DEA Finalizes Cuts in 2023 Opioid Supply

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has finalized plans to further reduce the supply of oxycodone, hydrocodone and other commonly prescribed opioids by about 5 percent in 2023, ignoring complaints from patients and healthcare providers that a seventh consecutive year of cuts in opioid production would cause shortages and interfere with the treatment of pain patients.

In a notice published in the Federal Register, DEA said the reduced supply of opioids in 2023 would be “sufficient to meet all legitimate needs.”  The agency has broad legal authority under the Controlled Substances Act (CSA) to establish annual production quotas for drug manufacturers, based on estimated medical, scientific and research needs.  

The 5% production cut in 2023 for Schedule II opioids is not as steep as in prior years, but continues a trend that began a decade ago. Since their peak in 2013, DEA production quotas have fallen by 65% for oxycodone and 73% for hydrocodone.

It’s hard to find any evidence that reducing the opioid supply prevents overdoses. Prescription opioid use has fallen by nearly 50 percent in recent years, but drug deaths have climbed to record levels, fueled primarily by street drugs made with illicit fentanyl.

‘You’re Just Going to Kill People’

Over 350 people and organizations commented on the DEA’s new quotas during a 30-day public comment period that ended in mid-November. Many fear that further cuts in the opioid supply will lead to more suffering and suicides due to untreated pain.

“The DEA should not impose further reduction in the supply of Rx opioids for 2023. There is no correlation between prescriptions and diversion. All the street drugs out there come from Mexico by way of China, NOT a pharmacy,” wrote Anne Hoch. “The DEA are acting as doctors and determining how a doctor does his or her job. The government has to get out of healthcare and respect patient privacy again.”

“Stop reducing production of opioids. There already is a large shortage of pain meds. Why in the world are you reducing AGAIN??! Stop torturing Americans with your disastrous policies. It's quite clear that access to prescription opioids is a problem, so I'm not at all sure what you think you'll gain from reducing production -- you're just going to kill people,” wrote Amber Bullington.

Several people also pointed out that the CDC recently updated its opioid guideline to emphasize there is no hard limit on doses and to give doctors more flexibility in prescribing opioids.

“I believe that the DEA must take into consideration these revised Guidelines, because physicians will no longer be constrained to any arbitrary, hard and fast limit. More, rather than less, opioid daily dosages could be prescribed to certain individual patients who have high impact, intractable pain,” said an anonymous poster.

But the DEA said it would proceed as planned and take a wait-and-see approach to the revised guideline before making any changes to its aggregate production quotas (APQ).

“DEA will consider the impact of CDC's revised guidelines over time, in determining whether DEA may need to publish a revision to the currently proposed APQ values during the 2023 calendar year, when there is sufficient data to provide an understanding of the impact of the guidelines on the actual prescribing as practitioners seek to implement this guidance,” wrote DEA Administrator Anne Milgram, a former Attorney General of New Jersey who has no experience in medicine.

“In addition, DEA's regulations do not impose a maximum limit on the amount of medication that may be prescribed on a single prescription. DEA has consistently emphasized and supported the authority of individual practitioners under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards.” 

That comment about no “maximum limit” on prescriptions and the DEA supporting the “authority of individual practitioners” would come as a surprise to many doctors. For years, DEA task forces have targeted doctors who prescribe high doses of opioids deemed to be “outside the usual course of professional practice.” 

Last month the agency suspended the DEA license of Dr. David Bockoff, a California doctor who was treating 240 pain patients, including some from out-of-state who need high doses but were unable to find a local provider. Although Bockoff has practiced medicine for 53 years and has no record of any disciplinary action or complaints with the state medical board, the DEA alleged that he was “an imminent threat” to public safety. Milgram herself issued the order suspending Bockoff’s license to prescribe opioids and other controlled substances.

Within a week of the suspension, a distraught high-dose patient and his wife died in a double suicide in Georgia because he was unable to find another doctor willing to treat his pain. PNN has learned of a second Bockoff patient who died this past weekend, apparently from complications caused by opioid withdrawal. 

