- President Donald Trump signed into law this week a sweeping opioid measure that includes expanded patient data sharing regarding opioid and other substance addiction treatment information.
The law, however, does not include a provision supported by many in healthcare that would have allowed the sharing of information about a substance abuse patient’s treatment without the patient’s consent for the purposes of treatment, payment, and operations, similar to what is allowed under the HIPAA Privacy Rule.
Current law (42 CFR Part 2) authorizes disclosure of substance abuse patient records without a patient’s written consent only to medical personnel in a medical emergency, to specified personnel for research or program evaluations, or pursuant to a court order.
The new opioid law now permits the disclosure of opioid and other substance abuse treatment information on a patient's medical record with the patient's consent.
The law directs the HHS secretary in consultation with stakeholders to develop best practices regarding:
“(A) the circumstances under which information that a patient has provided to a health care provider regarding such patient’s history of opioid use disorder should, only at the patient’s request, be prominently displayed in the medical records (including electronic health records) of such patient;
(B) what constitutes the patient’s request for the purpose described in subparagraph (A); and
(C) the process and methods by which the information should be so displayed.”
The law defines stakeholders as a patient with a history of opioid use disorder, an expert in electronic health records, an expert in the confidentiality of patient health information and records, and a health care provider.
Once developed, the best practices would be distributed to healthcare providers and state agencies.
In developing these best practices, HHS should consider the following factors:
“(1) The potential for addiction relapse or overdose, including overdose death, when opioid medications are prescribed to a patient recovering from opioid use disorder.
(2) The benefits of displaying information about a patient’s opioid use disorder history in a manner similar to other potentially lethal medical concerns, including drug allergies and contraindications.
(3) The importance of prominently displaying information about a patient’s opioid use disorder when a physician or medical professional is prescribing medication, including methods for avoiding alert fatigue in providers.
(4) The importance of a variety of appropriate medical professionals, including physicians, nurses, and pharmacists, having access to information described in this section when prescribing or dispensing opioid medication, consistent with Federal and State laws and regulations.
(5) The importance of protecting patient privacy, including the requirements related to consent for disclosure of substance use disorder information under all applicable laws and regulations.
(6) All applicable Federal and State laws and regulations.”
Several healthcare organizations, including the American Hospital Association, American Health Information Management Association, and College of Healthcare Information Management Executives, lobbied Congress last month to include a provision that would bring 42 CFR Part 2 in line with the HIPAA Privacy Rule.
In a letter to congressional leaders, the Partnership to Amend 42 CFR Part 2 argued: “Alignment of Part 2 with HIPAA will allow appropriate access to patient information that is essential for providing safe, effective, whole-person care, while protecting this information with enhanced penalties for unlawful disclosure and use.”
“The Partnership strongly believes that the modernization of privacy regulations and medical records for persons with substance use disorders is a critical component for tackling the opioid crisis and will improve the overall coordination of care in the United States,” it concluded.
However, the American Medical Association (AMA) opposed the effort to change current law.
The AMA argued in a letter to Congress that amending 42 CFR Part 2 would discourage addicted individuals from seeking treatment out of concern that their addiction treatment information will be shared without their permission.