- Background of the CDC Guidelines
- Who should comment?
- Where do I put my comment?
- Why should I comment?
- Rules for commenting (the CDC commenter's checklist)
- What should I say in my comment?
- Other articles about the updated/expanded guidelines
- CDC docket comment from us at The Doctor Patient Forum
As many of you know, the 2016 CDC Opioid Guidelines have caused harm to many. Whether the guidelines themselves are the problem or if they have just been misapplied has been widely discussed by experts. In July 2021, the CDC released their draft of the updated opioid guidelines. We explained it all in detail in our newsletter. If you haven't had a chance to read it, please do. It helps put all of this in context. The new draft of the guidelines was published last week. Here are two very important links:
Word and pdf of this information
Some CPP advocates created this Community Sign-On Letter for anyone who'd like to sign. Please sign this as well as submitting your own comment on the docket.
- Here is the 229 page draft of the updated Guidelines.
- Here is a chart comparing the 2016 Guidelines vs 2022 draft version of the updated/expanded Guidelines.
- All Chronic Pain Patients (CPP's) should comment.
- All loved ones (family and friends) of a CPP should comment. They should include the following information:
- What it's like for them to watch you suffer needlessly.
- If your pain is currently adequately treated, they should write what you're able to do and how you're able to function due to medication.
- If your pain was adequately treated and has been tapered or stopped, they should write how your life has changed since the medication has been taken away. Emphasize function. What things were you able to participate in before your medication was stopped? What things are you unable to do now?
- CDC is accepting comments here on the draft of the updated/expanded Guidelines until April 11, 2022. You can also read comments that are already posted.
- ***IMPORTANT INFORMATION - The link for leaving comments about the draft of the guidelines has been broken off and on. If you find the link is broken when you're trying to leave a comment, please contact Arlene Greenspan at 770-488-4696 or e-mail her at opioids@cdc.gov
- We can't express strongly enough how important it is that you comment. Every single person who has been devastated by these Guidelines needs to post a comment.
- We also suggest that you send a copy of your comments to your local legislators. They need to hear from their constituents about how devastating the 2016 Guidelines have been and how your lives have been harmed.
- CDC will review ALL comments, and based on what they see will update the draft accordingly. The new draft will come out by the end of 2022 and will replace the 2016 Guidelines.
****We list some suggestions for you, but please don't use these suggestions word for word. If you do, there is a good chance the CDC will remove your comments.****
The CDC lists the "commenter's checklist." The checklist includes the following:
"Tips for Submitting Effective Comments
Overview
A comment can express simple support or dissent for a regulatory action. However, a constructive, information-rich comment that clearly communicates and supports its claims is more likely to have an impact on regulatory decision making.
These tips are meant to help the public submit comments that have an impact and help agency policy makers improve federal regulations.
Summary
- Read and understand the regulatory document you are commenting on
- Feel free to reach out to the agency with questions
- Be concise but support your claims
- Base your justification on sound reasoning, scientific evidence, and/or how you will be impacted
- Address trade-offs and opposing views in your comment
- There is no minimum or maximum length for an effective comment
- The comment process is not a vote – one well supported comment is often more influential than a thousand form letters
Detailed Recommendations
- Comment periods close at 11:59 eastern time on the date comments are due - begin work well before the deadline.
- Attempt to fully understand each issue; if you have questions or do not understand a part of the regulatory document, you may ask for help from the agency contact listed in the document.
Note: Although the agency contact can answer your questions about the document's meaning, official comments must be submitted through the comment form. - Clearly identify the issues within the regulatory action on which you are commenting. If you are commenting on a particular word, phrase or sentence, provide the page number, column, and paragraph citation from the federal register document.
- If a rule raises many issues, do not feel obligated to comment on every one – select those issues that concern and affect you the most and/or you understand the best.
- Agencies often ask specific questions or raise issues in rulemaking proposals on subjects where they are actively looking for more information. While the agency will still accept comments on any part of the proposed regulation, please keep these questions and issues in mind while formulating your comment.
- Although agencies receive and appreciate all comments, constructive comments (either positive or negative) are the most likely to have an influence.
- If you disagree with a proposed action, suggest an alternative (including not regulating at all) and include an explanation and/or analysis of how the alternative might meet the same objective or be more effective.
- The comment process is not a vote. The government is attempting to formulate the best policy, so when crafting a comment it is important that you adequately explain the reasoning behind your position.
- Identify credentials and experience that may distinguish your comments from others. If you are commenting in an area in which you have relevant personal or professional experience (i.e., scientist, attorney, fisherman, businessman, etc.) say so.
