Draft_PWS_1.pdf

Contents SECTION 1: Audit – Medicare Parts A, B, D and Medicaid (OAS) SECTION 2: Audit – Medicare Part C (OAS) SECTION 3: Evaluations and Inspections (OEI)

SECTION 4: OFFICE OF INVESTIGATIONS (OI)

SECTION 5: OFFICE OF COUNSEL TO THE INSPECTOR GENERAL (OCIG)

Performance Work Statement (PWS)

SECTION 1: Audit – Medicare Parts A, B, D and Medicaid

1.0 Background

The Office of Inspector General’s (OIG’s) mission is to provide objective oversight to promote the economy, efficiency, effectiveness, and integrity of Health and Human Services (HHS) programs, as well as the health and welfare of the people they serve. Since its establishment, OIG has been at the forefront of the nation’s efforts to fight waste, fraud, and abuse in Medicare, Medicaid, and more than 100 other HHS programs.

To carry out its mission, OIG conducts oversight activities, including audits, evaluations, and investigations. OIG is authorized to conduct audits, investigations and inspections of HHS programs and operations by the Inspector General Act of 1978, as amended, and exercises independence and discretion in doing so. OIG also conducts audits specifically mandated by Acts of Congress. Audits examine the performance of HHS programs and/or its grantees and contractors in carrying out their respective responsibilities and are intended to provide independent assessments of HHS programs and operations. These audits help reduce waste, abuse, and mismanagement and promote economy and efficiency throughout HHS. To carry out our mission, OIG’s work may require obtaining consultative services and medical record review to determine whether payments met program requirements. Reports containing the results of medical record review are typically publicly released and available on the OIG’s website. OIG conducts its work in accordance with Government Auditing Standards issued by the Comptroller General of the United States; the Single Audit Act Amendments of 1996; applicable Office of Management and Budget circulars; and other legal, regulatory, and administrative requirements.

This section of the PWS outlines the requirements to provide successful and acceptable Medical Record Review support and Consultation Services and for the HHS OIG/Office of Audit Services, Medicare Parts A, B, D and Medicaid.

1.1 Scope

The scope of the resulting contract will include medical review and consultative services associated with the oversight activities of the OIG primarily involving Medicare Fee-For-Service (FFS) payments. Occasionally, it may include assessment of services and claims for Medicaid or Medicare Part D. Based on prior experience, the resulting contract(s) will require medical review of approximately 100 to 200 claims and associated medical records per audit and approximately 1,500 claims and associated medical records per annum (approximately 15 audits per year), but actual workload under the resulting contract(s) could fluctuate based on potential future changes in OIG’s budget, shifts in OIG’s priorities, and other factors. In addition to these expected audits, OIG may request medical review and/or consultative services in support of a small number of evaluations.

The scope of the resulting contract will not include determining OIG priorities; identifying auditees and subject matter of audits; claims sampling; and establishing audit objectives, scope, and methodology; however, OIG may in its discretion ask for input on these matters as part of consultative services (see Section 4.0, Consultative Services). OIG will collect claims data, medical records, and other supporting documents in accordance with each audit’s objectives.

OIG will transmit those documents electronically through its secure file transfer system or, occasionally, in hard copy through the U.S. Postal Service or other parcel delivery service. The Medical Review Contractor (the Contractor) shall participate in discussions with the OIG (e.g., the Contracting Officer Representative (COR), OIG Team, or other OIG officials), the Centers for Medicare & Medicaid Services (CMS), Medicare Administrative Contractors (MACs), other CMS contractors, and OIG auditees, as necessary.

1.2 Specific Tasks

The OIG requires tasks to be completed in accordance with the deliverables schedule of this PWS as listed below.

1.3 Deliverables

There are 2 types of deliverables OIG has specified in this section of the PWS: (1) Task Order (TO) deliverables, Section 1.3.2 and (2) Consult Service Deliverables, Section 1.3.3. The TO and consultant service deliverables establish the workflow and timeline for key deliverables for a specific task order or consultative needs. These schedules also list the recipients for each deliverable, including the COR, OIG Team, the Contractor’s Project Director (PD), and the Contracting Officer (CO). All deliverables shall be timely, accurate, legible, and complete.

When a deliverable is scheduled on a Federal Holiday, the deliverable will become due the next working day following the holiday. The Contractor shall comply with the PWS required timeframes in Section 1.3, Deliverables, hereby incorporated by reference, unless otherwise altered as follows:

1.3.2 Task Order (TO) Deliverables

Deliverable No. Description Recipient Required Timeframe

2.0 Determine Complexity

Level COR/OIG Team Before TO Issuance

3.1 Kick-off Meeting COR/OIG Team

To be scheduled no later than 7 days1 after TO award date

3.2 Kick-off Meeting Minutes COR/OIG Team Provided no later than 7 days after kick-off meeting

1.4 Period of Performance

(POP) instrument COR/OIG Team No later than 7 days after

TO award date

3.4.a Medical Review Instrument (MRI) – Initial Draft COR/OIG Team

No later than 14-28 days after TO kick-off meeting, depending on complexity

1 References to days refers to calendar days.

3.4.b MRI – OIG Review PD 21 days

3.4.c MRI – Contractor Revisions COR/OIG Team 7-14 days depends on complexity of revisions