‘You Ruined My Life’: Patients Blame CDC for Poor Pain Care

By Pat Anson, PNN Editor

Nearly 5,400 people have left comments in the Federal Register sharing their experiences and concerns about the quality of pain care in the United States. Tuesday was the final day for people to make public comments, which the Centers for Disease Control and Prevention will consider as it updates and possibly expands its controversial opioid prescribing guideline.

Most of the respondents are patients who blame the CDC for their poorly treated or untreated pain. Although the 2016 guideline was only intended for primary care physicians treating chronic pain, the CDC’s recommended limits on opioid prescribing have been widely adopted as policy by federal agencies, states, insurers, pharmacies and many doctors — who use the guideline as excuse to take people off opioids or greatly reduce their doses.  

“The day the CDC guidelines came out, I was taking 400mg oxycodone and leading a productive life. Then I was taken completely off all my medication. I went through hell and wanted to kill myself,” wrote Wren Lum. “I lost my job because I couldn't work anymore. I could no longer get out of bed. Lost my house because I could no longer pay the mortgage. CDC, you ruined my life.”

“I am not being prescribed the right dose of pain medication and it’s all because of the CDC guidelines. I used to be on three times the amount of oxycodone that I am now on and it’s taken away my ability to walk. I’m only 34 years old. This is devastating to me and my family, and now have such a lack of quality of life,” wrote Holly Letendre.

“I was given opioid medicine for 8 years. I could work, volunteer, socialize, care for my children, my husband, my home, and importantly, myself. I now shower every 10-14 days, it's too painful. When I do, I am curled up in horrendous pain for hours afterwards,” said Donna Johnson. “This is due to the CDC’s guidelines. It was then that doctors became afraid to prescribe, even to compliant patients living happy lives. I want my life back.”

The CDC is planning to update or expand the guideline to include recommendations for treating short-term acute pain and tapering patients safely off opioid medication. It took the agency three years to acknowledge that some patients were being taken off opioids too rapidly, putting them at risk of withdrawal, uncontrolled pain and suicide.

“My life has become miserable. I suffer every day after my doctor cut my dosage by almost 90 percent. Ninety percent! My blood pressure meds have had to be tripled. I have gained weight since I am now for all intents and purposes nearly bedridden,” said Kendal Rice in her comment to the CDC. “You people are just monsters. Every one of you. You certainly are not healers.”

PROP ‘Urgent Action Request’

Thousands of people – mostly pain patients and their loved ones – left comments critical of the CDC guideline. That prompted anti-opioid activists to launch their own campaign in support of the agency.

Dr. Andrew Kolodny, founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), emailed an “urgent action request” to supporters last night, urging them to leave their own comments. He claimed without any evidence that the backlash against the CDC was bankrolled by drug companies.

“The CDC has been receiving pressure to weaken the recommendations in its 2016 CDC Guideline,” wrote Kolodny. “Not surprisingly, much of this pressure is coming from pain organizations funded by drug companies and from opioid-dependent pain patients. Many of these patients are fearful and angry because they're having a harder time finding clinicians willing to prescribe opioids aggressively.” 

In a joint letter to CDC Director Dr. Robert Redfield, Kolodny and several PROP members said the guideline was “tremendously helpful” to primary care physicians and has led to “downward trends in inappropriate prescribing.” The letter also claimed that long term use of opioids often makes pain worse and leads to “intolerable negative mood changes” in patients. 

“We know from clinical experience and from controlled studies that opioids are rarely beneficial for chronic pain,” Kolodny wrote. “Now is not the time to reverse the gains of the 2016 guideline. The focus now should be twofold: to find better ways to help people already on opioids and improve access to better means than opioids to treat chronic pain.” 

Alternative Treatments

Many patients say they’ve already tried non-opioid treatments and found them ineffective for severe pain. 

