Part C QIC - Statement of Work.pdf

Part C Qualified Independent Contractor (QIC) Attachment J-1: Statement of Work

Medicare Part C 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 1852(g) of the Social Security Act (the Act), as amended by Title II of 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 C Qualified Independent Contractor (QIC), responsible for conducting reconsiderations of adverse organization determinations and adverse reconsiderations made by Medicare Advantage (MA) organizations.

Organization determinations and reconsiderations include the amount of cost sharing, if any, that the enrollee is required to pay. The contractor is also responsible for reviewing MA organization dismissals of appellant reconsideration requests.

The contractor’s workload shall also include conducting reconsiderations of adverse determinations by cost contracts (under section 1876 of the Act), Health Care Prepayment Plans (HCPPs) (under section 1833 of the Act), any CMS approved Medicare managed care demonstrations where the Medicare requirements for appeals and independent review have not been waived by CMS, and PACE organizations (under section 1894 of the Act).

For purposes of this Task Order (TO), the entities identified in the two prior paragraphs shall be referred to as Part C plans.

I.A. Background:

CMS has issued final regulations that establish procedures for grievances, organization determinations, and appeals under the MA program. These regulations are set forth at 42 CFR Part 422, Subpart M. Effective January 1, 2006, cost plans and HCPPs began following the appeal procedures at Part 422, Subpart M. The PACE program regulations concerning the appeals process are set forth at 42 CFR Part 460, Subpart G (see 42 CFR § 460.122 - 124). The following sections provide an overview of the most salient features of the Part C appeals process for purposes of this TO.

I.A.1. Overview of the Part C Appeals Process:

The MA program was enacted in Title II of the MMA and replaced the Medicare+Choice (M+C) program established under Part C of Title XVIII of the Act, while retaining most key features of the M+C program. Accordingly, Part C plans must have standard and expedited processes for organization determinations and reconsiderations. When making an organization determination or dismissing an organization determination request, a Part C plan must notify the enrollee and provider, as applicable, of its decision as expeditiously as the enrollee’s health condition requires, but no later than the timeframes listed in the chart below. The timeframes are calculated using calendar days and are based on when the Part C plan received the organization determination request.

Type Standard Timeframe Expedited Timeframe

Timeframe Extension

Part B Drug 72 hours 24 hours N/A Item or Service Subject to Prior Authorization

7 days 72 hours 21 days (standard) 17 days (expedited)

Item or Service Not Subject to

Prior Authorization

14 days 72 hours 28 days (standard) 17 days (expedited)

Payment: Clean Claim

30 days N/A N/A

Payment: Other Claims

60 days N/A N/A

The processing timeframes for reconsideration requests are listed below. The timeframes are calculated using calendar days and are based on when the Part C plan received the reconsideration request.

Type Standard Timeframe Expedited Timeframe

Timeframe Extension

Part B Drug 7 days 72 hours N/A Item or Service 30 days 72 hours 44 days (standard)

17 days (expedited) Payment 60 days N/A N/A

When dismissing a reconsideration request or issuing a fully favorable reconsideration decision, a Part C plan must notify the enrollee and physician, as applicable, of its decision before the end of the applicable timeframe. If a Part C plan affirms an adverse organization determination, in whole or in part, at the reconsideration level, the plan must prepare and automatically forward to the Part C QIC an explanation of its decision and an appeal casefile for all issues remaining in dispute. If a Part C plan fails to meet the adjudicatory timeframes for reconsiderations, this failure constitutes an affirmation of the adverse organization determination and the plan must immediately forward a casefile for the issues remaining in dispute to the Part C QIC. Part C plans do not automatically forward the dismissal of a reconsideration request to the Part C QIC. Instead, appellants must submit a request for review of the plan’s dismissal of a reconsideration request directly to the Part C QIC.

I.A.2. Overview of PACE:

The Balanced Budget Act of 1997 (BBA) added sections 1894 and 1934 to the Act which authorized coverage of Programs of All-inclusive Care for the Elderly (PACE) under the

Medicare and Medicaid programs. PACE is a unique model of managed care service delivery for frail elderly individuals who have been determined to meet their State’s nursing facility eligibility standard, but who may be safely maintained in the community. In order to maintain its enrollees (participants), PACE organizations provide comprehensive, coordinated care to meet all their healthcare needs, including physician, therapeutic, ancillary, and social support services.

In addition, they arrange for hospital, nursing home, home health, and other specialized services.

