OM DME QIC SOW_RFI.pdf

Attachment 1 – Statement of Work

HHSM-500-2004-00007I-75FCMC23F0001

Durable Medical Equipment Qualified Independent Contractor (DME QIC)

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. More specifically, the contractor shall act as a “Qualified Independent Contractor” (QIC) responsible for conducting reconsiderations of initial Medicare claims determinations in the jurisdiction identified in Section A below.

A. Background

The DME QIC workload includes, at a minimum, processing reconsideration requests in accordance with 42 CFR Part 405 for Medicare fee-for-service claims related to durable medical equipment (including, but not limited, wheelchairs, hospital beds, oxygen, and walkers), prosthetics and orthotics (P & O), parenteral and enteral nutrition (PEN), and supplies.

DME QIC Reconsiderations Workload:

There is only one DME QIC jurisdiction for processing reconsiderations on DME claims. The workload estimate in the Letter Request for Proposal (LRFP) includes all reconsideration activities under this task order including but not limited to: Durable Medical Equipment Medicare Administrative Contractor (DME MAC), Recovery Audit Contractor (RAC), Unified Program Integrity Contractor (UPIC), and Supplemental Medical Review Contractor (SMRC) appeals.

The workload estimates are reflected in the LRFP by period of performance (POP). Claims received shall be billed against the POP in which they are received even if the case/claims are completed by the DME QIC in a subsequent POP. For example, a claim received during the 12-month Base Operational Period shall be billed against the appropriate Contract Line-Item Number (CLIN) for the Base Period even if the case/claim is not completed/closed until Renewal I.

In addition, each claim may only be billed to the task order once. All subsequent actions on the claim including, but not limited to, reopenings, corrected letters, Administrative Law Judge (ALJ) remands, and corrected dismissals (including claims that were previously dismissed for no redetermination) will not be reimbursed separately.

For any cases that contain more than 250 claims, the QIC shall contact the Contracting Officer’s Representative (COR) to discuss utilizing statistical extrapolation for that case in accordance with Task 9 below.

The workload also includes responding to a minimal number of reopening requests, ALJ remand orders, and/or inquiries on cases received/processed by the outgoing QIC. CMS does not anticipate a large volume of appeals activities/inquiries related to these functions. If the QIC receives a reopening request and/or ALJ remand order on cases in which it has not been previously decided, the QIC may bill for such claims under the appropriate CLIN for this task order given it has not previously been paid for those claims under this and/or any other QIC task order.

General Background Relative to Reconsideration Activities as Outlined in this SOW:

This is a Firm-Fixed-Price (FFP) per claim/reconsideration task order (TO). The QIC shall perform all tasks as funded and authorized by exercise of award terms.

The QIC shall include all costs associated with any activities related to processing reconsiderations as defined in this SOW (including but not limited to, Medicare Appeals System (MAS) activities, adjudicating claims, mailroom activities, responding to telephone and written inquiries, reopenings processing including previously dismissed appeals, ALJ activities, responding to remands, etc.) in the unit cost per claim proposed in the respective CLIN/SLINs by POP.

B. Purpose

The purpose of this TO is to conduct reconsiderations of DME MACs redeterminations. The outcomes of this TO shall include, at a minimum:

• Timely, accurate, consistent, and high-quality adjudication of reconsiderations of initial determinations using established protocols;

• Case management and documentation, including electronic case management/document imaging into the MAS;

• Timely and accurate collection and transmission of information regarding the receipt, workflow, and disposition of reconsiderations via the MAS;

• Timely and accurate document imaging to produce a complete second level electronic case file;

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

and,

• Participating and coordinating with other entities in the Medicare appeals chain, including, but not limited to: CMS, the Administrative QIC (AdQIC), other QICs, DME MACs, the Office of Medicare Hearings and Appeals (OMHA), and the Medicare Appeals Council located within the Departmental Appeals Board (DAB), as well as, the Department of Justice, the Office of Inspector General, and the General Accountability Office, as needed to support the activities as outlined in this SOW.

C. Technical Considerations

The following are the minimum specifications of the PC hardware and software that the QIC will need to procure for implementation of the MAS:

QIC Desktop Computer Notes Operating System Microsoft Windows 10 or later Processor Pentium 4 Processor 2.8 GHz Memory size 8 GB Disk size 200 GB Monitor 17” Color (dual monitors recommended) CD-ROM Drive For Installation of Software Software Microsoft Office 2016 or latest version

Java version 1.8 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.

The following are the minimum specifications of the CMS security policies that must be maintained.

QIC Notes CMS Rules of Behavior Form To be completed by the QIC individuals who will be accessing the QIC network remotely prior to receiving a CMS User ID.

CMS Interconnection Security Agreement

To be completed by the QIC as an Organization 15 days after the date of award.

CMS Data Use Agreement To be completed by the QIC as an Organization 30 days after the date of award.

Security Test of the QIC infrastructure

Will occur 60 days after date of award, or at CMS discretion.

CMS Acceptable Risk Safeguards

(ARS)

CMS IT security policy to enforce FISMA compliance for all IT systems.

