Thread by @StefanKertesz

1/The revised draft version of @CDCgov opioid Rx guideline is covered appropriately here by @DrewQJoseph

This guideline must be assessed not just for what it says,but for how it may or may not guide institutional actions that abused the prior guideline & could do the same here

https://twitter.com/statnews/status/1491811702882508804

2/This means that whatever arguments we may offer about the *science*, a key challenge is what to do about other agencies, including those in @HHSGov itself, that decided to make a *misreading* of the 2016 Guideline key to their regulation of care, despite resultant patient harm

3/The most crucial examples are the Office for the Inspector General of HHS and the nonprofit @NCQA, because the @OIGatHHS refers prescribers for criminal investigation, while the @NCQA obligates the hand of all payers and providers

4/The OIG has, since 2016, mis-cited the 2016 Guideline as detailing a dose >90 mg as “to avoid”.

OIG never acknowledged that even in 2016, CDC declared a dose >90 could be justified.

It also never acknowledged that the CDC didn’t call for forcible taper of all patients!

5/Similarly @NCQA has long held all health care organizations to a standard dose quality metric of first 120, later 90, without allowance for either the prior CDC-acknowledged need to ⬆️ dose sometimes, or for the reports of harm following dose reduction- ncqa.org/hedis/measures…

6/To explain: the words of CDC in 2016 never justified the @NCQA quality metric that in turn spurred forced dose ⬇️ across the board

I personally, by phone, warned their Vice President in 2017 that early research data showed harm & death would result. No impact. I wasn’t alone

7/A list of respected experts affirmed that concern, in 2017, to @NCQA including @DrChinazo (who directed this cycle of the Opioid Guideline Workgroup) and powerful respected voices who had advised CDC.

None of these people led NCQA to alter course stefankertesz.medium.com/an-opioid-qual…

8/Even after CDC, FDA & HHS all cautioned against mandating forced opioid dose reduction in 2019, NCQA’s “High dosage” HEDIS measure continues, even now, to incentivize the dose reductions that these 3 federal agencies all said merited caution
s21151.pcdn.co/wp-content/upl…

9/Scientific side note: there exists some real (& causal) association between Rx dose and risk for a patient. Benefits of dose escalation are unproven.

However the Rx dose alone was never the only risk factor, and usually not the main one (excerpt) stefankertesz.medium.com/our-response-t…

10/so we are left trying to guess something:

The key question for the safety of patients comes down to whether a revised Guideline will be enough to induce agencies like NCQA, DEA & to alter their frameworks to stop harm, even when they disregarded authoritative concerns

11/A confession: I have been on the front lines of responding to traumatic stoppages and seen they were not scientifically justified, and they involved wholesale abrogation of core ethical responsibilities to patient safety.

That was, my @TEDx talk:

12/But to be honest, I have absorbed the trauma. Like any person who is traumatized, I actually can’t be sure I trust that the trauma will stop.

I would call for assurances that might not seem necessary to a person to a person who has not been confronted with the harms directly

13/Ideally, any revised Guideline must include a program to de-implement the misapplications of the prior one.

Ideally, as part of revision, @CDCgov will explain what new actions it will take to correct the misuse and mistreatment of patients

I’d love to help!

14/As for myself, I intend to continue to study the scientific statements in the revised Guideline, and to listen to people who are experiencing the impacts of the last one.

You can review and comment here regulations.gov/document/CDC-2…

/fin