From the Toolbelt
What Should You Do If You Receive an Investigatory Letter From the OCR?
My 22 year old daughter loves to send mail—a little old-fashioned, but endearing. Opening mail still carries the potential of discovering a treasure. Unfortunately for many organizations, the envelope may contain unpleasant information, namely an investigatory letter from the Office for Civil Rights (OCR), the entity that enforces the Health Insurance Portability and Accountability Act (HIPAA).
When individuals feel that an entity has violated HIPAA, they have the right to file a complaint with OCR. As of March 31, 2013, OCR had received nearly 80,000 complaints since HIPAA went into effect in 2003, with a lack of safeguards among the most common compliance issues.
Healthcare entities may be accustomed to receiving these letters, but come September 23, there are many other entities who may receive such letters. The Department of Health and Human Services (HHS) estimates there are 700,000 covered entities and up to 500,000 Business Associates (BAs). Although some BAs are duplicated among covered entities and HHS has sophisticated number crunchers, the numbers seem low. If every covered entity has at least three business associates, then that would equal 2.1 million BAs. Regardless, it is certainly no surprise that the federal government would like to directly govern BAs.
So what should you do if you receive an investigatory letter from the OCR?
Such a letter can be a little daunting, scary, and produce reactions from anger to disdain—neither of which is conducive to a successful resolution. Receiving an investigatory letter does not indicate that you have violated HIPAA, merely that someone thinks you did. Some complaints receive streamlined processing, such as a denial of a patient’s right to her record—meaning you may receive the letter within weeks of the OCR receiving the complaint. Other complaints work their way through the system and may take six months or longer before the OCR sends an investigatory letter. Your record-keeping system needs to be thorough and detailed because few remember all the details after such time passes.
Steps to Take:
First, review your files to verify that this individual is part of your records and whether you are able to retrieve the information quickly. If you are a BA, contact the covered entity for coordination even if the complaint is strictly against the BA.
Second, contact the OCR to let them know that you have received the letter and inform them if you foresee any complications on your end in responding by the due date, e.g. the records are in off-site storage. Ask if the OCR would like your response via mail, e-mail or fax. You may also ask the OCR for clarification of the complaint if the letter includes limited information. The OCR may be able to read the complaint to you, or a portion thereof, but cannot send it to you.
Third, collect your information, the applicable policy and determine what your response may be, both to the OCR and the individual. For example, if the complaint alleges that you refuse to allow the patient access to their record, you should explain the circumstances to the OCR, provide the policy, include any details of any mitigation action taken such as employee retraining, process change and improved record-keeping. You might also want to fulfill the patient’s request. You could contact OCR and ask how they would like you to proceed. Sometimes, you can fulfill the patient’s request and include this documentation—not to record itself—in the response to the OCR. In such cases, send the patient’s record via certified mail to have a receipt. Other times, depending on the sensitivity, the OCR may want to review your response prior to you responding to the patient.
Then, you wait. Track all of your actions and keep detailed documentation. Contact the OCR if you have not heard from them within 30 days. You could do this every 30 days until you get final resolution, because their resolution may be lost in the mail.
Some individuals complain to multiple enforcement agencies, such as their state insurance department, consumer protection or attorney general. State attorneys general have been active in privacy enforcement. You may face investigations on multiple fronts simultaneously or sequentially. The key is having the policies in place, presenting the facts, taking appropriate action and responding professionally.
About the Author
K Royal, CIPP/US, CIPP/E, is privacy counsel at Align Technology and has over 20 years of professional experience in the legal and health-related fields. Royal has a particular interest in the relationship between health and technology—such as telesurgery, bioethics and privacy. As an attorney, she has been recognized as a Forty-under-40 honoree for Phoenix, as an educational leader through the YWCA and as one of the top pro bono attorneys in Arizona. Royal is currently an in-house global privacy counsel and finishing her PhD in public affairs.