AB IN WEEK 7

Chapter 18:
Corporate Compliance

Fundamentals of for Health Informatics and Information Management, Third Edition

© 2017 American Health Information Management Association

© 2017 American Health Information Management Association

Compliance
Refers to adherence to federal statutes and regulations designed to
Prevent unjust financial enrichment
Patient privacy breaches by healthcare providers or organizations

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Fraud and Abuse
Fraud
A false representation of fact
A failure to disclose a fact that is material (relevant) to a healthcare transaction
Damage to another party that reasonably relies on the misrepresentation or failure to disclose

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Fraud and Abuse (continued)
Abuse
Inconsistent handling of sound fiscal, business, or medical practices resulting in
Unnecessary costs to the program
Improper payment
Services that fail to meet professionally recognized standards of care or are medically unnecessary
Services that directly or indirectly result in adverse patient outcomes or delays in appropriate diagnosis or treatment

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Most Common Types of Fraud
Billing for services that were never rendered
Billing for more expensive services or procedures than were actually provided—upcoding
Performing medically unnecessary services
Misrepresenting noncovered treatments as medically necessary
Falsifying a patient’s diagnosis to justify tests or procedures
Unbundling
Billing patients more than the copay amount for services
Accepting kickbacks for patient referrals
Waiving patient copays or deductibles and overbilling the health plan (NHCAA)

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To Combat Fraud and Abuse
Revenue cycle management
Supervision of all administrative and clinical functions that contribute to the capture, management, and collection of patient service revenues
Role of documentation
Documentation must support the billing
Claims, requests for reimbursement, and supporting documentation must be complete and accurate
Reflect reasonable and necessary services ordered by an appropriately licensed medical professional

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Key Federal Fraud Statutes
False Claims Act (FCA) (31 USC 3729)
Primary litigation tool for combating fraud, contains both criminal and civil provisions
Qui tam (whistleblower)
Private persons known as relators may enforce the FCA by filing a complaint, under seal, alleging fraud committed against government.
Provides protection to qui tam relators who are discharged, demoted, suspended, threatened, harassed, or in any other way discriminated against

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False Claims Act (FCA) (31 USC 3729)

What constitutes a false claim?
Must establish that the claim was false or fraudulent
Furnishing inaccurate or misleading information
FCA has been extended to cover quality of care cases

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False Claims Act (FCA) (31 USC 3729)
The Knowing Standard
Provider must have knowingly submitted the false claim
FCA defines “knowing” and “knowingly” to mean that a person:
Has actual knowledge of falsity of information
Acts in deliberate ignorance of truth or falsity of information
Acts in reckless disregard of truth or falsity of information

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Key Federal Fraud Statutes
Fraud Enforcement and Recovery Act of 2009: Revisions to FCA
Expanded potential for liability under FCA and also expanded government’s investigative powers
FCA penalties apply to “any person who knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval,” regardless of to whom the claim was made
Definition of a “claim” expanded to broaden the types of payments that fall within the scope of FCA

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Fraud Enforcement and Recovery Act of 2009: Revisions to FCA

Established that FCA penalties apply to “any person who knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim”
Expanded antiretaliation protections for whistleblowers
Expanded US attorney general’s authority to issue civil investigative demands
Broadened the federal government’s authority to share documents obtained through subpoena with qui tam relators and other parties

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Patient Protection and Affordable Care Act: Revisions to the FCA

Known as the health reform bill
Further amends the FCA by allowing private individuals more successful in filing false claims lawsuits
Broadened the definition of “original source” to allow public disclosure defense to be overcome if individual bringing suit possesses knowledge that adds to publicly disclosed information
Clarified retention of overpayments

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Federal Anti-Kickback Statute
(42 USC 1320a-7b)

Establishes criminal penalties for individuals and entities that knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce business for which payment may be made under any federal healthcare program
Remuneration: Defined broadly to include the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind
Violation constitutes a felony punishable by a fine of up to $25,000, imprisonment for up to five years, or both
Clearly prohibits payments for patient referrals

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Federal Anti-Kickback Statute
(42 USC 1320a-7b) (continued)

Statutory exceptions created to protect legitimate business arrangements
Discounts that are properly disclosed and reflected in the costs claimed
Payments by an employer to an employee for provision of covered items and services
Certain risk-sharing arrangements
Waivers of coinsurance amounts in connection with certain federally qualified healthcare centers

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Federal Anti-Kickback Statute
(42 USC 1320a-7b) (continued)

Safe harbors: Activities that are not subject to prosecution and protect the organization from civil or criminal penalties
Investments in certain large or small entities
Investments in entities in underserved areas
Space and equipment rental
Common theme: To protect certain arrangements in which commercially reasonable items or services are exchanged for fair market value compensation

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Safe Harbor for EHRs
Are intended to protect beneficial arrangements that would eliminate perceived barriers to the adoption of EHRs without creating undue risk that the arrangements might be used to induce or reward the generation of Federal healthcare program business (HHS OIG 2006, 2013a).
Figure 18.1 lists the safe harbors for EHRs

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Civil Monetary Penalties (CMP)
Provides administrative remedies
Authorizes secretary and inspector general of HHS to impose CMPs, assessment, and program exclusions on individuals and entities whose wrongdoing caused injury to HHS programs or their beneficiaries
Up to $50,000 per violation and treble damages

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The Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, part of the Bipartisan Budget Act (Pub. L. 114-74), required federal agencies to update the level of their civil monetary penalties to account for inflation, with automatic annual adjustments thereafter.
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Federal Physician Self-Referral Statute (the Stark )

