Attachment J-1

QUALIFIED INDEPENDENT CONTRACTOR

(QIC)

UMBRELLA STATEMENT OF WORK

I. SCOPE

The contractor shall provide adjudication services in support of the Medicare, Medicaid, and State Children’s Health Insurance Program Benefits Improvement and Protection Act of 2000 (BIPA), Public Law 106-554, Subtitle C - Changes in Medicare Coverage and Appeals Process, Section 521 Revisions to Medicare Appeals Process, and the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 Public Law 108-173. More specifically, the contractor shall act as a “Qualified Independent Contractor” (QIC) responsible for conducting reconsiderations of initial Medicare claims determinations and service requests. The overarching goal of having QICs perform reconsiderations is to issue informative and accurate decisions which will lead to a reduction in the number of unnecessary appeals filed, dismissals issued and reopenings requested. In addition, one of the selected contractors shall perform administrative services associated with conducting Medicare Part A and Part B reconsiderations and shall be known as the Administrative QIC or the “AdQIC.” Administrative services related to Part C and Part D reconsiderations shall be performed as set out in the statements of work for the Part C QIC and Part D QIC.

I. A Background

This chapter provides background material necessary to understand the purpose and requirements of this Umbrella Statement of Work (USOW).

I.A.1 Medicare Part A and Part B

Medicare is a nationwide, federal health insurance program enacted in 1965 as title XVIII of the Social Security Act (the Act). Medicare provides health insurance for people 65 years of age or older, certain younger disabled persons, and persons with permanent kidney failure (end stage renal disease). Beneficiaries may choose between the traditional, fee-for-service Medicare program, or a private health plan option referred to as Medicare Advantage Program. The Medicare program consists of two primary parts:

• Hospital Insurance (HI), also known as “Part A;” and

• Supplementary Medical Insurance (SMI), also known as “Part B.”

Medicare Part A covers some of the costs of providing medically necessary inpatient hospital care, skilled nursing facility care following a hospital stay, home health care, and hospice care. Individuals entitled to Social Security or Railroad Retirement benefits are automatically entitled to Part A hospital insurance beginning with the first day of the month in which the individual attains the age of 65. Those younger than age 65 who receive Social Security disability benefits and those with end-stage renal disease (ESRD) are also entitled to Part A. Individuals who worked in certain Medicare-qualified federal, state, or local government employment may also qualify for coverage provided certain conditions are met.

Medicare Part B helps pay for certain physician services (in both hospital and non-hospital settings,) outpatient hospital services, and many other medical services, equipment, and supplies not covered under Part A. Part B benefits are available to almost anyone age 65 or older regardless of entitlement to Medicare Part A and to disabled beneficiaries entitled to Part A. Part B is an “optional program,” meaning that eligible individuals may elect or decline to enroll in the program, which requires payment of a monthly premium.

The Department of Health and Human Services (DHHS) has overall responsibility for administering the Medicare Program, with assistance from the Social Security Administration (SSA). The Centers for Medicare & Medicaid Services (CMS), an agency of DHHS, administers the Medicare Program on a day-to-day basis, including formulation and promulgation of Medicare Program policy and guidance; contract execution, operation and management; maintenance and review of utilization records;

providing inquirers with basic information; general Medicare financing. The responsibility of adjudicating Administrative Law Judge (ALJ) hearing requests lies with the Office of Medicare Hearings and Appeals (OMHA) within DHHS. SSA is responsible for determining whether an individual is entitled to Medicare and for maintaining the Medicare master beneficiary record.

Section 911 of the Medicare Prescription Drug Improvement, and Modernization Act of 2003 required CMS to undergo contract reform in which the Part A and Part B functions would be combined and performed by a Medicare Administrative Contractor (MAC). The MAC workload also includes home health and hospice claims that were previously processed by Regional Home Health Intermediaries (RHHIs). The CMS also contracts with four Durable Medical Equipment MACs (DME MACs) to process DME, Orthotics, and Prosthetic (DMEPOS) claims

I.A.2 Medicare Part C and the Programs of All-inclusive Care for the Elderly (PACE) Program

Title II of the Medicare Modernization Act (MMA) modified and re-named the existing Medicare+Choice (M+C) program established under Part C of title XVIII of the Act. The program is now called the Medicare Advantage (MA) program. Although the MMA made some changes that were already in effect (such as higher payments), several new features took effect beginning with the 2006 contract year. These new features included authority for new MA regional plans that were organized as preferred provider organizations (PPOs). The MMA also introduced a new process for determining beneficiary premiums and benefits for 2006 and future years under which MA organizations submit a “bid” reflecting their revenue needs for covering the benefits they plan to offer. This new process applied to all MA plans beginning in 2006.

