Part D QIC - Statement of Work.pdf

Contract No. HHSM-500-2004-00005I Task Order No. 75FCMC25FJXXX

Attachment J-2 – Statement of Work

Medicare Part D Qualified Independent Contractor (QIC) Task Order

Statement of Work

I. Scope

The contractor shall provide adjudication services in support of the coverage determinations, reconsiderations, and appeals requirements set forth at section 1860D-4(g) and section 1860D- 4(h) of the Social Security Act (Act), as added by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). The contractor shall act as an independent review entity (IRE), hereinafter referred to as the Part D Qualified Independent Contractor (QIC), responsible for conducting reconsiderations of adverse coverage determinations and adverse redeterminations. For purposes of this Task Order (TO), adverse redeterminations include a request for covered drug benefit or review of an at-risk determination made by Part D plans. Coverage determinations and redeterminations include the amount of cost sharing, if any, that the enrollee is required to pay for a drug. The Part D QIC shall conduct reconsiderations of decisions made by stand-alone prescription drug plans (PDPs), Medicare Advantage Prescription Drug Plans (MA-PDs), and cost plans that offer qualified prescription drug coverage. The contractor is also responsible for reviewing requests for review of a dismissal when a PDP or MA-PD dismisses a redetermination request.

The Part D QIC’s workload shall also include conducting reconsiderations of adverse determinations related to prior creditable prescription drug coverage/imposition of a late enrollment penalty (LEP) under the Medicare Part D program.

I.A. Background

CMS has issued regulations that establish procedures for grievances, coverage determinations, redeterminations, and appeals under the Medicare Part D prescription drug benefit program.

These regulations are set forth at 42 CFR Part 423, Subpart M and Subpart U. Regulations related to creditable prescription drug coverage determinations and the late enrollment penalty are set out at 42 CFR Part 423 Subpart B (see, for example, 42 CFR §423.46(c) related to LEP reconsiderations). The following sections provide an overview of the most salient features of the Part D appeals process for purposes of this Task Order (TO).

I.A.1 Overview of the Part D Benefit Appeals Process

Section 1860D-4(g) of the Act requires that procedures for making coverage determinations and redeterminations for Part D drug benefits be the same as the procedures under the Medicare Advantage (MA) program set forth at 42 C.F.R. §§ 422.560-626. Accordingly, Part D plans must have standard and expedited processes for coverage determinations and redeterminations.

A Part D plan is required to make coverage determinations and redeterminations as expeditiously as the enrollee’s health condition requires, and notify the enrollee in writing of the decision no later than the timeframes listed below (based on when the plan receives the request):

Type of Request Part D Plan Notice Standard Coverage Determination No later than 72 hours Expedited Coverage Determination*

No later than 24 hours

Standard Redetermination No later than 7 calendar days Expedited Redetermination No later than 72 hours Payment No later than 14 calendar days

*Where applying the standard timeframes may seriously jeopardize the enrollee’s life, health, or ability to regain maximum function.

In the case of a coverage determination involving an exceptions request, the adjudication timeframe begins when the Part D plan sponsor receives the prescriber’s supporting statement. If a supporting statement is not received by the end of 14 calendar days from receipt of the exceptions request, the Part D plan sponsor must notify the enrollee (and the prescribing physician or other prescriber involved, as appropriate) of its determination as expeditiously as the enrollee's health condition requires, but no later than 72 hours from the end of 14 calendar days from receipt of the exceptions request for a standard request and no later than 24 hours from the end of 14 calendar days from receipt of the exceptions request for an expedited request.

Section 1860D-4(h) of the Act requires that appeals procedures for Part D plans be similar to the procedures that apply to MA organizations with respect to the independent review entity level of appeal. There are some procedures that apply to Part D plans with respect to the Part D QIC that are different than the MA process. Under the Part D process, an enrollee or prescriber must request an appeal in writing from the Part D QIC. However, if a Part D plan fails to meet the adjudication timeframes, or if on redetermination the Part D plan affirms, in whole or in part, its denial related to an at-risk determination under the Part D plan’s drug management program, the plan must automatically forward the case to the Part D QIC within 24 hours of the expiration of the adjudication timeframe. When a plan makes a fully favorable decision in less than 24 hours after the end of the adjudication timeframe, the plan should consider effectuating and notifying the enrollee of the favorable decision, in lieu of forwarding the case to the Part D QIC. Another distinctive feature of the Part D appeals process is the exceptions process, which is discussed in the next section.

I.A.2. Exceptions

If a Part D plan manages its drug benefits through the use of a formulary, it must have reasonable and complete procedures in place for enrollees or enrollee’s prescriber to request an exception.

A Part D plan’s exceptions processes are subject to approval by CMS. The exceptions processes apply in two cases: (1) when an enrollee or enrollee’s prescriber requests an exception to a plan’s tiered cost-sharing structure (tiering exception); and (2) when an enrollee or enrollee’s prescriber requests a Part D drug that is not on the plan’s formulary or requests an exception to a utilization management tool, such as a quantity limit, step therapy or prior authorization (formulary exception).

