HHS Grants and Fraud Prevention

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Questions and Answers

What is the primary requirement for an arrangement to qualify for safe harbor protection?

Meeting at least half of the safe harbor conditions

Obtaining prior approval from the Federal government

Involving only non-profit organizations

Satisfying all conditions set forth in the safe harbor (correct)

What happens if an arrangement fails to meet even one safe harbor condition?

It may still be lawful, but does not qualify for safe harbor protection (correct)

It is subject to a fine, but notcriminal prosecution

It is automatically deemed illegal

It is exempt from the Federal anti-kickback statute

What is the purpose of reviewing the totality of facts and circumstances?

To identify problematic arrangements under theFederal anti-kickback statute (correct)

To determine whether an arrangement is illegal

To apply for safe harbor protection

To determine the intent of the parties involved

What is one of the key inquiries to explore when identifying problematic arrangements?

The nature of the relationship between the parties Signup and view all the answers

What may be a relevant factor in determining whether remuneration is prohibited?

The volume or value of business generated Signup and view all the answers

What is the purpose of 42 C.F.R.§ 1001.952?

To provide a safe harbor for certain arrangements Signup and view all the answers

What is true about the list of questions used to identify problematic arrangements?

It is an illustrative, but not exhaustive, list of questions to explore Signup and view all the answers

What is the primary focus of the Federal anti-kickback statute?

Regulating business relationships in the healthcare industry Signup and view all the answers

What is the recommended approach when evaluating an arrangement that may implicate the PSL and the Federal anti-kickback statute?

Start with an assessment under the PSL Signup and view all the answers

What is the primary purpose of the False Claims Act?

To prevent fraud and abuse in government programs Signup and view all the answers

What is a consequence of violating the Physician Self-Referral Law (PSL)?

Both fines and penalties and exclusion from Medicare and Medicaid Signup and view all the answers

What is prohibited by the False Claims Act?

All of the above Signup and view all the answers

What is the main difference between the PSL and the Federal anti-kickback statute?

One is a strict liability statute and the other is not Signup and view all the answers

What is the relationship between PSL violations and False Claims Act violations?

PSL violations may give rise to FCA violations Signup and view all the answers

What is the purpose of the Physician Self-Referral Law (PSL)?

To prevent physician self-referrals that could lead to improper Medicare and Medicaid payments Signup and view all the answers

What is a key factor to consider when evaluating an arrangement that may implicate the PSL and the Federal anti-kickback statute?

The arrangement's potential impact on Medicare and Medicaid Signup and view all the answers

What is the primary reason for HHS awardees to understand OIG's authority?

To avoid liability under OIG's authority Signup and view all the answers

What is the purpose of OIG's Exclusion Authorities?

To exclude individuals and entities from participation in all Federal health care programs Signup and view all the answers

What is included in the definition of Federal health care programs?

All plans and programs that provide health benefits funded directly or indirectly by the United States Signup and view all the answers

What is the purpose of the List of Excluded Individuals/Entities (LEIE)?

To maintain a list of all currently excluded individuals and entities Signup and view all the answers

What is the basis for OIG's mandatory exclusions?

Individuals and entities convicted of certain types of criminal offenses Signup and view all the answers

What type of criminal offenses are grounds for OIG's mandatory exclusions?

Offenses related to the delivery of an item or service under Medicare or a State health care program Signup and view all the answers

What is the purpose of section VI.G, OIG Self-Disclosure Information?

To discuss self-disclosure information specific to HHS grants and contracts Signup and view all the answers

What is the purpose of the OIG's Exclusions Page?

To provide information about the List of Excluded Individuals/Entities (LEIE) Signup and view all the answers

What is the purpose of having a means for employees to contact the compliance officer or members of the Compliance Committee?

To provide a way for employees to ask questions about policies or procedures Signup and view all the answers

What is the outcome of an effective compliance program?

Reduced risk, safe and high-quality care, and cost savings Signup and view all the answers

What is the role of senior leadership in a compliance program?

