Starting August 14, methadone patients face the very real possibility that their long-protected privacy will be gone. The Substance Abuse and Mental Health Service Administration (SAMHSA) final rule on the regulation 42 CFR Part 2 allows opioid treatment programs (OTPs, known as methadone clinics) to put patient information into prescription drug monitoring programs (PDMPs). The confirmed rule was published last month, following the release of the proposed rule a year ago.
Organizers and proponents of PDMPs—electronic databases that enable doctors and other prescribers, pharmacists and law enforcement to track prescribing of controlled substances—will undoubtedly want to add methadone prescriptions to these widely available records.
Whether states will agree—or instead side with methadone patients, who want their information kept private and OTPs, which generally take the same line—is uncertain. But a clear message came from the National Governors Association earlier this month: PDMPs can be money-makers.
On August 10, the American Association for the Treatment of Opioid Dependence (AATOD) issued recommendations, mainly related to consent, advising OTPs to make sure patients know what they’re “consenting” to in the release of their information.
OTPs should “check with [state authorities] to determine if they are expected to report patient data.”
SAMHSA’s final rule states: “OTPs are permitted to enroll in a state Prescription Drug Monitoring Program (PDMP) and are permitted to report data into the PDMP.”
AATOD interprets this change to “permit—but not require—OTPs to report data to the PDMP if required by state law and authorized by patient consent.” AATOD adds: “If a patient chooses not to provide a written consent, then the OTP cannot share information with the PDMP.”
But SAMHSA has opened the door for state regulations to remove that choice. It is therefore important, says AATOD, for OTPs to “check with their respective PDMPs or State Opioid Treatment Authority to determine if they are expected to report patient data. If it is determined that OTPs are not expected to report such patient data, then obtaining a written consent from the patient would not be necessary.”
AATOD’s guidelines state:
It is critically important for OTPs to inform their patients that:
* Once such information is provided to the PDMP, it cannot be taken back;
* PDMPs share information with law enforcement agencies with the exception of Indiana and Nebraska. Pennsylvania has limited authority to share patient information with state level law enforcement;
* PDMPs also share information with other healthcare and non-healthcare organizations, including Drug Courts, Medicaid Drug Utilization and Review entities, medical interns/residents, prosecutors, regulatory/licensing boards and state health departments to cite a few; and
* Patients are not required to consent to the disclosure.
SAMHSA’s new rule is in stark contrast with its previous policy. In 2011, SAMHSA told OTPs they should not put patient information into the PDMP, but rather should check the PDMP to see if patients were receiving any other medications which could conflict with the medication the OTP was dispensing.
The federal confidentiality law, at least for now, requires that patients give consent for release of their substance use disorder treatment information, regardless of whether states tell OTPs they must put information into the PDMP. States may interpret the rule differently, and some may not even require OTPs to obtain consent before putting patient data into the PDMP—even though the Legal Action Center interprets the rule to say they have to obtain it.
More likely—and especially where state policies exert pressure—patients will consent without knowing what they’re consenting to.
This is confusing to everyone, but the possibility is there that patients may not be given the opportunity to consent or refuse to consent. What is more likely in practice, however—and especially where state policies exert pressure on OTPs to obtain consent—is that patients will consent without knowing what they’re consenting to. Once in the PDMP, data won’t be removed. And it can be used by anyone.
PDMPs report to states’ governors, and the governors seem to love the possibilities of PDMPs. The National Governors Association has just released a toolkit extolling their value. It refers in glowing terms to possibilities for revenue generation by putting the information into Electronic Health Records (EHRs), with funding from Medicaid, for example; to opportunities to investigate patient “behavior;” and more.
Some further strategies espoused by the NGA toolkit include:
* Expand types of substances and overdose information tracked through the PDMP to identify potential overdoses or misuse of potentially addictive substances or dangerous drug combinations.
* Permit staff of prescribers and dispensers and providers who have no prescribing authority to access PDMP data to facilitate clinical decision support and care coordination across health care providers.
* Support use of PDMP data by public health authorities to identify hotspots, trends, and improve understanding of drug-related overdoses.
* Promote interstate data sharing for an improved picture of residents’ controlled substance prescription histories to identify potential doctor shopping and create opportunities for greater care coordination across state lines.
In some states, law enforcement is actually in charge of PDMPs—not the health department, which manages EHRs. Do you see where this is going?
Pain patients already know the harms of opioid scrutiny But for methadone patients, it’s about more than potentially not getting medication. It’s about potentially losing custody of a child, losing a home, losing insurance, losing employment, losing freedom.
Discrimination against patients with substance use disorders, especially opioid use disorder, is widespread. Just ask all the doctors who say they need methadone data in the PDMP because they don’t trust their patients, who are “addicts,” to tell them the truth.
Photo via Pixnio/Public Domain