Financing of the PACE model is made through prospective capitation of Medicare and Medicaid payments, since most participants are dually-eligible for Medicare and Medicaid.

Although the PACE program has certain fundamental similarities to MA and other MCOs, PACE is not an MA plan. The BBA established distinct requirements for the PACE program.

PACE is similar to some MA options in these ways: it is capitated; it is risk-based; it provides managed care; and, it is an elective option. However, PACE differs significantly from MA plans in other ways such as: it includes statutory waivers that expand the scope of covered services to include certain services that are excluded from Medicare coverage, e.g., transportation, meals, and the Medicaid covered services in the State in which the organization is located; it is not available to all beneficiaries (only to a defined subset of the frail elderly); and, in most cases, it is a joint Medicare/Medicaid program. However, it is important to note that a potential participant is not required to be a Medicare beneficiary or Medicaid recipient. Also, PACE requires the use of a PACE center where most services are delivered, and an interdisciplinary team to coordinate and deliver care. The PACE center includes a primary care clinic, areas for therapeutic recreation, restorative therapies, socialization, personal care and dining, and serves as the focal point for coordination and provision of most PACE services.

With regard to participant appeal of coverage and payment decisions, PACE organizations have similar, but not identical timeframes to those applied to MA and other MCOs. PACE organizations must have standard and expedited appeal processes for organization determinations. If the health or psychosocial status of a participant changes or if the participant believes there is a need to initiate, eliminate, or continue a particular service (which may include prescription drugs), the PACE interdisciplinary team must conduct an in-person reassessment of the participants health status. The interdisciplinary team must notify the participant of its decision to approve or deny the request to initiate, eliminate, or continue services as expeditiously as the participant’s condition requires but no later than 3 calendar days after the date the interdisciplinary team receives the request for reassessment. The team may extend the notification timeframe by no more than 5 additional days if the participant requests the extension or the team documents its need for additional information and how the delay is in the interest of the participant.

If the participant is dissatisfied with the team’s decision, the participant may appeal the decision to the PACE organization. For standard service and payment appeals, the PACE organization must respond to and resolve appeals as expeditiously as the participant’s health condition requires, but no later than 30 calendar days after the organization receives the appeal. The PACE organization also must have an expedited appeals process and respond to expedited appeals as expeditiously as the participant’s health condition requires, but no later than 72 hours after it receives the appeal. The PACE organization may extend the 72-hour timeframe by up to 14 calendar days if the participant requests the extension or if the organization justifies to the PACE State administering agency the need for additional information and how the delay is in the interest of the participant.

For a determination that is wholly or partially adverse to a participant, the PACE organization must notify CMS, the State administering agency, and the participant. They are also required to inform the participant of his or her applicable appeal rights under Medicare or Medicaid, or both, and assist the participant in developing and forwarding the appeal to the appropriate entity. A dually-eligible participant may choose to access the State Medicaid fair hearings process to reconsider the PACE organization’s appeal determination or the participant may choose the Part C QIC reconsideration process.

To summarize, the PACE benefit package is tailored to each participant's individualized needs and includes all Medicare covered services, all Medicaid covered services specified in the State's Medicaid plan, and all additional items or services determined reasonable and necessary by the interdisciplinary team. Given the broad and individualized nature of the PACE benefits package, QIC adjudications of standard and expedited reconsiderations shall not be limited to Medicare and/or Medicaid coverage guidelines, but shall be based on a review of medical necessity.

PACE Part D Prescription Drug Coverage

PACE organizations provide Medicare Part D prescription drug coverage to eligible PACE enrollees. However, the Part D appeals process applicable to Part D sponsors has been waived on behalf of PACE organizations allowing these organizations to follow the PACE appeals process outlined in the PACE regulations for prescription drug related appeals. As a result, Part C QIC adjudications of reconsiderations shall include prescription drugs.

I.A.3. Role of the Part C QIC:

The Part C QIC’s primary responsibility shall be to adjudicate standard and expedited reconsiderations in an accurate, efficient, timely, and consistent manner.

