[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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