Are the CDC Opioid Guidelines Really Voluntary?

By Pat Anson, Editor

When is a medical guideline voluntary and when does it become a “standard of practice” that doctors are expected to follow?

That is one of the key questions in the ongoing debate over controversial guidelines for opioid prescribing unveiled last month by the Centers for Disease Control and Prevention (CDC).

The draft guidelines recommend “non-pharmacological therapy” and other types of pain relievers as preferred treatments for chronic non-cancer pain. Smaller doses and quantities of opioids are also recommended when the drugs are used to treat acute or chronic pain.  A complete list of the guidelines can be found here.

The CDC says the guidelines are needed to help primary care providers. Many lack adequate training in pain management and opioid prescribing, yet they treat the vast majority of chronic pain patients.

“It’s important to note that CDC is not a regulatory agency, unlike the Food and Drug Administration.  Physicians are not required to use the guideline, instead it is intended to support informed clinical decision making regarding the provision of safer, more effective pain treatment for patients,” said Courtney Leland, a spokesperson for the CDC.

But the CDC’s own internal documents make clear that the agency’s ultimate goal is for the guidelines to be widely adopted.

“Efforts are required to disseminate the guideline and achieve widespread adoption and implementation of the recommendations in clinical settings,” the agency says in briefing papers obtained by Pain News Network.  “CDC is dedicated to translating this guideline into user-friendly materials for distribution and use by health systems, medical professional societies, insurers, public health departments, health information technology developers, and providers, and engaging in dissemination efforts.”

“Clearly the intent of CDC is that the guideline be distributed to and adopted by state public health entities and certifying organizations as if it had the legal authority of a regulation,” a representative with the American Cancer Society wrote in a recent letter to CDC Director Tom Frieden.  

The letter said the American Cancer Society “cannot endorse the proposed guidelines in any way” because they “have the potential to significantly limit cancer patient access to needed pain medicines.”

Experts and patient advocacy organizations say the guidelines – voluntary or not – could quickly be adopted by state licensing boards and have a chilling effect on doctors who prescribe opioids.

“If a healthcare provider receives correspondence from the CDC, the assumption can be made that more often than not, the healthcare provider will consider such correspondence relevant and necessary to follow so as to not face any backlash from the CDC or similar agency,” said Shaina Smith, Director of State Policy and Advocacy for the U.S. Pain Foundation, one of the nation’s largest patient advocacy organizations.

“A guideline coming from CDC will be viewed as having a stronger pedigree than a guideline coming from a professional society or other source, and will thus be more likely to be adopted as reflecting a standard of practice, or adopted as a rule by state licensing boards,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

Once in place, Twillman says a guideline or rule could be used in court by a disgruntled patient to challenge the competency of their doctor.

“If a prescriber is sued, one of the things that will be raised at trial is whether or not the prescriber demonstrated that the care provided conforms to the standard of practice. Standard of practice is a bit of an ill-defined term, but I can guarantee you that one question that would be asked in making this determination is, ‘Did you, or did you not, provide care that conforms to the most up-to-date and evidence-based guidelines?’ Any prescriber who can’t show that the care in question conformed to guidelines is going to be in a world of hurt,” Twillman wrote in an email to Pain News Network.

“It can get further complicated because guidelines also come up in disciplinary hearings by licensing boards and other agencies. Again, the same question will be asked, and again, a prescriber whose treatment does not conform to guidelines will be in jeopardy.”

Guidelines Can Become Laws

Twillman says there are precedents for guidelines to turn into laws. Such was the case in Washington State in 2007, when the Agency Medical Director’s Group (AMDG) adopted what was then the nation’s toughest guidelines for physicians who treat pain and prescribe opioids. In 2010, Washington’s Governor signed many of those same guidelines into law, the first in the world to set specific dosing levels for opioids.

Interestingly, two key members of the AMDG were Drs. Gary Franklin and David Tauben, who now sit on CDC panels that are helping to develop and draft the agency’s opioid guidelines. A third CDC panelist, Dr. Jane Ballantyne, has spoken at several hearings in favor of the AMDG guidelines.

Ballantyne and Franklin are the President and Vice-President, respectively, of an advocacy group called Physicians for Responsible Prescribing (PROP), which seeks to reduce the overprescribing of opioid pain medication. Tauben is a board member of PROP, as are two other CDC panelists providing input on the opioid guidelines.

The CDC says it is only fulfilling its mandate to protect the public from a serious health issue.

“Although CDC has not previously issued guidelines on opioid prescribing, we have consulted on and supported guideline development by professional organizations,” said the CDC’s Leland, citing as an example guidelines developed by the American College of Emergency Physicians on the use of opioids in hospital emergency rooms.

“CDC is the nation's health protection agency, operating to strengthen our nation’s public health systems. One way we do this is by developing and issuing guidelines and recommendations on any number of health issues, including those guiding clinical practice,” Leland added. “Prescription drug abuse and overdose is a serious public health issue and improving the way opioids are prescribed through clinical practice guidelines can ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse, abuse, or overdose.”

