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According to the Association of American Medical Colleges (AAMC), "[t]he United States is suffering from a dramatic shortage of psychiatrists and other mental health providers."1 There were an estimated 111 million people living in areas that have a limited number of mental health The Special Registration for Telemedicine:
In Brief
Updated November 28, 2018
Congressional Research Service
https://crsreports.congress.gov
R45240
The Special Registration for Telemedicine: In Brief
Contents
Introduction ..................................................................................................................................... 1
Legislative Activities ....................................................................................................................... 2
Special Registration Requirements.................................................................................................. 3
The Practice of Telemedicine .......................................................................................................... 4
Tables
Table 1. Descriptions of the Seven Categories Under the Practice of Telemedicine ....................... 6
Contacts
Author Information......................................................................................................................... 9
Congressional Research Service
The Special Registration for Telemedicine: In Brief
Introduction
According to the Association of American Medical Colleges (AAMC), “[t]he United States is
suffering from a dramatic shortage of psychiatrists and other mental health providers.”1 There
were an estimated 111 million people living in areas that have a limited number of mental health
providers, as of September 2017.2 The shortage of mental health providers is of concern because
an estimated 50% of all Americans are diagnosed with a mental illness or disorder at some point
in their lives, according to the Centers for Disease Control and Prevention (CDC) of the
Department of Health and Human Services (HHS).3providers, as of September 2017.2 To increase patients'’ access to mental health
care, mental health care providers can provide the care through a telemedicine platform. Telemedicine telemedicine platform.
Telemedicine is the electronic delivery of a clinical health care service via a technological
method.34 Examples of telemedicine platforms that mental health providers can use to deliver
mental health care services include telepsychiatry and telepsychology.4
5
In response to the concerns about the opioid epidemic, the Trump Administration proposed "
“[expanding] access to telemedicine services, including services involving remote prescribing of
medicine commonly used for substance abuse or mental health treatment,"” as an intervention to
address the opioid crisis.56 Section 311(h)(1) of the Controlled Substance Act (CSA),67 which was
added by Section 3 of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan
Haight Act; P.L. 110-425), authorized the special registration for telemedicine with the goal of
increasing patients'’ access to practitionerspractitioners that can prescribe controlled substances via
telemedicine in limited circumstances.78 Section 802(21) of Title 21, U.S.C. defines a practitioner as
as
a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other
person licensed, registered, or otherwise permitted, by the United States or the jurisdiction
in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the
Stacy Weiner, “Addressing the Escalating Psychiatrist Shortage,” Association of American Medical Colleges (AAMC)
NEWS, February 13, 2018, https://news.aamc.org/patient-care/article/addressing-escalating-psychiatrist-shortage/.
2 U.S. Congress, House Committee on Appropriations, Subcommittee on Labor, Health and Human Services,
Education, and Related Agencies, Statement by Dr. Luis Padilla, Associate Administrator, Bureau of Health
Workforce, Health Resources and Services Administration, of HHS, 115th Cong., April 12, 2018, p. 2,
https://docs.house.gov/meetings/AP/AP07/20180412/108104/HHRG-115-AP07-Wstate-PadillaL-20180412.pdf.
3 The Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services (HHS) is
the federal agency charged developing and supporting community-based and population-wide programs and systems to
promote quality of life and prevent the leading causes of disease, injury, disability, and death. See CDC, Mental
Health: Data and Publications, https://www.cdc.gov/mentalhealth/data_publications/index.htm; and CRS Report
R44916, Public Health Service Agencies: Overview and Funding (FY2016-FY2018).
4 HHS, Report to Congress: E-health and Telemedicine, August 12, 2016, pp. 4-5, https://aspe.hhs.gov/system/files/
pdf/206751/TelemedicineE-HealthReport.pdf.
5 American Psychiatric Association, What is Telepsychiatry?, https://www.psychiatry.org/patients-families/what-istelepsychiatry; and American Psychological Association, What are Telehealth and Telepsychology?,
http://www.apa.org/pi/disability/resources/publications/telepsychology.aspx.
