(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—

(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

(f) Effective date

The amendments made by this section shall take effect on the date of enactment of this Act.

(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.

(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—

(b) Rule of construction

Nothing in this section shall be construed—

(c) Definitions

In this Act:

(d) Effective date

This section shall take effect on the date of enactment of this Act.