The Part C QIC shall conduct its reconsideration as expeditiously as the enrollee’s health condition requires, but shall not exceed the processing timeframes that apply to Part C plan reconsiderations. More specifically, the Part C QIC is to process reconsiderations received from Part C plans and requests to review the dismissal of a reconsideration request within the following timeframes:

Expedited Reconsiderations for an item/service or a Part B drug – within 72 hours Standard Reconsiderations for an item/service – within 30 calendar days

Standard Payment Reconsiderations – within 60 calendar days Standard Reconsiderations for a Part B Drug– within 7 calendar days

The processing timeframes begin from when the Part C QIC receives the reconsideration case file from the Part C plan or the request to review a dismissal. For expedited reconsiderations and standard item or service reconsiderations, an extension of up to 14 calendar days is available if: 1) requested by the enrollee; or 2) action is required by the QIC to address deficiencies in the reconsideration case file, with appropriate notification to the enrollee in accordance with regulations. The QIC shall document the case file with the justification and rationale for the extension. Extensions are not permitted for Part B drug or payment reconsiderations.

The Part C QIC shall complete a minimum of 97% of its reconsiderations within the specified timeframes. Excluded from this standard will be cases where the QIC requires policy clarification from CMS in order to proceed with a reconsideration determination.

In cases where a lack of medical necessity formed the basis for the denial of coverage, the Part C QIC’s reconsideration shall be made by a physician with expertise in the field of medicine that is appropriate for the disputed services. The physician need not, in all cases, be of the same specialty or subspecialty as the treating physician. The physician shall, however, possess the appropriate level of training and expertise in the field of medicine to evaluate the necessity of the service at issue. The Part C QIC, at a minimum, shall have access to physicians in the major specialty areas.

The Part C QIC is responsible for conducting a de novo review of the record and for making an independent determination regarding the medical necessity of the service or the appropriateness of the service in accordance with the Part C plan’s evidence of coverage.

The Part C QIC shall be responsible for -issuing a notice of its reconsideration determination to the appellant and the Part C 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 appellant of the right to an administrative law judge (ALJ) hearing if the reconsideration determination is adverse; shall describe the procedures for obtaining an ALJ hearing, including meeting the amount in controversy requirement; and, shall satisfy any other requirements established by CMS. The Part C QIC may satisfy its responsibility for issuing a copy of the decision to the Part C plan by transmitting the decision letter via a secure method (i.e., secure fax line or secure portal).

The Part C QIC is also responsible for monitoring Part C plans’ compliance with timely effectuation of decisions that reverse, in whole or in part, a Part C plan’s determination. The Part C QIC shall be responsible for providing CMS with monthly reports of those plans which are not in compliance with timely effectuation requirements.

The Part C QIC is responsible for referring an enrollee’s alleged quality of care concern to the appropriate Quality Improvement Organization (QIO), through channels and procedures prescribed by CMS.

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

Finally, the Part C QIC is responsible for case file handling and storage through the Medicare Appeals System (MAS) and for various administrative services and report activities related to the Part C 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 C QIC Workload:

The Part C QIC’s jurisdiction will be national. Actual workload may fluctuate given the possibility of changes in Part C enrollments and appeal program requirements.

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 12-month Base Operational Period shall be billed against the appropriate Contract Line Item Number (CLIN)/Sub-Line Item (SLIN) for the Base Operational 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 re-openings, 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 Task Order (TO) Statement of Work (SOW) is to set forth the contractor’s responsibilities for conducting reconsiderations of adverse organization determinations and adverse reconsiderations made by Part C plans and reviewing Part C plan dismissals of appellant reconsideration requests. The Part C QIC’s responsibilities also include administrative tasks associated with the adjudication of Part C reconsiderations. The outcomes of this TO shall include:

• Issuing an acknowledgement letter to appellants for expedited and standard reconsideration requests;

• Timely and accurate adjudication of standard and expedited reconsiderations of Part C plans’ adverse organization determinations and adverse reconsiderations (including determinations related to applicable cost sharing) which include cases forwarded by Part C plans due to failure to meet adjudication timeframes and appellant review of dismissed reconsideration requests, using protocols that will be established by the Part C QIC;

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

• Case management, development, and documentation to produce 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 Medicare Appeals System (MAS);

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

• Referrals of quality of care concerns and suspected fraud and abuse concerns in accordance with procedures prescribed by CMS;

• Case file maintenance;

• Administrative services necessary to support the Part C appeals process, including data analyses and reporting; and,

• Perform thorough quality assurance checks on all collected data and performed data analyses. The Part C QIC shall provide written documentation to the Contracting Officer’s Representative (COR) detailing any data quality issues that have been identified; this documentation shall be provided to the COR within 24 hours of the Part C QIC identifying the quality issue. For any data issues identified, the Part C QIC shall provide a comprehensive summary of the issue and resolution. The summary of the data issue and resolution shall be included in the contractor’s monthly updates to the COR.