When an enrollee or enrollee’s prescriber requests a tiering or formulary exception, the Part D plan’s decision is a coverage determination that may be appealed. While the regulations in subpart M of part 423 set forth certain situations and criteria that a Part D plan’s exceptions processes must address, these provisions are not overly prescriptive. Under both types of exceptions, the prescribing physician or other prescriber (hereinafter, “prescriber”) must provide a statement that supports the exceptions request. The regulations describe the necessary content of the prescriber’s supporting statement. The regulations establish specific safeguards for enrollees when formulary exceptions are approved and also require that Part D plans provide notice to affected enrollees when certain changes are made to the formulary.

I.A.3. Role of the Part D QIC

The Part D QIC shall be responsible for adjudicating standard and expedited Part D benefit reconsiderations in an accurate, efficient, timely, and consistent manner.

An enrollee or enrollee’s prescriber who is dissatisfied with a redetermination made by a Part D plan has the right to appeal the adverse redetermination to the Part D QIC. This is the second level of appeal (reconsideration). An enrollee or prescriber must file a written request for reconsideration with the Part D QIC within 65 calendar days of the date of the Part D plan’s redetermination notice. The 65 calendar day timeframe may be extended if the appealing party provides good cause for late filing. In all cases, the Part D QIC shall notify the enrollee or enrollee prescriber, if applicable of its reconsideration decision as expeditiously as the enrollee’s health condition requires. Notification timeframes are discussed in task 5.A.

When an enrollee requests a reconsideration, the Part D QIC is required to solicit the views of the prescriber and shall include a written account of the prescriber’s views in the record. An enrollee’s request for a Part D QIC reconsideration of a Part D plan’s determination not to approve a tiering exception must be supported by the prescriber’s determination that all covered Part D drugs on the preferred tier for treatment of the same condition would not be as effective for the enrollee as the non-preferred drug, would have adverse effects, or both. A request for a Part D QIC reconsideration that involves a formulary exception request must be supported by the prescriber’s determination that all covered Part D drugs on any tier of the formulary would not be as effective for the enrollee as the non-formulary drug, would have adverse effects, or both. For a formulary exception request related to a utilization management tool, the prescriber’s supporting statement shall indicate that the application of the utilization management tool has been ineffective or has caused adverse effects for the enrollee or is likely to be ineffective or cause adverse effects for the enrollee. In cases where a lack of medical necessity formed the basis for the denial of coverage, the Part D QIC’s reconsideration shall be made by a physician with expertise in the field of medicine that is appropriate for the requested prescription drug.

The Part D QIC is responsible for conducting a de novo review of the record and for making an independent determination regarding the medical necessity of the drug. The Part D QIC can review whether the Part D plan properly applied its exceptions criteria, but it does not have any discretion with respect to the validity of the plan’s exceptions criteria or formulary.

The Part D QIC is responsible for mailing a notice of its reconsideration decision to the enrollee, the enrollee’s prescriber if applicable, and the Part D plan. The notice shall: state the specific reasons for the decision; inform the enrollee of the right to an administrative law judge (ALJ) hearing if the reconsideration determination is adverse; describe the procedures for obtaining an

ALJ hearing, including meeting the amount in controversy requirement; and satisfy any other requirements established by CMS. The Part D QIC may satisfy its responsibility for mailing a copy of the decision to the Part D plan by transmitting the decision letter to the Part D plan via a secure fax line or secure portal.

The Part D QIC is also responsible for monitoring the Part D plans’ compliance with timely effectuation of decisions that reverse, in whole or in part, the Part D plan’s coverage decision.

The Part D QIC is responsible for referring suspected fraud and abuse concerns in accordance with procedures prescribed by CMS.

Finally, the Part D QIC is responsible for case file handling and storage through the Medicare Appeals System (MAS) and for various administrative services related to the Part D appeals process.

The QIC is required to obtain CMSnet access and connection and any other requirements that may become necessary to connect to the MAS.

I.A.4 Part D QIC Workload

The Part D QIC’s jurisdiction shall be national. CMS shall provide estimates for the annual workload for Part D benefit and LEP reconsiderations in the Part D QIC business proposal.

The actual workload for both prescription drug benefit and LEP reconsiderations may fluctuate given the possibility of change in the Part D enrollment and appeal program requirements.

The workload estimates are delineated by period of performance (POP) of 12 months. Appeals received shall be billed against the POP in which they are received even if the appeals are completed in a subsequent POP. For example, an appeal received during the Base Period shall be billed against the appropriate Contract Line Item Number (CLIN)/Sub-Line Item (SLIN) for the Base Period even if the appeal is not completed/closed until Renewal Period 1.

In addition, each appeal may only be billed to the TO once. Any and all subsequent actions on the appeal, including but not limited to reopenings, corrected letters, Administrative Law Judge (ALJ) remands, and corrected/vacated dismissals (including appeals that were previously dismissed), will not be reimbursed separately.

