the sub-file used as the basis for the analyses. CMS will check the count of beneficiaries provided in the reports against the count of beneficiaries resident in the plan’s service area.
Applicants should assign an Urban, Suburban, or Rural indicator to each Medicare beneficiary record in the Population file using the GeoNetworks® function, “Assign Place Names.” Place names may be assigned by navigating to Data > Assign Place Names > Selecting and open the file. The Input field should be set to “ZIP”. The default place name classification “STD_CLASS” will assign a Urban (U), Suburban (S), or Rural (R) designation to ZIP codes consistent with the definitions specified in 42 CFR § 423.100.
If geocodes are not assigned when the population file is created, Applicant may assign geocodes by navigating to Data > Assign Geocodes > Select and open file > Click OK. Applicants must use “representative” geocoding as the method to assign locations to each record in the Population file. This is the default GeoNetworks® method of assignment of geocodes when no address information is provided in the file (i.e., in this instance).
Applicants must define one employer group for all beneficiaries using the Medicare Beneficiary File Extract used in their analyses. The all beneficiaries file is used in the service area report.
To define all beneficiaries, navigate to Define > Employee Groups > Add > on the Connection tab, select the data source > on the Filter Tab not tests should be set > Under the Options tab, enter the label of “All Beneficiaries” in the Description field and specify that Service Area Restriction is set to “inside”> click OK.
Applicants must define three subsets of the Medicare Beneficiary File Extract used in their analyses. These subsets are based on filtering on the designation of urban/suburban/rural assigned in the step above. These three subsets are used in the accessibility reports.
To define the subset of Urban beneficiaries, navigate to Define > Employee Groups > Add > on the Connection tab, select the data source > on the Filter Tab, select “filename.STD_CLASS” as the field > “Test” should be “=” (equal to) > Value should be ‘U’ (Note: the single quotes signify a text field) > Under the Options tab, enter the label of “Urban Beneficiaries” in the Description field and specify that Service Area Restriction is set to “inside”> click OK.
To define the subset of Suburban beneficiaries, navigate to Define > Employee Groups > Add > on the Connection tab, select the data source > on the Filter Tab, select “filename.STD_CLASS” as the field > “Test” should be “= “ (equal to) > Value should be ‘S’ (Note: the single quotes signify a text field) > Under the Options tab, enter the label of “Suburban Beneficiaries” in the Description field and specify that Service Area Restriction is set to “inside”> click OK.
To define the subset of Rural beneficiaries, navigate to Define > Employee Groups > Add > on the Connection tab, select the data source > on the Filter Tab, select “filename.STD_CLASS” as the field > Test should be “= “ (equal to) > Value should be ‘R’ (Note: the single quotes signify a text field) > Under the Options tab, enter the label of “Rural Beneficiaries” in the Description field and specify that Service Area Restriction is set to “inside”> click OK.
Quality Check: Applicant should verify that the urban, suburban, and rural definitions are defined appropriately for each page of the report. These (filtered) sub-populations are used to verify access compliance of each of your plans. CMS will compare the total of urban, suburban, and rural beneficiaries for specific counties to totals derived from the Medicare Beneficiary File. Additionally, Applicant should verify that only beneficiaries within their service area are included in the report. This setting can be checked under the Options tab, in the Service Area Restriction box. The “within” radio button should be selected.
Applicants must use their listing of contracted Part D retail pharmacies. The listing used in these analyses must be consistent with the pharmacy listing provided under the instructions in Section 3.4.1G 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 3.4.1F of this solicitation to represent one complete Part D network.
Applicant may use representative ZIP Geocoding or the more precise geocoding methods (i.e., the ZIP+ 4 Centroid Method, the ZIP+2 Centroid Method, or address-based geocoding).
Applicant must define Geocodes for their provider file by navigating to Data > Assign Geocodes > Select and open the provider file > Click OK. To the extent possible, CMS recommends that Applicants use “address-based” geocoding as to assign locations to pharmacies as it is more precise. If this function is not available on your version of GeoNetworks®, the default, representative geocoding, methodology is acceptable.
Next, Applicant shall define the Provider Group by navigating to Define > Provider Groups > Add > on the Connection tab, select the data source > on the Options tab, enter the label of “Part D Retail Pharmacy Network” in the Description field > Select OK.
Quality Check: Applicant should verify that the total counts for pharmacy providers match the counts in the Part D contracted retail pharmacy listing that must also be provided to CMS in accordance with the instructions in Section 3.4.1G of this solicitation. CMS will check total counts of pharmacies provided in the service area against the record count from submitted pharmacy listings.
