Industry_Day_Package_.pdf

FOR MARKET RESEARCH PURPOSES ONLY

Health and Human Services, Office of Inspector General Office of Audit Services

Medical Review of Medicare Parts A and B Claims & Consultative Services

Industry Day Notice

Background

The Office of Inspector General (OIG), Office of Audit Services (OAS) conducts independent audits of the Department of Health and Human Service (HHS) programs, including Medicare Parts A and B. The Medicare Parts A and B programs are administered by the Centers for Medicare & Medicaid Services (CMS). The OIG conducts audits of Medicare Parts A and B services to help reduce fraud, waste and abuse. In this regard, our audits include hospitals, home health agencies and durable medical equipment (DME) suppliers, just to name a few. The OIG/OAS contract for medical review services to assess whether the services were billed in accordance with Medicare requirements (e.g. medical necessity and documentation), when needed.

The core Tasks under the medical review contract include:

1) Meetings,

2) Medical Review of Claims, and

3) Consultative Services & Followup Medical Review of Claims. The bullets listed below, provide detail on the tasks that the medical review contractor (Contractor) will perform and outlines how the medical review process is structured.

1. Meetings – To accomplish this task, the contract requires standing and ad hoc meetings. For new medical review, kickoff meetings will be necessary, which will occur prior to or early on in the medical review process. If needed, the OIG/OAS may meet with the Contractor to obtain, for example clarification on the medical review determinations made on the claim(s) under review and the rationale for the determination.

2. Medical Review of Claims – This task requires that the Contractor conduct a medical review of claims and the supporting documentation. Prior to the medical review, the OIG/OAS will select the claims for review and collect the medical documentation. The Contractor will conduct a medical review of either a small subset of claims on a compressed timeframe (referred to as a “pretest review”) and/or a large number of claims on an expanded timeframe (referred to as a “full medical review”). Although the number of claims and timeframes as noted above may vary between medical reviews (i.e. pretest and full medical review), the OIG/OAS’s process and expectations will not vary by review. A brief summary of the steps and deliverables for the medical review are outlined below.

a. An error matrix is provided by OIG/OAS to the Contractor. The error matrix is a tool designed to be used by the medical reviewers to make a determination as to whether the services are (1) medically necessary, (2) properly documented, and/or (3) correctly coded in accordance with Medicare requirements. The Contractor is then expected to conduct independent research of the applicable Medicare requirements, regulations, and guidelines.

b. The Contractor reviews and provides comments on the error matrix.

c. The medical records and supporting documentation are collected by the

OIG/OAS and are submitted to the Contractor electronically via a secure server.

d. The Contractor assesses medical record documentation for completeness and submits a request to the OIG/OAS to obtain any missing documents from the provider(s).

e. The OIG/OAS submits the missing documents to the Contractor.

f. The Contractor completes the medical review of all claims and the supporting documentation that the OIG/OAS collected from the provider(s).

g. The Contractor communicates the results of the medical review per claim in writing (in an agreed upon format, by submitting determination letters to the

OIG/OAS.

h. OIG/OAS reviews and submits comments to the Contractor on the determination letters.

i. To address the OIG/OAS comments, the Contractor reviews the comments from OIG/OAS, addresses the OIG/OAS comments by revising the determination letters where needed, and provides a response to the OIG/OAS comments.

j. OIG/OAS reviews the revised determination letters and the Contractor’s response to the comments, and if acceptable, OIG/OAS provides a final acceptance of the determinations letters.

3. Consultative services & Followup Medical Review of Claims – These tasks include assisting the OIG/OAS in responding to auditee comments regarding a specific medical review, assessing new information for relevance to a previously conducted review, and completing a second medical review of claims when the provider under audit has submitted new information to the OIG/OAS subsequent to completion of the initial medical review. The second review is conducted on a compressed timeline.

The OIG/OAS is seeking suggestions on how these tasks could be accomplished under a new contract in the future.

Industry Day Questions

1. Describe your technical experience and knowledge in conducting medical reviews of

Medicare Parts A and Part B claims.

2. Our claims will include various services in the Medicare A and B programs. In the past, some of our medical reviews of Part A claims included hospital inpatient and outpatient, home health, and hospice. Additionally, in the past some of the Part B claims that we reviewed included physical therapy, evaluation & management, chiropractic, and DME.

a. Please describe the composition of your medical review team. Who is in charge of this team and what is their day to day level of involvement? We expect that a physician accredited in an appropriate specialty to be the final decision maker in any adverse determinations made on a claim.

b. How would you adequately staff and ensure qualified reviewers are assigned to the wide variety of Parts A and B claims we audit?