I.B. Purpose

The purpose of this TO Statement of Work (SOW) is to set forth the Part D QIC’s responsibilities for conducting reconsiderations of adverse decisions, including at-risk determinations made by Part D plans and reviewing Part D plan dismissals of redeterminations. The Part D QIC workload also includes reconsiderations related to imposition of the Part D late enrollment penalty. The Part D QIC’s responsibilities include administrative tasks associated with the adjudication of Part D benefit and LEP reconsiderations. The outcomes of this TO shall include:

• Timely and accurate adjudication of standard and expedited reconsiderations of Part D plans’ adverse coverage determinations and adverse redeterminations (including cases auto-forwarded by Part D plans due to failure to meet adjudication timeframes), using protocols that will be established by the Part D QIC; Timely and accurate adjudication of Part D benefit cases remanded to the Part D QIC by an administrative law judge (ALJ)/attorney adjudicator or the Medicare Appeals Council (Council);

• Reconsiderations of adverse determinations related to prior creditable prescription drug coverage/imposition of a late enrollment penalty under the Medicare Part D program;

• Effective monitoring of Part D plans’ compliance with effectuation requirements;

• Case management, documentation, and development of a complete administrative record for second level appeals;

• Collection and transmission of information regarding the receipt and disposition of standard and expedited reconsiderations via the MAS;

• Participation and coordination with other entities in the Medicare appeals process including: CMS and its contractors; Part D plans; the Office of Medicare Hearings and Appeals (OMHA); and the Council; and

• Administrative services necessary to support the Part D appeals process, including ad hoc data analyses/reporting and case file maintenance. The Part D QIC is expected to perform thorough quality assurance checks on all data collected and analyses performed. The Part D QIC shall provide written documentation to the COR detailing any data quality issues that have been identified; this documentation shall be provided to the COR within 24 hours of the Part D QIC identifying the quality issue. For any data issues identified, the Part D QIC shall provide a comprehensive summary of the issue and resolution. The summary of the data issue and resolution shall be included in the monthly updates.

I.C. Technical Considerations

Hardware/Software: The Part D QIC shall be responsible for procuring hardware and software as set out in Section II.A.1 of the Umbrella Statement of Work (USOW).

II. Requirements

The USOW is incorporated into this TO with the same force and effect as if it were provided in full text. Independently, and not as an agent of the Government, the Part D QIC shall furnish all of the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to perform the requirements of the USOW and this TO

SOW.

The Part D QIC shall perform all of the relevant requirements of the current USOW

EXCEPT FOR THE FOLLOWING SECTIONS:

USOW

Section: Description of Exempted Requirement

II.B.1

Monthly Progress Report (Note: Monthly Progress Report requirements applicable to the Part D QIC are specified in this Task Order)

II.B.4 Cost Reports II.B.5 Annual Self-Assessment Report II.B.6 Award Fee Plan Self-Assessment II.F Administrative Services (performed by the AdQIC)

USOW

Section: Description of Exempted Requirement II.F.1 Protocols (developed by AdQIC) II.F. 2 QIC Manual (developed by AdQIC) II.F.3 Training (conducted by the AdQIC)

III.A

Reconsideration Adjudication (Note: Reconsideration Adjudication requirements applicable to the Part D QIC are specified in this Task Order)

III.A.1 Processing Reconsiderations III.A.2 Acknowledgement Letters

III.A.3

Timely Adjudication of Reconsiderations (per section 1869 of the Social Security Act (Act)).

III.A.4

MAS Data Entry (The only part of this section that is exempt is the requirement to transfer the request to the QIC with appropriate jurisdiction.)

III.B Finding of Potential Fraud or Misrepresentation III.E Effectuation of Reconsideration Decision III.F Holding Unfavorable and Partially Favorable Reconsideration Decisions III.G Expedited Reconsiderations per section 1869 of the Act III.G.1 Dismissal of Request for Expedited Reconsideration III.G.2 Expedited Reconsideration Decision

III.H

Control Procedures, Case File Handling and Storage (Note: Case File Handling and Storage requirements applicable to the Part D QIC are specified in this Task Order)

III.H.1 ALJ Hearings III.H.2 Appeals Council Review IV.A Notice of Reconsideration Decision or Notification of Processing Delay IV.B Coordination with External Organizations IV.B.1 QIC Monthly Meetings (coordinated by the AdQIC) IV.B.2 Quarterly AC and QIO Meetings IV.B.3 Training Sessions (developed and delivered by the AdQIC) IV.B.5 Protocol Refinement Committee Meetings (conducted by the AdQIC) IV.F Joint Operating Agreements IV.G.3 Panel of Clinical Experts VI Award Fee Plan

With respect to the USOW requirements that apply to the Part D QIC, any reference to administrative services performed by the AdQIC in the USOW shall be deemed to refer to the administrative services performed by the Part D QIC under this TO SOW.

II.A. Periods of Performance

Transition Phase (if applicable):

The Part D QIC shall ensure that the following actions (inclusive of start-up activities), at a minimum, are accomplished during the Transition Phase:

• Procuring necessary facilities and hiring staff;

• Establishing Medicare Data Communications Network (MDCN) line connectivity;

• Becoming familiar with the MAS and participating in training sessions;

• Becoming familiar with the Health Plan Management System (HPMS) and participating in training sessions;

• Developing a Project Management Plan;

• Developing a Reconsideration Procedures Manual that contains technical and process information that Part D plans will use for communicating and coordinating with the Part

D QIC;

• Developing standardized protocols covering Part D QIC functions that present risk to the CMS policy of consistency.