- Agency reviewers look for sound science and reasoning in the comments they receive. When possible, support your comment with substantive data, facts, and/or expert opinions. You may also provide personal experience in your comment, as may be appropriate. By supporting your arguments well you are more likely to influence the agency decision making.
- Consider including examples of how the proposed rule would impact you negatively or positively.
- Comments on the economic effects of rules that include quantitative and qualitative data are especially helpful.
- Include the pros and cons and trade-offs of your position and explain them. Your position could consider other points of view, and respond to them with facts and sound reasoning.
- If you are uploading more than one attachment to the comment web form, it is recommend that you use the following file titles:
- Attachment1_<insert title of document>
- Attachment2_<insert title of document>
- Attachment3_<insert title of document>
- Keep a copy of your comment in a separate file – this practice helps ensure that you will not lose your comment if you have a problem submitting it using the Regulations.gov web form.
Posted Comments
After submission, your comment will be processed by the agency and posted to Regulations.gov. At times, an agency may choose not to post a submitted comment. Reasons for not posting the comment can include:
- The comment is part of a mass submission campaign or is a duplicate.
- The comment is incomplete.
- The comment is not related to the regulation.
- The comment has been identified as spam.
- The comment contains Personally Identifiable Information (PII) data.
- The comment contains profanity or other inappropriate language.
- The submitter requested the comment not be posted.
Form Letters
Organizations often encourage their members to submit form letters designed to address issues common to their membership. Organizations including industry associations, labor unions, and conservation groups sometimes use form letters to voice their opposition or support of a proposed rulemaking. Many in the public mistakenly believe that their submitted form letter constitutes a "vote" regarding the issues concerning them. Although public support or opposition may help guide important public policies, agencies make determinations for a proposed action based on sound reasoning and scientific evidence rather than a majority of votes. A single, well-supported comment may carry more weight than a thousand form letters.
* Throughout this document, the term "Comment" is used in place of the more technically accurate term "Public Submission" in order to make the recommendations easier to read and understand.
Disclaimer: This document is intended to serve as a guide; it is not intended and should not be considered as legal advice. Please seek counsel from a lawyer if you have legal questions or concerns."
Sometimes it's hard to know what to say. We created some basic comment ideas.
In case you would like some suggestions on what to say in your comments, here are some ideas:
- Tell your story and how you've been affected by the 2016 CDC Guidelines.
- You can use your name or remain anonymous.
- Mention your state and if your state has laws based on the CDC Guidelines.
- Briefly describe how you've been hurt by the Guidelines.
- Be sure to emphasize not just pain relief but also address function. What were/are you able to do with adequate pain medication that you weren't/aren't able to do without it.
- Remove ALL mention of MME (Milligrams of Morphine Equivalent)including in the supporting text.
- Not only is there not a standard way to count MME, the hard thresholds mentioned in the 2016 Guidelines of 50 and 90 MME have caused great harm both to doctors and patients. We wrote all the details about the issues with MME in our Debunking Lies section on our website.Although CDC did remove MME thresholds from the main Guidelines, they still are mentioned many times throughout the supporting text.
- Remove ALL mention of limit of days for prescription for acute pain including in the supporting text.
- Although they removed mention of 3, 5, or 7 day limits in the actual Guidelines, the supporting text still has "a few days" and "7 days" mentioned. This needs to be removed.
- Fund and execute a plan for how to de-implement the 2016 CDC Guidelines.
- Although CDC claims these were "just guidelines" arbitrary limits such as MME limits and 3,5, or 7 day limits are an issue because:
- Many state laws have been created based on them.
- They are worked into EHR (Electronic Health Records).
- Risk score algorithms such as NarxCare use them.
- CDC funded an extensive implementation plan for them.
- DEA also uses risk scores to flag doctors who "prescribe outside of the CDC Guidelines."
- Although CDC claims these were "just guidelines" arbitrary limits such as MME limits and 3,5, or 7 day limits are an issue because:
- The Guidelines need to be redacted and redone due to bias and conflicts of interest (COI's).
- Read about the lack of transparencyand COI's.
- Roger Chouwas involved in every aspect of the CDC Guidelines and has COI's.
- PROP members who were being paid by law firms involved in opioid litigation were involved with the Guidelines.
- Deborah Dowell, an author of both 2016 and 2022 CDC Guidelines was listed as a PROP member at a meeting with FDA regarding PROP’s 2012 petition. Here is the document showing Dowell as a PROP member
- Pain is not one condition and they need to mention there are MANY very painful conditions that might require opioids.
- Exclusions didn't work in 2016 and won't work now.
- They excluded "cancer pain" in 2016 Guidelines yet cancer patients have been affected.
