Draft MEDIC SOW.pdf

Attachment 4.2 MEDIC

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MEDICARE DRUG INTEGRITY CONTRACTOR

STATEMENT OF WORK

I. Scope

The Medicare Drug Integrity Contractor (MEDIC), acting as an independent Contractor and not as an agent of the government, 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 MEDIC shall perform fraud, waste, and abuse (FWA) detection, deterrence, and prevention activities for Medicare Part D by focusing primarily on complaint intake and response, data analysis; audits of Medicare Advantage Prescription Drug (MA-PD) plans and Part D Plan Sponsors (PDPs); assessing leads from various sources; investigative actions; administrative remedies; and referrals. The MEDIC shall coordinate with staff from the Centers for Medicare & Medicaid Services (CMS), 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.

II. Purpose of this Contractor

The purpose of the MEDIC is to perform FWA detection and prevention activities to proactively deter fraud, waste, and abuse in Medicare Part D. The MEDIC shall perform their responsibilities under the direction of CMS. The MEDIC shall develop and conduct audits and investigations thoroughly and in a timely manner and take immediate action to ensure that the Medicare Trust Fund is protected. The MEDIC shall use or interact with CMS-required systems as needed in the performance of its functions. Further, the MEDIC shall coordinate its activities not only with CMS, but also with agencies at the federal, state, and local levels of government as well as other CMS partners and contractors.

III. Background

CMS has traditionally used two contractors to carry out program integrity work in Medicare Parts C and D. The Investigations Medicare Drug Integrity Contractor (I-MEDIC) focused on program integrity efforts, and the Plan Program Integrity (PPI)-MEDIC focused on plan audits and Medicare Part C and D analysis. This contract will consolidate the Part D program integrity work previously done by the I-MEDIC and PPI-MEDIC. In the base year, the PPI MEDIC shall transition its Part D work to the MEDIC. At the conclusion of the I-MEDIC contract, the I-MEDIC shall transition its Part D work to the MEDIC. Another contract (XXXXXXXXX, “CPIC”) will consolidate the Part C program integrity work.

A. General Responsibilities

The MEDIC’s primary role is to perform plan audits and provider investigations to detect, prevent, and deter FWA in Medicare Part D. The MEDIC role in Medicare Parts A, B, and C will focus on analysis of data to support and supplement Medicare Part D audits and investigations.

B. Statutes, Regulations, and Documents

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

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

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 Manuals Medicare Manuals

For purposes of this contract, MEDIC shall immediately contact the COR and/or the Contracting Officer (CO) if discrepancies are identified between these sources. The 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.

IV. Tasks

A. Task A: MA-PD and PDP Oversight and Technical Assistance

1. Subtask A1: Program Integrity Focused Audits

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

The MEDIC shall assist CMS in conducting risk assessments to identify plans that may not have an effective FWA program. The MEDIC shall coordinate with various entities throughout the course of an audit in an effort to obtain relevant information. When applicable, such as for audits of MA-PDs, the MEDIC shall coordinate its auditing efforts with other entities, such as the CPIC.

The MEDIC shall develop and update as necessary an audit plan for each audit. The plan shall include the audit methodology and steps and timeframe necessary to meet approved audit objectives. The MEDIC, as directed by CMS, shall accompany CMS to conduct virtual and onsite audits of plans to review documentation and systems related to the risk assessments. This may https://www.ssa.gov/OP_Home/ssact/title18/1893.htm https://www.healthcare.gov/where-can-i-read-the-affordable-care-act/ https://www.govinfo.gov/content/pkg/PLAW-104publ191/pdf/PLAW-104publ191.pdf https://www.congress.gov/108/plaws/publ173/PLAW-108publ173.pdf https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-420 https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-422 https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-423 https://www.cms.gov/medicare/regulations-guidance/manuals include reviewing documentation, systems, and procedures related to investigations, proactive data projects, and potential FWA complaints. The MEDIC shall complete the audit and prepare an audit report including the findings and any recommendations to plan sponsors as a result of the audit.

The MEDIC shall conduct post-audit activities to ensure continual improvement for the PI Focused Audits process (e.g., lessons learned, etc.) and provide a report regarding lessons learned to CMS.

2. Subtask A2: MA-PD and PDP Technical Assistance

The MEDIC shall perform a range of FWA proactive data analysis of Medicare data to support audits of MA-PDs and PDPs. The MEDIC shall analyze the applicable data, including data from multiple health care databases, internal and external to CMS, when performing their work.

Examples of data sources for the work to be performed by the MEDIC can include those listed in Section VI. While awaiting data sources that may not be fully available, the MEDIC shall collaborate with CMS to determine innovative approaches so that the most complete and accurate data possible becomes available to perform data analysis work in pursuit of strong program integrity.