• Developing a Project Website

• Working with the outgoing QIC on the handling of Part D QIC tasks such as reconsiderations and reopening requests, effectuations, written and telephonic correspondence, and OMHA and Council appeals that may occur during the transition out phase and base operational period to ensure a smooth transition

When the Part D QIC has successfully completed all transition phase activities, it shall submit a “Letter of Readiness” attesting to the fact that the Part D QIC is ready to proceed to the fully operational phase. The “Letter of Readiness” shall be completed and sent to the Contracting Officer’s Representative (COR).

Fully Operational Periods:

The Base Period and Renewal Periods shall be considered fully operational periods during which the Part D QIC shall, at a minimum, perform the specific tasks set out under Section II.B of this SOW and the applicable tasks contained in the USOW.

II.B. Specific Tasks to be Performed

The following tasks are in addition to those already defined in the USOW.

Task 1: Initial Meeting

The Part D QIC shall arrange an initial kick-off meeting (which may be conducted via teleconference) with the COR and other CMS staff no later than 15 business days after the TO award. The purpose of the meeting will be to identify and clarify issues relating to the work to be performed.

Task 2: Project Management Plan

The Part D QIC shall develop and submit a Project Management Plan that defines the milestones, resources, and constraints of the project. The Project Management Plan shall be submitted in electronic format no later than 15 business days after the TO award.

All project plans shall be modified and updated continuously after these initial submissions to reflect any major changes in the project. A major change is defined as something that shifts the work or plan by at least 30 business days. When changes are identified, a draft plan shall be submitted for review within 10 business days of identifying the change. The COR will provide comments and the final plan shall be due 10 business days after receipt of COR’s comments.

The Project Management Plan shall include, at a minimum, the following:

• Description of key tasks and activities;

• Key staff types devoted to each task or activity, if appropriate, and time allocation for each;

• Key milestones signifying successful completion of each task and periodic internal assessment/progress reports planned; and,

• Activity interdependency and critical path for completion of all tasks.

Task 3: Communications

The Part D QIC shall develop and distribute a Reconsideration Procedures Manual that provides technical and process information that the Part D plans will follow for communicating and coordinating with the Part D QIC. The Reconsideration Procedures Manual shall be submitted in electronic format no later than 30 business days after the TO award. Revisions to the Reconsideration Procedures Manual will be subject to approval by the COR.

As necessary, the Part D QIC shall enter into an agreement with the OMHA ALJ Field Offices that reflects the joint responsibilities of the ALJs/attorney adjudicators and the Part D QIC to provide timely and accurate disposition of appeals and that sets forth duties for coordination and communication with appellants and other parties. The Part D QIC shall also develop and distribute any other necessary written materials related to procedures for communicating with the OMHA and the Council. The COR must review and approve any memoranda of understanding (MOU) or other agreements.

The Part D QIC shall develop, prepare and post to the QIC’s website, as needed or upon the request of CMS, for conveying information on emerging trends or frequently misunderstood procedures for working with Part D plans and other relevant parties. The COR must approve all developed material prior to its release.

The Part D QIC shall use required formats and notices or model language, as applicable, including templates that are stored in the MAS. Models of all notices used for notifying parties of a reconsideration determination by the Part D QIC or any other necessary correspondence between the Part D QIC and a party, a Part D plan, a Regional Office, the ALJ or attorney adjudicator, or other relevant party regarding the reconsideration program shall be submitted to the COR for review and approval.

The Part D QIC is responsible for mailing a notice of its reconsideration determination to the enrollee and the Part D plan. The notice shall state the specific reasons for the decision and reference the regulatory citations and/or policy instructions on which the decision is based;

shall inform the enrollee of the right to an ALJ hearing or attorney adjudicatory review if the reconsideration determination is adverse and relates to a Part D benefit; shall describe the procedures for obtaining an ALJ hearing or attorney adjudicator review (if the decision relates to a Part D benefit), including meeting the amount in controversy requirement; and shall satisfy any other requirements established by CMS. The reconsideration determination as well as any other correspondence shall be prepared in a clear and culturally competent manner to include, as appropriate, an 8th grade literacy level, upon request, written translation services for individuals with limited English proficiency, or alternate format (large print, audio braille etc.)

For purposes of this TO, translation services may be required in less than 5% of cases.

The Part D QIC shall also establish and maintain a website for viewing by Part D plans, advocacy groups, or other interested entities. The website shall be developed and maintained in accordance with CMS standards and guidelines for contractor websites and shall contain various types of information, such as the Reconsideration Procedures Manual, forms, newsletters, and appeal status inquiries.

Training provided by the Part D QIC or course materials (hard copy or electronic presentations, handouts, aides, and guides) developed by the Part D QIC shall be compliant with Section 508 of the Rehabilitation Act and delivered to all participants at least five (5) business days before the start of class. However, the parties understand that this time period may be shortened due to unanticipated circumstances, for example, ad-hoc trainings, trainings to address urgent matters, etc. If requested, an electronic version (i.e., cd or electronic pdf) of the training materials should be made available to CMS. All virtual classes must be delivered using a 508 compliant platform and shall be compliant with Section 508 of the Rehabilitation Act.

