In 2001, the Food and Drug Administration transferred regulation of methadone treatment programs for opioid use disorder (nowadays called Opioid Treatment Programs or OTPs) to the Drug Enforcement Administration and the Substance Abuse and Mental Health Services Administration. DEA and SAMHSA work together to establish and enforce criteria for treating people with substance use disorder and the regulations that govern how health care practitioners prescribe and administer opioids as medication assisted treatment (MAT) for opioid use disorder. The rules govern the dose and number of drugs clinicians prescribe and even dictate if and when patients may be given medication to take home.

For several years, the DEA and SAMHSA have allowed practitioners to prescribe the Schedule III opioid buprenorphine to patients they see in their offices or clinics as take-home medication for opioid use disorder, provided they take an 8‑hour course and go through a burdensome application process to receive a waiver on the federal narcotics prescribing license they receive from the DEA (a so-called “X‑waiver,” because the letter ”X” is appended to the license number). The DEA limits how many patients such practitioners can treat at any given time and, until recently, only gave these waivers to physicians.

The DEA and SAMHSA apply different regulations to using methadone to treat opioid use disorder. For example, practitioners may only administer methadone at DEA/SAMHSA-approved OTPs, and regulators have required people with opioid use disorder to have been addicted to opioids for at least one year before qualifying for admission to a program. The programs must include counseling sessions and social services. Patients must show up every day and ingest the methadone in front of clinic staff to prove they are not injecting it or selling it on the street. The regulations have allowed some patients to take a small amount of methadone home with them, but only after clearing several hurdles and with many strings attached.

During the COVID public health emergency, SAMHSA relaxed several regulations so people with substance use disorder could access these medications while minimizing the risk of contracting the virus. For example, SAMHSA allowed OTPs to give a 28-day supply of take-home methadone to “stable” patients and a 14-day supply to “less stable” patients. The agency permitted OTPs to operate vans that can go out to the patients where they live. To deal with pandemic-related OTP staffing problems, SAMHSA allowed people to receive “interim treatment” from OTPs (daily methadone but without the counseling and other services typically offered by OTPs) for up to 180 days. SAMHSA allowed certain OTP follow-up visits to use telemedicine and permitted community practitioners prescribing buprenorphine under the X‑waiver to perform initial evaluations of new patients via telemedicine. SAMHSA also expanded the categories of health care practitioners it permits to prescribe buprenorphine, including physician assistants, nurse practitioners, certified nurse anesthetists, and nurse midwives.

After numerous reports that the relaxed regulations did not result in misuse or diversion of methadone into the black market, SAMHSA decided to extend the relaxed rules until one year after the President officially declared the public health emergency over.

On December 16, 2022, SAMHSA published a Notice of Proposed Rulemaking (NPRM) and solicited comments. In the notice, SAMHSA stated it had extended the COVID-related relaxation of standard regulations to provide time so the agency could issue a proposal to permanently change the rules. The NPRM would make all the emergency measures permanent. The agency expressed a serious commitment to destigmatizing people with substance use disorder and, consequently, proposed changing many of the terms that policymakers have used when discussing the overdose crisis and substance use disorder. For example, the agency offers to replace the term “medication assisted treatment” with “medication for opioid use disorder” (MOUD).

I submitted my comment to the agency. In it, I argued that the relaxed rules were a step in the right direction, but that I and many others have long argued that health care practitioners—especially primary care providers interested in treating substance use disorder—should be allowed to prescribe take-home methadone to treat their patients with substance use disorder as they have been doing for over 50 years in the U.K., Canada, and Australia. I also pointed out that the omnibus bill passed by Congress on December 23 and signed by President Biden on December 29 contained the Mainstreaming Addiction Treatment Act, which ended the X‑waiver required to prescribe buprenorphine, expanded the categories of providers who may dispense buprenorphine, and permitted telemedicine. Therefore, the Mainstreaming Addiction Treatment Act might have rendered many of SAMHSA’s proposed changes to the rules concerning buprenorphine moot.

I commended the agency for committing to destigmatizing people with substance use disorder. However, I argued that the agency perpetuates the stigma attached to substance use disorder by maintaining a unique set of rules that govern how clinicians may give care and treatment to people with substance use disorder apart from how they would treat other patients. Changing the words policymakers use is nice. But “action speaks louder than words.” In the penultimate paragraph of my comments, I wrote:

The only way to completely destigmatize people with substance use disorder, and thus facilitate their access to care and improve the likelihood of recovery, is to remove the regulations and restrictions unique to opioid treatment programs. This includes rules affecting the use of telemedicine technology. Licensed health care practitioners should be able to prescribe opioid agonists such as methadone, as well as the partial agonist buprenorphine, to people with substance use disorder the same way the government allows them to prescribe beta blockers to treat hypertension and insulin to treat diabetes. In short, if the Substance Abuse and Mental Health Services Administration seriously wants to destigmatize people with substance use disorder, it can start by destigmatizing how they receive treatment.