Medicare Managed Care organizations (MCOs) include MA plans, cost contracts, and Health Care Prepayment Plans (HCPPs). Under the provisions of the Act, CMS may enter into contract with MCOs[federally qualified MA plans (under section 1851 of the Act), cost contracts (under section 1876 of the Act), and HCPPs (under section 1833 of the Act), including any one of these organizations if it participates in a CMS approved demonstration] to have such organizations provide health care services to Medicare beneficiaries who enroll in the organization.

The Balanced Budget Act (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. To maintain their enrollees (participants), PACE organizations provide comprehensive, coordinated care to meet all their healthcare needs, including physician, therapeutic, ancillary, and social support services. In addition, PACE organizations must 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, a PACE organization is not an MA plan. The BBA established distinct requirements for the PACE program. PACE is like 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 it is a joint Medicare/Medicaid program.

Regarding 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 no later than seventy-two (72) hours after the date the interdisciplinary team receives the request for reassessment. The team may extend the seventy-two (72) hour notification timeframe by no more than five (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 thirty (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 seventy-two (72) hours after it receives the appeal. The PACE organization may extend the seventy-two

(72) hour timeframe by up to fourteen (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 Medicare Part D

Title I of the MMA established a voluntary outpatient prescription drug benefit known as Medicare Part D. The Part D program began on January 1, 2006. Part D prescription drug coverage is provided by private prescription drug plans (PDPs) that offer drug-only coverage and Medicare Advantage plans that offer both prescription drug coverage and all other Medicare benefits (MA-PDs). Qualified prescription drug coverage can also be offered through a PACE plan or a cost plan. Part D plans must offer standard prescription drug coverage but have the flexibility to vary the drug benefit within actuarial equivalency parameters. Part D plans are allowed to manage the drug benefit through a formulary. Assistance with premiums and cost sharing are provided to eligible low-income beneficiaries. Cost-sharing amounts and the annual out-of-pocket spending limit are subject to change each year.

I.A.4 Quality Improvement Organizations

A Quality Improvement Organization (QIO) is a group of health quality experts, clinicians, and consumers organized to improve the care delivered to people with Medicare. QIOs work under the direction of CMS to assist Medicare providers with quality improvement and to review quality concerns for the protection of beneficiaries and the Medicare Trust Fund. Information regarding the CMS QIOs can be found at:

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment- Instruments/QualityImprovementOrgs/index.html.

Under the Beneficiary and Family Centered Care (BFCC) QIO program, CMS contracts with entities to improve healthcare services and protect beneficiaries through expeditious statutory review functions, including complaints and quality of care reviews for people with Medicare. The BFCC-QIO ensures consistency in the case review process while taking into consideration local factors and local needs for general quality of care, medical necessity, and readmissions. The BFCC-QIOs also perform expedited determinations for beneficiaries who receive notice (1) that a provider plans to terminate services, and a physician certifies that failure to continue the services is likely to place the beneficiary’s health at risk or (2) that a provider plans to discharge the beneficiary. This applies to home health agencies, skilled nursing facilities, comprehensive outpatient rehabilitation facility and hospices.

BFCC-QIOs also make initial determinations regarding whether inpatient hospital services furnished or proposed are reasonable, necessary, or delivered in the most appropriate setting.

I.A.5 The Medicare Fee For Service (FFS) Appeals Process

Under the original Medicare plan, a beneficiary may generally obtain health services from any institution, agency, or person qualified to participate in the Medicare program that undertakes to provide the service to the individual. After the care is provided, the provider or supplier (or, in some cases, a beneficiary) submits a claim for benefits under https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityImprovementOrgs/index.html https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityImprovementOrgs/index.html the Medicare program to the appropriate government contractor/MAC. If the claim is for an item or service that falls within a Medicare benefit category, is medically reasonable and necessary for the individual, and is not otherwise statutorily excluded, then the contractor pays the claim. However, the Medicare program does not cover all health care expenses. If the Medicare contractor determines that the medical care is not covered under the Medicare program, it denies the claim.