CMS Business Partner System Security Manual (BPSSM)

CMS IT security policy for business partners who utilize CMS data and connect with CMS systems.

Note: In accordance with the BPPSM, the DME QIC shall undergo a security audit and attain an Authority To Operate (ATO) within 6 months of contract award.

II. REQUIREMENTS

The QIC umbrella SOW 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 QIC shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to perform the requirements of the QIC umbrella SOW and this TO SOW for this jurisdiction.

The QIC shall perform all the requirements of the QIC umbrella SOW EXCEPT FOR THE

FOLLOWING SECTIONS:

I.A.2—Medicare Part C and the PACE Program I.A.3—Medicare Part D I.A.4—Quality Improvement Organizations I.A.6—The Medicare Part C Appeals Process I.A.7—The Medicare Part D Appeals Process II.B.2—Future Enhancement Report II.B.6—Award Fee Plan Self-Assessment II.F—Administrative Services II.F.1—Protocols II.F.2—QIC Manual II.F.3—Training

III.G—Expedited Reconsiderations III.G.1—Dismissal of Request for Expedited Reconsideration III.G.2—Expedited Reconsideration Decision

III.H.1—ALJ Hearings III.H.2—Appeals Council Review VI—Award Fee Plan

A. Phases Work on this contract shall occur in two (2) phases: “transition,” and “on-going”. The base period shall include a 3-month transition period and a 12-month operational period. Renewal Periods I – III shall include a 12 month fully operational period, and 4 additional/optional months for transition out activities as described below. The period of performance is as follows:

Base Period-Transition: June 1, 2023 - August 31, 2023 Base Period-Operational: September 1, 2023 - August 31, 2024 Renewal Period I: September 1, 2024 – August 31, 2025 Renewal Period II: September 1, 2025 – August 31, 2026 Renewal Period III: September 1, 2026 – August 31, 2027 Transition Out: September 1, 2027 – December 31, 2027

Note: The QIC shall no longer receive/process new reconsideration requests received on or after September 1, 2023. The QIC shall process reconsideration requests received on or before August 31, 2023, in accordance with existing regulatory and/or SOW requirements.

A.1 Optional Transition Phase (Transition In) The optional transition phase shall begin upon task order award and shall conclude on August 31, 2023. The QIC shall ensure that the following actions, at a minimum, are accomplished during the Transition Phase:

• Procuring necessary facilities and hiring staff;

• Establishing Medicare Data Communication Network (MDCN) line connectivity and a document imaging process into the MAS;

• Actively participating in training sessions and the All QIC calls conducted by the AdQIC;

• Working with/communicating with the outgoing QIC to ensure a smooth transition;

• Commenting on the protocols the AdQIC has drafted;

• Coordinating and developing joint operating agreements with the MACs, Unified

Program Integrity Contractors (UPICs), Recovery Audit Contractors (RACs), Supplemental Medical Review Contractor (SMRC) (as directed by the COR), the AdQIC, and OMHA; and,

• Testing the MAS including the ability to upload data and case file documentation.

When the QIC has successfully completed all transition phase activities, it shall submit a “Letter of Readiness” to the COR and upload it into CMS Analysis Reporting and Tracking System (CMS ART) or other specified CMS Deliverable System of Record, as directed by CMS, attesting to the fact that the QIC is ready to proceed to the on-going phase. The “Letter of Readiness” shall be completed and sent to COR on or before the last day of the transition period.

A.2 Operational Phase

The operational phase shall commence on September 1, 2023. During the operational phase, the QIC, at a minimum, shall complete all the activities in the USOW and TO SOW including, but not limited to:

• Adjudicate accurate, high quality, consistent, and timely second level Medicare appeals;

• Request and receive all pertinent appeals case files from the DME MACs;

• Expeditiously and accurately scan and upload all document images and related case file information (including all related correspondence) into the MAS;

• Expeditiously and accurately update MAS in accordance with the MAS required fields

(Appendix C is current as of the date of this RFP and is subject to change);

• Forward case files to OMHA in accordance with the QIC/OMHA Memorandum of

Understanding (MOU) (Attachment J-3 to this task order);

• Participate in ALJ hearings;

• Respond to written and telephone inquiries activities in a timely and accurate manner;

• Identify, report, and respond to issues or inquiries that require CMS input in an expeditious, timely, and accurate manner;

• Comply with the panel of clinical experts’ requirements;

• Review and respond to reconsideration requests in the language in which it was received

(e.g., a reconsideration request received in Spanish shall have a reconsideration decision letter issued in Spanish). The appeals case file shall also include a copy of the English version of the respective decision letter;

• Respond to a minimal number of post-transition reopening requests and ALJ remand orders on cases decided by the outgoing QIC;

• Participate in training conducted by the AdQIC and as requested by CMS;

• Provide feedback to the AdQIC on the development of protocols;

• Upon completion of the reconsideration, provide accurate and timely effectuation information to the DME MACs; and

• Provide feedback to the MAS system maintainer.