3.4.d MRI – Final Approval PD 7-14 days upon receipt of revisions

1.4 Documentation

Completeness Review COR/OIG Team

Starts upon delivery of medical records. Provide results to OIG in 7-14 days

3.5 Initial Review Results

Letters (RRLs) COR/OIG Team

Starts upon Final Acceptance of MRI & receipt of applicable medical records. 7-14 days to produce products

3.5.a Initial RRL - OIG Review PD 7-14 days

3.5.b Initial RRL - Contractor Revisions COR/OIG Team 7-14 days depends on complexity of revisions

3.5.c Initial RRLs - Finalized COR/OIG Team 5 days upon OAS acceptance of RRLs

3.5.1 Remaining RRLs COR/OIG Team

Starts after acceptance of the initial RRLs. 30-60 days to produce products depending on number of claims.

3.5.1.a Remaining RRL - OIG Review PD The OIG will provide feedback within 7-14 days

3.5.1.b Remaining RRL - Contractor Revisions COR/OIG Team 7-14 days depends on complexity of revisions

3.5.1.c Remaining RRLs- Finalized COR/OIG Team 5 days upon OAS acceptance of RRLs

3.6 Preliminary Results

Provided to Entity PD No later than 21 days after

Final acceptance of RRLs

3.6.a Preliminary Results – Contractor Revisions COR/OIG Team 7-14 days depends on updates

3.6.b Preliminary Results – Final Approval The Contractor 7-14 days depends on updates

3.7.a Draft Report – Contractor Revisions COR/OIG Team 7-14 days depends on updates

3.7.b Draft Report – Final Approval PD 7-14 days depends on updates

3.8 Inspection and Acceptance COR Upon Final Approval of

Preliminary Results

1.3.3 Consult Service Deliverables

Deliverable No. Description Recipient Required Timeframe

4.0 OIG Submits Request for

Consultative Needs PD Can occur at any time

4.0 Determine estimated timeframe, quantity of hours and cost

COR

No later than 5 days upon Receipt of Request for Consultative Needs

4.0 Delivery of Consult

Services as Agreed Upon COR/OIG Team

No later than 30 days from Receipt of Request for Consultative Needs

The deliverable schedules listed at Sections 1.3.2 through 1.3.3, may be used as a quick reference guide for the contract requirements; however, if there are other required documents or tasks noted throughout this document the contractor must also comply with those specified terms.

1.4 Description of Work

Period of Performance (POP). No later than 7 days after the TO award, the Contractor will schedule the required kick-off meeting. No later than 7 days after the TO kick-off meeting, the Contractor shall develop the POP instrument that provides the timeframes for all TO deliverables and submit it to the OIG for review and approval. The Contractor shall conduct the medical review in accordance with the agreed timeframes in each POP instrument. OIG may apply penalties and pay a reduced rate for the contracted services, if the Contractor does not meet the defined deliverables schedule (recognizing that unforeseen circumstances may occur).

Potential Penalties. The Government may assess liquidated damages when the Contractor fails to deliver medical review products within the timeframes established in the contract or task order. Because late medical reviews negatively impact program operations, beneficiary services, and statutory deadlines, the parties agree that actual damages would be difficult to quantify.

Accordingly, if the Contractor does not provide a required deliverable (e.g. TO or consult deliverables as defined in Section 1.3.2 through 1.3.3) by the specified due date, the Government may assess liquidated damages. Assessment of liquidated damages does not limit the Government’s right to pursue additional remedies under the contract.

Task Order Kick-off Meeting. The Contractor will meet with the OIG at the mutually agreed upon time to discuss the OIG project topic and be prepared to discuss the proposed POP schedule for medical review. The kick-off meeting can cover logistics of the work including but not limited to the number of reviewers to be included on the project, level qualifications (doctor, nurse practitioner, etc.), and their names.

Medical Review Instruments (MRI). The Contractor will develop the review instruments to ensure the systematic, complete, and accurate review of selected claim/provider types according to Medicare and Medicaid criteria. The MRI will be subject to review by the OIG and must receive OIG approval prior to claim reviews commencing under the task order. MRIs shall be firmly grounded in correct and applicable Medicare and Medicaid criteria defined in Sections 3.0 through 3.8. The use of the MRIs may result in various types of determinations, including but not limited to:

• Coverage determinations (i.e. medical necessity determinations),

• Coding determinations,

• Documentation sufficiency/adequacy determinations, and

• Individual claim determinations.2

Medical Records and Data. The Contractor will work with the OIG to establish a means for intake (i.e., transfer, receipt, and compliant storage) of medical records, other documentation, and claims data provided by the OIG. During the kickoff meeting OIG and the contractor will discuss medical records delivery timeframes. The Contractor will conduct a review of claims data and a full review of medical records (completeness review) to identify core deficiencies (e.g., missing documents) that could hinder a thorough and complete review. This review is comprehensive, and it is intended to make the OIG process more transparent to, and efficient for, all stakeholders by ensuring clear deficiencies in documentation are addressed up front. The contractor shall provide the OIG with the results of the completeness review no later than 14 days after the receipt of the medical records.