CMS recognizes that some local MA-PDPs contract with PBMs to provide national networks. CMS also recognizes that these PBM contracts are to the benefit or the beneficiary. Our review testing will reject instances where the total number of pharmacies in the GeoNetworks® analysis is greater than the number of retail pharmacies provided in the retail Pharmacy listing provided in Section 3.4.1G of this solicitation.
Applicant must define access standards in accordance with the Part D standards, as defined in 42 CFR § 423.120 (a) (1).
To define the Urban access standard, navigate to Define > Access Standards > Add > in the Description field, type “Urban: 1 provider within 2 miles” > Ensure that the Number of Providers is 1, the Test is within, and Miles is 2 > Click OK.
To define the Suburban access standard, navigate to Define > Access Standards > Add > in the Description field, type “Suburban: 1 provider within 5 miles” > Ensure that the Number of Providers is 1, the Test is within, and Miles is 5 > Click OK.
To define the Rural access standard, navigate to Define > Access Standards > Add > in the Description field, type “Rural: 1 provider within 15 miles” > Ensure that the Number of Providers is 1, the Test is within, and Miles is 15 > Click OK.
The following two sections provide instructions specific to the type of Part D Sponsor. Section 4.a. should be referenced by Local MA-PD and Cost Plan Applicants. Section 4.b. should be referenced by MA-PD Regional (RPPO) Applicants.
a. Local MA-PD Applicants
Service Areas may be defined in GeoNetworks® by navigating to Define > Service Areas > Add > Use buttons on right to select your service area.
Within each contract number, MA-PD and Cost Plan Applicants must define their service areas. As specified in 42 CFR 423.120 (a), access standards must be met at the plan level. However, as discussed in Part A (1) (b) of this chapter, New MA-PD applicants or MA-PDs seeking Service Area Expansions for Part D should submit their pharmacy access analyses at the contract level, including the entire service area for the contract. GeoNetworks® reports provided at the contract level must include detail on the number of beneficiaries and the number of contracted pharmacies at the county level. New MA-PD applicants or MA-PDs seeking Service Area Expansions for Part are not required to submit separate geographic accessibility analyses for each unique PBP service area or each unique combination of PBPs offered in the same service area.
Table III, D.4.a.1 Example MA-PD Contractor PBP Offerings |
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Contract |
Contract Service Area |
Pharmacy Network |
Hxxxx - |
Anne Arundel County Baltimore County Carroll County Frederick County |
Part D Pharmacy Network 1 |
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The applicant would create one contract service area with the applicable network (Part D Pharmacy Network 1).
Quality Check: Applicants must verify that the contract and its service area are represented appropriately. CMS will verify the service area of plans using data submitted to the Health Plan Management System (HPMS). Inconsistencies between the Contract’s Part D service area specified in HPMS and the Contract Service Area specified in the GeoNetworks Analysis will cause delays in review and, potentially, denial of the Applicants Part D application.
a. MA-PD and Cost Plan Reports
Applicant reports must include a title page and a table of contents. To add a title page navigate to Page > Add > Title Page. To add a table of contents navigate to Page > Add > Table of Contents. Double click on the new Table of Contents page. Under the Options tab select Tab leaders, Page specifications, and Roman page numbers to be included in the report.
Accessibility Detail pages should be generated to represent urban/suburban/rural beneficiaries with and without access in each of the service areas defined. There should be six reports for each unique combination of a plan service area(s) and pharmacy network(s).
As stated earlier in this appendix, for a given contract number Local MA-PD and Cost Plans must provide separate retail pharmacy accessibility analyses for beneficiaries classified as Urban, Suburban, and Rural for each unique combination of plan service area and pharmacy network (i.e., preferred only; preferred and non-preferred). For each of these accessibility analyses, separate reports are required for (a) beneficiaries meeting the applicable access requirement (“with access”) and (b) beneficiaries not meeting the applicable access requirement (“without access”). As specified in the instructions below, statistics for each county within the service area individually, and statistics for the entire contract service area in total must be provided.
Using the example outlined in part 4.a the steps to define the accessibility detail report for urban beneficiaries with access in the service area of Exxxx are as follows:
Navigate to Page > Add > Accessibility Detail > Double click on the page that appears
Under the Specifications tab for the new Accessibility Detail Page set Employee Group to be your urban beneficiaries, set Provider Group to be “Part D Retail Network”, set Access Standard to be “Urban: 1 provider within 2 miles”, set Access filter to “with”, and set Service Area to “Exxxx”.
