J.1 - PPI MEDIC- Statement of Work.docx

Plan Program Integrity Medicare Drug Integrity Contractor (PPI MEDIC) Attachment J.1

STATEMENT OF WORK

Table of Contents

2.6.1.3.1 First Level of Appeal (Reconsideration) ………………………………………………………. 10

Appendix A- Deliverables Schedule…………………………………………………………………………………..37 Appendix B- Information Security Requirements…………………………………………………………………….43 Appendix C- 508 Compliance Requirements…………………………………………………………………………58

Scope

The Plan Program Integrity Medicare Drug Integrity Contractor (PPI MEDIC), acting as an independent contractor and not as an agent of the government, shall perform fraud, waste and abuse (FWA) detection, deterrence, and prevention activities for Medicare Parts C and D programs. The PPI MEDIC shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the government, as needed to perform the work described in this Statement of Work (SOW). The PPI MEDIC’s work includes data analyses; audits and reviews of Medicare Advantage Organizations (MAOs) and Prescription Drug Plans (PDPs), outreach and education, and referrals to law enforcement and other appropriate entities. The PPI MEDIC shall coordinate with staff from the Centers for Medicare & Medicaid Services (CMS), other CMS contractors, and other stakeholders as needed and as directed by the CMS Contracting Officer’s Representative (COR), in collaboration with Business Function Leads (BFL), to perform this program integrity work.

Background and Purpose

The PPI MEDIC serves as a national contractor responsible for providing oversight of the Medicare Parts C and D programs to ensure the protection of the Medicare Trust Fund. CMS seeks to contract with an external entity to support CMS audits and program integrity oversight activities related to fraud, waste, and abuse efforts within the Medicare Parts C and D programs.

The purpose of this effort is to support CMS’s strategy in maintaining and strengthening program integrity for Medicare Parts C and D programs by monitoring and addressing program vulnerabilities, risks and ensuring plan sponsors’ adherence to regulatory requirements. Technical assistance is necessary to assist the Agency in executing its oversight responsibilities. CMS has historically used the PPI MEDIC for Medicare Parts C and D plan sponsor oversight, including audits, outreach and education, and data analysis.

Statutes, Regulations, and Documents

The PPI MEDIC shall perform the requirements of this contract in accordance with applicable federal and state laws, regulations, Medicare Internet Only manuals (Pub. #100-08; #100-16; #100 18), and CMS requirement documents to assure the integrity of the Medicare Parts C and D programs. The following is a non-exhaustive list of the applicable documents:

For purposes of this contract, the PPI MEDIC shall immediately contact the COR and/or the Contracting Officer (CO) if discrepancies are identified among these sources. The PPI MEDIC shall identify any budgetary concerns that may occur as a result of any conflict. Moreover, in accordance with CMS policy, the Contractor cannot assert clinical review judgment to override, supersede, or disregard a Medicare policy requirement.

Retention and Destruction of Records

The PPI MEDIC is required to retain all records for 10 years. Records that are not under active litigation or negotiation shall be destroyed 10 years after the record is submitted and are cut off annually. The PPI MEDIC is authorized to return records or certify destruction of documents after 10 years. Files that need to be returned to CMS will need to be coordinated with the COR and Records Retention office.

Tasks

The PPI MEDIC shall perform a range of FWA proactive data analysis of Medicare data to support oversight of MAOs and PDPs. The PPI MEDIC shall analyze the applicable data, including data from multiple health care databases that are both internal and external to CMS, when performing their work. While awaiting data sources that may not be fully available, the PPI MEDIC shall collaborate with CMS to determine innovative approaches, to ensure the most complete and accurate data becomes available to perform data analysis work in pursuit of strong program integrity. This requirement applies to all of the following tasks.

Reports

At CMS’s direction, the PPI MEDIC shall be required to produce data analytics reports to MAOs and PDPs to assist plan sponsors in their FWA efforts. These reports shall educate plan sponsors about aberrant billing and other information related to the data analysis projects. Proactive data analysis reports can include such topics as utilization trends for certain high-risk drugs, items, or services, and lists of outlier prescribers or pharmacies. These reports shall include detailed data in table and figure format, long-format descriptions of what the data is showing, a discussion of whether these trends may relate to larger industry developments (e.g., new technologies or drugs), and instructions for appropriate use of the data by the MAOs and PDPs.

