Federal regulators want most patients to see a healthcare provider in person before receiving prescriptions for potentially addictive drugs through telehealth, which hasn’t been required in more than three years.
During the covid-19 public health emergency, the Drug Enforcement Administration has allowed doctors and other healthcare professionals to prescribe controlled medications during telehealth appointments without examining the patient in person. The emergency declaration ended on May 13, and in February, the agency proposed new rules that would require providers to see patients at least once in person before prescribing many of those drugs during telehealth visits.
Controlled drugs include many stimulants, sedatives, opioid pain relievers, and anabolic steroids.
Regulators said they have decided to extend the current regulations — which don’t require an in-person appointment — through Nov. 11 after receiving more than 38,000 comments on the proposed changes, a record amount of feedback. They also said patients receiving controlled drugs from prescribers they have never met in person will have until Nov. 11, 2024 to comply with the agency’s future rules.
The public comments discuss the potential effects on a variety of patients, including people being treated for mental disorders, opioid addiction or attention-deficit/hyperactivity disorder. Thousands of commentators have also mentioned possible impacts on rural patients.
Opponents wrote that healthcare professionals, not law enforcement agencies, should decide which patients need in-person appointments. They said the rules would make it difficult for some patients to get treatment.
Other commentators have called for exemptions for specific drugs and conditions.
Supporters wrote that the proposal would balance goals of increasing access to health care and helping prevent drug abuse.
Zola Coogan, 85, lives in Washington, Maine, a town of about 1,600 northeast of Portland. Coogan has volunteered with hospice patients and said it was important for very ill and terminally ill people in rural areas to have access to opioids to ease their pain. But she said it can be difficult to see a doctor in person if she has no transportation or is too debilitated to travel.
Coogan said he supports the DEA’s proposed rules because of a provision that could help patients who can’t travel to meet with their telehealth prescriber. Instead, they could visit a local healthcare provider, who could then write a special referral to the telehealth prescriber. But she said access to controlled medicines would still be difficult for some rural residents.
“It could end up being a very sticky wicket” for some patients to access care, he said. “It won’t be easy, but it looks like it’s doable.”
Some healthcare providers may be hesitant to offer such referrals, said Stefan Kertesz, a physician and professor at the University of Alabama at Birmingham whose experience includes addiction treatment. Kertesz said the proposed referral process is confusing and would require onerous registration.
Ateev Mehrotra, a doctor and Harvard professor who has studied telemedicine in rural areas, said different controlled drugs carry different risks. But overall, he finds the proposed rules too restrictive. He is concerned that people who have started receiving telehealth prescriptions during the pandemic would be cut off from the medicine that helps them.
Mehrotra said he hasn’t seen clear evidence that every patient needs an in-person appointment before receiving controlled medicines through telehealth. She also said it’s unclear whether providers are less likely to write inappropriate prescriptions after in-person appointments than after telehealth appointments.
Mehrotra described the proposed rules as “a situation where there is no clear benefit, but there is substantial harm to at least some patients,” including many in rural areas.
Beverly Jordan, an Alabama family physician and state medical board member, supports the proposed rule, as well as a new Alabama law that requires annual in-person appointments for patients receiving controlled medications. Jordan prescribes such drugs, even to rural patients who come to her clinic in the small town of Enterprise.
“I think the once-a-year hurdle probably isn’t too big for anyone to jump, and it’s a really big part of patient safety,” Jordan said.
Jordan said it’s important for healthcare professionals to physically examine patients to see if the exam matches how patients describe their symptoms and if they need any other types of treatment.
Jordan said that, early in the pandemic, he couldn’t even view most telehealth patients on his computer. Three-quarters of her appointments were by phone, because many rural patients have poor Internet service that doesn’t support online video.
The proposed federal rules also provide special allowance for buprenorphine, which is used to treat opioid use disorder, and most categories of non-narcotic controlled substances, such as testosterone, ketamine and Xanax.
Providers could prescribe these drugs for 30 days after telehealth appointments before requiring patients to have an in-person appointment to extend the prescription. Tribal health care workers would be exempt from the proposed regulations, as would Department of Veterans Affairs providers in emergency situations.
Many people who work in the health sector were surprised by the proposed rules, Kertesz said. He said they expected the DEA to allow prescribers to apply for special permission to dispense controlled drugs without in-person appointments. Congress ordered the agency to create such a program in 2008, but it didn’t.
Agency officials said they considered creating a version of that program for rural patients but decided against it.
Denise Holiman disagrees with the proposed regulations. Holiman, who lives on a farm outside Centralia, Missouri, suffered from postmenopausal symptoms, including forgetfulness and insomnia. The 50-year-old now feels back to normal after being prescribed estrogen and testosterone by a Florida-based telehealth provider. Holiman said she doesn’t think she should go to her telehealth provider in person to keep her prescriptions.
“I’m supposed to get on a plane to go to Florida. I won’t do it,” he said. “If the government forces me to do it, it’s wrong.”
Holiman said her primary care physician does not prescribe injectable hormones and she would not have to find another in-person prescriber to refer to her provider in Florida.
Holiman is one of thousands of patients who have shared their views with the DEA. The agency also received feedback from advocacy, health care and professional groups, such as the American Medical Association.
The doctors’ organization said the in-person rule should be eliminated for most categories of controlled drugs. Telehealth prescriptions for drugs with a higher risk of misuse, such as Adderall and oxycodone, should also be waived when medically necessary, the group said.
Some states already have laws that are stricter than the DEA’s proposed rules. Amelia Burgess said Alabama’s annual exam requirement, which went into effect last summer, was taking a toll on some patients. The Minnesota doctor works at Bicycle Health, a telehealth company that prescribes buprenorphine.
Burgess said hundreds of the company’s patients in Alabama couldn’t switch to state prescribers because many weren’t getting new patients, were too far away, or were more expensive than the telehealth service. So Burgess and his colleagues flew to Alabama and opened a clinic in a hotel in Birmingham. About 250 patients showed up, with some rural patients driving five hours away.
Critics of the federal proposal are lobbying for exemptions for drugs that can be hard to obtain due to a lack of specialists in rural areas.
Many of the public comments focus on the importance of telehealth-based buprenorphine treatment in rural areas, including prisons and jails.
Rural areas also have a shortage of mental health providers who can prescribe controlled substances for anxiety, depression and ADHD. Patients across the country who use opioids for chronic pain are having a hard time finding prescribers.
It can also be difficult to find rural providers who prescribe testosterone, a controlled drug often taken by transgender men and people with various medical conditions, such as menopause. Controlled drugs are also used to treat seizures, sleep disturbances, and other conditions.
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