FTC Releases Interim Staff Report on Prescription Drug Middlemen

https://www.ftc.gov/news-events/news/press-releases/2024/07/ftc-releases-interim-staff-report-prescription-drug-middlemen

The Federal Trade Commission today published an interim report on the prescription drug middleman industry that underscores the impact pharmacy benefit managers (PBMs) have on the accessibility and affordability of prescription drugs.

The interim staff report, which is part of an ongoing inquiry launched in 2022 by the FTC, details how increasing vertical integration and concentration has enabled the six largest PBMs to manage nearly 95 percent of all prescriptions filled in the United States.

This vertically integrated and concentrated market structure has allowed PBMs to profit at the expense of patients and independent pharmacists, the report details. 

“The FTC’s interim report lays out how dominant pharmacy benefit managers can hike the cost of drugs—including overcharging patients for cancer drugs,” said FTC Chair Lina M. Khan. “The report also details how PBMs can squeeze independent pharmacies that many Americans—especially those in rural communities—depend on for essential care. The FTC will continue to use all our tools and authorities to scrutinize dominant players across healthcare markets and ensure that Americans can access affordable healthcare.”

The report finds that PBMs wield enormous power over patients’ ability to access and afford their prescription drugs, allowing PBMs to significantly influence what drugs are available and at what price. This can have dire consequences, with nearly 30 percent of Americans surveyed reporting rationing or even skipping doses of their prescribed medicines due to high costs, the report states.

The interim report also finds that PBMs hold substantial influence over independent pharmacies by imposing unfair, arbitrary, and harmful contractual terms that can impact independent pharmacies’ ability to stay in business and serve their communities. 

The Commission’s interim report stems from special orders the FTC issued in 2022, under Section 6(b) of the FTC Act, to the six largest PBMs—Caremark Rx, LLC; Express Scripts, Inc.; OptumRx, Inc.; Humana Pharmacy Solutions, Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. In 2023, the FTC issued additional orders to Zinc Health Services, LLC, Ascent Health Services, LLC, and Emisar Pharma Services LLC, which are each rebate aggregating entities, also known as “group purchasing organizations,” that negotiate drug rebates on behalf of PBMs.

PBMs are part of complex vertically integrated​ health care conglomerates, and the PBM industry is highly concentrated. As shown in the below image, this concentration and integration gives them significant power over the pharmaceutical supply chain. The percentages reflect the amount of prescriptions filled in the United States.  ​

Image

The interim report highlights several key insights gathered from documents and data obtained from the FTC’s orders, as well as from publicly available information:

• Concentration and vertical integration: The market for pharmacy benefit management services has become highly concentrated, and the largest PBMs are now also vertically integrated with the nation’s largest health insurers and specialty and retail pharmacies.
  • The top three PBMs processed nearly 80 percent of the approximately 6.6 billion prescriptions dispensed by U.S. pharmacies in 2023, while the top six PBMs processed more than 90 percent.
  • Pharmacies affiliated with the three largest PBMs now account for nearly 70 percent of all specialty drug revenue.
• Significant power and influence: As a result of this high degree of consolidation and vertical integration, the leading PBMs now exercise significant power over Americans’ ability to access and afford their prescription drugs.
  • The largest PBMs often exercise significant control over what drugs are available and at what price, and which pharmacies patients can use to access their prescribed medications.
  • PBMs oversee these critical decisions about access to and affordability of life-saving medications, without transparency or accountability to the public.
• Self-preferencing: Vertically integrated PBMs appear to have the ability and incentive to prefer their own affiliated businesses, creating conflicts of interest that can disadvantage unaffiliated pharmacies and increase prescription drug costs.
  • PBMs may be steering patients to their affiliated pharmacies and away from smaller, independent pharmacies.
  • These practices have allowed pharmacies affiliated with the three largest PBMs to retain high levels of dispensing revenue in excess of their estimated drug acquisition costs, including nearly $1.6 billion in excess revenue on just two cancer drugs in under three years.
• Unfair contract terms: Evidence suggests that increased concentration gives the leading PBMs leverage to enter contractual relationships that disadvantage smaller, unaffiliated pharmacies.
  • The rates in PBM contracts with independent pharmacies often do not clearly reflect the ultimate total payment amounts, making it difficult or impossible for pharmacists to ascertain how much they will be compensated.
• Efforts to limit access to low-cost competitors: PBMs and brand drug manufacturers negotiate prescription drug rebates some of which are expressly conditioned on limiting access to potentially lower-cost generic and biosimilar competitors.
  • Evidence suggests that PBMs and brand pharmaceutical manufacturers sometimes enter agreements to exclude lower-cost competitor drugs from the PBM’s formulary in exchange for increased rebates from manufacturers.