Task 3A: QIC Appeals Decision Data File Submission

The Part D QIC shall provide CMS with a Comma-Separated Values (CSV) data file of Part D QIC appeals decisions via NetStorage. The CSV data shall be free of protected health information (PHI), personally identifiable information (PII), and health plan information.

Additionally, the file should be sent on a weekly basis and include historical and current appeals data with the following elements:

• Decision Date

• Appeal Type

• Appeal Disposition

• Drug

• Condition

• Decision Rationale

• Medicare coverage rules

The purpose of this task is to provide the general public with Part D QIC appeals decisions to increase transparency. The decisions that are transferred to CMS will be publicly available at: www.cms.gov/qic-decision-search.

Task 4: Protocols

CMS seeks to ensure efficiency and consistency in the adjudication of reconsiderations. In order to promote this goal, the Part D QIC shall develop protocols covering the functions that present risk to the CMS policy of consistency, including:

• Case tracking protocols;

• Review protocols for standard and expedited reconsiderations involving medical necessity determinations;

• Review protocols for reconsiderations that do not involve medical necessity determinations;

• Review protocols for standard and expedited reconsiderations involving formulary and tiering exception requests;

• Protocols related to the preparation and transfer of case files to the OMHA and the Council;

• Information release protocols regarding standard and expedited reconsiderations and case file documentation to Part D plans, Part D plan enrollees, the OMHA, the Council, and others in accordance with Privacy Act and HIPAA regulations; and

Protocols related to monitoring Part D plans’ compliance with the effectuation requirements.

Protocols shall be submitted in electronic format to the COR no later than 30 business days after the TO award. Changes to the protocols will be subject to approval by the COR.

Task 5: Perform Timely Reconsiderations

Task 5.A General Part D Benefit Reconsideration Requirements

The Part D QIC shall conduct accurate and timely standard and expedited reconsiderations in accordance with the standards described herein and the regulations set out in Subpart M and Subpart U of Part 423 of the Code of Federal Regulations (CFR) and any revisions to the regulations governing Part D coverage determinations and appeals that may be made through future rulemaking. A Part D plan enrollee who is dissatisfied with a Part D plan’s redetermination related to coverage for a Part D drug or at risk-determination has a right to request a reconsideration from the Part D QIC. The enrollee or enrollee’s prescriber must file a written request for reconsideration with the Part D QIC within 65 calendar days of the date of the redetermination by the Part D plan. The 65 calendar day timeframe may be extended if the appealing party provides good cause for late filing.

The Part D QIC may also receive cases that are auto-forwarded by Part D plans and cases that are remanded by ALJs/attorney adjudicators and the Council.

Requests for reconsideration include, for example, coverage issues that involve a medical necessity determination, an exception request, a request for payment, at-risk determinations or a dispute over the amount of cost-sharing for a drug. The Part D QIC is responsible for performing any research (e.g. regulations, plan documents, CMS manual instructions) necessary to determine whether or not a drug is covered and under what circumstances.

When an enrollee requests a reconsideration, the Part D QIC shall solicit the views of the prescriber. The Part D QIC may solicit the prescriber’s statement orally or in writing. The case file shall contain a written account of the prescriber’s views in the record. In cases where a lack of medical necessity formed the basis for the denial of coverage, the Part D

QIC’s reconsideration shall be made by a physician with expertise in the field of medicine that is appropriate for the disputed services. The Part D QIC shall conduct a de novo review of the record and make an independent determination regarding the medical necessity of the drug.

The Part D QIC shall conduct reconsiderations as expeditiously as the enrollee’s health condition requires and notify the enrollee in writing of the decision no later than the timeframes listed below (based on when the QIC receives the reconsideration request):

Type of Request Part D QIC Reconsideration Notice Standard Benefit, including at-risk reconsiderations

No later than 7 calendar days

Expedited Benefit* No later than 72 hours Payment No later than 14 calendar days

The Part D QIC shall use the most cost efficient and effective means to ensure that the enrollee receives written notice of the decision within the required timeframe.

*An expedited reconsideration is made if applying the standard timeframe may seriously jeopardize the enrollee’s life, health, or ability to regain maximum function.

(Note: For standard and expedited reconsiderations, a case may be tolled for up to 14 calendar days when the request involves a formulary or tiering exception and the case is received without a prescriber supporting statement. The Part D QIC shall make reasonable attempts to contact the prescriber to obtain the required supporting statement prior to rendering a decision. The QIC shall document the case file with the justification and rationale for tolling the case.)

The Part D QIC shall mail a notice of its reconsideration decision to the enrollee, enrollee’s prescriber, if applicable, and the Part D plan. The Part D QIC may satisfy the requirement for mailing the decision to the Part D plan by transmitting the decision to the Part D plan via a secure fax or secure portal.

