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Two University of Massachusetts Medical School pharmacists make the case to reform or align 42 CFR Part 2 with HIPAA to better serve patients with substance use disorder.
In a healthcare society where we are focused on increasing transparency, driving accountable care and the best patient outcomes, we continue to be fraught with obstacles to integrated care delivery. Some of the most cumbersome barriers include those that protect patients from disclosure of their substance use disorder, including any pertinent treatment for their chronic disease.
Enacted in 1987, 42 CFR Part 2 was designed to protect the confidentiality of those who seek treatment for drug and alcohol use disorder.
While drug overdoses were a concern at that time, three decades later, drug overdoses have become the single-largest cause of injury-related death in the country. More than half these deaths are attributed to opioid-based prescription drugs and other illicit substances, including heroin, according the Centers for Disease Control.
42 CFR Part 2 presents a major barrier, effectively blocking insurers from informing the prescriber when dangerous combinations of medications are being prescribed to patients in treatment for substance use disorder.
The federal confidentiality statute requires that a patient sign multiple written consent forms granting insurers the authority to alert prescribers about medical and/or claims records that indicate a history of drug abuse.
Certainly, 42 CFR Part 2 was designed to achieve an important and worthy goal-providing a shield of privacy for those struggling with drug and/or alcohol addiction so they would feel more comfortable seeking treatment.
Protecting the privacy of those seeking help with substance use disorder is still important, but the need for written consent in advance from the patient may prevent important communication between healthcare professionals.
Take the example of an insurer processing a payment for a long-acting opioid or high quantity of opioid for a patient whose records show recent prescriptions for buprenorphine/naloxone, a medication often used to treat addiction.
In general, practitioners do not prescribe chronic opioids to a patient who is struggling with substance abuse. Not only does this present a risk for relapse, but could increase the risk of overdose.
While prescribers control the issuance of opioid prescriptions, all healthcare professionals share a responsibility to ensure their safe and judicious use. It is unrealistic to expect prescribers to address all of the gaps in care given the limited resources and the behavioral health and medical complexities of each patient.
One resource that has been made available to prescribers is the Prescription Drug Monitoring Program (PDMP), an electronic database fed by outpatient retail pharmacy claims. All controlled substance classes II-V are recorded and available for the prescriber to see on any given patient. Information includes medications, dates of fill, prescriber, quantity, day supply, and payment type. While payers do not have access, it is important for the prescribers and pharmacies that do, to use this valuable resource. While useful, the PDMP has its limitations.
The PDMP does not list methadone when it is received for maintenance treatment for opioid use disorder; nor does it list Vivitrol (naltrexone), another form of medication assisted treatment (MAT). While buprenorphine/naloxone is listed in the PDMP, the reality is that prescribers do not always have the time or resources to review it before seeing a patient.
The federal government, in particular the Substance Abuse and Mental Health Services Administration, has come to recognize that the current consent process needs to be updated to reflect current practice.
A recent revision to 42 CFR Part 2 streamlines the current disclosure process under which a patient can agree to have substance abuse records shared. Multiple written disclosures would be replaced with a single waiver.
But the proposal, in retaining the disclosure requirements beyond HIPAA, does not allow insurers to communicate effectively with prescribers to address the escalating opioid addiction crisis.
It may now be up to Congress to intervene and provide a solution to this growing dilemma.
The Partnership to Amend 42 CFR Part 2, a coalition of 20 different insurers and other health care stakeholders, is preparing to seek legislation that would remove the barrier that blocks the sharing of crucial substance abuse information between payers and providers.
This would bring rules regarding the sharing of substance abuse records in line with HIPAA, passed in 1996, which has extensive patient privacy and security provisions to safeguard medical information.
Coalition members, who range from Blue Cross Blue Shield Association to the National Association of State Mental Health Program Directors, are committed to retaining protections against the misuse of substance abuse treatment records, including the disclosure to law enforcement, employers, divorce lawyers, and anyone else seeking to use this information against the patient.
Ironically, the very rules designed to protect patients from the stigma associated with substance use disorder may be exacerbating the stigma by sending the message that we should be treating the disease differently than other chronic diseases. This is also resulting in denying those in treatment the comprehensive care they deserve.
Kimberly Lenz, PharmD, is a clinical pharmacy manager at the University of Massachusetts Medical School.
Tyson Thompson, PharmD, is a clinical consultant pharmacist at the University of Massachusetts Medical School.