The report notes that several of the PBMs that were issued orders have not been forthcoming and timely in their responses, and they still have not completed their required submissions, which has hindered the Commission’s ability to perform its statutory mission. FTC staff have demanded that the companies finalize their productions required by the 6(b) orders promptly. If, however, any of the companies fail to fully comply with the 6(b) orders or engage in further delay tactics, the FTC can take them to district court to compel compliance.

The FTC remains committed to providing timely updates as the Commission receives and reviews additional information.

The Commission voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. Chair Lina M. Khan issued a statement joined by Commissioners Rebecca Kelly Slaughter and Alvaro Bedoya. Commissioners Andrew N. Ferguson and Melissa Holyoak each issued separate statements.  

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If “we” end up with “Medicare for all” or some form of “universal healthcare system”  Could this be the template for such a program? Does anyone believe that our private health insurance industry would be against that or would they throw untold $$$ into hiring lobbyists to help ensure that Congress goes down the path to create such a “healthcare for all”

Insurers brought in $50B through ‘questionable’ Medicare Advantage coding: WSJ

https://www.beckerspayer.com/payer/insurers-brought-in-50b-through-medicare-advantage-coding-wsj.html

Medicare Advantage plans received $50 billion in payments between 2018 and 2021 for “questionable diagnoses” insurers added to medical records, a Wall Street Journal investigation published July 8 has found. 

The Journal investigated billions of Medicare Advantage records and found that some conditions were diagnosed at a much higher rate among Medicare Advantage beneficiaries than among traditional Medicare beneficiaries. For example, diabetic cataracts were diagnosed much more often among Medicare Advantage beneficiaries than among traditional Medicare beneficiaries, the Journal found. 

The federal government pays Medicare Advantage plans a rate per beneficiary based on their diagnoses.  

CMS does not reimburse MA plans for beneficiaries with non-diabetic cataracts, a common condition among older adults, according to the Journal. The government does reimburse for diabetic cataracts. CMS paid Medicare Advantage plans more than $700 million for diabetic cataracts diagnoses between 2018 and 2021, the investigation found. 

A spokesperson for UnitedHealth, the largest Medicare Advantage insurer, told the Journal its analysis was “inaccurate and biased.” Medicare Advantage plans code diagnoses more completely and ensure diseases are caught earlier, the spokesperson told the outlet. 

The Journal’s investigation also found some Medicare Advantage beneficiaries were diagnosed with serious diseases in their medical records, but no evidence of treatment for the disease appeared in these patients’ records. Among beneficiaries who had a diagnosis of HIV added to their record by their insurer, just 17% received treatment for the disease, according to the investigation. Among beneficiaries who were diagnosed with HIV by their physician, 92% received treatment. 

The Journal’s investigation is the latest examining upcoding by MA plans. A 2022 report in The New York Times alleged some insurers incentivized employees or physicians to add diagnoses to patients’ reports. Nearly every major payer has been accused of overbilling by a whistleblower, the federal government or an investigation by HHS’ Office of Inspector General. 

MedPAC, which advises the government on Medicare issues, estimates the federal government will spend $83 billion more on Medicare Advantage beneficiaries than if they were enrolled in fee-for-service Medicare. Coding intensity in MA will be 20% higher than in fee-for-service in 2024, according to the commission. 

Read the Journal’s full report here. 

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I don’t agree with this author’s opinion of what the overturning of Chevron doctrine is going to do to necessarily harm our society’s health. One of the biggest generators of CO2 is the biological functions of most organisms’ metabolism.

One thing that appears that could happen is that the DEA will have its hands tied in generating new interpretations of the CSA. I doubt that anyone within the chronic pain community believes that there is anyone working in the DEA who is an expert on controlled substances’ appropriate use in treating chronic pain and other appropriate uses for controlled meds?  Does anyone think that anyone within the DEA has a clue about the underlying causes of addiction and substance abuse, nor have a working knowledge about how to help those who are labeled as a addict and wish to get sober?