Medical Review. The Contractor will perform post-payment reviews of claims and supporting medical records to identify improper payments, medical necessity, medical appropriateness, incorrect coding, documentation discrepancies, quality of care issues, and adverse events made under Part A, Part B, or Part D of Title XVIII, or Medicaid under Title XIX, of the Social Security Act. This includes review of all Medicare and Medicaid claim and provider types. The results of the review will be documented in an RRL. RRLs shall clearly describe the medical review performed, explain any determinations in clear language, and specifically reference the criteria (e.g., Social Security Act, Medicare, and Medicaid regulations; CMS policies; Local Coverage Determinations (LCDs); National Coverage Determinations (NCDs); or industry standards) that led to the determination. The Contractor shall ensure it identifies pertinent facts and associated cross-referenced pages contained in the medical record/documentation to support the review determination. Claim reviews require, at a minimum, the clinical evaluation of medical records and related documents to determine whether Medicare and Medicaid claims were billed and paid in compliance with Medicare and Medicaid coding, medical necessity, coverage, billing, and payment requirements. A medical record documents a single beneficiary’s medical history and care across time. Medical record review is the evaluation of the beneficiary’s information and medical records to ensure payment is made only for services that meet all Medicare and Medicaid coverage, coding, and medical necessity and appropriateness requirements. A medical record review must be performed by appropriate licensed and/or certified professionals within the scope of their practice. If medical professional specialists are needed, they must be readily available to perform the medical records review upon the TO being awarded.

2 The term “individual claim determination” refers to a complex review performed by the Contractor in the absence of written Medicare or Medicaid criteria.

Summary of Findings. Upon completion and agreement of the final RRLs, the OIG team shall present the preliminary summary of findings to the entity under review (referred to as “the entity” throughout this section). The Contractor shall be agreeable to receive entity commentary and/or rebuttals at this stage. The Contractor will review the entity response in its entirety and prepare a written response to the entity’s comments and/or revise RRLs as needed. The summary of findings phase will be considered a part of the task order and not consultative services.

Quality Assurance (QA). To ensure consistent, high-quality products are provided to the OIG, the Contractor will implement a QA process for each MRI and RRL issued to OIG. This QA process may involve the use of the Contractor’s Medical Director, editor, and an attorney. The plan shall outline the proposed methodology for the QA process. This QA plan shall be provided to the COR no later than 45 calendar days after the contract kick-off meeting. Upon written approval of the QA by the OIG, the Contractor shall implement the process and produce monthly reports due no later than the 15th calendar day of the month to the COR.

Artificial Intelligence. The Contractor will be prohibited from using OIG provided documents and medical records, and any of their deliverables (e.g., MRIs, RRLs) for machine learning. The Contractor shall disclose any use of Artificial Intelligence on OIG contracted services.

Consultative Services. The Contractor shall be available under a separate task order/s each fiscal year for consultative services (as funding permits) at a fixed fee per hour. Outside the OIG process outlined in Section 2.0, the Contractor may be asked to review entity feedback on medical reviews previously conducted by the Contractor and/or on an ad-hoc basis to support other OIG initiatives. Topics would include, but not be limited to:

• During the reporting process - reviewing entity comments and associated documents (including independent third-party reports based on a review of the medical records)

• Meeting with the entity (with OIG staff) to listen to concerns

• Assisting the OIG in formulating a formal response to the entity in the final report

Re-assessing the final RRLs (if additional documentation is provided) to ensure they are accurate and adequately supported, and reissuing RRLs where necessary

In addition, the Contractor shall provide consultative services on medical issues as the OIG develops its work plan and other activities. Such activities may include expert clinical services and/or medical review services in support of OIG’s planning, designing, collecting records, and conducting evaluation projects regarding HHS programs such as Medicare and Medicaid.

2.0 Performance Objectives

In furtherance of the overall work to be performed in Section 1.4, Description of Work, the Contractor shall perform the tasks described in this section.

Determine Complexity Level

Medical review topics for both Medicare and Medicaid claims may be deemed to be of either Moderate or High Complexity.

• Moderate Complexity. Review topics featuring a single date of service or single claims of less than extended services duration and not involving longitudinal analysis of patient or treatment history.

• High Complexity. Review topics requiring review of multiple claims (such as an episode of care, history of treatment, or other “case-based” review) and/or review of claims for extended services duration.

The Contractor should consult with the OIG for TO details so the complexity level can be appropriately assigned. The complexity level must be determined before the TO is issued.

Apply Appropriate Criteria

The Contractor shall apply applicable criteria (e.g. the Social Security Act, Medicare and Medicaid regulations, NCDs, national coverage/coding articles, LCDs, local coverage/coding articles, and, when applicable, provisions in Internet-Only Manuals, such as the Claims Processing Manual and the Program Integrity Manual (PIM)).

The Contractor should not retroactively apply any criterion to claims processed prior to the effective date of the criterion. The Contractor shall ensure policies utilized in making a review determination are applicable at the time the service was rendered.

The Contractor shall keep in mind that not all criteria carry the same weight in the appeals process. In addition, the Contractor will refer to the highest-level criteria for each determination.

If the OIG instructs the Contractor on the interpretation of any criterion, the Contractor shall abide by OIG’s decision.

Coverage Determinations.