Peer Activity Reports (PARs)

The PPI MEDIC shall create and manage PARs for the Medicare Parts C and D programs. The PARs compare a plan sponsor’s, prescriber’s, or pharmacy’s utilization trends and payment patterns for various drug categories or services to their peers on a city, county, state, and national level. The goal of PARs is to help CMS and its partners, plan sponsors and their first-tier, downstream, and related entities analyze claims and other data related to outliers and other aberrant behavior and to educate the identified outliers on these patterns. The PPI MEDIC shall develop potential areas for study and maintain an inventory of these areas for prioritization and risk assessment purposes. The PPI MEDIC shall develop PAR strategy, including PAR topics, statistical methodologies, study timeframes, a communication plan, and evaluation methodologies. The PAR topics and methodology are subject to change at CMS’s discretion. PAR analyses shall be based on Medicare data or other data sources available to the Contractor. The PPI MEDIC shall communicate PAR results to plan sponsors/providers/suppliers. This communication may include letters, emails, memos etc., created by CMS and the PPI MEDIC. The PPI MEDIC shall be responsible for responding to questions from plan sponsors, providers, and suppliers about the PARs. When applicable, the PPI MEDIC shall coordinate its auditing efforts with other entities, such as the Investigations Medicare Drug Integrity Contractor (I-MEDIC).

Plan Sponsor Alerts

Plan Sponsor Alerts (PSAs) are issued by CMS to plan sponsors when trends have been identified that may be associated with FWA in the Medicare Parts C and D programs. The PPI MEDIC shall identify topics for PSAs based on its work. CMS may, at its discretion, identify topics for PSAs as well. When the PPI MEDIC or CMS identifies an appropriate topic for a PSA, the PPI MEDIC shall provide CMS with a PSA plan, including a description of the issue identified; supporting information, such as data analyses; and timeframes for drafting and issuing the PSA. If a PSA plan is approved, the PPI MEDIC shall draft the PSA and submit it to CMS for approval and dissemination. The PPI MEDIC shall be responsible for collecting, tracking, and responding to any inquiries from plan sponsors as a result of PSAs. When applicable, the PPI MEDIC shall coordinate its efforts with other entities, such as the I-MEDIC.

CMS Medicare Parts C and D Plan Correspondence Mailboxes

CMS communicates with plans through notification letters or email correspondence. CMS established a separate Parts C and D Plan Correspondence Mailbox for email inquiries from plans. The PPI MEDIC will be granted access to the Medicare Parts C and D Plan Correspondence Mailboxes and shall monitor, compile, and log all communication received. The PPI MEDIC shall develop draft responses to frequently asked questions (FAQs), propose responses for CMS review and approval, and disseminate CMS-approved responses to plan sponsors as directed. The PPI MEDIC shall ensure that any Medicare Parts C and D related communications are appropriately processed through each mailbox.

Medicare Prescription Payment Oversight

MA-PDs and PDPs are required to offer enrollees the option to pay out-of-pocket prescription drug costs in the form of capped monthly installment payments in accordance with provisions found at CMS-4208-F. The PPI MEDIC shall develop and provide CMS with recommendations, audit strategies, and data analytic methodologies to monitor program risk, identify potential vulnerabilities, and conduct oversight of this program. These activities may include but are not limited to data analysis, education, conducting audits of plan sponsors, and developing methodologies for recovering overpayments.

Audits

The PPI MEDIC shall create and manage a project from inception to completion for conducting Self-Audits, National Audits, Program Integrity (PI) Audits, and Ad hoc audits for the Medicare Parts C and D programs. The PPI MEDIC shall identify topics and methodologies for these audits based on its work. CMS may, at its discretion, identify topics and methodologies for these audits as well.

The PPI MEDIC shall provide plan sponsors with audit findings including observations and promising practices. The PPI MEDIC shall, when applicable, draft Plan Sponsor Remedy Action Plans (RAPs) and Corrective Action Plans (CAPs) to be issued by CMS to plan sponsors whose audit results are indicative of noncompliance to CMS-issued guidance. The PPI MEDIC shall draft the RAP/CAP, submit it to CMS for approval, and if approved, the PPI MEDIC shall disseminate the RAP/CAP through the Payment Recovery Information System Medicare Parts C & D Plan Portal (PMPP) to the plans. The PPI MEDIC shall be responsible for collecting, tracking, and responding to any inquiries from plan sponsors as a result of RAPs/CAPs.

Part C Encounter record and Part D Prescription Drug Event Record Review Audits When the PPI MEDIC or CMS identifies a potential topic for a Self-Audit, National Audit, PI Audit, or Part C Oversight Audit, the PPI MEDIC shall provide CMS with a high-level overview including but not limited to:

· Topic Description

· How the topic was identified

· Policy concern including all applicable CMS policies or regulations

· Estimated financial exposure (when applicable)

· Estimated return on investment (ROI) (when applicable)

· Any identified enhancements to the audit methodology, including sampling and extrapolation, to be used

All topics require approval by CMS and require the PPI MEDIC to provide a presentation and conduct a walkthrough to applicable CMS staff.

