New DEA Rule Expected to Extend Controlled Substance Telemedicine Prescribing Flexibilities Through 2025

After considerable pressure from both Congress and the White House, the Drug Enforcement Administration (DEA) submitted a proposed rule regarding flexibilities on telemedicine prescribing of controlled substances on October 11, 2024. Specifics of the proposed rule are not yet available, but we anticipate the rule will extend the current DEA telemedicine prescribing flexibilities for at least one more year, possibly two. The proposed rule is expected to be released and available for public review before the end of the year and should extend both the in-person exam waiver and the state-by-state DEA registration waiver. 

In late August 2024, POLITICO broke news on the DEA’s internal plans to release an unworkable regulation that would render telemedicine prescribing of controlled substances functionally impractical. Although the draft rule was not publicly released, reporters uncovered how the U.S. Department of Health and Human Services strongly opposed the DEA’s draft, having formally objected to its release at least three times and lodging approximately 400 line-item concerns regarding it. After the news broke, stakeholders were stunned and disappointed. Soon after, patients, clinicians, and leading advocacy associations such as the American Telemedicine Association, ATA Action, and the Alliance for Connected Care, took action through online petitions, and a series of scathing letters from Senators and other members of Congress urged the DEA to honor its prior promises to issue a set of telemedicine regulations before the end of 2024.

Now, with insufficient time before the end of the year to enact a special registration rule, the only path forward to avoid the Telehealth Cliff is to extend the flexibilities further. This will allow time for the DEA to draft a new proposed rule (ideally doing so in collaboration with a taskforce comprised of practicing clinicians and industry stakeholders). Without an extension, the flexibilities that have increased access to health care for individuals in rural and underserved communities over the past four years will disappear after December 31, 2024, resulting in thousands of patients facing the Telehealth Cliff and losing access to critical medications.

简史

这些规定源于《瑞安·海特法案》，该法案修订了《管制物质法》，规定临床医生必须对患者进行面诊后才能开具管制药物处方。此外，《管制物质法》还要求临床医生在其患者所在的每个州分别获得美国缉毒局的注册许可。 国会原期望DEA在2008年《瑞安·海特法案》签署生效后立即颁布特别注册规则。由于DEA多年未能履行此项义务，国会与白宫于2018年签署《支持法案》，这项联邦法律要求DEA必须在2019年10月前颁布特别注册规则。五年后的今天，DEA仍未发布该规则。

在新冠肺炎公共卫生紧急状态期间，美国缉毒局（DEA）实施了若干灵活措施，允许临床医生在无需面诊且仅持有单一州注册资质的情况下开具管制药物处方。2023年2月，即紧急状态结束前两个月，DEA就远程医疗开具管制药物处方提出新规，但该提案未获好评。 该提案引发私营企业与政府官员的强烈批评，共收到创纪录的38,000条公众意见，其中绝大多数对该规则予以严厉抨击，指出其未能认识到临床医生和药房实际提供医疗服务的运作方式。 面对公众强烈反弹，DEA迅速撤回提案并两次延长疫情期间的特殊许可（2023年5月首次延长，同年10月再次延长）。 两次延期旨在为DEA争取更多时间，以制定关于远程医疗处方管制药物专项注册的可行规则。（详情请参阅我们此前关于DEA远程医疗处方管制药物提案规则及两次延长疫情时期灵活措施临时规则的讨论。）

What Happens if the Flexibilities Expire?

If the flexibilities expire, clinicians planning to prescribe controlled substances via telemedicine must:

• Meet one of the seven (narrow) exceptions under the Ryan Haight Act or conduct an in-person exam of the patient; and
• Obtain a separate DEA registration in every state in which their patients are located.

These requirements must be met even if the clinician has been treating the patient since 2020 under the COVID-era flexibilities because DEA has stated there is no “grandfathering” provision under the law that would allow clinicians to continue to prescribe for these patients after the flexibilities expire. The stakes are high for clinicians, as failure to comply with these requirements constitutes a per se violation of the Controlled Substances Act and may lead to criminal or civil penalties and revocation or suspension of the clinician’s DEA registration. Any adverse action taken against the clinician’s DEA registration would trigger disclosures to state professional licensing boards, Medicare, Medicaid, and likely the clinician’s employer.

让人们听到你的声音

Although there is no published rule to comment on yet, in order to maintain patients’ ongoing access to controlled medications, stakeholders should continue to make their voice heard so the DEA will:

• Extend the telemedicine prescribing flexibilities for two more years.
• 组建由利益相关方和通过远程医疗开具处方的执业临床医生组成的公私联合工作组，向美国缉毒局（DEA）提供关键反馈，使其更有能力起草新提案规则，确立特殊注册流程。
• Publish the new proposed special registration rule early in 2025 so the rule has adequate time to go through the administrative rulemaking process before the expiration of the flexibilities.

关心此事的人士可通过以下渠道表达关切：

• 给美国缉毒局发邮件
• 请将信件或电子邮件发送至：
  • Senator Mark Warner‘s office
  • US Representative Buddy Carter’s office
  • Senator Doris Matsui‘s office
  • 您所在地区的国会议员
• Sign the online petition for Women’s Health access urging the DEA to extend the telemedicine prescribing flexibilities
• Sign the ATA Action online petition calling on Congress and the Biden Administration to support extending the telemedicine prescribing flexibilities

结论

We will continue to monitor the rule development and provide updates. 

有关远程医疗、远程健康、虚拟护理、远程患者监测、数字健康及其他医疗创新的更多信息（包括团队介绍、出版物及代表性案例），请访问 Foley远程医疗与数字健康行业团队。