You can read my entire comment here.

Late on the afternoon of December 23, the U.S. House of Representatives passed the approximately 1.7 trillion-dollar omnibus spending package, which now awaits President Biden’s signature. As is usually the case with such legislative monstrosities, the bill contains a few positive features and many negative ones. One positive part is that it repeals the so-called “X‑waiver” (an X is added to the DEA narcotics prescribing license), which the Drug Enforcement Administration has long required health care practitioners to apply for to prescribe the Schedule III opioid buprenorphine as medication-assisted treatment for substance use disorder. Inexplicably, health care practitioners have not needed an X‑waiver to prescribe the drug to treat pain. The X‑waiver requirement, which also limits the number of patients providers can treat, discouraged many practitioners from treating addiction.

Buprenorphine and methadone are both effective for treating opioid addiction, with some patients responding better to buprenorphine and others responding better to methadone. Unfortunately, the Drug Enforcement Administration regulates methadone outpatient treatment programs (OTPs) and requires most patients to take the methadone in the presence of clinic staff. Buprenorphine, on the other hand, is prescribed as a take-home medication by health care providers in their medical clinics.

In response to the COVID emergency, the DEA, in conjunction with the Substance Abuse and Mental Health Services Administration, permitted OTPs to disburse up to 28 days of take-home methadone to “stable patients” and 14 days of take-home methadone “less stable” patients. The success of the take-home program led the SAMHSA to extend it to one year past the date when the President declares an end to the COVID Public Health Emergency.

I and many others have called on Congress to end the DEA’s requirement that health care providers apply for an X‑waiver on their narcotics license to treat substance use disorder. By including the Mainstream Addiction Treatment Act (MAT Act) within the giant omnibus bill that Congress just passed, Congress finally removed the X‑waiver requirement and, along with it, any limits on the number of patients practitioners are allowed to treat. The act also makes it easier to prescribe buprenorphine using telemedicine.

Unfortunately, a fly in the ointment is that the omnibus bill also contained the Medication Access and Training Expansion (MATE) Act which, among other things, will require all health care practitioners who apply for or seek to renew their DEA narcotics prescribing license to take an 8‑hour government-approved course in understanding and treating addiction. This unnecessary burden might provide money-making opportunities to organizations that offer courses. Still, it may make many health care practitioners not renew or seek a narcotics prescribing license, making it even more difficult for patients in pain to get relief.

In a July letter to the Chair and Ranking Members of the Senate Health, Education, Labor, and Pensions Committee, the President of the American Medical Association rightly opposed the 8‑hour course requirement, stating:

There could be serious unintended consequences for patient care were many physicians to forgo registration with the DEA to prescribe controlled substances instead of taking the eight-hour training. This could have the opposite of the MATE Act’s intended effect by leading to fewer instead of more physicians and other health professionals having the ability to treat opioid and other SUDs with evidence-based medications. It could lead to less access for patients with psychiatric and other mental health conditions that are effectively managed with controlled substances having access to medically necessary care. There could be severe consequences for patients with painful conditions or postoperative pain obtaining effective pain control as far fewer physicians may be able to prescribe any scheduled medications for them. In addition, physicians who continue to be registered with the DEA could be inundated by patients who could no longer be treated by their usual source of care.

Many states, including my state of Arizona, impose their own course requirements on licensed health care practitioners who wish to prescribe controlled substances. In Arizona, practitioners must take a 3‑hour course every two years. The letter from the AMA mentioned this:

There is no evidence showing that a one-time mandated education requirement, as the MATE Act requires, will have the result that we all want, which is improving patient outcomes and stopping patients from dying from a drug-related overdose. In response to increasing numbers of people dying from a drug related overdose, beginning in 2016–2017, states began enacting mandates to restrict opioid prescribing, require use of state prescription drug monitoring programs and require prescribers to take specific continuing medical education (CME) classes. These policy interventions have not had a positive effect on reducing drug-related overdose or increasing access to evidence-based treatment for SUDs. This includes the 40 states with mandated CME requirements. A one-time training mandate for SUDs, no matter how well-intentioned, will not have meaningful impact on reducing drug-related overdose for the same reasons state-level CME mandates have not had the desired effect.

Sadly, but not uncharacteristically, lawmakers give with one hand and take away with the other.