Once an audit is approved by CMS, the PPI MEDIC shall develop an Audit Plan. The Audit Plan shall contain, at a minimum:

· Audit strategy and timeline

· Risk assessment

· Data methodology (when applicable)

· Estimated ROI (when applicable)

· Any identified enhancements to the audit methodology, including sampling and extrapolation, to be used

As part of its audit work, the PPI MEDIC shall identify the universe(s) of PDE records or encounter data records to be included in the audit; prepare and provide the audit notification package; alert plans to their role in the audits; review documentation submitted by plans; and prepare and provide close out letters and audit report packages, including lessons learned and educational materials to plans.

The PPI MEDIC shall make every effort to maximize audit ROI, when applicable, and conduct all audits in a manner that prioritizes program integrity concerns before the full audit is conducted. This includes the identification, by the PPI MEDIC or CMS, of potential new innovative approaches and higher ROI for Medicare Part D audits.

During the course of the audits, there may be findings that warrant a referral to the Center for Medicare (CM). The PPI MEDIC shall work with CMS to set the parameters of when such findings rise to the level to warrant such a referral. As appropriate, the PPI MEDIC shall prepare PSAs based on the audit results.

2.6.1.1 Self-Audits

Self-Audits are targeted audits in which CMS require plans to conduct reviews on their own PDE records or encounter records. These audits generally focus on potentially improper Medicare Parts C and Part D payments that have not been paid in accordance with CMS regulations.

The PPI MEDIC shall identify topics for these audits based on its work. The PPI MEDIC shall work with CMS to set the parameters (audit review period, PDE records, encounter record exclusions, etc.) of the Self-Audit. The PPI MEDIC and CMS shall provide plan sponsors with a file containing potentially improper PDE records or encounter records identified through the audit methodology and will meet with the plan to ensure the plan sponsor understands the audit process and expectations. The PPI MEDIC and CMS will notify the plan sponsor to conduct the Self-Audit after the webinar, pre-validation phase, and virtual meetings with the plan sponsor.

The plan will submit Self-Audit results to the PPI MEDIC. CMS and the PPI MEDIC shall work together to validate a sample of the results of the Self-Audit by reviewing plan sponsors documentation to support coverage under Medicare Parts C and D benefits. The PPI MEDIC will prepare and provide close-out materials and perform PDE record deletion check(s) in the IDR. CMS may, at its discretion, provide the PPI MEDIC with existing and previously approved audit topics that shall be reused.

2.6.1.2 National Audits

CMS may conduct a National Audit for audit topics identified across multiple Part D plan sponsors. These may include, but are not limited to, FWA issues that pose a risk of beneficiary harm, drugs with a high likelihood of improper billing, are high-dollar drugs, or are high risk drugs.

The PPI MEDIC shall identify topics for these audits based on its work. The PPI MEDIC shall work with CMS to set the parameters (audit review period, PDE record exclusions, sampling and extrapolation approaches, as appropriate, etc.) of the National Audit. The PPI MEDIC and CMS shall provide plan sponsors with a file containing potentially improper PDE records based on the audit methodology. The PPI MEDIC and CMS shall request documentation from plans to support payment under the Medicare Part D program. The PPI MEDIC and CMS will review the plans documentation to determine if the PDE record(s) in question was paid properly under the Medicare program.

The PPI MEDIC will prepare and provide close-out materials and perform PDE record deletion check(s). After a National Audit, an analysis may be conducted on the contracts included in the audit to identify plan sponsors whose patterns are indicative of noncompliance with statutory regulations or CMS-issued guidance related to the audit. Additional analysis may be performed on plan sponsors identified as an outlier from a previous iteration of a National Audit.

2.6.1.3 Appeals (When approved to proceed by CMS)

CMS is authorized to evaluate, through audit, inspection, or other means, the appropriateness of services furnished to Medicare enrollees under a Part D contract. See Social Security Act (“Act”) §§ 1860D-2(d), 1893; 42 C.F.R. § 423.505(e). Consistent with this authority, CMS, through CPI, conducts PDE record review audits that identify improper PDE records paid under the Part D benefit; this includes identifying instances where a drug, item, or service does not meet the definition of a covered Part D drug under Section 1860D-2(e) of the Act.

As part of these audits (which CMS refers to as “Part D program integrity PDE record review audits”), CMS identifies PDE records that it believes are potentially improper and plan sponsors submit supporting documentation to rebut this finding. If CMS determines, based on a review of documentation, that Medicare Part D rules and regulations were not met and therefore the PDE is improper, CMS notifies the Part D plan sponsor to submit PDE deletion or adjustment records for the associated record(s). The deleted PDE records ultimately result in a savings to the Medicare Trust Fund.

Previously, Part D plan sponsors did not have the opportunity to dispute these determinations outside of the audit process itself. However, as outlined in proposed rulemaking (CMS-4212-P), CMS is establishing the following three-level appeals process for Part D program integrity PDE record review audits:

· First Level of Appeal: Reconsideration (42 C.F.R. § 423.2605);

· Second Level of Appeal: Hearing Official Review (42 C.F.R. § 423.2610); and

· Third Level of Appeal: Administrator Review (42 C.F.R. § 423.2615).

