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1 _____________ BILL NO. _____________
2 INTRODUCED BY _________________________________________________
(Primary Sponsor)
3
4 A BILL FOR AN ACT ENTITLED: “AN ACT GENERALLY REVISING LAWS RELATED TO TELEHEALTH
5 SERVICES; ALLOWING HEALTH CARE PROVIDERS TO PROVIDE SERVICES BY MEANS OF
6 TELEHEALTH; ALLOWING MEDICAID COVERAGE OF SERVICES PROVIDED BY MEANS OF
7 TELEHEALTH; PROVIDING DEFINITIONS; CLARIFYING RULEMAKING AUTHORITY; AND AMENDING
8 SECTIONS 37-7-101, 37-7-201, 37-11-101, 37-11-105, 37-15-102, 37-15-202, 37-15-314, 37-15-315, 53-6-
9 113, AND 53-6-155, MCA.”
10
11 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MONTANA:
12
13 NEW SECTION. Section 1. Telehealth services -- rulemaking authority. (1) A person licensed
14 under this title to provide health care in the ordinary course of business or practice of a profession may provide
15 services by means of telehealth when the use of telehealth:
16 (a) is appropriate for the services being provided;
17 (b) meets the standard of care for delivery of services; and
18 (c) complies with any administrative rules for telehealth adopted by the board that licenses the health
19 care provider.
20 (2) A board may adopt rules establishing requirements for the use of telehealth by its licensees.
21 (3) (a) For the purposes of this section, "telehealth" means the use of audio, video, or other
22 telecommunications technology or media, including audio-only communication, that is:
23 (i) used by a health care provider or health care facility to deliver health care services; and
24 (ii) delivered over a secure connection that complies with the requirements of state and federal privacy
25 laws.
26 (b) The term does not include delivery of health care services by means of facsimile machines or
27 electronic messaging alone. The use of facsimile machines and electronic messaging is not precluded if used in
28 conjunction with other audio, video, or telecommunications technology or media.
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1 (c) For physicians providing written certification of a debilitating medical condition pursuant to 50-46-
2 310, the term does not include the use of audio-only communication unless the physician has previously
3 established a physician-patient relationship through an in-person encounter.
4
5 NEW SECTION. Section 2. Telehealth services -- requirements -- limitations. (1) Providers
6 enrolled in the medicaid program may provide medically necessary services by means of telehealth if the
7 service:
8 (a) is clinically appropriate for delivery by telehealth as specified by the department by rule or policy;
9 (b) comports with the guidelines of the applicable medicaid provider manual; and
10 (c) is not specifically required in the applicable provider manual to be provided in a face-to-face
11 manner.
12 (2) A provider shall:
13 (a) ensure an enrollee receiving telehealth services has the same rights to confidentiality and security
14 as provided for traditional office visits;
15 (b) follow consent and patient information protocols consistent with the protocols followed for in-
16 person visits; and
17 (c) comply with recordkeeping requirements established by the department by rule.
18 (3) Telehealth services:
19 (a) may be provided using secure portal messaging, secure instant messaging, telephone
20 communication, or audiovisual communication;
21 (b) may not be provided in a setting or manner not otherwise authorized by law; and
22 (c) must be reimbursed at the same rate of payment as services delivered in person.
23 (4) An enrollee's residence is not reimbursable as an enrolled originating site provider.
24 (5) The department shall adopt rules for the provision of telehealth services, including but not limited
25 to:
26 (a) billing procedures for enrolled providers;
27 (b) the services considered clinically appropriate for telehealth purposes;
28 (c) recordkeeping requirements for providers, including originating site providers; and
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1 (d) other requirements for originating site providers, including allowable provider types,
2 reimbursement rates, and requirements for the secure technology to be used at originating sites.
3 (6) Nothing in this section may be construed as altering the scope of practice of any enrolled provider
4 delivering services by means of telehealth.
5
6 Section 3. Section 37-7-101, MCA, is amended to read:
7 "37-7-101. Definitions. As used in this chapter, the following definitions apply:
8 (1) (a) "Administer" means the direct application of a drug to the body of a patient by injection,
9 inhalation, ingestion, or any other means.
10 (b) Except as provided in 37-7-105, the term does not include immunization by injection for children
11 under 18 years of age.
