AMA recommends specific changes to CDC guideline

The full AMA letter and each recommendation to revise the CDC guideline – (continued from yesterday’s post)

…the CDC Guideline could be substantially improved in three overarching ways.

1. First, by incorporating some fundamental revisions that acknowledge that many patients experience pain that is not well controlled, substantially impairs their quality of life and/or functional status, stigmatizes them, and could be managed with more compassionate patient care.
2. Second, by using the revised CDC Guideline as part of a coordinated federal strategy to help ensure patients with pain receive comprehensive care delivered in a patient-centric approach. And
3. Third, by urging state legislatures, payers, pharmacy chains, pharmacy benefit management companies, and all other stakeholders to immediately suspend use of the CDC Guideline as an arbitrary policy to limit, discontinue or taper a patient’s opioid therapy.

Recommendation 1

• Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.

I can agree with this: non-opioid treatments should be emphasized and tried first. However, many patients simply can’t afford the money or time away from their jobs that regular physical therapies require.

But I’m glad to see this problem not only mentioned but even addressed as an edit to the guideline.

the AMA recommends the following revisions to the first recommendation of the 2016 CDC Guideline:

• Non-pharmacologic therapy and non-opioid pharmacologic therapy are preferred for patients with chronic pain. Providers should consider using opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy, as appropriate.
  In order to achieve this goal, public and private payer policies must be fundamentally altered and aligned to support payment for non- pharmacologic treatments and multimodal, multidisciplinary pain care. In addition, more evidence must be developed to inform clinical decision-making on the use of nonpharmacologic approaches, and more clinicians need to be trained in their effective use.

Recommendation 2

• Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.

…some situations exist where patients may have intractable pain and sufficient disability such that functional improvement is not possible, and relief of pain and suffering alone is a supportable primary goal.

Somehow, I don’t think the writers of the guideline ever considered “pain and suffering” to be a problem. Their only goal was to remove opioids from pain management options and they had no concern for patient outcomes, only milligrams of opioids.

Accordingly, the AMA recommends the following revisions:

• Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function and should consider how therapy will be adjusted, including the potential for tapering and/or discontinuation, discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful benefit improvement in achieving treatment goals for improving or maintaining levels of pain and function that outweighs risks to patient safety.

Recommendation 3

• Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy.

AMA recommends the following be added to the recommendation:

• Clinicians are encouraged to have open and honest discussions with their patients so as to avoid stigmatizing the decision to start, continue, or discontinue opioids or non-opioid therapy. This discussion also must account for the treatment options accessible to the patient based on their health condition, social determinants of health (e.g. transportation, employment, childcare responsibilities, race, gender, age) and insurance coverage.

Recommendation 4

• When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids.

Recommendation 5

• When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when increasing dosage to =50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to =90 MME/day or carefully justify a decision to titrate dosage to =90 MME/day.

the truth of the matter is that MME thresholds remain as hard policy by many health insurers, pharmacy chains, and PBMs. The AMA strongly urges CDC to add language to the revised CDC Guideline urging those entities to rescind these policies.

AMA recommends recasting this recommendation in its entirety:

• Before starting long-term opioid therapy, and at periodic intervals thereafter, physicians should establish and review treatment goals with all patients, including shared goals for pain and function. Physicians should initiate opioid therapy with the lowest effective dose. Continued opioid therapy and/or dose escalation should occur only if there is clinically meaningful improvement or maintenance in treatment goals for pain and function that outweighs risks to patient safety.
  Hard thresholds should never be used.

Recommendation 6

• Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.

As with Recommendation 5, the AMA recommends that Recommendation 6 clearly include CDC’s own admission concerning: “Misapplication of recommendations to populations outside of the Guideline’s scope. The Guideline is intended for primary care clinicians treating chronic pain for patients 18 and older. 

The AMA has heard from many physicians and patients from whom needed pain therapy with opioid analgesics was withheld based on a rationale that the treatment team was following the CDC guidance.

Patients with sickle cell disease or advanced cancer have been accused of manufacturing acute pain and engaging in drug seeking behavior.

This is truly an outrage. Even if some small number of patients tried to get more opioids, this suspicious view of pain due to a fatal illness or its treatment is destructive for both the patients and the doctors trying to do their job and treat pain appropriately.

We have heard from physicians and patients in hospice or who have cancer that opioid analgesics were denied because the prescribed amounts did not comply with the CDC Guideline.

In revising its Guideline, the CDC must address these concerns. This includes any implication that long-term opioid therapy is automatically negative

we urge CDC to remain focused on treatment recommendations rather than subjective statements that lend themselves toward further stigmatizing those who benefit from long-term opioid therapy.