3. Subtask A3: Reports

At CMS’s direction, the MEDIC shall be required to produce data analytics reports to MA-PDs 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 and lists of outlier prescribers or pharmacies. These reports shall include detailed data in table and figure form, long-form 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 MA-PDs and PDPs.

2. Subtask A4: Peer Activity Reports

The MEDIC shall create and manage a provider Peer Activity Report (PAR) project for the Medicare Part D program. PARs compare a 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 for outliers and aberrant behavior.

The MEDIC shall develop potential areas for study and maintain an inventory of these areas for prioritization and risk assessment purposes. The MEDIC shall develop PAR plans, including PAR topics, statistical methodologies, study timeframes, a communication plan, and evaluation methodologies. PAR topics and methodology are subject to change at CMS’ discretion. PAR analyses shall be based on prescription drug event (PDE) data or other data the contractor may have access to. The MEDIC shall communicate PAR results to providers. This communication may include letters, emails, memos etc., created by CMS and the MEDIC. The MEDIC shall be responsible for responding to questions from providers and suppliers about the PARs. When applicable, such as for PARs of certain prescribers, the MEDIC shall coordinate its auditing efforts with other entities, such as the CPIC.

3. Subtask A5: 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 of the Medicare Parts C and D programs. The MEDIC shall identify topics for PSAs based on its work. CMS may, at its discretion, identify topics for PSAs as well. When the MEDIC or CMS identifies an appropriate topic for a PSA, the 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 MEDIC shall draft the PSA, and submit it to CMS for approval and dissemination.

The MEDIC shall be responsible for collecting, tracking, and responding to any inquiries from plan sponsors as a result of PSAs. When applicable, such as for PSAs of certain prescription drugs, the MEDIC shall coordinate its auditing efforts with other entities, such as the MEDIC.

4. Subtask A6: Plan Sponsor Targeted Compliance Notifications

Plan Sponsor Targeted Compliance Notifications (TCNs) are issued by CMS to plan sponsors whose audit results are indicative of noncompliance to CMS-issued guidance. The MEDIC shall identify topics for TCNs based on its work. CMS may, at its discretion, identify topics for TCNs as well. When the MEDIC or CMS identifies an appropriate topic for a TCN, the MEDIC shall provide CMS with a TCN plan, including a description of the issue identified; supporting information, such as audit results; and timeframes for drafting and issuing the TCN. If a TCN plan is approved, the MEDIC shall draft the TCN, submit it to CMS for approval, and if approved, the MEDIC shall disseminate the TCN through PRIS to the plans. The MEDIC shall be responsible for collecting, tracking, and responding to any inquiries from plan sponsors as a result of TCNs.

5. Subtask A7: CMS Part D Plan Correspondence Mailbox

CMS communicates with plans through notification letters or email correspondence. CMS established a Part D Plan Correspondence Mailbox for email inquiries from plans. The MEDIC will be granted access to the Part D Plan Correspondence Mailbox and shall monitor, compile, and log all communication received through the Part D Plan Correspondence Mailbox. The MEDIC shall propose responses to questions from plans and disseminate responses after they have been approved by CMS. The MEDIC shall coordinate with the CPIC as appropriate to ensure any Part C-related communications are appropriately processed.

6. Subtask A8: Medicare Prescription Payment Plan Oversight

Beginning in 2025, 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. The MEDIC shall develop recommendations to monitor program risk and conduct oversight of this program.

Oversight recommendations may include but are not limited to data analysis, education of plan sponsors, and conducting audits of plan sponsors.

7. Subtask A9: Audits

The MEDIC shall create and manage a project to conduct Self and National Audits for the Medicare Part D program. The MEDIC shall identify topics for these audits based on its work.

CMS may, at its discretion, identify topics for these audits as well.

When the MEDIC or CMS identifies an appropriate topic for a Self or National Audit, the MEDIC shall provide CMS with an Audit Plan. The Audit Plan shall contain, at a minimum:

• Audit strategy and timeline;

• Risk assessment;

• Data methodology;

• Return on investment estimate;

• Audit notices to plans;

• Communication plan.

As part of its audit work, the MEDIC shall identify the universe of PDEs to be included in the audit; alert plans to their role in the audits; review pre-validation samples and documentation submitted by plans; conduct validation samples by reviewing audit results submitted by plans; and prepare and provide close out letters and audit report packages, including lessons learned and educational materials, to plans.

During the course of the audits, there may be findings that warrant a referral to the Center for Medicare. The 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 MEDIC shall prepare Plan Sponsor Alerts based on the audit results.

8. Subtask A9.1: Self-Audits

Self-audits are targeted audits that CMS requires plans to conduct on their own PDEs. Targeted audits generally focus on crossover claims (claims that may be billed to Part D as well as Part A/B/C) and other inappropriate Part D coverage concerns. The plan shall conduct any necessary medical review for self-audits.