6 U.S. President (Trump), “President Donald J. Trump is Taking Action on Drug Addiction and the Opioid Crisis,”
115th Cong., October 26, 2017.
7 The primary federal law governing the manufacture, distribution, and use of prescription and illicit opioids is the
CSA, a statute that the Drug Enforcement Agency (DEA) is principally responsible for administering and enforcing.
See CRS Report R45164, Legal Authorities Under the Controlled Substances Act to Combat the Opioid Crisis.
8 Letter from Senator Claire McCaskill, Senator Lisa Murkowski, and Senator Dan Sullivan to Robert W. Patterson,
Acting Administrator, Drug Enforcement Administration (DEA), January 30, 2018, https://www.hsgac.senate.gov/imo/
media/doc/2018-01-30%20CMC%20Murkowski%20Sullivan%20ltr%20to%20DEA%20re%20telemedicine.pdf.
1
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The Special Registration for Telemedicine: In Brief
respect to, administer, or use in teaching or chemical analysis, a controlled substance in the
course of professional practice or research.
course of professional practice or research.
The registration would enable a practitioner to deliver, distribute, dispense, or prescribe via
telemedicine a controlled substance to a patient who has not been medically examined in-person
by the prescribing practitioner.89 For example in the event of an opioid overdose, a patient might
need a prescription for an opioid antagonist such as naloxone from a provider who has never
examined the patient in-person prior to the telemedicine encounter.9
10
While the CSA authorizedauthorizes the special registration for telemedicine, practitioners have not been
able to apply for this special registration. The Drug Enforcement Administration (DEA), of the
Department of Justice (DOJ), has yet to finalize a rule on the registration'’s application process
and procedures and the limited circumstances that warrant it.1011 (On April 6, 2009, the DEA stated
in an interim final rule that the agency would issue a separate rule regarding the special registration for telemedicine.11) As a result, Congress is considering the Special
registration for telemedicine.12) According to the Fall 2018 Unified Agenda of the Office of
Management and Budget (OMB), the DEA plans to publish in the Federal Register a proposed
rule on the special registration.13
Legislative Activities
On October 24, 2018, the President signed into law the Substance Use-Disorder Prevention that
Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (P.L.
115-271; the SUPPORT for Patients and Communities Act, or the SUPPORT Act).14 Section 3232
of the SUPPORT Act amends CSA Section 311(h)(2) to require that not later than one year after
enactment, the Attorney General, in consultation with the HHS Secretary, promulgate final
regulations specifying the limited circumstances in which a special registration for telemedicine
may be issued and the procedure for obtaining the registration. The amendment replaces the
provision found in CSA Section 311(h)(2) with new language, as follows (with italics indicating
new language and strike-throughs indicating deleted language):
(2) Regulations
The Attorney General shall, with the concurrence of the Secretary, promulgate regulations
specifying the limited circumstances in which a special registration under this subsection
may be issued and the procedures for obtaining such a special registration.
9
21 U.S.C. §831(h); and 21 U.S.C. §829(e).
Naloxone is an emergency overdose reversal medication. See National Institute on Drug Abuse, within the National
Institutes of Health, Opioid Overdose Reversal with Naloxone (Narcan, Evzio), April 2018,
https://www.drugabuse.gov/related-topics/opioid-overdose-reversal-naloxone-narcan-evzio; and Letter from Claire
McCaskill, U.S. Senator, Lisa Murkowski, U.S. Senator, and Dan Sullivan, U.S. Senator, to Robert W. Patterson,
Acting Administrator of the Drug Enforcement Administration, January 30, 2018, https://www.hsgac.senate.gov/imo/
media/doc/2018-01-30%20CMC%20Murkowski%20Sullivan%20ltr%20to%20DEA%20re%20telemedicine.pdf.
11 21 U.S.C. §831(h)(2).
12 DEA, “Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008,” 74 Federal
Register 15603, April 6, 2009.
13 Office of Management and Budget (OMB), Unified Agenda: Special Registration to Engage in the Practice of
Telemedicine, RIN: 1117-AB40, 2018,
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201810&RIN=1117-AB40.