CMS anticipates these regulations will be finalized as proposed later this year.

2.6.1.3.1 First Level of Appeal (Reconsideration)

The Contractor shall conduct the first level of appeal (Reconsideration), in accordance with 42 C.F.R. § 423.2605.

Performance of the first level of appeal includes:

1. The Contractor shall establish and maintain a Medicare Part D appeals team responsible for reviewing reconsideration requests and making reconsideration determinations that is independent of the Medicare Part D audit team/function.

1. The Contractor shall ensure that the Medicare Part D appeals team is:

1. Organizationally and operationally separate from the Medicare Part D audit team, including a separate supervisory chain of command; and

2. Not involved in the original audit, audit findings, or audit determination process.

2. The Contractor shall develop, implement, and maintain written policies and procedures that:

1. Define and enforce independence between audit and appeal functions; and

2. Identify and mitigate actual or perceived conflicts of interest, including prohibitions on financial, performance, or incentive-based compensation tied to audit findings or appeal outcomes.

2. The Contractor shall establish a process and work within a CMS designated system to receive reconsideration requests when Plan Sponsors are informed of a determination that a PDE record(s) is improper. Requests may be received through electronic mail and/or an electronic system.

3. The Contractor shall review reconsideration requests and conduct appeals in accordance with all applicable regulatory requirements and timelines established at 42 C.F.R. Part 423, Subpart Z.

4. The Contractor will work within the CMS designated system to ensure that reconsideration requests are timely filed (within 60 calendar days from the date of the audit close out letter received by the Plan Sponsor).

1. The Contractor shall establish an exceptions process for the 60-day filing deadline in cases where a Plan Sponsor can demonstrate “good cause” for missing the deadline. In coordination with CMS, the Contractor shall develop examples and standards for when good cause may be demonstrated.

5. The Contractor shall establish rules for ensuring that reconsideration requests meet the requirements of 42 C.F.R. § 423.2605(a) and (b) and involve appealable issues under 42 C.F.R. § 423.2600. The Contractor shall also establish a process for dismissing appeals that do not meet these requirements (including timeliness) or do not involve appealable issues.

6. The Contractor shall establish a process and will work within a CMS designated system to receive rebuttals submitted by CMS, including ensuring that any CMS rebuttal is timely submitted.

7. The Contractor shall establish a process for reviewing all materials pertinent to an appeal, including the close-out letter/demand for submission of a PDE record deletion or adjustment records, the evidence and findings upon which it was based, and any argument and evidence submitted by the Plan Sponsor or by CMS.

8. The Contractor shall establish a process for deciding reconsideration appeals within 60 calendar days after the timeframe for filing a rebuttal has expired.

9. The Contractor will notify the Plan Sponsor and CMS of the reconsideration determination, within 60 calendar days after the timeframe of filing a rebuttal. The determination must be in writing and must contain an explanation of the reasoning for the decision. The Contractor’s determination must also inform the Plan Sponsor of additional appeal rights, if applicable.

2.6.1.3.2 Appeal Support to CMS (All Appeal Levels)

The Contractor shall provide support to CMS at all three levels of appeal resulting from Part D program integrity PDE record review audits, including: (1) Reconsideration; (2) Hearing Official Review; and (3) Administrator Review. This support shall be provided by the Medicare Part D audit team that performed the audit under appeal.

Provision of support for all levels of appeals will include:

1. The Contractor shall establish a process and utilize a CMS designated system for reviewing first-, second-, and third-level appeal submissions and supporting documentation.

2. The Contractor shall prepare written responses or clarifications to support and/or explain audit methodology, findings, and determination(s), as requested by CMS. Additionally, the Contractor shall prepare any rebuttal requested by CMS.

3. The Contractor shall revise audit findings and reissue audit results, as directed by CMS or as required based on a decision at the first, second, or third level of appeal.

4. The Contractor shall provide testimony or subject matter expert support at hearings to address contested audit findings, as requested by CMS.

5. The Contractor shall maintain independence between the Medicare Part D appeals team by ensuring the Medicare Part D audit team is organizationally and operationally separate from the appeals function, including the supervisory chain of command.

In accordance with these tasks, the Contractor shall provide the following deliverables:

1. The completed process for the performance of the first level of appeal (Reconsideration).

2. The completed process for the provision of support to CMS at the first, second, and third levels of appeal.

Program Integrity (PI) Audits

MAOs and PDP plan sponsors shall adopt and implement an effective compliance program, and shall include measures that prevent, detect, and correct FWA in accordance with 42 CFR §§ 422.503 and 423.504. The PPI MEDIC shall develop and conduct audits of MAOs and PDPs to ensure they are complying with statutes, federal regulations and sub-regulatory guidance regarding their FWA efforts and appropriately identifying and responding to program integrity risks. At CMS’s discretion, the PPI MEDIC shall address other program integrity risks identified by CMS using PI Audits.

