H.R. 6994

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6994 Introduced in House (IH)]

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119th CONGRESS
2d Session
H. R. 6994

To amend the Controlled Substances Act to modify requirements relating 
to the prescription of controlled substances by means of the internet, 
and for other purposes.

_______________________________________________________________________

IN THE HOUSE OF REPRESENTATIVES

January 9, 2026

Mr. Dunn of Florida introduced the following bill; which was referred 
to the Committee on Energy and Commerce, and in addition to the 
Committee on the Judiciary, for a period to be subsequently determined 
by the Speaker, in each case for consideration of such provisions as 
fall within the jurisdiction of the committee concerned

_______________________________________________________________________

A BILL

To amend the Controlled Substances Act to modify requirements relating 
to the prescription of controlled substances by means of the internet, 
and for other purposes.

Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Mental Health TALK SAFE Act of 
2026''.

SEC. 2. TELEHEALTH PRESCRIBING OF CONTROLLED SUBSTANCES.

(a) Definition of Valid Prescription.--Section 309(e)(2)(A) of the 
Controlled Substances Act (21 U.S.C. 829(e)(2)(A)) is amended--
(1) in clause (i), by striking ``or'' at the end;
(2) in clause (ii), by striking the period at the end and 
inserting a semicolon; and
(3) by adding at the end the following:
``(iii) a telehealth practitioner who, for 
purposes of prescribing an approved mental 
health controlled substance, has conducted at 
least 1 telehealth evaluation of the patient; 
or
``(iv) a practitioner who, for purposes of 
prescribing a controlled substance in schedule 
II, III, IV, or V for the treatment of an 
opioid use disorder, has conducted at least 1 
telehealth evaluation of the patient.''.
(b) Definition of Covering Practitioner.--Section 309(e)(2)(C)(i) 
of such Act (21 U.S.C. 829(e)(2)(C) (i)) is amended to read as follows:
``(i) has conducted at least 1 in-person 
medical evaluation of the patient, an 
evaluation of the patient through the practice 
of telemedicine, or a telehealth evaluation of 
the patient, within the previous 90 days; 
and''.
(c) Additional Definitions.--Section 309(e)(2) of such Act (21 
U.S.C. 829(e)(2)) is amended by adding at the end the following:
``(D) The term `approved mental health controlled 
substance' means a controlled substance in schedule II 
non-narcotics, III, IV, or V that is being prescribed--
``(i) for the treatment of a mental health 
disorder; and
``(ii) only for the conditions, and only in 
the manner of administration and oversight, 
approved by the Food and Drug Administration.
``(E) The term `exempt entity' means--
``(i) a federally qualified health center;
``(ii) a hospital;
``(iii) a non-profit organization;
``(iv) a Federal, State, or local 
government agency; or
``(v) an exempt health care organization.
``(F) The term `exempt health care organization' 
means a legal entity that, directly or indirectly, 
acquires all, or substantially all, of the stock, 
equity interests, or assets of, or merges with or into, 
a telehealth entity where such telehealth entity, as of 
the effective date of such acquisition or merger--
``(i) has met the criteria to be a 
telehealth entity for each of the previous 24 
months;
``(ii) employs at least 250 psychiatrists 
who each work at least 30 hours per week for 
the telehealth entity; and
``(iii) has at least 75 percent of the 
telehealth entity's total patient volume 
attributed to individuals who are direct 
patients of the telehealth entity.
``(G) The term `federally qualified health center' 
means an organization described in section 1861(aa)(4) 
of the Social Security Act (42 U.S.C. 1395x(aa)(4)).
``(H) The term `health care provider' means any 
individual who--
``(i) is engaged in the delivery of health 
care services in a State; and
``(ii) is required by State law (including 
regulations) to be licensed or certified by the 
State to engage in the delivery of such 
services in the State.
``(I) The term `hospital' means an institution in 
any State in which State or applicable local law 
provides for the licensing of hospitals, that is--
``(i) licensed as a hospital pursuant to 
such law; or
``(ii) approved, by the agency of such 
State or locality responsible for licensing 
hospitals, as meeting the standards established 
for such licensing.
``(J) The term `interactive telecommunications 
system' means the multimedia communications equipment 
that includes, at a minimum, audio-only or audio-video 
equipment permitting two-way, real-time interactive 
communication between the patient and the health care 
provider.
``(K) The term `nonprofit organization' means an 
