MEDICARE PRESCRIPTION DRUG BENEFIT
Solicitation for Applications for New Medicare Advantage - Prescription Drug Plans (MA-PD) Sponsors
2012 Contract Year
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Expiration:
1.1. Purpose of Solicitation 7
1.3. Objectives and Structure 7
1.5. Summary of MA-PD Sponsor Role and Responsibilities 10
1.6. Summary of CMS Role and Responsibilities 11
1.6.1. Application Approval, Part D Bid Review, and Contracting Processes 11
1.6.2. Part D Program Oversight 12
1.6.3. Education and Outreach 13
1.6.4. Marketing Guidelines and Review 13
1.6.5. Eligibility for the Low Income Subsidy Program 13
1.6.6. General Enrollment Processing 14
1.6.7. Payment to Part D Sponsors 14
2.2. Other Technical Support 15
2.3. Health Plan Management System (HPMS) Data Entry 15
2.4. Instructions and Format of Qualifications 15
2.4.2. Applicant Seeking to Offer New Employer/Union-Only Group Waiver Plans (EGWPs) 17
Applicants Offering Individual and “800 Series” Plans – Pharmacy Access 18
Applicants Only Offering “800 Series” Plans – Pharmacy Access 18
2.4.3. Applicant Seeking to Offer New Employer/Union Direct Contract PFFS 18
2.4.4. Applicant Entity Same as Contracting Entity 19
2.4.5. Joint Enterprise as Applicant and Contracting Entity 19
2.4.6. Automatic Enrollment of Full-benefit Dual Eligible Individuals 20
2.4.7. Withdrawal of a Part D Application 20
2.4.8. Technical Assistance 20
2.5. Submission Software Training 20
2.6. System Access and Data Transmissions with CMS 21
2.6.2. Enrollment and Payment 21
2.6.3. Payment for MA–PD Sponsors 22
2.7. Summary Instruction and Format for Individual Market Bids 22
2.7.3. Overview of Bid Negotiation 24
2.8.1. Retail Pharmacy Access 24
2.8.2. Home Infusion Pharmacy Access 25
2.8.3. Long-Term Care Pharmacy Access 26
2.8.4. Indian Tribe and Tribal Organization, and Urban Indian Organization (I/T/U) 26
2.8.5. Waivers Related to Pharmacy Access 26
2.9. Waivers Related to Attestations for MA-PD EGWP and Direct Contract Applicants 27
2.10. Standard Contract with MA-PD Sponsors 28
2.11. Protection of Confidential Information 28
3.1. Applicant Experience, Contracts, Licensure and Financial Stability 30
3.1.2. Business Integrity 2 CFR Part 376; Prescription Drug Benefit Manual, Chapter 9 36
3.3. Service Area/Regions 42 CFR §423.112; Prescription Drug Benefit Manual, Chapter 5 51
3.5. General Pharmacy Access 42 CFR §423.120(a); Prescription Drug Benefit Manual, Chapter 5 53
3.5.2. Out of Network Access 42 CFR §423.124; Prescription Drug Benefit Manual, Chapter 5 57
3.5.3. Mail Order Pharmacy 42 CFR §423.120(a)(10); Prescription Drug Benefit Manual, Chapter 5 58
3.5.4. Home Infusion Pharmacy 42 CFR §423.120(a)(4); Prescription Drug Benefit Manual, Chapter 5 59
3.5.7. Specialty Pharmacy Prescription Drug Benefit Manual, Chapter 5 63
3.9. Grievances 42 CFR Part 423 Subpart M; Prescription Drug Benefit Manual, Chapter 18 68
3.13. Medicare Secondary Payer 42 CFR §423.462; Prescription Drug Benefit Manual, Chapter 14 77
3.15. Provider Communications Prescription Drug Benefit Manual, Chapter 2 81
3.16. Compliance Plan 42 CFR §423.504(b)(4)(vi); Prescription Drug Benefit Manual, Chapter 9 82
3.17. Reporting Requirements PPACA § 6005; 42 CFR §423.514; 2010 Reporting Requirements 84
3.18. Data Exchange between Part D Sponsor and CMS 42 CFR §423.505(c) and (k) 86
3.21. Record Retention 42 CFR §423.505(d) 89
3.24. Premium Billing 42 CFR §423.293, CMS issued guidance 03/08/2007 93
3.25. Consumer Assessment Health Providers Survey (CAHPS) Administration 42 CFR §423.156 94
APPENDIX II – Direct Contract MA-PD Attestations 101
Appendix III --Organization Background and Structure 105
APPENDIX V -- Crosswalk for Retail Pharmacy Access Contracts 111
APPENDIX VI -- Crosswalk for Mail Order Pharmacy Access Contracts 114
APPENDIX VII -- Crosswalk for Home Infusion Pharmacy Access Contracts 117
APPENDIX VIII -- Crosswalk for Long-Term Care Pharmacy Access Contracts 121
APPENDIX X -- Applicant Submission of P&T Committee Member List and Certification Statement 132
The Centers for Medicare & Medicaid Services is seeking applications from Medicare Advantage organizations to enter into 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). Please submit your applications according to the process described in Section 2.0.
If your organization, or your parent or affiliated organization already has a Medicare Advantage-Prescription Drug (MA-PD) contract with CMS to offer the Part D benefit, and you are expanding your service area offered under the existing contract please refer to the www.cms.hhs.gov/ website for the Part D Service Area Expansion application for instructions to complete an application for a Service Area Expansion (SAE). If your organization, or your parent or affiliated organization already has a MA-PD or Cost Plan contract with CMS to offer the Part D benefit, and you are seeking a PDP contract, you are required to complete the PDP application package.
If your organization or your parent or affiliated organization already has a MA-PD contract with CMS to offer the Part D benefit, and you are seeking to offer a new product line under a new contract, then you are required to complete this application.
The Medicare Prescription Drug Benefit program was established by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and is codified in sections 1860D-1 through 1860 D-42 of the Social Security Act (the Act). Section 101 of the MMA amended Title XVIII of the Social Security Act by 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”).
The Patient Protection and Affordable Care Act (PPACA) as amended by the Health Care and Education Reconciliation Act of 2010 (HCERA) (together “the Affordable Care Act”) adds section 1860D-43 which will close the Medicare Prescription Drug Benefit’s coverage gap by implementing a manufacturer discount program and providing coverage to generic drugs over a span of 10 years. PPACA The Affordable Care Act also added or revised certain existing Part D requirements, including requirements associated with low-income subsidy, calculation of true out-of-pocket spending, drug classes and categories, LTC pharmacy dispensing techniques, establishedment of a single uniform exceptions and appeals model, and strengthened CMS’ ability to deny bids.
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.
In general, coverage for the prescription drug benefit is provided predominantly through prescription drug plans (PDPs) that offer drug-only coverage, or through Medicare Advantage (MA) plans that offer integrated prescription drug and health care coverage (MA-PD plans). PDPs must offer a basic drug benefit and may also offer an enhanced or alternative basic drug benefit. MA-PD sponsors must offer either a basic benefit, or broader coverage for no additional cost. Medicare Cost Plans may, at their election, offer a Part D drug plan as an optional supplemental benefit, subject to the same rules that apply to an MA-PD plan. Program of All-Inclusive Care for the Elderly (PACE) organizations may elect to offer a Part D plan in a similar manner as MA-PD local sponsors in order to account for the shift in payor source from the Medicaid capitation rate to a private Part D Sponsors. If the MA-PD sponsor meets the basic requirement, then it may also offer supplemental benefits through enhanced alternative coverage for an additional premium. MA organizations approved to offer Part D benefits (hereinafter referred to as “MA-PD sponsors”) must offer Part D coverage throughout their approved MA service area.
Applicants who offer either a PDP or MA-PD plan may offer national plans (with coverage in every region) or regional plans. MA-PD plan applicants may also offer local plans. CMS has identified 26 MA Regions and 34 PDP Regions; in addition, each territory is its own PDP region. Additional information about the regions can be found on the www.cms.gov/ website.
This solicitation is only for entities seeking to operate a MA-PD plan (either in the individual market, employer market or a combination of both markets). Separate Part D solicitations are also posted on the CMS website for entities offering PDP Plans, for entities offering Cost Plans with a Part D benefit, and for entities offering PACE Plans with a Part D benefit.
Only specific types of MA organizations (i.e., entities offering Medicare coordinated care plans or Medicare private fee-for-service plans) may submit a Part D application in response to this solicitation. Medicare reasonable cost plans (as defined under Section 1876 of the Social Security Act), Program of All Inclusive Care for the Elderly (PACE) organizations (as defined in section 1894 of the Social Security Act), and employer groups may also offer pharmacy benefits under the MMA. Those entities must not complete this Part D qualification application, but should refer to the separate applications posted on the CMS website.
It is important to note that MA organizations offering coordinated care plans must qualify to offer at least one plan that includes both Part C and Part D benefits throughout the organization’s approved Part C service area. Similarly, MA organizations offering a preferred provider organization (PPO) plan must offer Part D coverage throughout the PPO regions in which they are approved to offer a Part C plan. However, MA organizations offering private fee-for-service plans may, but are not required to, offer a Part D benefit.
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 will have flexibility in terms of benefit design. This flexibility includes, but is not limited to, authority to establish a formulary that designates specific drugs that will be available within each therapeutic class of drugs, and the ability to have a cost-sharing structure other than the statutorily defined structure (subject to certain actuarial tests). (Sponsors are required to follow our formulary guidance. See Section 2.7.1 of this application for information regarding the submission of formulary materials). The plans also may include supplemental benefits coverage such that the total value of the coverage exceeds the value of basic prescription drug coverage.
APPLICATION REVIEW PROCESS
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Date |
Milestone |
November 12, 2010 |
Submit Notice of Intent to Apply Form to CMS |
December 2, 2010 |
CMS User ID form due to CMS |
January 4, 2011 |
Final Applications posted by CMS |
February 24, 2011 |
Applications due |
March 28, 2011 |
Release of Health Plan Management System (HPMS) formulary submissions module |
April 8, 2011 |
Plan Creation module, Plan Benefit Package (PBP), and Bid Pricing Tool (BPT) available on HPMS |
April 18 2011 |
Formulary submission due to CMS Transition Policy Attestations and Policy due to CMS |
May/June 2011 |
CMS sends Part D contract eligibility determination to Applicants, based on review of application. Applicant’s bids must still be negotiated (see below) |
May 20, 2011 |
PBP/BPT Upload Module available on HPMS |
June 6, 2011 |
All bids due |
Early August 2011 |
CMS publishes national average Part D premium |
September 2011 |
CMS completes review and approval of bid data. CMS executes Part D contracts to those organizations who submit an acceptable bid |
October 15, 2011 |
2012 Annual Coordinated Election Period begins |
NOTE: This timeline does not represent an all-inclusive list of key dates related to the Medicare Prescription Drug Benefit program. CMS reserves the right to amend or cancel this solicitation at any time. CMS also reserves the right to revise the Medicare Prescription Drug Benefit program implementation schedule, including the solicitation and bidding process timelines.
Key aspects of each MA-PD Sponsor shall include the ability to:
Submit a formulary (considered an element of the bid) each year for CMS approval.
As part of the annual bidding process MA Coordinated Care Plans (CCPs) must submit at least one MA-PD plan for CMS approval. An MA organization offering a coordinated care plan must offer at least one MA-PD plan throughout its approved MA service area. An MA private fee-for-service (MA-PFFS) contractor may, but is not required to, offer a Part D Benefit to beneficiaries within its service area.
Enroll all eligible Medicare beneficiaries who apply and reside within the MA-PD sponsor’s approved service area.
Administer the Part D benefit (consistent with the Part D Sponsor’s approved bid), 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, making discounts for applicable name brand drugs available to eligible enrollees (i.e., non-LIS beneficiaries in the coverage gap) at the point of sale, 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 meeting certain criteria) 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 MA-PFFS plans meeting specific requirements, must also provide drug utilization review, and medication therapy management programs.
Administer coverage determinations, grievances, exceptions, and an appeals process consistent with CMS requirements.
Provide customer service to beneficiaries, including enrollment assistance, toll-free telephone customer service help, and education about the Part D benefit.
Protect the privacy of beneficiaries and beneficiary-specific health information.
Develop marketing materials and conduct outreach activities consistent with CMS standards.
Develop and/or maintain systems to support enrollment, provide claims-based data to CMS, accept CMS payment (including subsidies for low-income beneficiaries), track true out-of-pocket costs and gross covered prescription drug costs, coordinate benefits with secondary insurers (or primary insurers when Medicare is secondary) and support e-prescribing.
Provide necessary data to CMS to support payment (including Prescription Drug Event (PDE) records and data on direct and indirect remuneration, oversight, and quality improvement activities and otherwise cooperate with CMS oversight responsibilities.
Provide accurate drug pricing and pharmacy network data that will be published on the Medicare Prescription Drug Plan Finder tool. Sponsors must submit data based on the format and schedule provided by CMS.
There are three distinct phases to the overall review to determine whether CMS will enter into a contract with an Applicant. The first phase is the application review process. CMS reviews the applications submitted on or by February 24, 2011 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 28, 2011 and the bid upload which begins May 20, 2011. 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; includes all drugs and certain classes and categories as established by the Secretary, and includes an appropriate transition policy. CMS will contact 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 the Part D bid submission date which is on the first Monday in June each year. The second step involves the bid review and negotiations with applicants to ensure valuations of the proposed 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 will be 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 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, marketing, program safeguard activities, customer service, confidentiality and security of enrollee information, and effectiveness of tracking true out-of-pocket costs and gross covered prescription drug costs. The types of reporting that CMS requires of Part D sponsors are presented in the application. For additional information on reporting requirements, refer to the www.cms.gov/ website. (NOTE: Part D sponsors, as covered entities under the Health Insurance Portability and Accountability Act of 1996, are subject to investigation and penalties for findings of HIPAA 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 records, direct and indirect remuneration data, cost data, benefit management data, marketing review information, customer satisfaction and complaints data, and information used to determine low-income subsidy (LIS) match rates. We also conduct beneficiary satisfaction surveys and operate a complaints tracking system to monitor and manage complaints brought to our attention that are not satisfactorily resolved through MA-PD sponsors’ grievance processes as well as conduct periodic site visits to verify MA-PP sponsor compliance with Part D program requirements. We use information from all the specified sources to analyze the appropriateness and value of the benefit delivered, and to evaluate the opportunity for additional value and quality improvement. We publish the results of our monitoring activities on CMS’ websites, including performance ratings on the Medicare Prescription Drug Plan Finder, and we also post information regarding the issuance of Corrective Action Plans on our website.
If any trends we identify indicate less than satisfactory performance, contract violations, significant departures from the marketed Part D offering, or fraud or other violations of State or Federal laws, appropriate action is taken consistent with 42 CFR §423.509 and Part 423, Subpart O. We also make referrals if appropriate to the 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 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. For example, the Medicare Prescription Drug Plan Finder assists beneficiaries in finding a plan to meet their specific needs; refer to the www.medicare.gov/MPDPF website. CMS displays data that allow comparisons of plans’ costs, quality and operational performances. These data may also be used for monitoring purposes.
Marketing Guidelines are posted on the www.cms.gov/ website. Part D sponsors are required to adhere to these guidelines in developing their marketing materials and marketing strategy. Review of MA-PD plan materials will be conducted in conjunction with review of Part C marketing materials under 42 CFR §422.80 and 42 CFR §423.50. MA-PD sponsors are required to submit materials to CMS based on the Medicare Marketing Guidelines.
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), Specified Low-Income Medicare Beneficiaries (SLMBs), and Qualifying Individuals (QIs). Beneficiaries who are low-income and who do not fall into one of the automatic subsidy eligibility groups apply for a low-income subsidy and have their eligibility determined by either the state in which they reside or the Social Security Administration (SSA). CMS has developed a database to track individuals who are automatically deemed subsidy-eligible or who are determined subsidy-eligible by states or SSA, and communicates the names and eligibility category of those individuals to Part D sponsors as part of the enrollment files from the enrollment processing system described below. Occasionally, due to time lags, CMS’s database does not reflect a low-income subsidy eligible individual true maximum cost sharing amount under the program or an individual’s correct low-income subsidy status. Part D Sponsors are required to adhere to CMS’s Best Available Evidence policy under 42 CFR §423.800(d), under which an individual can provide acceptable evidence supporting a revised cost-sharing amount that the sponsor must accept for the purpose of administering the benefit. For additional information regarding the low income subsidy program, refer to the www.cms.gov/ website.