The MEDIC shall identify topics for these audits based on its work. The MEDIC shall work with CMS to set the parameters (audit review time period, PDE records, etc.) of the self-audit, then will notify the plan to conduct the self-audit. The plan will submit self-audit results to the MEDIC.

CMS and the MEDIC shall work together to validate a sample of the results of the self-audit by reviewing supporting documentation provided by plans. CMS may, at its discretion, provide the MEDIC with existing and previously approved audit topics that shall be reused.

9. Subtask A9.2: National Audits

CMS may conduct a national audit when a specific FWA issue is identified across many plans.

The MEDIC shall identify topics for these audits based on its work. The MEDIC shall request the appropriate documents from plans and shall receive and review documentation. 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.

The MEDIC shall make recommendations on how to maximize the ROI of national audits by implementing strategies such as probe audits and identifying high-risk PDE universes.

10. Subtask A9.3: Return on Investment Report

The MEDIC shall prepare a regular report that calculates the overall return on investment of National and Self-Audits. The assumptions in this report shall be based on actual PDE records related to National and Self-Audits performed. The report shall reflect calculations from the initial amounts identified during the methodology phase of the audit and the actual improper payment amounts determined and recovered at the final stage of the audit.

9. Subtask A10: Education & Outreach

10. Subtask A10.1: National FWA Training

The MEDIC 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 schemes, trends, data analysis, and investigations related to Part D. When appropriate, the MEDIC shall coordinate with the CPIC to incorporate Part C-related information into trainings.

11. Subtask A10.2: Opioid Education Missions

The MEDIC shall host and facilitate periodic Opioid Education Missions to promote collaboration between law enforcement, PDPs, program integrity contractors, and other relevant stakeholders about opioid FWA. Missions may be held in person or via webinar and shall feature the latest schemes, trends, data analyses, and investigations related to opioids.

12. Subtask A11: PI Portal for FWA Reporting Module

The MEDIC shall maintain access to the Health Plan Management System (HPMS) PI Portal for FWA Reporting module. The MEDIC shall, in coordination with the CPIC, develop quarterly reports based on data submitted by plan sponsors to the PI Portal for FWA Reporting module within HPMS. The MEDIC, in coordination with the CPIC, 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; credible evidence of suspicious activities of a provider/supplier of services related to fraud; and 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 and CPIC 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 portal to develop new reports, audits, or other activities to promote program integrity in Part D.

• Perform and participate in user acceptance testing and other meetings as necessary with the HPMS developer and CMS stakeholders.

B. Task B: Part D Investigations and Complaints

1. Subtask B1: Lead Management

The MEDIC shall partner with CMS to identify and prioritize leads for investigation. A lead is an indication that points toward a suspected instance of fraud, waste, or abuse. The MEDIC shall accept leads from a variety of external sources that can include, but are not limited to: the Unified Program Integrity Contractors (UPICs), the Office of Investigations (OIG), Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Assistant United States Attorney (AUSA), the 1- 800-Medicare call center, CMS/, the I-MEDIC, the CPIC, the Medicare Administrative Contractors (MACs), State Medicaid Agency (SMAs), Medicaid Fraud Control Units (MFCUs), Medicare Advantage (MA) Plans, Part D Plans, CMS analytical contractors, Healthcare Fraud Prevention Partnership (HFPP) Trusted Third Party (TTP), fraud alerts, and direct complaints from program beneficiaries and health care providers/suppliers. Additionally, CMS may assign the MEDIC leads based on referrals from other CPI data analytics contractors. The MEDIC may identify leads through proactive and reactive data analysis, coordination with the SMA, CMS, and/or Law Enforcement, and through various sources which may include, but are not limited to, tips and newspaper/internet articles/publications, etc. The MEDIC shall monitor Fraud Prevention System (FPS) to identify Alert Summary Reports (ASR) that warrant further review. If an ASR does not warrant further review, the MEDIC shall indicate in FPS the reason for not reviewing further.

The MEDIC shall develop an administrative protocol, or triage process, that governs the disposition of leads based on the likelihood of fraud, waste, and abuse identification. The protocol shall accurately link screening measures to potential fraud, waste, and abuse risk factors to assure that MEDIC resources are dedicated to leads with the highest likelihood of fraud, waste, and abuse.

The protocol must be flexible to allow the MEDIC and CMS to address evolving fraud, waste, and abuse issues. For requirements of lead management protocols and vetting of leads, please refer to IOM Pub. 100-08.

The MEDIC shall be flexible and shall have the capability to adapt to the changing landscape of fraud, waste, and abuse. The MEDIC shall keep CMS informed as to the highest investigative priorities in such a way as to assure that CMS always has a full understanding of the MEDIC’s highest priorities and how the MEDIC is allocating its resources among these activities.