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 “Exxxx”
The steps to define the service area report for all beneficiaries with access in the service area of Exxxx 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”, set Service Area to Exxxx.
Under the Options tab for the new Service Area Detail Page, select to summarize by county, set service area filter to inside, ensure that the following options are checked: state, number of employees, number of providers, and totals.
Under the Titles tab, uncheck the default Title 1 and specify a title that describes the unique service area. In this instance the title would be “Exxxx”
Ensure that no specifications are indicated under the Include tab.
Under the Sort tab Ensure that sort order is State (ascending), then County (ascending).
Including the title and table of contents, all page reports will be generated using the CMS example, and following all of the specifications including: (1) use of the appropriate employee group, (2) correct definition of the access standards, (3) correct definition of the service area; and (4) generation of analyses with both “with” and “without” specifications. An overview of this report is specified in Table III.5.a.1.
An example of the actual reports for MA-PD Exxxx is provided in this Appendix entitled, “Sample_MA-PD and cost Plan Accessibility Analyses”.
Table III.5.a.1: Example Exxxx Report Pages Specification |
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Rpt # |
Page |
Summarized by |
Employee Group |
Provider Group |
Access Standard |
Service Area / Title 1 |
Access Filter |
1 |
Title |
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2 |
Table of Contents |
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3 |
Accessibility Detail |
County |
Urban Beneficiaries |
Part D Retail Pharmacy Network |
Urban: 1 provider within 2 miles |
Exxxx |
With |
4 |
Accessibility Detail |
County |
Urban Beneficiaries |
Part D Retail Pharmacy Network |
Urban: 1 provider within 2 miles |
Exxxx |
Without |
5 |
Accessibility Detail |
County |
Suburban Beneficiaries |
Part D Retail Pharmacy Network |
Suburban: 1 provider within 5 miles |
Exxxx |
With |
6 |
Accessibility Detail |
County |
Suburban Beneficiaries |
Part D Retail Pharmacy Network |
Suburban: 1 provider within 5 miles |
Exxxx |
Without |
7 |
Accessibility Detail |
County |
Rural Beneficiaries |
Part D Retail Pharmacy Network |
Rural: 1 provider within 15 miles |
Exxxx |
With |
8 |
Accessibility Detail |
County |
Rural Beneficiaries |
Part D Retail Pharmacy Network |
Rural: 1 provider within 15 miles |
Exxxx |
Without |
9 |
Service Area |
County |
All Beneficiaries |
Part D Retail Pharmacy Network |
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Exxxx |
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10 |
GeoNetworks Report (auto generated summary information to be included in submission) |
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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.
Sample MA-PD reports are provided in this Appendix.
Quality Check: Applicants must verify that accessibility detail reports are provided for each unique combination of service area and pharmacy network consistent with the example table above. Additionally, each submission should include the report information page for each report.
Applicants must provide both a single hardcopy of their GeoNetworks® reports as well as Adobe Acrobat readable (*.pdf) versions of the reports. These reports must be submitted as attachments pursuant to the instructions in Section 2.4 of this solicitation.
APPENDIX XV
Instructions for Additional Employer/Union-Only Group Waiver/Modification Requests
As part of the application process, Direct Contract MA-PD Sponsors may submit individual waiver/modification requests to CMS. These requests must be identified as requests for additional waivers/modifications and must fully address the following items:
Provisions of existing statutory and/or regulatory requirement(s) the entity is requesting to be waived/modified (please be explicit as to whether you are requesting a waiver or a modification of these requirements);
How the particular requirements hinder the design of, the offering of, or the enrollment in, the employer-sponsored group plan;
Executive summary of the requested waiver/modification;
Detailed description of the waiver/modification requested including how the waiver/modification will remedy the impediment (i.e., hindrance) to the design of, the offering of, or the enrollment in, the employer-sponsored group prescription drug plan;
Other details specific to the particular waiver/modification that would assist CMS in the evaluation of the request; and
Contact information (contract number, name, position, phone, fax and email address) of the person who is available to answer inquiries about the waiver/modification request.
| File Type | application/msword |
| File Title | Medicare Prescription Drug Benefit |
| Author | CMS |
| Last Modified By | CMS |
| File Modified | 2006-11-08 |
| File Created | 2006-11-08 |