“The majority of antidepressant and anti-seizure medications available today pose just as much a risk for dependency, withdrawal and death as opioids, if not more. Yet these medications are prescribed 1,000 times more and have much more severe side effects and withdrawal effects,” wrote Lois Luesing, who says her 36-year old son is housebound and unable to work because of chronic pain.

“He’s tried numerous available Rx meds, creams, alternative treatments, supplements, patches, etc. and nothing works. The only medication that will work to relieve his pain and give him his life back are opioids, yet we can’t find a doctor to prescribe this life-saving medication for him. It’s not his fault that’s the only thing that works. There are millions of others that this is the same for.”

Some patients have found alternatives that do work.  Although the herbal supplement kratom isn’t even mentioned in the CDC guideline, hundreds of kratom users left comments in the Federal Register asking the CDC not to regulate kratom.  

“Kratom is a life saver for me. I was being personally prescribed opiates for almost 20 years due to chronic pain. Although I always took as directed and never let them ruin my life, there's a very fine line to not go over the edge with them. They are so addictive and pretty dangerous for that matter. Since finding kratom this past year, I've been able to stop taking the opiates,” wrote Michael B. “Please don’t take this wonderful plant away from us. I assure you it will end up destroying many people's lives.” 

An update to the CDC guideline is not expected until late 2021, nearly six years after the initial guideline was released.  The agency has funded a series of new studies on opioid and non-opioid treatments for chronic pain.

The report on opioids was released in April. It concluded that opioids were no more effective in treating pain than nonopioid medication, and that long-term use of opioids increases the risk of abuse, addiction and overdose.

Critics Pan Medicare Plan to Reduce High Dose Opioids

By Pat Anson, Editor

Over 1,200 people have left public comments in the Federal Register about changes to Medicare's Part D prescription drug plan, most of them sharply critical of rules that would make it harder for Medicare patients to obtain high doses of opioid pain medication.

Under the proposed regulations for 2019, a ceiling for opioid doses would be set at 90mg morphine equivalent units (MME) for all Medicare beneficiaries.  Any prescription at or above that level would trigger a “hard edit” rule requiring pharmacists to talk with the insurer and doctor about the appropriateness of the dose – with the insurer being the final arbiter in deciding who gets the higher dose.  

If adopted, critics say the rule would force many high-dose opioid patients to be abruptly tapered to lower doses, causing severe pain and withdrawal symptoms -- and possibly leading to illegal drug use and suicide.

“Suddenly dropping opioid doses will cause acute opioid withdrawal, exacerbation of pain, and increased disability with decreased productivity. It also increases the risk that patients will migrate to riskier alternatives such as heroin or fentanyl,” wrote David Kan, MD, an addiction psychiatrist.

“The proposed rule change is in the right spirit but very, very risky in reality. I urge CMS to reconsider the arbitrary dose limit on opioids. The unintended consequences are potentially devastating to our patients and community.”

“This is archaic medicine and does more harm than one can imagine,” wrote pain patient Henry Yennie. “The DEA, HHS, private insurers, and now CMS are pursuing policies and restrictions that will cause harm and suffering to millions of people... You are complicit in the pain, suffering, and documented damage that will result.”

“I cannot understand how Medicare can be so uncaring about the pain people have,” wrote Mikal Casalino, a 72-year old pain patient. “Limiting the dosage to an arbitrary amount is not going to be helpful for individuals. Each person who needs medication deserves the best care possible, and that will depend on both condition and need.”

“I think it is absolutely ludicrous to imagine that a third party could presume to place a maximum daily or monthly limit on my, or any other chronic pain patient's, medication. Each person's tolerance for and requirement of medication varies tremendously. How could you possibly imagine that you could come up with a generic formula which could fit every chronic pain patient across the board?” wrote Cyrynda Walker.

A joint letter opposing the rule change was submitted by 180 doctors and academics, including some who assisted in drafting the CDC’s controversial 2016 opioid prescribing guidelines. The letter points out that a 48 percent reduction in high dose prescribing since 2010 has not reduced the number of opioid overdoses. And it faults CMS for being focused on reducing high dose prescriptions – not the quality of patient care.