CMS has a system to receive and process enrollment, disenrollment and membership information provided by MA organizations. Beneficiaries enrolled in an MA plan must obtain qualified prescription drug coverage through that plan (42 CFR §423.30(b)), unless they are enrolled in a MA private fee-for-service plan that does not provide qualified prescription drug coverage (42 CFR §423.30(b)(1)), or they are enrolled in a MSA plan (42 CFR §423.30(b)(2)).
CMS reviews an individual’s status as a Medicare beneficiary. CMS tracks subsidy status and auto-enrollments of full-benefit dual eligible beneficiaries in Part D plans and “facilitated enrollments” for other low-income Medicare beneficiaries. Full-benefit dual eligible beneficiaries who do not enroll in Part D plans are automatically enrolled into a stand-alone drug plan, and other low-income beneficiaries are enrolled through “facilitated enrollment”. Finally, CMS tracks dis-enrollments from Part D plans and will deny new enrollments during any given year unless the enrollment occurs during an allowable enrollment period. For additional information regarding enrollment processing, refer to the www.cms.gov/ website.
CMS provides payment to MA-PD sponsors in the form of advance monthly payments (consisting of the MA-PD plan’s standardized bid, risk adjusted for health status, minus the beneficiary monthly premium), estimated reinsurance subsidies, estimated low-income subsidies (low-income cost sharing and premiums), and estimated gap discount payments. After the end of the payment year, CMS reconciles the actual amounts of low-income cost sharing subsidies, reinsurance amounts, and gap discount amounts reported on PDE records against the amount paid as a part of the prospective monthly payments. Risk sharing amounts (if applicable) are determined after all other reconciliations have been completed. For a more complete description refer to CMS’ prescription drug event reporting instructions that are posted at www.csscoperations.com and on the www.cms.gov website.
This application is to be completed by those MA organizations that intend to offer a new MA-PD during 2012. This application is to be submitted to CMS in conjunction with the documents required for participation in the Part C program during 2012. 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 2012.
CMS conducts technical support calls, also known as User Group calls, for Applicants and existing Part D sponsors. CMS operational experts (e.g., from areas such as enrollment, information systems, marketing, bidding, formulary design, and coordination of benefits) are available to discuss and answer questions regarding the agenda items for each meeting. Registration for the technical support calls and to join the list serve to get updates on CMS guidance can be found at www.mscginc.com/Registration/.
CMS also conducts special training sessions, including a user group call dedicated to addressing issues unique to sponsors that are new to the Part D program.
CMS provides two user manuals to assist applicants with the technical requirements of submitting the Part D application through the Health Plan Management System (HPMS). The Basic Contract Management User’s Manual provides information on completing and maintaining basic information required in Contract Management. These data must be completed prior to the final submission of any application. The Online Application User’s Manual provides detailed instructions on completing the various online applications. Both manuals can be found in HPMS by clicking on Contract Management>Basic Contract Management>Documentation.
MA-PD and/or Regional Preferred Provider Organizations (RPPOs) 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 apply for and receive their CMS User ID(s) and password(s) for HPMS access and need to input contact and other related information into the HPMS (see section 3.1.3). 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.
Applications may be submitted until February 24, 2011. Applicants must use the 2012 solicitation. CMS will not accept or review in anyway those submissions using the prior versions of the solicitation, including the use of CMS provided templates from prior years (e.g. 2011 and earlier).
Applicants will complete the entire solicitation via HPMS.
In preparing your application in response to the prompts in Section 3.0 of this solicitation, please mark “Yes” or “No” or “Not Applicable” in sections organized with that format within HPMS.
In many instances Applicants are directed to affirm within HPMS that they will meet particular requirements by indicating “Yes” next to a statement of a particular Part D program requirement. By providing such attestation, an Applicant is committing that its organization complies with the relevant requirements as of the date your application is submitted to CMS, unless a different date is stated by CMS.
CMS will not accept any information in hard copy. If an Applicant submits the information via hard copy, the application will not be considered received.
Organizations will receive a confirmation number from HPMS upon clicking final submit. Failure to obtain a confirmation number indicates that an applicant failed to properly submit its Part D application by the CMS-established deadline. Any entity that experiences technical difficulties during the submission process must contact the HPMS Help Desk and CMS will make case by case determinations where appropriate regarding the timelines of the application submission.
CMS will check the application for completeness shortly after its receipt. Consistent with the 2010 Call Letter, CMS will make determinations concerning the validity of each organization’s submission. Some examples of invalid submissions include but are not limited to the following: Applicants that fail to upload executed agreements or contract templates, Applicant that upload contract crosswalks instead of contracts, or Applicants that fail to upload any pharmacy access reports. CMS will notify any Applicants that are determined to have provided invalid submissions.
For those Applicants with valid submissions, CMS will notify your organization of any deficiencies and afford a courtesy opportunity to amend the applications. CMS will only review the last submission provided during this courtesy cure period.
CMS will provide communication back to all Applicants throughout the application process via email. The email notifications will be generated through HPMS, so organizations must ensure that the Part D application contract information provided through the “Notice of Intent to Apply” process is current and correct, and that there are no firewalls in place that would prevent an email from the hpms@cms. hhs.gov web address from being delivered.
CMS has established that all aspects of the program that the Applicant attests to must be ready for operation by the application due date.
CMS clarified its Part D application review standards in a final rule (4085-F) published in the Federal Register on April 15, 2010, with an effective date of June 7, 2010. Applicants must demonstrate that they meet all (not substantially all) Part D program requirements to qualify as a Part D sponsor in their proposed service area.
As with all aspects of a MA-PD sponsor’s operations under its contract with CMS, we may verify a sponsor’s compliance with qualifications it attests it will meets, through on-site visits at the MA-PD sponsor’s facilities as well as through other program monitoring techniques. Failure to meet the requirements attested to in this solicitation and failure to operate its Part D plan(s) consistent with the requirements of the applicable statutes, regulations, call letter, and the Part D contract may delay a MA-PD sponsor’s marketing and enrollment activities or, if corrections cannot be made in a timely manner, the Part D sponsor will be disqualified from participation in the Part D program.
An individual with legal authority to bind the Applicant shall execute 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 the time period specified by CMS for responding could result in the applicant receiving a notice of intent to deny the application, in which case, the Applicant will then have 10 days to seek to remedy its application. The end of the 10 day period is the last opportunity an Applicant has to provide CMS with clarifications or corrections. CMS will only review the last submission provided during this cure period. Such materials will not be accepted after this 10-day time period.
This solicitation does not commit CMS to pay any cost for the preparation and submission of an application.
CMS will not review applications received after 11:59 P.M. Eastern Standard Time on February 24, 2011. CMS will lock access to application fields within HPMS as of this time. CMS will not review any submissions based on earlier versions of the solicitation. Applicants must complete the 2012 solicitation in order to be considered for Part D sponsorship.
If a subsidiary, parent, or otherwise related organization is also applying to offer Part D benefits, these entities MUST submit separate applications. There are four types of Part D solicitations for which applications are due on February 24, 2011; they are PDP, MA-PD, Cost Plan solicitations, and the Service Area Expansion Application. Organizations that intend to offer more than one of these types of Part D contracts must submit a separate application for each type. (PACE sponsors will also have separate solicitations). For example, a MA-PD and PDP product may not be represented in the same application. Entities intending to have both local MA-PD and Regional PPO contracts must submit separate MA-PD applications.
All new Part D Applicants seeking to offer new “800 series” EGWPs – with or without corresponding individual plans, including applicants that have not previously applied to offer plans to individual beneficiaries or “800 series” EGWPs must complete the appropriate EGWP attestation provided in the 2011 Application Instructions for MA Organizations to Offer New Employer/Union-Only Group Waiver Plans. The 2012 Application Instructions for MA Organizations to Offer New Employer/Union-Only Group Waiver Plans provides the Applicant with the ability to choose between only offering “800 series” plans and participating in both the individual and group markets for Private Fee-For-Service products. The document further specifies those individual market requirements that are not applicable in the employer market. The document is available on the cms. hhs.gov website.
Applicants offering both individual and “800 series” plans are not required to submit retail pharmacy lists or other pharmacy access submittals (mail order, home infusion, long-term care, I/T/U) for their “800 series” service areas in addition to those required to be submitted for their individual plan service areas. Applicants will not initially be required to have retail and other pharmacy networks in place for those designated EGWP service areas outside of their individual plan service areas. However, in accordance with employer group waiver pharmacy access policy, pharmacy access sufficient to meet the needs of enrollees must be in place once the Applicant enrolls members of an employer or union group residing in particular geographic locations outside of its individual plan service area.
Applicants that intend to only offer “800 series” plans (i.e., no plans will be offered to individual Medicare beneficiaries under this contract number) will be required to submit retail and other pharmacy access information (mail order, home infusion, long-term care, I/T/U) for the entire defined EGWP service area during the application process and demonstrate sufficient access in these areas in accordance with employer group waiver pharmacy access policy.
New Direct Contract Applicants will be able to enter their service area directly into HPMS during the application process.
In general, Part D sponsors can only cover beneficiaries in the service areas in which they are licensed and approved by CMS to offer benefits. CMS has waived these requirements for Direct Contract Sponsors. Direct Contract Sponsors can extend coverage to all of their retirees, regardless of whether they reside in one or more regions in the nation. In order to provide coverage to retirees wherever they reside, Direct Contract Applicants must set their service areas to include all areas where retirees may reside during the plan year.
Direct Contract Applicants are required to submit retail and other pharmacy access information for the entire defined service area during the application process and demonstrate sufficient access in these areas in accordance with employer group waiver pharmacy access policy.
Those employers or unions seeking to directly contract with CMS to become Sponsors for their Medicare-eligible retirees must complete the following materials:
The 2012 Medicare Advantage Application
The 2012Solicitation for Applications for New Medicare Advantage Prescription Drug Plan (MA-PD) Sponsors
The 2012 Initial Application for Employer/Union Direct Contract Private Fee-For-Service (PFFS) Medicare Advantage Organization
The 2012 Financial Solvency & Capital Adequacy Documentation for Direct Contract MA-PD Applicants (submitted electronically through fiscal soundness section for the MA Supporting Files; Appendix can be found in the 2012 Initial Application for Employer/Union Direct Contract Private Fee-For-Service (PFFS) Medicare Advantage Organization
Appendix II—2012 Direct Contract Attestation
The legal entity that submits this application must be the same entity with which CMS enters into a Part D contract, or in the case of an MA-PD and Cost Plan sponsor, the same legal entity seeking an addendum to an MA or Cost Plan contract. An entity that qualifies for a Part D contract, or for an addendum to an MA or Cost Plan contract, may hold multiple contracts for the same plan type (e.g. PDP, MA-PD, or Cost Plan) in the service area described in the application.
When reviewing MA-PD applications from potential MA Regional PPO sponsors (RPPOs), CMS will recognize as Applicants those joint enterprises formed by agreement among multiple state-licensed organizations (or organizations that have applied to CMS for a licensure waiver) for the purpose of administering a Medicare Prescription Drug Plan in at least one entire PDP region. Each member of the joint enterprise will be contractually liable to CMS for the administration of the Part D benefit in the State(s) in which it is licensed or for which it has received a CMS licensure waiver.
The joint enterprise need submit only one MA-PD application on behalf of the enterprise’s member organizations and such application shall represent the joint enterprise’s commitment to offering a uniform benefit in each service area in which it will offer Part D benefits. However, the information requested in Section 3.1 of this solicitation must be provided for each member of the joint enterprise with separate accompanying Appendices as necessary. For example, each joint enterprise member must provide identifying information about its organization, copies of its executed contracts with entities performing critical tasks related to the delivery of the Part D benefit, and information related to its business integrity. The responses provided in the remainder of the application may be made once by the joint enterprise applicant and will be considered binding on each member of the joint enterprise. Also, a separate certification statement, shown in Section 4.0, must be provided for each joint enterprise member organization. Each certification statement must be signed by an individual specifically granted the authority to bind the member organization.
Joint enterprise applicants are required to submit to CMS for approval a copy of the executed agreement among the joint enterprise member organizations. Please see Section 3.1.2.G, for instructions concerning this requirement.
Upon CMS’ determination that the members of the joint enterprise are qualified to enter into a Part D addendum to the Applicant’s Medicare Advantage contract to offer a RPPO, and approval of the bid(s) submitted by the joint enterprise, CMS will enter into a multiple-party MA Part D addendum signed by authorized representatives of CMS and each member of the joint enterprise.
As provided for in 42 CFR §423.34(d), individuals who are dually eligible for Medicare and Medicaid benefits, and who fail to enroll in a Part D plan, will be enrolled automatically in a Part D plan, unless the individual declines the enrollment. As such, CMS requires that MA organizations offering both MA-PD and MA-only plans have a process for auto- and facilitated enrollment. All low-income eligible individuals who elect an MA plan without Medicare prescription drug benefits (MA-only plan) will be auto- or facilitated enrolled into the MA-PD plan in the same organization with the lowest combined Part C and Part D premium amount. If more than one MA-PD plan have the same lowest premium amount, enrollment must be random among the available MA-PD plans. For PFFS plans, if the organization offers a stand-alone PDP in the same region with a basic benefit and a premium at or below the low-income premium subsidy amount for that region, the organization may auto/facilitate enrollment into that PDP. The MA organization’s auto- and facilitated enrollment processes will occur monthly.
In those instances where an organization seeks to withdraw its application or reduce the service area of a pending application prior to the execution of a Part D contract, then the organization must send an official notice to CMS. The notice should be on organization letterhead and clearly identify the pending application number and service area (as appropriate). The notice should be delivered via email to MA_Applications@cms.hhs.gov and drugbenefitimpl@cms.hhs.gov and the subject line of the email should read “Pending application withdrawal or reduction to pending service area.” The withdrawal will be considered effective as of the date of the requested letter.
For technical assistance in the completion of this Application, contact:
Linda AndersMarla Rothouse by email at linda.anders@cms.hhs.gov.marla.rothouse@cms.hhs.gov, or by phone at 410-786-04598063. As stated in section 2.4.1, Applicants must contact the HPMS Help Desk if they are experiencing technical difficulties uploading any part of this solicitation within HPMS prior to the submission deadline.
Applicants use the CMS Health Plan Management System (HPMS) during the application, formulary, and bid processes. Applicants are required to enter contact and other information collected in HPMS in order to facilitate the application review process.
Applicants are required to upload their plan formularies to HPMS using a pre-defined file format and record layout. The formulary upload functionality will be available on March 28, 2011. The deadline for formulary submission to CMS is 11:59 PM EDT on April 18, 2011. CMS will use the last successful upload received for an Applicant as the official formulary submission.
In order to prepare plan bids, Applicants will use HPMS to define their plan structures and associated plan service areas and then download the Plan Benefit Package (PBP) and Bid Pricing Tool (BPT) software. For each plan being offered, Applicants will use the PBP software to describe the detailed structure of their Part D benefit and the BPT software to define their bid pricing information. The formulary must accurately crosswalk to the PBP.
Once the PBP and BPT software has been completed for each plan being offered, Applicants will upload their bids to HPMS. Applicants will be able to submit bid uploads to HPMS on their PBP or BPT one or more times between May 20, 2011 and the CY 2012- bid deadline of June 6, 2011. 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 2011.
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 applicants are required to secure access to HPMS in order to carry out these functions.
All 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 MAPD Help Desk at 1-800-927-8069 for specific guidance on establishing connectivity and the electronic submission of files. Instructions are also on the MAPD Help Desk web page, www.cms.gov/mapdhelpdesk, in the Plan Reference Guide for CMS Part C/D systems link. The MAPD Help Desk is the primary contact for all issues related to the physical submission of transaction files to CMS.
Daily, weekly and monthly, CMS provides responses to Sponsor submitted information and reports to each MA-PD sponsor for each of their plans with member and plan-level information. MA-PD sponsors must compare the membership and payment information in those reports on an ongoing basis with their records and report any discrepancies to CMS according to the instructions and within the timeframes provided by CMS for that purpose. Each MA-PD sponsor must complete and submit the monthly CEO certification of enrollment data for payment on or before the due date each month. The due date is provided in the Plan Monthly MARx Calendar, which is updated annually. Definitive information about the format and submission of files, as well as the MARx calendar, can be found in the Plan Communications User’s Guide (available at http://www.cms.gov/MAPDHelpDesk/02_Plan_Communications_User_Guide.asp#TopOfPagewww.cms.gov/MedicareMangCareSys/). The MAPD Help Desk also provides additional system and technical information at www.cms.gov/mapdhelpdesk/.