A review finding of a full or partial overpayment exists if the service is not covered (i.e., it fails to meet one or more of the conditions for coverage listed below). To be covered by Medicare or Medicaid, a service must:

a. Be included in one of the benefit categories described in Title XVIII and/or Title XIX of the Act;

b. Meet all coverage requirements set forth in the Social Security Act and Medicare and Medicaid regulations;

c. Not be excluded from coverage on grounds other than 1862(a)(1); and

d. Be reasonable and necessary under Section 1862(a)(1) of the Act. In the absence of an

NCD and LCD, Medicaid regulation or guideline, or other clear governing criteria, the Contractor shall consider a service to be reasonable and necessary if the Contractor determines the service is

i. Safe and effective;

ii. Not experimental or investigational (Exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000 that meet the requirements of the clinical trial’s NCD are considered reasonable and necessary);

iii. Appropriate, including the duration and frequency considered appropriate for the service, in terms of whether it is:

• Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;

• Furnished in a setting appropriate to the patient’s medical needs and condition;

• Ordered and furnished by qualified personnel;

• One that meets, but does not exceed, the patient’s medical need; and

• At least as beneficial as an existing and available medically appropriate alternative.

Coding Determinations. The Contractor may find that an improper payment exists if the service is not correctly coded (e.g., it fails to meet one or more of the coding requirements listed in an NCD, local coding article, Coding Clinic, or Current Procedural Terminology (CPT)).

Other Determinations. The Contractor may determine an improper payment exists if the service was paid twice (e.g., a “duplicate claim”), was priced incorrectly, the claims processing contractor did not correctly apply a payment criterion (e.g., paying the second surgery at 50% of the fee schedule amount), or due to deficiency in quality-of-care determinations.

Individual Claim Determinations. The term “individual claim determination” refers to a review performed by the Contractor in the absence of written Medicare or Medicaid criteria. In rendering such reviews, the Contractor should follow the principles outlined in the CMS PIM. In applying these principles, the Contractor shall utilize appropriate medical literature and apply appropriate clinical judgment. The Contractor shall consider the broad range of available evidence and evaluate its quality before making individual claim determinations. The extent and quality of supporting evidence is key to defending challenges to individual claim determinations.

Individual claim determinations that challenge the standard of practice in a community shall be based on sufficient evidence to convincingly refute evidence presented in support of coverage.

The Contractor shall ensure a clinician with board-certification appropriate to the type of claim under review is actively involved in examining all evidence used in making individual claim determinations.

3.0 Medical Review Process and Deliverables

3.1 Kick-Off Meeting. The OIG requires a kick-off meeting for every TO with each respective OIG team. The kick-off meeting must be scheduled no later than 7 days after TO award date. A kick-off meeting will be held at a time mutually agreed upon by the Contractor and COR. The Contractor, COR, OIG team, and other OIG personnel will participate in the kick-off meeting.

The Contractor, COR, and OIG team will determine the agenda for the kick-off meeting.

Additionally, the Contractor, in consultation with OIG, shall develop an agenda for the kick-off meeting. The OIG team will provide any relevant information that should be taken into consideration in the development of the MRI. The OIG and the Contractor will also evaluate if the TO should include a Preliminary Evaluation (see Initial RRL – Section 3.5.1) and define the quantity of claims to be reviewed.

3.2 Kick-Off Meeting Minutes. The Contractor will document the minutes of the kick-off meeting and provide them to the COR and OIG team. The meeting minutes must be provided no later than 7 days after kick-off meeting.

3.4 Medical Review Instruments (MRI). The Contractor shall develop detailed written review instruments. The MRI will allow the Contractor to operationalize correct and applicable Medicare and Medicaid criteria to ensure consistent and accurate review determinations. MRIs shall:

• Document a detailed step-by-step approach for evaluating whether coverage requirements are met and to assist reviewers in making logical decisions based on the information in the supporting documentation.

• Be firmly grounded in correct and applicable Medicare and Medicaid criteria.

• Clearly describe the required qualifications for personnel conducting the review and those overseeing the review for final approval of determination.

The Contractor shall develop MRIs using applicable Medicare and Medicaid criteria. The Contractor shall provide MRIs to OIG for review and approval. In the event that criteria do not address the specific focus of a review, the Contractor will compile evidence-based guidelines from industry sources, such as coding clinics, professional associations, published peer- reviewed journals, and other accepted sources, as approved by a board-certified physician and pending approval by OIG, to assist reviewers in making an individual claim determination.

a. Draft MRIs. The Contractor shall be responsible for all criteria research, guidelines formulation, and provision of consultative support to the OIG, such as ensuring full and accurate application of applicable Medicare and Medicaid criteria, the appropriate CMS policy or applicable evidence-based industry standards suitable to the review topic. MRIs shall be drafted by the Contractor’s personnel (if applicable, including any subcontractor personnel) with appropriate subject matter expertise and experience as documented in Section 5.0. For sake of clarity, MRIs will be drafted by at least a Registered Nurse (RN), certified coder, the Contractor’s Medical Director, and certified clinical specialist appropriate to the medical review topic for the task order. At the end of the drafting process, MRIs must receive final approval from the Contractor’s Medical Director. The Contractor shall be responsible for legal research, as well as criteria research, to cover Medicare and Medicaid requirements found in the Social Security Act and Medicare and Medicaid regulations.