B. Specific Tasks to be Performed: The following tasks are in addition to those already defined in the USOW.

Task 1: Initial Meeting/Kickoff Conference

Meeting with CMS:

In preparing to implement new requirements, the QIC shall arrange an initial meeting/kick-off conference with CMS. This meeting shall be held no later than 10 calendar days after the TO award and shall be held via teleconference or online medium compatible with CMS computer systems. Prior to this meeting, the QIC shall provide CMS with information regarding the new mailing address (postal and courier information) and/or other relevant information as to where new reconsideration requests shall be submitted during the operational phase.

Following the meeting, the QIC shall be responsible for providing meeting minutes to the COR related to the initial/kick off conference with CMS. These minutes shall be submitted to the COR within three (3) business days following the meeting.

Meeting with the DME MACs:

The QIC also shall have an initial meeting/kick off conference call with the DME MACs. This meeting shall occur no later than 15 calendar days after TO award and shall be held via teleconference or an online medium compatible with CMS computer systems. At this initial meeting, the QIC shall work with the DME MACs and provide, at a minimum, with the following information:

• A list of workgroup members;

• A list of all deliverables necessary to ensure a smooth transition of documentation, if applicable, between the MACs and the QIC and the dates upon which these will be sent to the QIC;

• A draft JOA; and

• The QIC shall work with the DME MACs to determine the appropriate types and timing of communication and education activities needed to inform beneficiaries and providers about the QIC’s role.

Meeting with OMHA:

CMS will notify the QIC, upon contract award, if an initial kick off meeting will occur between CMS, the QIC, and the OMHA.

The QIC shall be responsible for providing draft meeting minutes and deliverables to the COR for all activities no later than 3 business days following each meeting. Final meeting minutes and deliverables listings shall be provided to all participants within 3 business days of receipt of any comments from the COR.

Task 2: Project Plan

Task 2 activities are only applicable if the Transition phase is exercised.

The QIC shall ensure effective and efficient communication, cooperation, consultation, and coordination between the QIC and the AdQIC, the DME MACs, OMHA, and the Appeals Council is maintained.

As part of the Project Plan, the QIC shall develop a transition management team to ensure communication, cooperation, consultation, and coordination between the MACs, OMHA, and the outgoing QIC, if appropriate, is maintained in support of the transition. The team shall have regular meetings and shall monitor the work of any subgroups during the transition.

The QIC shall submit both a draft and a final Project Management Plan during the transition phase.

The draft plan shall include the information described as appropriate and shall be submitted in hard copy and electronic format no later than 15 days after TO award. The final plan shall be submitted no later than 15 days after the initial meeting/kick off conference with the DME MACs.

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 days. When changes are identified, a draft plan shall be submitted for review within 10 days of identifying the change. The COR will provide comments, and the final plan shall be due 10 days after receipt of COR’s comments.

In addition, the QIC shall submit a transition deliverables list, if applicable, to the COR no less than every 2 weeks during the transition period.

Task 3: JOAs & CMS/OMHA/QIC MOU

The AdQIC has developed JOA templates relative to the AdQIC/QIC, QIC/DME MACs, QIC/ UPICs and QIC/RACs. The QIC shall utilize existing JOA templates and/or other related documents to continue established communications with the respective CMS contractors, including, if directed by the COR with the SMRC.

AdQIC/DME MAC/UPIC/RAC JOAs:

The QIC/DME MAC JOAs shall include a statement that the QIC will accept imaged case files if the DME MACs are able to provide them to the QIC electronically, via CD, or other acceptable imaging technology. The QIC shall work with the DME MACs upon TO award to ensure a compatible methodology for the MAC and the QIC to exchange the case file information electronically and to the extent possible, other information, such as effectuations data to support an electronic communications environment between the two entities.

As the DME MACs begin utilizing the MAS for processing redeterminations (timeframe TBD at this time), the QIC shall work with the DME MACs to update the JOAs to include language indicating that the appeals case file will be obtained via electronic promotion of the level one appeal record within the MAS. As updates occur to reflect this process change, the QIC/DME MAC JOA shall include language to address situations in which the MAS is down or otherwise unavailable for short term and/or long-term periods of time. In addition, the JOA shall include language to address processes and procedures for providing case files that are not in the MAS due to the redetermination having been processed prior to the level one MAS implementation and/or the rare instance that the file is otherwise not available in the MAS.

Note: Currently no DME MACs are utilizing the MAS to process redeterminations and there is no estimated time in which this shall occur.

• Establishing New JOAs, as applicable: Should the QIC not already have an existing/established JOA related to this workload with the AdQIC/DME MACs/ZPICs/RACs, the QIC shall submit a draft written JOA to the COR and the relevant party to each JOA for comment no later than 15 days after the transition phase begins. For purposes of this section, the relevant party to the JOA is defined as the DME MAC, ZPIC/UPIC, RAC, and AdQIC. The QIC shall submit final written JOAs to the COR and the relevant party no later than 15 days prior to the start of the operational phase. The QIC shall obtain the appropriate signatures from the QIC and relevant parties on the JOA and submit the final signed JOA to the Contracting Officer no later than the first day of the fully operational period. The QIC shall furnish a copy of the signed JOA to the COR, Contract Specialist, and the relevant party and upload it into CMS ART.

• Updating Existing JOAs, as applicable: If the QIC has existing JOAs with the relevant parties noted above, the QIC shall update the existing JOAs, as applicable, based upon the requirements in this SOW and obtain concurrence on the revised JOAs no later than 15 days prior to the start of the operational phase. The QIC shall obtain the appropriate signatures from the QIC and relevant parties on the JOA and submit the final signed JOA to the Contracting Officer no later than the first day of the fully operational period. The QIC shall furnish a copy of the signed JOA to the COR, Contract Specialist, and the relevant party.

The QIC shall update the AdQIC/MAC/UPIC/RAC JOAs on an annual basis on January 1st (or a mutually agreeable time between the respective parties, 1 time per year) or more frequently if significant changes warrant an interim update, or on a date that is mutually agreeable between the two entities. In addition, if an annual update is mutually agreeable between the QIC and the respective entity, the QIC has the discretion to update this deliverable on an annual basis.

However, the QIC shall notify the COR within 5 calendar days of agreement with the respective entity to follow an annual update process and identify the mutually agreeable timeframe in which this update will occur so that the COR can update the due date(s) in CMS ART (or other specified CMS Deliverable System of Record) accordingly. The QIC shall track changes through an appropriate means from the previous document and distribute changes to the relevant parties.

If during the mutually agreeable update period, no changes are identified, the QIC shall submit a statement to this effect to the COR via CMS Analysis, Reporting, and Tracking System (CMS ART or other specified CMS Deliverable System of Record), or any mandated system as directed by the COR, and the relevant parties. The JOAs shall be uploaded into CMS ART (or other specified CMS Deliverable System of Record) and distributed to the CO, COR, and the relevant party to each JOA.

The JOAs will not be incorporated into task order contracts as this document is a mutual agreement between the QIC and the relevant party to the JOA. However, the JOAs shall contain, among other things, a dispute resolution process, which details the steps to be followed in the event of a dispute between the QIC and the relevant party to the JOA with regard to the terms and conditions of the JOA.

At a minimum, the QIC and the relevant party shall first attempt to resolve the above issue(s). If they are unable to come to a resolution, the matter will be raised to the respective CORs. In the event that a dispute between the QIC and the relevant party to the JOA cannot be resolved by the COR and related parties within 30 days (excludes budget issues) the QIC shall direct the issue in writing to the CMS CO, Contract Specialist (CS), and the COR for resolution by a JOA Alternative Dispute Resolution (ADR) team. The CMS will determine the members of the ADR team on a case-by-case basis depending on the issue(s). The ADR team will issue a determination on the matter in writing to both the QIC and the relevant party to the JOA.

Reports to CMS of QIC non-compliance will be investigated. If the non-compliance issue is validated, at a minimum, it will be considered an adverse finding in the annual performance evaluation.

DME QIC/CMS/OMHA/MOU:

The QIC also shall be responsible for complying with the requirements as outlined in the attached CMS/QIC/OMHA MOU (see Attachment J-3). The OMHA MOU shall outline the policies and procedures for the QICs interactions with OMHA. CMS shall work with OMHA and the QIC to review the MOU that was included with this RFP and update it on an annual basis.

While CMS will lead the negotiations of any changes to the OMHA/CMS/QIC MOU, the QIC shall be responsible for expeditiously reviewing any suggested changes and providing feedback to CMS. Additional information regarding this process shall be provided upon TO award.

Reports to CMS of QIC non-compliance with the terms of the OMHA MOU will be investigated.

If the non-compliance issue is validated, at a minimum, it will be considered an adverse finding in the annual performance evaluation.

Task 4: Medicare Appeals System

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 all documentation and/or records as obtained as part of the tasks associated with the Medicare appeals demonstration. This task also further defines the following MAS entry requirements that, at a minimum, the QIC shall perform:

• Timely and accurately enter data into the MAS required fields as provided in Appendix C to this SOW; and

• Populate the claims data within MAS exactly as the claims are populated in the Medicare shared systems utilizing the MAS claim interface, or manual data entry when the claims interface is unavailable. This includes entering claims data on cases that are dismissed if the claims can be identified by the QIC.

Task 5: Document Imaging into the MAS

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 or appeal records and load them into the MAS using MAS document importer (as directed below). MAS document importer allows both PDF and TIFF document file formats. Once imported, these documents can be viewed through the MAS custom image viewer.

Document imaging shall include scanning a case in its entirety when it reaches the QIC, performing Quality Assurance (QA) on scanned images, indexing the scanned images appropriately, and using these scanned images to make-a-decision on the appeals. The QIC shall coordinate this effort with CMS to ensure a seamless transition to complete electronic appeals processing.