I.C. Technical Considerations

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

II. REQUIREMENTS

The QIC 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 C 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.

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

The Part C QIC shall perform all of the relevant requirements of the 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 C 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.D

Represent CMS in ALJ Hearings and Proceeding levels of the Appeals Process

II.F Administrative Services (performed by the AdQIC) 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 C 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

USOW Section: Description of Exempted Requirement 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 C 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

II.A. Periods of Performance

Transition Phase (if applicable):

The Part C 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 C plans will use for communicating and coordinating with the Part C QIC;

• Developing standardized protocols covering Part C 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 C 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 C QIC has successfully completed all transition phase activities, it shall submit a “Letter of Readiness” attesting to the fact that the Part C 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).

The periods of performance under this TO are as follows: TBD

Fully Operational Periods

The Base Operational Period and Renewal Periods shall be considered fully operational periods during which the Part C 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 defined in the USOW.

Task 1: Initial Meeting

The Part C QIC shall arrange an initial 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 C 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 the 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 C QIC shall develop and distribute a Reconsideration Procedures Manual that provides technical and process information that the Part C plans will follow for communicating and coordinating with the Part C 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. The Part C QIC shall review and make changes, as necessary, to the Reconsideration Procedures Manual at a minimum of once per year to ensure accuracy and compliance with MA program requirements.

As necessary, the Part C 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 C 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 C QIC shall also develop and distribute any other necessary written materials related to procedures for communicating with the OMHA and the MAC. The COR shall review and approve any memoranda of understanding (MOU) or other agreements.

The Part C QIC shall develop a project website no later than 60 calendar days after the TO award for viewing by Part C plans, appellants, advocacy groups, or other interested entities. The website shall be maintained in accordance with CMS standards and guidelines for contractor websites and shall contain various types of information, such as the Reconsideration Procedures Manual, newsletters, and appeal status inquiries.

The Part C QIC shall develop, prepare, and post to the project website a newsletter, as needed or upon the request of CMS, for conveying information on emerging trends or frequently misunderstood procedures for working with Part C plans and other relevant parties. The COR will approve all developed material prior to its release. Generally, newsletters can be expected to be prepared no more frequently than semi-annually.

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

The Part C QIC is responsible for issuing a notice of its reconsideration determination to the appellant and the Part C 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 appellant of the right to an ALJ hearing or attorney adjudicator review if the reconsideration determination is adverse; shall describe the procedures for obtaining an ALJ hearing or attorney adjudicator review, including meeting the amount in controversy requirement; and, must 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 and upon request, written translation services for individuals with limited English proficiency. For purposes of this TO, translation services may be required in less than 5% of cases.

The Part C QIC shall forward a copy of certain reconsideration determinations (e.g., favorable, withdrawal, or dismissal determinations) to the appropriate CMS Regional Office (RO). For reconsideration determinations that affect PACE plans, the Part C QIC shall also provide the appropriate CMS RO with a copy of the reconsideration determination.

All deliverables shall be compliant with Section 508 requirements of the Rehabilitation Act.

All virtual classes must be delivered using a 508 compliant platform and shall be compliant with Section 508 of the Rehabilitation Act.

All course materials (hard copy or electronic presentations, handouts, aides, and guides) 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.

Task 3A: QIC Appeals Decision Data File Submission

The Part C QIC shall provide CMS with a Comma-Separated Values (CSV) data file of Part C 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:

• QIC Appeal Number/Reference Number

• Decision Date

• Appeal Type

• Appeal Disposition

• Item/Service Type

• Condition

• Decision Rationale

• Medicare coverage rules

The purpose of this task is to provide the general public with Part C QIC appeals decisions to increase transparency. The decisions that are transferred to CMS will be publicly available at:

www.cms.gov/qic-decision-search http://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 C 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 Part C plan reconsideration request dismissals;

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

• Protocols for release of case file documentation regarding both standard and expedited reconsiderations to Part C plans, Part C plan enrollees, the OMHA, the MAC, and others in accordance with Privacy Act and HIPAA regulations; and,

• Protocols related to monitoring Part C 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

The Part C QIC shall conduct accurate and timely standard and expedited reconsiderations in accordance with the standards described herein, the regulations set out in Subpart M of Part 422 of the Code of Federal Regulations (CFR), any revisions to the regulations governing Part C organization determinations and appeals that may be made through future rulemaking, and the Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance.