Then there is this little law that has been “on the books” since 1935

42 USC 1395: Prohibition against any Federal interference

https://uscode.house.gov/view.xhtml?req=(title:42%20section:1395%20edition:prelim)

With the End of Chevron, Health and Environmental Experts’ Hands Are Tied

We need the rule of law to protect public health

https://www.medpagetoday.com/opinion/climate-checkup/110995

The irony of a jubilant Fourth of July parade I attended with my kids last week — with marching bands, people in costume, and colorful floats — is that the U.S. government has never been more chaotic. The fragility of our democracy has been thrown into sharp relief over the past few months with a partisan Supreme Court placing a heavy finger on rightward leaning scales and the great unknown of November elections. The legislative branch of government, with all its foibles, then becomes the most secure path forward for those of us who like to breathe air, drink water, and not overheat.

The Supreme Court’s ruling in Loper Bright Enterprises v. Raimondo on June 27 overturning what’s known as “Chevron deference” prioritizes business interests over public health in a decision that weakens the ability of agencies to enforce regulations, such as restricting power plant pollution It says that agencies like the Environmental Protection Agency (EPA) are actually not the experts in environmental protection, but rather judges are. Now, agencies must go to court with industries that dump pollutants into the water or that poison our air because their right to make money precedes everyone’s right to breathe.

There is an obvious problem with this: judges are not experts in everything, only the law. When I take care of patients, I don’t present a variety of therapeutic approaches to a judge so they can adjudicate what I should prescribe. I work with my patient to find the right treatment for them. Similarly, I don’t want a judge and an oil company deciding how much environmental damage is just enough because they are decidedly not experts in environmental or public health protection, nor do they necessarily have the public interest at heart.

The downstream consequences of the ruling are broad. Anything that requires regulation could be affected: from publicly funded health insurance programs (CMS) to the food and drug review systems (FDA) to our environment. For decades, Chevron deference has protected programs like Medicare and Medicaid, with expert federal agencies like CMS being charged with interpreting and implementing the regulations. Issues related to environmental, public, and individual health are extremely complex and should be in the hands of experts, but after this Supreme Court ruling, experts’ hands are tied.

Those of us working to protect public health have supported regulations to advance air quality standards and to limit toxic substances like PFAS. Environmental regulations form a bulwark, checking the potential unregulated greed of industries whose corporate goals are profit and not public health (not even the public health of their shareholders). The hostility to government regulation also comes at the expense of the lives of the hostile: overturning rules that protect all of us will harm the entire country. It amounts to shooting ourselves in the foot, with the caveat that insurance companies can argue in court if they want to cover the doctor bills.

Many medical societies came together to draft an amicus brief  from which Justice Elena Kagan drew on in her dissent as she highlighted the “judicial hubris that the court has demonstrated in its overreaching power play. The long-standing rule of Chevron deference has allowed agencies to protect and advance the public’s health and has ensured that healthcare laws are interpreted and implemented appropriately. Since the Supreme Court’s conservative majority seeks to up end  the power of administrative agencies to do their jobs, legislation appears to be one of our few options to protect public health from climate and environmental degradation.

For example, one legal theory that has come up time and again is a carbon price that would function independently of a biased judiciary and would nudge the economy toward clean energy options and thus a healthier planet. Such federal legislation would acknowledge the health costs of climate change and fossil fuel pollution and be an effective means to reduce climate pollution. Congressional authority to cap carbon dioxide emissions was even noted by Chief Justice John Roberts to be a “sensible solution,” although the Chevron ruling curtails EPA’s ability to engage in cap-and-trade systems. Federal legislation that places a steadily increasing carbon fee at the source (where coal, oil, or gas comes out of the ground or into the country), rather than cap-and-trade, may circumvent those limitations while at the same time catalyzing the predictable transition to healthy non-carbon forms of energy throughout the country.

What we have seen the Supreme Court do is the exact opposite of democracy. It pins the biases of a minority against the welfare and well-being of the majority. With a judicial branch in the pocket of big business and fossil fuel, it becomes even more important to support legislation that cannot be so easily undone. Putting a price on carbon pollution is one example of commonsense and economically feasible legislation that has a chance to extend the environmental protections our communities deserve.

I waved my flags with everyone else at that July 4 parade, but that doesn’t mean I’m satisfied with the current state of the government. I want our leaders to do better to support us and our health.

Elizabeth Cerceo, MD, is an associate professor, academic hospitalist, and director of climate health at her medical school. Cerceo also co-chairs the Education Committee and Climate-Smart Health Care Committee for the Medical Society Consortium on Climate and Health. Her views do not necessarily reflect the views of her employer.

