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  • Developing Model Compliance 1/14/2014

    Developing Model Compliance Programs- APF and ASCP 2014 1

    A joint collaboration between Preparing Laboratory

    Leaders for Today and

    Tomorrow

    Developing Model Compliance Programs

    Your Faculty

    Karen Rupke MT(ASCP)DLM

    CMQ/OE, CQA (ASQ)

    Grand Rapids, MI

    Heather Signorelli, DO Pathology Resident, PGY-4

    University of Colorado Anschutz Medical Campus

    Aurora, CO

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    Developing Model Compliance Programs- APF and ASCP 2014 2

    Importance of

    Compliance

    Compliance programs are essential to

    your labs ethical and business policies

    establishing a culture of prevention,

    detection and resolution

    meeting federal and state laws for patient

    safety

    meeting federal, state and private payer

    health care requirements

    INTRODUCTION

    Benefits COMPLIANCE

    PLANS

    What are the benefits of compliance plans?1

    1. Demonstrate the clinical laboratorys strong commitment to

    honest and responsible corporate conduct

    2. Provide a more accurate view of employee behavior relating to

    fraud and abuse

    3. Identify and prevent criminal and unethical conduct

    4. Improve the quality, efficiency and consistency of services

    5. Create a centralized source for distributing information related to

    fraud and abuse and related issues

    health care statutes

    regulations

    other program directives

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    Benefits COMPLIANCE

    PLANS

    What are the benefits of compliance plans?1

    7. Develop a methodology that encourages employees to report

    potential problems

    8. Develop procedures that allow the prompt, thorough investigation

    of alleged misconduct by corporate officers, managers and other

    employees

    9. Initiate immediate, appropriate, and decisive corrective action

    10.Through early detection and reporting, minimizing the loss to the

    Government from false claims

    Objectives INTRODUCTION

    Upon completion of this course, you should be able to

    Define critical areas of compliance for all laboratories

    List the basic elements of a model compliance plan (OIG)

    State the basic requirements of HIPAA

    Describe types of CLIA certification

    State key requirements of CLIA compliance

    Define required Quality Systems in a lab

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    Edward and Celeste have been tasked by their supervisor to ensure the

    current compliance planS for their lab have all the bases covered.

    INTRODUCTION

    Thanks for meeting with me about this

    Celeste. Between the two of us, I think we

    can make sure our policies are up to

    FEDERAL standards.

    I am happy to help- I know it is a big

    undertaking. Can you tell me a little

    more about what areas of compliance

    we need to review?

    Areas of Compliance INTRODUCTION

    THREE critical areas of compliance for all laboratories are defined by

    Office of Inspector General (OIG)

    Health Insurance Portability and Accountability Act (HIPAA)

    Centers for Medicare and Medicaid Services (CMS) and the Clinical

    Laboratory Improvement Amendments of 1988 (CLIA)

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    Office of Inspector Generals (OIG) Mission

    Protect the integrity of the Department of Health and Human Services

    (DHHS) programs and health and welfare of the program beneficiaries.