The Part C QIC shall issue an acknowledgement letter to the appellant within 24 hours of receipt of an expedited reconsideration request and within 2 business days of receipt of a standard reconsideration request from the Part C plan. At a minimum, the acknowledgement letter shall:

• If the appellant is a beneficiary, include the 1-800-Medicare telephone number for further questions;

• If the appellant is a non-contract provider, instruct the provider to visit the Part C QIC’s website for status inquiries. In addition, the QIC shall include a telephone number. On occasion the QIC may receive provider telephone inquiries regarding non status issues, and shall respond to the inquiries;

• For all appellant types, include an explanation of their right to and the procedures for submitting additional information that may be important for the Part C QIC review;

• For all appellant types, an explanation that the enrollee has a right to get a copy of the case file sent to the Part C IRE from their Part C plan. Include instructions that the enrollee should contact their plan and that there may be a small fee for copying and sending the file.

Requests for reconsideration include, for example, coverage issues that involve a medical necessity determination, a request for payment, or a dispute over the amount of cost-sharing for a service. The Part C QIC is responsible for performing any research (e.g., regulations, coverage guidelines, plan documents, CMS manual instructions, etc.) necessary to determine whether or not a service is covered. The Part C QIC will receive from Part C plans any appeal request where the plan has continued to uphold its adverse determination, regardless of the basis for the denial.

In cases where a lack of medical necessity formed the basis for the denial of coverage, the Part C 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 C QIC shall conduct a de novo review of the record and make an independent determination regarding the medical necessity of the service under Medicare coverage guidelines or the appropriateness of the service in accordance with the health plan’s evidence of coverage.

The Part C QIC shall conduct reconsiderations within the following timeframes:

Standard Item or Service Reconsiderations: The Part C QIC shall conduct a standard reconsideration for a medical item or service and notify the enrollee in writing of its decision as expeditiously as the enrollee’s health condition requires, but no later than 30 calendar days from the date the Part C QIC receives the request. The Part C QIC shall use the most cost efficient and effective means to ensure that the enrollee receives written notice of the decision within the timeframe.

Standard Payment Reconsiderations: The Part C QIC shall conduct a standard payment reconsideration and notify the enrollee in writing of its decision no later than 60 calendar days from the date the Part C QIC receives the request. The Part C QIC shall use the most cost efficient and effective means to ensure that the enrollee receives written notice of the decision within the timeframe.

Standard Part B Drugs Reconsiderations: The Part C QIC shall conduct a standard Part B Drug reconsideration and notify the enrollee writing of its decision no later than 7 calendar days from the date the Part C QIC receives the request. The Part C QIC shall use the most cost efficient and effective means to ensure that the enrollee receives written notice of the decision within the timeframe.

Expedited Reconsiderations: The Part C QIC shall conduct an expedited reconsideration for a medical item/service or a Part B drugs and notify the enrollee of its decision as expeditiously as the enrollee’s health condition requires, but no later than 72 hours after receiving a request for an expedited reconsideration—for example, an oral notification followed up by written notice. The Part C QIC shall use the most cost efficient and effective means to ensure that the enrollee receives notice of the decision within the 72 hour timeframe. Mailing a notice within 72 hours in and of itself is insufficient.

Dismissals: The Part C QIC shall conduct a review of a Part C plan’s dismissal of a reconsideration request when a request is received within 65 calendar days of the date on the dismissal notice. The Part C QIC must complete the review of a timely filed dismissal within the processing timeframe applicable to the type of reconsideration request that was dismissed (e.g., a review of a dismissed standard reconsideration request for an item or service must be completed within 30 days).

Note: For expedited reconsiderations and standard item/service reconsiderations, an extension of up to 14 calendar days is available if: 1) requested by the enrollee; or 2) actions are required by the Part C QIC to address deficiencies in the reconsideration case file, with appropriate notification to the enrollee in accordance with regulations. The Part C QIC shall document the case file with the justification and rationale for the extension Extensions are not permitted for Part B drug or payment reconsiderations.

The Part C QIC is responsible for issuing a written notice of its reconsideration determination to the enrollee and the Part C plan. The Part C QIC may satisfy the requirement for issuing the decision to the Part C plan by transmitting the decision via a secure method (i.e., secure fax or secure portal).

