This article was written by Matt Fisher and originally appeared on the Mirick O’Connell Health Law Blog. It is published here with permission.
At some point in time most group practices, hospitals or other provider organizations will receive a letter from the Office for Civil Rights (“OCR”). The letter will state that OCR received a complaint from a patient, employee or some other party with knowledge or information as to alleged acts at the healthcare organization. The letter will further state that the complaint alleges the organization is not in compliance with some aspect of the HIPAA Privacy Rule, Security Rule, Breach Notification Rule, or some combination of those rules.
An initial response may well be panic because no organization wants to face an investigation by a government agency. Further, any hint that HIPAA could have been violated may conjure fears of becoming the next headline of an organization paying a major fine. After taking a moment to be panicked or worried, an organization should then get down to the business of responding to the letter. This process does not need to be scary and some foreknowledge and planning make it a lot more manageable.
For organizations that have not received an OCR letter or for those that have and need a refresher, this post will walk through the contents of a letter and some considerations for responding.
The first thing to note about an investigatory letter from the OCR is that it is a form document. There will not be much variation from one letter to the next other than identification of the recipient organization, the name of the complainant (if not anonymous), and possibly the nature of the complaint. Since the letter is a form, there is a lot of language explaining what HIPAA is, OCR’s responsibility for enforcing HIPAA, and a statement of the basis of OCR’s authority. The first statement that will likely catch an organization’s attention is the time in which a response must be provided. That time is 14 days following the organization’s receipt of the letter.
The 14 day period can and will fly by very quickly. The burden of responding will depend upon the type of violation since the type of violation will drive the scope of documents requested. However, the 14 day period is also not locked in stone. In many instances, OCR is willing to provide organizations additional time to respond. However, an extension can never be assumed or self-determined. Instead, organizations are well advised to reach out to the investigator or other designated official from OCR. Contacting and establishing a relationship with the OCR representative is helpful for many reasons. Opening a dialogue will demonstrate to the OCR representative that the organization takes the letter seriously and is addressing the issues raised. Additionally, during a conversation insight behind the complaint may be learned and an opportunity may exist to narrow the scope of the document request. All of these potential benefits are good because OCR should know what an organization is doing. Most importantly, the request for a response extension should be presented.
When asking for an extension, an organization should be reasonable and understand that asking for months to submit documents is unlikely to be accepted. Instead, make a reasonable assessment of how long it will take to gather the requested documents and be honest with the OCR representative. If an extension is granted, remain in contact with the OCR representative, which can help head off any problems in the event more time becomes necessary.
The second primary component of the letter is the actual document or data request. The request will specify the exact information that OCR wants to receive from the organization. The request could be focused upon a certain subset of policies and procedures that pertain to the nature of the complaint or could be as broad as the full scope of the organization’s HIPAA policies and procedures. No matter the exact scope, it is essential to carefully parse through the request and understand exactly what is being sought.
However, what happens if an organization does not have all of the requested documents or policies? Such a discovery offers an opportunity for the organization to address the issue and implement a change or update. Ignoring the discovery would not be suggested.
Preparing and submitting the actual response is the next step. An organization should not merely dump documents on OCR. To the contrary, an organization should take the response as an opportunity to prepare a written statement (which may be called for anyway by the request) and paint a picture for OCR. An organization should create the opportunity to take a hold of the narrative and provide background to OCR as to what happens within the organization. While any written response should always be ground in reality, there is the chance to frame actions in a certain way. For example, the written response could reveal that a particular document was not available prior to the response, but explaining the immediate action taken to fill in the gap shows that the organization is taking remedial action without needing a specific prompt from OCR.
The hardest part of the investigatory letter will be waiting once a response is submitted. OCR could simply resolve the complaint by finding that no non-compliance occurred, resolve through background resolution, seek more information, or find that a serious issue exists. Regardless of the outcome, being prepared ahead of time is essential and will help to reduce the fear and consternation that arise when any letter from OCR arrives in the mail.
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