When a contractor issues an initial determination on a claim, it notifies the provider, supplier and/or beneficiary, and provides direction on how to appeal the initial decision.

The existing appeals procedures for the original Medicare plan are set forth in regulations at chapter 42, part 405, subpart I of the Code of Federal Regulations (CFR). After an appellant has exhausted the administrative appeals procedures offered under the Medicare program, the Medicare statute provides the opportunity for a dissatisfied individual to seek review in U.S. District Court.

Once an initial determination has been issued, the beneficiary, provider, supplier or their authorized representative may appeal the claim to the contractor who made the initial determination. The request must be filed within one hundred and twenty (120) calendar days of the receipt date of the notice of the initial determination. This first level of appeal is known as redetermination, which is performed by the MAC. The individual conducting the redetermination must not have been involved in making the initial determination and must issue a decision to all parties to the appeal within sixty (60) calendar days of receipt of the appeal request.

If the appellant is dissatisfied with the redetermination decision, then they may request a reconsideration with the QIC within one hundred and eighty (180) calendar days of the date of receipt of the redetermination decision. The QIC then has sixty (60)-calendar days from the date of receipt of the reconsideration request to: (1) issue a decision; (2) notify the appellant they will be unable to complete their request within the sixty (60) calendar-day timeframe and offer the appellant the option to escalate their appeal to the next level of the appeals process; or (3) dismiss the request.

If the appellant is dissatisfied with the QIC’s reconsideration, then they may request a hearing before an ALJ. The appellant has sixty (60) calendar days from the date of receipt of the QIC’s reconsideration decision to request a hearing and the ALJ has ninety (90) calendar-days to issue a decision.

If an appellant is dissatisfied with the ALJ’s decision, they may request a review with the Medicare Appeals Council at the Departmental Appeals Board, herein the Appeals Council. The appellant has sixty (60) calendar days to request Appeals Council review and if the Appeals Council accepts the request, the Appeals Council has ninety (90) calendar days to issue a decision. This is the last stage of the administrative appeals process and appellants who continue to be dissatisfied can appeal to federal district court.

QIOs also make certain types of Medicare determinations, mostly involving inpatient hospital discharges under sections 1154 and 1155 of the Act. These decisions are also subject to ALJ hearings, if the amount in controversy is at least $200. In accordance with § 405.1006(b)(1), to be entitled to a hearing before an ALJ, the party must meet the amount in controversy requirements of this section. The required amount remaining in controversy must be $100 increased by the percentage increase in the medical care component of the consumer price index for all urban consumers (U.S. city average) as measured from July 2003 to the July preceding the current year involved. CMS will publish changes to the amount in controversy requirement in the Federal Register when necessary.

I.A.6 The Medicare Part C Appeals Process

The MA statute provides for CMS to contract with an independent review entity (IRE) (from this point forward the IRE will be referred to as the Part C QIC) to review and resolve in a timely manner MA plan reconsiderations that affirm denial of coverage, in whole or in part. CMS has issued regulations that establish procedures for organization determinations, reconsiderations, and review of plan dismissals under the MA program.

These regulations are set forth at 42 CFR Part 422, Subpart M and apply to all MA organizations, Medicare cost contracts, and HCPPs (hereinafter collectively referred to as “MA plans”).

When an MA plan dismisses a reconsideration request or, after completion of a reconsideration review, upholds its initial denial of an authorization or payment request for an item, service, or Part B drug (in whole or in part), the MA plan must refer the reconsideration to the Part C QIC for review and resolution. The MA plan must forward all information, relevant to the case at issue (e.g., medical records) to the Part C QIC for review. The Part C QIC is required to develop guidelines for MA plans that stipulate the types of information and/or documents that are considered necessary for inclusion in an appeal case file (i.e. a minimum set of documents that must be included in the case file when submitted by an organization).

