Pharmacies requiring treatment plans to fill opioids?

[rev ronin]

So I had a new one today--Prescribed for a long-term chronic pain patient.  He has a PMP query a mile long, from me or my partners, but has been completely stable and nonaberrant with respect to his opioid use.

Safeway faxes me back, and I quote: "I now have to keep the treatment plan on file for any patient with MME >50"

Called the pharmacy, and the manager confirmed that was new policy at all Safeway pharmacies (presumably in the greater Puget Sound region, but who knows how far this might extend), to which I replied that the pharmacy is not directly involved in the treatment of the patient, and thus I have no HIPAA-waived reason to share patient's medical info with the pharmacy beyond the minimum needed, nor any patient release to do so: They already had received a legal prescription that meets all the state requirements for chronic pain prescribing, and pharmacies are not required by state law to verify that a treatment plan exists.

I called the state pharmacy board, and the nice lady I talked to believed that they did have a right to ask for that information, but agreed she couldn't find any supporting statute or administrative law.

So now my patient may or may not have been able to retrieve the script and get his pain meds from a different pharmacy before the long holiday weekend.

Anyone else run into this?  Thoughts? Opinions?

[Boatswain2PA]

Send to a different pharmacy.  Walmart here limits to >50 mmes a day for new rx's.  When they call me to ask me to reduce my doses I tell them to send the pt to another pharmacy.

Sometimes with acute injuries you need moderate opioid analgesia for a few days.

[rev ronin]

48 minutes ago, Boatswain2PA said:

Send to a different pharmacy.

Indeed.  If this stands, I'm considering sending ALL patients to other pharmacies; >50 MED prescribing is pretty much limited to this one patient anymore, but I'm not in favor of corporate policy exceeding the requirements set by government regulatory agencies in statute to the detriment of my patients.

[Lightspeed]

2 hours ago, rev ronin said:

So I had a new one today--Prescribed for a long-term chronic pain patient.  He has a PMP query a mile long, from me or my partners, but has been completely stable and nonaberrant with respect to his opioid use.

Safeway faxes me back, and I quote: "I now have to keep the treatment plan on file for any patient with MME >50"

Called the pharmacy, and the manager confirmed that was new policy at all Safeway pharmacies (presumably in the greater Puget Sound region, but who knows how far this might extend), to which I replied that the pharmacy is not directly involved in the treatment of the patient, and thus I have no HIPAA-waived reason to share patient's medical info with the pharmacy beyond the minimum needed, nor any patient release to do so: They already had received a legal prescription that meets all the state requirements for chronic pain prescribing, and pharmacies are not required by state law to verify that a treatment plan exists.

I called the state pharmacy board, and the nice lady I talked to believed that they did have a right to ask for that information, but agreed she couldn't find any supporting statute or administrative law.

So now my patient may or may not have been able to retrieve the script and get his pain meds from a different pharmacy before the long holiday weekend.

Anyone else run into this?  Thoughts? Opinions?

I like your logic that you had no patient release document. That’s pretty strong right there. I guess their answer might be that you need to get one to use their pharmacy. That kind of development is an entirely new approach to care... changes everything about prescriptions.

[rev ronin]

Dear Washington State Medical Commission:

 

On Friday 8-30-2019, a prescription I had written for Oxycodone was declined by Safeway Pharmacy [location]. After the patient had left my office and presented the prescription to be filled, I received a fax from the pharmacy stating "I now have to keep the treatment plan on file for any patient with MME >50” (I understand MME to be milligrams of Morphine Equivalency; I use MED, morphine equivalency dosage, below) Upon calling and speaking with a woman who identified herself as a pharmacist and the pharmacy manager, whose name I did not record, she noted that this was now Safeway-wide policy.  I informed her that I was unable to comply with her request, because I did not have a release from the patient to provide that medical record to the pharmacy.

 

I have three questions:

 

1) Am I permitted to disclose a chronic opioid treatment plan to a pharmacy, absent appropriately documented patient consent for such disclosure?

 

2) Am I required to disclose a chronic opioid treatment plan to a pharmacy?

 

3) Is a pharmacy allowed to decline to fill a lawfully written prescription on the basis of a provider or patient’s refusal to respectively disclose or authorize disclosure of a chronic opioid treatment plan?

 

The factual background:  This prescription was written for 120 MED (80 mg/day) of Oxycodone, an increase from the patient’s more recently typical 60 MED, but per my conversation with the pharmacist, this would apparently have triggered at 50 MED per the new protocol.  This patient has been receiving opioids from me, or predecessor clinicians, for the five-year duration of the PMP query, with a highest MED listed of 180.  The script had EXEMPT noted on it, indicating a legacy chronic opioid patient.  The same written script also included Intranasal Naloxone.  It was typed on tamper-evident paper meeting state standards, pre-printed with both my and [My SPs] DEA numbers, business address, and voice and fax phone numbers.  This patient also receives benzodiazepine medications from a psychiatric ARNP, with whom I periodically coordinate, and we and the patient are all well aware of the concurrent medications and their risks.

 

In short, it met the same standards as every other opioid prescription I’ve had accepted by pharmacies across Western Washington.