Payments will be wired to sponsor accounts on the first day of each month (or the last business day of the prior month if the first day of the month is not a business day). CMS must receive current banking information at a minimum of 6 weeks prior to the first payment to your organization. The specific banking information form and instructions may be obtained from the CMS Central Office contacts listed in Appendices B of the Plan Communication User’s Guide found at MAPDHelp@cms.gov.
The monthly payment includes premiums that SSA or other agencies are deducting from beneficiary Social Security payments or other payments as well as those premiums CMS is paying on behalf of low-income individuals. Estimated monthly reinsurance subsidies, low-income subsidies, and estimated gap discount amounts are also included.
Each MA-PD Applicant must submit to CMS a bid for each prescription drug plan it intends to offer. Applicants using this solicitation may apply to offer full risk Part D plans. Applicants must submit their formularies to HPMS on or before April 18, 2011 and the PBPs and BPTs on or before the bid submission date.
Bid-Related Sections Due Prior to Bid Submission Date
To facilitate the timely review of all the bid submissions, CMS requires Applicants to submit the portion of their bid related to formulary and covered drugs from March 28- April 18, 2011. CMS reviews areas of each proposed drug plan formulary by tier and drug availability and evaluates each element against evidence-based standards such as widely accepted treatment guidelines. Elements include, but may not be limited to the list of drugs, the categories and classes, tier structures (not cost sharing), and utilization management tools such as quantity limits, step therapy, and prior authorization. CMS makes the review criteria available to Applicants well in advance of the date Applicants must submit this information to CMS. Outliers are selected for further evaluation during the formulary review process prior to CMS approval of the bid. CMS makes reasonable efforts to inform Applicants of their outliers so that they may substantiate their offering. If such substantiation is not satisfactory to CMS, the Applicant is given the opportunity to modify the formulary. CMS intends to complete as much of this work as possible before the, PBP and BPT submissions so that any modification may be reflected in those documents.
Bid Submissions
The Applicant’s bid represents the expected monthly cost to be incurred by the Applicant to provide qualified prescription drug coverage in the approved service area for a Part D-eligible beneficiary on a standardized basis. The costs represented in each bid should be those for which the Applicant would be responsible. These costs would not include payments made by the plan enrollee for deductible, coinsurance, co-payments, or payments for the difference between the plan’s allowance and an out-of-network pharmacy’s usual and customary charge. The bid requires the separate identification, calculation, and reporting of costs assumed to be reimbursed by CMS through reinsurance. CMS requires that the bid represent a uniform benefit package based upon a uniform level of premium and cost sharing among all beneficiaries enrolled in the plan. The benefit packages submitted must be cross walked appropriately from the formulary. Pursuant to 42 CFR §423.505(k)(4), the CEO, CFO, or an individual delegated 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 42 CFR §423.265 of the regulations. In addition, consistent with section 43 CFR §423.265(c)(3), the pricing component of the bid must also be certified by a qualified actuary.
As part of its review of Part D bids, CMS conducts an analysis to ensure that multiple plan offerings by a sponsor only when they represents a meaningful variation based on plan characteristics that will provide beneficiaries with substantially different options. In general, CMS expects that more than three bids from a sponsoring organization would not provide meaningful variation. CMS reviews multiple bids received from a Part D Applicant as a whole and applies a reasonableness test to determine examples of a strong likelihood of incompetence and/or ‘gaming’, including, but not limited to: a) multiple bid submissions that would fail a reasonableness test; b) multiple bid submissions based on different formulary drug lists; c) multiple bid submissions based on different levels of utilization management control; and d) multiple bid submissions that reflect a significant unexplained variation in costs between the plans, particularly between plans offered to the group versus the individual market. Pursuant to section 42 CFR §423.265(b), multiple bid submissions must reflect differences in benefit packages or plan costs that CMS determines represent substantial differences relative to a sponsor’s other bid submissions. In order to be considered “substantially different,” each bid must be significantly different from the sponsor’s other bids with respect to beneficiary out-of-pocket costs or formulary structures. Applicants should review the CMS guidance on the submission of bids that are meaningfully different released on April 16, 2010.
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 that 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).
CMS evaluates the reasonableness of bids submitted by MA-PD sponsors by means of an actuarial valuation analysis. This requires evaluating assumptions regarding the expected distribution of costs, including average utilization and cost by drug coverage tier. CMS may test these assumptions for reasonableness through actuarial analysis and comparison to industry standards and other comparable bids. Bid negotiation may take the form of negotiating changes upward or downward in the utilization and cost per script assumptions underlying the bid’s actuarial basis. We may exercise our authority to deny a bid if we do not believe that the bid and its underlying drug prices reflect market rates.
An integral component of this Solicitation concerns the pharmacy access standards established under section 1860D-4(b)(1)(C) of the Social Security Act. The standards require in part that each Part D sponsor must secure the participation in their pharmacy networks of a sufficient number of pharmacies to dispense drugs directly to patients (other than by mail order) to ensure convenient access to covered Part D drugs by Part D plan enrollees. To implement this requirement, specific retail pharmacy access rules consistent with the TRICARE standards were developed and are delineated in 42 CFR §423.120. Furthermore, 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.
Applicants must ensure that their retail pharmacy network meets the criteria established under 42 CFR §423.120. Applicants must ensure the pharmacy network has a sufficient number of pharmacies that dispense drugs directly to patients (other than by mail order) to ensure convenient access to Part D drugs. CMS rules require that Applicants establish retail pharmacy networks in which:
In urban areas, at least 90 percent of Medicare beneficiaries in the Applicant’s service area, on average, live within 2 miles of a retail pharmacy participating in the Applicant’s network;
In suburban areas, at least 90 percent of Medicare beneficiaries in the Applicant’s service area, on average, live within 5 miles of a retail pharmacy participating in the Applicant’s network; and
In rural areas, at least 70 percent of Medicare beneficiaries in the Applicant’s service area, on average, live within 15 miles of a retail pharmacy participating in the Applicant’s network.
Applicants may count I/T/U pharmacies and pharmacies operated by Federally Qualified Health Centers and Rural Health Centers towards the standards of convenient access to retail pharmacy networks.
Applicants may use their contracted PBM’s existing 2011 Part D network to demonstrate compliance with retail pharmacy access standards. If an Applicant is creating a new Part D network, the submission must be based on executed contracts for Year 2012. CMS conducts the review of Retail Pharmacy Access based on the service area that the Applicant has provided in HPMS by February 24, 2011. In an effort to reduce Applicant errors, CMS has automated the retail pharmacy access review. Applicants are required to input their pending service area into HPMS per the instructions at section 3.3B and as explained in section 3.5.1B Applicants must upload the retail pharmacy list in HPMS. Based on the pending service area documented in HPMS, and the retail pharmacy list uploaded by the Applicant, and the Medicare Beneficiary Count file available on the CMS application guidance website, CMS will generate the access percentages for all applicants. (In prior years, applicants provided their geo-reports as part of the pharmacy updaloads.) In addition, CMS will use the information gathered from the pharmacy list upload to identify pharmacy addresses.
With limited exceptions, this information gathered from the pharmacy lists will be used by CMS to geo-code the specific street-level locations of the pharmacies to precisely determine retail pharmacy access. Exceptions to this process may include, but not belimited to, those instances where a street-level address cannot be precisely geo-coded. In those situations, CMS will utilize the ZIP code-level address information to geo-code the approximate pharmacy location.
In previous years CMS allowed Part D applicants to use one of several geo-coding methodologies: representative ZIP code geo-coding, or the more precise geo-coding methods including ZIP+4 Centroid Method, ZIP+@ Centroid Methodad, referred to as address-based geo-coding. As a result, some organizations may previously have coded all pharmacy addresses at the ZIP code/county level as opposed to the more precise street-level coding. CMS strongly encourages applicants conduct a closer and more precise inspection of their retail pharmacy locations and network access prior to submitting their pharmacy list.
The retail pharmacy list may contain contracted pharmacies that are outside of the Applicant’s pending service area (to account for Applicant’s whothat contract for a national pharmacy network); however, CMS will only evaluate retail pharmacy access for the pending service area.
The retail pharmacy access calculations must meet the established standards at one of the following points in time:
At the HPMS gate closing time of the initial application submission (a fully passing retail access review at this point in the application process will not require a subsequent review even if the service area is later reduced), or
At the HPMS gate closing time of the courtesy submission window after CMS has issued an interim deficiency notice, if the initial application retail submission is found to contain retail access related deficiencies of any type (a fully passing retail access review at this point in the application process will not require a subsequent review even if the service area is later reduced), or
At the HPMS gate closing time of the final submission window after CMS has issued a Notice of Intent to Deny (see Section 2.4), if the courtesy retail submission is found to contain retail access related deficiencies of any type.
While Applicants are required to demonstrate that they meet the Part D pharmacy access requirements at the time this solicitation application is submitted to CMS, CMS expects that pharmacy network contracting will be ongoing in order to maintain compliance with our retail pharmacy access requirements.
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 3.5.4). CMS uses this pharmacy listing to compare Applicants’ home infusion pharmacy network against existing Part D sponsors in the same service area to ensure that Applicants have contracted with an adequate number of home infusion pharmacies. The adequate number of home infusion pharmacies is developed based on data provided by all Part D sponsors through the annual Part D Reporting Requirements. A reference file entitled “Adequate Access to Home Infusion Pharmacies” is provided on the CMS website.
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 3.5.5). CMS uses this pharmacy listing, as well as information reported as part of Applicant’s reporting requirements and complaints data, to evaluate initial and ongoing compliance with the convenient access standard.
Applicants must demonstrate that they have offered standard contracts to all I/T/U pharmacies residing within the Applicants’ service areas. In order to demonstrate convenient access to I/T/U pharmacies, Applicants must provide a list of all I/T/U pharmacies to which they have offered contracts (see section 3.5.6). CMS provides the current national list of all I/T/U pharmacies to assist Applicants in identifying the states in which I/T/U pharmacies reside at the www.cms.gov/PrescriptionDrugCovContra/ website.
Waivers for MA-PD Plans. CMS guidance regarding waivers of the pharmacy access and any willing pharmacy requirements for certain MA-PD sponsors is contained at sections 50.7 and 50.8.1 of Chapter 5 of the Prescription Drug Benefit Manual. These waivers are described below.
Waiver of Retail Convenient Access Standards for MA-PDs
As described in section 50.7.1 of Chapter 5 of the Prescription Drug Benefit Manual, the requirement that MA-PD sponsors must offer their Part D plan benefit through a contracted retail pharmacy network that meets CMS convenient access standards is waived for MA-PD sponsors that operate their own pharmacies. MA-PD sponsors must demonstrate at the plan level that a majority (50%) of the prescriptions are filled at retail pharmacies owned and operated by the organization in order to be granted the waiver.
Waiver of Convenient Access Standards for MA-PFFS
As described in section 50.7.2 of Chapter 5 of the Prescription Drug Benefit Manual, the requirement that MA-PD sponsors 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 3.4.
Waiver of Any Willing Pharmacy Requirements for MA-PD
As described in section 50.8.2 of Chapter 5 of the Prescription Drug Benefit Manual, the requirement that MA-PD sponsors must offer a network pharmacy contract to any willing pharmacy that agrees to accept MA-PD sponsor’s standard terms and conditions is waived for MA-PD sponsors that own and operate the pharmacies in their network. MA-PD sponsors must demonstrate at the plan level that at least 98% of prescriptions are filled through pharmacies that are owned and operated by plan sponsor in order to be granted the waiver.
Waivers for Plans in the Territories (excluding Puerto Rico)
To ensure access to coverage in the territories, §1860D-42(a) of the Social Security Act grants CMS the authority to waive the necessary requirements to secure access to qualified prescription drug coverage for Part D eligible individuals residing in the territories. The regulations at 42 CFR §423.859(c) allow CMS to waive or modify the requirement for access to coverage in the territories to be waived or modified either through an Applicant’s request or at CMS’ own determination. Under that authority, CMS will consider waiving the convenient access requirements for a plan’s Part D contracted retail pharmacy network, found in 42 CFR §423.120(a)(1) for the Territories, if an Applicant requests such a waiver, and demonstrates that it has made a good faith effort to meet the requirements described in Section 3.5.1F of this solicitation.
As a part of the application process, those organizations seeking to offer 800 series plans may submit individual waiver/modification requests to CMS. Applicants should submit an attachment via an upload in the HPMS Part D Attestations section that addresses the following:
Specific provisions of existing statutory, regulatory, and/or CMS policy requirement(s) the entity is requesting to be waived or modified (please identify the specific requirement (e.g., 42 CFR §423.32, Section 30.4 of the Part D Enrollment Manual) and whether you are requesting a waiver or a modification of these requirements);
How the particular requirement(s) hinder the design of, the offering of, or the enrollment in, the employer-sponsored group plan;
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.
Note: Applicants should review the waivers currently approved by CMS in Chapter 12 of the Medicare Prescription Drug Benefit manual to assess whether the sponsoring organization is similarly situated to qualify for an existing waiver prior to submitting a request to CMS.
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. 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. Approved Part D applications are valid for the forthcoming contract year. Should an applicant decide to not execute a contract after receiving application approval, then the organization will need to submit a new application if it chooses to enter the Part D market in a future contract year.
Applicants may seek to protect their information from disclosure under the Freedom of Information Act (FOIA) by claiming that FOIA Exemption 4 applies. The Applicant is required to label the information in question “confidential” or “proprietary”, and explain the applicability of the FOIA exemption it is claiming. This designation must be in writing. When there is a request for information that is designated by the Applicant as confidential or that could reasonably be considered exempt under Exemption 4, CMS is required by its FOIA regulation at 45 CFR §5.65(d) and by Executive Order 12,600 to give the submitter notice before the information is disclosed. To decide whether the Applicant’s information is protected by Exemption 4, CMS must determine whether the Applicant has shown that— (1) disclosure of the information might impair the government's ability to obtain necessary information in the future; (2) disclosure of the information would cause substantial harm to the competitive position of the submitter; (3) disclosure would impair other government interests, such as program effectiveness and compliance; or (4) disclosure would impair other private interests, such as an interest in controlling availability of intrinsically valuable records, which are sold in the market. Consistent with our approach under the Medicare Advantage program, we would not release information under the Medicare Part D program that would be considered proprietary in nature.
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 II). 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 because the Part D requirement is duplicative of or conflicting with Part C requirements or the waiver will improve 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 upload in HPMS, a statement that includes:
1. The Part D regulation reference.
2. The appropriate waiver criteria (e.g., duplicative, conflicts, improves benefit coordination).
3. A discussion of how the requested waiver meets at least one of the three waiver criteria.
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 should check both the “Yes” box and the “Waiver Requested” box within HPMS. In the event that CMS does not approve a particular waiver, the Applicant will still have attested that it will meet all the applicable Part D program requirements and remain eligible to enter into a Part D addendum upon approval of its bids. This process will prevent Applicants from having to submit additional application responses after the original February 24, 2011 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, 2011. 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 Medicare
Attention: Application Withdrawal
7500 Security Boulevard
Mail Stop C1-26-12
Baltimore, Maryland 21244-1850
Note: Nothing in this application is intended to supersede the regulations at 42 CFR Part 423. Failure to reference a regulatory requirement in this application does not affect the applicability of such requirement, and MA-PD sponsors and/or Applicants are required to comply with all applicable requirements of the regulations in Part 423 of 42 CFR. In particular, the attestations in this application are intended to highlight examples of key requirements across a variety of functional and operational areas, but are in no way intended to reflect a complete or thorough description of all Part D requirements.
For most of the Part D program requirements described in this solicitation, CMS has issued operational policy guidance that provides more detailed instructions to Part D sponsors. Organizations submitting an application in response to this solicitation acknowledge that in making the attestations stated below, they are also representing to CMS that they have reviewed the associated guidance materials posted on the CMS web site and are in compliance with such guidance. Applicants must visit the CMS web site periodically to stay informed about new or revised guidance documents.
NOTE: All uploads and templates will be accessed in HPMS through the HPMS Contract Management Module. Applicants should refer to the Contract Management – Online Application User’s Guide Version 2.0 for further instructions.
SPECIAL INSTRUCTIONS FOR JOINT ENTERPRISE APPLICANTS: If an application is being submitted by a joint enterprise, as described above in Section 2.4, a separate set of responses to the requirements in Section 3.1 must be provided as part of this application by each member organization of the joint enterprise.