There are five (5) types of reconsiderations that can be filed by an MA plan enrollee: (1) a standard item, service, or Part B drug reconsideration of an adverse decisions made before or concurrent to delivery, (2) a standard payment reconsideration made retrospective to rendering, (3) an expedited item, service, or Part B drug reconsideration of an adverse decision made before or concurrent to delivery (refer §§422.578 – 422.590), (4) a fast track reconsiderations (refer §§422.620 – 422.626), and (5) a review of an MA dismissal of appellant reconsideration request. Upon initial receipt of the reconsideration case from the MA plan, the Part C QIC will log the reconsideration into the Medicare Appeals System (MAS) for tracking and MA plan enrollment verification purposes. The Part C QIC will maintain data on all reconsiderations in sufficient detail to provide the required reports and analyses.

The Part C QIC shall adhere to timeliness standards for completing reconsideration reviews that mirror the timeframes established for MA organizations at § 422.590.

Specifically, reconsideration cases received from MA plans and PACE organizations are to be processed within the following timeframes:

• Expedited Reconsiderations - within 72 hours

• Standard Item/Service Reconsiderations - within 30 calendar days

• Standard Payment Reconsiderations - within 60 calendar days

• Standard Part B Drug Reconsiderations – within 7 calendar days

(NOTE: For expedited reconsiderations and standard item and service reconsiderations, an extension of up to fourteen (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 appeal case file, with appropriate notification to the enrollee in accordance with regulations. The Part C QIC will 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 expected to complete a minimum of 98% of its reconsideration cases within the specified timeframes. Excluded from the 98% standard are cases where it is necessary for the Part C QIC to request policy clarification from CMS to proceed with a reconsideration determination.

The requirements governing how a PACE organization must conduct its internal appeals process are similar (although not identical) with the MA requirements. In addition, the PACE regulations at §460.124 provide for a participant's right to appeal denials under either the Medicare or Medicaid managed care appeal processes.

I.A.7 The Medicare Part D Appeals Process

The Part D coverage determinations, reconsiderations, and appeals requirements are set forth at section 1860D-4(g) and section 1860D-4(h) of the Social Security Act (Act), as added by the MMA (Pub. L. 108-173).

CMS has issued regulations that establish procedures for coverage determinations, redeterminations, review of plan dismissals, 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.

Part D Benefit Appeals

Section 1860D-4(g) of the Act requires that the procedures for making coverage determinations and redeterminations for Part D drug benefits be the same as the procedures under the MA program set forth at 42 CFR. §§ 422.560-.626. Accordingly, Part D plans must have standard and expedited processes for coverage determinations and redeterminations. Section 1860D-4(g) of the Act requires that appeals procedures for Part D plans be like the procedures that apply to MA organizations. There are some procedures that apply to Part D plans with respect to the Part D QIC that are different than MA processes. Under the Part D process, an enrollee or prescriber must request an appeal in writing from the Part D QIC. However, if the Part D plan fails to meet the adjudicatory 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 enrollee’s request to the Part D QIC within twenty-four (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 IRE.

Another distinctive feature of the Part D appeals process is the exceptions process. If a Part D plan manages its drug benefits using a formulary, it must have reasonable and complete procedures in place for enrollees 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 requests an exception to a plan’s tiered cost-sharing structure (tiering exception); and (2) when an enrollee 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). Under both types of exceptions, the prescriber must provide a statement that supports the exceptions request.

An enrollee or an 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 must file a written request for reconsideration with the Part D QIC within sixty-five (65) calendar days of the date of the Part D plan’s redetermination notice. The sixty-five (65) calendar day timeframe may be extended if the appealing party provides good cause for late filing. In all cases, the Part D QIC must notify the enrollee and the enrollee’s prescriber, if applicable, of its reconsideration decision as expeditiously as the enrollee’s health condition requires, but no later than the following timeframes:

• Standard Benefit Reconsideration, including an at-risk reconsideration - within seven (7) calendar days

• Standard Payment Reconsideration - within fourteen (14) calendar days

• Expedited Benefit Reconsideration, including an at-risk reconsideration - within seventy-two (72) hours

(Note: For standard and expedited reconsiderations, a case may be tolled for up to fourteen

(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.)

When an enrollee requests a reconsideration, the Part D QIC is required to solicit the views of the prescriber and must include 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 must be made by a physician with expertise in the field of medicine that is appropriate for the disputed services. 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 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 determination, case file handling and storage through MAS, and various administrative services related to the Part D appeals process.