The decision notice shall state the specific reasons for the decision and reference the regulatory citations, coverage guidelines, and/or policy instructions on which the decision is based; shall inform the enrollee of the right to an administrative law judge (ALJ) hearing if the reconsideration determination is adverse; shall describe the procedures for obtaining an ALJ hearing, including meeting the amount in controversy requirement; and, shall satisfy any other requirements established by CMS.

Task 6: Referring Quality of Care Concerns to QIOs

The Part C QIC shall refer to the appropriate QIO, through procedures prescribed by the COR, any issue where the appellant makes the assertion or the Part C QIC has reason to believe (based on information contained in the appeal documentation) that the quality of care provided through the Part C plan was inappropriate.

Task 7: Referring Suspected Fraud and Abuse Concerns

The Part C QIC shall refer to CMS, through procedures prescribed by the COR, any reconsideration request where suspected fraud and/or abuse concerns are identified. The Part C QIC’s referral shall include a synopsis of the basis for the suspected fraud or abuse, along with a copy of the reconsideration case file.

Task 8: Effectuation Requirements

The Part C QIC shall develop/maintain procedures for monitoring Part C plans’ compliance with the effectuation requirements at 42 CFR §§ 422.618 and 422.619.

The Part C QIC shall forward a copy of its fully or partially favorable reconsideration decision and other information necessary to effectuate the decision to the Part C plan by the end of the reconsideration adjudication timeframe. Effectuation of the reconsideration decision is the responsibility of the Part C plan that made the initial organization determination.

The Part C QIC shall forward a copy of the fully or partially favorable ALJ decision and MAC decision and other information necessary to effectuate the decision to the Part C plan within two

(2) calendar days of receipt of the decision. Effectuation of decisions is the responsibility of the Part C plan that made the initial organization determination.

If the Part C plan’s determination is reversed in whole or in part by the Part C QIC, the Part C plan must authorize the item or service within 72 hours or provide the service as expeditiously as the enrollee’s health condition requires, but no later than 14 calendar days from the date it receives notice reversing the determination. When the Part C QIC reverses a determination for a Part B drug, the Part C plan must authorize or provide the Part B drug within 72 hours from the date the Part C plan received the reversal decision. In cases where the appeal involves a request for payment, if the Part C plan’s determination is reversed in whole or in part by the Part C QIC, the Part C plan must pay for the service no later than 30 calendar days from the date it receives notice reversing the determination. If the expedited determination by the Part C plan is reversed in whole or in part by the Part C QIC, the Part C plan must authorize or provide the item, service, or Part B drug as expeditiously as the enrollee’s health condition requires, but no later than 72 hours (for items and services) and 24 hours (for Part B drugs) from the date it receives notice reversing the determination. The Part C plan is responsible for informing the Part C QIC that it has effectuated a decision.

If the Part C plan’s standard determination is reversed in whole or in part by the ALJ, or at a higher level of appeal, the Part C plan must pay for, authorize, or provide the item, service, or Part B drug as expeditiously as the enrollee’s health condition requires, but no later than 60 calendar days from the date it receives notice reversing the determination. For expedited Part B drug requests, the Part C plan must authorize or provide the Part B drug as expeditiously as the enrollee’s health condition requires, but no later than 24 hours from the date it receives notice reversing the determination. The Part C plan is responsible for informing the Part C QIC that it has effectuated the decision or that it has appealed the decision. The Part C QIC shall send a reminder notice if it does not receive a compliance notice from the Part C plan within 2 weeks.

Effectuation Exception: If the Part C plan requests MAC review of the ALJ decision, the Part C plan may await the outcome of the review before it pays for, authorizes, or provides the service.

A Part C plan that files an appeal with the MAC must concurrently send a copy of the appeal request and any accompanying documents to the enrollee and must notify the Part C QIC that it has requested MAC review.

As part of the monthly report, the Part C QIC shall report to CMS those Part C plans that are not in compliance with the effectuation requirements and include the percentage of plans who are not in compliance with the effectuation requirements.

Task 9: Reopenings

The Part C QIC shall develop procedures for reopening and revising reconsideration decisions consistent with the rules in 42 CFR §§ 405.980 through 405.986, as applicable, and related guidance in the Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance

Task 10: CMS Analysis, Reporting and Tracking System (ART)

The Part C QIC shall submit various monthly activity and workload reports via the CMS ART at https://arts.cms.gov/CMSART/.

