Even Guideline Writers Express Concern over its Use

What’s in that Opioid Plan from CMS? by @StefanKertesz 2/28/17

Several physicians have asked me to justify concerns regarding a plan announced by the Centers for Medicare and Medicaid Services (CMS), a plan that Dr. Adam Gordon and I have described as enforcing opioid prescribing recommendations laid out by the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain in a non-patient-centered way.

“When four CDC Guideline experts express a degree of concern at what CMS proposes to do, it suggests that CMS is not adhering to the intent of the CDC Guideline, but violating it.”

They don’t doubt our clinical concern. However, they want details on why we think the CMS Plan will have the impact that we project it will have, given what’s in it.  

Let me restate the core concern first, however. CMS is proposing to expand ongoing policies that it believes will implement the objectives central to the 2016 CDC Guideline on Prescribing Opioids for Chronic Pain. They posted an Advance Notice on February 1. CMS will accept public comment to AdvanceNotice2018@cms.hhs.gov until March 3, 2017, a short 4-week comment period.

In my judgment, some of the CMS-proposed practices will accelerate a well-remarked national pattern of involuntary, non-patient-centered dose reduction or discontinuation, with attendant harms to patients.

Dr. Gordon and I lay these out here, but you can also read anecdotes in the medical literature here, and from patients here.

Involuntary, non-patient centered dose reductions were NOT endorsed by the CDC Guideline.

As of March 1, I had heard from two members of the CDC Guideline’s Core Expert Group who have expressed alarm at what CMS proposes to do.

I have heard similar concerns from 2 other experts who assisted the CDC in its Guideline, although they have not committed to write to CMS.

These cowards won’t even speak up to help the pain patients their policies are literally killing.

When four CDC Guideline experts express a degree of concern at what CMS proposes to do, it suggests that CMS is not adhering to the intent of the CDC Guideline, but violating it.

We are seeing harm from such practices, but it’s only reported anecdotally thus far.

The particulars:

The CMS Advance Notice proposal for open comment until March 3, 2017 appears on pages 145 to 150. They are further explained by CMS under Section C below, and illustrated by pharmacist James DiMicco in items A1 and A2 below.

In broad strokes CMS will push for the following two key metrics to be used to guide practice, with the general objective that both numbers be reduced.

1. “number of patients at >90 MME” (that’s Morphine Milligram Equivalents) and
2. “number of patients >200 MME”

Both figures appear in the CMS Advance notice, but the figure of 90 MME also appears as key to a CMS strategy declaration, on page 12.

• First, CMS will require a “hard formulary safety edit” (bottom of page 148) in which prescriptions are stopped at point of sale if calculated MME exceeds 200

This means the patient brings their prescription, is likely to leave the pharmacy empty-handed until or unless the physician can overcome utilization review.

If they enter acute withdrawal over the weekend, so be it. Patient hospitalization for withdrawal or death from suicide is not a quality metric in the CMS Opioid Strategy.

• Second, CMS calls for “case management” and “retrospective case review” based on any patient where MME exceeds 90 MME (top of page 148). This sounds more benign, but reality is that CMS has recommended Pharmacy Plans act aggressively

As Mr. Ahern explains, CMS encourages a “soft edit”, which means any prescription >90 MME is refused payment at point of sale, unless the pharmacist decides to override, based on considerations that are essentially up to the pharmacist.

Obviously, those considerations could include race, sex, ethnicity, gender, clothing, etc, since there is no guidance.

Even Mr. Ahern’s email is not a full description of what is happening in practice. As pharmacist James DiMicco writes below in sections A1 and A2 below. “It has been my experience that Medicare plans and some commercial plans have already been imposing hard edits when it is not currently required.”

He sent me a PDF plan rejection that he managed to override, but he said a “soft edit” (where he can override) is increasingly the exception, even for doses of >90 MME.

• Third, CMS seeks to refine and broaden a category called “Opioid overutilization” (bottom of page 145 through 147), which is based on a combination of number of pharmacies, number of prescribers, and a maximum dose of 90 MME or greater.

In a separate document, this is targeted as “egregious overutilization” in which the goal is to “implement appropriate plan-level claim controls at point-of-sale (POS) for opioids,

use improved retrospective drug utilization review to identify beneficiaries at high risk for an adverse event due to opioids, and

perform case management with the identified beneficiaries’ prescribers followed by beneficiary-specific POS edits to prevent Part D coverage of opioid overutilization, if necessary.”

How does this relate to the CDC Guideline?
How about evidence?

For physicians wishing to get out of the firing line, the implicitly encouraged step is involuntary dose reduction to bring doses down, even if the patient is functionally “stable” on their current dose, and without their consent. But that course of action has absolutely no trial data to support it.

What the CDC Guideline review did summarize was that higher doses are, on average, associated with higher risk of overdose (and other outcomes, e.g. depression, falls, etc). We should assume that there is a component of cause and effect here, at least for overdose

For patients where I have determined that harm frankly outweighs benefit, I have executed involuntary tapers, to good effect.

But the impact of the CMS plan will not involve voluntary dose tapering by expert physicians, but

involuntary tapering by non-expert physicians.

The CDC Guideline explicitly concluded that there was insufficient evidence to support this, and that is because we have no clinical trials and no prospective follow-up studies on this practice.

The cumulative impact of CMS policies, including those initiated last year, alongside the more aggressive Pharmacy Benefit Plans, has already been to force non-patient-centered decision-making, i.e. what the CDC Guideline counsels against

For that reason I hope you will look at the material below, the links as much as you wish, and consider writing at least a short note to CMS by March 3 at: AdvanceNotice2018@cms.hhs.gov