Axios reports that the Drug Enforcement Administration seized 379 million doses of fentanyl in 2022, which included 50.6 million fentanyl-laced counterfeit prescription pain pills and more than 10,000 pounds of powdered fentanyl (which can be mixed in with cocaine, methamphetamine, and heroin or used to make counterfeit prescription pain pills). As David J. Bier and I wrote recently, the vast majority of these drugs are seized at legal border crossings, mostly smuggled in by U.S. citizens working for Mexican drug cartels.

In its December 20 announcement, the DEA stated:

“In the past year, the men and women of the DEA have relentlessly worked to seize over 379 million deadly doses of fentanyl from communities across the country,” said Administrator Anne Milgram. “These seizures – enough deadly doses of fentanyl to kill every American – reflect DEA’s unwavering commitment to protect Americans and save lives, by tenaciously pursuing those responsible for the trafficking of fentanyl across the United States. DEA’s top operational priority is to defeat the two Mexican drug cartels—the Sinaloa and Jalisco (CJNG) Cartels—that are primarily responsible for the fentanyl that is killing Americans today.”

If this sounds like a broken record, it’s because law enforcement agencies have trumpeted such announcements for years. Earlier in this century, the DEA was announcing record heroin seizures. Non-medical drug users preferred prescription pain pills that made their way to the black market. But as policymakers and law enforcement punished prescribers and patients, and the DEA ratcheted down opioid manufacturing quotas, the cartels filled the void with heroin.

Law enforcement cannot avoid the “iron law of prohibition.” And lawmakers cannot repeal it. In our chapter entitled “The Overdose Crisis” in the latest edition of the Cato Handbook for Policymakers, Trevor Burrus and I explain:

The iron law of prohibition states that, all things being equal, as enforcement ramps up, smugglers prefer higher potency forms of a drug for the same reason those who sneak alcohol into a football game prefer hard alcohol in flasks to 12‐​packs of beer. The lethal logic of the iron law of prohibition means that we cannot enforce our way out of the opioid crisis. And if fentanyl smugglers become somehow easy to catch, there’s always carfentanil, which is about 100 times more potent than fentanyl and has already been showing up in America’s drug supply.

The iron law was already responsible for the rise in fentanyl smuggling before the COVID-19 pandemic. But pandemic-related disruptions in the movement of opium products and the supply of acetic anhydride needed to process heroin made fentanyl an attractive substitute for heroin and accelerated illicit fentanyl production.

Nitazenes are another category of synthetic opioids that are roughly 20 times the potency of fentanyl. They are already appearing in the toxicology studies of overdose victims in Europe and the U.S. Don’t be surprised if, in a few years, the press will sound alarms about a growing nitazene crisis. Then look for the DEA to announce record nitazene seizures. And, after nitazenes, there will be other drugs for the DEA to seize.

Reports of new and more deadly drugs, record drug seizures, and high-profile arrests will never stop—like a broken record—as long as drug prohibition continues.

The American Medical Association (AMA) has been quite transparent about its commitment to preventing America’s health care consumers from choosing to get care from non-physician health care professionals. The organization actively opposes legislative attempts to expand non-physician health providers’ “scope of practice.” It has long fought against state laws that permit nurse general practitioners (NPs) and board-certified family practice nurse practitioners (FNPs) from providing primary care independently from medical doctors, arguing that it would lead to higher costs and reduced safety for patients. It is hypocritical for an organization representing professionals who swear an oath to respect patients’ autonomy to presume to control patients’ choices of health care providers.

Last week the AMA trumpeted a new working paper published by the National Bureau of Economic Research that concludes, “Nurse practitioners (NPs) delivering emergency care without physician supervision or collaboration in the Veterans Health Administration (VHA) increase lengths of stay by 11% and raise 30-day preventable hospitalizations by 20% compared with emergency physicians.” The study used quasi-experimental variation to study the patient outcomes and utilization costs between nurse practitioners and emergency physicians rendering care to patients in Veterans Health Administration hospital emergency departments from 2017 to 2020. The authors conclude:

We use the quasi-random arrival of patients at the ED between times that may differ in the availability of NPs on shift, which drives the probability of being treated by an NP versus a physician. Compared to physicians, NPs incur greater resource costs to treat patients but achieve worse patient outcomes.

The study found that “lower productivity” was the primary contributor to higher costs—NPs tended to order more tests and consult medical specialists more frequently on patients they saw in the emergency department than emergency physicians. This often led to delays in admitting the patients to the hospital, contributing to poorer outcomes.

The AMA news report stated, “Overall, the study shows that NPs increase the cost of ED care by 7%, or about $66 per patient. Increasing the number of NPs on duty to decrease wait times raised total health care spending by 15%, or $238 per case.”

