Bill Summary – FastDemocracy

SECOND REGULAR SESSION
                        HOUSE BILL NO. 2757
                               103RD GENERAL ASSEMBLY


                               INTRODUCED BY REPRESENTATIVE POUCHE.

     4560H.01I                                                                    JOSEPH ENGLER, Chief Clerk


                                                AN ACT
     To repeal section 338.010, RSMo, and to enact in lieu thereof five new sections relating to
            access to medical products.


     Be it enacted by the General Assembly of the state of Missouri, as follows:

             Section A. Section 338.010, RSMo, is repealed and five new sections enacted in lieu
 thereof, to be known as sections 338.010, 338.740, 376.681, 376.687, and 376.689, to read as
 follows:
             338.010. 1. The "practice of pharmacy" includes:
         (1) The interpretation, implementation, and evaluation of medical prescription orders,
 including any legend drugs under 21 U.S.C. Section 353, and the receipt, transmission, or
 handling of such orders or facilitating the dispensing of such orders;
         (2) The designing, initiating, implementing, and monitoring of a medication
 therapeutic plan in accordance with the provisions of this section;
         (3) The compounding, dispensing, labeling, and administration of drugs and devices
 pursuant to medical prescription orders;
         (4) The ordering and administration of vaccines approved or authorized by the U.S.
 Food and Drug Administration, excluding vaccines for cholera, monkeypox, Japanese
 encephalitis, typhoid, rabies, yellow fever, tick-borne encephalitis, anthrax, tuberculosis,
 dengue, Hib, polio, rotavirus, smallpox, and any vaccine approved after January 1, 2023, to
 persons at least seven years of age or the age recommended by the Centers for Disease
 Control and Prevention, whichever is older, pursuant to joint promulgation of rules
 established by the board of pharmacy and the state board of registration for the healing arts
 unless rules are established under a state of emergency as described in section 44.100;