Coordination of this effort shall include the following, at a minimum:

• The QIC shall upload all images/case file documentation into MAS within fifteen (15) business days after the date of the reconsideration decision letter. 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 cases where the QIC is unable to successfully load the imaged documentation in accordance with this task. Note: big box cases are defined as 40 claims or more.

• Purchasing high volume scanners as needed;

• Developing workflow processes for imaging and indexing (minimum indexing items shall include appeal number, claim number/id, and beneficiary Health Insurance Claim Number (HICN)/Medicare Beneficiary Identifier (MBI), and all second level appeal information;

• Installing scanners, workstations, relevant software, and T1 line connectivity;

• Developing an electronic document management system to store imaged appeals case files and load them into MAS;

• Using these scanned images to make decisions on appeals; and,

• Adhering to CMS’ standards for information security including the CMS ARS and the

BPSSM.

This system shall adhere to all: CMS IT security standards for sensitive data, CMS security requirements in the ARS, CMS document retention policies, and be able to provide timely access to the images for case adjudication purposes.

The QIC shall also submit a contingency plan for imaging failure in accordance with USOW Section II.A.2 within 30 days of the TO award.

In addition, in accordance with Task 3, JOA/MOU, the QIC shall accept imaged case files from the DME MACs that are not yet utilizing the MAS to process appeals and/or as otherwise necessary to obtain the appeals case file. The methodology for information exchange shall be negotiated as part of the JOA development process and shall comply with the Health Insurance Portability & Accountability Act of 1996 (HIPAA), the Privacy Act, the CMS ARS, the BPSSM, and the National Institute of Standards and Technology (NIST) guidance.

Images Loaded into MAS/Verification Protocol:

The images loaded into MAS shall be verified as an exact duplicate of the hard copy/original documentation. To ensure compliance with this, the QIC shall develop and submit a protocol to ensure that the images loaded into MAS are exact duplicates of the original hard copy. This protocol shall be submitted to CMS for review and approval within 30 days of the date of TO award. Additional details will be provided upon award.

Task 6: Data Analysis and Semi-Annual Report of Findings

The QIC shall analyze and trend their reconsideration decisions utilizing the standard reports in the MAS, AdQIC findings, and/or other materials, as appropriate, to provide the COR, MACs, UPICs, RACs, and/or other CMS contractors with information regarding the appeals activities in their respective jurisdictions. The QIC shall communicate substantial findings regarding the appeals activities and/or other issues on a semi-annual basis. This report may include identifying areas in which, for example, additional education is necessary from the MACs, problems/issues in the appeals process, etc. This analysis shall also include a review of completed cases to determine the consistency of the decision-making process by appeal type. The QIC shall solicit feedback from the relevant parties to determine the specific contents to be included in this report.

The QIC also shall use such findings to improve their operations and the appeals process.

Note: Providing trending reports to the UPIC does not replace the USOW requirement regarding fraud referrals. The QIC shall comply with the requirements regarding fraud referrals as outlined in USOW section III.B.

Task 7: Website

The QIC shall develop and go live with a public facing DME QIC website no later than 60 calendar days after the TO award. After development, the QIC shall maintain the website. The DME QIC shall ensure that the website is fully compliant with Section 508 of the Rehabilitation

Act and the Department of Health & Human Services Section 508 implementation policy.

Section 508 requires that all Web site content be equally accessible to people with disabilities. This applies to Web applications, Web pages and all attached files. It applies to intranet as well as public-facing Web pages. Additional information can be found at the following link:

http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information- Technology/Section508/index.html

The DME QIC shall submit to the COR(s) the website content prior to going live for review/approval. The DME QIC website shall include, at a minimum, the following information:

• DME QIC’s name and jurisdiction;

• Easily accessible/identifiable information regarding the contract transition, if applicable;

• DME QIC’s contact information (including telephone numbers and mailing information);

and

• Reconsideration request requirements as established in 42 CFR §405.964.

Task 8: Telecommunications

The QIC is required to obtain (or simply maintain) a CMSnet connection to the CMS network to connect to the MAS.

CMS, using will provide and install routers used for the Wide Area Network (WAN) connectivity. The DME QIC is responsible for the LAN configuration to those routers, including any circuits, cables, routers, switches, servers, or any other device and/or software necessary to connect to the CMS infrastructure.

The DME QIC shall install all necessary telecommunication software and have the ability to transmit and receive data via standard telecommunication parts and protocols including, at a minimum, ports 80 and 443.

The DME QIC shall submit a request for telecommunications services through their COR and the OIT COR. The COR shall provide the DME QIC with the documentation that needs to be completed upon task order award. The DME QIC shall submit the completed documentation to the COR and OIT COR expeditiously, but no later than 10 calendar days after task order award (if no new connectivity is needed, no action is necessary).