The decision notice shall state the specific reasons for the decision; shall inform the enrollee of the right to an administrative law judge (ALJ) hearing/attorney adjudicator review if the reconsideration determination is adverse and relates to a Part D benefit; shall describe the procedures for obtaining an ALJ hearing/attorney adjudicator review, including meeting the amount in controversy requirement; and shall satisfy any other requirements established by CMS.

The reconsideration determination shall be prepared in a clear and culturally competent manner to include, as appropriate, an 8th grade literacy level and upon request, written translation services for individuals with limited English proficiency or alternate format.

The Part D QIC shall include a copy of the form for requesting an ALJ hearing/attorney adjudicator review (OMHA-100) with the reconsideration decision sent to the enrollee.

Task 5.B Exceptions Requests

The Part D QIC shall conduct standard and expedited reconsiderations related to formulary and tiering exception requests. Formulary exceptions requests include requests for exceptions to utilization management tools. A request for a Part D QIC reconsideration of a Part D plan’s determination not to approve a tiering exception must be supported by the prescriber’s determination that all covered Part D drugs on the preferred tier for treatment of the same condition would not be as effective for the enrollee as the non-preferred drug, would have adverse effects, or both. A request for a Part D QIC reconsideration of a Part D plan’s adverse determination on a formulary exceptions request must be supported by the prescriber’s determination that all covered Part D drugs on any tier of the formulary would not be as effective for the enrollee as the off-formulary drug, would have adverse effects, or both. For a formulary exception request related to a utilization management tool, the prescriber’s supporting statement shall indicate that the application of the utilization management tool has been ineffective or has caused adverse effects for the enrollee or is likely to be ineffective or cause adverse effects for the enrollee. The Part D QIC can review whether the Part D plan properly applied its exceptions criteria, but it does not have discretion with respect to the validity of the plan’s exceptions criteria or formulary. Reconsiderations related to exceptions requests may necessitate that the Part D QIC access Part D plan formulary information via the HPMS.

Task 5.C Part D Creditable Coverage/Late Enrollment Penalty Reconsiderations

The Part D QIC shall conduct reconsiderations of adverse determinations related to the imposition of a late enrollment penalty under the Medicare Part D program.

Reconsiderations will be conducted consistent with 42 CFR § 423.46(c) and CMS guidance set forth in the Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance §60.8, applicable standard operating procedures (SOPs) and any other CMS guidance related to creditable prescription drug coverage determinations and the late enrollment penalty.

The Part D QIC shall provide written notice of an LEP reconsideration to the enrollee and the enrollee’s current Part D plan (and prior Part D plan, if applicable) within the adjudication timeframe established in §60.8.5 in the Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance. Under current guidance, the Part D QIC generally shall notify the enrollee of the LEP reconsideration decision within 90 calendar days of receiving the enrollee’s request. The Part D QIC may take an additional 14 calendar days if the enrollee requests an extension or if the Part D QIC finds good cause to extend the timeframe. LEP reconsideration decisions issued by the Part D QIC are not subject to further appeal, but may be reviewed and revised at the discretion of CMS.

Task 6: Effectuation Requirements

The Part D QIC shall develop a procedure for monitoring Part D plans’ compliance with the effectuation requirements at 42 CFR §423.636 and §423.638.

The Part D QIC shall forward a copy of the fully or partially favorable Part D benefit reconsideration decision and other information necessary to effectuate the decision to the originating Part D plan within two (2) calendar days of the reconsideration decision. Effectuation of the reconsideration decision is the responsibility of the Part D plan that made the initial coverage determination.

The Part D QIC shall forward a copy of the fully or partially favorable ALJ/attorney adjudicator decision and Council decision and other information necessary to effectuate the decision to the originating Part D plan within two (2) business days of the receipt of the decision. Effectuation of decisions is the responsibility of the Part D plan that made the initial coverage determination.

If the Part D plan’s coverage decision is reversed in whole or in part by the Part D QIC, or at a higher level of appeal, the plan must authorize or provide the benefit as expeditiously as the enrollee’s health condition requires, but no later than the timeframes listed below (based on when the plan receives the QIC’s decision notice):

Type of Request Part D QIC Reconsideration Notice Standard Benefit No later than 72 hours Expedited Benefit No later than 24 hours Payment Authorize payment within 72 hours, make payment (i.e. mail the payment), no later than 30 days

The Part D plan is responsible for informing the Part D QIC that it has effectuated a decision. If the Part D QIC does not receive a compliance notice within 2 weeks, it will send the plan a reminder notice.

As part of the monthly report, the Part D QIC shall report to CMS those Part D plans that are not in compliance with the effectuation requirements.

Task 7: Reopenings

The Part D QIC shall develop procedures for reopening and revising reconsideration decisions consistent with the rules in 42 CFR § 423.1978 – § 423.1986 and related guidance in the Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance.

Task 8: CMS Analysis, Reporting and Tracking System (ART)

The Part D QIC shall submit a monthly activity and workload report by the 20th of each month via the CMS Analysis, Reporting and Tracking System (ART) at https://arts.cms.gov/CMSART/.

CMS ART is the system that will be used by CMS to track and analyze Part D QIC reports, key workload measures and other data elements, as necessary. Information on the use of CMS ART will be available on-line within the system. All significant CMS ART system changes will be communicated via the News/Updates feature of the CMS ART system.

