Policy News Roundup: January 23, 2025

DEA unveils new telehealth prescribing rules

The Drug Enforcement Administration (DEA) proposed several rules last week to continue to allow providers to prescribe controlled substances via telehealth.

The backstory:

• In 2008, Congress passed the Ryan Haight Act, which required the DEA to create a special registration process for prescribers who wished to prescribe controlled substances remotely.
• When COVID hit in 2020 and the need for telehealth surged, the DEA still had not yet issued regulations to create such a process, and prescribers could not prescribe controlled substances without an in-person visit.
• To meet the demand for teleprescribing necessitated by the pandemic, the federal government created flexibilities allowing providers to prescribe controlled substances via telehealth without an in-person visit. Those flexibilities have been extended through the end of 2025, but a permanent solution to address the special registration process required by the Ryan Haight Act is needed.
• In 2023, the DEA proposed to set permanent rules surrounding remote prescribing, but they faced backlash for being too restrictive. One previous proposal, for example, would have allowed remote prescribing of buprenorphine for just 30 days before requiring an in-person visit. The DEA has grappled with balancing how to allow for continued access to buprenorphine via telehealth while addressing concerns that online companies are over-prescribing controlled substances such as Adderall.

Special Registration Proposed Rule: Last week, the DEA issued a proposed rule to set up that process, allowing providers to seek “special registration” to prescribe controlled substances virtually without an in-person visit. The rule creates three tiers of registration:

1. One would apply to mid-level practitioners seeking to prescribe Schedule III-V controlled substances via telehealth.
2. The “advanced special registration” would require heightened scrutiny for providers seeking to prescribe Schedule II controlled substances. The advanced registration would only be available to providers in certain specialties (psychiatrists; hospice care physicians; physicians rendering treatment at long-term care facilities; pediatricians). For Schedule II substances, the patient and provider would need to be located in the same state, and the provider could prescribe no more than half of Schedule II prescriptions via telehealth.
3. The third tier would register with the DEA telemedicine platforms seeking to prescribe Schedule II-V substances. For a telemedicine company to register in all 50 states, it could cost upwards of $40,000.

The rule would require providers to be licensed by the DEA in each state where they prescribe and, after three years, require providers to check all 50 states’ prescription drug monitoring programs (PDMP).

• But: This provision is controversial. The telemedicine industry has argued that the system linking PDMPs does not connect to every state, making it difficult to do a comprehensive check. The DEA said it expects the interoperability of the state registries to advance in coming years.

The special registration process is a proposed rule, meaning the Trump administration could change it.

Buprenorphine Final Rule: The DEA also issued a final rule to allow prescribers to continue providing six months’ worth of buprenorphine via telehealth without an in-person visit.

• After six months, patients could refill their prescriptions either via an in-person visit or remotely if the DEA’s broader telehealth proposal (above) is finalized and the prescriber is specially registered under the new system.
• Pharmacists would be charged with verifying patients’ identification on pickup. Pharmacies often pose a roadblock for patients seeking buprenorphine, however, as many do not stock the medication.
• Buprenorphine prescribers will be required only to check a PDMP in the state where the patient is located (as opposed to in every state under the special registration rule for other controlled substances).
• Patients who have seen a provider in person would not be impacted. Providers would not need any registration beyond their current DEA prescriber licensing to prescribe buprenorphine via telehealth (continuing current COVID flexibilities).
• The rule is set to take effect in mid-February. It is final, meaning it would be far more difficult for the Trump administration to reverse.

Why it’s important: Telehealth can help expand access to needed addiction treatment. Studies during COVID found that the telehealth flexibilities increased access to care and led to positive treatment outcomes for patients, without increasing diversion or adverse events.

• The final buprenorphine rule ensures that patients will not be abruptly cut off from care if the extended telehealth flexibilities are allowed to expire at the end of this year.
• The rules are less restrictive for buprenorphine than other controlled substances, noting the limited risk of diversion with buprenorphine and the need for expanded treatment access.
• Requiring telemedicine platforms to register with the DEA aims to cut down on the unscrupulous prescribing and diversion of controlled substances.

Source: DEA proposes special registration to prescribe controlled substances virtually (Politico); DEA, HHS finalize rule allowing telehealth drug treatment (Roll Call); DEA unveils telehealth rules for Adderall, buprenorphine, other controlled medications (STAT); DEA proposes long-awaited special registration for telehealth prescribing, with heightened scrutiny for virtual platforms (Fierce Healthcare)

The main point: The Food and Drug Administration (FDA) last week issued a proposed rule that would make cigarettes and certain other combusted tobacco products minimally/nonaddictive by limiting the level of nicotine in those products.

• The U.S. would be the first country to take such action if it is finalized.

The details:

• The FDA is proposing to cap the nicotine level at 0.7 milligram per gram of tobacco in cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars and pipe tobacco.
• The average nicotine content in the top 100 cigarette brands for 2017 is 17.2 mg/g, meaning the proposal represents a 96% cut.