To support and commit to the compliance program's success Signup and view all the answers

What is the term used to describe the group of leaders who report directly to the executive leading the entity?

Senior Leadership Signup and view all the answers

Why should an entity devise a means of communicating and documenting interim policies and procedures?

To facilitate rapid implementation of a needed process change Signup and view all the answers

What is the role of the Compliance Officer in an entity?

To lead an effective and successful compliance program Signup and view all the answers

What is the key indicator of the board and senior leadership's commitment to compliance?

The appointment and support of a compliance officer Signup and view all the answers

What is the purpose of designating a leader as the entity's compliance officer?

To lead an effective and successful compliance program Signup and view all the answers

What is the primary purpose of the criminal health care fraud statute?

To pursue defendants who orchestrate complex health care fraud schemes Signup and view all the answers

What is the maximum imprisonment for violating the criminal health care fraud statute?

10 years Signup and view all the answers

Which agency is responsible for administering and enforcing the HIPAA Privacy, Security, and Breach Notification Rules?

HHS's OCR Signup and view all the answers

What is the main focus of the HIPAA Privacy Rule?

Protecting the privacy of individually identifiable health information Signup and view all the answers

What is the maximum fine for violating the criminal health care fraud statute?

$250,000 Signup and view all the answers

Who is responsible for enforcing the criminal health care fraud statute?

DOJ, OIG, and other law enforcement partners Signup and view all the answers

What type of entities are subject to the HIPAA Privacy Rule?

Health plans, health care clearinghouses, and those health care providers that conduct certain health care transactions electronically, and their business associates Signup and view all the answers

What is required to prove a case of criminal health care fraud?

Proof beyond a reasonable doubt Signup and view all the answers

Study Notes

Conduct Leading to Liability

HHS awardees should understand conduct that leads to liability under OIG's authority and other fraud and abuse laws
Internal controls should be in place to prevent and identify issues early

OIG Exclusion Authorities

OIG has the authority to exclude individuals and entities from participating in all Federal health care programs under Section 1128 of the Act (42 U.S.C.§ 1320a-7)
Federal health care programs include plans and programs that provide health benefits funded directly or indirectly by the United States, except for the Federal Employees Health Benefits Program
OIG maintains a list of currently excluded individuals and entities called the List of Excluded Individuals/Entities (LEIE)

Mandatory Exclusions

OIG is required by law to exclude from participation in all Federal health care programs individuals and entities convicted of certain types of criminal offenses
Offenses related to the delivery of an item or service under Medicare or a State health care program are included

Safe Harbors

Failure to meet a safe harbor does not render an arrangement automatically illegal
Individuals and entities should evaluate arrangements that implicate the statute and do not fit into a safe harbor by reviewing the totality of the facts and circumstances, including the intent of the parties

Fraud and Abuse Laws

The Federal anti-kickback statute prohibits knowingly and willfully offering, paying, soliciting, or receiving any remuneration in exchange for referrals
The False Claims Act provides a way for the Government to recover money when an individual or entity knowingly submits or causes to be submitted false or fraudulent claims for payment to the Government
The criminal health care fraud statute prohibits knowingly and willfully executing, or attempting to execute, a scheme to defraud any health care benefit program

HIPAA Privacy and Security Rules

HHS's OCR is responsible for administering and enforcing the HIPAA Privacy, Security, and Breach Notification Rules
The Privacy Rule addresses the use and disclosure of individuals' identifiable health information (protected health information or PHI) by covered entities and their business associates

Compliance Programs

Effective compliance programs reduce and mitigate risk, provide patients with safe and high-quality care, and save costs
Boards and senior leadership are vital to effective compliance programs
A compliance officer should be designated to lead the compliance program

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Description

Learn about the liabilities and internal controls related to HHS grants, contracts, and agreements, and how to prevent fraud and abuse. Understand the importance of self-disclosure and internal controls.