PPI MEDIC- DRAFT SOW-SSN-Final.pdf

Plan Program Integrity Medicare Drug Integrity Contractor (PPI MEDIC)

STATEMENT OF WORK

Table of Contents 1 Scope

1.1 Background and Purpose

1.2 Statutes, Regulations, and Documents ............................................................. Error! Bookmark not defined.

1.3 Retention & Destruction of Records

2 Tasks

2.1 Reports

2.2 Peer Activity Reports (PARs)

2.3 Plan Sponsor Alerts

2.4 CMS Medicare Parts C and D Plan Correspondence Mailboxes

2.5 Medicare Prescription Payment Oversight

2.6 Audits

2.6.1 Improper Payment Audits……………………………………………………………………………..……8

2.6.1.1 Self-Audit

2.6.1.2 National Audits

2.6.2 Program Integrity (PI) Audits

2.6.3 Ad hoc Audits…………………………………………………….……………………………………….10

2.6.3.1 Part C Oversight Audits…...…………………………………………………………………………….10

2.6.4 Return on Investment (ROI) Report……………………………………………………………………….11

2.7 Audit Protocols……………………………………………………………………………………………..11

2.8 Outreach and Education

2.8.1 National FWA Training

2.8.2 Outreach and Education Missions

2.9 PI Portal for FWA Reporting Module

3 Functional Requirements

3.1 Incoming Transition/Implementation Requirements

3.1.1 Kickoff Meeting with CMS

3.1.2 Transition Meetings

3.1.3 Implementation Status Report……………………………………………………………………………15

3.2 Outgoing Transition Requirements

4 PI Support Requests………………………………………………………………………………………………. 16

4.1 Requests for Information from Outside Entities

4.2 Requests for Assistance from Outside Entities

4.3 Congressional Inquiries

4.4 Freedom of Information Act (FOIA) Requests

4.5 Other PI Support and Requests

4.5.1 Requests from CMS

4.5.2 Other Requests from Outside Agencies and/or Entities

5 CMS Systems and Data Support ………………………………………………………………………………… 17

5.1 Fraud Prevention System (FPS)

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

5.3 Other

5.4 Datasets, Systems, and Sources

5.4.1 CMS Provided Datasets and Systems

5.4.2 Integrated Data Repository (IDR)

5.4.3 One Program Integrity (OnePI)

5.4.4 Payment Recovery Information System (PRIS) Medicare Part C & D Plan Portal (PMPP)

5.4.5 Unified Case Management System (UCM)

5.4.6 Health Plan Management System (HPMS)

5.5 Examples of Medicare Data Sources

5.5.1 Primary Sources of Data

5.5.2 Secondary Sources of Data

5.6 CMS Systems Roster

6 Administrative Requirements

6.1 Key Personnel Requirements

6.2 Joint Operating Agreements (JOA)

6.3 Contractor Training

6.4 Stakeholder Education

6.5 System User Groups

6.6 Foreign Language Capabilities

6.7 CPAR Self-Assessment

6.8 Software Compatibility

7 Reporting

7.1 Audit Activity Project Management Report

7.2 Monthly Status Reports

7.3 Audit Issues Log

7.4 FOIA Reports

7.5 Workload & Cost Reporting

7.6 Annual Lessons Learned Reports

7.7 Program Vulnerability Reports

7.8 Ad-Hoc Requests

8 Meetings, Workgroups, and Conferences

8.1 Bi-Weekly Status Meetings

8.2 Monthly I-MEDIC and PPI MEDIC Coordination Meetings

8.3 Ad hoc Meetings

8.4 Annual PI Meeting

8.5 Durable Medical Equipment (DME) Coordination Meeting

8.6 All Other Conferences

9 Stakeholder Coordination and Communication

9.1 Appropriate CMS Staff

9.2 Other Medicare Parts C and D Program Integrity Contractors

9.3 OnePI and the IDR

9.4 Unified Program Integrity Contractors (UPICs)

9.5 Participation in User Groups

9.6 Working with Other Medicare Organizations

9.7 Office of Inspector General

9.8 Department of Justice

9.9 Federal Bureau of Investigation

9.10 Law Enforcement Health Care Task Forces

9.11 State Licensure of Agents and Brokers

9.12 State and Local Licensure and Enforcement Agencies

9.13 Professional Societies

9.14 Quality Improvement Organizations

9.15 Private Health Plans

9.16 Other Federal, State, & Local Agencies

9.17 Data Analysis Coordination

9.18 Other Contractors

10 Systems and IT Requirements

1 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.

1.1 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.