14 CRS Report R45405, The SUPPORT for Patients and Communities Act (P.L. 115-271): Food and Drug
Administration and Controlled Substance Provisions.
10
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The Special Registration for Telemedicine: In Brief
Not later than 1 year after the date of enactment of the SUPPORT for Patients and
Communities Act, in consultation with the Secretary, the Attorney General shall
promulgate final regulations specifying—
(A) the limited circumstances in which a special registration under this subsection
may be issued; and
B) the procedure for obtaining a special registration under this subsection. 15
The language in Section 3232 of the SUPPORT Act that requires the DEA to promulgate a rule on
the special registration not later than one year after enactment originates from the Special
Registration for Telemedicine Clarification Act of 2018 (H.R. 5483). This bill is included in the
SUPPORT Act.16 H.R. 5483 would require the DEA, in a joint effort with the Secretary of the Department of Health and Human Services (HHS), to issue a rule on the special registration for telemedicine within one year of the enactment of the bill (as amended).12 would not have, however, replaced the language that is found in CSA
Section 311(h)(2). The bill would have amended CSA Section 311(h)(2) as follows (with italics
indicating new language and strikethroughs indicating deleted language):
(2) Regulations
The Attorney General shall, with the concurrence of the Secretary, promulgate regulations
Not later than 1 year after the date of enactment of the Special Registration for
Telemedicine Clarification Act of 2018, the Attorney General shall, with the concurrence
of the Secretary, promulgate interim final regulations specifying the limited circumstances
in which a special registration under this subsection may be issued and the procedures for
obtaining such a special registration.
On June 12, 2018, the House passed H.R. 5483 under suspension of the rules.13 On June 13, 2018, the Senate referred the bill to the Senate Health, Education, Labor, and Pensions Committee.
Under Sections 823 and 831(h)(1) of Title 21, U.S.C., Congress established three H.R. 5483 through a motion to suspend the rules and pass
the bill, as amended and agreed to by voice vote.17 On June 13, 2018 (the same day that the
House introduced the SUPPORT Act), the Senate received H.R. 5483, read it twice, and referred
it to its Committee on Health, Education, Labor, and Pensions (HELP).18
The Congressional Budget Office (CBO) provided a cost estimate for H.R. 5483,19 which
estimated that implementing the bill would cost less than $500,000 over the 2019-2023 period. It
can be assumed that this cost estimate is the same for that of Section 3232 of the SUPPORT Act
since Congress chose to fold H.R. 5483 into the act.
Special Registration Requirements
Under Sections 823 and 831(h)(1) of Title 21 of the U.S. Code, Congress established three
general requirements that practitioners must meet while using the special registration to deliver,
distribute, dispense, or prescribe controlled substances via telehealth. First, the practitioners must
15
This new language is not viewable online at the official U.S. Code website because the online version is only current
up to October 16, 2018. See Office of the Law Revision Counsel, United States Code: Currency and Updating,
http://uscode.house.gov/currency/currency.shtml;jsessionid=319C0F3879943F4E4C4C2AAD88F967AC. Accessed on
November 19, 2018.
16 Congress.gov, H.R. 6 - SUPPORT for Patients and Communities Act, Related Bills,
https://www.congress.gov/bill/115th-congress/house-bill/6/related-bills.
17 Representative John J. Faso (Speaker pro tempore), "Special Registration for Telemedicine Clarification Act of
2018," House debate, Congressional Record, vol. 164, part 97 (June 12, 2018), p. H5060.
18 Congress.gov, H.R. 5483 - Special Registration for Telemedicine Clarification Act of 2018, All Actions,
https://www.congress.gov/bill/115th-congress/house-bill/5483/all-actions.
19 Congressional Budget Office (CBO), Cost Estimate: Opioid Legislation, June 6, 2018, pp. 17 and 21,
https://www.cbo.gov/system/files?file=115th-congress-2017-2018/costestimate/53949-opioid.pdf. According to CBO,
the agency’s estimate of H.R. 5483 derives from information that DOJ provided to the agency.