A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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B. Upload in HPMS, organizational structure, and history information related to your organization, the parent organization, and the corporate structure. Submit this information by downloading the appropriate template found in HPMS that mimics the Appendix entitled, Organization Background and Structure.
C. First tier, Downstream and Related entities Function Chart
In HPMS, on the Contract & Management/Part D Information/Part D Data Page, provide names of the first tier, downstream and related entities you will use to carry out each of the functions listed in this chart and whether the first tier, downstream, and related entities are off-shore: (Indicate with “name of Applicant’s Organization” where applicant will perform those functions) |
Function |
First tier, Downstream and Related entities |
Off-Shore Yes/no |
A pharmacy benefit program that performs adjudication and processing of pharmacy claims at the point of sale. |
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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, including TrOOP balance processing. |
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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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A pharmacy benefit program that 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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A pharmacy benefit program that maintains a pharmaceutical and therapeutic committee. |
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A pharmacy benefit program that performs enrollment processing. |
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D. In HPMS, upload copies of executed contracts, fully executed letters of agreement, administrative services agreements, or intercompany agreements (in .pdf format) with each first tier, downstream and related entities identified in Sections 3.1.1 C that:
Clearly identify the parties to the contract (or letter of agreement).
Describe the functions to be performed by the first tier, downstream or related entity. 42 CFR §423.505(i)(4)(i)
Describe the reporting requirements the first tier, downstream, or related entity has to the Applicant. 42 CFR §423.505(i)(4)(i)
Contain language clearly indicating that the first tier, downstream, or related entity has agreed to participate in your Medicare Prescription Drug Benefit program (except for a network pharmacy if the existing contract would allow participation in this program).
Contains flow-down clauses requiring their activities be consistent and comply with the Applicant’s contractual obligations as a Part D sponsor. 42 CFR §423.505(i)(3)(iii)
Describe the payment the first tier, downstream, or related entity will receive for performance under the contract, if applicable.
Clearly indicates that the contract is for a term of at least the initial one-year contract period (i.e., January 1 through December 31) for which this application is being submitted. Where the contract is for services or products to be used in preparation for the next contract year’s Part D operations (e.g., marketing, enrollment), the initial term of such contract must include this period of performance (e.g., contracts for enrollment-related services must have a term beginning no later than October 15 extending through the full contract year ending on December 31 of the next year).
Are signed by a representative of each party with legal authority to bind the entity.
Contain language obligating the first tier, downstream, or related entity to abide by all applicable Federal laws and regulations and CMS instructions. 42 CFR §423.505(i)(4)(iv)
Contain language obligating the first tier, downstream, or related entity to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for this program at 42 CFR §423.136.
Contain language ensuring that the first tier, downstream, or related entity will make its books and other records available in accordance with 42 CFR 423.505(e)(2) and 42 CFR 423.505(i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to audit, evaluate and inspect any books, contracts, records, including medical records and documentation involving transactions related to CMS’ contract with the Part D sponsor and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later. 42 CFR §423.505(e)(2) and (i)(2)
Contain language that the first tier, downstream, or related entity will ensure that beneficiaries are not held liable for fees that are the responsibility of the Part D sponsor. 42 CFR §423.505(i)(3)(i)
Contain language that the first tier, downstream, or related entity indicates clearly that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees, or will be provided directly to CMS or its designees. 42 CFR §423.505(i)(3)(iv)
Contain language that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the first tier, downstream, or related entity, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the first tier, downstream, or related entity has not performed satisfactorily. Note: The contract/administrative services agreement may include remedies in lieu of revocation to address this requirement. 42 CFR §423.505(i)(4)(ii)
Contain language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the first tier, downstream, or related entity on an ongoing basis. 42 CFR §423.505(i)(4)(iii)
If the first tier, downstream, or related entity will establish the pharmacy network or select pharmacies to be included in the network contain language that the Part D sponsor retains the right to approve, suspend, or terminate any arrangement with a pharmacy. 42 CFR §423.505(i)(5)
If the first tier, downstream, or related entity will establish the pharmacy network or select pharmacies to be included in the network contain language that payment to such pharmacies (excluding long-term care and mail order) shall be issued, mailed, or otherwise transmitted with respect to all clean claims submitted by or on behalf of pharmacies within 14 days for electronic claims and within 30 days for claims submitted otherwise. 42 CFR §423.505(i)(3)(vi)
If the first tier, downstream, or related entity will establish the pharmacy network or select pharmacies to be included in the network contain language that if a prescription drug pricing standard is used for reimbursement, identify the source used by the Part D sponsor for the standard of reimbursement. 42 CFR §423.505(i)(3)(viii)(B)
If the first tier, downstream, or related entity will establish the pharmacy network or select pharmacies to be included in the network and a prescription drug pricing standard is used for reimbursement, contain a provision that updates to such a prescription drug pricing standard occur not less frequently than once every 7 days beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug. 42 CFR §423.505(b)(21) and (i)(3)(viii)(A)
If the first tier, downstream, or related entity will establish the pharmacy network or select pharmacies to be included in the network contain language requiring the network pharmacies to submit claims to the Part D sponsor or first tier, downstream or related entity whenever the membership ID card is presented or on file at the pharmacy unless the enrollee expressly requests that a particular claim not be submitted. 423.120(c)(3)
If the first tier, downstream, or related entity will adjudicate and process claims at the point of sale and/or negotiate with prescription drug manufacturers and others for rebates, discounts, or other price concessions on prescription drugs contain language that the first tier, downstream, or related entity will comply with the reporting requirements established in Section 6005 of the Patient Protection and Affordable Care Act of 2010 (PPACA).
Each complete contract must meet all of the above requirements when read on its own.
E. Upload in HPMS electronic lists of the contract/administrative service agreement/intercompany agreement citations demonstrating that the requirements of Section 3.1.D are included in each contract and administrative service agreement. Submit these data by downloading the appropriate spreadsheet found in HPMS that mimics the Appendix entitled, Crosswalk of Citations of Section 3.1.1D to location in contracts/administrative service agreements/intercompany agreements submitted as attachments to Section 3.1.1.
F. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
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G. Special Requirement for Joint Enterprise Applicants: If Applicant answered 3.1.1F1 (table above) as YES, then Joint Enterprise Applicants must upload (in .pdf format) a copy of the agreement executed by the State-licensed entities describing their rights and responsibilities to each other and to CMS in the operation of a Medicare Part D benefit plan. Such an agreement must address at least the following issues:
Termination of participation in the joint enterprise by one or more of the member organizations; and
Allocation of CMS payments among the member organizations.
A. In HPMS, complete the table below:
Applicant must attest ‘yes’ or ‘no’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, in the Contract Management/Contact Information/Contact Data page provide the name/title; mailing address; phone number; fax number; and email address for the following required Applicant contacts:
Note: The same individual should not be identified for each of these contacts. If a general phone number is given then CMS requires specific extensions for the individual identified. Under no circumstances should these numbers merely lead to a company’s general automated phone response system. Further, Applicants must provide specific email addresses for the individuals named.
Note: Contact definitions are provided in HPMS in the Contract Management/Contact Information/Contact Data/Documentation link entitled Contact Definitions.
Contact |
Name/Title |
Mailing Address (PO Boxes may not be used) |
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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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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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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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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Bid Audit Contact |
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Plan Directory Contact for Public Website |
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CAP Report Contact for Public Website |
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Financial Reporting Contact |
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Best Available Evidence Contact |
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Automated TrOOP Balance Transfer Contact |
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Agent/Broker Compensation Data Contact |
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Complaint Tracking Module (CTM) Contact |
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Part D Reporting Requirements Contact |
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Fraud Investigations Contact |
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Reconcilliation Contact |
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DIR Contact |
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B. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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B. In HPMS, complete the table below:
If Applicant is intending for its Part D benefit to include the use of a formulary, then Applicant must also provide a P&T committee member list either directly or through its pharmacy benefit manager (PBM). Applicant must attest ‘yes’ or ‘no’ that it is using its PBM’s P&T committee, in order to be approved for a Part D contract. Attest ‘yes’ or ‘no’ by clicking the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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Note: While the P&T committee may be involved in providing recommendations regarding the placement of a particular Part D drug on a formulary cost-sharing tier, the ultimate decision maker on such formulary design issues is the Part D plan sponsor, 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 either directly by the Applicant or by the Applicant’s PBM. The membership of the P&T committee must be comprised as described in items B, 10, 11 and 13 above. If Applicant is providing names of P&T committee directly, then provide the membership in HPMS’ Contract Management/Part D Data page. If the PBM operates under a confidentiality agreement (where the Applicant does not know the membership of the PBM’s P&T Committee) refer to the Appendix entitled Applicant Submission of P&T Committee Member List and Certification Statement for additional instructions.
D. In HPMS complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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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 MA-PFFS Applicants should proceed to subsection 3.2.3 “Quality Assurance and Patient Safety” of the application.
A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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If the Applicant is an 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 MA-PFFS Applicants should proceed to sub-section 3.2.5 “Electronic Prescription Program” of the application.
A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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If Applicant is offering a local MA-PD plan (as defined under 42 CFR §422.2) then the plan service area does not have to meet a regional definition.
A. Only Applicants that intent to offer a Regional PPO plan must complete the table below in HPMS:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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B. Complete in HPMS, in the Contract Management/Contract Service Area/Service Area Data page, the service area information indicating the regions (including territories) you plan to serve. Information on MA regions may be found on the www.cms.hhs.gov/ website. Be sure to list both the MA region name and associated number. Note: CMS bases its pharmacy network analyses on the service area your organization inputs into HPMS. Please make sure that the service area information you input into HPMS corresponds to the pharmacy lists that are provided under the Pharmacy Access section of the application.
A. In HPMS, complete the table below ONLY if you are a Private Fee For Service Applicant. Otherwise, proceed directly to General Pharmacy Access.
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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Note: Only if Applicant attests No to 3.4.1, and Yes to 3.4A2-4, Applicant may move directly to Section 3.6 and will be granted a waiver of convenient access.
A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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are included in the respective downstream pharmacy network contracts. |
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B. Upload in HPMS a contract template in .pdf format for each for the following types of pharmacies: Retail, Mail Order, Home Infusion, Long-Term Care and I/T/U. The mail order contract template is only necessary if the plan is offering mail order. The I/T/U template is only necessary if the Applicant’s service area includes states in which I/T/U pharmacies reside. If Applicant has contracted with a Pharmacy Benefit Manager to provide a pharmacy network, those downstream contract templates must also be uploaded. If there are several different types of standard terms and conditions for the same type of pharmacy, please provide a contract template for all versions and label according to type of pharmacy. For example, if different terms for retail pharmacies apply depending upon geographic location, a separate template representing each variation must be provided. Each contract template type must contain the unsigned standard terms and conditions, including the provisions listed in the Appendices entitled
Crosswalk for Retail Pharmacy Contracts
Crosswalk for Mail Order Pharmacy Contracts
Crosswalk for Home Infusion Pharmacy Access Contracts
Crosswalk for Long-Term Care Pharmacy Access Contracts
Crosswalk for I/T/U Pharmacy Access Contracts.
C. Upload in HPMS crosswalks of the Pharmacy Access Contract Citations [for Retail, Mail Order (if offered), Home Infusion, Long-Term Care and I/T/U Pharmacy networks] demonstrating that all applicable requirements are included in such contracts. Submit this data by downloading the Microsoft Excel worksheets from HPMS that are located on the Pharmacy Upload page, complete the worksheets and upload the finished document back into HPMS for each of the Appendices entitled
Crosswalk for Retail Pharmacy Contracts
Crosswalk for Mail Order Pharmacy Contracts
Crosswalk for Home-Infusion Pharmacy Access Contracts
Crosswalk for Long-Term Care Pharmacy Access Contracts
Crosswalk for I/T/U Pharmacy Access Contracts.
A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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B. Upload in HPMS the Retail Pharmacy List:
To submit retail pharmacy listings to CMS, Applicants must download the Microsoft Excel worksheet from HPMS that is located on the Pharmacy Upload page, complete the worksheet and upload the finished document back into HPMS.
C. Submission of Supporting Discussion in Areas Failing to Meet Access Standards
CMS will consider supporting discussion provided by an Applicant in evaluating the applicant’s application to determine if Applicant is qualified to be a Part D Sponsor. While you have the opportunity to provide this discussion, CMS’ expectation is that your organization will meet the required access standards in all cases. Providing the discussion below does not mean CMS will allow you to fail the access standards, but in extreme or unusual circumstances, we may consider this information.
Provide as an upload in HPMS, in .pdf format, the following information to demonstrate that meeting the access standard within the service area is not practical or is impossible.
Indicate the geographic areas in which the applicant cannot demonstrate that it meets the retail pharmacy convenient access standards.
Explain why these standards cannot be met. Include in the discussion relevant information such as geographic barriers, pharmacy infrastructure barriers, and/or market barriers.
Describe how the pharmacies in the Applicant’s retail contracted network will provide access to all eligible Part D individuals enrolled in the Applicant’s plan(s) in each of the geographic areas defined in item 1 above.
D. In HPMS, indicate whether you are seeking a waiver of the convenient access standards for the territories in which your organization intends to offer the Part D benefit. If your organization is not intending to offer the Part D benefit in the territories check N/A within HPMS.
Request for a Waiver of Convenient Access Standards for the Territories Yes No N/A |
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Region 35 – American Samoa |
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Region 36 – Guam |
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Region 37 – Northern Mariana Islands |
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Region 39 – US Virgin Islands |
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E. Complete the following if you marked YES to requesting a waiver of convenient access standards for any of the territories in 3.5.1D. In HPMS, in .pdf format, provide the following information:
Explain why your organization cannot demonstrate compliance with the access standards or why these standards cannot be met.
Describe the Applicant’s efforts to identify and contract with all of the retail pharmacies in each of the applicable territories.
Describe how the pharmacies in the Applicant’s contracted network demonstrate convenient access to all eligible Part D individuals enrolled in the Applicant’s plan(s) in each of the territories listed above as not meeting the standards in §423.120(a)(1).
F. In HPMS complete the table below:
Waiver of Retail Convenient Access Standards for MA-PDs |
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Provide the number of prescriptions provided in 2010 by retail pharmacies owned and operated by Applicant. |
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Provide the number of prescriptions provided in 2010 at all retail pharmacies contracted by Applicant. |
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NOTE: CMS will determine the percentage of prescriptions provided at retail pharmacies owned and operated by Applicant over total prescriptions provided at all retail pharmacies contracted by Applicant.
G. In HPMS complete the table below:
Waiver of Any Willing Pharmacy Requirements for MA-PDs |
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Provide the number of prescriptions provided in 2010 by all pharmacies owned and operated by Applicant. |
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Provide the number of prescriptions provided in 2010 at all pharmacies contracted by Applicant. |
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NOTE: CMS will determine the percentage of prescriptions provided at all pharmacies owned and operated by Applicant over total prescriptions provided at all pharmacies contracted by Applicant.
A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicants may offer a mail order option in addition to their contracted Part D pharmacy network but mail order pharmacies do not count in meeting network adequacy standards. Indicate in HPMS ‘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
To submit mail order pharmacy listings to CMS, Applicants must download the Microsoft Excel worksheet template from HPMS that is located on the Pharmacy Upload page, complete the worksheet and upload the finished document back into HPMS.
A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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B. Home Infusion Pharmacy List
To submit home infusion pharmacy listings to CMS, Applicants must download the Microsoft Excel worksheet template from HPMS that is located on the Pharmacy Upload page, complete the worksheet and upload the finished document back into HPMS.
A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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B. LTC Pharmacy List
To submit LTC pharmacy listings to CMS, Applicants must download the Microsoft Excel worksheet template from HPMS that is located on the Pharmacy Upload page, complete the worksheet and upload the finished document back into HPMS.