12 (2) "Board" means the board of pharmacy provided for in 2-15-1733.
13 (3) "Cancer drug" means a prescription drug used to treat:
14 (a) cancer or its side effects; or
15 (b) the side effects of a prescription drug used to treat cancer or its side effects.
16 (4) "Chemical" means medicinal or industrial substances, whether simple, compound, or obtained
17 through the process of the science and art of chemistry, whether of organic or inorganic origin.
18 (5) "Clinical pharmacist practitioner" means a licensed pharmacist in good standing who meets the
19 requirements specified in 37-7-306.
20 (6) "Collaborative pharmacy practice" means the practice of pharmacy by a pharmacist who has
21 agreed to work in conjunction with one or more prescribers, on a voluntary basis and under protocol, and who
22 may perform certain patient care functions under certain specified conditions or limitations authorized by the
23 prescriber.
24 (7) "Collaborative pharmacy practice agreement" means a written and signed agreement between
25 one or more pharmacists and one or more prescribers that provides for collaborative pharmacy practice for the
26 purpose of drug therapy management of patients.
27 (8) "Commercial purposes" means the ordinary purposes of trade, agriculture, industry, and
28 commerce, exclusive of the practices of medicine and pharmacy.
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1 (9) "Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or
2 device based on:
3 (a) a practitioner's prescription drug order;
4 (b) a professional practice relationship between a practitioner, pharmacist, and patient;
5 (c) research, instruction, or chemical analysis, but not for sale or dispensing; or
6 (d) the preparation of drugs or devices based on routine, regularly observed prescribing patterns.
7 (10) "Confidential patient information" means privileged information accessed by, maintained by, or
8 transmitted to a pharmacist in patient records or that is communicated to the patient as part of patient
9 counseling.
10 (11) "Controlled substance" means a substance designated in Schedules II through V of Title 50,
11 chapter 32, part 2.
12 (12) "Department" means the department of labor and industry provided for in Title 2, chapter 15, part
13 17.
14 (13) "Device" has the same meaning as defined in 37-2-101.
15 (14) "Dispense" or "dispensing" means the interpretation, evaluation, and implementation of a
16 prescription drug order, including the preparation and delivery of a drug or device to a patient or patient's agent
17 in a suitable container appropriately labeled for administration to or use by a patient.
18 (15) "Distribute" or "distribution" means the sale, purchase, trade, delivery, handling, storage, or receipt
19 of a drug or device and does not include administering or dispensing a prescription drug, pursuant to section
20 353(b)(1), or a new animal drug, pursuant to section 360b(b) of the Federal Food, Drug, and Cosmetic Act, 21
21 U.S.C. 301, et seq.
22 (16) "Drug" means a substance:
23 (a) recognized as a drug in any official compendium or supplement;
24 (b) intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in humans or
25 animals;
26 (c) other than food, intended to affect the structure or function of the body of humans or animals; and
27 (d) intended for use as a component of a substance specified in subsection (16)(a), (16)(b), or (16)(c).
28 (17) "Drug utilization review" means an evaluation of a prescription drug order and patient records for
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1 duplication of therapy, interactions, proper utilization, and optimum therapeutic outcomes. The term includes
2 but is not limited to the following evaluations:
3 (a) known allergies;
4 (b) rational therapy contraindications;
5 (c) reasonable dose and route administration;
6 (d) reasonable directions for use;
7 (e) drug-drug interactions;
8 (f) drug-food interactions;
9 (g) drug-disease interactions; and
10 (h) adverse drug reactions.
11 (18) "Equivalent drug product" means a drug product that has the same established name, active
12 ingredient or ingredients, strength or concentration, dosage form, and route of administration and meets the
13 same standards as another drug product as determined by any official compendium or supplement. Equivalent
14 drug products may differ in shape, scoring, configuration, packaging, excipients, and expiration time.
15 (19) "FDA" means the United States food and drug administration.
16 (20) "Health care facility" has the meaning provided in 50-5-101.
17 (21) (a) "Health clinic" means a facility in which advice, counseling, diagnosis, treatment, surgery,
18 care, or services relating to preserving or maintaining health are provided on an outpatient basis for a period of
19 less than 24 consecutive hours to a person not residing at or confined to the facility.