organization described in section 501(c)(3) of the 
Internal Revenue Code of 1986 that is exempt from 
taxation under section 501(a) of such Act.
``(L) The term `physician' means a doctor of 
medicine or osteopathy legally authorized to practice 
medicine by the State in which such individual performs 
such function or action.
``(M)(i) The term `psychiatric-mental health 
advanced practice nurse' means a registered 
professional nurse who meets the requirements specified 
in clause (ii) or (iii).
``(ii) If the State specifies qualifications for 
psychiatric-mental health advanced practices nurses, 
the individual must--
``(I) be currently licensed to practice in 
the State as a registered professional nurse; 
and
``(II) meet the State requirements for 
qualification as a psychiatric-mental health 
advanced practice nurse in the State in which 
the individual furnishes the services.
``(iii) If the State does not specify 
qualifications for psychiatric-mental health advance 
practice nurses, the individual must--
``(I) meet the qualifications for nurses in 
advanced practice or general nurse 
practitioners as defined by the State; and
``(II) maintain an active psychiatric-
mental health nursing certification from the 
American Nurses Credentialing Center or the 
American Academy of Nurse Practitioners 
Certification Board.
``(N) The term `psychiatrist' means a physician who 
has completed a psychiatry residency program accredited 
by the Accreditation Council for Graduate Medical 
Education and whose practice focuses predominantly on 
the diagnosis, treatment, prevention, or study of 
mental health disorders.
``(O)(i) The term `telehealth affiliate' means as 
to any telehealth entity, any other legal entity that--
``(I) directly or indirectly, is in 
control of, is controlled by, or is 
under common control with, such 
telehealth entity; or
``(II) provides the majority of the 
administrative or business services 
that do not constitute the practice of 
medicine or any other licensed 
profession, to, or on behalf of, such 
telehealth entity.
``(ii) For purposes of this definition, 
control of an entity means the power, directly 
or indirectly, to direct or cause the direction 
of the management and policies of such entity 
whether by contract or otherwise.
``(P) The term `telehealth entity' means an entity 
organized and operating within the United States that 
employs or engages with practitioners who prescribe 
controlled substances via a telehealth evaluation and, 
except in the case of an exempt entity, meets each of 
the following requirements:
``(i) The telehealth entity does not, 
directly or indirectly, through a telehealth 
affiliate or otherwise, maintain an ownership 
interest, investment interest, or management 
relationship with any pharmacy that--
``(I) does not dispense medications 
from physical locations that are 
accessible to the public; and
``(II) fills and delivers the 
majority of its pharmaceutical products 
via the mail service.
``(ii) The telehealth entity does not, 
directly or indirectly, through a telehealth 
entity or otherwise, charge patients pursuant 
to a financial arrangement where patients agree 
to make recurring payments at regular intervals 
in exchange for medications or patient care 
services provided by a health care provider 
employed or engaged with the telehealth entity 
(or a telehealth affiliate).
``(iii) For the duration of any 12-month 
period, no more than 50 percent of all charges 
for patient care services provided by a health 
care provider employed or engaged with the 
telehealth entity (or a telehealth affiliate) 
are paid by patients directly on an out-of-
pocket basis.
``(iv) At least 25 percent of the total 
actual time spent performing patient care 
services by all health care providers engaged 
or employed by the telehealth entity (or a 
telehealth affiliate) relates to the diagnosis, 
treatment, prevention, or study of mental 
health disorders.
``(v) At least 10 percent of all health 
care providers employed or engaged by the 
telehealth entity (or a telehealth affiliate), 
excluding any covering practitioners, are 
practitioners who are bona fide employees who 
work at least 30 hours per week for the 
telehealth entity.
``(vi) At least 25 percent of all health 
care providers employed or engaged by the 
telehealth entity (or a telehealth affiliate), 
excluding any covering practitioners, are bona 
fide employees of the telehealth entity who 
work at least 30 hours per week for the entity.
``(vii) The total number of advanced 
practice nurses employed or engaged with the 
telehealth entity (or a telehealth affiliate), 
excluding any covering practitioners, does not 
exceed two-thirds of the total number of 
practitioners employed or engaged with the 