A. In HPMS, complete the table below:
Applicant must attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS to be approved for a Part D contract: |
Yes |
No |
N/A |
Requesting Waiver? Yes or No |
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Not all Part D regions have I/T/U pharmacies. If the Applicant’s service area covers any region that includes I/T/U pharmacies, then the Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. If all of the Applicant’s service area does not include I/T/U pharmacies, then the Applicant may answer ‘no’ or n/a and still be approved for a Part D contract since these requirements do not apply. Attest ‘yes,’ ‘no’ or n/a to each of the following qualifications by clicking on the appropriate response in HPMS. |
Yes |
No |
N/A |
Requesting Waiver? Yes or No |
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B. I/T/U Pharmacy List
In order to demonstrate that a Part D Applicant meets these requirements Applicants must submit a complete list of all I/T/U pharmacies to which it has offered contracts. CMS provides the current list of I/T/U pharmacies, including the official name, address, and provider number (when applicable). The Applicant’s list must be submitted using the Microsoft Excel template provided by CMS on the HPMS Pharmacy Upload page, and must include all I/T/U pharmacies residing in any and all counties within its service area. To submit I/T/U pharmacy listings to CMS, Applicants must first download the Microsoft Excel worksheet template from HPMS that is located on the Pharmacy Upload page, complete the worksheet and upload the finished document back into HPMS.
A. In HPMS, complete the table below.
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No? |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS. |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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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 PDP 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 PDP 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.
A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waivers? Yes or No |
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These requirements also apply to exceptions requests by Medicare eligible children for off-formulary Part D pediatric drugs and doses that are medically appropriate. |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS. |
Yes |
No |
Requesting Waiver? Yes or No |
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• NOTE: For information regarding the TrOOP facilitator, Applicant may link to http://medifacd.ndchealth.com/home/medifacd_home.htm
A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS. |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS. |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS. |
Yes |
No |
Requesting Waiver? Yes or No |
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A. Provide as an upload via HPMS, in a .pdf format, a copy of your organization’s Medicare Part D Compliance Program that you intend to use for this contract.
The Part D compliance program must be in accordance with 42 CFR §423.504(b)(4)(vi). In addition, the Part D compliance program must demonstrate that all 7 elements in the regulation and in Chapter 9 are being implemented and are specific to the issues and challenges presented by the Part D program. A general compliance program applicable to healthcare operations is not acceptable.
Note: Please be advised that the Part D Applicant is ultimately responsible for the implementation and monitoring of the day-to-day operations of its Part D compliance program. Section 40.1 of Chapter 9 of the Prescription Drug Benefit Manual indicates that the compliance officer and compliance committee functions may not be delegated or subcontracted. This means the Medicare Compliance Officer identified in HPMS Contacts (see section entitled HPMS Part D Contacts) must be an employee of the Applicant. A compliance plan adopted and operated by a Part D Applicant’s (first tier, downstream and related entities) is not sufficient to demonstrate that the Part D Applicant meets the compliance program requirement.
B. In HPMS, complete and upload the table below. Applicant must clearly identify where each requirement can be found in the uploaded documents.
Crosswalk for Part D Compliance Program |
Document Page Number |
Written policies, procedures, and standards of conduct that address Part D issues and articulates your organization’s commitment to abide by all applicable Federal and State standards. For full requirement see, 42 CFR §423.504(b)(4)(vi)(A). |
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Designation of an employee of the Applicant, parent organization or corporate affiliate as the compliance officer vested with day-to-day operations of the compliance program. The compliance officer and compliance committee periodically report to the governing body of the Applicant on the activities and status of the compliance program, including issues identified, investigated, and resolved by the compliance program. (Note: This requirement cannot be delegated to a first tier, downstream, or related entity). For full requirement see 42 CFR §423.504(b)(4)(vi)(B). |
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Effective training and education for Applicant’s employees including, the chief executive and senior administrators or managers; governing body members; and first tier, downstream, and related entities. For full requirement see 42 CFR §423.504(b)(4)(vi)(C). |
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Effective lines of communication, ensuring confidentiality, between the compliance officer, members of the compliance committee, Applicant’s employees, managers and governing body, and the Applicant’s first tier, downstream and related entities. Such lines of communication must be accessible to all and allow compliance issues to be reported including a method for anonymous and confidential good faith reporting of potential compliance issues as they are identified. For full requirement see 42 CFR §423.504(b)(4)(vi)(D). |
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Well-publicized disciplinary standards through the imposition of procedures which encourage good faith participation by all affected individuals. Enforcement of standards through disciplinary guidelines that are well-publicized in the organization. For full requirement see 42 CFR §423.504(b)(4)(vi)(E). |
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Effective system for routine monitoring and identification of compliance risks. The system should include internal monitoring and audits and, as appropriate, external audits to evaluate the Applicant and first tier entities’ compliance with CMS requirements and the overall effectiveness of the compliance program. For full requirement see 42 CFR §423.504(b)(4)(vi)(F). |
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Procedures and a system for promptly responding to compliance issues as they are raised, investigating potential compliance problems as they are identified in the course of self-evaluations and audits, correcting such problems promptly and thoroughly to reduce the potential for recurrence, and ensure ongoing compliance with CMS requirements. For full requirement see 42 CFR §423.504(b)(4)(vi)(G). |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
Reporting Requirements Guidance |
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Claims Data |
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Rebate Data |
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Other Data |
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Supporting www.medicare.gov |
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Conflict of Interest |
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PBM Transparency |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS. |
Yes |
No |
Requesting Waiver? Yes or No |
HPMS |
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Enrollment & Payment |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS. |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS. |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS. |
Yes |
No |
Requesting Waiver? Yes or No |
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Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS: |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS. |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS. |
Yes |
No |
Requesting Waiver? Yes or No |
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A. In HPMS, complete the table below:
Applicant must attest ‘yes’ to each of the following qualifications to be approved for a Part D contract. Attest ‘yes’ or ‘no’ to each of the following qualifications by clicking on the appropriate response in HPMS. |
Yes |
No |
Requesting Waiver? Yes or No |
1. Applicant agrees once its enrollment is more than 600 enrollees (as of July in the preceding contract year), it will contract with an approved CAHPS survey vendor and pay for the CAHPS data collection costs. |
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2. Applicant agrees to abide by CMS guidance to the process for contracting with approved CAHPS survey vendors. |
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Upload in HPMS, in a .pdf format, the following certification:
I, ___________________________________, attest to the following:
NAME & TITLE
I have read the contents of the completed application and the information contained herein is true, correct, and complete. If I become aware that any information in this application is not true, correct, or complete, I agree to notify the Centers for Medicare & Medicaid Services (CMS) immediately and in writing.
I authorize CMS to verify the information contained herein. I agree to notify CMS in writing of any changes that may jeopardize my ability to meet the qualifications stated in this application prior to such change or within 30 days of the effective date of such change. I understand that such a change may result in termination of the approval.
I agree that if my organization meets the minimum qualifications and is Medicare-approved, and my organization enters into a Part D contract with CMS, I will abide by the requirements contained in Section 3.0 of this Application and provide the services outlined in my application.
I agree that CMS may inspect any and all information necessary including inspecting of the premises of the Applicant’s organization or plan to ensure compliance with stated Federal requirements including specific provisions for which I have attested. I further agree to immediately notify CMS if despite these attestations I become aware of circumstances which preclude full compliance by January 1 of the upcoming contract year with the requirements stated here in this application as well as in Part 423 of 42 CFR of the regulation.
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 contract with CMS.
I acknowledge that I am aware that there is operational policy guidance, including the forthcoming Call Letter, relevant to this application that is posted on the CMS website and that it is continually updated. Organizations submitting an application in response to this solicitation acknowledge that they will comply with such guidance should they be approved for a Part D contract.
__________________________ ____________________
Authorized Representative Name (printed) Title
__________________________________ _________________________
Authorized Representative Signature Date (MM/DD/YYYY)
Part D Regulation |
Regulatory Requirement(s) Description |
Basis for Waiver |
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42 CFR 423Subpart I, excepting 42 CFR §423.440 (which concerns Federal preemption of State law and prohibition of State premium taxes) |
Licensure and Solvency – Applicant must be licensed to bear risk in the State in which it intends to operate or apply for a licensure waiver and meet CMS solvency standards. |
Duplicative of MA Organization requirements for licensure and solvency under 42 CFR §422.6 (i); 42 CFR §422.400; and 42 CFR §422.501). |
42 CFR §423.153(b) 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 42 CFR §423.153 (b). |
42 CFR §423.153(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 §423.153(d).
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42 CFR §423.112 (a) |
Service Area – Applicant must offer a Part D plan that serves at least an entire PDP region. |
Conflicts with MA regulations (42 CFR§ 422.2) that allow MA organizations to offer local MA plans (i.e., plans that serve less than an entire state). |
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 and operated by the MA organization if that organization’s pharmacy network access meets 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 and operated by the MA organization and dispense at least 98% of all prescriptions through pharmacies owned and operated by Applicant. |
42 CFR §423.34 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). |
42 CFR §423.512 |
Experience and Capabilities – Applicant must reach the minimum enrollment standard within the first year it offers a Part D benefit. |
Conflicts with MA regulation at 42 CFR §422.514 that permits three years to achieve the minimum enrollment level. |
1. EGWP Service Area & PHARMACY ACCESS Requirements
In general, Part D plans can only cover beneficiaries in the service areas in which they are licensed and approved by CMS to offer benefits. CMS has waived this requirement for Direct Contract MA-PD Sponsors. Direct Contract MA-PD Sponsors can extend coverage to all of their retirees, regardless of whether they reside in one or more MA regions in the nation. In order to provide coverage to retirees wherever they reside, Direct Contract MA-PD Sponsors must set their service areas to include all areas where retirees may reside during the plan year. Applicants are required to submit retail and other pharmacy access information (mail order, home infusion, long-term care, I/T/U) for the entire defined service area during the application process and demonstrate sufficient access in these areas in accordance with employer group waiver pharmacy access policy.
I certify that I am an authorized representative, officer, chief executive officer, or general partner of the business organization that is applying for qualification to offer employer/union Direct Contract MA-PD. I have read, understand, and agree to comply with the above statement about service areas and pharmacy access. If I need further information, I will contact one of the individuals listed in the instructions for this application.
{Entity MUST complete for a complete application.}
2. Certification
All provisions of this underlying Solicitation apply to all plan benefit packages offered by the Direct Contract MA-PD except where the provisions are specifically modified and/or superseded by particular employer/union-only group waiver guidance, including those waivers/modifications set forth below (specific sections of the 2012 Solicitation for Applications for New Medicare Advantage Prescription Drug Plan (MA-PD) Sponsors that have been waived or modified for new Direct Contract MA-PD Applicants are noted in parentheses).
I, the undersigned, certify to the following:
1) Applicant is applying to offer new employer/union-only Direct Contract Medicare Advantage Prescription Drug Plans and agrees to be subject to and comply with all CMS employer/union-only group waiver guidance.
2) Applicant must complete and submit the 2012 Medicare Advantage Application, 2012 Initial Application For Employer/Union Direct Contract Private Fee-For-Service (PFFS) or Direct Contract (CCP) Medicare Advantage Organization, and the underlying 2012 Solicitation for Applications for New Medicare Advantage Prescription Drug Plan (MA-PD) Sponsors in addition to the Appendix entitled “Part D Financial Solvency & Capital Adequacy Documentation for Direct Contract MA-PD Applicants”. All these documents comprise new Direct Contract MA-PD Applicant’s entire Direct Contract MA-PD application.
3) Applicant agrees to restrict enrollment in its Direct Contract MA-PD plans to those Medicare eligible individuals eligible for the employer’s/union’s employment-based group coverage.
4) Applicant understands and agrees that it is not required to submit a 2012 Part D bid (i.e., bid pricing tool) to offer its Direct Contract MA-PD. (Section 2.7)
5) In order to be eligible for the CMS retail pharmacy access waiver of 42 CFR §423.120(a)(1), Applicant attests that its retail pharmacy network is sufficient to meet the needs of its enrollees throughout the Direct Contract MA-PD’s service area, including situations involving emergency access, as determined by CMS. Applicant acknowledges and understands that CMS reviews the adequacy of the Applicant’s pharmacy networks and may potentially require expanded access in the event of beneficiary complaints or for other reasons it determines in order to ensure that the Applicant’s network is sufficient to meet the needs of its employer group population. (Section 3.5.1A1)
6) Applicant understands and agrees that as part of its completion of the underlying application, it submits retail pharmacy access and other pharmacy access submissions (mail order, home infusion, long-term care, I/T/U) required at the time of application for its entire designated service area. (Section 3.5)
7) Applicant understands that its Direct Contract MA-PD plans are not included in the processes for auto-enrollment (for full-dual eligible beneficiaries) or facilitated enrollment (for other low income subsidy eligible beneficiaries). (Section 3.6.A2)
8) Applicant understands that CMS has waived the requirement that the Direct Contract MA-PD provide beneficiaries the option to pay their premium through Social Security withholding. Thus, the premium withhold option is not be available for enrollees in Applicant’s Direct Contract MA-PD. (Sections 3.6.A10 and 3.24.A2-A4)
9) Applicant understands that dissemination materials for its Direct Contract MA-PD plans are not subject to the requirements contained in 42 CFR §423.50 to be submitted for review and approval by CMS prior to use. However, Applicant agrees to submit these materials to CMS at the time of use in accordance with the procedures outlined in Chapter 9 of the Medicare Managed Care Manual (MMCM). Applicant also understands that CMS reserves the right to review these materials in the event of beneficiary complaints or for any other reason it determines to ensure the information accurately and adequately informs Medicare beneficiaries about their rights and obligations under the plan. (Section 3.14A1)
10) Applicant understands that its Direct Contract MA-PD is not subject to the requirements regarding the timing for issuance of certain dissemination materials, such as the Annual Notice of Change/ Evidence of Coverage (ANOC/EOC), Summary of Benefits (SB), Formulary, and LIS rider when an employer’s or union’s open enrollment period does not correspond to Medicare’s Annual Coordinated Election Period. For these employers and unions, the timing for issuance of the above dissemination materials should be appropriately based on the employer/union sponsor’s open enrollment period. For example, the Annual Notice of Change/Evidence of Coverage (ANOC/EOC), Summary of Benefits (SB), LIS rider, and Formulary are required to be received by beneficiaries no later than 15 days before the beginning of the employer/union group health plan’s open enrollment period. The timing for other dissemination materials that are based on the start of the Medicare plan (i.e., calendar) year should be appropriately based on the employer/union sponsor’s plan year. (Section 3.14A12)
11) Applicant understands that the dissemination/disclosure requirements set forth in 42 CFR §423.128 do not apply to its Direct Contract MA-PD plans when the employer/union sponsor is subject to alternative disclosure requirements (e.g., the Employee Retirement Income Security Act of 1974 (“ERISA”)) and complies with such alternative requirements. Applicant complies with the requirements for this waiver contained in employer/union-only group waiver guidance, including those requirements contained in Chapter 9 of the MMCM. (Section 3.14.A1-A2, A10)
12) Applicant understands that its Direct Contract MA-PD plans are not subject to the requirements contained in 42 CFR §423.48 to submit information to CMS, including the requirements to submit information (e.g., pricing and pharmacy network information) to be publicly reported on www.medicare.gov (Medicare Prescription Drug Plan Finder). (Sections 3.8A and 3.17A14)
13) Applicant understands that its Direct Contract MA-PD plans are not subject to the Part D beneficiary customer service call center hours and call center performance requirements. Applicant has a sufficient mechanism available to respond to beneficiary inquiries and provides customer service call center services to these members during normal business hours. However, CMS may review the adequacy of these call center hours and potentially require expanded beneficiary customer service call center hours in the event of beneficiary complaints or for other reasons in order to ensure that the entity’s customer service call center hours are sufficient to meet the needs of its enrollee population. (Section 3.14A7)
14) In general, Part D plan Sponsors must report certain information to CMS, to their enrollees, and to the general public (such as the cost of their operations and financial statements) under 42 CFR §423.514(a). Applicant understands that in order to avoid imposing additional and possibly conflicting public disclosure obligations that would hinder the offering of employer sponsored group plans, CMS modifies these reporting requirements for Direct MA-PDs to allow information to be reported to enrollees and to the general public to the extent required by other law (including ERISA or securities laws), or by contract. (Section 3.17A12-A13)
15) This Certification is deemed to incorporate any changes that are required by statute to be implemented during the term of the contract, and any regulations and policies implementing or interpreting such statutory provisions.
16) 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 CMS immediately and in writing.
17) 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.
18) 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.
19) I acknowledge that I am aware that there is operational policy guidance, including the forthcoming Call Letter, relevant to this application that is posted on the CMS website and that it is continually updated. Organizations submitting an application in response to this solicitation acknowledge that they will comply with such guidance at the time of the application submission date.
I certify that I am an authorized representative, officer, chief executive officer, or general partner of the business organization that is applying for qualification to offer employer/union Direct Contract plans in association with my organization’s MA-PFFS Contract with CMS. I have read and agree to comply with the above certifications.