Late Enrollment Penalty Reconsiderations

The Part D QIC is responsible for conducting 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 Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance, and any other CMS guidance related to creditable prescription drug coverage determinations and the late enrollment penalty.

The Part D QIC will 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 of Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance. 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.

I. B QIC USOW Purpose

The purpose of this USOW is to ensure that, at a minimum, the following functions are performed:

• Adjudication of reconsiderations of initial claims determinations, service requests, prescription drug requests, and expedited reconsiderations of initial determinations made by the QIOs, using established protocols;

• Timely, accurate, and quality review of MAC dismissals using established protocols.

• Timely, accurate, and quality dispositions of all reconsideration and expedited reconsiderations for Medicare Parts A, B, C and D;

• Collection and transmission of information regarding the receipt and disposition of reconsiderations and expedited reconsiderations via the Medicare Appeals System (MAS);

• Communicate decisions about appeals with appellants and other parties to the appeal;

• Administrative services (e.g., training, protocol development, data analysis and reporting);

• Timely adjudication of adverse determinations related to the imposition of a late enrollment penalty under the Medicare Part D program;

• Effective monitoring of Part C MA plans and Part D plan sponsors compliance with effectuation requirements;

• Case management and documentation, including document imaging to produce a complete electronic case file for second level appeals; and,

• Participation and coordination with other entities in the Medicare appeals process including: CMS; the true out-of-pocket (TROOP) facilitator; other CMS contractors (e.g.- MACs, DME MACs, Recovery Auditors (RACs), Unified Program Integrity Contractors (UPICs), the Supplemental Medical Review Contractor (SMRC), the Benefits Coordination & Recovery Center (BCRC), the Commercial Repayment Center (CRC), and Quality Improvement Organizations (QIOs); the Administrative QIC (AdQIC); Part D plan sponsors; Medicare Advantage Organizations (MAOs); OMHA; and the Appeals Council.

• Compliance with Section 504 of the Rehabilitation Act of 1973 (Section 504), 29 U.S.C. §794.

II. QIC REQUIREMENTS

Independently, and not as an agent of the Government, the QIC shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the requirements of this SOW.

II.A Medicare Appeals System (MAS)

MAS is a government owned system developed for use on this contract. The QIC shall procure hardware as described below, for the MAS to be used at its facility. The QIC shall use this system to capture information on all reconsideration cases filed. CMS will provide additional information on the MAS at the time of the award.

At a minimum, the QIC shall perform the following routine tasks:

• Test connectivity and the system’s ability to perform its intended purpose;

• Enter and track information regarding the progress and disposition of each reconsideration;

• The QIC shall analyze case receipt and disposition data to identify trends and aberrations regarding reconsideration processing; identify ALJ training needs; and provider, supplier, and beneficiary educational needs and discuss them with the MACs;

• Analyze provider, supplier and beneficiary reconsiderations to identify trends and aberrations and notify CMS of its findings;

• Image and upload all images/case file documentation into MAS within fifteen

(15) business days after the date of the reconsideration decision letter. In big box cases, the QIC shall upload all images to MAS within thirty (30) business days after the date of the reconsideration decision letter. The QIC shall notify the COR and include information in the monthly report regarding any case where QIC is unable to successfully load the imaged documentation. Note: for purposes of this SOW, big box cases are defined as forty (40) claims or more; and

• Attend regularly scheduled calls to address issues with and develop/submit change requests (CRs) to, MAS team.

Contingency Plan for MAS:

The contractor shall develop and submit a contingency plan for continuing full production in case the MAS is unavailable or temporarily inoperable. The contingency plan shall distinguish between different time periods of unavailability, including (at a minimum) a plan for the system to be down for a 24-hour, 48-hour, one (1) week or indefinite period. The contingency plan shall be submitted within thirty (30) calendar days of the task order award.