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Two dozen members of Congress sent a letter recently to the assistant secretary of defense for health affairs and the director of the Defense Health Agency regarding concerns about Express Scripts and how it’s running the Tricare pharmacy program. Led by Sen. Elizabeth Warren (D-Mass.) and Rep. Buddy Carter (R-Ga.), the letter highlights that the second largest PBM in the nation is both administering the program and participating in it, raising the bipartisan concern that it’s using this exclusive contract to overcharge taxpayers and drive out competition at the expense of our service members. It also quotes Hugh Chancy, NCPA’s immediate past president, who spoke at a House Oversight Committee hearing in September 2023 and described the harms of ESI’s steering practices on one of his patients, helping to illustrate the problems people are experiencing as a result. We applaud the legislators for holding the Department of Defense and ESI accountable and pushing to preserve patient access to medications and pharmacies.

https://ncpa.org/newsroom/qam/2024/07/09/icymi-legislators-slam-express-scripts-re-tricare-pharmacy-program

you will have to CLICK  ONCE OR TWICE TO GET GRAPHIC TO BE READABLE

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NY State’s Self-Congratulatory BS Report on Opioid ‘Progress’

https://www.acsh.org/news/2024/06/28/ny-states-self-congratulatory-bs-report-opioid-progress-48835

Let’s have a round of zero applause for the New York State Department of Health for its June 24th publication to physicians, misnamed “Data to Action Opioid Prescribing in New York State.” In a mastery of the self-evident, the authors reached this lame conclusion: if New York State actively discourages opioid prescriptions, then there will be fewer opioid prescriptions written in the state. Unstated is that this antiquated notion is doing far more harm than good, something that should be quickly apparent.

Intro: SOSDD (1)

The document starts with the traditional faux attempt to appear impartial.

“When used properly, opioids can provide benefits to the patient suffering from pain.”

If this isn’t the perfect time for the word “however” I’ll eat my shoes. 

“However, there are inherent risks to the use of these medications such as unintended overdose, substance use disorder, and negative societal impacts.”

My shoes are safe. And so are the antiquated beliefs, overblown fears, and downright lies about opioid use that should have been put to rest long ago:

• Prescription opioids actually have very little to do with overdose deaths, unintended or otherwise. Even the miscreants at PROP have changed their tune, now acknowledging that illegal drugs like illicit fentanyl, either with or without some of the current additives are responsible for overdoses.
• Substance use disorder? Why single out opioids – useful and essential medicines – rather than street drugs like cocaine, and methamphetamine as well? Let’s put them in.

Here are data from the CDC on the number of drug overdose deaths from different drugs in 2023:

• Illicit fentanyl, analogs, and other synthetic additives: ~74,000
• Psychostimulants (mostly methamphetamines): ~36,000
• Cocaine: ~30,000
• So-called “semisynthetics” (prescriptions like oxycodone, hydrocodone): ~10,000

Doing the “new math,” of the roughly 108,000 people who died from drug overdoses in 2023 only 9% did so from prescription pain medications. But the percentage is actually smaller. Significantly smaller.

Let’s add in the 178,000 annual deaths from excess alcohol (why this is not included in the discussion isn’t clear) and now the annual deaths from substance abuse (not counting cigarettes) are about 278,000, with a whopping 3.6% of these due to prescription pain meds. This is what we’re still getting hysterical about? 

And even that number is artificially high because in overdose deaths where a prescription opioid is implicated multiple other drugs are frequently found, contributing to the lethality of the opioid. Suffice it to say that prescription opioid drugs only when taken properly and under medical supervision are minuscule contributors to overdose death totals, probably in the 1-2% range.

 New York State to the rescue! Not. 

State and federal regulators “have employed various strategies in response to the opioid crisis and its impacts.”

Here are a few of the “accomplishments” that New York DOH brags about.

1. Prescription Monitoring Program Registry (PMP) and electronic-only prescribing
2. The limitation of initial opioid prescriptions for the treatment of acute pain
3. A provision requiring providers to prescribe an opioid antagonist yearly when certain risk factors are present

How’s that working out?

Not so well, really.

(Top) Between 2013 and 2022 the rate of opioid prescriptions in NY State was cut by half. (Bottom) During that same time, overdose deaths nearly tripled. How exactly does this represent progress?