{Entity MUST check box for a complete application.}
Instructions: Applicants must complete and upload in HPMS the following information.
Legal Entity Background
Date Legal Entity Established: _________________
Date Health and Drug Insurance Operations Began: _______________________
Date for First Health Insurance License
Date for Current Health Insurance License
Location of Domestic License
State of Incorporation
Management of Legal Entity
Identify the Executive Officers of the legal entity
Identify the Board of Directors of the legal entity
Identify the staff with legal authority to sign/enter into contracts on behalf of the legal entity
Identify the Executive Manager whose appointment and removal are under control of the Board of Directors
How often does the Board of Directors meet?
Identify the Medical Director of the legal entity?
Is the Medical Director considered part of the executive staff?
Provide the NPI number for the Medical Director.
Identify the state(s) the Medical Director holds a clinical license.
Enrollment Information
Total Medicare Enrollment as of January 1st of this year
Total Medicaid Enrollment as of January 1st of this year
Total Commercial Market Enrollment as of January 1st of this year
Parent Organization Information
Name of Parent Organization
Date Parent Organization established
Organizational Charts
Provide an organizational chart of the legal entity’s parent organization, affiliates, subsidiaries and related entities.
Provide an organizational chart solely of the internal structure of the legal entity by department (i.e., marketing, compliance, pharmacy network/contracting, and claims adjudication). Do not provide the internal structure of the parent organization.
INSTRUCTIONS: Applicants must complete and upload in HPMS the following chart for each contract/administrative services agreement submitted under Section 3.1.1D. Applicants must identify where specifically (i.e., the pdf page number) in each contract/administrative services agreement the following elements are found. |
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Section |
Requirement |
Location in Subcontract by Page number and Section |
3.1.1D1 |
The parties to the contract |
|
3.1.1D2 |
The functions to be performed by the first tier, downstream, or related entity. 42 CFR §423.505(i)(4)(i) |
|
3.1.1D3 |
Describe the reporting requirements the first tier, downstream, or related entity identified in Section 3.1.1C of the application has to the applicant. 42 CFR §423.505(i)(4)(i) |
|
3.1.1D4 |
Language clearly indicating that the first tier, downstream, or related entity has agreed to participate in your Medicare Prescription Drug Benefit program (except for a network pharmacy if the existing contract would allow participation in this program). |
|
3.1.1D5 |
Contains flow-down clauses requiring the first tier, downstream, or related entity’s activities to be consistent and comply with the Applicant’s contractual obligations as a Part D sponsor. 42 CFR §423.505(i)(3)(iii) |
|
3.1.1D6 |
The payment the first tier, downstream, or related entity will receive for performance under the contract, if applicable. |
|
3.1.1D7 |
Are for a term of at least the one-year contract period for which application is submitted. Note: Where the contract is for services or products to be used in preparation for the next contract year’s Part D operations (marketing, enrollment), the initial term of such contract must include this period of performance (e.g., contracts for enrollment-related services must have a term beginning no later than October 15 extending through the full contract year ending on December 31 of the next year). |
|
3.1.1D8 |
Are signed by a representative of each party with legal authority to bind the entity. |
|
3.1.1D9 |
Language obligating the first tier, downstream, or related entity to abide by all applicable Federal laws and regulations and CMS instructions. 42 CFR §423.505(i)(4)(iv) |
|
3.1.1D10 |
Language obligating the first tier, downstream, or related entity to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
|
3.1.1D11 |
Language ensuring that the first tier, downstream, or related entity will make its books and other records available in accordance with 42 CFR §423.505(e)(2) and 42 CFR §423.505(i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to audit, evaluate and inspect any books, contracts, records, including medical records and documentation involving transactions related to CMS’ contract with the Part D sponsor and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later. 42 CFR §423.505 |
|
3.1.1D12 |
Language stating that the first tier, downstream, or related entity will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. 42 CFR §423.505(i)(3)(i) |
|
3.1.1D13 |
Language indicating that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees. 42 CFR §423.505(i)(3)(iv) |
|
3.1.1D14 |
Language ensuring that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the first tier, downstream, or related entity , that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the first tier, downstream, or related entity has not performed satisfactorily. Note: The contract/administrative services agreement may include remedies in lieu of revocation to address this requirement. 42 CFR §423.505(i)(4)(ii) |
|
3.1.1D15 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the first tier, downstream, or related entity on an ongoing basis. 42 CFR §423.505(i)(4)(iii) |
|
3.1.1D16 |
Language that the Part D sponsor retains the right to approve, suspend, or terminate any arrangement with a pharmacy if the first tier, downstream, or related entity will establish the pharmacy network or select pharmacies to be included in the network. 42 CFR §423.505(i)(5) |
|
3.1.1D17 |
Language that if the first tier, downstream, or related entity will establish the pharmacy network or select pharmacies to be included in the network contain language that payment to such pharmacies (excluding long-term care and mail order) shall be issued, mailed, or otherwise transmitted with respect to all clean claims submitted by or on behalf of pharmacies within 14 days for electronic claims and within 30 days for claims submitted otherwise. 42 CFR §423.505(i)(3)(vi) |
|
3.1.1D18 |
Language that if the first tier, downstream, or related entity will establish the pharmacy network or select pharmacies to be included in the network contain language that if a prescription drug pricing standard is used for reimbursement, identify the source used by the Part D sponsor for the prescription drug pricing standard of reimbursement. 42 CFR §423.505(i)(3)(viii)(B) |
|
3.1.1D19 |
Language that if the first tier, downstream, or related entity will establish the pharmacy network or select pharmacies to be included in the network contain language that updates to such a prescription drug pricing standard occur not less frequently than once every 7 days beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug. 42 CFR §423.505(i)(3)(viii)(A) |
|
3.1.1D20 |
Language that if the first tier, downstream, or related entity will establish the pharmacy network or select pharmacies to be included in the network contain language requiring the network pharmacies to submit claims to the Part D sponsor or first tier, downstream or related entity whenever the membership ID card is presented or on file at the pharmacy unless the enrollee expressly requests that a particular claim not be submitted. 42 CFR §423.120(c)(3)
|
|
3.1.1D21 |
Language that if the first tier, downstream, or related entity will adjudicate and process claims at the point of sale and/or negotiate with prescription drug manufacturers and others for rebates, discounts, or other price concessions on prescription drugs contain language requiring that the first tier, downstream, or related entity will comply with the reporting requirements established in Section 6005 of the Patient Protection and Affordable Care Act of 2010 (PPACA).
|
|
|
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INSTRUCTIONS: Applicants must complete and upload in HPMS the following chart (which contains applicable Section 3.11D requirements AND additional requirements specific to Pharmacy Access) for each Retail pharmacy contract template submitted under Section 3.4. Applicants must identify where specifically (i.e., the pdf page number ) in each contract template the following elements are found. |
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The provisions listed below must be in all pharmacy contracts. If contracts reference policies and procedures to with which the pharmacy must comply, provide the relevant documentation as evidence and cite this documentation accordingly. |
||
Section |
Requirement |
Citation |
|
|
|
3.1.1D2 |
The functions to be performed by the first tier, downstream, or related entity. 42 CFR §423.505(i)(4)(i) |
|
3.1.1D3 |
Describes the reporting requirements the first tier, downstream, or related entity identified in Section 3.1.1C of the application has to the Applicant. 42 CFR §423.505(i)(4)(i) |
|
3.1.1D8 |
Language obligating the first tier, downstream, or related entity to abide by all applicable Federal laws and regulations and CMS instructions. 42 CFR §423.505(i)(4)(iv) |
|
3.1.1D9 |
Language obligating the first tier, downstream, or related entity to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
|
3.1.1D110 |
Language ensuring that the first tier, downstream, or related entity will make its books and other records available in accordance with 42 CFR §423.505(e)(2) and 42 CFR §423.505(i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to audit, evaluate and inspect any books, contracts, records, including medical records and documentation involving transactions related to CMS’ contract with the Part D sponsor and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later. 42 CFR §423.505 |
|
3.1.1D121 |
Language stating that the first tier, downstream, or related entity will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. 42 CFR §423.505(i)(3)(i) |
|
3.1.1D132 |
Language indicating that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees. 42 CFR §423.505(i)(3)(iv) |
|
3.1.1D143 |
Language ensuring that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the first tier, downstream, or related entity, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the first tier, downstream, or related entity has not performed satisfactorily. Note: The contract may include remedies in lieu of revocation to address this requirement. 42 CFR §423.505(i)(4)(ii) |
|
3.1.1D154 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the first tier, downstream, or related entity on an ongoing basis. 42 CFR §423.505(i)(4)(iii) |
|
3.1.1D17 |
Provisions requiring that payment shall be issued, mailed or otherwise transmitted with respect to all clean claims submitted by or on behalf of pharmacies within 14 days for electronic claims and within 30 days for claims submitted otherwise. 42 CFR §423.505(i)(3)(vi) |
|
3.1.1D18 |
For those contracts that use a prescription drug pricing standard for reimbursement, a provision indicating the source used by the Part D sponsor for the prescription drug pricing standard of reimbursement.42 CFR §423.505(i)(3)(viii)(B) |
|
3.1.1D19 |
For those contracts that use a prescription drug pricing standard for reimbursement, a provision that updates to such a standard occur not less frequently than once every 7 days beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug.42 CFR §423.505(i)(3)(viii)(A) |
|
3.1.1D20 |
Language requiring the network pharmacy to submit claims to the Part D sponsor or first tier, downstream or related entity whenever the membership ID card is presented or on file at the pharmacy unless the enrollee expressly requests that a particular claim not be submitted. 42 CFR §423.120(c)(3)
|
|
3.1.1D21 |
Language requiring the first tier, downstream, or related entity adjudicating and processing claims at the point of sale and/or negotiating with prescription drug manufacturers and others for rebates, discounts, or other price concessions on prescription drugs, to comply with the reporting requirements established in Section 6005 of the Affordable Care Act. |
|
3.4A3 |
Provisions governing submitting claims to a real-time claims adjudication system. 42 CFR §423.505(j) and §423.505(b)(17)
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. 42 CFR §423.104(g) |
|
3.4A5 |
Provisions regarding charging/applying the correct cost-sharing amount. 42 CFR §423.104 |
|
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. 42 CFR §423.132 |
|
INSTRUCTIONS: Applicants must complete and upload in HPMS the following chart (which contains applicable Section 3.1.1D requirements AND additional requirements specific to Pharmacy Access) for each Mail Order pharmacy contract template submitted under Section 3.4. Applicants must identify where specifically (i.e., the pdf page number) in each contract template the following elements are found. |
||
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 |
|
|
|
3.1.1D2 |
The functions to be performed by the first tier, downstream, or related entity. 42 CFR §423.505(i)(4)(i) |
|
3.1.1D3 |
Describes the reporting requirements the first tier, downstream, or related entity identified in Section 3.1.1C of the application has to the Applicant. 42 CFR §423.505(i)(4)(i) |
|
3.1.1D8 |
Language obligating the first tier, downstream, or related entity to abide by all applicable Federal laws and regulations and CMS instructions. 42 CFR §423.505(i)(4)(iv) |
|
3.1.1D9 |
Language obligating the first tier, downstream, or related entity to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
|
3.1.1D110 |
Language ensuring that the first tier, downstream, or related entity will make its books and other records available in accordance with 42 CFR §423.505(e)(2) and 42 CFR §423.505(i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to audit, evaluate and inspect any books, contracts, records, including medical records and documentation involving transactions related to CMS’ contract with the Part D sponsor and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later. 42 CFR §423.505 |
|
3.1.1D121 |
Language stating that the first tier, downstream, or related entity will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. 42 CFR §423.505(i)(3)(i) |
|
3.1.1D132 |
Language indicating that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees. 42 CFR §423.505(i)(3)(iv) |
|
3.1.1D143 |
Language ensuring that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the first tier, downstream, or related entity, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the first tier, downstream, or related entity has not performed satisfactorily. Note: The contract may include remedies in lieu of revocation to address this requirement. 42 CFR §423.505(i)(4)(ii) |
|
3.1.1D154 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the first tier, downstream, or related entity on an ongoing basis. 42 CFR §423.505(i)(4)(iii) |
|
3.1.1D18 |
For those contracts that use a prescription drug pricing standard for reimbursement, a provision indicating the source used by the Part D sponsor for the prescription drug pricing standard of reimbursement. 42 CFR §423.505(i)(3)(viii)(B) |
|
3.1.1D19 |
For those contracts that use a prescription drug pricing standard for reimbursement, a provision that updates to such a standard occur not less frequently than once every 7 days beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug.42 CFR §423.505(i)(3)(viii)(A) |
|
3.1.1D20 |
Language requiring the network pharmacy to submit claims to the Part D sponsor or first tier, downstream or related entity whenever the membership ID card is presented or on file at the pharmacy unless the enrollee expressly requests that a particular claim not be submitted. 42 CFR §423.120(c)(3)
|
|
3.4A3 |
Provisions governing submitting claims to a real-time claims adjudication system. 42 CFR §423.505(j) and §423.505(b)(17) |
|
3.4A4 |
Provisions governing providing Part D enrollees access to negotiated prices as defined in 42 CFR 423.100. 42 CFR §423.104(g) |
|
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. 42 CFR §423.132 |
|
INSTRUCTIONS: Applicants must complete and upload in HPMS the following chart (which contains applicable Section 3.1.1D requirements AND additional requirements specific to Pharmacy Access) for each Home Infusion pharmacy contract template submitted under Section 3.4. Applicants must identify where specifically (i.e., the pdf page number ) in each contract template the following elements are found. |
||
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 |
|
|
|
3.1.1D2 |
The functions to be performed by the first tier, downstream, or related entity. 42 CFR §423.505(i)(4)(i) |
|
3.1.1D3 |
Describes the reporting requirements the first tier, downstream, or related entity identified in Section 3.1.1C of the application has to the Applicant. 42 CFR §423.505(i)(4)(i) |
|
3.1.1D8 |
Language obligating the first tier, downstream, or related entity to abide by all applicable Federal laws and regulations and CMS instructions. 42 CFR §423.505(i)(4)(iv) |
|
3.1.1D9 |
Language obligating the first tier, downstream, or related entity to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
|
3.1.1D110 |
Language ensuring that the first tier, downstream, or related entity will make its books and other records available in accordance with 42 CFR §423.505(e)(2) and 42 CFR §423.505(i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to audit, evaluate and inspect any books, contracts, records, including medical records and documentation involving transactions related to CMS’ contract with the Part D sponsor and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later. 42 CFR §423.505 |
|
3.1.1D121 |
Language stating that the first tier, downstream, or related entity will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. 42 CFR §423.505(i)(3)(i) |
|
3.1.1D132 |
Language indicating that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees. 42 CFR §423.505(i)(3)(iv) |
|
3.1.1D143 |
Language ensuring that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the first tier, downstream, or related entity, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the first tier, downstream, or related entity has not performed satisfactorily. Note: The contract may include remedies in lieu of revocation to address this requirement. 42 CFR §423.505(i)(4)(ii) |
|
3.1.1D154 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the first tier, downstream, or related entity on an ongoing basis. 42 CFR §423.505(i)(4)(iii) |
|
3.1.1D17 |
Provisions requiring that payment shall be issued, mailed or otherwise transmitted with respect to all clean claims submitted by or on behalf of pharmacies within 14 days for electronic claims and within 30 days for claims submitted otherwise. 42 CFR §423.505(i)(3)(vi) |
|
3.1.1D18 |
For those contracts that use a prescription drug pricing standard for reimbursement, a provision indicating the source used by the Part D sponsor for the prescription drug pricing standard of reimbursement. 42 CFR §423.505(i)(3)(viii)(B) |
|
3.1.1D19 |
For those contracts that use a prescription drug pricing standard for reimbursement, a provision that updates to such a standard occur not less frequently than once every 7 days beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug.42 CFR §423.505(i)(3)(viii)(A) |
|
3.1.1D20 |
Language requiring the network pharmacy to submit claims to the Part D sponsor or first tier, downstream or related entity whenever the membership ID card is presented or on file at the pharmacy unless the enrollee expressly requests that a particular claim not be submitted. 42 CFR §423.120(c)(3)
|
|
3.1.1D21 |
Language requiring the first tier, downstream, or related entity adjudicating and processing claims at the point of sale and/or negotiating with prescription drug manufacturers and others for rebates, discounts, or other price concessions on prescription drugs, to comply with the reporting requirements established in Section 6005 of the Affordable Care Act. |
|
3.4A3 |
Provisions governing submitting claims to a real-time claims adjudication system. 42 CFR §423.505(j) and §423.505(b)(17)
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. 42 CFR §423.104(g) |
|
3.4A5 |
Provisions regarding charging/applying the correct cost-sharing amount. 42 CFR §423.104 |
|
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. 42 CFR §423.132 |
|
3.4.4A5 |
Provisions ensuring that before dispensing home infusion drugs, pharmacy ensures that the professional services and ancillary supplies are in place. 42 CFR §423.120(a)(4)(iii) |
|
3.4.4A6 |
Provisions ensuring that pharmacy that delivers home infusion drugs provides delivery of home infusion drugs within 24 hours of discharge from an acute care setting, or later if so prescribed. 42 CFR §423.120(a)(4)(iv) |
|
INSTRUCTIONS: Applicants must complete and upload in HPMS the following chart (which contains applicable Section 3.1.1D requirements AND additional requirements specific to Pharmacy Access) for each Long-Term Care pharmacy contract template submitted under Section 3.4. Applicants must where specifically (i.e., the pdf page number) in each contract template the following elements are found. |
|||
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 |
|
|
|
|
|
3.1.1D2 |
The functions to be performed by the first tier, downstream, or related entity. 42 CFR §423.505(i)(4)(i) |
|
|
3.1.1D3 |
Describes the reporting requirements the first tier, downstream, or related entity identified in 3.1.1C of the application has to the Applicant. 42 CFR §423.505(i)(4)(i) |
|
|
3.1.1D98 |
Language obligating the (first tier, downstream, or related entity to abide by all applicable Federal laws and regulations and CMS instructions. 42 CFR §423.505(i)(4)(iv) |
|
|
3.1.1D109 |
Language obligating the first tier, downstream, or related entity to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
|
|
3.1.1D110 |
Language ensuring that the first tier, downstream, or related entity will make its books and other records available in accordance with 42 CFR §423.505(e)(2) and 42 CFR 423. §505(i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to audit, evaluate and inspect any books, contracts, records, including medical records and documentation involving transactions related to CMS’ contract with the Part D sponsor and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later. 42 CFR §423.505 |
|
|
3.1.1D121 |
Language stating that the first tier, downstream, or related entity will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. 42 CFR §423.505(i)(3)(i) |
|
|
3.1.1D132 |
Language indicating that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees. 42 CFR §423.505(i)(3)(iv) |
|
|
3.1.1D143 |
Language ensuring that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the first tier, downstream, or related entity, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the first tier, downstream, or related entity has not performed satisfactorily. Note: The contract may include remedies in lieu of revocation to address this requirement. 42 CFR §423.505(i)(4)(ii) |
|
|
3.1.1D154 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the subcontractor (first tier, downstream and related entities) on an ongoing basis. 42 CFR §423.505(i)(4)(iii) |
|
|
3.1.1D18 |
For those contracts that use a prescription drug pricing standard for reimbursement, a provision indicating the source used by the Part D sponsor for the prescription drug pricing standard of reimbursement. 42 CFR §423.505(i)(3)(viii)(B) |
|
|
3.1.1D19 |
For those contracts that use a prescription drug pricing standard for reimbursement, a provision that updates to such a standard occur not less frequently than once every 7 days beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug.42 CFR §423.505(i)(3)(viii)(A) |
|
|
3.1.1D20 |
Language requiring the network pharmacy to submit claims to the Part D sponsor or first tier, downstream or related entity whenever the membership ID card is presented or on file at the pharmacy unless the enrollee expressly requests that a particular claim not be submitted. 42 CFR §423.120(c)(3)
|
|
|
3.4A3 |
Provisions governing submitting claims to a real-time claims adjudication system. 42 CFR §423.505(j) and §423.505(b)(17)
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. 42 CFR §423.104(g) |
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3.4A5 |
Provisions regarding charging/applying the correct cost-sharing amount. 42 CFR §423.104(g) |
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Elements Specific to Long-Term Care Contracts
Note: CMS Long-Term Care Guidance included in Chapter 5 of the Prescription Drug Benefit Manual contains an updated list of performance and service criteria for contracting with long-term care pharmacies. Applicants should, at a minimum, incorporate these criteria in ALL LTC pharmacy network contracts. Applicant must list the criteria below, and then identify where the elements reside in the contract template(s) submitted.