Drafting of MRIs should occur within the following timeframes, unless otherwise noted for special circumstances by the Contractor and approved by the OIG:

Type of Medical

Review Instrument

Definition

Timeframe

Reuse (Moderate and High Complexity)

Review topics that have been previously conducted for the OIG by the Contractor

14 days from TO kick-off meeting

New Moderate Complexity

Review topics featuring single claims of less than extended services duration and not involving longitudinal analysis of patient or treatment history

21 days from TO kick-off meeting

New High Complexity

Review topics requiring review of multiple claims (such as an episode of care, history of treatment, or other “case-based” review), and/or review of claims for extended services duration

28 days from TO kick-off meeting

OIG may apply penalties for the contracted services, if the Contractor does not abide by the defined deliverables schedule (see Section 1.4, Description of Work).

b. OIG Review. Upon completion of research and drafting, the Contractor’s PD shall present the proposed MRI to the OIG. The OIG will analyze the MRI for thoroughness, accuracy, and clarity. The OIG expects that this review will take 21 days. If the OIG encounters delays, it will notify the Contractor.

c. Contractor Revisions. The OIG shall provide feedback on MRI. Based upon criteria research and additional review by certified clinical specialists, the contractor shall revise the MRI as needed to address the OIG's feedback. Upon receipt of the OIG’s feedback on the draft MRI, the Contractor shall evaluate the feedback and the PD will confirm to the OIG, within 7 days, the degree of updates required, per the table below:

Type of Update Definition Timeframe

Minimal Updates

Draft guidelines requiring minimal updates from the OIG review process, as agreed upon between the Contractor and OIG

7 days from OIG return of feedback to the Contractor

Significant Updates

Draft guidelines requiring significant rework, which may include clarification of additional review process steps, fresh rounds of criteria review or research, and/or significant refashioning of rationale explanations, as agreed upon between the Contractor and OIG

14 days from OIG return of feedback to the Contractor

OIG may apply penalties for the contracted services, if the Contractor does not abide by the defined deliverables schedule (see Section 1.4, Description of Work).

d. Final Approval. Upon completion of updates to MRI, the Contractor shall present the proposed final draft to the OIG. The OIG will review the proposed final draft and provide additional feedback for further update or approval. If further updates are required, the process will iterate between Sections 3.4.b through 3.4.d, as needed, until final OIG approval of MRI is obtained.

If more than 2 rounds of OIG feedback are required to develop and finalize the MRI, OIG may apply penalties for the contracted services (see Section 1.4, Description of Work).

3.5 Medical Review. Medical review must be conducted by personnel, which may include subcontractor personnel, with levels of qualifications and/or specialty certifications fitting those detailed in the approved MRIs and meeting the minimum qualifications specified in Section 5.0.

The results of the review of each claim must be documented in an RRL. For sake of clarity, RRLs will be drafted by at least an RN, certified coder, the Contractor’s Medical Director, and if appropriate a certified clinical specialist. RRLs shall be approved by a board-certified specialist appropriate to the review topic, as defined in the MRI, and the Contractor’s Medical Director (if not the same individual). The Contractor shall clearly document a detailed rationale for each review determination. This rationale shall include a detailed description of Medicare and Medicaid criteria violated and a statement as to whether the violation resulted in an improper payment. The Contractor shall ensure it identifies pertinent facts and associated cross-referenced pages contained in the medical record/documentation to support the review determination. Each rationale shall be specific to the claim(s) under review, drafted in clear language, and provided in the agreed upon format of an RRL.

The Contractor must establish a QA process that ensures consistency when conducting a review of the same type of service. The Contractor must ensure that the medical review methodology, applicable Medicare requirements, and the basis for the medical review determination are consistently applied throughout the medical review process.

The Contractor shall provide staff with the ability to read, write and converse in English and Spanish for use during customer service/provider interactions and for review of medical records as needed.

The Medical Review stage begins upon OIG’s final acceptance of the MRI. Reviews must be completed and results delivered to the OIG within the following timeframes, unless an extension is requested on reasonable grounds by the Contractor and granted by the OIG:

Review Volume Timeframe

0 to 100 claims 30 days from receipt of medical documentation, claims data from the OIG, OIG Final acceptance of the MRI, and acceptance of Initial RRLs (if initiated)

101 to 250 claims 45 days from receipt of medical documentation, claims data from the OIG, OIG Final acceptance of the MRI, and acceptance of Initial RRLs (if initiated)

251 to 500 claims 60 days from receipt of medical documentation, claims data from the OIG, OIG Final acceptance of the MRI, and acceptance of Initial RRLs (if initiated)

3.5. Initial RRLs. Upon either OIG or the Contractor initiation, an Initial Review of 5 – 10 medical review determinations and draft RRLs may be conducted by the OIG prior to the Contractor’s completion of the medical review of all claims for the TO. This Initial Review is purposed to increase alignment between the Contractor and the OIG, and to limit the risk of rework, protect review timelines, and safeguard review quality. Depending on the nature of the Initial Review, the Contractor and OIG will collaborate to agree upon any modifications to the timeframe for review completion.