1.2 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:

Acts, Regulations, and Manuals Section Medicare Integrity Program Section 1893 of the Social Security

Act Patient Protection and Affordable Care Act and Health Care and Education Reconciliation Act

Full text

Health Insurance Portability and Accountability Act Full text Medicare Prescription Drug, Improvement, and Modernization Act

Full text

Substance Use-Disorder Prevention that Promotes Opioids Recovery and Treatment for Patients and Communities Act

Full Text

Inflation Reduction Act Full Text Medicare Program Integrity Regulations 42 CFR Part 420 Medicare Advantage Program Regulations 42 CFR Part 422 Medicare Prescription Drug Benefit Regulations 42 CFR Part 423 Medicare Internet Only Manuals Pub. #100-08; #100-16; #100-18 about:blank about:blank about:blank about:blank https://www.congress.gov/bill/115th-congress/house-bill/6/text https://www.congress.gov/bill/117th-congress/house-bill/5376/text about:blank

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.

1.3 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.

2 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.

2.1 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.

2.2 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).

2.3 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.

2.4 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.

2.5 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.

2.6 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.

2.6.1 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.

2.6.2 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.

2.6.3 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.

2.6.4 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.

2.7 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.

2.8 Outreach and Education

2.8.1 National FWA Training

The PPI MEDIC and CMS shall host and facilitate 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.

2.8.2 Outreach and Education Missions

The PPI MEDIC and CMS shall host and facilitate 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.

2.9 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:

o 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 o 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.

o 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 o The information is to be anonymized in the monthly report without identifying the source of the information o Any other pertinent information

The PPI MEDIC shall:

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

o Payment suspensions resulting from credible allegations of fraud;

o Information on investigations;

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

o Other actions taken by the plan sponsors related to inappropriate prescribing of opioids; and o Referrals of substantiated and suspicious activities of a provider/supplier of services related to FWA.

• Develop quarterly reports for the plan sponsors:

o 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.

o 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:

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

o Were subject of an active exclusion, payment suspension, or active revocation; and o 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).

3 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.

3.1 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:

• 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 Section 10.

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

• Hiring (as applicable) and training staff.

• Conducting validation and discussion between the incumbent PPI MEDIC and 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.

3.1.1 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.

3.1.2 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.

3.1.3 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.

3.2 Outgoing Transition Requirements

The outgoing PPI MEDIC shall work with the incoming contractor to transition all fraud and abuse detection and prevention information, documents, data, and activities. The outgoing PPI MEDIC shall begin the three month transition-out after the end date of the final period of performance. The outgoing PPI MEDIC will be expected during this time to complete all deliverables associated with the outgoing 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 outgoing PPI MEDIC shall assist the incoming contractor with transition activities, provide training, attend the incoming contractor’s Kick-Off Meeting (if needed), transition meetings, 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 implementation. 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 transition period shall be three months. In a successful transition:

• Validation and discussion shall be had between the incoming and outgoing contractors regarding the outgoing contractor’s 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.

4 PI Support Requests

4.1 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 case management 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.

4.2 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 case management 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.

4.3 Congressional Inquiries

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

4.4 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.

4.5 Other PI Support and Requests

4.5.1 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.

4.5.2 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.

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

5.1 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.

5.2 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.

5.3 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 integrity work.

5.4 Datasets, Systems, and Sources

5.4.1 CMS Provided Datasets and Systems

The PPI MEDIC shall interact with and utilize a robust CMS dataset and CMS-provided IT toolset as directed by CMS to perform its work rather than developing its own proprietary systems and datasets. In general, the PPI MEDIC shall be prepared to use any standard interfaces available in CMS systems to avoid duplication of information and data entry and to ensure the ease of accessibility of all information during contract performance.

A list of CMS primary systems and datasets is below. This list is not exhaustive.

5.4.2 Integrated Data Repository (IDR)

The PPI MEDIC shall access and use the Integrated Data Repository Cloud henceforth referred to as the IDR; CMS’s data warehouse for claims and related reference information to perform tasks associated with FWA prevention and detection. It provides a single national view of timely and integrated Medicare claims; encounter data; provider/supplier, beneficiary, and related data as well as the capability to import, store, and manipulate Medicaid claims, Transformed Medicaid Statistical Information System (T-MSIS) data, and provider/supplier, prescriber, beneficiary, and related data.

5.4.3 One Program Integrity (OnePI) Portal

The PPI MEDIC shall use the One PI portal, which includes Analytical Data Marts (ADMs) and a centralized suite of robust business intelligence and modeling tools for fighting FWA.

The system allows for cross program analysis with harmonized data, simplifying comparisons of data from multiple data sources.