telehealth entity (or a telehealth affiliate).
``(viii) Neither the telehealth entity nor 
any telehealth affiliate compensates any 
practitioner in a manner where more than 75 
percent of the total annual compensation of 
such practitioner varies, directly or 
indirectly, with the volume or value of 
telehealth evaluations provided by such 
practitioner.
``(ix) The telehealth entity (or a 
telehealth affiliate) at all times employs a 
full-time Chief Compliance Officer who--
``(I) dedicates the majority of 
such individual's time working for the 
telehealth entity on compliance 
matters; and
``(II) does not also serve as the 
Chief Clinical Quality Practitioner or 
Chief Medical Officer.
``(x) The telehealth entity (or a 
telehealth affiliate) at all times employs a 
full-time Chief Clinical Quality Practitioner 
who--
``(I) is a board-certified 
psychiatrist;
``(II) dedicates the majority of 
such individual's time working for the 
telehealth entity on clinical quality 
matters; and
``(III) does not also serve as the 
Chief Compliance Officer or Chief 
Medical Officer for the telehealth 
entity.
``(xi) The telehealth entity (or a 
telehealth affiliate) at all times employs a 
full-time Chief Medical Officer who--
``(I) is a board-certified 
psychiatrist;
``(II) dedicates the majority of 
such individual's time working for the 
telehealth entity on clinical quality 
matters; and
``(III) does not also serve as the 
Chief Compliance Officer or Chief 
Clinical Quality Practitioner of the 
telehealth entity.
``(xii) The telehealth entity conducts 
routine monitoring to ensure all approved 
mental health controlled substances prescribed 
by telehealth practitioners employed or engaged 
by the telehealth entity are prescribed only 
for the conditions, and only in the manner of 
administration and oversight, approved by the 
Food and Drug Administration.
``(xiii) The telehealth entity at all times 
maintains active accreditation from the 
Accreditation Counsel for Continuing Medical 
Education.
``(Q) The term `telehealth evaluation' means a 
medical evaluation that is conducted in accordance with 
applicable Federal and State laws by a health care 
provider who is--
``(i) at a location remote from the 
patient; and
``(ii) communicating with the patient using 
an interactive telecommunications system.
``(R) The term `telehealth practitioner' means a 
psychiatrist or a psychiatric-mental health advanced 
practice nurse who meets the following requirements:
``(i) The individual is an employee or 
independent contractor of a telehealth entity.
``(ii) Except in the case of an exempt 
entity, the individual works at least 10 hours 
per week for the telehealth entity.
``(iii) Except in the case of an exempt 
entity, no more than 75 percent of the total 
annual compensation received by the individual 
from the telehealth entity (or a telehealth 
affiliate) varies with the volume or value of 
the telehealth evaluations provided by such 
practitioner.
``(iv) The individual only prescribes 
controlled substances under subparagraph 
(A)(ii) for one telehealth entity in any given 
calendar month.''.
(d) Minimum Standards Before Refusing To Fill a Prescription.--
Section 309(e) of such Act (21 U.S.C. 829(e)) is amended by adding at 
the end the following:
``(4) Minimum standards before refusing to fill a 
prescription.--
``(A) Prohibition.--A pharmacist shall not refuse 
to fill a prescription for a controlled substance 
issued in compliance with this subsection based solely 
upon a concern the prescription was issued via a 
telehealth evaluation.
``(B) Validation of prescription.--Before a 
pharmacist can refuse to fill a prescription based 
solely upon a concern with the validity of the 
prescription, the pharmacist shall attempt to resolve 
those concerns and shall attempt to validate the 
prescription by performing the following:
``(i) Initiate communication with the 
patient (or the patient's representative) to 
acquire information relevant to the concern 
with the validity of the prescription.
``(ii) Initiate communication with the 
prescriber or the prescriber's agent to--
``(I) describe the pharmacist's 
concern with the validity of the 
prescription; and
``(II) acquire information relevant 
to the pharmacist's concern with the 
validity of the prescription.
``(C) Civil penalty.--Any person who violates this 
paragraph shall, with respect to any such violation, be 
subject to a civil penalty of up to $25,000 per 
violation.''.
(e) Repeals.--
(1) Practice of telemedicine defined.--Section 102(54)(E) 
of such Act (21 U.S.C. 802(54)(E)) is repealed.
(2) Special registration for telemedicine.--Section 311(h) 
of such Act (21 U.S.C. 831(h)) is repealed.
(f) Effective Date.--The amendments made by this section shall take 
effect on the date of enactment of this Act.

