Revision of SAMHSA’s 42 CFR Part 2: Better Coordination of Care Balanced with Patient Privacy

The federal law holds providers of services to patients with mental health and substance use disorders to a higher standard of privacy than ordinary medical providers. While other providers must obey HIPPA privacy laws, physicians in our field have always had to meet the more stringent 42 CFR standards.

This year, long-standing rules guarding the confidentiality of patients in treatment for substance use disorders were revised, with the intent of allowing better coordination of care for these patients.

Last week, a group of medical providers who work in North Carolina’s opioid treatment programs met on a teleconference when this issue was discussed. (Pre-COVID we held a conference once a month; now we meet once a week). It was obvious that most of us, including me, didn’t know the exact changes made in the revision. Out of curiosity, I decided to dive deeper into this issue and thought I’d pass it along on my blog.

SAMHSA has a great Fact Sheet that describes all of these changes at this website: https://www.hhs.gov/about/news/2020/07/13/fact-sheet-samhsa-42-cfr-part-2-revised-rule.html

The major changes boil down to a few items. Chief among them is that non-opioid treatment program providers can query a central registry of patients receiving care at opioid treatment programs, in order to prevent double enrollment and (hopefully) prevent adverse drug interactions. In the past, providers who didn’t work at opioid treatment programs didn’t have access to this sensitive information.

On the plus side, advocates of this change say that patients being prescribed methadone or buprenorphine at opioid treatment programs will get better care, because their non-OTP doctors will see which of their patients are receiving methadone or buprenorphine from opioid treatment programs, and won’t prescribe medications which may interact.

On the negative side, we worry patients on methadone or buprenorphine could face discrimination and judgmental attitudes from providers who don’t know any better.

I don’t think this revision will change anything at all. It’s difficult enough getting physicians and other providers to check our state’s prescription monitoring program. I doubt any providers will be savvy enough to know they can get access to our state’s central registry of patients in opioid treatment programs, let alone have the enthusiasm to access this registry.

And speaking of prescription monitoring programs…under the revision, opioid treatment programs are now permitted to report the medications they dispense (nearly always methadone or buprenorphine) to their state’s prescription monitoring program.

Again, proponents of this new rule say it will allow for better coordination of care and will prevent medication interactions. Opponents say, as mentioned for the other change outlined above, that it could lead to discrimination against patients getting treatment for opioid use disorder with medications.

Of course, the wording of the revised CFR 42 says the OTP “may” report prescribing data, not that they “must” report. For now, it’s up to the OTP to decide. At present, I don’t think a system is in place to receive this data anyway. During our latest teleconference here in NC, none of the providers said their OTP was reporting to the state’s PMP.

My opinion – and why have a blog in the first place if I can’t blather about my views – is that this new rule is a mistake. I am opposed to OTPs reporting their dispensing data to the prescription monitoring program.

In my county, patients are sometimes treated differently by medical personnel after they reveal they have opioid use disorder and are in treatment with us. And by differently, I don’t mean they are congratulated on their recovery and offered words of encouragement. Instead, they are told something like, “I hope you aren’t here to ask for any pain medication because I’m not going to prescribe it,” even if they are at a routine office visit for treatment of hypertension.

In some cases, patients are told they can’t be accepted as a new patient because the doctor isn’t comfortable treating them. These providers pretend that the patient’s issues are just so complicated that they don’t have the medical expertise. This is an excuse meant to hide an attitude of judgment and contempt for our patient who have the disease of opioid use disorder, and who are viewed as “difficult” patients.

I don’t think patients know about this recent change to privacy law, and I worry they won’t be happy about it. I hope it won’t deter people from entering treatment at opioid treatment programs. Before these changes become operational, we should tell our OTP patients, so they won’t be caught off guard. Of course, patients receiving buprenorphine products at doctors’ offices (so-called office-based practices) already have their data reported to the state’s prescription monitoring program, so it won’t be any change for them.

This revision also said that natural disasters which disrupt treatment facilities should be considered medical emergencies, allowing for patient information to be disclosed without patient consent. I interpret that to mean that if our facility is swallowed by a giant sink hole (not an unreasonable fear in our little town), we could send patient data to another OTP so that our patients could be dosed, without waiting for individual consent forms to be signed. This would streamline care and be more practical. We could also give patient data to hospital emergency departments or other facilities helping those patients during emergencies.

The revision document takes pains to declare that many things have not changed under this revised rule. For example, the document clearly states that law enforcement is still prohibited from obtaining substance use disorder treatment records without a court order. In other words, random police officers can’t come into the OTP and ask if an individual is a patient. We are still prohibited from releasing this information.

This is how things are at the federal level. At state levels, there are different laws about who can access prescription monitoring programs.

In North Carolina, the law changed in 2018, with the HOPE (Heroin and Opioid Prevention and Enforcement) Act. Prior to this, law enforcement had to have a court order to look at a subject’s data on the prescription monitoring program. After HOPE was passed, law enforcement officers can access PMP data if they have a “reasonable, good-faith belief based on specific facts and circumstances,” to access the data. The law has a few safeguards in place; the officer has to a “certified diversion investigator” before given access to the PMP.

I don’t know how this law slipped past me. I don’t like it. It makes me uneasy. With the previous court-ordered access, at least there was a judge who balanced (thoughtfully, one would hope) patient privacy against legitimate law enforcement goals. Now it appears to be left to the judgment of law enforcement officers who may be predisposed to believe their goal is justified.

I remember all the caution that abounded in 2007, when the NC prescription monitoring program first became operational. There was argument about whether the NC PMP could be accessed without patient consent (it could). I was told not to store the printed record of a patient’s PMP report with the rest of the chart, least it inadvertently be forwarded with any request to send records to other providers. The prescription monitoring program was hush-hush private, only for doctors’ eyes, and only to be used to provide better healthcare.

Now, law enforcement doesn’t even need a court order to access it.

I worry law enforcement officers won’t be able to interpret the data they find on the prescription monitoring program. For example, if they look at one of my patients being prescribe buprenorphine/naloxone films, will they look at the “overdose score” that is usually very high for patients on buprenorphine products? Despite warnings from the American Society of Addiction Medicine and other experts, who say it’s not possible to assign an MME (morphine milligram equivalent) to buprenorphine…our prescription monitoring program does just that, thereby implying a patient on sixteen milligrams of buprenorphine is more likely to overdose than a patient on oxycodone and a benzodiazepine. Ridiculous.

I’d like to hear from readers about how you feel about the changes to privacy laws. I don’t think patients, at least in North Carolina, know about the HOPE law that passed in 2018.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: