The Opioid Epidemic continues to be one of the biggest medical issues of our day. In 2016, over 42,000 people died from opioid overdoses, equating to roughly one person every twelve minutes. Over 80% of current heroin users began with prescription opioids. As participants in the healthcare industry, we have an obligation to do our part to support overdose prevention efforts and build safe environments for our patients to be treated and seek support. Recent government actions, such as the Opioid Crisis Response Act of 2018, include provisions to ensure that care providers have access to prior patient history, thus supporting prevention efforts. However, there are legitimate concerns with patient privacy and potential legal consequences to patients whose history becomes known and available to others. HR 3545—The Overdose Prevention and Patient Safety Act—seeks to remedy those issues by providing clarity around what can be disclosed and who can access those records as well as align regulatory language with HIPAA standards. The Act also seeks to provide legal protection to patients struggling with opioid misuse. As with any bill, there are positives and negatives.
HR 3545 seeks to amend regulations found in 42 CFR Part 2 that segregates patient’s general medical records from disorder records. Part 2 originally provided safety and dignity for patients, allowing them to directly control who saw disorder records and in which situations they would be disclosed. Part 2, however, has also created a bureaucratic quagmire and inconsistencies across the general provider network. These issues have created a varying level of care and privacy for patients based on how the regulations were interpreted by individual providers.
The Overdose Prevention and Patient Safety Act maintains patient privacy and allows patients to own and make decisions regarding their medical history. On the other hand, decision making, treatment efforts, and coordinated care efforts are hindered when healthcare and social data exchange is restricted. While HR 3545 provides safeguards to ensure that patient information cannot be used to initiate or substantiate criminal proceedings with the intent of helping patients feel more secure in sharing and disclosing that information, there are some who will continue to choose to withhold their patient information, leading to increased risk for patients.
The bill also provides for a streamlined consent process. 42 CFR Part 2 requires written consent from the patient in order to share disorder records with each institution. Even in our modern day of digital records and electronic-based care coordination, this is a cumbersome and time-consuming process. HR 3545 allows consent to move to a single consent option. The bill also defaults data sharing to all disorder records as opposed to requiring an itemized list of what can be shared. While patients may still opt out of providing all records to all providers, the overall effect is a significantly reduced administrative burden. Finally, revoking consent may be done verbally as it does not require written notice.
Although consent changes on the surface may appear overwhelmingly beneficial, there are risks to moving to HR 3545. Foremost is that patients may not be fully aware of what consent actually means and are, therefore, not fully integrated in their own care coordination, especially where there are concerns that the data could be misused against them. Additionally, current legislation does not provide clear guidance on reporting and transparency around medical and disorder records. In order to ensure patient privacy, there is a need for clearly defined responsibilities and procedures.
Despite some uncertainties and potential risks around HR 3545, the overall message remains the same: The Opioid Epidemic is a health crisis, and communities must come together to coordinate efforts to reduce and eliminate this crisis. The ability to share patient data between providers will play a key role in helping individuals with substance use disorder get the care and services they need to thrive.