II.A.1 MAS Hardware and Software Requirements at the QIC

Location

The following is an estimate of the minimum hardware and software that the QIC will need to procure for implementation of the MAS:

Summary of Requirements

Requirement

1. Desktop computers for QIC personnel

2. Office printers for the QIC

3. Network connectivity among QIC desktops and with QIC printers

4. Network connectivity from QIC desktops to the MAS server

5. Desktop application software for the QIC

QIC Desktop Computer Requirements

QIC Desktop Computer Notes Platform Microsoft Windows 10 or later Memory size 8GB recommended Disk size 200 GB recommended

Monitor 17” Color (dual monitors recommended) CD-ROM Drive For Installation of Software Software Microsoft Office 2016 or latest version

Java version 8 Adobe Acrobat Reader (recommended) TIFF image reader (recommended)

Web Browser Chrome, Edge, or latest version specified by MAS Support Anti-Virus software Anti-virus software must be kept up to date and full virus scans must be performed weekly.

II.A.2 Document Imaging

The QIC shall coordinate and implement a document imaging system designed to produce a complete electronic second level appeal. The QIC shall image all medical records and appeal records. The 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:

• Purchasing high volume scanners

• Developing workflow processes for imaging and indexing all second level appeal information (At a minimum, all images must be indexed by: Appeal number, claim number, and beneficiary Medicare number (which can be either the Health Insurance Claim Number (HICN), or the non-Social Security number-based Medicare beneficiary identifier (MBI));

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

• Implementing and verifying connectivity and successful transmission of images via MAS web services;

• Verifying that transmitted images can be viewed appropriately within the

MAS image viewer; and,

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

Contingency Plan for imaging failure:

The QIC shall develop and submit a contingency plan within thirty (30) calendar days of task order award to the Contracting Officer’s Representative (COR) detailing how it will manage the case files and documentation in the event the imaging system is unavailable or temporarily inoperable.

II. A. 3 Data Communications

The Government will provide the QICs with wide area network (WAN) data communications connecting CMS and the QICs. The QIC shall use the data communications provided by the Government for transmission of reconsideration and expedited reconsideration related data between the QICs and CMS. At the time of the award, the QIC’s COR will forward an application for the WAN data communication line. The QIC shall fill out and return the application within two (2) business days to their

COR.

II.A.4 System Security

The QIC shall ensure that the highest level of security is maintained for all personnel, telecommunications systems, and its physical and operational processes, in accordance with the requirements located on the CMS web site at https://www.cms.gov/Research- Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity and https://security.cms.gov/, in addition to any Chief Information Security Officer (CISO) directives. In addition, the QIC shall sign and adhere to the policies laid out in the CMS Interconnection Agreement Form, Rules of Behavior Form and Data Use Agreement Form.

DHHS requires all contractor employees (including subcontractor employees) who will be working in a Federally owned or leased facility and/or will have access to federal equipment, and/or proprietary, non-public, or trade secret information to undergo a background investigation. The background investigation is conducted by the Office of Personnel Management as coordinated through CMS. Additional information regarding security clearance can be in the CMS Security Clause.

II.A.5 Requirements for The New Medicare Card Project

The Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 required CMS to remove Social Security Numbers (SSNs) from all Medicare cards. The SSN-based HICN has been replaced by the randomly generated MBI, to decrease Medicare beneficiaries’ vulnerability to identify theft. HICNs will continue to exist and be generated for new beneficiaries but will be used only for internal processing (CMS systems/contractors, and between federal partners, like OMHA and SSA) with some exceptions.

The New Medicare Card Project had a transition period following the initial assignment of MBIs during which CMS and its contractors accepted either the HICN or MBIs from all external stakeholders. After the transition period, which ended January 1, CMS would only interact with beneficiaries, providers, plans, and other third-parties using the MBI, with some exceptions.

In the case of claim appeals, an indefinite exception to the above transition end date was granted. The reasons for this exception are: 1) to uphold due process for appellants, 2) to require that only an MBI be used on appeal requests after the transition period may place an undue burden on providers or beneficiaries who may appeal a claim submitted for payment prior to the transition period, 3) implementing the transition period may be difficult for our process due to the length of the appeals process for some claims. The claim appeals exception allows that even after the transition, appeals operations shall accept HICN as well as MBI number as valid beneficiary identifiers for an appeal request, regardless of the beneficiary identifier submitted on the claim at issue.

System enhancements were made to MAS and QIC internal systems particularly relating to correspondence. MAS tracks beneficiary MBIs as well as HICNs. In addition, MAS https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity tracks the claim receipt date as well as the beneficiary identifier that a claim was received with (either MBI or HICN). Because of the indefinite exception allowing appellants to use either the HICN or MBI (or both), CMS will refer to both beneficiary identifiers as the Medicare number in most public facing documents, such as the Internet Only Manual (IOM), or on CMS.gov.