Leland says the agency is currently revising its draft opioid guidelines – after getting input from healthcare providers and some patients – and remains on track to finalize and release the guidelines in January 2016.

CDC Opioid Guidelines Being Revised

By Pat Anson, Editor

In the wake of growing criticism by pain sufferers and patient advocacy groups, the Centers for Disease Control and Prevention (CDC) is revising its controversial guidelines for primary care physicians who prescribe opioids.

“CDC is currently in the midst of the scientific process and the draft guidelines document is still being revised, without final language that we can disseminate at present. At each step of this process, we’ve incorporated feedback and revisions have been made.  We do not want clinicians using these guidelines until they are finalized,” said Courtney Leland, a CDC spokesperson in an email to Pain News Network.

The extent of the revisions is unclear and the agency says it is still on track to finalize the guidelines in January, 2016.

The draft guidelines released last month recommend “non-pharmacological therapy” and other types of pain relievers as preferred treatments for chronic non-cancer pain. Smaller doses and quantities of opioids are recommended for patients who continue using the drugs for acute and chronic pain.  A complete list of the guidelines can be found here.

“Prescription drug abuse and overdose is a serious public health issue and improving the way opioids are prescribed through clinical practice guidelines can ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse, abuse, or overdose,” said Leland.

Many pain patients are worried the guidelines could further restrict their access to opioid pain medications. The CDC has also been criticized for a lack of transparency in developing the guidelines and for seeking little public input.

In a letter to CDC Director Tom Frieden, the American Cancer Society called for the guidelines’ development to be suspended until numerous issues are addressed.

“We believe the proposed guidelines have the potential to significantly limit cancer patient access to needed pain medicines. We have concerns about the lack of evidence on which the guidelines were based, the methodology used to develop the guidelines, and the transparency of the entire process,” wrote Christopher Hansen, President of the American Cancer Society Cancer Action Network.

“Our concerns are so serious that we cannot endorse the proposed guidelines in any way and suggest suspending the process until the methodological flaws are corrected and more evidence is available to support prescribing recommendations.”

Hansen’s letter was also addressed to Debra Houry, MD, Director of the CDC’s National Center for Injury Prevention and Control, which is developing of the guidelines.

In an email Monday to a “Stakeholders Review Group” composed mainly of physician organizations, Houry invited the groups to listen to a conference call on October 21 to update them on the drafting of the guidelines.  

“As a reminder, the recommendations in the document you reviewed are pre-decisional, draft, and confidential. We ask that you refrain from sharing them widely at this point because they are not yet final, will change based on the feedback we received through the various comment processes, and we do not want clinicians to refer to the guidelines until we complete the peer review, revisions, and clearance process,” Houry wrote.

Secrecy had surrounded the development of the guidelines from the beginning and continues today. Only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on them.

Even the number of public comments the agency has received about the guidelines is unclear. In her email to stakeholders, Houry said there were “more than 250 comments.” But Pain News Network was told there were “more than 1,200 comments from patients, health care professionals, and members of organizations.”

When asked to explain the discrepancy, a CDC spokesperson said the agency had actually received just 167 emails during the public comment period, “but note that this is just the number of emails and doesn’t necessarily equate with the number of comments incorporated within each of the email messages.”

As many as 11.5 million Americans are on long term opioid therapy. The American Cancer Society called on the CDC to give those patients and the public a better chance to review and comment on the guidelines.

“We have concerns that the attempts to solicit public input on the draft guidelines were cursory and did not allow adequate opportunity for thoughtful responses. While a public webinar was held to discuss the recommended guidelines, it was not well advertised and many interested parties were denied access because the webinar lacked sufficient capacity,” Hansen wrote in his letter to the CDC.

As Pain News Network has reported, over 50 invitations to the webinar were sent to groups representing physicians, insurance companies, pharmacists, anti-addiction advocacy groups and other special interests. Only two patient advocacy groups – the American Cancer Society and the American Chronic Pain Association (ACPA) – were invited.

“U.S. Pain Foundation was disappointed to have learned that the CDC drafted the proposed prescriber guidelines on opioid medications without, in the organization’s opinion, appropriately notifying the pain community at-large,” said Shaina Smith, Director of State Policy and Advocacy for the U.S. Pain Foundation, one of the nation’s largest patient advocacy organizations.U.S. Pain feels it was not afforded the opportunity to participate in these important discussions which could have a significant impact on the lives of individuals with pain.

“Despite the CDC stating that 55 diverse organizations were invited to join the webinar's discussion, none of the collaborating patient advocacy organizations U.S. Pain works alongside were granted an invitation. Furthermore, pain patients were not alerted of this opportunity until after the guidelines were made available to the public.”

Repeated calls and emails to Penney Cowan, executive director of the American Chronic Pain Association (ACPA), for comment on the guidelines were not returned.

"We apologize, but Ms. Cowan has been traveling extensively and will not be back in the office until Oct 20th.  She indicated that she does not have time in her schedule to discuss this," a spokesperson for ACPA explained in an email.