- They added Sickle Cell Disease as an exclusion in these Guidelines (which is good since SCD patients have been horribly affected by the 2016 Guideline), but they also need to mention there are many painful diseases and conditions. Just saying "palliative care" patients are exempt won't help anyone. It didn't help in the 2016 Guidelines.
- There is no scientific basis for the distinction of cancer and non-cancer pain.
- Mentioning some conditions and not others leads to a lack of individualized care.
OTHER ARTICLES ABOUT THE UPDATED/EXPANDED CDC GUIDELINES
Many media outlets covered this story. Our favorite is from Josh Bloom "Panic in PROPville."
Here is an article from Pain News Network called "Why CDC Dropped One-Size-Fits-All Approach to Pain Care":
By Pat Anson, PNN Editor
The reaction from patients, advocates and the medical community to a revised draft of the CDC’s opioid guideline has largely been positive, with many cheering the flexibility it gives doctors in deciding whether to prescribe opioids for pain.
Although voluntary and only intended for primary care physicians, the original 2016 guideline’s dose limits became hard thresholds for doctors in all specialties, who feared scrutiny from regulators and law enforcement if they didn’t follow them. The revised draft still recommends caution when prescribing opioids, but emphasizes that physicians should use their own judgement.
“Treating pain is complex. There are a variety of factors at play. And we know that patients respond differently to different types of pain. We tried to incorporate that nuance so that we’re not coming out with something that’s a one-size-fits-all. It really needs to be individualized and flexible,” said Christopher Jones, PharmD, Acting Director of the CDC’s National Center for Injury Prevention and Control.”
People who’ve been closely following the guideline process were surprised at how extensive the changes are. At a July 2021 public meeting, an independent panel advising the CDC expressed alarm that the agency seemed intent on keeping a recommendation that opioid doses be limited to no more than 90 morphine milligram equivalents (MME) per day.
In the last six months, that dose threshold was taken out of the revised draft, which was published Thursday in the Federal Register.
“It was exciting to open up the draft and see a significant pivot,” said David Dickerson, MD, who chairs the American Society of Anesthesiologists’ Committee on Pain Medicine. “I think the CDC authors have acknowledged that they wanted to do it different this time.”
Dickerson was not only pleased to see the 90 MME threshold go away, but a stronger focus on the many different types of pain, whether its temporary acute pain from surgery or chronic pain from a disabling, incurable disease.
“I think the text of this manuscript is really well done in its draft form right now. When I read through it, it was a great refresher and highlighted some studies that perhaps I had missed,” Dickerson told PNN. “They are instructive, they’re specific, but they also have an intentional vagueness to them to allow for clinicians to practice medicine.”
Importantly, the guideline also makes clear that it shouldn’t be used by third parties to dictate how pain should be treated.
“This voluntary clinical practice guideline provides recommendations only and is intended to be flexible to support, not supplant, clinical judgment and individualized, person-centered decision-making. This clinical practice guideline should not be applied as inflexible standards of care across patient populations by healthcare professionals, health systems, pharmacies, third-party payers, or state, local, and federal organizations or entities.”
“States and insurers have turned the guideline into laws and unbending regulations, preventing physicians from treating patients as individuals with specific needs,” Bobby Mukkamala, MD, Chair of the American Medical Association’s Board of Trustees, said in a statement. “The list of misapplications of the 2016 guideline is long, and its impact has been tremendous harm.
“The CDC’s new draft guideline — if followed by policymakers, health insurance companies and pharmacy chains — provides a path to remove arbitrary prescribing thresholds, restore balance and support comprehensive, compassionate care.”
Nearly 40 states have codified the 2016 guideline in some way, often by limiting the number of opioid pills that can be dispensed for an initial prescription to seven days’ supply or less. Dickerson hopes those states will review and revise their laws and regulations to better reflect what the CDC recommends in its revised draft – that enough opioids be prescribed for “the expected duration of pain.”
“We should right-size our care for the individual patient and be procedure specific. Before it was one-size-fits-all, three to seven days’ (supply),” Dickerson said.
He also thinks the Department of Justice (DOJ) and Drug Enforcement Administration (DEA) should reconsider their aggressive prosecution of doctors for prescribing high doses.
“The work that the DOJ and DEA is doing, I want to believe is done in good intent,” he said. “I think that many of their cases will look at the prescriptions or the doses, but they might not look at the context for why the patient was receiving that care or why they were receiving those medicines.”
The CDC is not expected to finalize its draft guideline until late this year. You can read the guideline and leave an online comment in the Federal Register. Comments must be received by April 11.
