Most healthcare providers will find themselves investigated at some point in their career. Even the most careful and compliance minded practitioners ae likely to run afoul of one of these acronym agencies. That is because these agencies have been proliferating in recent years. With the risk of an investigation growing, it is important to understand how handle a visit or call from one of these state or federal investigators.
Who can come calling?
- FBI – Federal Bureau of Investigation
- AG- The Attorney General
- OIG- Office of the Inspector General
- OMIG- Office of the Medicaid Inspector General
- OSHA- Occupational Safety and Health Administration
- OPMC- Office of Professional Medical Conduct
- OPD- Office of Professional Discipline
- BOM- Board of Medicine
- DEA- Drug Enforcement Agency
- MEC- Medical Executive Committee
- CMS- Centers for Medicare Services
- HMO- Health Maintenance Organization
- IRS- Internal revenue service
What Laws do they utilize?
- FCA- the False Claims Act
- AKS- Anti-Kickback Statute
- EMTALA- Emergency Medical Treatment and Active Labor Act
- CLIA – Clinical Laboratory Improvement Act
- PSRL- Physician Self-Referral Law (Stark Act)
- HIPAA- health Insurance Portability and Accountability Act
- CMPL- Civil Monetary Penalties Law
The organizations listed above are all interested in investigating healthcare practices and will cross report their investigations to other agencies. This level of cooperation between agencies is made easier thanks to the National Practitioner Database (NPD) which all physicians are obligated to register. This databank records medical malpractice, hospital actions, licensing actions, government actions and actions taken by health plan or managed care companies.
How should I respond?
The best way to respond is to follow the golden rule: no physician or employee should speak or allow anyone to speak to investigators, an attorney (other than their own retained counsel) or the media. You can manage your exposure to risk simply by not answering any questions. What you do not say, cannot hurt you.
Request Proper ID:
If you, or one of your staff members, receive a knock at the door from an investigator, the first thing you, or your staff member, should do is check the investigator’s identification and credentials. It is important to keep a copy of this information containing such individual’s name, title, agency and contact information including phone, fax, address and email (i.e. in the form of a business card), as well as the date and time the investigator arrived at the office. This information should be kept in a safe place for future reference.
Physicians must remember to live by the golden rule — NEVER speak to, or allow anyone in your office to speak to, any investigator! Although these investigators are often friendly, it is important to remember that their intention is to obtain as much information from you and your staff as possible with respect to your practice. Other tactics often used by investigators are intimidation and promises of leniency. It is especially important to never speak with an investigator without counsel as anything that is said to the investigator can and will be used against you. Unfortunately, many physicians and their staff speak freely and recklessly with investigators without counsel, and they often share information which is detrimental to the practice. Even if counsel is retained after the discussions, the information initially shared will always remain in the record.
You and your staff are not obligated to speak with anyone without counsel, and therefore you should explain to any visiting investigator that you would be more than happy to speak with the investigator, however, he/she needs to speak with your attorney first. It is important to note that government investigators do not possess subpoena power or have other legal authority by which to compel you to speak with them. Once counsel is obtained, you, the investigator and your attorney can set up a mutually convenient time to speak. Prior to such meeting, the attorney can often ascertain information from the investigator as to why your practice is under investigation and the specific areas of concern. This can often help in formulating an appropriate response at the meeting. Furthermore, you will be able to make certain that there is no disruption in the continuity of patient care and office operations generally.
Request for Records/Documents:
In most instances, visiting investigators will make a request to obtain a copy of medical records and other documents involving the practice, including contracts and corporate documents. Your staff should be informed that they should not release any records without first speaking with you. Furthermore, it is recommended that you not provide the investigator with the requested records immediately upon request. Instead, it is recommended that you or your attorney request that all such requested information be provided in writing so that you and your attorney can ensure that the requested records are within the appropriate scope and that the investigator is entitled to such records. Furthermore, by providing the records directly to the agency, you are in control of what is provided, and you can ensure that complete copies of the records are provided. Unfortunately, when investigators make copies upon an initial visit, often the investigators do not make complete copies of the records, or they copy additional information that may not be part of the initial request. As such, it is best to either provide the records directly, or set up a time for the investigator to come back after hours to make the copies. In addition to controlling the information disclosed, this will limit disruptions to your office.
Prior to turning over such information, specifically medical records, you also need to confirm that such disclosure is compliant with HIPAA and state privacy rules and regulations, and that the appropriate authorizations have been obtained.
A visit from an investigator can be an overwhelming and daunting experience. As such, even the most informal, initial contact by an investigator should prompt an immediate and well-coordinated reaction. It is therefore important to be prepared and to inform your staff ahead of time of the practice’s protocols with respect to responding to a visit from an investigator. As such, it is recommended to have a written policy in place outlining the specific steps that your staff should take in such instances, including contacting legal counsel and providing medical records. These protocols are extremely important and can often mitigate an agency’s findings. As noted above, physicians need to ensure that they protect their interests and limit their exposure while cooperating with investigators, as the results of an investigation can be detrimental to a practice.
About the Authors
Mathew J. Levy is a Shareholder/Director at Weiss Zarett Brofman Sonnenklar & Levy, PC and co-chairs the Firm’s corporate transaction and healthcare regulatory practice. Mr. Levy has extensive experience in, defending healthcare professionals in actions brought by State licensing authorities and Federal agencies. Mr. Levy has successfully defended numerous healthcare providers in actions involving the US Attorney’s Office investigations, Medicare Fraud Waste and Abuse investigations, Medicaid Fraud Control Unit investigations, OPMC, OPD, Medicare, Medicaid as well as commercial insurance audits. Mr. Levy has successfully structured and negotiated joint venture agreements, private equity transactions, venture capital transactions, stock purchase agreements, asset sale agreements, shareholders agreements, partnership agreements, employment contracts, managed care agreements and commercial leases. Mathew Levy can be reached at 516-926-3320 or [email protected].
Stephen J. Cucolo is an associate at Weiss Zarett Brofman Sonnenklar & Levy, PC with experience representing healthcare providers in connection with transactional and regulatory matters including the formation and structure of business entities, negotiating and drafting contracts. Mr. Cucolo can be reached at 516-627-7000 or [email protected].
Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a Long Island law firm providing a wide array of legal services to the members of the health care industry, including corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.
This article contains general advice that is not designed to apply to the reader’s specific situation and does not constitute the formation of an attorney-client relationship.
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By Mathew J. Levy, Esq.
Stephen Cucolo, Esq.