JO - Health Care Compliance Association

More documents

Recommendations

Info

COMPLIANCE 101 September 2006 36 Investigations 101: Practical advice for new compliance officers By Kenny A. Johnson, Esq. Editor’s note: Mr. Johnson is the Director, Legal Compliance for Quest Diagnostics, Incorporated. He may be reached by email at kenny.a.johnson@questdiagnostics.com or by telephone at 972/884-1063. A health care organization’s ability to perform timely and thorough compliance investigations is critical in helping to demonstrate an Effective Compliance and Ethics Program as required by the Federal Sentencing Guidelines for Organizations (FSGs). 1 Specifically, a good investigative process satisfies the FSG elements that require an organization to: (1) ensure its compliance program is followed, promoted, and consistently enforced; (2) take appropriate disciplinary measures for confirmed violations; and (3) take reasonable steps to respond appropriately to an offense. 2 In addition to the FSGs, the Office of Inspector General (OIG) has issued numerous compliance guidance documents that echo these requirements and emphasize the importance of an independent and rigorous investigative process. For example, the OIG’s Compliance Program for Clinical Laboratories Guidance contains a specific section entitled “Corrective Action – Investigating, Reporting and Correcting Identified Problems.” 3 This article is designed to provide Compliance officers—particularly new Compliance officers—with practical advice on how to conduct compliance investigations that satisfy the FSGs and program guidance requirements listed above. 4 This guidance is tailored to the internal compliance investigation that a Compliance officer is likely to perform in the normal course of business. It is not intended as guidance on how to investigate more serious matters that may require a formal legal investigation, such as in response to a government subpoena. For these matters, compliance officers should immediately contact legal counsel or senior management for advice before taking any actions. Initial considerations—Should legal counsel direct the investigation? In many cases, compliance infractions not only constitute policy violations, they may also constitute violations of federal and state laws (e.g., the federal anti-kickback statute, Stark legislation, and civil false claims act). Confirmed violations of these laws can result in significant liability and negative consequences for any health care provider, including severe fines, restitution payments, a Corporate Integrity Agreement, or in extreme cases, exclusion from participating in federally funded health care programs. Due to these perils, compliance officers should carefully evaluate compliance allegations prior to beginning any investigation. For example, if the allegations relate to potential violations of federal or state fraud and abuse laws, it may be in the organization’s best interest to have legal counsel perform or direct the investigation to help ensure the review will be protected by the attorney-client privilege. In general, a compliance officer’s investigation is protected by the attorney-client privilege Kenny A. Johnson Health Care Compliance Association • 888-580-8373 • www.hcca-info.org only if legal counsel directs the investigation and only if the investigative findings are reported to counsel for the purpose of providing legal advice. This privilege cannot be claimed after the fact—any review performed prior to involving legal counsel is not privileged, even if legal counsel is subsequently retained. As such, it may be advisable for health care providers to adopt specific policies and procedures that provide compliance officers with advance directives on how to investigate compliance matters and when to involve legal counsel. Compliance officers should be aware that even if an attorney performs or directs an investigation, it does not automatically mean the matter will be privileged. For example, some courts have ruled that no privilege exists for matters performed or directed by in-house counsel on the basis that the work was performed in the ordinary course of business and not to provide legal advice. Beginning the investigation A compliance officer’s primary role in performing a compliance investigation is to obtain all relevant facts to help management determine if a violation has occurred. In almost all cases, this will require interviewing employees and reviewing pertinent documents. Most internal investigations involve only employee interviews. If individuals Continued on page 38
The Health Care Compliance Association presents Medicare Prescription Drug Par t D Compliance Conference The Health Care Compliance Association (HCCA) will be holding a Medicare Prescription Drug Part D Compliance Conference in Baltimore, MD, September 10–12, 2006. Topics to include: Part D Drug Coverage Fraud and Abuse Under Part D Long-Term Care Issues Pharmacy Appeals & Grievance Auditing & Monitoring Discipline & Enforcement Save the Date September 10–12, 2006 Renaissance Baltimore Harborplace Hotel 202 East Pratt Street, Baltimore, MD 21202 Tel 800-535-1201 • Fax 410-539-5780 To register, please visit www.hcca-info.org Health Care Compliance Association • 888-580-8373 • www.hcca-info.org September 2006 37
Page 1 and 2: Volume Eight Number Nine September
Page 3 and 4: ASK John asks the leadership your q
Page 5 and 6: the Health Care Compliance Associat
Page 7 and 8: Health Care Compliance Association
Page 11 and 12: You’re a compliance professional,
Page 13 and 14: A-110, or applicable regulation. n
Page 15 and 16: ogy, human resources, Erickson Adva
Page 19 and 20: is to make your hotel reservations
Page 21 and 22: September 2006 Health Care Complian
Page 25 and 26: those that have already enrolled in
Page 27 and 28: New Medicare enrollment regulations
Page 29 and 30: New Medicare enrollment regulations
Page 33 and 34: properly documented IRB or Privacy
Page 35: ment, on the theory that although d
Page 39 and 40: Register Today! Physician Practice
Page 41 and 42: They also are extremely credible an
Page 43 and 44: FYI ...continued from page 22 Sterr
Page 45 and 46: ■ William Munson, North Colorado
Page 47 and 48: ® SMART2.o : bringing HIM people a

JO - Health Care Compliance Association

Create successful ePaper yourself

Delete template?

Save as template?