By: Karen Davila
You do everything right. You’re careful to dot your i’s and cross your t’s. Compliance is hard-wired because you’re in an industry that’s highly regulated and you’ve built into your operations a series of compliance checks and balances. However, even with strong controls in place, compliance efforts sometimes fall short– and whether you’re a physician group, a pharmacy, a durable medical equipment company, a home health agency, or any other health care provider, someday you might find yourself face-to-face with law enforcement officials or regulatory enforcement authorities. What do you do? How do you assure the most successful outcome with minimal business disruption?
Compliance is the foundation to mitigating the risks inherent in any health care operation. Compliance can reduce the likelihood that regulators or law enforcement suddenly appear on your doorstep. But preparation for emergencies and uncertainties is the key to reducing the risk that non-compliance leads to lengthy business interruption. Although you may be saying “if”, you really should be thinking and acting more like “when”. It costs everything to be ill-prepared and it costs very little to be well-prepared. The following preparation can prevent much of the uncertainty that arises in these cases.
POLICIES AND PROCEDURES
First and foremost, make sure you have well-developed policies and procedures for what to do in such instances. You should review these policies and procedures with your employees regularly, focusing on the importance of compliance. Out of fear and uncertainty, employees can do things that create unnecessary challenges. Educating them as to what their rights and responsibilities are will mitigate those risks. Make sure your policies and procedures include the designation of who is in charge (“person in charge”) when the government does show up.
“KNOCK-KNOCK”: EMERGENCY CONTACTS
Your policies and procedures should include the required notifications. Instruct employees to immediately notify a supervisor. Supervisors should know who they are to alert. These contacts should be maintained on a list accessible to appropriate employees and supervisors at all times of day/night. And the organization should establish and maintain a relationship with an attorney who has expertise in regulatory enforcement. This can be done through a retainer arrangement or simply through an established relationship with ability to contact the attorney by cell phone in emergencies.
The employee or supervisor who is present upon arrival of the authorities should immediately obtain a business card for each investigator. If a business card is not available, the employee should obtain and write down the name, agency affiliation, business telephone number and address of each investigator. The employee should also inquire of the investigators as to the purpose for the visit. If there is a subpoena or warrant, the employee should request a copy. In some instances, these steps may not be possible at the onset of the visit where, for example, individual employees are detained or restrained. In such instances, the employee should be prepared to ask for this information at some point prior to the end of the visit.
Employees should be polite and courteous and should never obstruct or interfere with an investigation or search. Employees should cooperate but NOT CONSENT to any search (as employees do not have authority to consent to any such search unless they are the owner/manager of the operation). An employee can and should request that the investigator(s) wait for the person in charge, designated per policy, if that person is not already on site.
Employees must cooperate in the production of appropriate records and may not remove, alter, or destroy documents during the pendency of any such investigation. If documents have been subpoenaed and those documents exist, they must be produced. However, when possible, it is important to maintain copies of what is produced. One way of doing this is to photograph such documents if the person in charge has access to their cell phone. If not, request the investigators to provide copies. In the worst-case scenario, documents that are removed from the premise must be inventoried by the investigator(s) and a copy of the inventory will be provided to the person in charge prior to the end of the investigator’s visit.
The person in charge should immediately:
- Object to the search as unjustified because the organization is prepared to voluntarily cooperate with the investigation and the search violates the rights of the organization and employees. The objection will likely be ignored but make it for the sake of the record and note the investigator(s) to whom the objection was voiced.
- Request the opportunity to consult with the organization’s attorney, prior to the search beginning.
- Put the organization’s attorney in direct contact with the lead investigator to manage the search activities, conduct of investigator(s) and begin the dialogue of cooperation and negotiation. If the organization’s attorney is not available, the person in charge should contact the prosecutor and request that the search be stopped until such time as the attorney can be reached.
- Obtain the business cards or identification of each investigator, if not already collected by another employee.
- Monitor and record all details of the search and any documents seized or copied. The person in charge should consider videotaping the search (a cell phone is sufficient for these purposes). If the investigator(s) objects, make a record of the refusal (videotaped, if possible).
- Obtain an inventory of documents seized as well as copies. If copies are not available at that time, request them immediately and document that request.
- Never consent to a search beyond the scope of any warrant.
- Do not waive the right to remain silent.
With respect to interviews, employees should be informed/educated that such interviews are voluntary unless a subpoena is issued to compel such an interview. The employee has no obligation to consent to an interview and can stop it at any time. Employees have the right to their own legal counsel and can have counsel present during an interview. The organization should be represented by its own attorney.
It is never a happy moment when you learn your business practices have become target of regulators and law enforcement. However, preparation can help to avoid missteps in that early period just after arrival, when everyone is nervous and uncertain. Consult with an attorney who has expertise in regulatory compliance in health care. They can assist you in adopting proactive strategies and hardwiring compliance into your everyday practices. A proactive approach to compliance and training for all your employees can mitigate the risk that law enforcement will ever come to your door and prepare your team to protect the interests of your company if/when they do.