    Overview of OIG OFFICE OF

    INSPECTOR

    GENERAL

    hospitals

    clinical laboratories

    home health agencies

    third-party billing

    companies

    durable medical equipment

    prosthetics

    orthotics

    supply industry

    hospices

    Medicare advantage

    organizations

    nursing facilities

    ambulance suppliers

    physicians

    pharmaceutical

    manufactures

    Compliance programs are mandatory for all Medicare and Medicaid

    providers including

    Components of

    Compliance Plans

    OFFICE OF

    INSPECTOR

    GENERAL

    The 7 elements of an effective compliance program include

    1. written policies and procedures

    2. compliance officer and compliance committee

    3. training and education

    4. lines of communication

    5. well-publicized disciplinary guidelines

    6. auditing and monitoring

    7. prompt response and corrective action

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    Written Policies &

    Procedures

    COMPLIANCE

    PLANS

    Standards of Conduct

    Medical Necessity

    Billing

    Reliance on Standing Orders

    Compliance with Applicable HHS Fraud Alerts

    Marketing

    Prices Charged Physicians for Profiles

    Retention of Records

    Compliance as an Element of a Performance Plan

    This should include

    Compliance Officer &

    Compliance Committee

    COMPLIANCE

    PLANS

    Oversees and monitors the implementation of the compliance program

    Regularly reports to clinical laboratorys governing body

    Develops and distributes written polices and procedures to all affected

    employees

    Revises the program based on necessary changes within the organization

    Develops, coordinates and participates in educational and training

    programs on the elements of the compliance plan

    The Compliance Officer

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    Compliance Officer &

    Compliance Committee

    COMPLIANCE

    PLANS

    Ensures physicians who order services from the clinical laboratory are

    informed of the compliance program standards

    Assists the clinical laboratorys financial management in coordinating

    internal compliance review and monitoring activities

    Responds and investigate to all reports of compliance problems

    Develops policies and programs that encourage employees to report

    suspected problems without fear of retaliation

    Compliance Committee should be established to advise the compliance

    office and assist in the implementation of the compliance program.

    The Compliance Officer

    Training &

    Education

    COMPLIANCE

    PLANS

    At first hire

    Periodically thereafter (i.e. yearly)

    This should include training in Federal and State

    statutes, regulations, program requirements, the

    policies of private payers and ethics.

    Targeted training for employees whose actions

    affect the accuracy of the claims submitted to the

    government and private payers.

    All affected employees should be required to attend specific training

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    Well-published

    Guidelines

    COMPLIANCE

    PLANS

    Discipline policy and actions for employees who have failed to comply with

    the clinical laboratorys standards of conduct, policies and procedures or

    Federal and State Laws

    New employee policy that has a prudent background investigation

    including a reference check for each employee that may have

    discretionary authority to make decisions that involve compliance with the

    law or compliance oversight

    This should include a

    Lines of

    Communication

    COMPLIANCE

    PLANS

    Access to the compliance officer

    Use of hotlines or other forms of anonymous

    communication can :

    foster compliance throughout your department

    encourage continuous improvement

    awareness of problems

    This should include

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    Auditing & Monitoring COMPLIANCE

    PLANS

    Establish ongoing evaluation processes involving thorough monitoring

    and regular reporting to the clinical laboratorys corporate officers.

    Compliance audits by either internal or external auditors with experience in

    Federal and State health care statues, regulations and program requirements

    of private insurers is recommended.

    Suggested techniques include

    On-site visits

    Interviews with personnel

    Questionnaires

    Review of requisition forms and

    other documents that support

    claims for reimbursement

    Review of written materials and

    documentation produced by the

    lab and used by the physicians

    and other staff that order tests

    Trend analysis looking for

    deviations in billing or ordering

    Be independent of line

    management

    Have access to existing audit

    resources and personnel

    Present written reports on

    compliance activities

    Identify areas for improvement

    Assessing the compliance plan is an component of the compliance

    plan under OIG guidelines

    Identifies weaknesses

    Provides insight for improvements

    Demonstrates effective policies and procedures

    Ensures a complete and effective compliance plan

    Assessing

    Compliance Plans

    COMPLIANCE

    PLANS

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    Prompt Response &

    Corrective Action

    Click NEXT to continue

    COMPLIANCE

    PLANS

    This is important for the compliance office to promptly investigate deal

    with violations and take corrective actions if necessary.

    Report the matter to the appropriate governmental authority within a

    reasonable period, but no more than 60 days after determining that there is a

    credible evidence of violation.

    Knowledge Check

    Scenario

    An employee comes to you and says she knows that the techs are not

    putting in the proper computer codes for a TNP (test not performed) on

    clotted samples. She is concerned that the lab is billing for these tests.

    COMPLIANCE

    PLANS

    What are the next steps for the compliance office?

    Compare your response to this model answer:

    The next steps are for the compliance office are:

    1. Investigate the alleged fraudulent activity

    2. Take corrective actions

    3. Take disciplinary actions if necessary

    4. Report the incident within a reasonable time frame (no more than

    60 days)

    5. Provide re-training/education for employees

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    Health Insurance Portability and Accountability Act of 1996 (HIPAA)2

    specifies a series of administrative, technical and physical security

    procedures

    assures the confidentiality of electronic protected health information

    provides national standards and training to improve efficiency of the

    health care system

    Overview of HIPAA HIPPA

    Health plans

    Health care clearinghouses

    Health care providers that

    transmit health information in

    electronic form

    What information is protected?3

    Any information that identifies a patient as it relates to

    the individuals past, present or future health condition

    the provision of health care received by the individual

    the past, present, or future payment for the provision of health

    care to the individual

    HIPPA Privacy Rule

    Who is covered by the HIPPA

    privacy rule?