More on the “accomplishments,” such as they are.

PDMS’s

Prescription drug monitoring plans made sense when pill mills were alive and well in the US. NY State fails to recognize that pill mills, which peaked around 2010, were largely gone in Florida – ground zero for illegal opioids – by 2015. 

Now I don’t even know where operators of “mills” would get pills to sell. Since 2013, oxycodone production quotas (set by the DEA) have decreased by 65% and oxycodone is now on the drug shortages list. PDMPs have morphed into a law enforcement tool to invade doctor and patient privacy and create an atmosphere of fear for physicians and guilt for anyone who dares fill a prescription for Ambien, especially if they have other scheduled drugs on their “records.” (3)

An arbitrary 7 days

New York, much like other states, has determined that 7 days is the magic number after which people no longer have acute pain. Notably absent is that different surgeries and conditions have very different pain levels and timelines for recovery and the wide variation in individual response to opioids. One size fits none. Seven days may or may not be appropriate. Let’s let physicians and patients, not the government, make that determination.

Obligatory naloxone – just plain dumb

Requiring that physicians write prescriptions for Narcan/naloxone when they prescribe opioids for certain people? (2) I’ll let my frequent writing partner Dr. Jeffrey Singer of the Cato Institute and also a practicing surgeon tackle this:

This is a stupid one-size-fits-all edict that assumes our patients are too dumb to follow our instructions and haven’t yet heard that it is possible to overdose on opioids. I usually tell my patients, ‘I have to prescribe Narcan for you, but you don’t have to pick it up from the pharmacist and pay for the drug unless you think you might not follow my instructions about what other substances to avoid while taking the pills or if you think you might ignore the dosage instructions and take too many pills at once.’

That’s enough ragging on New York for now. However, perhaps it’s time to update the logo:

The AI-generated image above may be humorous, but New York’s nonsensical antiquated policies are anything but. Much like the damaging “voluntary” guidelines concocted by the CDC in 2016 they need to go away.

NOTES:

(1) SOSDD is an acronym for “same old s### different day.”

(2) The “certain people” include those who are prescribed “a high dose” of opioids (90 morphine milligram equivalents or more), have a history of “substance use disorder,” and are also taking a sedative like Valium.

(3) PDMPs do have a legitimate function: To alert physicians to other medications being taken a valuable tool in a fragmented system where electronic health records do not “speak” to one another. This is fine. Punitive use by law enforcement? Not so fine.

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This is a graphic representing the fictitious clinical facts that are starting to hit the fan

Pharmacists play a critical role in ensuring the safe and effective use of medications. There are several clinical and regulatory reasons why a pharmacist might refuse to fill a prescription without first contacting the prescriber. These reasons generally fall into categories related to patient safety, legal compliance, and prescription validity.

## Clinical Reasons

### **1. Missing or Incomplete Information**
A prescription must contain specific information to be valid, including the patient’s full name, medication name, dosage, quantity, instructions for use, and prescriber details. If any of this information is missing or incomplete, the pharmacist must contact the prescriber to obtain the necessary details before filling the prescription[1][2].

### **2. Potential Drug Interactions or Allergies**
Pharmacists are responsible for checking for potential drug interactions and known patient allergies. If a prescribed medication could potentially interact with another medication the patient is taking or if the patient has a known allergy to the medication, the pharmacist must contact the prescriber to discuss alternative options or confirm the prescription[6].

### **3. Dosage Concerns**
Incorrect dosages can pose significant health risks. If the pharmacist believes the dosage prescribed is too high or too low, they must verify the correct dosage with the prescriber to ensure patient safety[2][6].

### **4. Suspected Prescription Errors**
Handwritten prescriptions can sometimes be difficult to read, leading to potential errors. If a pharmacist cannot clearly read the prescription, they must contact the prescriber to confirm the details[2].

### **5. Potential Misuse or Abuse**
Pharmacists have a duty to prevent the misuse and abuse of medications, especially controlled substances. If there are red flags indicating possible misuse or abuse, such as frequent refills or high quantities of controlled substances, the pharmacist must verify the prescription with the prescriber[3][6].

## Legal and Regulatory Reasons

### **1. Controlled Substance Regulations**
Prescriptions for controlled substances must comply with specific regulations, including having the prescriber’s DEA number and being written on tamper-resistant paper. If these requirements are not met, the pharmacist must contact the prescriber to rectify the issue[1][5][6].