Congressional Research Service
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The Special Registration for Telemedicine: In Brief
demonstrate a legitimate need for the special registration.20demonstrate a legitimate need for the special registration.14 Second, the practitioners must be
registered to deliver, distribute, dispense, or prescribe controlled substances in the state where the
patient is located.1521 Third, the practitioners must maintain compliance with federal and state laws
when delivering, distributing, dispensing, and prescribing a controlled substance.16
22
The Ryan Haight Act expressly exempts certain manufacturers, distributors, and dispensers of
controlled substances and certain Department of Veterans Affairs (VA) practitioners and VA-contractedVAcontracted practitioners from needing to obtain a special registration for telemedicine in each
state where the entities and practitioners choose to practice.1723 To be exempted, a manufacturer,
distributor, or dispenser of a controlled substance must have a DEA waiver that exempts the
entity from needing to obtain an annual registration to manufacture, distribute, and dispense the
controlled substance.1824 A VA practitioner or VA-contracted practitioner must meet two conditions
to be exempted.1925 First, the practitioner must prescribe the controlled substance within the scope
of his or her employment at the VA. Second, the practitioner must either (1) hold at least one state
registration to prescribe a controlled substance or (2) prescribe in a VA health care facility while
using the registration of that facility.
The special registration for telemedicine is one of seven categories under the practice of
telemedicine authority recognized by the CSA.20 26 Table 1 describes the seven categories. The
practice of telemedicine is the federal authority that allows a health care practitioner to prescribe
a controlled substance via telemedicine even in the absence of performing an in-person medical
examination of the patient.2127 Section 802(54) of Title 21, U.S.C., defines the practice of
telemedicine as "“the practice of medicine in accordance with applicable [f]ederal and [s]tate laws
by a practitioner (other than a pharmacist) who is at a location remote from the patient and is
communicating with the patient, or health care professional who is treating the patient, using a
telecommunication system referred to in section 1395m(m) of title 42, [U.S.C.]."22
”28
A practitioner who prescribes a controlled substance via telemedicine in noncompliance with the
requirements described in Table 1 would be considered to be in violation of the CSA.23
|
Seven Categories |
Health Care Practitioner Requirements |
Other Requirements |
Exemptions |
|
Category 1. The practice of telemedicine is delivered to a patient that is located in a hospital or clinic. |
(1) The practitioner must practice in accordance with federal and state laws. (2) The practitioner must be registered to prescribe via telemedicine a controlled substance in the state where the patient is located.
|
(1) The hospital and clinic must hold a DEA registration to dispense or conduct research on controlled substances. |
(2) VA practitioners and VA-contracted practitioners are exempted, if they meet two conditions. First, the practitioners must practice within the scope of their employment or under their contracts at the VA. Second, the practitioners must either (1) hold at least one state registration to prescribe or conduct research on controlled substances or (2) prescribe or conduct research on controlled substances in a VA health care facility while using the registration of that facility. |
|
|
|
|
|
Category 3. The practice of telemedicine is conducted through the Indian Health Service (IHS). |
|
None. |
None. |
|
Category 4. The practice of telemedicine is conducted during a public health emergency. |
(2) The practitioner must provide the telemedicine services to patients that live in the area that is declared a public health emergency. |
(1) The Secretary of the Department of Health and Human Services (HHS) must declare the public health emergency. |
None. |
|
|
None. |
(2) A VA practitioner or VA-contracted practitioner must meet two conditions to be exempted. First, the practitioner must prescribe the controlled substance within the scope of their employment or under their contracts at the VA. Second, the practitioner must either (1) hold at least one state registration to prescribe a controlled substance or (2) prescribe in a VA health care facility while using the registration of that facility. |
|
Category 6. The practice of telemedicine is conducted during a medical emergency situation. |
(1) The practitioner must meet three conditions to practice under this category. First, the practitioner must be a VA practitioner or VA-contracted practitioner who is practicing within the scope of his or her employment or contract within the VA. Second the practitioner must either (1) hold at least one state registration to prescribe or conduct research on controlled substances or (2) prescribe or conduct research on controlled substances in a VA health care facility while using the registration of that facility. Third, the practitioner is prohibited from writing more than a five-day prescription for a controlled substance that is refillable and extendable, for a single patient. |
(1) There are four conditions that make a situation a medical emergency situation under this category. First, the situation must prevent the patient from receiving an in-person examination from a VA practitioner or VA-contracted practitioner. Second, the situation must prevent the patient from being seen in a VA health care facility. Third, the situation must prevent the patient's primary care practitioner and other VA telehealth practitioners from examining the patient. Fourth, the situation must require that the patient receives an immediate prescription for a controlled substance. |
None. |
|
Category 7. The practice of telemedicine is conducted at the discretion of the DEA. |
(1) The practitioner must provide the telehealth service at the discretion of the DEA. |
None. |
None. |
Source: Table prepared by CRS using 21 U.S.C. §802(54) and 21 U.S.C. §831(h).