“The proposal does not consider adverse impacts on pharmacies, physicians or patients in the context of multiple regulatory initiatives, and it will accelerate patient abandonment,” the letter warns. “The plan avows no metric for success other than reducing certain measures of prescribing. Neither patient access to care nor patient health outcomes are mentioned.”

The public comment period on the CMS proposal ended March 5. To see the comments that were posted, click here.

CMS Seeking ‘Dialogue’ About Opioids

According to CMS, 1.6 million Medicare beneficiaries met or exceeded opioid doses of 90mg MME for at least one day in 2016. Medicare officials said the goal of the “hard edit” rule is to get pharmacists, doctors and insurers to “engage in a dialogue” about the risks associated with high dose opioid prescriptions.

"We are proposing important new actions to reduce seniors' risk of being addicted to or overdoing it on opioids while still having access to important treatment options," said CMS deputy administrator Demetrios Kouzoukas in announcing the rule changes last month. “We believe these actions will reduce the oversupply of opioids in our communities."

To reduce the risk of “unintended consequences” from the hard edit rule, CMS would allow high dose patients to receive a temporary 7-day supply of opioids while they seek an exception to the 90mg MME rule. If approved, patients would then need to get a new prescription from their doctor. The 7-day supply would only be granted once.

Under the proposed rules, CMS would also create a new 7-day limit for initial prescriptions of opioids for acute, short-term pain. CMS would also start monitoring “high risk beneficiaries” who are prescribed opioids and “potentiator” drugs such as gabapentin (Neurontin) and pregabalin (Lyrica). Recent research has shown that combining the medications increases the risk of overdose.

CMS contracts with dozens of insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid. CMS policy changes often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.

Unless changes are made, the proposed Medicare Part D rules for 2019 will be finalized April 2.

Tell Medicare to Stop Its War on Pain Patients

By Richard A. Lawhern, Guest Columnist

In March 2016, the Centers for Disease Control and Prevention published a deeply biased and scientifically unsupported guideline for the prescription of opioid pain relievers.  Congress made this “guideline” mandatory in the Department of Veterans Affairs three months before it was even published.  The VA has since enacted practice guidelines that effectively eliminate opioids as a treatment option for many veterans. 

Now the Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) are doubling down on this bureaucratic atrocity.

CMS has posted in the Federal Register and is inviting public comment on its plans to change the rules for Medicare Part D prescription drug plans in 2019.  

They propose that "all sponsors [are] to implement hard formulary-level cumulative opioid safety edits at point-of-sale (POS) at the pharmacy (which can only be overridden by the sponsor) at 90 morphine milligram equivalent (MME)" – which is the dose ceiling recommended by the CDC.

The so-called “sponsors” are insurance companies that provide health care coverage funded by taxpayers to 54 million Medicare beneficiaries. If implemented, this proposal will effectively deny reliable pain treatment to millions of seniors, poor and disabled people.  When applied to private health insurance and Medicaid as they inevitably will be, these regulations will damage all U.S. citizens.

As I have commented to CMS, their proposals “mandate a dangerous, unfounded and medically unethical intrusion into medical practice by third parties operating without face to face knowledge of the patient. These … changes will damage and deny care to large numbers of the 1.6 million patients whom CMS estimates are presently treated with opioids above 90 morphine milligram equivalent dose per day.”   

Few pain patients ever display diagnostic symptoms of opioid use disorder. Yet drug-related overdoses have risen steadily in the past ten years -- despite restrictions on the medical supply of opioids -- a death toll largely associated with illegal opioids and nonprescription drugs. Managed medical exposure to opioids contributes almost nothing to the widely hyped “opioid crisis.”

Over-regulation of prescribing is already harming hundreds of thousands of stable patients coerced into opioid doses below therapeutic levels.  Mandated VA restrictions on opioid prescribing are directly responsible for hundreds of deaths among veterans. 