3. Medical review is an important method that we use in many of our Medicare Parts A and B audits. The combination of reviewing sample cases and conducting second reviews when the provider submits additional information has led to a significant volume of claims that the OIG/OAS sends for medical review. We need the reviews to be consistent and accurate but also timely so audits are not significantly delayed.

a. What is the volume of claims you could accept for medical review each month?

b. How long would it take you to review 100 claims and submit the deliverables? If this varies by type of claim could you provide several examples?

Each audit could be focused on a single provider or a nationwide audit of multiple providers. Past experience has shown the split among Medicare Parts A and Part B claims reviewed to be more heavily weighted to Medicare Part A. In the past, the typical volume per month ranged from 300 to 500 new claims submitted for medical review.

4. Do you have current or past contracts with other government agencies to conduct medical review of claims? This could include state agencies not just Federal agencies. Please give a brief overview of the scope of work involved in these previous contracts.

5. If your company holds current contracts with other Federal agencies for medical review, how do you anticipate mitigating the potential conflict of interest? As the

OIG for the HHS, we conduct independent audits of the HHS programs, and we must maintain our independence in fact and appearance. Attached is our conflict of interest requirements that the Contractor and its employees and subcontractors are required to meet (Attachment). Please review these requirements and give us your feedback on how the company would mitigate any potential conflict of interest and describe any anticipated difficulties in complying with these requirements.

6. The OIG/OAS may seek a contract for medical review of Medicare Part D claims

(i.e. prescription drug event). Please describe any experience and knowledge you may have in conducting medical reviews of Medicare Part D claims.

Attachment

ORGANIZATIONAL CONFLICT OF INTEREST

I. General: It is essential that the Contractor and its assigned employees and subcontractors under this contract are free, to the greatest extent possible, of all conflicts of interest.

Conflicts of interest could arise related to work under this contract in primarily one of two ways: (1) the Contractor or Offeror may have a conflict of interest; (2) the Contractor’s employees or subcontractors or Offeror’s employees or proposed subcontractors or their employees may have a conflict of interest.

Except as provided below, the Contracting Officer shall not enter into a contract with an Offeror, a call order with a Contractor, or maintain a contract with a Contractor that the Contracting Officer determines has, or has the potential for, an unresolved conflict of interest. The Contracting Officer may contract with an Offeror or Contractor that has an unresolved conflict of interest if the Contracting Officer, in consultation with HHS OIG, determines that it is in the best interest of the Government to do so.

II. Definitions:

As used in this subpart, the following definitions apply:

A. Financial Relationship

1. “Financial relationship” means—

(A) A direct or indirect ownership, financial, or investment interest (including an option or nonvested interest) in any entity that exists through equity, debt, contract, or other means and includes any indirect ownership, financial, or investment interest no matter how many levels removed from a direct interest;

(B) A compensation arrangement with an entity; or

(C) A relationship with an entity that indirectly results in the individual receiving pecuniary benefit (e.g. a physician has privileges at a hospital).

2. A financial relationship may exist either—

(A) Through an Offeror’s or Contractor’s parent company, subsidiaries, affiliates, subcontractors, or current clients; or

(B) From the activities and relationships of the officers, directors (including medical directors), or managers of the Offeror or Contractor and may be either direct or indirect.

(C) From the activities and relationships of the key personnel who are to be assigned to a call order under this contract and may be direct or indirect.

3. An indirect financial relationship includes –

(A) An officer, director, or manager has an indirect financial relationship if an ownership or investment interest is held in the name of another but provides benefits to the officer, director, or manager.

(B) Other examples of indirect financial relationships are, but are not limited to, holdings in the name of a spouse or dependent child of the officer, director, or manager and holdings of other relatives who reside with the officer, director, or manager.

B. Conflict of interest—

“Conflict of interest” means that because of activities or financial relationships with other persons, the Contracting Officer has determined that a person is unable or potentially unable to render impartial assistance or advice to the Government, or the person’s objectivity in performing the contract work is or might be otherwise impaired, or the person gains an unfair competitive advantage.