Even if emergency physicians provide more cost-effective and better-quality care to emergency patients than NPs, improving access to emergency medical care by adding NPs to the provider workforce might make the tradeoff worthwhile.

But the study’s authors—and the AMA news report—missed the Easter egg in the study’s conclusion section:

We show that the performance gap between NPs and physicians narrows as NPs gain more experience, suggesting that differences in training could explain some of the gap.

The study compares apples to oranges. Unlike many states, the VHA does not require nurse practitioners to be emergency certified (ENP), so most are FNPs trained to practice family medicine, not emergency medicine. A survey of NPs working in emergency care found that 78% were certified as FNPs and in 2020 only 0.9% of NPs were emergency certified, according to the American Association of Nurse Practitioners (AANP).

Since emergency care includes adult and pediatric primary care, critical care, and behavioral medicine, there is wide variability in the requirements for emergency NPs. On the other hand, most physicians who work in hospital emergency departments are specialists certified by the American Board of Emergency Medicine. Physicians eligible to take the certification exam must have completed postgraduate training (a residency program) in emergency medicine.

Had this study compared utilization costs and patient outcomes from emergency care rendered by board-certified emergency physicians to physicians trained in family medicine, it might have found disparities like those found with FNPs and ENPs.

Board-certified general surgeons may be quite competent in rendering care to patients in the ED with acute surgical emergencies but are less likely to compare well to board-certified emergency physicians when managing non-surgical emergencies, such as chest pain, shortness of breath, stroke, or a hypertensive crisis.

The AMA news report did not mention a study from the Netherlands that found no difference in diagnostic and clinical outcomes or waiting times for treatment between patients seen by ENPs and patients seen by junior or senior “house” physicians.

Those seeking an accurate apples-to-apples comparison can review the study we reported last month. This study also employed a quasi-experimental approach to maximize randomization and compared NPs to physicians providing primary care to more than 800,000 patients in the VHA system from 2010 to 2012. It concluded:

[T]his study shows that NP patients did not differ from MD patients in VA health care costs, but had less utilization of primary care, specialty care, and inpatient services.

Further, NP and MD reassigned patients achieved similar quality of care in chronic disease management. This study supports the evidence that use of NPs can improve access to primary care with similar quality and cost of care.

The VHA emergency medicine study that the AMA is touting makes no case against NPs and FNPs independently providing primary care. However, its findings do suggest that hospitals should prefer board-certified ENPs to FNPs when staffing their emergency departments with non-physicians.

Spencer Pratt is a Research Associate in the Department of Health Policy Studies

I have written for years that the Food and Drug Administration should make the opioid overdose antidote naloxone over-the-counter. Public health attorney Corey Davis spoke of how urgent it is for the FDA to move quickly to reclassify this safe and effective harm reduction tool at a Cato Institute conference in 2019.

Even though, as I and others have pointed out, the FDA Commissioner can unilaterally reclassify the prescription-only drug as over the counter, the FDA has been deferential to the naloxone manufacturers, who have been reticent to submit applications. Over the past several years the agency has tried to nudge the manufacturers to apply for reclassification, even going to the trouble of developing the Drug Facts Label (DFL) the FDA requires manufacturers to place on OTC products. Then-FDA Commissioner Scott Gottlieb called this move “unprecedented.”

And last month the FDA issued a notice in the Federal Register that “a preliminary assessment that certain naloxone drug products–up to 4 milligrams (mg) nasal spray and up to 2 mg autoinjector for intramuscular (IM) or subcutaneous (SC) use–may be approvable as safe and effective for nonprescription use.”

It appears the FDA’s nudging might be finally having an effect. The Wall Street Journal reported yesterday that Emergent BioSolutions, Inc., makers of the popularly used Narcan brand naloxone nasal spray applied to the FDA to have the product reclassified to OTC. The FDA announced plans to fast-track the approval process and the drug might be available over the counter as soon as March, 2023.

Perhaps Emergent BioSolutions was further nudged by the announcement, last week, that a new start-up company planned to produce a naloxone nasal swab and seek over the counter approval from the FDA. A randomized trial of the product suggests it might even work to reverse opioid overdoses faster than the nasal spray. And Harm Reduction Therapeutics, Inc. a non-profit partially funded with settlement funds from government lawsuits brought against now bankrupt Purdue Pharma, the makers of OxyContin, also announced plans to develop an OTC naloxone product.

Soon competition in the OTC naloxone market will drive prices down while increasing access to the valuable harm reduction tool. It is upsetting to think of the overdose deaths that could have been averted while Americans waited to get to this point, but they soon may have ready access to naloxone off the shelf in pharmacies, supermarkets, convenience stores, and even vending machines.