20 (b) The term includes an outpatient center for primary care and an outpatient center for surgical
21 services, as those terms are defined in 50-5-101, and a local public health agency as defined in 50-1-101.
22 (c) The term does not include a facility that provides routine health screenings, health education, or
23 immunizations.
24 (22) "Health information system" means one of the following systems used to compile and manage
25 patient health care information:
26 (a) an electronic health record system;
27 (b) a health information exchange approved by the board;
28 (c) a pharmacy dispensing system; or
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1 (d) a system defined by the board by rule.
2 (23) "Hospital" has the meaning provided in 50-5-101.
3 (24) "Immunization-certified pharmacist" means a pharmacist who:
4 (a) has successfully completed an immunization delivery course of training that is approved by the
5 accreditation council for pharmacy education or by an authority approved by the board and that, at a minimum,
6 includes instruction in hands-on injection technique, clinical evaluation of indications and contraindications of
7 immunizations, storage and handling of immunizations, and documentation and reporting; and
8 (b) holds a current basic cardiopulmonary resuscitation certification issued by the American heart
9 association, the American red cross, or another recognized provider.
10 (25) "Intern" means:
11 (a) a person who is licensed by the state to engage in the practice of pharmacy while under the
12 personal supervision of a preceptor and who is satisfactorily progressing toward meeting the requirements for
13 licensure as a pharmacist;
14 (b) a graduate of an accredited college of pharmacy who is licensed by the state for the purpose of
15 obtaining practical experience as a requirement for licensure as a pharmacist;
16 (c) a qualified applicant awaiting examination for licensure; or
17 (d) a person participating in a residency or fellowship program.
18 (26) "Long-term care facility" has the meaning provided in 50-5-101.
19 (27) "Manufacturing" means the production, preparation, propagation, conversion, or processing of a
20 drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by
21 means of chemical or biological synthesis.
22 (28) "Medicine" means a remedial agent that has the property of curing, preventing, treating, or
23 mitigating diseases or which is used for this purpose.
24 (29) "Outsourcing facility" means a facility at one geographic location or address that:
25 (a) engages in compounding of sterile drugs;
26 (b) has elected to register as an outsourcing facility with FDA; and
27 (c) complies with all the requirements of section 353b of the Federal Food, Drug, and Cosmetic Act,
28 21 U.S.C. 301 et seq.
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1 (30) "Participant" means a physician's office, pharmacy, hospital, or health clinic that has elected to
2 voluntarily participate in the cancer drug repository program provided for in 37-7-1403 and that accepts donated
3 cancer drugs or devices under rules adopted by the board.
4 (31) "Patient counseling" means the communication by the pharmacist of information, as defined by
5 the rules of the board, to the patient or caregiver in order to ensure the proper use of drugs or devices.
6 (32) "Person" includes an individual, partnership, corporation, association, or other legal entity.
7 (33) "Pharmaceutical care" means the provision of drug therapy and other patient care services
8 intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a
9 patient's symptoms, or arresting or slowing of a disease process.
10 (34) "Pharmacist" means a person licensed by the state to engage in the practice of pharmacy and
11 who may affix to the person's name the term "R.Ph.".
12 (35) "Pharmacy" means an established location, either physical or electronic, registered by the board
13 where drugs or devices are dispensed with pharmaceutical care or where pharmaceutical care is provided.
14 (36) "Pharmacy technician" means an individual who assists a pharmacist in the practice of pharmacy.
15 (37) "Poison" means a substance that, when introduced into the system, either directly or by
16 absorption, produces violent, morbid, or fatal changes or that destroys living tissue with which it comes in
17 contact.
18 (38) "Practice of pharmacy" means:
19 (a) interpreting, evaluating, and implementing prescriber orders;
20 (b) administering drugs and devices pursuant to a collaborative practice agreement, except as
21 provided in 37-7-105, and compounding, labeling, dispensing, and distributing drugs and devices, including
22 patient counseling;
23 (c) properly and safely procuring, storing, distributing, and disposing of drugs and devices and
24 maintaining proper records;
25 (d) monitoring drug therapy and use;
26 (e) initiating or modifying drug therapy i