a. Initial RRL - OIG Review. The Contractor’s PD shall present the initial RRLs to the OIG. The OIG will analyze the RRL for thoroughness, accuracy, and clarity. The OIG expects that this review will take 7-14 days depending on the complexity of work to be performed. If the OIG encounters delays, it will notify the Contractor. The OIG shall provide feedback on the initial RRLs.

b. Initial RRL - Contractor Revisions. The Contractor will review the feedback from OIG, seek clarification if needed, and/or revise the RRLs. The Contractor shall evaluate OIG feedback and the PD will confirm, within 7 days, the degree of updates required, as per the table below:

Update Definition Timeframe

Minimal Updates

RRLs requiring minimal updates from the OIG review process

7 days from OIG return of feedback to the Contractor

Significant Updates

RRLs requiring significant rework, which may include clarification of additional review process steps, fresh rounds of criteria review or research, and/or significant refashioning of rationale explanations

14 days from OIG return of feedback to the Contractor

c. Initial RRL - Final Approval. Upon completion of updates to the initial RRLs, the

Contractor shall present the proposed final RRLs to the OIG. The OIG will review the proposed final RRLs and provide additional feedback for further update or approval. If further updates are required, the process will iterate between Sections 3.5.a through 3.5.c, as needed, until final OIG approval of initial RRLs is obtained. The Contractor must provide the “Final” version of these RRLs within 5 days from OIG’s acceptance of the RRLs.

If more than 2 rounds of OIG feedback are required to develop and finalize the initial RRLs, OIG may apply penalties for the contracted services (see Section 1.4, Description of Work).

3.5.1 RRLs. RRLs shall clearly describe the medical review, explain any determinations in clear language, and specifically reference the Social Security Act, Medicare and Medicaid regulations, CMS policies, industry standards, or other approved criteria that led to the determination. The RRLs shall be approved by the appropriately certified clinician, as previously mutually agreed upon and documented in the MRI. The final RRLs must contain an accurate and appropriate summary of all facts needed to support the determination and correctly summarize Medicare and Medicaid requirements. The letter must clearly explain the basis for each decision in a logical, thorough, and fact-based manner. The letter must be written in plain English with all medical terminology that would be unfamiliar to a layman defined. The Contractor must ensure that any feedback provided by the OIG on the initial RRLs is adequately addressed and incorporated into the remaining RRLs.

a. RRLs - OIG Review. The Contractor’s PD shall present the RRLs to OIG. OIG will analyze RRLs for thoroughness, accuracy, and clarity. The OIG will have 7-14 days to review RRLs and provide feedback. If the OIG encounters delays, it will notify the Contractor.

b. RRLs - Contractor Revised RRLs. Based upon criteria research and additional review by the contractor’s staff (including certified clinical specialists, when they have been identified on the TO), the Contractor shall revise the RRLs as needed to address the OIG's feedback. The revised RRLs must be provided to the OIG within the timeframes established in the table below:

Update Definition Timeframe

Minimal Updates

RRLs requiring minimal updates from the OIG review process

7 days from OIG return of feedback to the Contractor

Significant Updates

RRLs requiring significant rework, which may include clarification of additional review process steps, fresh rounds of criteria review or research, and/or significant refashioning of rationale explanations

14 days from OIG return of feedback to the Contractor

Additional Records Received

If, upon obtaining feedback from the OIG, claims must be re-reviewed, the Contractor shall provide the OIG an estimated timeframe required to complete re-review and update the RRLs

No later than 14 days from the receipt of the new records and feedback from OIG

c. RRLs - Final Approval. Upon completion, the Contractor’s PD shall present the proposed final version of the RRLs to the OIG. The OIG will review the proposed final documents and provide additional feedback for further update or issue approval. If further updates are required, the process will iterate between Sections 3.5.1.a through 3.5.1.c, as needed, until final OIG approval of the RRLs is obtained. The OIG will have 14 days to review the RRLs and provide feedback. The Contractor must provide the “Final” version of these RRLs within 5 days from OIG’s acceptance of the RRLs.

If claim(s) were denied due to missing documentation, the team will have 7 days to provide the documentation to the Contractor. The Contractor will have 14 days to assess the new documentation and revise the RRL if needed. If delays are expected, the OIG will notify the Contractor. The Contractor must receive OIG approval before finalizing the RRLs.

If more than 2 rounds of OIG feedback are required to develop and finalize the RRLs, OIG may apply penalties for the contract services (see Section 1.4, Description of Work).

3.6 Preliminary Results Presented to Entity. Upon acceptance of all RRLs in the TO, the OIG team shall present the entity with the medical review findings. If the entity has additional records that were not included in the original submission for the claims under review, OIG will provide those records to the Contractor. The Contractor agrees to re-review the impacted claims, all medical records (including the new information), and adjust the RRLs, if needed.

a. Contractor Revised RRLs - Preliminary Results Presented to Entity. If, upon obtaining feedback from the OIG, claims must be re-reviewed, the Contractor shall provide the OIG an estimated timeframe required to complete re-review and update the RRLs (no longer than 14 days form the receipt of the new records and feedback from OIG).