Table prepared by CRS using 21 U.S.C. §802(54) and 21 U.S.C. §831(h).
Notes: This table provides only the requirements that are found in 21 U.S.C. §802(54) and 21 U.S.C. §831(h). The Ryan Haight Online Pharmacy Consumer Protection
Act of 2008 (Ryan Haight Act; P.L. 110-425) contains other important requirements that practitioners must meet to adhere to the practice of medicine, but those
requirements are beyond the scope of this table. For example and according to 21 U.S.C. §829(e)(2)(A)(i), a practitioner must have performed at least one in-person
medical examination on his or her patient prior to prescribing a controlled substance via the internet.
c. During the delivery of telemedicine, the distant site is where the provider is located and the originating site is where the patient is located; see 42 C.F.R. §410.78(a).
d. The DEA designates a health care provider as an Internet Eligible Controlled Substances Provider when there is a legitimate need for the provider to prescribe
controlled substances via telemedicine to patients that are experiencing access barriers to health care in remote areas; see 21 U.S.C. §831(g)(2).
f.
f.
Under a special registration for telemedicine, a practitioner may deliver, distribute, dispense, or prescribe via telemedicine a controlled substance to a patient who
has not been medically examined in-person by the prescribing practitioner.
CRS-8
The Special Registration for Telemedicine: In Brief
Author Information
Victoria L. Elliott
Analyst in Health Policy
Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan
shared staff to congressional committees and Members of Congress. It operates solely at the behest of and
under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other
than public understanding of information that has been provided by CRS to Members of Congress in
connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not
subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in
its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or
material from a third party, you may need to obtain the permission of the copyright holder if you wish to
copy or otherwise use copyrighted material.
Congressional Research Service
R45240 · VERSION 4 · UPDATED
9
has not been medically examined in-person by the prescribing practitioner.
Author Contact Information
| 1. |
Stacy Weiner, "Addressing the Escalating Psychiatrist Shortage," Association of American Medical Colleges (AAMC) NEWS, February 13, 2018, https://news.aamc.org/patient-care/article/addressing-escalating-psychiatrist-shortage/. |
| 2. |
U.S. Congress, House Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Statement by Dr. Luis Padilla, Associate Administrator, Bureau of Health Workforce, Health Resources and Services Administration, of HHS, 115th Cong., April 12, 2018, p. 2, https://docs.house.gov/meetings/AP/AP07/20180412/108104/HHRG-115-AP07-Wstate-PadillaL-20180412.pdf. |
| 3. |
Department of Health and Human Services (HHS), Report to Congress: E-health and Telemedicine, August 12, 2016, pp. 4-5, https://aspe.hhs.gov/system/files/pdf/206751/TelemedicineE-HealthReport.pdf. |
| 4. |
American Psychiatric Association, What is Telepsychiatry?, https://www.psychiatry.org/patients-families/what-is-telepsychiatry; and American Psychological Association, What are Telehealth and Telepsychology?, http://www.apa.org/pi/disability/resources/publications/telepsychology.aspx. |
| 5. |
U.S. President (Trump), "President Donald J. Trump is Taking Action on Drug Addiction and the Opioid Crisis," 115th Cong., October 26, 2017. |