The AMA therefore recommends the following revisions:

• Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater in a quantity than needed only for the expected duration of pain severe enough to require opioids. Three or fewer days will often be sufficient; more than seven days will rarely be needed. Hard thresholds should never be used. Where such thresholds have been implemented based on the previous CDC Guideline, they should be eliminated.

Recommendation 7

• Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids

In addition, we note that this recommendation is another example where CDC’s use of specific numbers has caused states to adopt the Guideline as hard policy.

The AMA asks, therefore, that the CDC acknowledge the burdens patients face

• Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy at appropriate clinical intervals determined by the clinician. every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other available and affordable therapies and, if necessary, discuss with patients a shared plan to carefully and gradually lower dosages, or to taper, or and discontinue opioids.

Recommendation 8

• Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (=50 MME/day), or concurrent benzodiazepine use, are present.

The AMA remains concerned that the discussion of risk has increased stigma to patients with pain. Too many states, health insurers, pharmacy chains, and PBMs have adopted one-size-fits-all policies that attempt to address risk by putting so many restrictions on care that the new policies have increased harm.

we recommend the following revisions to this recommendation:

• Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid-related overdose, such as history of overdose, history of substance use disorder, or higher opioid dosages (≥50 MME), or concurrent benzodiazepine use, are present. Risk factors should be discussed with the patient, but no single risk factor should be used as a determining factor in decisions to discontinue or deny care.

Recommendation 9

• Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

While PDMPs can help identify patients receiving multiple prescriptions from multiple prescribers or dispensers,

we believe the steps to be taken after identifying such individuals are much more complex and require further research and attention.

a patient who has multiple prescriptions from multiple prescribers and/or pharmacies is one who needs treatment, not law enforcement intervention.

The guideline encouraged the use of law enforcement as a part of our medical treatment and I’m surprised the AMA waited this long to specifically state that patients need treatment, not arrest.

AMA recommends the following revisions:

• Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to help inform the provider’s clinical decisionmaking. determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should continue to review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy at clinically appropriate intervals. PDMP reports raising questions should be carefully examined but not used, by themselves, as reasons to discontinue or deny care to the patient , ranging from every prescription to every 3 months.

Recommendation 10

• When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

we continue to point out that the evidence used by CDC in 2016 still does not support the conclusion that urine drug testing improves outcomes in patients receiving opioids for chronic pain.

While a urine drug screen can serve as an objective measure as part of a broader risk mitigation strategy

, it is not a panacea and should not be used as a “gotcha” element. Unfortunately, the CDC Guideline encourages that belief and approach.

AMA recommends the following revisions:

• When prescribing opioids for chronic pain, clinicians’ potential use of urine drug testing should be made in consultation with the patient, including discussion of the limitations of such testing and assurances that test results are only one factor in ongoing treatment decisions. Urine drug testing should not, by itself, be a determining factor in whether to discontinue or deny care to a patient. should use urine drug testing before starting chronic opioids therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled substances and illicit drugs.

Recommendation 11

• Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.

we recommend that the language be framed in a way that recognizes the clinical decision making authority of the treating physician, to read as follows

This is a good point. It’s about time someone pointed out that the doctor is the one who should be making decisions based on your medical situation, not some standard guideline document.

• Clinicians should avoid prescribing opioid medication and benzodiazepines concurrently whenever possible, unless it is clinically indicated and required for optimal patient management.

Recommendation 12

• Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

The ability of primary care physicians to “ensure that patients get treatment for opioid use disorder when needed” is severely constrained by a lack of access to treatment and numerous public and private payer policies that are based on a lack of understanding that addiction is a chronic brain disease.

health insurers have largely gone unchecked in noncompliance with federal and state mental health and substance use disorder parity laws.

there is clearly a role for CDC to make clear that administrative barriers to treatment for opioid use disorder must be removed for the epidemic to end.

we urge that this recommendation be revised to read as follows:

• Clinicians should offer or arrange evidence-based treatment, including medications used to treat opioid use disorder in combination (usually opioid agonist treatment in combination with behavioral therapies, where available) for patients with opioid use disorder.

New recommendation for patients with pain who may have a history of an opioid use disorder

Patients with pain may have co-morbidities that need to be addressed as part of a comprehensive treatment plan. This includes the possibility that they may have a known or undiagnosed substance use disorder.

CDC can help undo some of the damage from the CDC Guideline by acknowledging how patients with pain can and should receive treatment for their pain even if they have a current or history of an opioid use disorder.

By placing so much emphasis on reducing opioid prescribing, the CDC has caused considerable fear in the patient and medical community that opioid therapy for pain will automatically cause opioid use disorder, overdose, and death.

This has led to patients sometimes being denied effective pain care in the emergency department, after surgery, and in primary care settings.

the AMA recommends the following:

Recommendation 13

• Patients with a current or history of an opioid use disorder should receive effective pain care, including opioid therapy when clinically indicated and in consideration of known risks and benefits.