The PPI MEDIC shall assist CMS in conducting risk assessments to identify plans that may not have an effective FWA program. The PPI MEDIC shall coordinate with various entities throughout the course of an audit to obtain relevant information. The PPI MEDIC shall develop and update as necessary an audit plan for each audit. The plan shall include the audit methodology and timeline necessary to meet approved audit objectives. The PPI MEDIC, as directed by CMS, shall accompany CMS to conduct virtual and onsite audits of plans to review documentation and systems related to risk assessments. This may include reviewing documentation, systems, and procedures related to investigations, proactive data projects, potential FWA complaints, requests for information (RFIs), referrals, and effective compliance with reporting requirements for the Health Plan Management System (HPMS) PI Portal. The PPI MEDIC shall complete the audit and prepare an audit report including the findings, observations, and promising practices identified during the audit, recommendations to plan sponsors, and recommendations to CMS for enhanced regulatory requirements to address deficiencies that could not be addressed during the audit. The PPI MEDIC shall conduct post-audit activities to ensure continual improvement.

Ad hoc Audits

2.6.3.1 Part C Oversight Audits

As new fraud, waste, and abuse schemes and trends evolve in Part C, CMS may identify other ad hoc Part C Oversight Audits that are necessary to protect the Trust Funds. CMS will identify the topic areas of these audits and work with the PPI MEDIC to develop an audit methodology; sampling and extrapolation approach, as appropriate; and any other processes/documents needed for the audit.

For example, the Office of Inspector General (OIG) conducts audits on High-Risk Diagnosis Codes on certain MAO contracts. CMS monitors plan sponsors’ implementation of recommendations as a result of these reports. The OIG also conducts evaluations to examine the MAO’s use of chart reviews and health risk assessments in risk adjustment. The PPI MEDIC shall develop a strategy to include processes and procedures to assess MAO compliance with OIG audit and evaluation recommendations. Additionally, the contractor shall ensure the MAOs have taken the appropriate steps (e.g., audits and desk review) to close the OIG recommendations and develop standard correspondence with the identified MAOs to document CMS approved findings and conclusions. The PPI MEDIC may also be required, at the direction of CMS, to conduct additional audits or other oversight activities of MAOs that are identified as at high-risk of risk adjustment overpayments.

CMS will inform the PPI MEDIC of additional ad hoc Part C Oversight Audits that may be necessary.

ROI Report The PPI MEDIC shall prepare a quarterly report (see Deliverable Schedule) that calculates the overall return on investment of recovery audits (e.g. National Audits and Self -Audits). The assumptions in this report shall be based on actual PDE records or encounter records related to audits performed that identify improper payments.

The report shall reflect calculations from the initial amounts identified during the methodology phase of the audit and the actual improper payment amounts (All-payer and Medicare only) determined and recovered at the final stage of the audit.

Audit Protocols

The PPI MEDIC shall develop audit protocols for plan sponsors that encompass each audit conducted by CMS. The protocols shall include, but are not limited to, the CMS audit authority, the purpose of the audit, audit methodologies, key milestones/steps, audit instructions, and audit expectations.

Outreach and Education

National FWA Training

The PPI MEDIC and CMS shall host, facilitate, and moderate designated sessions and panels during FWA trainings to educate and promote collaboration between law enforcement, plan sponsors, program integrity contractors, and other relevant stakeholders. The trainings shall feature the latest fraud schemes, trends, data analysis, and investigations related to Medicare Parts C and D programs.

Outreach and Education Missions

The PPI MEDIC and CMS shall host, facilitate, and moderate periodic Outreach and Education Missions to promote collaboration between law enforcement, plan sponsors program integrity contractors, and other relevant stakeholders about specific FWA topics. Missions may be held in person or via webinar and shall feature the latest schemes, trends, data analyses, and investigations related to the topic.

PI Portal for FWA Reporting Module

The I-MEDIC shall develop monthly reports based on data submitted by plan sponsors to the PI Portal for FWA Reporting module within HPMS. The PPI MEDIC shall develop quarterly reports (see Deliverable Schedule) based on the I-MEDIC monthly reports.

The I-MEDIC shall provide the monthly report which includes the following:

Information based on the complaints received through the HPMS FWA Reporting module including:

Total number of complaint submissions received broken out by each of the following reporting categories:

1. Opioid prescribing

2. Part D payment suspensions implemented by plans

3. Substantiated and suspicious activities of FWA FWA schemes and trends in identifying suspicious activities, including (1) administrative actions, (2) pertinent information related to opioid overprescribing and (3) any other data deemed appropriate.