Type of Update Definition Timeframe

Minimal Updates RRLs requiring minimal updates

7 days from OIG return of feedback to the Contractor

Significant Updates

RRLs requiring significant rework, which may include clarification of additional review process steps, fresh rounds of criteria review or research, and/or significant refashioning of rationale explanations

14 days from OIG return of feedback to the Contractor

b. Final Approval – Preliminary Results Presented to Entity. Upon completion, the

Contractor’s PD shall present the proposed final version of the RRLs to OIG. The OIG will review the proposed final documents and provide additional feedback for further updates or issue approval.

Should the Contractor and the OIG agree an error or omission in the medical review should have reasonably been identified and addressed by the Contractor during the RRL review stage, then the Contractor shall present to the OIG, within 7 days, a mitigation plan for addressing the lack of performance. Both the mitigation plan and revisions to the RRLs will be performed at no additional cost to the OIG.

3.7 OIG Draft Report. Upon issuance of the Draft Report, the entity may present additional records that were not included in the original submission for the claims under review. OIG will provide those records to the Contractor. The Contractor shall re-review the impacted claims, all medical records (including the new information), and adjust the RRLs, if needed.

a. Contractor Revised RRLs – Draft Report. If, upon obtaining feedback from the OIG, claims must be re-reviewed, the Contractor shall provide the OIG an estimated timeframe required to complete re-review and update the RRLs (no longer than 14 days from the receipt of the new records and feedback from OIG).

Type of Update Definition Timeframe

Minimal Updates RRLs requiring minimal updates

7 days from OIG return of feedback to the Contractor

Significant Updates

RRLs requiring significant rework, which may include clarification of additional review process steps, fresh rounds of criteria review or research, and/or significant refashioning of rationale explanations

14 days from OIG return of feedback to the Contractor

b. Final Approval – Draft Report. Upon completion, the Contractor’s PD shall present the proposed final version of the RRLs to OIG. The OIG will review the proposed final documents and provide additional feedback for further updates or issue approval. Should the Contractor and the OIG agree an error or omission in the medical review should have reasonably been identified and addressed by the Contractor during the RRL review stage, then the Contractor shall present to the OIG, within 7 days, a mitigation plan for addressing the lack of performance. Both the mitigation plan and revisions to the RRLs will be performed at no additional cost to the OIG.

3.8 Inspection and Acceptance

The COR, as a duly authorized representative of the CO, shall assume the responsibilities for monitoring the Contractor’s performance, evaluating the quality of services provided by the Contractor, and performing final inspection and acceptance of all deliverables.

For work completed under this PWS, inspection and acceptance shall be as follows:

1. Upon OIG Acceptance of the Final RRLs (Section 3.5.2.c) the Contractor shall submit an invoice for 85% of the total cost of the individual TO.

2. Upon OIG Acceptance of the Final Approval – Preliminary Results Presented to Entity (Section 3.6.b) the Contractor shall submit an invoice for 10% of the total cost of the individual TO.

3. Upon issuance of the Draft report (Section 3.7.b), the Contractor shall submit an invoice for the remaining 5% of the total cost of the individual TO.

4.0 Consultative Services

Consultative services consist of “OIG Support Services” and “Ad-Hoc Consultative Services.”

The Contractor shall, upon request, make available for discussions with the OIG and CMS or an entity, the professional personnel who performed work in support of any given OIG project.

a. OIG Support Services include the following major components:

i. Reviewing entity comments and associated documents (including independent third-party reports based on a review of the medical records)

ii. Meeting with the entity (with OIG staff) to listen to concerns

iii. Assisting the OIG in formulating a formal response to the entity in the final report

iv. Re-assessing the final RRLs (and underlying medical record documentation) to ensure that they are accurate and adequately supported

b. Ad-Hoc Consultative Services include consultation on medical review issues as the OIG develops its work plan and other activities. On an ad-hoc basis, Consultative Services will include the Contractor providing expertise on a wide variety of medical-related issues, including:

i. assistance assessing risk in designing future oversight activities or assessing the

Medicare and Medicaid program to identify fraud, waste, and abuse vulnerabilities.

ii. attending planning meetings regarding specific OIG topics and methodology.

iii. analyzing and providing a determination on OIG-developed MRI and preliminary determinations.

iv. provide expert clinical services and/or medical review services in support of OIG’s planning, designing, collecting records and conducting evaluation projects regarding HHS programs such as Medicare and Medicaid.

To acquire and produce Consultative Services under the open task order:

a. The OIG would provide a written statement of consultation needs (either OIG Support Services or Ad Hoc Consultative Services) and the Contactor shall inform the OIG within two business days whether they need clarification on the request for consultative needs.

i. For OIG Support Services, upon receiving the statement of consultative needs, the

Contractor will confirm the timeline for addressing the entity or other party feedback and provide an estimate for the staff (including clinical specialists), quantity of hours and cost.

ii. For Ad Hoc Consultative Services, upon receiving the statement of consultative needs, the Contractor shall reply within 14 days with an understanding of the needs and provide an estimate for the staff (including clinical specialists), deliverable timeline, quantity of hours and cost.

b. Upon acceptance by the OIG, the Contractor would provide the desired Consultative Services, notifying the OIG when the estimated quantity of hours has been reached.

Extending the quantity of hours or requesting a subsequent Ad Hoc Consultation would follow the same 3-step process.