| 6. |
The primary federal law governing the manufacture, distribution, and use of prescription and illicit opioids is the CSA, a statute that the Drug Enforcement Agency (DEA) is principally responsible for administering and enforcing. See CRS Report R45164, Legal Authorities Under the Controlled Substances Act to Combat the Opioid Crisis. |
| 7. |
Letter from Senator Claire McCaskill, Senator Lisa Murkowski, and Senator Dan Sullivan to Robert W. Patterson, Acting Administrator, Drug Enforcement Administration (DEA), January 30, 2018, https://www.hsgac.senate.gov/imo/media/doc/2018-01-30%20CMC%20Murkowski%20Sullivan%20ltr%20to%20DEA%20re%20telemedicine.pdf. |
| 8. |
21 U.S.C. §831(h); and 21 U.S.C. §829(e). |
| 9. |
Naloxone is an emergency overdose reversal medication. See National Institute on Drug Abuse, within the National Institutes of Health, Opioid Overdose Reversal with Naloxone (Narcan, Evzio), April 2018, https://www.drugabuse.gov/related-topics/opioid-overdose-reversal-naloxone-narcan-evzio; and Letter from Claire McCaskill, U.S. Senator, Lisa Murkowski, U.S. Senator, and Dan Sullivan, U.S. Senator, to Robert W. Patterson, Acting Administrator of the Drug Enforcement Administration, January 30, 2018, https://www.hsgac.senate.gov/imo/media/doc/2018-01-30%20CMC%20Murkowski%20Sullivan%20ltr%20to%20DEA%20re%20telemedicine.pdf. |
| 10. |
21 U.S.C. §831(h)(2). |
| 11. |
DEA, "Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008," 74 Federal Register 15603, April 6, 2009. |
| 12. |
Sandhya Raman, House Energy and Commerce Committee Markup: Panel Advances Opioid Bills in First Day of Markup, CQ Committee Coverage, May 9, 2018, http://www.cq.com/doc/committees-20180509393813?7&search=hlHkCcW5. |
| 13. |
Representative John J. Faso (the Speaker pro tempore), "Special Registration for Telemedicine Clarification Act of 2018," House debate, Congressional Record, vol. 164 (June 12, 2018), pp. H5060-H5061. |
| 14. |
21 U.S.C. §831(h)(1)(A). |
| 15. |
21 U.S.C. §831(h)(1)(B); and CRS Report R45164, Legal Authorities Under the Controlled Substances Act to Combat the Opioid Crisis. |
| 16. |
21 U.S.C. §802(54). |
| 17. |
21 U.S.C. §831(h)(1)(B). |
| 18. |
21 U.S.C. §822(d). |
| 19. |
21 U.S.C. §831(h)(1). |
| 20. |
21 U.S.C. §802(54). |
| 21. |
The Ryan Haight Act requires that a practitioner conduct an in-person medical evaluation of a patient prior to the delivery, distribution, or dispensing of controlled substances by means of the internet, 21 U.S.C. §829(e)(1), (e)(2), although 21 U.S.C. §829(e)(3)(A) is an exception to this requirement for any provider "engaged in the practice of telemedicine." |
| 22. |
A practitioner may use at least one of three telecommunication systems (referred to as telehealth modalities) under the practice of telemedicine: (1) live-video (synchronous), (2) remote patient monitoring (RPM), and (3) mobile health (mHealth); see 42 C.F.R. §410.78(a)(3) and CRS Report R45021, Telehealth Services Proposed for Medicare Part B Reimbursements, 2018: Fact Sheet. |
| 23. |
21 U.S.C. §829(e); and DEA, "Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008," 74 Federal Register 15599-15603, April 6, 2009. ("[T]he Ryan Haight Act makes it unambiguous that it is a per se violation of the CSA for a practitioner to issue a prescription for a controlled substance by means of the Internet without having conducted at least one in-person medical evaluation, except in certain specified circumstances.") |