    HIPPA

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    Knowledge Check

    Scenario

    A man walks into the clinical lab demanding a copy of his blood test

    results. He is unhappy because the physician that ordered the test has not

    provided his test results in a timely manner. The patient is upset when he

    hears that the lab does not routinely release patient test results to the

    patient and says I know my rights, HIPPA regulations says patients have

    the right to get copies of their medical records.

    Must the lab release his test results?

    oYes

    oNo

    HIPPA

    No. Labs certified under the Clinical Laboratory

    Improvements Amendments (CLIA) may

    disclose test results or reports only to

    authorized people. Individual states can choose

    to adhere to the federal laws definition of

    authorized person, which is the person who

    orders the test - in this case, the physician.

    Key Elements CLIA

    Based on complexity

    Proficiency Testing (PT)

    Quality assessment and quality

    systems

    Personnel standards

    Specific state laboratory

    requirements

    Can you tell me some basics about

    CLIA before we get into the specifics?

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    Who needs a CLIA Certificate?5

    All facilities performing even one test, including waived tests

    Tests completed on materials derived from the human body for the

    purpose of

    Clinical Laboratory

    Improvement Amendments

    CLIA

    diagnosis

    prevention

    treatment of any disease or

    impairment

    assessment of health

    This also includes procedures to determine,

    measure, or otherwise describe the presence

    or absence of various substances or organisms

    in the body.4

    CLIA

    Certificate of Waiver (COW)

    Certificate for Provider

    Performed Microscopy

    (PPM) Procedures

    Certificate of Registration

    (COR)

    Certificate of Compliance

    (COC)

    Certificate of Accreditation

    (COA)

    CLIA Certification CLIA

    Click on each of the certification types below to

    learn more.

    Note: All types of CLIA certificates are

    effective for two years.

    Certificate of Waiver (COW)5

    The certificate of waiver is issued to a

    lab that only performs waived tests.

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    CLIA

    Certificate of Waiver (COW)

    Certificate for Provider

    Performed Microscopy

    (PPM) Procedures

    Certificate of Registration

    (COR)

    Certificate of Compliance

    (COC)

    Certificate of Accreditation

    (COA)

    CLIA Certification CLIA

    Click on each of the certification types below to

    learn more.

    Note: All types of CLIA certificates are

    effective for two years.

    Certificate for Provider Performed

    Microscopy (PPM) Procedures5

    physician, midlevel practitioner or

    dentist performs specific

    microscopy procedures on the

    patient

    a limited list of microscopy

    procedures is included

    categorized as moderate

    complexity.

    CLIA

    Certificate of Waiver (COW)

    Certificate for Provider

    Performed Microscopy

    (PPM) Procedures

    Certificate of Registration

    (COR)

    Certificate of Compliance

    (COC)

    Certificate of Accreditation

    (COA)

    CLIA Certification CLIA

    Click on each of the certification types below to

    learn more.

    Note: All types of CLIA certificates are

    effective for two years.

    Certificate of Registration (COR) 5

    Issued to labs conducting

    nonwaived testing until the lab has

    been inspected to determine its

    compliance

    Only labs applying for a certificate

    of compliance or a certificate of

    accreditation will receive a

    certificate of registration

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    CLIA

    Certificate of Waiver (COW)

    Certificate for Provider

    Performed Microscopy

    (PPM) Procedures

    Certificate of Registration

    (COR)

    Certificate of Compliance

    (COC)

    Certificate of Accreditation

    (COA)

    CLIA Certification CLIA

    Click on each of the certification types below to

    learn more.

    Note: All types of CLIA certificates are

    effective for two years.

    Certificate of Compliance (COC) 5

    Issued to labs performing

    nonwaived (moderate and/or high

    complexity) testing

    Issued to a lab once CMS has

    ensured compliance with CLIA

    requirements (usually an on site

    inspection by CMS or a state

    agency)

    Laboratory remits appropria...

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