All for nothing.  And CMS is about to do more of the same.

A major study in the British Medical Journal illustrates the foolishness of the CMS proposal.  Diagnoses of opioid abuse disorder were tracked for 565,000 opioid-naïve post-surgical patients between 2008 and 2016. Only 0.6% were later diagnosed with Opioid Abuse Disorder (OAD).  Less than 1% renewed their prescriptions up to 13 weeks.  OAD incidence was only weakly sensitive to dose level from less than 20 to over 120  MME  per day.   

Another large study in JAMA Internal Medicine shows the incidence of extended post-surgical opioid prescriptions at just 0.174% to 0.9%, depending on the type of surgery.

CMS is trying to “solve” a non-problem by means guaranteed to create far worse problems.

The CDC Guidelines ignored the natural variability in liver enzymes governing the way opioids are broken down in the body.  Imposing hard limits on MME in “safety” audits will cause therapy failure in hundreds of thousands of patients who can benefit from opioids, but only at significantly higher doses than entertained by CDC and CMS. 

In January 2018 public hearings before the FDA Opioid Policy Steering Committee, the American Academy of Pain Management recommended against hard limits on opioid analgesics.  Other speakers advocated for leaving practice standards to medical professional associations which guide doctors in each specialty.  CMS has ignored both recommendations.

Forcing pain patients to go through an “exceptions” process before extending prescriptions beyond seven days is inappropriate and dangerous nonsense.  Prevailing practice allows for prescription duration sufficient to treat anticipated pain levels.  The alternative is to drown doctors in useless paperwork and to prompt patients to defer needed surgery because they fear being left without pain control.

There is no one-size-fits-all patient or treatment plan.  CMS should stand down from attempting to force restrictions on medical practice which have such predictable and horrid consequences.  

What Can Patients and Caregivers Do?

First, you can register your protest and concern with CMS before March 6th by selecting the “Comment Now!” buttons at this link.

You don’t have to be a doctor or researcher to do this.  Here are some examples of comments you might make.  Please edit them to fit your own situation.  Don’t copy these words exactly, as CMS will delete them.

    A. I am a chronic pain patient with ___________ (one or more diagnoses)

    B. My medical care will be greatly damaged by your regulation.

    C. I rely upon opioid medications to: (fill in)

• Preserve my way of life            
• Manage my incurable pain
• Allow for increased function
• Remain productive

     D. If CMS enforces a hard limit for opioid doses per day, this will give private insurance companies and pharmacies  an excuse to stop paying for my necessary prescriptions or dispensing them at all. 

     E. The proposed regulations are unsupported by any reliable science

     F. If enacted, these policies will: 

• Force even more doctors away from treating pain          
• Force more patients onto disability
• Create more demand for emergency room services
• Increase the rate of expensive and often ineffective surgical procedures
• Increase the rate of suicides

To review the comment process, feel free to visit the Facebook page for the Alliance for the Treatment of Intractable Pain (ATIP).

The second thing you can do is look up the Washington DC phone numbers of your House and Senate representatives. It’s easy. Just Google your state and the word “senators” or “Congress.”

Then call their office.  Tell the staffer who picks up that “I’m a pain patient and I vote in (name the state).  I want the Senator (Congressman or -woman) to tell the Centers for Medicare and Medicaid Services to withdraw their proposed regulation limiting the treatments I can receive.  If accepted, these regulations will destroy my life.”

It is time for people in pain and caregivers to speak up.  If we do not, then we will live – or die – as victims of a medical bureaucracy that doesn’t care about the damage it does to us.

Richard A Lawhern, PhD, is the co-founder and corresponding secretary for the Alliance for the Treatment of Intractable Pain (ATIP). He is a technically trained non-physician patient advocate with over 20 years experience in direct support to patients and caregivers in social media.  His work on public policy for pain management is widely published in multiple online and print media.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.