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Performance and Service Criteria |
Citation |
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Comprehensive Inventory and Inventory Capacity – Network Long Term Care Pharmacies [NLTCPs] must provide a comprehensive inventory of Plan formulary drugs commonly used in the long term care setting. In addition, NLTCPs must provide a secured area for physical storage of drugs, with necessary added security as required by federal and state law for controlled substances. This is not to be interpreted that the pharmacy will have inventory or security measures outside of the normal business setting.
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Pharmacy Operations and Prescription Orders -- NLTCPs must provide services of a dispensing pharmacist to meet the requirements of pharmacy practice for dispensing prescription drugs to LTC residents, including but not limited to the performance of drug utilization review (DUR). In addition, the NLTCP pharmacist must conduct DUR to routinely screen for allergies and drug interactions, to identify potential adverse drug reactions, to identify inappropriate drug usage in the LTC population, and to promote cost effective therapy in the LTC setting. The NLTCP must also be equipped with pharmacy software and systems sufficient to meet the needs of prescription drug ordering and distribution to an LTC facility. Further, the NLTCP must provide written copies of the NLTCP’s pharmacy procedures manual and said manual must be available at each LTC facility nurses’ unit. NLTCPs are also required to provide ongoing in-service training to assure that LTC facility staff isare proficient in the NLTCP’s processes for ordering and receiving of medications. NLTCP must be responsible for return and/or disposal of unused medications following discontinuance, transfer, discharge, or death as permitted by State Boards of Pharmacy. Controlled substances and out of date substances must be disposed of within State and Federal guidelines.
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Special Packaging -- NLTCPs must have the capacity to provide specific drugs in Unit of Use Packaging, Bingo Cards, Cassettes, Unit Dose or other special packaging commonly required by LTC facilities. NLTCPs must have access to, or arrangements with, a vendor to furnish supplies and equipment including but not limited to labels, auxiliary labels, and packing machines for furnishing drugs in such special packaging required by the LTC setting.
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IV Medications -- NLTCPs must have the capacity to provide IV medications to the LTC resident as ordered by a qualified medical professional. NLTCPs must have access to specialized facilities for the preparation of IV prescriptions (clean room). Additionally, NLTCPs must have access to or arrangements with a vendor to furnish special equipment and supplies as well as IV trained pharmacists and technicians as required to safely provide IV medications.
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Compounding /Alternative Forms of Drug Composition -- NLTCPs must be capable of providing specialized drug delivery formulations as required for some LTC residents. Specifically, residents unable to swallow or ingest medications through normal routes may require tablets split or crushed or provided in suspensions or gel forms, to facilitate effective drug delivery.
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Pharmacist On-call Service -- NLTCP must provide on-call, 24 hours a day, 7 days a week service with a qualified pharmacist available for handling calls after hours and to provide medication dispensing available for emergencies, holidays and after hours of normal operations.
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Delivery Service -- NLTCP must provide for delivery of medications to the LTC facility up to seven days each week (up to three times per day) and in-between regularly scheduled visits. Emergency delivery service must be available 24 hours a day, 7 days a week. Specific delivery arrangements will be determined through an agreement between the NLTCP and the LTC facility. NLTCPs must provide safe and secure exchange systems for delivery of medication to the LTC facility. In addition, NLTCP must provide medication cassettes, or other standard delivery systems, that may be exchanged on a routine basis for automatic restocking. The NLTCP delivery of medication to carts is a part of routine “dispensing”.
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Emergency Boxes -- NLTCPs must provide “emergency” supply of medications as required by the facility in compliance with State requirements.
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Emergency Log Books -- NLTCP must provide a system for logging and charging medication used from emergency/first dose stock. Further, the pharmacy must maintain a comprehensive record of a resident’s medication order and drug administration.
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Miscellaneous Reports, Forms and Prescription Ordering Supplies -- NLTCP must provide reports, forms and prescription ordering supplies necessary for the delivery of quality pharmacy care in the LTC setting. Such reports, forms and prescription ordering supplies may include, but will not necessarily be limited to, provider order forms, monthly management reports to assist the LTC facility in managing orders, medication administration records, treatment administration records, interim order forms for new prescription orders, and boxes/folders for order storage and reconciliation in the facility.
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INSTRUCTIONS: Applicants must complete and upload in HPMS the following chart (which contains applicable Section 3.1.1D requirements AND additional requirements specific to Pharmacy Access) for each I/T/U pharmacy contract template submitted under Section 3.4. Applicants must identify where specifically (i.e., the pdf page number) in each contract template the following elements are found. |
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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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Requirement |
Citation |
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3.1.1D2 |
The functions to be performed by the first tier, downstream, or related entity. 42 CFR §423.505(i)(4)(i) |
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3.1.1D3 |
Describes the reporting requirements the first tier, downstream, or related entity identified in Section 3.1.1C of the application has to the Applicant. 42 CFR §423.505(i)(4)(i) |
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3.1.1D8 |
Language obligating the first tier, downstream, or related entity to abide by all applicable Federal laws and regulations and CMS instructions. 42 CFR §423.505(i)(4)(iv) |
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3.1.1D9 |
Language obligating the first tier, downstream, or related entity to abide by State and Federal privacy and security requirements, including the confidentiality and security provisions stated in the regulations for the program at 42 CFR §423.136. |
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3.1.1D110 |
Language ensuring that the first tier, downstream, or related entity will make its books and other records available in accordance with 42 CFR §423.505(e)(2) and 42 CFR §423.505(i)(2). Generally stated these regulations give HHS, the Comptroller General, or their designees the right to audit, evaluate and inspect any books, contracts, records, including medical records and documentation involving transactions related to CMS’ contract with the Part D sponsor and that these rights continue for a period of 10 years from the final date of the contract period or the date of audit completion, whichever is later. 42 CFR §423.505 |
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3.1.1D121 |
Language stating that the first tier, downstream, or related entity will ensure that beneficiaries are not held liable for fees that are the responsibility of the Applicant. 42 CFR §423.505(i)(3)(i) |
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3.1.1D132 |
Language indicating that any books, contracts, records, including medical records and documentation relating to the Part D program will be provided to either the sponsor to provide to CMS or its designees or will be provided directly to CMS or its designees. 42 CFR §423.505(i)(3)(iv) |
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3.1.1D143 |
Language ensuring that if the Applicant, upon becoming a Part D sponsor, delegates an activity or responsibility to the first tier, downstream, or related entity, that such activity or responsibility may be revoked if CMS or the Part D sponsor determines the first tier, downstream, or related entity has not performed satisfactorily. Note: The contract may include remedies in lieu of revocation to address this requirement. 42 CFR §423.505(i)(4)(ii) |
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3.1.1D154 |
Language specifying that the Applicant, upon becoming a Part D sponsor, will monitor the performance of the first tier, downstream, or related entity on an ongoing basis. 42 CFR §423.505(i)(4)(iii) |
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3.1.1D17 |
Provisions requiring that payment shall be issued, mailed or otherwise transmitted with respect to all clean claims submitted by or on behalf of pharmacies within 14 days for electronic claims and within 30 days for claims submitted otherwise. 42 CFR §423.505(i)(3)(vi) |
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3.1.1D18 |
For those contracts that use a prescription drug pricing standard for reimbursement, a provision indicating the source used by the Part D sponsor for the prescription drug pricing standard of reimbursement. 42 CFR §423.505(i)(3)(viii)(B) |
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3.1.1D19 |
For those contracts that use a prescription drug pricing standard for reimbursement, a provision that updates to such a standard occur not less frequently than once every 7 days beginning with an initial update on January 1 of each year, to accurately reflect the market price of acquiring the drug.42 CFR §423.505(i)(3)(viii)(A) |
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3.1.1D20 |
Language requiring the network pharmacy to submit claims to the Part D sponsor or first tier, downstream or related entity whenever the membership ID card is presented or on file at the pharmacy unless the enrollee expressly requests that a particular claim not be submitted. 42 CFR §423.120(c)(3)
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3.1.1D21 |
Language requiring the first tier, downstream, or related entity adjudicating and processing claims at the point of sale and/or negotiating with prescription drug manufacturers and others for rebates, discounts, or other price concessions on prescription drugs, to comply with the reporting requirements established in Section 6005 of the Affordable Care Act. |
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3.4A3 |
Provisions governing submitting claims to a real-time claims adjudication system. 42 CFR §423.505(j) and §423.505(b)(17)
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. 42 CFR §423.104(g) |
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3.4A5 |
Provisions regarding charging/applying the correct cost-sharing amount. 42 CFR §423.104 |
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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. 42 CFR §423.132 |
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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 Addendum, located in Appendix XI or at www.cms.gov/10_RxContracting_SpecialGuidance.asp#TopOfPage and all I/T/U Contracts must contain language consistent with the model addendum that addresses 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 |
Sovereign Immunity |
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This appendix summarizes CMS policy on Part D Applicant/Sponsor and PBM submission of P&T Committee membership, and the accountability that each Part D Applicant/Sponsor holds regarding the integrity of the P&T Committee whose membership is submitted either directly by the Part D Applicant/Sponsor or by the applicant/sponsor’s PBM. This appendix also instructs Part D Applicants (or their PBM’s) on how to submit the Applicant’s P&T Committee membership list, and a Certification of P&T Integrity and Quality in the event the Applicant is planning to operate under a confidentiality agreement with its PBM (such that the PBM does not disclose the membership to the Applicant).
P&T Committee Member Disclosure to CMS
As provided in the regulation at CFR §423.120 (b)(1), a Part D Sponsor’s P&T Committee list must contain a majority of members who are practicing physicians and/or pharmacists, include at least one practicing physician and one practicing pharmacist who are experts regarding care of the elderly or disabled individuals, and includes at least one practicing physician and one practicing pharmacist who are independent and free of conflict relative to the Part D Sponsor or Plan and pharmaceutical manufacturers.
In the event the Part D Applicant/Sponsor has entered into a confidential agreement such that the PBM will not disclose its P&T Committee membership to the Part D Applicant/Sponsor, then it is the Part D Sponsor’s responsibility to notify CMS that this information will be submitted by the Sponsor’s PBM. Moreover, the Part D Applicant/Sponsor must ensure that the PBM notifies CMS of the P&T Committee membership. Also, the Part D Applicant/Sponsor should ensure that the PBM notifies the Sponsor that this information has been successfully submitted to CMS.
Instructions to Plans and PBMs
A. If the Part D Applicant sub-contracts with a PBM for its P&T Committee and operates under a Confidentiality Agreement (such that its members are not disclosed to the Part D Applicant) then the Applicant must (1) complete the attached Certification in HPMS, and (2) forward the attached P&T Committee Member Disclosure form to the sub-contracted PBM and direct the PBM to submit the form to CMS by February 24, 2011. The PBM should email the P&T Committee Member Disclosure form to the following email box: drugbenefitimpl@cms.hhs.gov.
B. In the event of any future changes to the membership of the Part D Sponsor’s P&T Committee or the PBM’s P&T Committee, Part D Sponsors must (or in the case of a confidential agreement the Part D Sponsor) assure that the PBM will notify the appropriate CMS account manager (to be assigned at a future date) and make the correct changes in HPMS on the Contract Management/Part D Data page within 30 days of the effective date of such change.
PHARMACY AND THERAPEUTICS COMMITTEE MEMBER DISCLOSURE
PBM must email the following form to drugbenefitimpl@cms.hhs.gov by February 24, 2011.
Name of Part D Plan or PBM: ______________________________________
If Part D Plan, provide Part D Contract number(s):_________________
Contact Person: ______________________________________
Phone Number: ______________________________________
Email: _____________________________________________
A. Complete the table below.
PROVIDE THE NAMES OF THE MEMBERS OF YOUR ORGANIZATION’S P&T COMMITTEE. INDICATE WHICH MEMBERS ARE PRACTICING PHYSICIANS OR PRACTICING PHARMACISTS. FURTHER, INDICATE WHICH MEMBERS ARE EXPERTS IN THE CARE OF THE ELDERLY OR DISABLED, AND FREE OF ANY CONFLICT OF INTEREST WITH YOUR ORGANIZATION AND PHARMACEUTICAL MANUFACTURERS. (APPLICANTS SHOULD MARK THE INFORMATION AS PROPRIETARY.) SUBMIT THIS DATA BY CREATING A SPREADSHEET IN MICROSOFT EXCEL THAT MIMICS THE TABLE BELOW. |
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Practice/Expertise Mark an ‘X’ in Appropriate Column |
Free of Any Conflict of Interest Type Yes or No |
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Full Name of Member Start Date and End Date |
Practicing Physician |
Practicing Pharmacist |
Elderly/Disabled Expert |
With Your Organization? |
With Pharmaceutical Manufacturers? |
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B. Complete the table below if a PBM submitting on behalf of Part D plan.