The MEDIC shall coordinate its lead development efforts with other entities, such as CMS, other CMS contractors, as well as state or Federal agencies, as directed by CMS. Support to CMS FOs and ROs may include, but not be limited to, providing clinical support during field interviews, and collaborating on investigations of specific providers/suppliers.

The Unified Case Management System (UCM) is the official system of record. The MEDIC shall use CMS’ UCM, and when needed for reporting/tracking purposes, the contractor’s internal case management systems, to track all leads unless alternate reporting systems are specified. The UCM allows the MEDIC to enter information about the initiation of a lead, follow its progress, and note specific outcomes.

Should the MEDIC identify a compromised beneficiary and/or provider/supplier number through the lead management process, the MEDIC shall follow the Identity Theft Investigations and Victimized Provider Waiver of Liability Process as outlined in IOM 100-08. The MEDIC is required to report validated compromised Medicare beneficiary and provider numbers, per the definition in IOM 100-08, to the Compromised Number Record (CNR) in UCM. Any reported compromised numbers must meet the IOM 100-08 “compromised number” definition before submission. In addition, any validated compromised number that meets this definition is considered a high risk. Therefore, contractors will no longer use risk or reason codes in the submission of a compromised number.

Should the MEDIC have justification during the Lead Screening stage for referral to Medical Review Board, Pharmacy Review Board, Quality Improvement Organizations (QIO), etc., they shall follow the instructions outlined in IOM Pub. 100-08.

Should the MEDIC identify circumstances that require Immediate Advisement to LE through the Lead Screening stage, they shall follow the process outlined in IOM Pub 100-08.

The MEDIC shall also have adequate foreign language capabilities to handle all communications, to include written documents, with all beneficiaries. For other beneficiary language groups, the MEDIC shall obtain foreign language support service by contract.

Workload Categories

The MEDIC investigative workload shall be split into three categories/origins:

• Stakeholder Identified leads: These leads shall be identified and prioritized through collaboration with a variety of stakeholders. This workload category may also include leads found through Contractor data mining. Other examples of work included in this category may include but is not limited to:

o Contractor-developed data projects, including those that are part of the approved data analysis project management plan;

o Leads found during Contractor data mining and analysis that pertain to local

Medicare and Medicaid issues;

o Leads from external sources or referrals (e.g., complaints) o Law Enforcement referrals;

o Contractor driven innovative approaches.

• CMS generated leads: The MEDIC may receive work directly from CMS in support of program integrity operations and other high priority issues. Examples include but are not limited to:

o Leads that involve urgent matters, such as provider activities that could result in patient harm;

o Congressional inquiries needing expedited analysis;

o Leads developed by other partners that are passed through CMS first (i.e.

TIGER team leads);

o Quality of care concerns.

• Fraud Prevention System leads: The leads prioritized in the FPS include vulnerabilities identified by many sources, including data models, HFPP referrals, and CMS and MEDIC intelligence, among others.

2. Subtask B2: Complaints

The MEDIC shall receive complaints about MA plans and providers via the sources detailed in this section. The MEDIC shall categorize complaints into two category tiers – Level I and Level II. Upon receipt, each complaint shall be placed in the Level I intake category. At Level I, the MEDIC shall determine if the information received is within the scope of FWA for the MEDIC.

Should it be determined that the complaint is not within the scope of FWA, the complaint shall be closed or submitted to the CMS Regional Offices (ROs) as needed.

Should it be determined that the complaint is within the scope of FWA and requires additional review, the MEDIC shall re-categorize the complaint as Level II. During the review of Level II complaints, the MEDIC may review additional (included) documentation, research potential fraud schemes, review previous complaints and billing information, etc.

If a Level II complaint is unable to be resolved, the complaint shall be forwarded for Lead review.

Complaint Triaging and Coordination

The MEDIC shall triage all complaints received from the sources in this section and refer them to the CPIC when appropriate. The CPIC and the MEDIC shall coordinate to resolve and respond to complaints that impact both contractors’ responsibilities.

3. Subtask B2.1 MEDIC Call Center

The MEDIC shall operate a Call Center that shall enable individuals to report potential MA Plan, Part D Plan prescriber, pharmacy, and beneficiary related FWA.

MEDIC Call Center Requirements

The Call Center shall have a toll-free number and be operational Mondays-Fridays from 8am- 6pm Eastern Standard Time, excluding designated Federal and contractor holidays. A voicemail option shall be available for calls received outside these business hours, and such received calls shall, when appropriate, be acknowledged the next business day.

The Call Center shall answer all inbound calls within 30 seconds. The MEDIC shall be able to track workload related to its FWA Call Center, such as the total number of inbound calls, as directed by CMS.