     EXPLANATION — Matter enclosed in bold-faced brackets [thus] in the above bill is not enacted and is
     intended to be omitted from the law. Matter in bold-face type in the above bill is proposed language.
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          (5) The participation in drug selection according to state law and participation in drug
 utilization reviews;
          (6) The proper and safe storage of drugs and devices and the maintenance of proper
 records thereof;
          (7) Consultation with patients and other health care practitioners, and veterinarians
 and their clients about legend drugs, about the safe and effective use of drugs and devices;
          (8) The prescribing and dispensing of any nicotine replacement therapy product under
 section 338.665;
          (9) The dispensing of HIV postexposure prophylaxis pursuant to section 338.730;
 [and]
          (10) The dispensing of an emergency supply of insulin under section 338.740;
 and
          (11) The offering or performing of those acts, services, operations, or transactions
 necessary in the conduct, operation, management and control of a pharmacy.
          2. No person shall engage in the practice of pharmacy unless he or she is licensed
 under the provisions of this chapter.
          3. This chapter shall not be construed to prohibit the use of auxiliary personnel under
 the direct supervision of a pharmacist from assisting the pharmacist in any of his or her duties.
 This assistance in no way is intended to relieve the pharmacist from his or her responsibilities
 for compliance with this chapter and he or she will be responsible for the actions of the
 auxiliary personnel acting in his or her assistance.
          4. This chapter shall not be construed to prohibit or interfere with any legally
 registered practitioner of medicine, dentistry, or podiatry, or veterinary medicine only for use
 in animals, or the practice of optometry in accordance with and as provided in sections
 195.070 and 336.220 in the compounding, administering, prescribing, or dispensing of his or
 her own prescriptions.
          5. A pharmacist with a certificate of medication therapeutic plan authority may
 provide medication therapy services pursuant to a written protocol from a physician licensed
 under chapter 334 to patients who have established a physician-patient relationship, as
 described in subdivision (1) of subsection 1 of section 191.1146, with the protocol physician.
 The written protocol authorized by this section shall come only from the physician and shall
 not come from a nurse engaged in a collaborative practice arrangement under section
 334.104, or from a physician assistant engaged in a collaborative practice arrangement under
 section 334.735.
          6. Nothing in this section shall be construed as to prevent any person, firm or
 corporation from owning a pharmacy regulated by sections 338.210 to 338.315, provided that
 a licensed pharmacist is in charge of such pharmacy.
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         7. Nothing in this section shall be construed to apply to or interfere with the sale of
 nonprescription drugs and the ordinary household remedies and such drugs or medicines as
 are normally sold by those engaged in the sale of general merchandise.
         8. No health carrier as defined in chapter 376 shall require any physician with which
 they contract to enter into a written protocol with a pharmacist for medication therapeutic
 services.
         9. This section shall not be construed to allow a pharmacist to diagnose or
 independently prescribe pharmaceuticals except to the extent described under section
 338.740.
         10. The state board of registration for the healing arts, under section 334.125, and the
 state board of pharmacy, under section 338.140, shall jointly promulgate rules regulating the
 use of protocols for medication therapy services. Such rules shall require protocols to include
 provisions allowing for timely communication between the pharmacist and the protocol
 physician or similar body authorized by this section, and any other patient protection
 provisions deemed appropriate by both boards. In order to take effect, such rules shall be
 approved by a majority vote of a quorum of each board. Neither board shall separately
 promulgate rules regulating the use of protocols for medication therapy services. Any rule or
 portion of a rule, as that term is defined in section 536.010, that is created under the authority
 delegated in this section shall become effective only if it complies with and is subject to all of
 the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter
 536 are nonseverable and if any of the powers vested with the general assembly pursuant to
 chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are
 subsequently held unconstitutional, then the grant of rulemaking authority and any rule
 proposed or adopted after August 28, 2007, shall be invalid and void.
         11. The state board of pharmacy may grant a certificate of medication therapeutic
 plan authority to a licensed pharmacist who submits proof of successful completion of a
 board-approved course of academic clinical study beyond a bachelor of science in pharmacy,
 including but not limited to clinical assessment skills, from a nationally accredited college or
 university, or a certification of equivalence issued by a nationally recognized professional
 organization and approved by the board of pharmacy.
         12. Any pharmacist who has received a certificate of medication therapeutic plan
 authority may engage in the designing, initiating, implementing, and monitoring of a
 medication therapeutic plan as defined by a written protocol from a physician that may be
 specific to each patient for care by a pharmacist.
         13. Nothing in this section shall be construed to allow a pharmacist to make a
 therapeutic substitution of a pharmaceutical prescribed by a physician unless authorized by
 the written protocol or the physician's prescription order.
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       14. "Veterinarian", "doctor of veterinary medicine", "practitioner of veterinary
medicine", "DVM", "VMD", "BVSe", "BVMS", "BSe (Vet Science)", "VMB", "MRCVS", or
an equivalent title means a person who has received a doctor's degree in veterinary medicine
from an accredited school of veterinary medicine or holds an Educational Commission for
Foreign Veterinary Graduates (EDFVG) certificate issued by the American Veterinary
Medical Association (AVMA).
       15. In addition to other requirements established by the joint promulgation of rules by
the board of pharmacy and the state board of registration for the healing arts:
       (1) A pharmacist shall administer vaccines by protocol in accordance with treatment
guidelines established by the Centers for Disease Control and Prevention (CDC);
       (2) A pharmacist who is administering a vaccine shall request a patient to remain in
the pharmacy a safe amount of time after administering the vaccine to observe any adverse
reactions. Such pharmacist shall have adopted emergency treatment protocols.
       16. In addition to other requirements by the board, a pharmacist shall receive
additional training as required by the board and evidenced by receiving a certificate from the
board upon completion, and shall display the certification in his or her pharmacy where
vaccines are delivered.
       17. A pharmacist shall inform the patient that the administration of a vaccine will be
entered into the ShowMeVax system, as administered by the department of health and senior
services. The patient shall attest to the inclusion of such information in the system by signing
a form provided by the pharmacist. If the patient indicates that he or she does not want such
information entered into the ShowMeVax system, the pharmacist shall provide a written
report within fourteen days of administration of a vaccine to the patient's health care provider,
if provided by the patient, containing:
       (1) The identity of the patient;
       (2) The identity of the vaccine or vaccines administered;
       (3) The route of administration;
       (4) The anatomic site of the administration;
       (5) The dose administered; and
       (6) The date of administration.