Task 9: Monthly Progress Reports

In addition to the general reporting requirements set out in the USOW, the Part D QIC shall submit a Monthly Progress Report into CMS ART by the 20th of each month. The COR and the Part D QIC shall agree upon the content and format of the Monthly Progress Report if information is required other than described below. The Monthly Report shall include, at a minimum:

• Prior month’s activities by task and activity;

• Summaries of biweekly meetings and areas of concentration for the upcoming month;

• Issues of concern that require CMS action;

• Updates with regard to quality assurance activities;

• Any resolved and unresolved issues from the prior month;

• Workload Report (submitted in the CMSART System only);

• Summary of favorable and partially favorable ALJ/attorney adjudicator decisions; and

• Other relevant information, as necessary.

Task 10: Case File Handling and Council Referrals The Part D QIC is responsible for maintaining reconsideration case files in accordance with CMS’ Records Management Program, including relevant guidance on records retention http://www.cms.gov/manuals/downloads/ge101c07.pdf.

The Department of Justice (DOJ) has placed a freeze on the destruction of Medicare documents.

However, in an effort to reduce associated costs for storing Medicare documents, the DOJ has agreed that electronic imaging is an acceptable method of storage. This provides the opportunity to destroy paper documents, as long as the following conditions are met:

1. The Part D QIC must certify the image is absolutely an identical replication of the paper document in every way;

2. The scanned image becomes the recordkeeping copy and is verified and documented as an identical replication of the paper document; and

3. The Part D QIC must maintain accessibility and the ability to read the document in accordance with changes in technology.

Reconsideration files shall be made accessible to CMS and to any authorized party consistent with the Privacy Act regulations.

When the Part D QIC receives a request for a case file from the ALJ/attorney adjudicator, the Part D QIC shall update the MAS with the relevant ALJ/attorney adjudicator filing and request information, upload the complete case file to MAS for OMHA retrieval and provide notification to the ALJ/attorney adjudicator that the case file is ready for access.

After the ALJ/attorney adjudicator has reviewed the case, the OMHA will send the case file to the Part D QIC. The Part D QIC shall update the MAS with the ALJ/attorney adjudicator disposition data and act as a repository for all completed ALJ/attorney adjudicator cases and associated files.

The Part D QIC shall notify the Part D plan of the ALJ/attorney adjudicator decision and provide the plan with the necessary effectuation information including, but not limited to, a copy of the ALJ/attorney adjudicator and reconsideration decision within two (2) business days after the Part D’s QIC receipt of the decision. See Task 10.A below regarding the Part D QIC’s responsibility http://www.cms.gov/manuals/downloads/ge101c07.pdf for determining, in consultation with the COR, the necessity of referring a case to the Council.

When the Part D QIC receives a request for a case file from the Council, the Part D QIC shall update MAS with the Council filing/request information, make and retain a copy of the case file and forward the case file information to the Council within five (5) calendar days of the Part D QIC’s receipt of the request. The Part D QIC shall comply with the Council’s request for the case file and supply the actual case file in the exact order and manner in regard to the mode of delivery in which it was received from the ALJ Hearing Office. Upon completion of a Council review and receipt of a Council decision, the Part D QIC shall update the MAS with Council/ disposition data and act as a repository for all completed Council cases and associated case files. The Part D QIC shall notify the Part D plan of the Council decision and provide the plan with the necessary effectuation information including, but not limited to, a copy of the Council decision and a copy of the ALJ/attorney adjudicator and reconsideration decision within two (2) business days after receipt of the decision.

Task 10.A Referral to the Council

Designated staff at the Part D QIC shall determine whether a motion to review should be sent to the Council based on regulations at 42 CFR Part 423, Subpart U and CMS guidance related to referrals to the Council. Within two (2) business days of receipt of the ALJ/attorney adjudicator decision, the Part D QIC shall review those ALJ/attorney adjudicator decisions that overturn, in whole or in part, the Part D QIC’s decision. The Part D QIC shall review the ALJ/attorney adjudicator decisions for perceived errors in application of Medicare statutes, regulations, and coverage guidelines or as otherwise instructed by CMS. Where such errors are noted, the Part D QIC shall consult with the COR and, if necessary, prepare a referral memorandum and file a motion for review with the Council consistent with 42 CFR §§ 423.2110 –2112 and other relevant guidance. The Part D QIC shall notify the plan and the enrollee or prescriber (if applicable) when a case has been referred to the Council for review. However, the Part D Plan must authorize or provide the benefit under dispute within the timeframes specified in the regulations at 42 CFR §

423.636 and 423.638 even when the case is being referred to the Council for review.

Task 10.B: Maintenance of Part D Case Files

The Part D QIC shall be responsible for maintaining all reconsideration case files and related administrative records developed under this Task Order Statement of Work. The Part D QIC shall also be responsible for maintaining case files for ALJ/attorney adjudicator level appeals and Council level appeals.

In accordance with USOW section III.A.4, the QIC shall enter all reconsiderations and related case file documentation within the QIC’s jurisdiction into the MAS promptly upon receipt and continuously update the MAS record throughout the adjudication process in accordance with the USOW and task order SOW. This includes entering cases that are dismissed.