The QIC shall not act as a means of translation between a HICN and MBI for appellants and parties to the appeal. The following beneficiary identifier shall be used on outbound correspondence:

• For Fee-for-Service - If a HICN is received on the claim at issue, a masked HICN (masked meaning to replace all characters except for the last few with a symbol, such as *) shall be placed on all outbound appellant correspondence. If an MBI is received on the claim at issue, a masked MBI shall be placed on all outbound correspondence to all parties.

• For Part C and D – If only the HICN is provided, through transition, use the masked HICN on outbound appellant correspondence. If both the HICN and the MBI are provided, through transition use the masked HICN on correspondence. If only the MBI is provided, use the masked MBI on correspondence. After the transition period ends, a masked MBI shall be placed on all outbound appellant correspondence.

The QICs shall have the ability to identify a beneficiary by both HICN and MBI in their workload systems. The QICs shall have the ability to determine the beneficiary identifier used on the claim at issue; MBI or HICN. The QICs shall have the ability to identify the date the claim at issue was received. QICs must have appropriate operational procedures, as well as correspondence generation systems to ensure that documents are issued to parties with the correct masked identifier based on what was received on the claim at issue. Those identifiers, whether MBI or HICN, will be masked with the same current masking scheme used for HICN. In addition, the QIC shall ensure that internal case management systems contain both HICN and MBI, claim receipt date, and the beneficiary identifier a claim was received with (MBI or HICN). QICs shall also ensure that additional workload systems accept all fields from MAS relevant to claim and beneficiary identifiers.

In cases such as identity theft, an MBI may need to be replaced with a new number.

Appeal requests should continue to be accepted, and outgoing correspondence should reflect the beneficiary identifier submitted on the claim at issue (HICN or MBI valid on the date of receipt of the claim).

II.B General Reporting Requirements

All reports shall be submitted electronically by entering them into CMS Analysis, Reporting and Tracking (ART) and/or other reporting systems as identified by CMS, with hard copy submissions as requested, unless otherwise instructed. All non-MAS reports shall be submitted in an electronic format compatible with a specified CMS software application (e.g., Microsoft Access, Microsoft Excel, or Microsoft Word) to the maximum extent possible. Hardcopy report requirements will be designated accordingly.

The QIC shall submit the data reports specified below. CMS may request additional reports, or reports in lieu of those identified herein, as required. The QIC shall modify reporting formats as laws, regulations, policies or other circumstances change.

II.B.1 Monthly Progress Report

The QIC shall submit a monthly progress report to the COR and Contracting Officer (CO) by the 15th of the month for the previous month’s effort. The report shall briefly state the progress made or difficulties encountered during the reporting period, as well as any remedial action taken, and a statement of activity anticipated during the subsequent reporting period.

The report shall detail the reconsiderations received and adjudicated. The QIC shall retrieve this information from the MAS and distribute these reports as instructed by the

COR.

The report will identify UPIC and RAC cases separately, so that reconsideration performed on either UPIC cases or RAC cases can easily be identified. QICs shall track and report both the workload associated with these appeals separately. RAC appeals shall also be tracked and billed separately within the respective invoices. In addition, as directed by the COR, the QIC shall also track and report on workload related to the

SMRC1.

QICs shall also include any late case files forwarded to OMHA as well as case files that are late in being forwarded from the MACs and DME MACs. The report should also include the number of case files that are close to or have surpassed the sixty (60) calendar day decision making timeframe. The report format will be determined by the QIC’s COR.

The COR may request that additional information is submitted with the monthly report as necessary.

As applicable, for each respective task order under this IDIQ, the contractor shall continuously monitor the workload (appeals/claims) received in the respective period of performance and notify the CO, Contract Specialist (CS), and COR, in writing, within one (1) business day of identification that it is likely to or may exceed exercised CLIN/SLIN volumes (e.g., the volume of claims exercised on a particular SLIN for a particular period of performance). The contractor shall take additional steps and actions to ensure oversight and management of the claim volumes received to ensure adequate notification to the CO, CS, and COR. If exercised claim ceilings are exceeded without adequate notification to CMS, there may be a delay in the availability of additional

1 Anticipate completion of a MAS update to support this tracking/reporting in calendar year 2023.

funding for the respective contracts. Further, CMS may consider the cause for the failure for adequate notification to determine if it is performance related.