### **2. Prescription Validity**
Pharmacists must ensure that prescriptions are valid and legally compliant. This includes verifying that the prescription is not post-dated, altered, or missing a required signature. If any of these issues are present, the pharmacist must contact the prescriber to confirm the prescription’s validity[1][5].

### **3. Ethical and Professional Responsibility**
Pharmacists have an ethical duty to ensure that the medications they dispense are appropriate and safe for patients. If a prescription raises ethical concerns, such as being for a medication that the pharmacist believes is not in the patient’s best interest, they must discuss these concerns with the prescriber[3][6].

In summary, pharmacists may refuse to fill a prescription without contacting the prescriber for reasons related to incomplete or missing information, potential drug interactions or allergies, dosage concerns, suspected prescription errors, potential misuse or abuse, controlled substance regulations, prescription validity, and ethical responsibilities. These measures are in place to ensure patient safety and compliance with legal and regulatory standards.

Citations:
[1] https://www.ncbi.nlm.nih.gov/books/NBK538424/
[2] https://medicopharmacyrx.com/reasons-why-a-pharmacist-might-refuse-to-fill-your-prescription/
[3] https://journalofethics.ama-assn.org/article/pharmacist-and-prescriber-responsibilities-avoiding-prescription-drug-misuse/2021-06
[4] https://rules.sos.ga.gov/gac/480-22
[5] https://gdna.georgia.gov/prescribers
[6] https://puschnguyen.com/understanding-your-rights-exploring-the-possibility-of-suing-a-pharmacist-for-refusing-to-fill-your-prescription/
[7] https://law.justia.com/codes/georgia/2022/title-16/chapter-13/article-2/part-1/section-16-13-41/

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This is a graphic representing the fictitious clinical facts that are starting to hit the fan

Does the DEA have any statutory authority to establish medical standard of care and best practices under the controlled substance act?

The Drug Enforcement Administration (DEA) does not have statutory authority to establish medical standards of care and best practices under the Controlled Substances Act (CSA). The DEA’s role under the CSA primarily involves the regulation and enforcement of controlled substances, including their scheduling based on factors such as potential for abuse, medical use, and safety or dependence liability[1][2].

The CSA outlines a collaborative process where the DEA works with the Department of Health and Human Services (HHS) to evaluate and recommend the scheduling of substances. This process involves scientific and medical evaluations conducted by HHS, which includes input from the Food and Drug Administration (FDA) and other relevant bodies[1][2]. However, the DEA’s responsibilities do not extend to setting medical standards of care or best practices, which are typically within the purview of medical and health organizations.

In summary, while the DEA plays a crucial role in regulating controlled substances and enforcing the CSA, it does not have the authority to establish medical standards of care and best practices. This responsibility lies with medical and health authorities, such as HHS and the FDA.

Citations:
[1] https://en.wikipedia.org/wiki/Controlled_Substances_Act
[2] https://www.dea.gov/drug-information/csa
[3] https://sgp.fas.org/crs/misc/R45948.pdf

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This is a graphic representing the fictitious clinical facts that are starting to hit the fan

Is there any clinical justification to establish fixed opioid doses to treat chronic pain less than the FDA dosing guidelines

Based on the available information, there is generally no clinical justification to establish fixed opioid doses below FDA guidelines for treating chronic pain. The current clinical practice guidelines emphasize individualized patient care and avoiding inflexible dosing standards. Here are the key points:

1. Individualized approach: The CDC Clinical Practice Guideline for Prescribing Opioids for Pain (2022) emphasizes that recommendations should not be applied as inflexible standards of care across patient populations[1]. The guideline stresses the importance of individualized patient care and careful consideration of the benefits and risks of all treatment options.

2. Avoiding dosage thresholds: The CDC guideline specifically discourages the misapplication of opioid pain medication dosage thresholds as inflexible standards[1]. Instead, it emphasizes principles such as avoiding increasing dosage above levels likely to yield diminishing returns in benefits relative to risks to patients.

3. Regular evaluation: The Medical Board of California’s guidelines recommend regularly evaluating the benefit and harm of opioid therapy for chronic pain after starting treatment or following dose escalation[5]. This suggests that dosing should be adjusted based on individual patient response rather than adhering to fixed doses.

4. Patient-centered goals: The VA/DoD Clinical Practice Guidelines for Use of Opioids in the Management of Chronic Pain (2022) emphasize assessing patient-centered goals and improvements in function, rather than focusing solely on fixed dose limits[2].