The MEDIC shall also make accommodations so it can communicate with any caller, such as those who are hearing impaired or those who speak languages other than English. If a caller reaches the Call Center and the complaint is not applicable to the MEDIC’s scope of work, the caller shall be referred to the appropriate entity to handle the caller’s complaint. The referral shall be tracked in the MEDIC’s internal system.

MEDIC Complaint Referrals

The MEDIC shall document and maintain a log using its own internal system.

Upon receipt of a new complaint via the MEDIC Call Center, the MEDIC shall review the complaint and, if appropriate, refer it to the CPIC. The MEDIC shall also review the complaint to determine if further screening should occur. The MEDIC complaints team shall resolve or refer the complaint to the MEDIC intake team with 30 calendar days of receipt.

If the MEDIC receives any complaints (or inquiries) that are outside its scope of responsibility, the MEDIC shall refer the complainant to the appropriate entity(ies). The MEDIC shall keep track of where ‘outside scope’ or misrouted complaints are originating from so that further education can be provided and/or the Contracting Officer Representative (CORs)/ Business Function Leads (BFLs) can take action as required.

The contractor shall maintain, and document information obtained from complaints in its own internal system. Any calls indicating potential FWA in Part C on specific providers or suppliers shall be referred as a lead to the CPIC intake team to pursue and document in UCM.

4. Subtask B2.1.1 Call Center Promotion

The contractor shall publicize the toll-free call center number, along with its address and fax number, so that FWA complaints are sent to them. Accordingly, the MEDIC shall, at a minimum, inform the following about its contact information:

• Prescribers, pharmacies, and beneficiaries that the MEDIC has the responsibility to monitor

FWA in Part D. When informing them on how to report potential FWA, the MEDIC should include a model letter approved by CMS.

• CMS contractors that may receive FWA complaints from individuals and entities such as UPICs, MACs, Part D plans, and QIOs.

• Organizations involved with beneficiary advocacy and protection, such as the American Association of Retired Persons, SHIPs, Area Office of Aging, and the SMP. The CMS CORs/BFLs will assist the MEDIC with contacting these organizations since many of these associations partner with CMS.

The contractor shall maintain, and document information obtained from complaints in its own internal system. Any calls indicating potential FWA in Part D on specific prescribers or pharmacies shall be referred as a lead to the MEDIC intake team to pursue and document in UCM.

5. Subtask B2.2 Plan Complaints

The MEDIC receives complaints via the Complaints Tracking Module (CTM) and effective 2022, the Health Plan Management System (HPMS) Program Integrity (PI) Portal.

6. Subtask B2.2.1 Plan Complaints from the CTM

CMS ROs rely upon the Complaints Tracking Module (CTM) to support the effective administration of the Medicare Part C and Part D programs. By using the CTM as a two-way communication system, the MEDIC and CMS ROs can communicate on sensitive matters securely, with the objective of routing beneficiary matters to the appropriate entity for investigation and/or resolution.

Upon receipt of a new complaint, the MEDIC shall review the complaint and, if appropriate, refer it to the CPIC. The MEDIC shall also review the complaint to determine if further screening should occur. The MEDIC complaints team shall resolve or refer the complaint to the MEDIC intake team within 30 calendar days of receipt.

The complaint will be entered into UCM when further investigation is warranted and close the CTM entry with a standard message approved by CMS. If the MEDIC determines that the complaint is not a related to Part D FWA, the MEDIC shall refer the complaint to the appropriate entity.

If the complaint is routed to the MEDIC from the RO via the CTM, the MEDIC shall:

• Check CTM to determine if there are open and/or duplicate complaints. If a duplicate CTM complaint is found and is still open, the MEDIC shall add a note to the complaint that it has determined is not within its purview. Further, the MEDIC complaint shall reference the CTM number(s) of the duplicate complaint(s) when redirecting to the RO.

• Check CTM to determine if the complaint has already been resolved and closed by the RO.

If a duplicate CTM complaint is found and has been resolved/closed by the RO, the MEDIC shall reference the resolved CTM number and mark the complaint as closed. In this instance, the complaint will not be redirected to the RO as it is already closed. Please note that all Congressional inquiries should be forwarded CMS as directed.

The MEDIC shall take the following steps when dealing with a complaint related to a potential Part D Plan prescriber, pharmacy, or beneficiary related FWA when after the screening process it is determined further investigation is warranted:

• Enter the complaint: The MEDIC shall enter all potential FWA complaints and all potential FWA leads into the MEDIC internal Case Management System within five business days of receiving the complaint from the complaints team (If the MEDIC received the complaint via CTM, then it should be noted in the Case Management System that the complaint was received from CTM).