 

The Treatment Plan: Nothing in https://app.leg.wa.gov/wac/default.aspx?cite=246-918-860 or anywhere else I can find requires that a treatment plan be a monolithic standalone document.  In the normal course of business at [my clinic], items (1)(b) through (1)(d) are documented as part of each visit note where opioids are prescribed, (1)(a) is maintained as carbon copies of each typed prescription, and (1)(e) is a separate document signed by provider and patient every six months.  These are maintained in paper charts, rather than any EMR.

 

In order to disclose any patient’s treatment plan, I would need to disclose an entire visit note to a pharmacy.  While a pharmacy is a covered entity under HIPAA, and might arguably be construed as treating the patient per RCW 70.02.050 (https://app.leg.wa.gov/RCW/default.aspx?cite=70.02.050), disclosing an entire visit note clearly violates the ‘least necessary’ principle.

 

In this specific case, the visit note includes discussion of the patient’s disability status, current legal issues, mental health issues, status as a crime victim, family relationship dynamics, and own religious perspectives on these issues.  If there was ever a medical record that would incur the highest level of scrutiny for disclosure, I expect this note would meet that standard.  I note that mental health services are subject to more strict scrutiny per RCW 70.02.230 (https://app.leg.wa.gov/RCW/default.aspx?cite=70.02.230), and that as mental health status constitutes part of my documentation of risk assessment for this patient, mental health information is inseparable from the treatment plan.

 

Thus, I am unwilling to disclose a treatment plan to a pharmacy absent statutory authority or competent legal interpretation from the state medical commission and/or pharmacy board that such is lawful without the consent and/or notification of the patient whose medical record, including mental health topics, would be disclosed.

 

Discussion

 

Responsibility for treatment plan: It my understanding that legal responsibility for prescribing opioids rests with the prescriber, not the pharmacist. (c.f. https://wmc.wa.gov/sites/default/files/public/documents/OpioidINS2019-01.pdf) I believe it would be reasonable for a pharmacist to ask, “Does a treatment plan per WAC 246-918-860 [or equivalent] exist for this patient?” to which an answer would be busywork (Again, I am responsible to the medical commission for such treatment plans, not to the pharmacy) but not a violation of the patient’s medical privacy.

 

Evaluation: While I am not intimately familiar with the scope of practice for a pharmacist, I am uncertain that a pharmacist would be able to fully evaluate and assess the appropriateness of a chronic pain treatment plan, especially to the extent that non-pharmaceutical treatment modalities are used.  While I greatly respect pharmacy education and rely on pharmacists as part of a collaborative health care team, I believe that only a medical provider (physician or physician assistant) would be competent to review the efficacy and appropriateness of a treatment plan.  Thus, any disclosure of a treatment plan to a pharmacy serves no medical treatment purpose.

 

Liability: The pharmacist I spoke to mentioned something about pharmacies being co-liable for inappropriate opioid prescriptions.  This would seem to fly in the face of RCW 69.70.070 (https://app.leg.wa.gov/RCW/default.aspx?cite=69.70.070) The state board of pharmacy has previously taken strong action against pharmacists referring for Plan B on a personal belief basis (Stormans vs. Wiesman), while Safeway in this case did not even offer facilitated referral to another pharmacy not requesting greater treatment documentation than required by law.

 

Ultimately I am concerned that compelling a patient, or provider as that patient’s proxy, to disclose protected medical information, including mental health information, is a well-meaning but misguided policy, and may constitute unprofessional behavior on the part of the pharmacy.  At a minimum, such a policy hampers access to prescribed opioid pain medications above and beyond the recently-strengthened regulations.  If all pharmacies adopt such policies, access to care could be severely restricted, again, beyond the recently-strengthened regulations.  

 

Obviously, the simplest thing for me to do would have been to comply with the request.  I do not believe I am legally or ethically permitted to do so, as I have outlined above.

 

Thus, I believe it is in the best interest of Washington state’s patients to have this matter addressed by the legal and policy experts at the Medical Commission and Pharmacy Board, and guidance to providers and pharmacies be disseminated appropriately once my objections have been assessed.

 

I have written this without direct reference to any patient information, so that this can be both submitted and disseminated in email, with the understanding that this submission constitutes a public record.  I would share it with Safeway as well for their input, but have no contact email to which I can send it.

 

Sincerely,

Me

(license number)

[ventana]

I would also add that there is FEDERAL regulation on the disclosure of any Opiate Use Disorder that might well apply.  

 

These have far more restrive and enforceable then HIPPA (sorry I don't remember their name but part or chapter 2 or 4 rings a bell)

 

I am unsure if these would apply as this is for OUD not just prescribing.

 

 

 

 

Well done, strong work

[sas5814]

An excellent and well reasoned response. Keep us posted.

[rev ronin]

4 hours ago, ventana said:

I would also add that there is FEDERAL regulation on the disclosure of any Opiate Use Disorder that might well apply. 

Interesting, hadn't thought of that.  The mental health information in question wasn't for OUD, though, but I hadn't even thought to look at the federal protections for mental health info.

Also, to Safeway's credit, the fact that I'm a PA not an MD/DO doesn't appear to make a difference to them.  So, this is just me advocating for my patients' rights, not me striking a blow for equal treatment for PAs.  I guess that's a good thing?