For purposes of the medical review contract, the activities and relationships described include those of the Offeror or Contractor itself, its employees, its subcontractors and their employees, and other business related to it and those of officers, directors (including medical directors), managers, and subcontractors.

C. Affiliate –

“Affiliate” means associated business concerns or individuals if, either directly or indirectly—

1. One controls or can control the other; or,

2. A third party controls or can control both.

For purposes of this contract, any business concern may be found to be an affiliate, whether or not it is organized for profit or located in the United States or its outlying areas. Control may be affirmative or negative and it is immaterial whether it is exercised so long as the power to control exists.

D. Contractor -

“Contractor” means the entity to whom the contract and subsequent call orders are awarded and includes the Contractor’s employees, affiliates, and subcontractors and their employees and affiliates.

E. Offeror –

“Offeror” means entities that submit proposals for the award of the contract, their employees, affiliates, and proposed subcontractors and their employees and affiliates.

III. Identifying and disclosing a conflict of interest:

A. Contractors and Offerors must identify and disclose actual, apparent and potential conflicts of interest to the Contracting Officer during the term of the contract. In addition, the Contractor and Offerors shall demonstrate that each has programs in place to identify, evaluate and mitigate all actual, apparent and potential conflicts of interest that preclude, or would appear to preclude, the Contractor or Offeror from rendering impartial assistance or advice on work performed for this contract;

impair the Contractor’s or Offeror’s objectivity in performing the contract work, or give the Contractor or Offeror an unfair competitive advantage.

A Contractor or Offeror is responsible for identifying whether a conflict of interest exists in any of its proposed or actual subcontractors and employees and disclosing that conflict or potential conflict of interest to the contracting officer.

The Offeror’s Organizational Conflict of Interest Certificate, the Offeror’s plan for identifying and mitigating all actual, apparent and potential conflicts of interest identified during the term of the contract, and the Offeror’s certification that all work to be performed under this contract is free of unresolved conflicts of interest will be incorporated into the contract after award and will be considered terms and conditions of the Contractor’s performance of this contract and any call orders under this contract.

B. The following are some examples of the types of situations that could give rise to a conflict of interest:

1. An officer, director, employee or subcontractor of the Contractor is an officer, director, employee or contractor of a hospital that is the subject of an OIG audit for which the Contractor’s services are sought under this contract.

2. An employee or subcontractor, who is a physician reviewing medical records under the Contract has privileges at the hospital that is being audited or one of its competitors.

3. The Contractor has previously been involved in a contract, subcontract or other agreement to provide advice or other services to the entity or individual being audited.

4. The Contractor is currently under audit or investigation by OIG or other state or federal agency regarding the delivery of or payment for health care services.

C. The Contracting Officer may determine that an Offeror or Contractor has a conflict of interest, or the potential for a conflict exists, based on the following:

1. Apparent conflict of interest. An apparent conflict of interest exists if a reasonable person would believe that the Offeror or Contractor would have a conflict of interest in performing the requirements of a contract under this subpart. No inappropriate action by the Offeror or Contractor is necessary for an apparent conflict of interest to exist.

2. Other healthcare-related agreements or relationships between the Offeror or Contractor and the Federal Government and private entities.

IV. Conflict of interest evaluation:

A. Disclosure.

Offerors that wish to be eligible for the award of the contract under this subpart and the Contractor, must submit, at times specified in paragraph IV.C. below, an Organizational Conflicts of Interest Certificate. The information must be submitted in an electronic, searchable format or either Excel or PDF file. The Certificate must contain the information specified in paragraphs (a) through (h) below as follows:

1. A description of all business, professional or contractual relationships or activities that could be viewed as a conflict of interest based upon the information provided in II.B. and III.B. above.

2. A description of the methods the Offeror or Contractor will apply to mitigate any situations listed in the Certificate that could be identified as a conflict of interest.

3. A description of the Offeror’s or Contractor’s program to monitor its compliance and the compliance of its proposed and actual subcontractors with the conflict of interest requirements as identified in the relevant solicitation.

4. A description of all healthcare related contracts or other financial arrangements with governmental (local, state or federal) or nongovernmental entities to include contracts with providers, suppliers, insurers, and other health care agencies and companies held by the Contractor, its parent company, subsidiaries or other affiliated entities.

5. A description of any relationships, whether compensated or not, between the Offeror/Contractor, its parent company, subsidiaries, or other affiliated entities and any providers, suppliers, insurers or other health care companies, including but not limited to positions on the board of directors, privileges, and other similar arrangements.