• Acknowledge the Complainant: The MEDIC shall send an acknowledgement letter to the complainant within five business days after initial receipt of the complaint. The letter shall be sent on the MEDIC letterhead and shall contain the SAFERx Hotline telephone number and the Call Center Manager’s name or designee. For complaints that require further investigation, upon referral to the MEDIC intake team, the MEDIC shall log the issuance of this letter into the UCM case notes and upload a copy of the letter. If a case was referred from an entity other than the complainant (e.g., SHIPs or SMPs), the MEDIC shall send the acknowledgement letter to the referring entity and the complainant if the complainant’s contact information is included with the complaint. When sending any information about a complainant to another entity, the MEDIC shall ensure that it is in compliance with all Health Insurance Portability and Accountability Act laws. The contractor is not required to send acknowledgement and resolution letters to CMS staff for complaints originating from

CMS.

• Resolve the Complaint: If the complaint did not require referral to the MEDIC intake team, the MEDIC shall update their internal complaint tracking system with a standard, CMS-approved message within five business days of resolution. If the complaint did require referral to the MEDIC intake team, the MEDIC shall update the MCMS with a standard, CMS-approved message within five business days of the referral. If the complaint requires referral to the MEDIC intake team, the complaint shall be entered into UCM within two business days when further investigation is warranted. The contractor shall also be responsible for sending the complainant a resolution letter within five business days of the resolution of the complaint or investigation.

7. Subtask B2.2.2 Plan Complaints from the HPMS PI Portal

The MEDIC shall receive fraud, waste, and abuse plan complaints via the Health Plan Management System (HPMS) Program Integrity (PI) Portal for review, action, and reporting and refer them to the CPIC as appropriate. Each business day the MEDIC shall download the formal HPMS PI complaint submissions.

Upon receipt of FWA plan complaints, during the initial complaint intake review process within the HPMS PI Portal, the MEDIC can reject the complaint submission by selecting the appropriate rejection option in the HPMS PI Portal and provide a written justification via the HPMS PI Portal without providing a resolution letter upload. This shall only apply if the MEDIC has not provided an acknowledgement letter to the plan. All other complaint submissions that do not receive an initial “not sufficient information” shall be provided an acknowledgment letter and a resolution letter once closed.

When the MEDIC accepts a complaint from the HPMS PI Portal, the MEDIC shall take the following steps:

• Enter the complaint: The MEDIC shall enter all potential FWA complaints into its internal case management system within five business days of receiving the complaint from the HPMS Portal. If the complaint originated from the HPMS PI Portal, the MEDIC shall notate in its internal case management system that the complaint originated from the HPMS PI Portal.

• Acknowledge the Complainant: The MEDIC shall send an acknowledgement letter to the complainant/plan/PBM, via the HPMS PI Portal, within five business days after initial receipt of the complaint. The letter shall be sent on MEDIC letterhead and shall contain the telephone number of the MEDIC complaints manager. For complaints that require further investigation, upon referral to the MEDIC intake team, the MEDIC shall log the issuance of this letter into the UCM case notes and upload a copy of the letter. When sending any information about a complainant to another entity, the MEDIC shall ensure that it is following all Health Insurance Portability and Accountability Act laws.

• Referral of the Complaint to the MEDIC Intake Team: If the complaint requires referral to the MEDIC intake team, the complaint shall be entered into UCM within two business days when further investigation is warranted. If the complaint originated in the HPMS PI Portal, it shall be notated in the UCM that the complaint originated in the HPMS PI Portal.

• Resolve the Complaint: If the complaint did not require referral to the MEDIC intake team, the MEDIC shall update its internal case management system with a standard, CMS-approved message within five business days of resolution. If the complaint does require referral to the MEDIC intake team, the MEDIC shall update its internal case management system with a standard, CMS-approved message within five business days of the referral.

The contractor shall also be responsible for sending the complainant a resolution letter within five business days of the resolution of the complaint or investigation.

The MEDIC complaints team shall resolve or refer the complaint to the MEDIC intake team within 30 calendar days of receipt.

If the MEDIC determines that the complaint is not related to Part D FWA, the MEDIC shall refer the complaint to the appropriate entity.

8. Subtask B3: Investigations

The MEDIC shall investigate suspected instances of fraud, waste, and abuse involving Medicare providers, suppliers, prescribers, and other entities receiving reimbursement under the Medicare programs. The MEDIC shall open approved investigations with the highest priority of potential fraud, waste, and abuse. The MEDIC shall investigate to determine the facts and the magnitude of the alleged fraud.

The MEDIC shall conduct a variety of activities to substantiate the allegations during the course of an investigation. Examples of activities that may be appropriate can be found in IOM Pub.100-

8. The MEDIC is not restricted to these activities and will determine the appropriate methods based on the nature of the allegation and the facts that are uncovered.