As applicable, for each respective task order under this IDIQ, the contractor shall also notify the CO, CS, and COR, in writing, within one (1) business day when the contractor has billed 50 percent of the exercised costs in a given period of performance and again once they have billed 75 percent of the exercised cost in a given period of performance.

II.B.2 Future Enhancement Report

The QIC shall prepare and submit to the COR each year a report that identifies recommended changes or improvements to the Medicare appeal process. The format of the future enhancement report shall be determined by the COR. The due date may differ by contract and therefore the due date of the future enhancement report will be listed in the task order statement of work.

II.B.3 Ad Hoc Reports

During the contract, the QIC may be required to prepare special reports on specific issues or analyses for CMS. For example, prior to a routine CMS monitoring visit to a QIC or for a CMS CO/RO conference on specific coverage policy, the QIC may be instructed by the COR to generate a report on a specific appealed service category (e.g., SNF services) and prepare a report or analysis regarding the number and types of reconsiderations received and adjudicated, including the analysis of any trends on types of claims being appealed.

II.B.4 Cost Reports

The QIC shall enter their cost report into CMS ART with the monthly voucher that indicates at a minimum the current monthly costs, cumulative to date costs, and remaining funding. The report shall track costs in accordance with the format in the QIC’s business proposal, including but not limited to:

• Labor categories

• Hours per labor category

• Labor rates

• Fringe benefits

• Travel costs

• Other direct costs

• Subtotal costs

• Fees/profit

• Total costs

The Cost Report will be entered into CMS ART by the 20th of the following month that the report covers. The cost report loaded into CMS ART must mirror the business proposal format.

Note: This requirement will be modified depending on the nature of the contract award.

II.B.5 Annual Self-Assessment Report

The QIC shall submit an annual self-assessment report 3 months prior to completion of the Task Order period of performance which addresses its performance over the past year. This report will be reviewed by the CMS, or other evaluation staff, when performing an assessment of the contractor’s performance over the previous year.

At a minimum, the report shall include:

• The self-assessment format will be determined by the QIC’s Project/Program Director and COR and indicate how the QIC performed broken out by Quality of Product or Service, Cost Control, Timeliness of Performance, Business Relations, and any other criterion as defined by the Government.

• Recommendations for areas that could be improved

• Identification of problem areas not anticipated throughout the year

• Assessment of the QIC’s overturn rate of MAC decisions, the number of dismissals, and the number of reopenings.

II.B.6 Award Fee Plan Self-Assessment

If applicable, the QIC shall submit an award fee self-assessment report IAW the award fee evaluation criteria identified in the Task Order award fee plan.

II.B.7 Freedom of Information Act Reports

The QIC shall submit FOIA reports as outlined in the FOIA Policy and Procedural Guide.

Please refer to IV.D.1 through IV.D.3 of this SOW.

II.C Miscellaneous Activities

The QIC shall perform the following additional activities as necessary:

• Assist the Office of the General Counsel (OGC) and the Department of Justice (DOJ) as requested by CMS;

• Assist the Office of Inspector General (OIG) or the Government Accountability Office (GAO) in conducting audits or evaluations of the reconsideration process;

• Assist with any, and all, law enforcement investigations; and

• Conduct special studies at CMS’ request.

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

The QIC shall perform the following functions, as necessary, in support of the proceeding levels of the appeals process:

• Participate in ALJ hearings, as a participant, a party, or a witness as further defined in the task order SOW, for the purpose of supporting appeals decisions.

• Provide litigation support including, but not limited to data research, responding to interrogatories, and production of documents;

• Make recommendations to CMS when it should evoke party status at ALJ Hearings instead of simply participating; and,

• Draft position papers explaining or elaborating on the coverage criteria, Local Coverage Determination (LCD) or National Coverage Determination (NCD) used in making the reconsideration decision or other information relevant to the QIC’s rationale in making the reconsideration decision. These position papers should not be copied from letters but papers written specific to the case in question.

NOTE: CMS would only invoke party status in select cases that represent a high dollar at risk or an important…