1. Trends shall include, but not be limited to, graphs, charts, and tables as necessary to show the breakdown of complaints received by trend including, but not limited to, allegation, description, totals, and percentages.

2. Schemes shall include, but not be limited to, graphs, charts and tables as necessary to convey specific schemes that fall within the trends each month. These schemes should include the name of the scheme and a high-level description that includes pertinent details of the scheme that will assist plan sponsors with their own FWA efforts.

A listing of all names, National Provider Identifiers (NPI), organization type, date of submission, and allegation of providers and pharmacies that have been reported in the HPMS FWA Reporting module, broken out by each of the following reporting categories:

1. Opioid prescribing

2. Part D payment suspensions implemented by plans

3. Substantiated and suspicious activities of FWA The information is to be anonymized in the monthly report without identifying the source of the information Any other pertinent information

The PPI MEDIC shall:

· Review the data submitted by plan sponsors to the PI Portal for FWA Reporting module, including:

· Payment suspensions resulting from credible allegations of fraud;

· Information on investigations;

· Credible evidence of suspicious activities of a provider/supplier of services related to fraud;

· Other actions taken by the plan sponsors related to inappropriate prescribing of opioids; and

· Referrals of substantiated and suspicious activities of a provider/supplier of services related to FWA.

· Develop quarterly reports for the plan sponsors:

· Each report must include anonymized information submitted by the plans (as to not identify the source of the information) to the FWA Reporting module, including (1) information on FWA schemes and trends in identifying suspicious activities, (2) administrative actions taken, (3) pertinent information related to opioid overprescribing, and (4) any other data deemed appropriate.

· The reports will be provided to the plan sponsors no later than April 15th, July 15th, October 15th, and January 15th of each year based on the information in the FWA Reporting module, respectively, as of the preceding October 1 through December 31, January 1 through March 31, April 1 through June 30, and July 1 through September 30.

· Assist CMS with providing to the plan sponsors, through the FWA Reporting module, all providers/suppliers that:

· Have been referred by the plan sponsors to the FWA Reporting module in the previous 12-month period;

· Were subject of an active exclusion, payment suspension, or active revocation; and

· Have been referred by the plan sponsors to the FWA Reporting module and are subject of an administrative action.

· Coordinate with the I-MEDIC when appropriate.

· Incorporate reviewed data and fraud schemes and trends, when appropriate, in new data analysis reports and future audits.

· Use the data in the PI portal to develop new reports, audits, or other activities to promote program integrity in the Medicare Parts C and D programs.

· Perform and participate in user acceptance testing (UAT), business requirements development, and other meetings as necessary with the HPMS developer and CMS stakeholders.

The PPI MEDIC and I-MEDIC shall detail this communication and collaboration as it relates to this task in their Joint Operating Agreement (JOA).

Functional Requirements

The PPI MEDIC shall perform various tasks to support its oversight of the Medicare Parts C and D programs’ plans and providers, including data analysis, reporting, and supporting various stakeholders that work to safeguard CMS program integrity.

Incoming Transition Requirements

The PPI MEDIC shall work with the outgoing contractor to transition all fraud and abuse detection and prevention information, documents, data, and activities, during the three-month transition-in period. As part of the transition period, the PPI MEDIC shall immediately coordinate with the outgoing contractor regarding workload inventory and identified risks/challenges, conduct a virtual Kick-Off Meeting, and submit deliverables in accordance with the PPI MEDIC SOW requirements. The PPI MEDIC shall lead regular transition/ implementation meetings with CMS, the outgoing contractor, appropriate contractors/stakeholders, and maintain minutes from those meetings. All meeting minutes shall be provided to CMS within three business days of the meeting date.

The outgoing contractor shall remain in effect during the three-month transition period to assist the incoming PPI MEDIC with transition activities and any operational issues that may be encountered. The Outgoing contractor shall be responsible for the completion of all deliverables associated with the outgoing contract, which have due dates within the three-month transition period. The incoming PPI MEDIC shall be responsible for all new workload assigned as of the start date of the contract and will be responsible for the completion of all deliverables associated with the outgoing contract, which have due dates beyond the three-month transition period.

The PPI MEDIC shall perform the tasks required to successfully implement program integrity operations, including transition of operations from the outgoing contractor to the incoming PPI MEDIC including:

· All persons seeking logical access will be required to submit to vetting and be appropriately credentialed prior to gaining logical access to CMS information and information systems. Immediately after the award, all PPI MEDIC personnel shall begin the security onboarding process to gain access to the CMS network and officially start working. The PPI MEDIC shall follow the Identity and Credentialing Tool (ICT) New Users Guide to complete the security onboarding for each individual seeking access. No person seeking access may begin working under this contract until all security requirements have been properly completed and approved.