Additionally, the DME QIC shall ensure arrangements have been made for the local phone company and/or other telecommunications staff to have access to buildings to install lines and/or equipment prior to the CMS telecommunications installation, should additional connectivity/connections be necessary during the TO period of performance.

http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/Section508/index.html http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/Section508/index.html

Task 9: Activities Related to Limited Cases that the QIC Conducts an Extrapolation of the Claims at Issue

In accordance with USOW section I, the QIC shall conduct reconsiderations of initial Medicare claims determinations and service the related requests. In rare instances, due to the nature of the volume of claims at issue, the DME QIC shall, at a minimum:

• Consult with CMS regarding use of statistical extrapolation on any cases that have more than 250 claims;

• Upon approval from CMS, solicit approval from the appellant and if concurrence is provided, identify a statistically valid random sample (SVRS) extrapolation of the claims at issue and perform a limited claim review of the selected sample; and,

• Review all claims selected as part of the SVRS consistent with the CMS standards and guidelines (e.g., HCFAR 86-1, Internet Only Manual, Pub. 100-08, Chapter 3, §3.10) as outlined in the USOW and this SOW.

• Enter claims data in MAS for the claims reviewed as part of the SVRS (the QIC is not required to populate the MAS with all claims in the universe).

Under the Medicare fee-for-service appeals process, appellants who are dissatisfied with the DME QIC’s reconsideration decision may request a hearing before an ALJ. If an ALJ (and/or higher level of appeal) issues a decision that requires a recalculation of the extrapolated overpayment on a case that involved a SVRS identified and performed by the DME QIC, the DME QIC shall be responsible for performing all related re-extrapolations.

Accordingly, the DME QIC shall, at a minimum:

• Upon notification from the DME MAC regarding a request for re-extrapolation and/or receipt of the related ALJ decision (whichever is sooner), the DME QIC shall coordinate with the DME MAC or other CMS stakeholders, as necessary, to obtain all related information to appropriately and accurately recalculate the extrapolated overpayment;

• Expeditiously utilize a statistician to recalculate the extrapolated overpayment; and,

• Provide the DME MAC with the necessary documentation to accurately effectuate the claims related to this case in accordance with the ALJ’s (and/or further level of appeal) decision.

The QIC also may receive a small volume of re-extrapolation requests from ALJ (and/or higher level of appeal) decisions issued on cases that were subject to SVRS by the previous QIC for this jurisdiction. The QIC shall conduct the re-extrapolation and follow the requirements as detailed above.

The QIC shall work with the outgoing QIC during the transition period to obtain additional information and related documentation, as appropriate, for cases in which the outgoing QIC previously performed a SVRS.

Task 10: Destruction of Documents

The DME QICs shall destroy all paper case files once the case has been imaged and the image quality is verified. Upon approval of the Verification Protocol as identified in Task 5, the DME QIC shall destroy all paper case files once the case has been imaged, the image quality is verified, the image is verified as stored in the MAS, and the image is held in accordance with CMS document retention policy. The DME QIC shall not be required to provide the AdQIC with hard copy case files for long term storage.

Task 11: Monthly Reporting

Monthly Progress Report:

In addition to the general reporting requirements set out in the USOW, the DME QIC shall submit a Monthly Progress Report of its monthly activity/workload and a Case File List Report via CMS ART (or other designated deliverables system as identified by CMS): CMSART Login.

This report shall be submitted on the 15th of the month for the previous month’s activities.

The COR and DME QIC shall agree upon the content and format of the Monthly Progress Report on DME QIC activities. At a minimum, the information shall include:

For the transition period, the Monthly Progress Report shall include, at a minimum:

• Administrative actions;

• Status of all transition activities;

• Summary of all transition workgroup activities;

• Staffing plan (identifying both full- and part-time employees by position);

• List of unresolved transition issues (including any data issues);

• List and status of all transition deliverables; and,

• Any lessons learned during the transition.

For the operational period, the Monthly Progress Report shall include, at a minimum:

• Prior month’s activities by task and activity;

• Report on the efficacy of the JOA;

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

• Issues of concern that require CMS’ action;

• Updates regarding quality assurance;

• Updates regarding receipt/response to ALJ remands;

• Any unresolved issues from the prior month;

• Workload report (submitted in the CMS ART System (or other specified CMS Deliverable

System of Record) only;

• Workload narrative support, if necessary; and,

• Workload projections (i.e., tracking and projecting claims received and claims remaining on respective SLINs).

https://arts.cms.gov/CMSART/logon.aspx?ReturnUrl=%2fCMSART%2fdisclosure.aspx

• A listing of any cases that were more than 250 claims, an indication of when the appeal was received, when CMS was notified of the appeal, when the DME QIC received notification from CMS and the appellant to begin statistical sampling, if applicable, and any other information relevant to these activities;

• Feedback/discussion regarding any trends in the appeals process and recommendations for policies that may need changes/clarification;

• A listing and discussion of any congressional, regional office, or COR related inquiries received during the prior month, the related case, the actions taken and/or the status.

Information submitted shall also include a self-assessment, as applicable, for process improvements on any issues identified in this process; and,

• A listing of any cases that were untimely in meeting the imaging case file uploading requirements as required under Task 4. In addition, the DME QIC shall also include an indication of the system or other issue(s) causing the delay in meeting this requirement and potential resolution.