The CMS ART is the system that will be used by CMS to track and analyze Part C 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 11: Monthly Progress Report

In addition to the general reporting requirements set out in the USOW, the Part C QIC shall submit a Monthly Progress Report into CMS ART by the 15th of each month. The COR and the Part C QIC shall agree upon the content and format of the Monthly Progress Report if information is required other than described below.

• Prior month’s activities by task and activity;

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

• Issues of concern that require CMS action;

• Updates with regard to quality assurance activities;

• Any unresolved issues from the prior month;

• Timeliness of reconsiderations completed; and,

• Other relevant information, as necessary.

Task 12: Monthly Workload Data Report

The Part C QIC shall submit a Workload Data Report into CMS ART by the 15th of each month.

The COR and the Part C QIC shall agree upon the content and format of the report, but at a minimum the report shall include:

• Number of appeals received, in various categories (e.g., by Appeal Priority; by Appellant Type; by Appeal Category/Type; by Contract Type);

• Appeal Disposition (e.g., Uphold, Overturn, Partial Overturn, Dismissal, Withdrawal);

• Appeal Decisions by Appeal Priority;

• Frequency of Medical Review; and,

• Number of and reasons for Dismissals.

Task 13: Case File Handling and Maintenance

When the Part C QIC completes a reconsideration that is unfavorable or partially favorable to the appellant, the Part C QIC shall organize the case file in accordance with the applicable protocol.

Upon receipt of an ALJ hearing request from an appellant or a case file request from an ALJ, the Part C QIC shall update the MAS with the relevant ALJ filing and request information, upload the complete case file to MAS for OMHA retrieval, and provide notification to the ALJ that the case file is ready for access. Concurrently, the Part C QIC shall notify the Part C plan of appeal cases forwarded for ALJ hearing. After the ALJ has adjudicated the case, the OMHA will return the case file to the Part C QIC. The Part C QIC shall update the MAS with the ALJ disposition data, and act as a repository for all completed ALJ cases and associated files.

The Part C QIC shall notify the Part C plan of the ALJ decision and provide the plan with the necessary effectuation information including, but not limited to, a copy of the ALJ and reconsideration decision within two (2) calendar days after receipt of the decision.

Upon receipt of the ALJ decision, the Part C QIC shall review those ALJ decisions that overturn, in whole or in part, the Part C QIC’s decision. The Part C QIC shall review the ALJ 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 C QIC shall prepare a synopsis of the perceived error(s) and forward the information to the COR via the CMS ART system by the 15th of each month.

When the Part C QIC receives a request for a case file from the MAC, the Part C QIC shall update the MAS with the MAC filing/request information, make and retain a copy of the case file, and forward the case file information to the MAC within five (5) calendar days of receipt of the request. The Part C QIC shall comply with the MAC’s request for the case file and supply the actual case file in the exact order and manner that it was sent from the ALJ Hearing Office.

Upon completion of a MAC review and receipt of a MAC decision, the Part C QIC shall update the MAS with MAC disposition data and act as a repository for all completed MAC cases and associated case files. The Part C QIC shall notify the Part C plan of the MAC decision and provide the plan with the necessary effectuation information including, but not limited to, a copy of the MAC decision and a copy of the ALJ and reconsideration decision within two (2) calendar days after receipt of the decision.

The Part C QIC is responsible for maintaining reconsideration case files in accordance with the CMS Records Management Program, including relevant guidance on records retention (http://www.cms.gov/manuals/downloads/ge101c07.pdf). Generally, reconsideration case files are retained for a period of 7 years from the end of the calendar year in which final action occurs.

Final action means a decision on an appeal by the highest level of appeal, not the decision made by the Part C QIC.

Currently, the Department of Justice (DOJ) has placed a freeze on the destruction of all Medicare documents. Therefore, until further instructions are released by CMS no reconsideration case files can be destroyed. 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 C QIC shall 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 C QIC shall maintain accessibility and the ability to read the document in accordance with changes in technology.

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

The Part C QIC shall be responsible for maintaining all reconsideration case files and related administrative records developed under this Task Order Statement of Work. The Part C 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 C QIC shall assume responsibility for maintaining existing Part C reconsideration and ALJ/attorney adjudicator and Council case files maintained by the existing Part C QIC(s), if applicable.

Task 14: Administrative Services and Ad Hoc Reporting

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

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

• Develop, update, and maintain a Reconsideration Procedures Manual;

• Review…