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Debbie Troklus, CHC-F, CCEP-F, CHRC, CHPCManaging Director

AEGIS Compliance & Ethics Centerdtroklus@aegis-compliance.com

Background Federal Sentencing Guidelines Seven Essential Elements Compliance Challenges Regulatory Introduction Resources Discussion

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Defines ethical and proper way to do business

Communicates commitment Encourages problems to be reported Provides constant monitoring Documents actions

Raises Awareness Can be a Mitigating Factor Can help to Avoid a Corporate Integrity

Agreement May reduce threat of Qui-Tams Recommended by Government

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Voluntary Disclosure Hospital Laboratory Home Health Third Party Billing DME Hospice

Medicare + Choice Nursing Facilities Ambulance Pharma Hospital Supplemental Research (draft)

Effective November 1, 1991 Revised November 2004 and 2010 Control sentencing of organizations for most

federal criminal violations Sentencing credit for “effective programs to

prevent and detect violations of law”

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Corporate responsibility Appropriate authority Adequate resources Ongoing risk assessments Effectiveness review Training an essential element Mandating means for anonymous reporting Add, “specifically encourage prevention and

deterrence of violations of the law as part of compliance programs”

First, the organization must respond appropriately to the criminal conduct, including restitution to the victims, self-reporting and cooperation with authorities.

Second, the organization must assess its program and modify it to make the program more effective. They seem to encourage the use of an independent monitor to ensure implementation of the changes.

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You can get credit for having an effective program, provided you meet the new criteria:

the head of the compliance program must report directly to the governing authority or appropriate subgroup,

the compliance program must discover the problem before discovery outside the organization was reasonably likely,

the organization must promptly report the problem to the government, and

no person with operational responsibility in the compliance program participated in, condoned or was willfully ignorant of the offense.

◦ Standards and Procedures◦ Oversight◦ Education and Training◦ Monitoring and Auditing◦ Reporting◦ Enforcement and Discipline◦ Response and Prevention

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Code of Conduct◦ Keep It Simple – understandable◦ Multi-lingual if necessary◦ Attestation

Compliance Plan Document◦ Annual review

Compliance Office Policies◦ Updated to reflect current processes

Institutional Policies

Records Management and Retention Conflict of Interest Confidentiality Privacy and Security Investigations Non-retaliation/Non-retribution Others

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Compliance Office scope as outlined in the CP document

Compliance Officer Oversight Committee◦ Membership◦ Responsibilities

Other Committees as needed Board

◦ Critical to success◦ Approve scope ◦ Review and approve plan and results◦ Periodic updates◦ Education◦ “Corporate Responsibility and Corporate Compliance: A Resource for Health Care

Boards of Directors”◦ Relevant OIG Guidance risk areas

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Annual education of at least an hour Focused education Orientation Varied methods Non-participation sanctions Evaluation

Annual Audit Plan External Environmental Factor Internal “Audits” vs. Compliance “Reviews” Concurrent or retrospective Prioritization

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Hotline◦ Internal or external◦ Confidentiality◦ Anonymous

Direct contacts Feedback No retribution for reporting

Sanctions for non-compliant behavior Fair and Consistent Institutional corrective action policy Include in Medical staff by-laws OIG and GSA sanctions reviews

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Internal Investigation◦ Is it really a problem?◦ How serious is it?◦ Are their enough facts to

investigate? Consult Audit Contact Legal Counsel

Interviews and Discovery Assess Findings Revise/Create

Policy/Procedure Follow up review

Protect process and initial data gathering Provides for internal assessment before

determining actions “Waiver of the privilege for the government

acts as a waiver for all purposes”

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Investigators have the right to contact you You have the right to ◦ decide on an interview – you may refuse◦ contact an attorney and have present◦ decide where and when to have interview◦ tell your employer

Staff policy

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Annual review of written program Continual review of policies and procedures◦ Are policies being followed?◦ Revisions necessary?◦ Awareness◦ Who is responsible?

FROM Ad Hoc Limited/Centralized

Oversight Informal or No

Policies/Procedures Inspect, Detect, React Unknown Risks

TO Planned, Continuous

Activity Oversight by Everyone Formal, Written Policies

and Procedures Anticipate, Prevent,

Monitor Risk Mitigation and

Prevention

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Kickbacks Physician self-referral (“Stark”) Pharmaceutical and marketing Clinical research Quality of care Medicaid Others

False Claims Act Criminal Penalties Civil Monetary Penalties Anti-kickback Laws Stark Laws Corporate Integrity Agreements (CIA)

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Applies to “any person” who “knowingly presents or causes to be presented”

A “false or fraudulent claim for payment” To the “United States Government” “Knowingly” includes acting in “reckless

disregard of truth or falsity of the information”

“No proof of specific intent to defraud is required’

Felony for failure to disclose a known overpayment even if initially obtained innocently

Continuing offense = pattern Failure to disclose = intent at time of decision Concealment after the fact = scheme Prison, fines and restitution Exclusion CMPs CIAs Others

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Applies to “any person (including an organization, agency or other entity, but excluding a beneficiary...)”