• A breakout of the volume of additional requests per month/POP;

• A breakout of the documentation requests by supplier;

• Data regarding the responsiveness of the requests for documentation;

• Innovations to Improve the Medicare Appeals Program, as required in Task 13.

Case File List Report:

In addition to the general reporting requirements set out in the USOW and this task, the QIC also shall submit a Monthly Case File List Report on the 20th of each month that identifies the reconsiderations completed in the previous month. Included in this report there should be a listing of cases, claims, and dispositions completed during the month, the date the cases were received, and the number of claims included, and the date the case was completed and closed in MAS. This case file listing report shall provide the documentation needed to support the cases billed for the month’s activities on the monthly voucher including a reconciliation of claims billed as compared to MAS data for the respective month invoiced. Contractors may only bill for claims that are closed in the MAS. The CMS shall provide additional details regarding this report upon TO award.

All significant CMS ART (or other specified CMS Deliverable System of Record) changes shall be communicated via News/Updates feature of the CMS ART System.

Task 12: Participation in ALJ Hearings as a Participant or Witness

Effective March 20, 2017, several changes were made to the regulations that outline the activities related to QIC participation in ALJ hearings. Under the new regulations, CMS contractors are limited to 3 roles in an ALJ hearing: Participant, Party, or Witness. These changes are outlined in 42 CFR §405.1010 and 42 CFR §405.1012. On November 22, 2017, CMS issued a modification to the AdQIC task order to develop a website that will assist with the coordination of CMS contractors’ participation in ALJ hearings.

This task establishes the minimum requirements related to the DME QIC’s participation and related coordination activities.

Role of the Participant:

Under the revised regulations, 42 CFR Part §405.1010(c)(d)(1)(2)(3), the QIC’s participation as a participant (i.e., non-party) shall be limited to: submitting written testimony and/or position papers.

The regulations do not prohibit multiple CMS contractors and/or related entities from participating in the ALJ hearing as a participant. However, if no contractor or CMS invokes party status, then the first entity to submit their election to participate to the ALJ may participate in the oral hearing (limited to clarification of factual or policy issues, as requested by the ALJ).

All other entities may elect to participate but are precluded from the hearing and may only submit written testimony and/or position papers as indicated above.

Oral participation in a hearing is limited solely to parties (including contractors who are made a secondary party to the hearing through the ‘leave’ process, as described below), and/or witnesses except for situations as described above. Additional information regarding the roles of these entities is described below and in Optional Task 14.

Role of the Party:

Optional Task 14 provides information regarding the party status role and related activities.

Role of the Witness:

If a contractor is precluded from participating as a party in an ALJ hearing, the contractor may submit a request for ‘leave’ to the ALJ. The process in which this shall occur shall be defined at a later date. Further, the request for ‘leave’ process shall occur outside of the AdQIC portal. The ALJ shall make the determination as to whether the contractor is granted ‘leave.’ If this is approved, the contractor shall become a secondary party or participant (e.g., if no contractor or CMS invokes party status) to the hearing. The secondary party or participant (e.g., only for the situation described above) shall have the same rights as the primary party or participant.

The DME QIC shall track and report on the volume of ‘leave’ requests, volume approved, and volume denied. See Optional Task 14 for additional information regarding the role of a party.

If the ALJ declines the request for contractor ‘leave’ on a particular hearing, the contractor may either request to participate as a participant or be called as a ‘witness’ by CMS or another CMS contractor that is a party to the hearing. A determination regarding the need for a ‘witness’ by the participating party shall be determined by the party and communicated to the DME QIC prior to the hearing. The DME QIC shall participate as a ‘witness,’ in any case in which another CMS contractor and/or CMS has requested their support in a hearing. The DME QIC shall notify the party and the CMS COR in rare instance in which the DME QIC is unable to support the party as a ‘witness.’ The DME QIC shall track and report on the number of ALJ cases in which the QIC accepted or declined the request to be called as a witness.

This process and the related roles and responsibilities shall be further defined and outlined in the respective JOAs. As a ‘witness,’ the DME QIC shall be tasked with supporting the party in responding to policy or factual issues related to a particular case through direct examination and is subject to cross examination by the opposing party.

NOTE: Contractors who are interested in acting as a witness may indicate their interest via the AdQIC Portal. CMS contractors may indicate interest in participating as witnesses without first making a request for ‘leave’ with an ALJ. Additionally, in accordance with 42 CFR §405.1020, witness designations/elections shall be made during the coordination of interest/role selection process, as described below, and shall be included in the response to a given Notice of Hearing (NOH). The contractor who is made the party to hearing will be notified via email as to those entities who opted to be a participant and/or witness.

Election of Participation Prior to Receipt of a Formal Notice of Hearing (NOH):

The regulations also allow CMS contractors the opportunity to elect to participate as a participant before issuance and/or receipt of the formal Notice of Hearing (NOH). See section of 42 CFR §4015.1010(b)(1) for additional information. CMS is currently working with the OMHA to further develop this process. Additional guidance regarding this activity shall be provided at a later date. CMS notes that in accordance with the regulations, a position paper or written testimony must be submitted within 14 calendar days of an election to participate, if no hearing has been scheduled, or no later than 5 calendar days prior to the hearing if a hearing is scheduled.