SEC. 3. CONTROLLED SUBSTANCES REGISTRATIONS.

(a) In General.--Section 302(e) of such Act (21 U.S.C. 822(e)) is 
amended by adding at the end the following:
``(5)(A) Notwithstanding paragraph (1), a registrant shall not be 
required to obtain additional registrations with the Drug Enforcement 
Administration in any additional State where the dispensing (including 
prescribing and administering) occurs if the dispensing is conducted 
via the practice of telemedicine or following a telehealth evaluation.
``(B) A registrant who is employed or contracted with a telehealth 
entity may use the address of such telehealth entity as the principal 
place of business or professional practice of the registrant so long as 
the registrant--
``(i) is a telehealth practitioner; and
``(ii) only dispenses (including prescribing and 
administering) controlled substances via the practice of 
telemedicine or a telehealth evaluation.''.
(b) Effective Date.--The amendment made by subsection (a) shall 
take effect on the date of enactment of this Act.

SEC. 4. PSYCHIATRIST LICENSURE.

(a) In General.--In the case of a covered psychiatrist who has in 
effect medical professional liability insurance coverage and provides 
in a secondary State covered psychiatry services that are within the 
scope of practice of such covered psychiatrist in the primary State to 
a patient--
(1) such medical professional liability insurance coverage 
shall cover (subject to any related premium adjustments) such 
covered psychiatrist with respect to such covered psychiatry 
services provided by the psychiatrist in the secondary State to 
such patient as if such services were provided by such 
psychiatrist in the primary State to such patient; and
(2) to the extent such covered psychiatrist is licensed 
under the requirements of the primary State to provide such 
services to such patient, the psychiatrist shall be treated as 
satisfying any licensure requirements of the secondary State to 
provide such services to such patient to the extent the 
licensure requirements of the secondary State are substantially 
similar to the licensure requirements of the primary State.
(b) Rule of Construction.--Nothing in this section shall be 
construed--
(1) to allow a covered psychiatrist to provide psychiatry 
services in the secondary State that exceed the scope of that 
psychiatrist's license in the primary State; or
(2) to allow a covered psychiatrist to provide psychiatry 
services in the secondary State that exceed the scope of a 
substantially similar psychiatrist license in the secondary 
State.
(c) Definitions.--In this Act:
(1) Covered psychiatrist.--The term ``covered 
psychiatrist'' means a physician--
(A) who has completed a psychiatry residency 
program accredited by the Accreditation Council for 
Graduate Medical Education;
(B) whose practice focuses predominantly on the 
diagnosis, treatment, prevention, or study of mental 
health disorders; and
(C) who is licensed to practice in the primary 
State.
(2) Covered psychiatry services.--The term ``covered 
psychiatry services'' means medical care relating to the 
diagnosis, treatment, or prevention of mental health or 
behavioral health disorders conducted by a covered psychiatrist 
who is at a location remote from the patient and is 
communicating with the patient through the use of telehealth 
technologies.
(3) License.--The term ``license'' or ``licensure'', as 
applied with respect to a covered psychiatrist, means a 
psychiatrist that has met the requirements and is approved to 
provide covered psychiatry services in accordance with State 
laws and regulations in the primary State.
(4) Primary state.--The term ``primary State'' means, with 
respect to a covered psychiatrist, the State in which--
(A) the covered psychiatrist is licensed to 
practice; and
(B) the majority of the covered psychiatrist's 
practice is underwritten for medical professional 
liability insurance coverage.
(5) Secondary state.--The term ``secondary State'' means, 
with respect to a covered psychiatrist, any State that is not 
the primary State.
(6) State.--The term ``State'' means each of the several 
States, the District of Columbia, and each commonwealth, 
territory, or possession of the United States.
(7) Substantially similar.--The term ``substantially 
similar'', with respect to the licensure by primary and 
secondary States of a psychiatrist, means that both the primary 
and secondary States have in place a form of licensure for such 
professionals that permits such professionals to provide 
covered psychiatry services.
(8) Telehealth technologies.--The term ``telehealth 
technologies'' means technologies relating to the use of 
electronic information and telecommunication technologies, to 
support and promote, at a distance, health care, patient and 
professional health-related education, health administration, 
and public health.
(d) Effective Date.--This section shall take effect on the date of 
enactment of this Act.

SEC. 5. STATE LAWS AFFECTED.

The provisions of this Act (including the amendments made by this 
Act) supersede and preempt any State statute, regulation, order, or 
interpretation to the extent such statute, regulation, order, or 
interpretation would directly or indirectly prohibit or restrict the 
activities permitted by this Act (or the amendments made by this Act).
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