The Part D QIC shall assume responsibility for maintaining existing Part D reconsideration and ALJ/attorney adjudicator and Council case files maintained by the existing Part D QIC(s).

Task 11: Administrative Services and Ad Hoc Reporting

The Part D QIC shall ensure that, at a minimum, the following administrative functions are performed:

• Develop, maintain, distribute, and update review protocols for expedited and standard reconsiderations;

• Develop, maintain, distribute and update the Reconsideration Procedures Manual;

• Review standard and expedited reconsideration data for statistical and analytical purposes;

• Coordinate, produce, and deliver training to Part D QIC employees in areas critical to the reconsideration adjudication process, including Medicare coverage policies, training on the use of MAS, HPMS, Eligibility and Enrolment Medicare Online (ELMO) and other areas or systems CMS may identify that require training;

• Participate in meetings/teleconferences related to MAS and suggest refinements to the system, including development and presentation of change requests (CRs), as necessary;

• Prepare and transfer case files to the ALJ/attorney adjudicator, Council and U.S. District Court and forward effectuation information to the Part D plans;

• Analyze ALJ/attorney adjudicator decisions to determine whether a request for Council review is appropriate and, if so, prepare a referral memorandum and refer the case to the Council after consultation with the COR;

• Coordinate various activities with Part D plans and ALJ Hearing Offices; and

• Send effectuation compliance reports related to Part D benefit reconsiderations in support of Regional Office (RO) caseworker functions.

The Part D QIC shall ensure that the following analyses and reporting functions are performed upon request by the COR:

• Effectuation compliance reports in support of Part D plan audits;

• Development of reconsideration data fact sheets;

• Reconsideration data reports in support of activities performed by the Medicare

Ombudsman’s office and other DHHS/CMS components; Information in support of Office of Inspector General (OIG) and Government Accountability Office (GAO) investigations and audits;

• Other ad hoc reports that may be needed in support of the Part D benefit appeals and LEP reconsideration processes; and

• Reconsideration data reports, including plan specific reports, in support of CMS activities related to Part D plan performance and compliance activities.

Task 11A: Enhancements Fact Sheet

The Part D QIC will analyze and trend their reconsideration decisions to provide CMS enhanced Fact Sheets on a quarterly basis. CMS will upload the approved Fact Sheets to its publicly available website.

The Fact Sheet will further enhance the information that is currently publicly available on aggregate by Part D appeals results.

The following Part D reconsideration data will be provided:

• Breakout of overturn rates by appeal priority

• Breakout of overturn rates by appeal issue

Optional Task 12: End of Contract (EOC) Transition Activities

The QIC shall work collaboratively with the incoming QIC to ensure a seamless transition of the applicable Part D QIC activities. CMS will exercise this optional task at a later date, as necessary. This task, if exercised, will include a 2-month period, ending at TO completion as stated in Section II.A of the Statement of Work.

The Part D QIC shall complete all case work in accordance with the requirements established in the SOW on or before the end of the designated contract period of performance. The completed reconsiderations are to be billed under the CLIN as of the date of receipt. Unless otherwise noted above, this optional transition task does not include the costs associated with processing reconsiderations or performing other activities related to reconsiderations as defined in this SOW (including, but not limited to, MAS activities, adjudicating appeals, mailroom activities, responding to telephone and written inquiries, processing reopenings, ALJ activities, responding to remands, etc.).

The Part D QIC is expected to provide the Government with all software, computer tapes, interim and final reports, and file documentation upon request by the COR. Final copies of all software, computer tapes, files, and adequate documentation for all files are required upon completion of this project.

The Part D QIC shall also:

• Work with the incoming Part D QIC to transition applicable Part D QIC activities;

• Participate in transition meetings with the incoming Part D QIC, as necessary;

• Identify, document, and notify the COR of any other tasks required for a successful transition no later than 15 business days prior to the end of the period of performance;

• Upon completion of all case work received through the end of the period of performance a letter of completion shall be delivered to the CMS COR.

Task 13: Document Imaging

The Part D QIC shall utilize a document imaging system designed to produce a complete electronic second level appeal. The Part D QIC shall image all medical records and appeal records. Document imaging shall include scanning a case in its entirety when it reaches the Part D QIC; performing Quality Assurance (QA) on scanned images;

indexing the scanned images appropriately; uploading and managing the images in MAS; and using the scanned images to make a decision in the case. The Part D QIC shall coordinate this effort with CMS to ensure a seamless transition to complete electronic appeals processing. Coordination of this effort includes the following, at a minimum:

• The QIC shall upload all images/case file documentation into MAS within fifteen (15) business days after the date of the reconsideration decision letter;

• Purchasing high volume scanners; Developing workflow processes for imaging and indexing all second level appeal information;

• Installing scanners, workstations, software, and T-1 line connectivity; and,

• Adhering to CMS’ standard for three-tier security architecture.

In the event that CMS is unable to present a fully functional three tier Content Management System for storing scanned images, the Part D QIC shall submit a detailed plan to develop a Content Management System outside of CMS.