· Establishing connectivity and participating in training sessions (as needed) and other appropriate systems as defined in Sections 5 and 6.

· Entering into a Data Use Agreement (DUA) with CMS, as referenced in Section5.4.2.

· Working with entities listed in Section 6 on establishing JOAs.

· Hiring (as applicable) and training staff.

· Conducting validation and discussion with the outgoing contractor regarding the outgoing contractor’s Outgoing Transition Plan, to include what workload shall remain open and be transitioned and what shall be closed.

· Receiving all appropriate data, files, and information from the outgoing contractor. The PPI MEDIC shall verify that all files and information have been received and are in a usable format.

· Ensuring minimal disruption to program integrity partner operations (e.g., Law Enforcement, prescribers/providers/suppliers, etc.).

· Keeping all interested parties informed of the transition’s status and progress.

· Ensuring transition resources are effectively and efficiently used, and transition activities are completed on schedule.

Kickoff Meeting with CMS

CMS will arrange a virtual Kickoff Meeting with the PPI MEDIC within a mutually agreed upon timeframe after the contract award. The purpose of the Kick-Off Meeting is to review and answer any questions that the PPI MEDIC has about the contract and to ensure that both the PPI MEDIC and CMS have a joint understanding of all work, timeframes, and deliverables required by the contract. The PPI MEDIC will work with CMS to compile the agenda for this meeting. The PPI MEDIC shall be prepared to provide CMS with a brief presentation outlining the PPI MEDIC’s ideas for completing the requirements of the contract. The PPI MEDIC is responsible for preparing minutes from the meeting and submitting them to CMS in accordance with the Deliverables Schedule.

Transition/ Implementation Meetings

The PPI MEDIC shall organize, host, and provide toll-free telecommunication lines and facilities for all implementation meetings. The meetings will be virtual and shall follow a prepared agenda and discuss the status of the major tasks, issues, deliverables, schedule, delays, problem resolution, and risk mitigation and contingencies. These meetings shall be held no less than every week, or more frequently if needed during the transition/ implementation period. These meetings shall include CMS representatives and all relevant stakeholders.

The PPI MEDIC shall document and submit to CMS the meeting minutes of each implementation meeting conducted within three business days of the meeting. The PPI MEDIC shall also maintain a transition issues log.

Implementation Status Report

The PPI MEDIC shall report on the status of the implementation in accordance with the Deliverables Schedule, to include the following basic work elements:

· Project Management - This element includes organizing project staff and work groups, preparing the various plans required by CMS, conducting meetings, monitoring and reporting progress, issue/problem resolution, managing costs, and managing risk.

· Communications - Activities include communicating with program integrity partners and all other participants and stakeholders on the project to ensure all are informed of the transition, its status, progress, and how changes may affect them.

· Program Integrity Operations - This element involves activities associated with preparing, maintaining, or closing down the business environment. Tasks include preparing operational activities, due diligence, asset inventory, and interaction with other organizations involved in the transition.

· Resources/Infrastructure - Activities include personnel activities, and the preparation of facilities and associated infrastructure.

· Workload/Records Transfer - This area includes file preparation, storage, and the activities associated with the actual cutover of program integrity operations and transfer of files.

Outgoing Transition Requirements

The PPI MEDIC shall work with the incoming contractor to transition all fraud and abuse detection and prevention information, documents, data, and activities. During the transition-out, the PPI MEDIC will be expected to complete all deliverables associated with the current contract, which have due dates within the three-month transition period, while also meeting the below transition out activities. As part of the transition period, the PPI MEDIC shall assist the incoming contractor with transition activities, provide training, and submit deliverables in accordance with the PPI MEDIC SOW requirements. The incoming contractor shall be responsible for maintaining minutes from the transition meetings.

The incoming contractor shall assume operational responsibilities at the beginning of the transition period. The incoming PPI MEDIC shall be responsible for all new workload assigned as of the start date of the transition period and will be responsible for the completion of all deliverables associated with the outgoing contract, which have due dates beyond the three-month transition period.

The transition period shall be three months. In a successful transition:

· Validation and discussion shall be had between the incoming and PPI MEDIC regarding the Outgoing Transition Plan, to include what workload shall remain open and be transitioned and what shall be closed.

· All appropriate data, files, and information are transferred and made accessible to the incoming contractor.

· There is minimal disruption to program integrity partner operations (e.g., States, Law Enforcement, and providers/suppliers).

· There is minimal disruption of ongoing audits, reports, and other work outlined in this SOW.

· All interested parties are kept informed of the transition’s status and progress.

· Transition resources are effectively and efficiently used, and transition activities are completed on schedule.

The PPI MEDIC shall develop, execute, and maintain the Outgoing Transition Plan Document, which includes a detailed description of all activities required to transfer all operations. This plan shall include any risks as well as mitigation and contingency planning where appropriate. This shall serve as a project management tool for the PPI MEDIC to successfully transition the program and for CMS to effectively oversee the transition and implementation.