Prohibits physicians from ordering designated health services for Medicare (and to some extent Medicaid) patients from entities with which the physician, or an immediate family member has a financial relationship
Exclusions
Services that are reimbursed by Medicare as part of a composite rate
Certain referral relationships are permitted, such as a request by a pathologist for clinical diagnostic laboratory tests.
Physician services exception
In-office ancillary services
Financial arrangements between academic institutions and their affiliated hospitals and physicians

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Figure 18.2 lists the designated health services under the Stark
Figure 18.3 lists Stark exceptions to the referral prohibition

pp. 448 of the text lists changes based on the 2016 Medicare fee schedule to add 2 new exceptions
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Sherman Antitrust Act

Illegal to restrain trade through contracts or conspiracies, and they prohibit price fixing and mergers that lessen competition
Federal Trade Commission (FTC) and the Department of Justice enforce these laws
Healthcare mergers and joint ventures and credentialing and peer review processes must be carefully handled to avoid anti-trust issues

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HIPAA—Expanded OIG
Sanction authorities
Application of CMP provisions beyond those funded by HHS to include all federal healthcare programs (e.g., Tricare, Veterans Affairs, and Public Health Service)
Strengthened the OIG’s CMP penalties for violations under Medicare and state healthcare programs

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Deficit Reduction Act of 2005

Transitioned compliance programs from voluntary to mandatory
Contains employee education about FCR provision
Written policy must provide
Detailed information about the FCA
Administrative remedies for false claims and statements
Any state laws pertaining to civil or criminal penalties for false claims and statements
Whistleblower protections
Detailed provisions regarding the entity’s policies and procedures for detecting and preventing fraud, waste, and abuse

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Employee education provision, which requires any entity that annually receives or makes at least $5 million in Medicaid payments to establish written policies for all employees of the entity (including management) and for any contractor or agent of the entity

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Patient Protection and Affordable Care Act (ACA)
Expanded funding of enforcement efforts
Expansion of RACs to Medicare Part C & D and Medicaid
Added penalties
Requiring Medicare and Medicaid overpayments to be returned in 60 days

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More information on pages 450-452 if you want to cover more detail
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OIG List of Excluded Individuals and Entities
Medicare fraud
Patient abuse or neglect
Felony convictions related to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct in connection with the delivery of a healthcare item or service
Felony convictions for unlawful manufacture, distribution, prescription, or dispensing of controlled substances
OIG has the discretion to impose exclusions for other reasons

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High-Risk Areas for Potential Fraud and Abuse
Billing for noncovered services
Altered claim forms
Duplicate billing
Misrepresentation of facts on claim form
Failing to return overpayments

Unbundling
Billing for medically unnecessary services
Overcoding or upcoding
Billing for items or services not rendered
False cost reports

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Healthcare Fraud and Abuse Control (HCFAC) program
Goal to coordinate state, federal, and local fraud and abuse activities
Healthcare Fraud Prevention Partnership (HFPP) goal is to be proactive in identifying fraud
Healthcare Fraud Prevention and Enforcement Action Team (HEAT)

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CMS—Center for Program Integrity
Fraud Prevention System (FPS)
Comprehensive Error Rate Testing (CERT) Program
MACs
Program Integrity Contractors

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Role of Department of Justice
(DOJ)

Root out fraud and safeguard taxpayers from illegal conduct
Works in collaboration with a number of other federal agencies to investigate and prosecute fraudulent activities

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Role of the Office of the Inspector General (OIG)
OIG office: Responsibility to report program and management problems to both the HHS Secretary and Congress, along with recommendations to correct them.
Annual OIG Work Plan outlines new and ongoing review activities
Fraud alerts and advisory opinions

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Corporate Compliance Programs
Evolved from 1991 US Sentencing Commission’s Federal Sentencing Guidelines
Fines and penalties reduced to organizations found guilty of fraud if organization has a fraud prevention and detection program in place
Helps organizations identify problems and improve performance and avoid a corporate integrity agreement (program imposed by government with oversight and outside expert involvement)
Program requires a compliance officer: Responsible for overseeing processes that promote an organization’s ethical business practices and its conformity to federal, state, and private payer program requirements

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Corporate Compliance Programs
Hospitals
Clinical laboratories
Home health agencies
Third-party medical milling companies
Durable medical equipment providers
Hospices
Medicare+Choice organizations

facilities
Ambulance suppliers
Individual and small group physician practices
Pharmaceutical manufacturers
Recipients of US Public Health Service (PHS) research awards
Part D plan sponsors (included in the Medicare Prescription Drug, Improvement and Modernization Act of 2003)

Who should have compliance programs place?

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Guidelines offer Seven Steps for an Effective Compliance Program

Establish compliance standards and procedures that are reasonably capable of reducing criminal conduct
Assign responsibility to oversee compliance with the standards and procedures to specific individual(s)
Use due care to avoid delegation of substantial discretionary authority to an individual
Communicate the standards and procedures to all
Achieve compliance with the standards through monitoring and auditing
Enforce standards through appropriate disciplinary mechanisms
Respond appropriately to any offense detected to prevent similar offenses in the future

© 2017 American Health Information Management Association

Figure 18.5 in text
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Elements of a Corporate Compliance Program
Compliance programs should be tailored specifically to individual organization but should at least include elements that address
Corporate code of conduct
Policies and procedures (practice standards)
Education and training
Auditing and monitoring
Offense detection and corrective action initiatives
Enforcing disciplinary standards through well-publicized guidelines

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