Not limited to provider/practitioners Remedies for false or fraudulent claims◦ Up to $10,000 for each item or service improperly claimed◦ Up to 3 times the amount improperly claimed◦ Exclusion

Knowing and willful offer, payment, solicitation, or receipt of remuneration to induce Federal program referrals

Penalty up to $50,000 for each act Assessment of up to 3 times the total

remuneration Exclusion

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Submits claims that knows or should know should not be paid because provider has improper financial relationship with physician referral source

$15,000 per service civil monetary penalty and imposition of a $100,000 civil monetary penalty for each arrangement considered to be a circumvention scheme.

Assessment of up to 3 times the amount improperly claimed

Exclusion

Currently monitoring over 400 CIAs Typically 3 to 5 years in duration (some are

for up to 8 years) Requires corporate integrity program in

exchange for the OIG’s agreement not to seek an exclusion

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Corporate Integrity Agreements include requirement to:

◦ Hire a compliance officer / appoint a compliance committee◦ Develop written standards and policies◦ Implement a comprehensive employee training program◦ Review claims submitted to Federal programs◦ Establish a confidential disclosure program◦ Restrict employment of ineligible persons; and◦ Submit a variety of reports to the OIG

The Federal Anti-Kickback Statute, found in Section 1128B(b) of the Social Security Act

Emergency Medical Treatment and Active Labor Act of 1986 codified at 42 U.S.C. § 1395DD

http://www.cbo.gov/showdoc.cfm?index=7028&sequence=0◦ DRA 2005

Fair Labor Standards Acts of 1938, as amended, 29 U.S.C.A. §216(a)(1947);

Employee Retirement Income Security Act of 1974 (ERISA), 18 U.S.C.A. §1027 (1974);

Export Administration Act of 1979, as amended 50 U.S.C.A. App §2410 (1988)

Comprehensive Environmental Response Compensation and Liability Act of 1980, 42 U.S.C.A. §9696(b) (1980);

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Clean Water Act, as amended, U.S.C.A. §1319(c) 91987); Clean Air Act, as amended, 42 U.S.C.A. §7513(c ) (1990); Toxic Substance Control Act, 15 U.S.C.A. §2615(b) (1976); Sherman Antitrust Act, as amended, 15 U.S.C.A. §2615(b)( 1976); Security Exchange Act of 1934, as amended, 15 U.S.C.A. §78Fff (1988) Hazardous Materials Transportation Act, 49 U.S.C.A. §1809(b) (1975); Foreign Corrupt Practices Act of 1977, as amended, 15 U.S.C.A. §78 dd-2

(1988); Federal Election Campaign Act of 1971, as amended, 2 U.S.C.A. §437(d)

(1974); Bribery of Public Officials and Witnesses, 18 U.S.C.A. §201 (1986); False Declarations Before a Grand Jury or Court, 18 U.S.C.A. §1623 (1976).

Securities Exchange Act off 1933, as amended, 15 U.S.C.A. §77x (1975); Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C.A. §77x

(1975); Occupational Safety & Health Act of 1970; 29 U.S.C.A. §666(e), (f),&(g)

(1970); Labor Management Reporting and Disclosure Act of 1959, 29 U.S.C.A.

§186(d) (1984), §439 (1959);

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http://www.firstgov.gov/Federal Register and much morehttp://www.house.gov/budget/Budget Informationhttp://www.usdoj.govThe U.S. Department of Justice home pagehttp://www.oig.hhs.gov/fraud/complianceg

uidance.htmlOIG Work Planshttp://www.taf.org/Tax Payers Against Fraud

http://www.hcca-info.orgHealth Care Compliance Associationhttp://www.acep.orgAmerican College of Emergency

Physicianshttp://www.biller.comInternational Billers Association

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http://www.aha.orgAmerican Hospital Associationhttp://www.ama.assn.orgAmerican Medical Associationhttp://www.aamc.orgAssociation of American Medical Collegeshttp://www.prnewswire.com/Health/Biotech news areahttp://www.harp.org/h1415sum.htmAccess to Responsible Health Care Acthttp://www.harp.org/index.htmlA resource for patients, providers, and attorneys seeking to establish the liability of managed health

care organizations and nursing facilities for the consequences of their decisions

http://www.hhs.gov/U.S. Department of Health and Human Serviceshttp://www.cms.hhs.gov/home/regsguidance.aspMedicare and Medicaid program manualshttp://www.irs.gov/exemptInternal Revenue Service (IRS) section on charities and non-profit organizations

http://www.cms.hhs.gov/NationalCorrectCodInitEd/National Correct Coding Initiative reference information

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http://www.prnewswire.com/Health/Biotech news areahttp://www.harp.org/h1415sum.htmAccess to Responsible Health Care Acthttp://www.harp.org/index.htmlA resource for patients, providers, and attorneys seeking to establish the liability of

managed health care organizations and nursing facilities for the consequences of their decisions