If the OIG requires additional support, but entity feedback and independent review show the Contractor has reasonably delivered upon the agreed OIG parameters, these additional consultative task order options would be appropriate vehicles for obtaining additional time for the contract. However, should the Contractor and the OIG agree an error or omission in the medical review should have reasonably been identified and addressed by the Contractor, then the Contractor shall present to the OIG, within 7 days, a mitigation plan for addressing the lack of performance. Both the mitigation plan and revisions to the RRLs will be performed at no additional cost to the OIG.

If more than 2 rounds of OIG feedback are required to accept the consultative task deliverable, OIG may apply penalties for the contract services (see Section 1.4, Description of Work).

5.0 Personnel Qualifications

Unless otherwise approved by the Contracting Office, the personnel for key positions noted below shall possess the following minimum work experience and educational requirements.

a. Program Director - The Program Director, at a minimum, shall possess:

• Work Experience - Ten years of professional experience with at least 3 years as a manager responsible for managing complex systems and workflow.

• Prior work experience in the health care industry is preferred.

• Educational Requirements - A bachelor’s degree from an accredited institution, plus a master’s degree from an accredited institution or substitution of 4 additional years of related work experience in lieu of the master’s degree.

b. Medical Director - The Medical Director shall possess:

• Work Experience - Prior work experience in the health insurance industry, a utilization review firm, or another health care claims processing organizations in a role that involved developing coverage or medical necessity policies and guidelines.

• Extensive knowledge of the Medicare and Medicaid programs, particularly the coverage and payment rules and clinical review judgment experience. Experience practicing medicine for at least 3 years as a board-certified doctor.

• Educational Requirements - Medical doctor who is currently licensed.

c. Lead Claims Review Analyst - The Lead Claims Review Analyst shall possess:

• Work Experience - At least 2 years utilization/quality assurance review and ICD-10 or ICD-11-CM/CPT-4 coding experience. Experience in coding and abstracting, working knowledge of Diagnosis Related Groups (DRGs), Prospective Payment Systems, Medicare coverage guidelines, and clinical review judgment is required.

Advanced knowledge of utilization review/quality assurance procedures, ICD-10 or ICD-11CM and CPT-4 coding, Medicare coverage guidelines, payment methodologies (i.e., Correct Coding Initiative, DRGs, Prospective Payment Systems, Local Coverage Determinations) and knowledge of Medicaid coverage and coding requirements.

• Educational Requirements - RN or Licensed Practical Nurse (LPN) with an active license.

d. Claims Review Analyst - The Claims Review Analyst shall possess:

• Work Experience - Extensive knowledge of medical terminology, experience in the analysis and processing of Medicare claims and clinical review judgment is required. Knowledge of Medicare guidelines and coverage is also required. Ability to read Medicare claims, both paper and electronic, and a basic knowledge of the Medicare claims system is required. Knowledge of Medicaid claims processing and coding requirements is desired.

• Educational Requirements - RN or LPN with an active license.

e. Coder - The Coder shall possess:

• Work Experience - At least 3 years of clinical medical record auditing experience. Extensive knowledge of Medicare claims. Demonstrated experience with DRG reimbursement system and ICD-10-CM coding. Knowledge of Medicaid claims processing and coding requirements is desired.

• Educational Requirements - Certified Professional Coder (CPC) or Certified Coding Specialist (CCS) with current certification. Bachelor’s degree in nursing and/or social or health service is preferred.

SECTION 2: Audit – Medicare Part C

1.0 Background

This section of the PWS outlines the requirements to provide successful and acceptable Medical Record Review support and Consultation Services and for the HHS OIG/Office of Audit Services, Medicare Part C.

The Medicare Advantage (MA) program offers beneficiaries managed care options by allowing them to enroll in private health care plans rather than having their care covered through Medicare’s traditional fee for service program. To provide benefits to these beneficiaries, CMS contracts with MA organizations, which in turn contract with Medical Providers. Federal Government requirements mandate that payments to MA organizations be based on the anticipated cost of providing Medicare benefits to a given beneficiary and, in doing so, also account for variations in the demographic characteristics and the health status of each beneficiary. Accordingly, MA organizations are paid more for providing benefits to beneficiaries with diagnoses associated with more intensive use of health care resources than to healthier beneficiaries, who would be expected to require fewer health care resources. To determine the health status of beneficiaries, CMS relies on the MA organizations to collect diagnosis codes from its Medical Providers and submit those codes to CMS, who then maps certain diagnosis codes, on the basis of similar clinical characteristics and severity and cost implications, into Hierarchical Condition Categories (HCC). Each HCC has a factor (which is a numerical value) assigned to it for use in each beneficiary’s risk score.

Under the MA program, CMS makes advance payments each month to MA organizations for the expected costs of providing health care coverage to beneficiaries. These payments are not adjusted to reflect the actual costs that the organizations incurred for providing benefits and services. Thus, MA organizations will either realize profits if their actual costs of providing coverage are less than the CMS payments or incur losses if their costs exceed CMS payments.

CMS uses two (2) principal components to calculate the risk adjusted payment that it will make to a MA organization for a beneficiary: A base rate that CMS sets using bid amounts received from the MA organization and the risk…