Further, there is a risk that the case may be later resolved by the ALJ or an Attorney Adjudicator within the OMHA without a hearing. If the hearing is later scheduled, the DME QIC will receive the formal notice of hearing and shall follow the guidelines below.

Required Activities Following Receipt of the Formal NOH:

As the AdQIC is tasked with coordinating contractor interest in participation among the related CMS contractors and/or CMS, all NOHs will be sent directly to the AdQIC from the OMHA.

The AdQIC, within 2 calendar days of receipt of the formal NOH from OMHA, shall send an alert, via e-mail, to all applicable CMS contractors notifying them that a hearing has been scheduled. For NOHs received after standard business hours (e.g., 4:00 p.m., ET) and/or during weekends or business holidays, as defined by the respective entity, the AdQIC portal is programmed to calculate the response time beginning with the next applicable business day [e.g., if the AdQIC receives the formal NOH on a Friday at 4:00 pm, the five (5) calendar day timeframe begins on Monday (with Monday being day 0)].

Upon receipt of the formal NOH e-mail alert, the DME QIC shall log in to the AdQIC website, http://participation.q2a.com, to access the NOH information. The DME QIC shall make their election, via the AdQIC website, within five (5) calendar days of the formal NOH e-mail sent date. To make an election, the QIC must sign in onto the AdQIC’s website (see above), and a dashboard will be available listing all appeals for the QIC that they may choose to participate in.

The QIC will also be able to search for appeals based on the information provided in the notification email.

The DME QIC shall then select the applicable NOH and complete/submit the CMS Contractor Participation Form indicating whether they would like to participate as a party, participant, or witness, and/or if they would like to call a witness if made a party to the hearing.

Note: the QIC will not be able to view the actual NOH document on the site. Additionally, the website/dashboard will allow the QIC to view all scheduled hearings for which they receive a

NOH.

NOTE: CMS contractors that fail to sign-in to the AdQIC system and make their respective participation role selections, in the required timeframe, may be precluded from the prioritization process as noted below.

Additionally, if OMHA issues an amended NOH, the amended NOH email will be sent from OMHA directly to the AdQIC. The AdQIC shall alert all applicable CMS contractors of the amended NOH within two (2) calendar days of receipt of the amended NOH email from OMHA. CMS contractor participation roles, as determined in the response to the original NOH and submitted to OMHA via a Notice of Intent (NOI), shall not be modified following the issuance of an amended NOH by OMHA. However, If a CMS contractor wishes to change their method of participation following the receipt of an amended NOH, then the CMS contractor must notify/work with the AdQIC and OMHA, as applicable (e.g., if another CMS contractor was designated as the Party and the QIC was made a non-party Participant, but now the QIC wishes to serve as a Party following the receipt of an amended NOH, then the QIC must request ‘leave’ with the ALJ and notify the AdQIC if the request for ‘leave’ is approved).

AdQIC Coordination of Interest in Hearing Process/CMS Prescribed Prioritization Process:

The AQIC shall coordinate contractor interest in participation among the related CMS contractors and/or CMS. To aid in the coordination of these activities, CMS established the Prescribed Prioritization Process. The CMS Prescribed Prioritization Process is as follows and noted below:

The contractor that issued the claim denial shall have the first/primary opportunity to elect to participate as a party.

CMS will provide additional prioritization guidelines at a later date. However, in the interim, the anticipated prioritization for the role of party status is as follows:

1. Primary opportunity for the ‘party’ role in an ALJ hearing shall be granted to the entity that conducted the initial claim denial (e.g., RAC, or medical review unit within the MAC);

2. If the entity that issued the initial claim denial does not have interest in participating as a party (due to workload considerations or otherwise) the QIC shall have the primary opportunity to participate as a party;

3. If no CMS contractors and/or CMS wish to invoke ‘party’ status in a hearing and multiple entities wish to be a participant, the primary participant (discussion on role noted above) shall be the entity that conducted the initial claim denial (e.g., UPIC, RAC, or medical review unit within the MAC); and,

4. If the entity that identified/conducted the initial claim denial does not wish to be the ‘primary’ participant in the case, the DME QIC shall have the next opportunity to assume this role.

Within two (2) calendar days of receipt of the contractors’ completed CMS Contractor Participation Form, the AdQIC shall review contractor submissions and prioritize role designations, using the CMS prescribed prioritization process. The website will systematically calculate the contractor’s Participation Form response and automatically prioritize participation elections on the next calendar day after the contractor response timeframe expires.

Participation/role designations will be sent via a system-generated email notification. The status of elections for a given NOH will be available on the AdQIC’s website once determinations have been made and notifications have been sent to the applicable CMS contractors.

On rare occasions, the DME QIC may need to facilitate a call with the CMS, the QIC, and the related contractors to determine the roles and/or responsibilities for a particular hearing. The DME QIC shall notify the COR of any issues related to prioritization and/or this process.

Within…