PROVIDE THE NAMES OF THOSE APPLICANTS FOR THE PART D BENEFIT FOR WHICH YOUR ORGANIZATION IS PROVIDING PHARMACY BENEFIT MANAGEMENT SERVICES, THE TYPE OF APPLICATION, AND THE CONTRACT NUMBER(S). ADD ADDITIONAL ROWS AS NECESSARY. |
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Organization Name
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Type of Application |
Contract Number(s) |
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Applicant must upload in HPMS:
CERTIFICATION FOR PART D SPONSORS USING A PHARMACY BENEFIT MANAGER’S PHARMACY& THERAPEUTICS COMMITTEE UNDER A CONFIDENTIALITY AGREEMENT
A. I, attest, on behalf of LEGAL NAME OF PART D SPONSOR APPLICANT (“Applicant”), to the following:
1) 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.
2) 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.
3) 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.
4) I agree that my organization has policies and procedures to ensure and confirm the ongoing integrity, qualifications and expertise of the PBM’s P&T Committee.
5) 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.
B. I agree that CMS may inspect the records and premises of my organization or my subcontractor (first tier, downstream and related entities) to ensure compliance with the statements to which I have attested above.
C. 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)
Note: All Part D sponsors will be required to use the attached revised version of the I/T/U Addendum. Existing Part D sponsors will be required to use this version of the I/T/U Addendum for any future re-contracting or new contracting.
Indian Health Addendum to Medicare Part D Plan Agreement
1. Purpose of Indian Health Addendum; Supersession.
The purpose of this Indian Health Addendum is to apply special terms and conditions to the agreement by and between __________________________(herein “Part D Sponsor”) and _____________________________(herein “Provider”) for administration of Medicare Prescription Drug Benefit program at pharmacies and dispensaries of Provider authorized by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, and implementing regulations in Parts 403, 411, 417, 422, and 423 of Title 42, Code of Federal Regulations. To the extent that any provision of the Part D Sponsor’s agreement or any other addendum thereto is inconsistent with any provision of this Indian Health Addendum, the provisions of this Indian Health Addendum shall supercede all such other provisions.
2. Definitions.
For purposes of the Part D Plan Sponsor's agreement, any other addendum thereto, and this Indian Health Addendum, the following terms and definitions shall apply:
(a) The term "Part D Plan Sponsor" means a nongovernmental entity that is certified under 42 CFR §417.472, 42 CFR Part 423 or 42 CFR Part 422 as meeting the requirements and standards that apply to entities that offer Medicare Part D plans.
(b) The terms "Part D Plan" means prescription drug coverage that is offered under a policy, contract, or plan that has been approved as specified in 42 CFR §423.272, 42 CFR §422.502 or 42 CFR §417.472 and that is offered by a PDP sponsor that has a contract with the Centers for Medicare and Medicaid Services that meets the contract requirements under subpart K of 42 CFR Part 423 or subpart K of 42 CFR Part 422.
(c) The term "Provider" means the Indian Health Service (IHS) and all pharmacies and dispensaries operated by the IHS, or an Indian tribe, tribal organization or urban Indian organization which operates one or more pharmacies or dispensaries, and is identified by name in Section 1 of this Indian Health Addendum.
(d) The term "Centers for Medicare and Medicaid Services" means the agency of that name within the U.S. Department of Health and Human Services.
e) The term "Indian Health Service" means the agency of that name within the U.S. Department of Health and Human Services established by Sec. 601 of the Indian Health Care Improvement Act (“IHCIA”), 25 USC §1661.
(f) The term "Indian tribe" has the meaning given that term in Sec. 4 of the IHCIA, 25 USC §1603.
(g) The term "tribal organization" has the meaning given than term in Sec. 4 of the IHCIA, 25 USC §1603.
(h) The term "urban Indian organization" has the meaning given that term in Sec. 4 of the IHCIA, 25 USC §1603.
(i) The term "Indian" has the meaning given to that term in Sec. 4 of the IHCIA, 25 USC §1603.
(j) The term "dispensary" means a clinic where medicine is dispensed by a prescribing provider.
3. Description of Provider.
The Provider identified in Section 1 of this Indian Health Addendum is (check appropriate box):
/_/ IHS operated health care facilities located within the geographic area covered by the Provider Agreement, including hospitals, health centers and one or more pharmacies or dispensaries (“IHS Provider”). Where IHS Provider operates more than one pharmacy or dispensary all such pharmacies and dispensaries are covered by this Addendum.
/_/ An Indian tribe that operates a health program, including one or more pharmacies or dispensaries, under a contract or compact with the Indian Health Service issued pursuant to the Indian Self-Determination and Education Assistance Act, 25 USC §450 et seq.
/_/ A tribal organization authorized by one or more Indian tribes to operate a health program, including one or more pharmacies or dispensaries, under a contract or compact with the Indian Health Service issued pursuant to the Indian Self-Determination and Education Assistance Act, 25 USC §450 et seq.
/_/ An urban Indian organization that operates a health program, including one or more pharmacies or dispensaries, under a grant from the Indian Health Service issued pursuant to Title V of the IHCIA.
4. Deductibles.
The cost of pharmaceuticals provided at a pharmacy or dispensary of Provider or paid for by the Provider through a referral to a retail pharmacy shall count toward the deductible applicable to an IHS beneficiary enrolled in a Part D Plan.
5. Persons eligible for services of Provider.
(a) The parties agree that the IHS Provider is limited to serving eligible IHS beneficiaries pursuant to 42 CFR Part 136 and section 813(a) of the IHCIA, 25 USC §1680c-(a) who are also eligible for Medicare Part D services pursuant to Title XVIII, Part D of the Social Security Act and 42 CFR Part 423.. The IHS Provider may provide services to non-eligible persons only under certain circumstances set forth in IHCIA section 813(b) and in emergencies under section 813(c) of the IHCIA.
(b) The parties agree that the persons eligible for services of the Provider who is an Indian tribe or a tribal organization or a Provider who is an urban Indian organization shall be governed by the following authorities:
(1) Title XVIII, Part D of the Social Security Act and 42 C.F.R. Part 423;
(2) IHCIA sections 813(a) and. 813(c), 25 USC §1680c (a) and (c);
(3) 42 CFR Part 136; and
(4) The terms of the contract, compact or grant issued to the Provider by the IHS for operation of a health program.
(c) No clause, term or condition of the Part D Plan Sponsor's agreement or any addendum thereto shall be construed to change, reduce, expand or alter the eligibility of persons for services of the Provider under the Part D Plan that is inconsistent with the authorities identified in subsection (a).
6. Applicability of other Federal laws.
Federal laws and regulations affecting a Provider, include but are not limited to the following:
(a) An IHS provider:
(1) The Anti-Deficiency Act 31 U.S.C. §1341;
(2) The Indian Self Determination and Education Assistance Act (“ISDEAA”); 25 USC §450 et seq.;
(3) The Federal Tort Claims Act (FTCA), 28 U.S.C. §2671-2680;
(4) The Federal Medical Care Recovery Act, 42 U.S.C. §§ 2651-2653;
(5) The Federal Privacy Act of 1974 (“Privacy Act”), 5 U.S.C. §552a, 45 C.F.R. Part 5b;
(6) Confidentiality of Alcohol and Drug Abuse Patient Records, 42 CFR Part 2;
(7) The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), 45 C.F.R. Parts 160 and 164.; and
(8) The IHCIA, 25 U.S.C. §1601 et seq.
(b) A Provider who is an Indian tribe or a tribal organization:
(1) The ISDEAA, 25 USC §450 et seq.;
(2) The IHCIA, 25 USC §1601, et seq.;
(3) The FTCA, 28 USC §§2671-2680;
(4) The Privacy Act, 5 USC §552a and regulations at 45 CFR Part 5b; and
(5) The HIPAA, and regulations at 45 CFR parts 160 and 164.
(c) A Provider who is an urban Indian organization:
(1) The IHCIA, 25 USC §1601, et seq.;
(2) The Privacy Act, 5 USC §552a and regulations at 45 CFR Part 5b;
(3) The HIPAA, and regulations at 45 CFR parts 160 and 164.
7. Non-taxable entity.
To the extent the Provider is a non-taxable entity, the Provider shall not be required by a Part D Plan Sponsor to collect or remit any Federal, State, or local tax.
8. Insurance and indemnification.
(a) As an IHS provider, FTCA coverage obviates the requirement that IHS carry private malpractice insurance as the United States consents to be sued in place of federal employees for any damages to property or for personal injury or death caused by the negligence or wrongful act or omission of federal employees acting within the scope of their employment. 28 U.S.C. §§2671-2680. Nothing in the Part D Plan Sponsor’s Agreement shall be interpreted to authorize or obligate any IHS employee to perform any act outside the scope of his/her employment. The IHS Provider shall not be required to acquire insurance, provide indemnification, or guarantee that the Plan will be held harmless from liability.
(b) A Provider which is an Indian tribe or a tribal organization shall not be required to obtain or maintain professional liability insurance to the extent such Provider is covered by the Federal Tort Claims Act (FTCA) pursuant to Federal law (Pub.L. 101-512, Title III, §314, as amended by Pub.L. 103-138, Title III, §308 (codified at 25 USC §450 F note); and regulations at 25 CFR Part 900, Subpt. M. To the extent a Provider that is an urban Indian organization is covered by the FTCA pursuant to section 224(g)-(n) of the Public Health Service Act, as amended by the Federally Supported Health Centers Assistance Act, Pub.L. 104-73, (codified at 42 USC §233(g)-(n)) and regulations at 42 CFR Part 6, such Provider shall not be required to obtain or maintain professional liability insurance. Further, nothing in the Part D Plan Sponsor’s agreement or any addendum thereto shall be interpreted to authorize or obligate Provider or any employee of such Provider to operate outside of the scope of employment of such employee, and Provider shall not be required to indemnify the Part D Plan Sponsor.
9. Employee license.
(a) States may not regulate the activities of IHS-operated pharmacies nor require that the IHS pharmacists be licensed in the State where they are providing services, whether the IHS employee is working at an IHS-operated facility or has been assigned to a pharmacy or dispensary of a tribe, tribal organization, or urban Indian organization. The parties agree that during the term of the Part D Plan Sponsor’s Agreement, IHS pharmacists shall hold state licenses in accordance with applicable federal law, and that the IHS facilities where the pharmacies and dispensaries are located shall be accredited in accordance with federal statutes and regulations. During the term of the Part D Plan Sponsor’s Agreement, the parties agree to use the IHS facility’s Drug Enforcement Agency (DEA) number consistent with federal law.
(b) To the extent that any directly hired employee of a tribal or urban Indian Provider is exempt from State regulation, such employee shall be deemed qualified to perform services under the Part D Plan Sponsor's agreement and all addenda thereto, provided such employee is licensed to practice pharmacy in any State. This provision shall not be interpreted to alter the requirement that a pharmacy hold a license from the Drug Enforcement Agency.
10. Provider eligibility for payments.
To the extent that the Provider is exempt from State licensing requirements, the Provider shall not be required to hold a State license to receive any payments under the Part D Plan Sponsor’s agreement and any addendum thereto.
11. Dispute Resolution.
a. For IHS Provider. In the event of any dispute arising under the Participating Part D Plan Sponsor’s Agreement or any addendum thereto, the parties agree to meet and confer in good faith to resolve any such disputes. The laws of the United States shall apply to any problem or dispute hereunder that cannot be resolved by and between the parties in good faith. Notwithstanding any provision in the Part D Plan Sponsor’s Agreement or any addendum thereto to the contrary, IHS shall not be required to submit any disputes between the parties to binding arbitration.
b. For Tribal and Urban Providers. In the event of any dispute arising under the Participating Part D Plan Sponsor’s Agreement or any addendum thereto, the parties agree to meet and confer in good faith to resolve any such disputes. Any dispute hereunder that cannot be resolved by and between the parties in good faith shall be submitted to the dispute resolution procedure pursuant to the Participating Part D Plan Sponsor’s Agreement.
12. Governing Law.
The Part D Plan Sponsor's agreement and all addenda thereto shall be governed and construed in accordance with Federal law of the United States. In the event of a conflict between such agreement and all addenda thereto and Federal law, Federal law shall prevail. Nothing in the Part D Plan Sponsor's agreement or any addendum thereto shall subject an Indian tribe, tribal organization, or urban Indian organization to State law to any greater extent than State law is already applicable.
13. Pharmacy/Dispensary Participation.
The Part D Plan Sponsor's agreement and all addenda thereto apply to all pharmacies and dispensaries operated by the Provider, as listed on the attached Schedule -------- to this Indian Health Addendum. A pharmacy is required to use a National Provider Indentifier (NPI) Council for Prescription Drug Programs (NCPDP) provider number for reimbursement. To the extent a dispensary does not have a NCPDP provider number, it is required to use an NCPDP Alternate Site Enumeration Program (ASEP) number for reimbursement.
14. Acquisition of Pharmaceuticals.
Nothing in the Part D Plan Sponsor's agreement and all addenda thereto shall affect the Provider’s acquisition of pharmaceuticals from any source, including the Federal Supply Schedule and participation in the Drug Pricing Program of Section 340B of the Public Health Service Act. Nor shall anything in such agreement and all addenda thereto require the Provider to acquire drugs from the Part D Plan Sponsor or from any other source.
15. Drug Utilization Review/Generic Equivalent Substitution.
Where the Provider lacks the capacity to comply with the information technology requirements for drug utilization review and/or generic equivalent substitution set forth in the Part D Plan Sponsor's agreement, the Provider and Part D Plan Sponsor agree that the Provider shall comply with the Part D Plan Sponsor's drug utilization review and/or generic equivalent substitution policies and procedures through an alternative method. Nothing in this paragraph shall be interpreted as waiving the applicability of the drug utilization review and/or generic equivalent substitution policies and procedures adopted by Part D sponsor in accordance with 42 C.F.R.§§423.153(b) and (c), as approved by CMS, to covered Part D drugs dispensed by the Provider to enrollees in the Part D Plan[s]. As specified at 42 C.F.R. §423.132(c)(3), the requirements related to notification of price differentials is waived for the Provider .
16. Claims.
The Provider may submit claims to the Part D Plan by telecommunication through an electronic billing system or by calling a toll-free number for non-electronic claims; in the case of the latter, Provider shall submit a confirmation paper claim.
17. Payment Rate.
Claims from the provider shall be paid at rates that are reasonable and appropriate.
18. Information, Outreach, and Enrollment Materials.
(a) All materials for information, outreach, or enrollment prepared for the Part D Plan shall be supplied by the Part D Plan Sponsor to Provider in paper and electronic format at no cost to the Provider.
(b) All marketing or informational material listing a provider as a pharmacy must refer to the special eligibility requirements necessary for service to be provided, consistent with the eligibility requirements as described in this Indian health addendum in paragraphs 5(a) for IHS providers and 5(b) for tribal and urban providers.
19. Hours of Service.
The hours of service of the pharmacies or dispensaries of Provider shall be established by Provider. At the request of the Part D Plan Sponsor, Provider shall provide written notification of its hours of service.
20. Endorsement
An endorsement of a non-Federal entity, event, product, service, or enterprise may be neither stated nor implied by the IHS provider or IHS employees in their official capacities and titles. Such agency names and positions may not be used to suggest official endorsement or preferential treatment of any non-Federal entity under this agreement.
21. Sovereign Immunity
Nothing in the Part D Plan Sponsor’s Agreement or in any addendum thereto shall constitute a waiver of federal or tribal sovereign immunity.
_______________________________ __________________________________
Signature of Authorized Representative
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Printed Name of Authorized Representative
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Title of Authorized Representative
| File Type | application/msword |
| File Title | MEDICARE PRESCRIPTION DRUG BENEFIT |
| Author | Marla Rothouse |
| Last Modified By | Linda Anders |
| File Modified | 2010-09-07 |
| File Created | 2010-02-23 |