5. Risk-benefit assessment: The FDA and other regulatory bodies consistently emphasize the need for careful risk-benefit assessment when prescribing opioids for chronic pain[4]. This approach is not compatible with establishing fixed doses below FDA guidelines without considering individual patient needs.

6. Transparency in decision-making: The FDA has been encouraged to be more transparent about its comprehensive, systems approach for incorporating public health considerations into regulatory decisions for opioid analgesics[6]. This suggests a move towards more nuanced and context-specific guidance rather than fixed dosing limits.

It’s important to note that while there is no general clinical justification for establishing fixed opioid doses below FDA guidelines, there may be individual cases where lower doses are appropriate based on patient-specific factors. Clinicians should consider factors such as the patient’s pain severity, functional improvement, risk factors for opioid-related harms, and individual response to treatment when determining appropriate dosing[1][5].

In conclusion, current clinical practice guidelines and regulatory approaches emphasize individualized patient care, regular assessment of benefits and risks, and avoiding inflexible dosing standards. Establishing fixed opioid doses below FDA guidelines for chronic pain treatment would not align with these evidence-based recommendations.

Citations:
[1] https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm
[2] https://www.healthquality.va.gov/guidelines/pain/cot/
[3] http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM522688.pdf
[4] https://www.fda.gov/drugs/information-drug-class/timeline-selected-fda-activities-and-significant-events-addressing-substance-use-and-overdose
[5] https://www.mbc.ca.gov/Download/Publications/pain-guidelines.pdf
[6] https://www.fda.gov/media/165238/download
[7] https://www.fda.gov/media/86875/download
[8] https://health.ri.gov/healthcare/medicine/about/safeopioidprescribing/

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Here is a published MME calculator https://globalrph.com/medcalcs/morphine-equivalent-dose-med-opioid-conversions/   This is the infamous MME system that those “so-called experts” based their 2016 CDC opioid dosing guidelines and what many bureaucracies – like the DEA & VA – seemed to have codified those guidelines as a standard of care and best practices as well as maybe 30+ states have codified the same at the state level. 

This is a graphic representing the fictitious clinical facts that are starting to hit the fan

Does the Morphine Milligram Equivalent system have any clinical studies supporting its conclusions?

The Morphine Milligram Equivalent (MME) system has some clinical basis, but there are significant limitations and concerns about its scientific foundation and broad application:

1. Limited clinical evidence: The MME system is based on small clinical studies with limited populations[1][2]. These studies were originally intended to assist clinicians in determining initial doses when converting an individual patient’s opioid therapy, not as a broad risk assessment tool.

2. Lack of standardization: There is no single standard formula for calculating MMEs, leading to inconsistencies across different resources and calculators[2].

3. Oversimplification: The MME system does not adequately account for important patient and drug characteristics that can affect opioid potency and risk, such as opioid tolerance, pharmacogenetics, and differences between full and partial agonists[2].

4. Epidemiological support: While not directly validating MMEs, epidemiologic studies have shown an association between increasing daily opioid dose (measured in MMEs) and increasing risk of overdose[2]. However, these studies generally used broad MME threshold categories rather than precise conversions.

5. Concerns about misuse: Multiple experts have expressed concern that emphasizing specific MME thresholds as authoritative absolutes could lead to potentially harmful consequences, such as noncollaborative tapers[3].

6. Limited evidence for high doses: Few trials have evaluated opioid dosages of ≥90 MME/day, and there is some evidence of a plateauing effect at ≥50 mg MME/day in terms of pain relief[3].

7. Ongoing research needs: The FDA has recognized the need for further research to refine and improve the scientific basis of MME applications[1]. They held a workshop in 2021 to discuss knowledge gaps and research opportunities related to MMEs.

In summary, while the MME system has some clinical and epidemiological support, there are significant limitations in its evidence base and concerns about its broad application. More research is needed to address knowledge gaps and improve the scientific foundation of MME calculations and applications.

Citations:
[1] https://www.fda.gov/drugs/news-events-human-drugs/morphine-milligram-equivalents-current-applications-and-knowledge-gaps-research-opportunities-and
[2] https://www.fda.gov/media/150436/download
[3] https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm
[4] https://www.jprasurg.com/article/S1748-6815%2824%2900336-X/fulltext
[5] https://meps.ahrq.gov/data_files/publications/rf45/rf45.shtml

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