The MEDIC shall coordinate with various entities throughout the course of an investigation, in an effort to obtain relevant case information and/or data. When applicable, the MEDIC shall coordinate its investigative efforts with other entities, such as CMS ROs, other CMS contractors, as well as state or Federal agencies, as directed by CMS. There may be situations where OIG/OI or other law enforcement agencies might recommend that administrative actions are postponed or not pursued as not to disrupt an active case. The MEDIC shall refer such requests, with any correspondence from law enforcement to CMS. CMS will provide direction to the MEDIC, after discussion with law enforcement.

Prior to conducting large scale onsite and/or “boots on the ground” initiatives, the MEDIC may be requested to prepare an Onsite Concept of Operations document in accordance with the Deliverables Schedule and attachment J.4 Onsite Concept of Operations. The purpose of this document is to provide CMS a detailed overview of the proposed onsite initiative(s), providers involved, allegation(s) and dollars at risk, etc.

For additional investigations requirements, please refer to IOM Pub. 100-08.

As part of the MEDIC’s investigative process (regardless of the source of the complaint), the contractor shall, as appropriate, reach out to the MA plan (42 CFR §§ 422.504(i)(2)(i)) or Part D sponsor (423.505(i)(2)(i)) to determine if they have requested and received medical records from the provider and request a copy of the records to assist in developing the investigation. In addition, if an MA plan (42 CFR §§ 422.504(i)(2)(ii)) or Part D sponsor (423.505(i)(2)(ii)) does not have the requested records, the MEDIC may request records directly from the provider. Prior to requesting records directly from a provider, the MEDIC shall make proper notification to the MA plan (42 CFR §§ 422.504(i)(2)(iii)) or Part D sponsor (423.505(i)(2)(iii)). Findings from record reviews could be used to revoke the subject based on abusive prescribing and other possible revocation authorities. If the MEDIC determines that it is not appropriate to request medical records from the plan sponsors, it shall document its reasoning in UCM. If the MEDIC requests records from a prescriber, pharmacy, or plan sponsor, and the prescriber, pharmacy, or plan sponsor declines to provide the requested record(s), the MEDIC shall, within two business days, inform its BFL(s) and COR, as prescribers, pharmacies, and plan sponsors are not required to provide records to MEDIC.

The UCM is the official system of record. The MEDIC shall use CMS’s UCM, and when needed for reporting/tracking purposes, the contractor’s internal case management systems, to track all investigative functions, with the exception of medical review (the UPIC shall solely use UCM to track Medical Review outcomes). The UCM allows the MEDIC to enter information about the initiation of an investigation, follow its progress, and note specific outcomes.

Should the MEDIC identify a compromised beneficiary or provider/supplier number through the investigation process, the MEDIC shall follow the Identity Theft Investigations and Victimized Provider Waiver of Liability Process as outlined in IOM 100-08. The MEDIC is required to report validated compromised Medicare beneficiary and provider numbers, per the definition in IOM 100-08, to the CNR in UCM. Any reported compromised numbers must meet the IOM 100-08 “compromised number” definition before submission. In addition, any validated compromised number that meets this definition is considered a high risk. Therefore, contractors will no longer use risk or reason codes in the submission of a compromised number.

The MEDIC shall also have adequate foreign language capabilities to handle all communications, to include written documents, with all beneficiaries. The MEDIC may obtain foreign language support service by contract.

Monitoring Provider/Supplier Compliance

The MEDIC shall follow the guidance as outlined in IOM 100-08 when re-reviewing a provider at least 6 months after the MEDIC has closed its investigation to ensure the propriety of future payments.

Investigation Coordination

The CPIC and the MEDIC shall coordinate to conduct investigations that impact both contractors’ responsibilities.

Planning Requirements

The MEDIC shall notate and continuously update in the UCM an investigative plan of action for each investigation.

The plan shall include the steps and timeframe necessary to meet investigative objectives.

Immediate Advisements to LE

Should the MEDIC identify circumstances that require Immediate Advisement to LE, they shall follow the process outlined in IOM 100-08.

MEDIC Case Coordination with CMS and LE

The MEDIC shall refer to IOM Pub. 100-08 regarding the Case Coordination process.

Recommending Administrative Action(s)

A range of administrative actions, as referenced in IOM 100-08 and in accordance with the appropriate federal/state regulations and statutes, are to be supported, developed and recommended by the MEDIC to the appropriate federal or state authority include, but are not limited to, the following:

• Medicare enrollment revocations

• Medicare and Medicaid program exclusions

The MEDIC shall conduct a peer-to-peer review for Revocation Authority (a)(14) according to the Revocation and Deactivation Policy Document. The MEDIC shall consult with their BFLs during their regularly scheduled calls prior to submitting proposed revocations for Revocation Authority (a)(14).