Swiss Medtech, a trade association representing the medical technology industry, issued a press release on November 28 praising the Swiss Parliament for enacting legislation allowing Swiss health care providers and patients to access medical devices approved by the U.S. Food and Drug Administration. Until now, the Swiss government only permitted patients and doctors to access devices that have a CE Marking, which indicates the device meets European Union standards, and the E.U. approves it for marketing among member states. The Swiss Parliament’s action should expand access and increase price competition for medical devices.

Australia began permitting patients and doctors to access FDA-approved medical devices in 2018 and has been allowing them to use E.U.-approved devices for several years. Israel allows devices approved in the U.S., E.U., Australia, and Canada.

U.S. lawmakers have proposed legislation permitting American health care consumers and providers to access drugs and/​or devices approved in other developed countries. Policymakers inaptly refer to the proposal as “reciprocity,” but the reform is not contingent upon the other countries permitting their residents to use FDA-approved drugs or devices in return.

In testimony before the Joint Economic Committee in September 2020, I stated:

Congress should pass legislation giving reciprocal approval to drugs and medical devices (which includes tests) in similar countries. Reciprocal approval already exists among the European Union states plus Iceland, Liechtenstein, and Norway. In July 2019 Senator Ted Cruz (R‑TX) introduced S.2161, the Reciprocity Ensures Streamlined Use of Lifesaving Treatment (RESULT) Act, which would allow for the marketing of drugs approved in certain countries, but not yet approved by the FDA, if “there is an unmet need.” While this is indeed a step in the right direction, in the interest of promoting competition and consumer choice, reciprocal approval should not be contingent on an unmet need.

In Drug Reformation, published later that year, Michael F. Cannon and I wrote:

…at a minimum Congress should eliminate the FDA’s ability to restrict truthful speech by manufacturers about their products and allow American consumers to purchase drugs that have won approval from designated certification agencies, including foreign regulatory bodies. According to one study, recognizing drug approvals by regulatory bodies in Canada and Europe between 2000 and 2010 would have given U.S. consumers quicker access to 37 “novel” drugs for which “no other FDA‐​approved prescription medicine had the same mechanism of action,” including 10 drugs treating mostly orphan diseases “for which no alternative therapy was available in the USA.” Such recognition would have allowed U.S. consumers to access those drugs a median of 13.6 months earlier.

If members of the incoming Congress are serious about increasing access to health care and reducing health care costs, they should, at a minimum, pass a law that allows for drug and device “reciprocity” with other developed nations.

A federal judge in Texas is weighing whether to free consumers nationwide from an unconstitutional ObamaCare requirement that they purchase coverage they do not want, the Wall Street Journal reports. He should do so.

In September, Judge Reed O’Connor of the U.S. District Court for the Northern District of Texas ruled that ObamaCare violates the Constitution by giving the U.S. Preventive Services Task Force (USPSTF) the power to dictate particular types of coverage consumers must purchase. O’Connor ruled that provision unconstitutional because USPSTF members would have to receive Senate confirmation to wield such power. (They do not.)

Maybe you don’t care if those mandates violate the rights of individuals to make their own health care decisions and violate the Constitution. But what if they are also counter-productive? When ObamaCare’s preventive care coverage mandate tried to make contraceptives “free,” prices for hormones and oral contraceptives skyrocketed. (See nearby figure.) How does that promote preventive care or reproductive rights?

The individual consumers and employers who challenged this ObamaCare provision “are asking Judge O’Connor to strike down all preventive-coverage requirements since 2010 that have been recommended by the task force…O’Connor could limit any relief to just the plaintiffs in the case, or he could issue a nationwide injunction that would strike down the requirement that insurers cover preventive services recommended by the task force.”

O’Connor should strike down all such requirements nationwide. The primary purpose of the judicial branch is to ensure the other two branches do not exceed the powers the people granted them through the Constitution. If a statutory provision is unconstitutional, it injures all the people. Not least by eroding trust in institutions. Failing to strike down this provision nationwide would erode trust in the Constitution and the judiciary.

Supporters of broader access to preventive care should demand an end to such mandates — not least because prices for oral contraceptives and other preventive care would likely fall — and demand that Congress and states remove regulatory barriers to preventive care.

A good place to start would be to end the Food and Drug Administration’s power to require prescriptions. In “Drug Reformation,” Jeff Singer and I show that giving the FDA that power blocks access to preventive care and has harmed rather than promoted health.

At a minimum, Congress should remove federal prescription requirements for oral contraceptives, PrEP, and other preventive goods and services.