One PI includes the following tools to access data in the IDR:

• Business Objects (BO) https://www.cms.gov/tra/Data_Management/DM_0080_IDRC_Cloud.htm

• Statistical Analysis Software (SAS) Tools

• Snowflake

• Databricks

• STARSInformant

5.4.4 Payment Recovery Information System Medicare Parts C & D Plan Portal

(PMPP)

PMPP is a web-based application that houses Medicare Parts C and D programs’ oversight, including but not limited to, audit information conducted by CPI. The PMPP application is also a tool used to conduct the Medicare Parts C and D programs’ audits and serves as a communication and document delivery tool for plan sponsors. The PPI MEDIC shall utilize this system for all audit materials, other communications, and activities as specified by

CMS.

5.4.5 Unified Case Management System (UCM)

The UCM is a government-owned workflow management, electronic case file system that aligns with the CMS strategy to implement a coordinated approach to support cooperation and efficiency between jurisdictional program integrity contractors while ensuring implementation of a national approach to address FWA trends that cut across jurisdictions.

The UCM system eliminates duplicate systems and tracking, increases the accuracy and transparency in reporting workload, and provides CMS/CPI with direct access to allow for oversight of each contractor’s work.

The UCM system is accessible through the secure CMS enterprise portal and incorporates a central repository to track all leads and investigations to improve Medicare and Medicaid FWA analysis and resolution.

5.4.6 Health Plan Management System (HPMS)

The PPI MEDIC shall maintain access to the HPMS and all modules that will be required for all program integrity work.

5.5 Examples of Medicare Data Sources

5.5.1 Primary Sources of Data

The contractor will need to access the following primary sources of data (this is not an all-inclusive list):

• The Medicare Part B Extract Summary System is an online, menu-driven query system that enables users to access data files and extract Medicare Part B claims information.

• The Health Care Customer Information System (HCIS) provides over 400 pre-set summaries for Home Health Agency, Skilled Nursing Facility, Hospice, Inpatient, Outpatient, Physician, Durable Medical Equipment (DME), Clinical Labs, Non- Physician Practitioner, Ambulance, and Enrollment data. The HCIS also utilizes a “point and click” function that allows users to gain access to the summarized data.

The user can easily perform a limited set of functions with these views/reports, such as sorting, trending, and mapping.

• The Medicare Beneficiary Database (MBD) is the single, central, authoritative repository for beneficiary demographic and entitlement data, including low-income subsidy information and eligibility information.

• The National Claims History Database is the central repository for Medicare Parts A and B data at CMS.

• HPMS contains the following information:

o General contract and plan data – This consists of general information about

MA-PD and PDP organizations and plans, such as contract information, service areas, plan types, website addresses, customer service hours and numbers, risk type, etc.

o Formularies – This consists of plan formularies that detail the drugs to be covered, their tiers, if prior authorization or step therapies are required, etc.

o Bids – This consists of the detailed Medicare Parts C & D plan benefit packages as well as the corresponding bid information for each plan.

o Performance monitoring reporting – This consists of routine reporting requirements in support of oversight. Possible reporting elements include performance measures, rebate reporting, and utilization summaries.

o The Complaint Tracking Module (CTM) – This module houses some Medicare Parts C & D beneficiary complaints.

o The PI Portal for FWA Reporting Module – This module was developed for MAOs, including MA-PD and stand-alone Prescription Drug Plans (PDPs) to report certain information to CMS in accordance with CMS 4190-F2.

o AICE-FWA Module – This module was developed for Medicare Parts C & D stakeholders to provide leads for possible investigations, share actions taken on providers and pharmacies suspected of FWA activity, as well as generate reports on high-risk providers and pharmacies.

o HPMS List Servs for Medicare Parts C and D programs

• Medispan, National Council for Prescription Drug Plans (NCPDP), and First

Databank – The contractor should assume that it will obtain access to these systems independently from the government and should prepare for any licensing fees accordingly\.

• Medicare Advantage Prescription Drug System (MARx) – This system contains premium information, and former Part C Medicare Managed Care System data.

MARx also maintains a master file of MA and MA-PD members for enrollment, accounting and payment control. The MARx system provides information for Medicare coverage determinations of renal (kidney) transplants to Medicare Part D plans.

• Eligibility and Enrollment Medicare Online (ELMO) - This system is CMS’s authoritative source of Medicare enrollment information that identifies each person entitled to Medicare benefits. ELMO adds newly enrolled beneficiaries each month and provides notification changes to other Medicare systems.

• Additional Beneficiary Information Initiatives (ABII) – This is a web portal that provides information on coordination of benefits for enrollees in a Medicare Part D

Plan. ABII provides two report types on the web portal: the Medicare-Covered Transplant Beneficiaries File and the Outpatient Dialysis Facility File.

• IDR – The IDR is a data warehouse that includes Medicare Parts A, B, C, D, and DME claims as well as beneficiary and provider data.

• Management Integrated Information Repository (MIIR) – This is a database which integrates key systems for Medicare Part D, including PDE,…