The impact:

• The proposed nicotine product standard could prevent approximately 48 million youth and young adults from starting smoking by 2100.
• More than 12.9 million people who smoke cigarettes would be projected to stop one year after the rule becomes effective, and more than 19.5 million would within 5 years.
• By 2060, it would avert an estimated 1.8 million tobacco-related deaths, rising to 4.3 million by 2100.
• The estimated benefits of the proposed rule are more than $1.1 trillion per year over the first four decades, compared to just $2 billion in costs. Benefits include less medical spending, savings from productivity loss, reduced exposure to thirdhand smoke and other environmental impacts.

What’s coming: The regulation must still be finalized, meaning it has an uncertain future with Trump returning to the White House.

• While the FDA first proposed such a plan during President Trump’s first term, the administration’s current level of support for the plan is unknown.
• But: The tobacco industry strongly opposes the plan. Even if the FDA does finalize the rule, the tobacco industry would probably mount vigorous legal battles that could wind up before a Supreme Court that has curbed federal regulatory power in recent years.

Source: FDA proposes to limit nicotine levels in cigarettes (Politico); The war on smoking turns to cigarettes with ultralow nicotine (The Washington Post)

The main point: The Food and Drug Administration (FDA) authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application pathway.

• Why it’s important: This is the first time the FDA has authorized nicotine pouch products.

The details:

• The FDA’s evaluation showed that the nicotine pouches pose lower risk of cancer and other serious health conditions (as compared to cigarettes and most smokeless tobacco products).
• ZYN provided evidence from a study showing that a substantial proportion of adults who use cigarettes and/or smokeless tobacco products completely switched to the nicotine pouch products.
• The FDA found that ZYN showed these products have the potential to provide a benefit to adults who smoke cigarettes or use other smokeless tobacco products that is sufficient to outweigh the risks, including to youth.

But: Concerns remain about youth exposure and use. While use among youth remains relatively low, ZYN sales to youth have increased in recent years.

What’s coming:

• The FDA will closely monitor the marketing and use of the products.
• ZYN products will be subject to stringent marketing restrictions for digital, TV and radio to reduce the potential for youth exposure to advertising. Ads must be targeted to adults 21+, and the demographics of the audiences reached must be tracked and measured.
• ZYN intends to implement measures to restrict youth access, reduce youth appeal and limit youth exposure. It will not use mass-market advertising on radio and TV, employ actors/models for marketing that are younger than 35 or styled to appear under 35 or use any content designed to target youth.

Source: FDA authorizes 20 popular Zyn nicotine pouches (Politico); FDA authorizes sale of Zyn nicotine pouches, saying public health benefits outweigh risk (STAT)

The Substance Abuse and Mental Health Services Administration’s Interagency Coordinating Committee for the Prevention of Underage Drinking (ICCPUD) report found that even moderate drinking could carry health risks, including injuries, liver disease and cancer, which increase the more a person consumes.

The larger context:

• The findings came just 11 days after Surgeon General Murthy issued an advisory on the links between alcohol and cancer.
• Another review, published last month by the National Academies of Sciences, Engineering, and Medicine (NASEM), linked moderate drinking to lower all-cause mortality but also to an increased risk of breast cancer.

Why it’s important: Both the NASEM and ICCPUD reports are set to inform the 2025 Dietary Guidelines for Americans.

• Their at-times contradictory results will add fuel to the existing debate about alcohol research and how much alcohol should be considered “safe” by health authorities.

The reactions:

• Members of Congress previously alleged ICCPUD convened its alcohol study groups “without the knowledge of Congress” to do work “duplicative” of the NASEM group’s congressional assignment.
• The alcohol industry said federal officials should “disregard” the ICCPUD report and favor NASEM’s conclusions in writing the dietary guidelines.
• Public health advocates largely celebrated the new report.

What’s coming: It is unclear how the Trump administration will deal with alcohol.

Source: Another federal report on alcohol finds even moderate drinking carries risks (STAT)

President Biden commuted the sentences of nearly 2,500 people convicted of nonviolent drug offenses who were serving disproportionately long sentences compared to the sentences they would receive today under current law, policy and practice.

The details: The action provides relief for individuals who received lengthy sentences based on discredited distinctions between crack and powder cocaine, as well as outdated sentencing enhancements for drug crimes.

The larger context: The move was the broadest commutation of individual sentences ever issued by a U.S. president, and Biden has now issued more individual pardons and commutations than any president in U.S. history.

• Biden had already issued a blanket pardon for thousands of people convicted of federal possession of marijuana, as well as pardons and commutations for many other individuals convicted of nonviolent drug offenses.

Source: Biden Will Commute Sentences of Nearly 2,500 Drug Offenders (The New York Times)