6. An affirmation, on the company letterhead and using language provided below, signed and dated by an official authorized to bind the Contractor:

I, (Name and Title), certify under penalty of perjury and to the best of my knowledge and belief: 1) I am an official authorized to bind the entity; 2) the information contained in the Organizational Conflict of Interest Certificate is true and accurate as of (Date); and 3) I understand that the Contracting Officer may consider any deception or omission in this Certificate to be grounds for non-consideration for contract award, modification or nonrenewal or termination of the current contract, and/or other contract or legal action.

An Offeror shall submit an affirmation certifying the information to be true and accurate as of the date the proposal is submitted. Upon award, the Contractor shall submit an updated affirmation, if necessary, certifying the information to be accurate as of the date of contract award.

7. Corporate and organizational structure.

8. Financial interests in other entities, including the following:

a. Percentage of ownership in any other entity.

b. Income generated from other sources.

c. A list of current or known future contracts or arrangements, regardless of size, with any--

(1) Insurance organization or subcontractor of an insurance organization; or

(2) Providers or suppliers furnishing health services for which payment may be made under Medicare and other CMS programs.

d. In the case of contracts or arrangements identified in accordance with paragraph (3) of this section, the dollar amount of the contracts or arrangements, the type of work performed, and the period of performance.

9. The following information for all of the Offeror's or Contractor's officers, directors (including medical directors), managers, physicians, coders, nurses and other personnel who would be, or are involved with, the performance of this contract:

a. The information required under paragraphs IV.A.1, IV.A.8.c. and

d. above.

b. The information specified in paragraphs IV.A.8.a. and b. above.

B. Offeror's or Contractor's responsibility with regard to subcontractors and employees.

An Offeror or Contractor is responsible for determining whether a conflict of interest exists in any of its proposed or actual subcontractors and employees at any tier and is responsible for ensuring that the subcontractors have mitigated any conflict of interest or potential conflict of interest. The Contracting Officer shall be notified of such identifications for a determination in accordance with paragraph III. above.

A Contractor shall maintain documentation necessary to support its determination that its subcontractors have identified and mitigated any conflict or potential conflict. A Contractor shall require its subcontractors to follow the procedures for identifying, evaluating and disclosing conflicts of interest and potential conflicts of interest as contained herein.

C. When disclosure is made.

The Organizational Conflict of Interest Certificate is submitted—

1. With the Offeror’s proposal;

2. Within 10 calendar days of submission of additional documentation by the

Government or within 10 calendar days of the Contractor’s notification to the Government that additional documentation is not required for each task order issued under this Contract;

3. When the Contracting Officer requests a revision in the Certificate;

4. Within 45 days of any change in the information submitted in accordance with paragraph IV.A., above.

5. Annually, if the Government exercises options years 1, 2, 3 and/or 4.

D. Evaluation. The Contracting Officer evaluates conflicts of interest and potential conflicts, using the information provided in the Conflicts of Interest Certificate, and information from other sources.

For each conflict identified, the Contracting Officer, in consultation with HHS OIG, will evaluate the plan proposed by the Offeror or Contractor to mitigate the conflict to determine if the mitigation plan will allow the Contractor to render impartial assistance or advice to the Government; or the Contractor’s objectivity in performing the contract work is not or will not be otherwise impaired; or the

Contractor will not or has not obtained an unfair competitive advantage. To the extent that the conflict was not identified by the Offeror or Contractor in its certificate, the Contracting Officer will request and the Contractor shall provide a mitigation plan.

E. Protection of proprietary information disclosed.

1. The Government protects disclosed proprietary information as allowed under the Freedom of Information Act (5 U.S.C. 552). All proprietary information should be identified by the Offeror or Contractor as proprietary and be marked with the legend “Proprietary Information” or “Confidential Business Information” as applicable.

2. The Contracting Officer requires signed statements from OIG personnel with access to proprietary information that prohibits personal use during the procurement process and term of the contract.

V. Conflict of Interest Resolution:

Resolution of a conflict of interest is a determination that:

A. The conflict has been mitigated;

B. The conflict precludes award of a contract or a task order under this contract to the Offeror;

C. The conflict requires that the Contracting Officer modify an existing contract;

D. The conflict requires that the Contracting Officer terminate an existing contract; or

E. It is in the best interest of the Government to contract with the Offeror or Contractor even though the conflict exists.