The Outgoing Transition Plan Document shall be submitted in accordance with the Deliverables Schedule.

PI Support Requests

Requests for Information from Outside Entities

The PPI MEDIC shall document all RFIs from Law Enforcement and outside entities in the UCM System, and when needed for reporting/tracking purposes, the Contractor’s internal tracking systems. The PPI MEDIC shall thoroughly document the details regarding the requestor, the nature of the request, any intervention by the CMS COR team, any modifications to the request, and the cost of furnishing the request.

To be in full compliance with the Privacy Act, the PPI MEDIC must receive all RFIs in writing and must satisfy the requirements of the disclosure provision. However, subsequent requests for the same provider/supplier that are within the scope of the initial request do not have to be in writing. The PPI MEDIC shall refer requests that raise Privacy Act concerns and/or issues to the CMS COR team for further consideration.

Requests for Assistance from Outside Entities

The PPI MEDIC shall document all requests for assistance from Law Enforcement and outside entities in the UCM System, and when needed for reporting/tracking purposes, the contractor’s internal tracking systems. The PPI MEDIC shall thoroughly document the details regarding the requestor, nature of the request, any intervention by the CMS COR team, any modifications to the request, and the cost of furnishing the request. As directed by CMS, the PPI MEDIC shall be prepared to serve as the lead for investigations or provide subject matter expertise and/or testimony based on the needs of CMS and law enforcement including the U.S. Department of Justice (DOJ) and the OIG. The PPI MEDIC shall follow up with the requestor to determine if the assistance provided satisfies the request.

Congressional Inquiries

The PPI MEDIC shall resolve and respond to Congressional Inquiries that impact the PPI MEDIC’s responsibilities within the specified requested timeframe.

Freedom of Information Act (FOIA) Requests

The PPI MEDIC shall resolve and respond to FOIA requests that impact the Contractor’s responsibilities within the specified requested timeframe.

Other PI Support and Requests

Requests from CMS

The PPI MEDIC shall provide responses to all CMS inquiries as they relate to tasks set forth in this SOW. Examples may include, but are not limited to, UCM look-ups, providing information related to a previous investigation, etc.

Other Requests from Outside Agencies and/or Entities

As directed by CMS, the PPI MEDIC shall comply with federal, state, and local subpoenas and requests that are directly related to the work outlined in this SOW.

The PPI MEDIC shall assist with requests and/or PI related tasks for all entities the PPI MEDIC coordinates with, at the direction of CMS.

Any federal, state, and/or local support requests that are received by the PPI MEDIC shall be approved by CMS prior to the PPI MEDIC fulfilling.

The PPI MEDIC shall assist with litigation holds and shall have a process to log all cases/files for which CMS/Office of the General Counsel (OGC) has issued. This log shall include at a minimum, documentation of the date received, and the status of the litigation hold; current, revised, and/or lifted. Litigation Holds remain in effect until expressly advised by CMS/OGC that it has been lifted. The PPI MEDIC shall submit verification by submitting a copy of the log and an attestation statement/document that the Litigation Hold log is current and accurate to the COR in accordance with the Deliverables Schedule.

CMS Systems and Data Support

The PPI MEDIC shall support CMS systems and data through the execution of various tasks.

Fraud Prevention System (FPS)

The PPI MEDIC shall utilize FPS when compiling quarterly reports to identify if the lead was additionally identified in FPS. The PPI MEDIC shall attend meetings as required and perform other activities related to FPS as directed by CMS.

HPMS Analytics and Investigations Collaboration Environment for Fraud, Waste and Abuse (AICE-FWA) Module

The AICE-FWA Module was developed to enable and assist plan sponsors, CMS, Law Enforcement, state regulators, Program Integrity Contractors, and other stakeholders in identifying, investigating and reporting potential fraud, waste and abuse. The module is utilized as a lead source for potential investigations and allows plans to report actions taken against providers and pharmacies of suspected FWA. It also supports the generation of reports that identify high-risk providers and pharmacies.

The PPI MEDIC shall review and provide feedback during the development of AICE-FWA project models. The PPI MEDIC shall also provide subject matter expertise to ensure project models accurately reflect Medicare Parts C and Part D policies.

Other

When requested by CMS, the PPI MEDIC shall provide testing for potential enhanced data or data from sources that are unfamiliar to the Medicare perspective, and update and/or adjust previously run analytics based upon the availability of improved source data or more state-of-the-art analysis techniques.

When data required to perform necessary functions cannot be found in the Integrated Data Repository (IDR) or via One Program Integrity (OnePI), the PPI MEDIC shall offer a strategy for obtaining and analyzing data to continue the performance of their program…