       18. A pharmacist licensed under this chapter may order and administer vaccines
approved or authorized by the U.S. Food and Drug Administration to address a public health
need, as lawfully authorized by the state or federal government, or a department or agency
thereof, during a state or federally declared public health emergency.
            338.740. 1. Notwithstanding any other provision of law, a pharmacist may
dispense an emergency supply of insulin to a patient without a current, valid
prescription if:
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         (1) The pharmacist makes every reasonable attempt but is unable to obtain
 authorization to refill the prescription from the prescribing health care provider or
 another health care provider responsible for the patient's care;
         (2) Either:
         (a) The pharmacist has a record of a prescription at the pharmacy or has been
 presented proof of a recent prescription for the insulin in the name of the patient who is
 requesting the emergency supply; or
         (b) In the pharmacist's professional judgment, the refusal to dispense an
 emergency supply of the insulin will endanger the patient's health or disrupt essential
 drug therapy for a chronic condition of the patient;
         (3) The amount of insulin dispensed does not exceed the amount of the most
 recent prescription or the standard quantity or unit-of-use package of the drug; and
         (4) The prescriber of the drug has not indicated that no emergency refills are
 authorized.
         2. A pharmacist, the pharmacist's employer, and the original prescriber of the
 drug are not civilly liable for an act or omission in connection with the dispensing of
 insulin under this section unless the act or omission constitutes negligence, recklessness,
 or willful or wanton misconduct.
         3. The board of pharmacy shall adopt rules, in consultation with the state board
 of registration for the healing arts and the state board of nursing, to establish standard
 procedures for pharmacists to follow in dispensing insulin under this section. The rules
 adopted shall include documentation requirements for a pharmacist to complete when
 dispensing insulin without a current prescription. Any rule or portion of a rule, as that
 term is defined in section 536.010, that is created under the authority delegated in this
 section shall become effective only if it complies with and is subject to all of the
 provisions of chapter 536 and, if applicable, section 536.028. This section and chapter
 536 are nonseverable and if any of the powers vested with the general assembly
 pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul
 a rule are subsequently held unconstitutional, then the grant of rulemaking authority
 and any rule proposed or adopted after August 28, 2026, shall be invalid and void.
             376.681. 1. As used in this section, the terms "pharmacy" and "pharmacy
 benefits manager" shall have the same meanings given to the terms in section 376.388.
         2. A pharmacy benefits manager shall not reimburse a pharmacy for each
 dispensed drug in an amount less than the actual acquisition cost of the drug. In
 addition to the reimbursement amount for the drug, the pharmacy benefits manager
 shall pay the pharmacy a dispensing fee of at least fifteen dollars for each prescription
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drug dispensed to fairly compensate for professional services, operational costs, and
patient counseling.
           376.687. 1. As used in this section, the following terms mean:
       (1) "Diabetes device", a prescribed device used to cure, diagnose, mitigate,
prevent, or treat diabetes or low blood sugar. The term "diabetes device" includes, but
is not limited to, a blood glucose monitor, continuous glucose monitor, or insulin pump;
       (2) "Epinephrine delivery device", a prescribed, single-use device used for the
delivery of a premeasured dose of epinephrine into the human body;
       (3) "Prescription insulin drug", a prescription drug that contains insulin and is
used to control blood glucose levels to treat diabetes but does not include an insulin drug
that is administered to a patient intravenously.
       2. This section applies to any group or individual policy of accident and health
insurance amended, delivered, issued, or renewed on or after August 28, 2026.
       3. (1) An insurer that provides coverage for prescription insulin drugs under the
terms of a health coverage plan the insurer offers shall limit the total amount that an
insured is required to pay for a thirty-day supply of covered prescription insulin drugs
at an amount not to exceed thirty-five dollars, regardless of the quantity or type of
covered prescription insulin drug used to fill the insured's prescription.
       (2) An insurer that provides coverage for diabetes devices under the terms of a
health coverage plan the insurer offers shall limit the total amount that an insured is
required to pay for one covered diabetes device at an amount not to exceed one hundred
dollars, regardless of the type of covered diabetes device used to fill the insured's
prescription.
       (3) An insurer that provides coverage for epinephrine delivery devices under the
terms of a health coverage plan the insurer offers shall limit the total amount that an
insured is required to pay for one covered epinephrine delivery device at an amount not
to exceed one hundred dollars, regardless of the type of covered epinephrine delivery
device used to fill the insured's prescription.
       4. On January first of each year, the limit on the amount that an insured is
required to pay for one covered diabetes device or epinephrine delivery device or for a
thirty-day supply of a covered prescription insulin drug shall increase by a percentage
equal to the percentage change from the preceding year in the medical care component
of the Consumer Price Index for All Urban Consumers for the United States as reported
by the Bureau of Labor Statistics of the United States Department of Labor.
       5. If, under federal law, application of any requirement under this section would
result in health savings account ineligibility under Section 223 of the Internal Revenue
Code of 1986, as amended, the requirements of this section shall apply to health savings
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 account-qualified high deductible health plans with respect to any cost-sharing of such a
 plan after the enrollee has satisfied the minimum deductible under Section 223, except
 with respect to items or services that are preventive care under Section 223(c)(2)(C) of
 the Internal Revenue Code of 1986, as amended, in which case the requirements of this
 section shall apply regardless of whether the minimum deductible under Section 223 has
 been satisfied.
        6. The director of the department of commerce and insurance may promulgate
 all necessary rules and regulations for the administration of this section. Any rule or
 portion of a rule, as that term is defined in section 536.010, that is created under the
 authority delegated in this section shall become effective only if it complies with and is
 subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This
 section and chapter 536 are nonseverable and if any of the powers vested with the
 general assembly pursuant to chapter 536 to review, to delay the effective date, or to
 disapprove and annul a rule are subsequently held unconstitutional, then the grant of
 rulemaking authority and any rule proposed or adopted after August 28, 2026, shall be
 invalid and void.
            376.689. 1. Before November 1, 2026, the department of commerce and
 insurance, in conjunction with the department of health and senior services and the
 department of social services, shall make available to the public a report that details
 each department's findings for the following:
        (1) A summary of pricing practices for insulin, diabetes devices, and epinephrine
 delivery devices and variables that contribute to the pricing of health coverage plans;
        (2) Public policy recommendations to control and prevent overpricing of
 prescription insulin drugs, diabetes devices, and epinephrine delivery devices made
 available to Missouri consumers; and
        (3) Any other information that the department of commerce