Editor's Note: This article is the second in a series addressing telemedicine prescribing and controlled substances,旨在为已建立的医疗保健提供者提供一些急需的实际指导和指导,必威官网bet医院,和企业家一样。这个first articleaddressed federal rules for prescribing controlled substances under the Ryan Haight Act.Subsequent articles will discuss the prescribing controlled substances via telemedicine under state laws.

随着医疗服务提供者越来越愿意通过远程医疗技术提供医疗服务,many of them are looking to explore betway体育appservices other than low acuity triage consults.  One area of patient service opportunity – and particular confusion – is prescribing controlled substances via telemedicine.

As discussed in greater detail in the本系列的第一篇文章,这个Ryan Haight Online Pharmacy Consumer Protection Act旨在打击20世纪90年代末激增的流氓互联网药店,在线销售受管制物质。尽管该法案旨在针对rogue"internet pharmacies,合法的医疗保健提供者通必威官网bet过远程医疗处方受管制物质,必须仔细审查法规,以确保遵守。该法案要求医生在为受管制物质开出处方前对患者进行至少一次亲自医疗评估。

然而,the Ryan Haight Act contains an important exception to the in-person exam requirement for practitioners engaged in the"远程医疗实践。”的确,there are seven separate"远程医疗的实践”法律规定的例外情况。它们是技术性的,提供者不应假定他们的远程医疗或远程保健方法,必威官网betin fact,遇到Ryan-Haight法案下的例外情况。供应商必须投入资源来真正了解这些法律,以及如何将其应用于其业务或服务。betway体育app

瑞安海特法案下的远程医疗实践

该法案包含以下内容”远程医疗的实践”exceptions:

(1)在医院或诊所治疗。在患者接受治疗时,正在进行远程医疗实践,物理位置,根据法案(21 U.S.C.)第303(f)节注册的医院或诊所。823(f))由在通常的专业实践课程中行事的从业人员,按照适用的州法律行事,以及根据法案第303(f)节(21 U.S.C.)注册的人员。823(f))患者所在州,除非医生:

(i) Is exempted from such registration in all States under section 302(d) of the Act (21 U.S.C.822(d);或

(ii) Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract,并根据法案第303(f)节(21 U.S.C.823(f)) in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f);;

(2)在医生在场的情况下进行的治疗。在患者接受治疗时,正在进行远程医疗实践,and in the physical presence of,在通常的专业实践课程中工作的从业者,按照适用的州法律行事,以及根据法案第303(f)节(21 U.S.C.)注册的人员。823(f))患者所在州,除非医生:

(i) Is exempted from such registration in all States under section 302(d) of the Act (21 U.S.C.822(d));或

(ii) Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract,并根据法案第303(f)节(21 U.S.C.823(f))在任何州,或正在使用根据第303(f)条注册的退伍军人事务部运营的医院或诊所的注册;;

(3)印度卫生服务或必威官网bet部落组织。远程医疗的实践由印度卫生服务的雇员或承包商的从业者进行,必威官网bet或根据《印度自决和教育援助法》为印度部落或部落组织工作,或与印度卫生服务机构签订合同;必威官网bet在受雇范围内行事,contract,或紧凑型;卫生和公众服务部部长根据《法案》第311(g)(2)条(21 U.S.C.)将世卫组织指定为合格的互联网管制物质提供者。必威官网betbetway体育app831(g)(2));;

(四)Public 必威官网bethealth emergency declared by the Secretary of Health andbetway体育app Human Services.在卫生和公众服务部部长根据《公共卫生服务法》(42 U.S.C.)第319节宣布的公共卫生紧急情况下,正在进行远程医疗实践。必威官网betbetway体育app247d),and involves patients located in such areas,and such controlled substances,作为卫生和公共服务部部长,必威官网betbetway体育app经管理员同意,designates,但该指定不受《行政程序法》(5 U.S.C.551–559 and 701–706);;

(五)特殊登记。远程医疗的实践由一名从业者进行,该从业者已根据《美国法典》第21卷第311(h)节从管理者处获得特殊登记。831(h));;

(6)退伍军人事务部医疗急救。正在进行远程医疗实践:

(i)在医疗紧急情况下:

(a)防止患者在根据法案第303(f)节(21 U.S.C.)注册的医生在场的情况下。823(f))是退伍军人健康管理局的雇员或承包商,在该雇员或承包商的正常业务和雇佣过程中,在其公务或合同范围内行事必威官网bet;;

(b)防止患者在根据法案(21 U.S.C.)第303(f)节登记的退伍军人事务部运营的医院或诊所中实际存在。823(f));;

(c)在该病人的初级护理执业者或本段所指以其他方式执业远程医疗的执业者不能提供护理或咨询的期间;and

(d)要求卫生保健从业人员立即使用受管制物质进行干预,以防止从业人员合理地真诚地认为即将发生必威官网bet的严重临床后果,如进一步受伤或死亡;and

(ii) By a practitioner that:

(a)是退伍军人健康管理局的雇员或承包商,在该雇佣或合同范围内行事;必威官网bet;

(b)根据法案(21 U.S.C.)第303(f)节注册。823(f)) in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f);and

(c)在紧急情况下,发出一份受管制物质处方,最多只能供应5天,不得延长或补充;或

(七)规定的其他情形。在行政长官和卫生及公众服务司共同采取的任何其他情况下,正在实施远程医疗,必威官网betbetway体育app按照规定,决定与针对转移的有效控制相一致,或与公共卫生和安全相一致。必威官网bet

Ryan Haight Act对远程医疗有多大帮助??

有些例外情况非常狭窄,不能解释当前的临床远程医疗实践。其他人非常适合机构远程医疗安排。其他人仅用于有限的从业者或特定环境(e.g.,,突发公共卫生事必威官网bet件,Indian tribal organization).  One exception requires a patient-site telepresenter who is also registered with the Drug Enforcement Agency (DEA) (and presumably independently able to prescribe controlled substances for the patient).

总体而言,这些例外在当代远程医疗安排中的效用有限,最显著的是直接到病人家的远程医疗服务。betway体育appthe exceptions do not easily align with direct-to-patient service models frequently sought by patients in areas such as telepsychiatry (e.g.,where the patient is at his or her home at the time of the telemedicine consult).  The main exception designed to accommodate this type of telemedicine practice – the special registration – has not yet been implemented by the DEA.

The DEA seems to recognize the exceptions没有跟上with the rapid developments in telemedicine-based practices.  To be fair,Congress gave the DEA a very brief window to draft regulations in order to implement the Act within the short time period between the passage of the Act and its effective date (only six months).  The DEA's interim final rule was effective a mere nine days after it was published,没时间发表评论。幸运的是,DEA已宣布计划启动特殊远程医疗注册条款(例外5)。这将允许从业者使用远程医疗处方受管制物质,而无需本身in-person exam.  The new rule is anticipated to be published this year.

If I Meet an Exception,我可以在没有任何亲自检查的情况下开受管制物质的处方吗??

不,不一定。无论考试是亲自进行还是通过远程医疗实践进行,a prescription for a controlled substance must always be issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice.  Moreover,practitioners must comply with both federal and state laws,as DEA considers a physician who engages in the unauthorized practice of medicine under state law to be someone who is not acting in the usual course of his or her professional practice.  For example,据DEA称,缺乏在州内行医所需的执照或其他权力的医师签发的受管制物质处方,根据联邦法律,不是有效处方。

Some states prohibit the prescribing of controlled substances via telemedicine,但是其他人确实允许其余的州都是沉默的,或者允许/禁止在某些专业中使用(例如,不能用于慢性非恶性疼痛的治疗。联邦和州法律必须相互协调阅读(与HIPAA如何与更严格的州医疗隐私法相互作用不同)。了解这些层的交叉方式将使提供者能够看到合规可用的途径和方法。通过远程医疗处方受管制物质。这对那些从事慢性病管理和药物治疗的远程医疗提供者特别有用,例如,adolescent and adult psychiatry,药物滥用/恢复,endocrinology,激素替代疗法,and medical weight loss.

有关远程医疗的更多信息,远程健康必威官网bet,虚拟护理,以及其他健康创新,必威官网betincluding the team,publications,and other materials,访问福利的 Telemedicine and Virtual Care practice.