The MEDIC shall support CMS in identifying innovative approaches to implementing administrative actions based on the authorities available to CMS. Additionally, the MEDIC shall be prepared to support additional administrative actions as Congress provides additional program integrity statutory authorities to CMS.

Referring Requirements

The following outlines the MEDIC’s referring requirements:

• Referral to CMS, State Medicaid Agency, and LE: The MEDIC shall refer recommendations for appropriate action to CMS, MFCU, State Medicaid Agency (when appropriate), and/or LE in accordance with SOW Section 4.4.5 MEDIC Case Coordination with CMS, LE, and State Medicaid Agencies, and IOM Pub. 100-08.

Once a referred investigation has been accepted by OIG/OI or other LE entity, the MEDIC, after consultation with LE, may inform the complainant within five business days that the investigation has been referred and that further requests concerning the matter should be referred to the appropriate LE entity. However, some cases may be sensitive, and, in those cases, the complainant is not to be informed of the referral to LE. The MEDIC shall contact the appropriate LE agency before responding to the complainant to determine if the case is a sensitive one.

When the MEDIC decides that a referral to any agency (federal, state, etc.) other than OIG/OI and FBI is warranted, it shall seek direction from the BFLs.

• Referral of Quality of Care Issues: The MEDIC shall refer suspected instances of apparent unethical or improper practices or unprofessional conduct (e.g., quality of care issues) to the appropriate entity in accordance with the timeframes identified in IOM 100-08.

Investigation Timeframes

The MEDIC shall initiate any appropriate administrative action, referral or closure within 210 calendar days, unless otherwise specified by CMS.

Closing Investigations

The MEDIC shall close investigations in accordance with IOM 100-08.

9. Subtask B3.1 Investigation Data Analysis

The MEDIC shall refer to IOM Pub. 100-08 regarding data analysis activities that are to be conducted during the investigative process.

10. Subtask B3.2 Medical Review

The MEDIC is authorized to conduct medical reviews (in accordance with 42 U.S.C. 1395ddd (b)(1) and 42 U.S.C.§ 1396U–6). The MEDIC shall provide medical review (MR) in support of an investigation to determine the appropriateness and medical necessity of the services in question.

Whenever performing complex coverage or coding reviews (i.e., reviews involving the medical record), the MEDIC shall assure that coverage/medical necessity determinations are made by Registered Nurses (RN) or therapists and that coding determinations are made by certified coders or clinicians with approved coding credentials. When necessary, these reviews will include determinations of medical necessity by licensed practitioner(s), as required by state rules and regulations. The MEDIC shall comply with all National Coverage Determinations (NCDs), Coverage Provisions in Interpretive Manuals, national coverage and coding articles, local coverage determinations (LCDs) (formerly called local medical review policies (LMRPs), and local coverage/coding articles.

11. Subtask BX.3 Appeals

The MEDIC shall support appeals, potentially including additional reviews, related to Medicare revocations, in accordance with IOM Pub. 100-08. The MEDIC shall provide testimony in specific cases when requested. In the case of Medicare appeals, this support includes participating in Administrative Law Judge (ALJ) hearings in the Civil Remedies Division with participant status, Departmental Appeals Board Appellate Division hearings, Federal District Court cases and possible appeals of the district court’s decision. The MEDIC shall also support appeals of judgements or convictions related to Medicare law enforcement activities. Additionally, the MEDIC shall support any reviews relating to settlement agreements or compliance initiatives resulting from MEDIC investigations.

The MEDIC’s activities may include, but are not limited to, the following:

• Participating in teleconferences with State and Federal partners;

• Maintaining documents and related work papers in support of the investigative findings in the UCM;

• Providing position papers or documents to support the appeal;

• Cooperate with the State and Federal partners and respond to their request for information to support the appeal;

• Providing required witnesses as necessary for deposition, hearing, explain the findings, subject of the investigation or other proceedings; and

• Participating and testifying in the deposition, hearing, or other proceedings.

V. Functional Requirements

The MEDIC shall perform various tasks to support its oversight and investigation of Part D plans and providers, including data analysis, reporting, and supporting various stakeholders that work to safeguard CMS program integrity.

A. Incoming Transition/Implementation Requirements

The MEDIC shall work with the outgoing contractor to transition all fraud and abuse detection and prevention information, documents, data, and activities. As part of the transition period, the MEDIC shall immediately coordinate with the outgoing contractor regarding workload inventory and identified risks/challenges, conduct a kick-off meeting, and submit deliverables in accordance with the MEDIC SOW requirements. The MEDIC shall lead regular transition meetings with CMS, the outgoing contractor, and the appropriate contractors/stakeholders and maintain minutes from those meetings.