Modifies provisions relating to access to medical products

SECOND REGULAR SESSION
HOUSE BILL NO. 2757
103RD GENERAL ASSEMBL Y
INTRODUCED BY REPRESENT A TIVE POUCHE.
4560H.01I JOSEPH ENGLER, Chief Clerk
AN ACT
T o 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Section A. Section 338.010, RSMo, is repealed and five new sections enacted in lieu
2 thereof, to be known as sections 338.010, 338.740, 376.681, 376.687, and 376.689, to read as
3 follows:
338.010. 1. The "practice of pharmacy" includes:
2 (1) The interpretation, implementation, and evaluation of medical prescription orders,
3 including any legend drugs under 21 U.S.C. Section 353, and the receipt, transmission, or
4 handling of such orders or facilitating the dispensing of such orders;
5 (2) The designing, initiating, implementing, and monitoring of a medication
6 therapeutic plan in accordance with the provisions of this section;
7 (3) The compounding, dispensing, labeling, and administration of drugs and devices
8 pursuant to medical prescription orders;
9 (4) The ordering and administration of vaccines approved or authorized by the U.S.
10 Food and Drug Administration, excluding vaccines for cholera, monkeypox, Japanese
11 encephalitis, typhoid, rabies, yellow fever , tick-borne encephalitis, anthrax, tuberculosis,
12 dengue, Hib, polio, rotavirus, smallpox, and any vaccine approved after January 1, 2023, to
13 persons at least seven years of age or the age recommended by the Centers for Disease
14 Control and Prevention, whichever is older , pursuant to joint promulgation of rules
15 established by the board of pharmacy and the state board of registration for the healing arts
16 unless rules are established under a state of emer gency as described in section 44.100;
EXPLANA TION — 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.
17 (5) The participation in drug selection according to state law and participation in drug
18 utilization reviews;
19 (6) The proper and safe storage of drugs and devices and the maintenance of proper
20 records thereof;
21 (7) Consultation with patients and other health care practitioners, and veterinarians
22 and their clients about legend drugs, about the safe and ef fective use of drugs and devices;
23 (8) The prescribing and dispensing of any nicotine replacement therapy product under
24 section 338.665;
25 (9) The dispensing of HIV postexposure prophylaxis pursuant to section 338.730;
26 [ and ]
27 (10) The dispensing of an emergency supply of insulin under section 338.740;
28 and
29 (1 1) The of fering or performing of those acts, services, operations, or transactions
30 necessary in the conduct, operation, management and control of a pharmacy .
31 2. No person shall engage in the practice of pharmacy unless he or she is licensed
32 under the provisions of this chapter .
33 3. This chapter shall not be construed to prohibit the use of auxiliary personnel under
34 the direct supervision of a pharmacist from assisting the pharmacist in any of his or her duties.
35 This assistance in no way is intended to relieve the pharmacist from his or her responsibilities
36 for compliance with this chapter and he or she will be responsible for the actions of the
37 auxiliary personnel acting in his or her assistance.
38 4. This chapter shall not be construed to prohibit or interfere with any legally
39 registered practitioner of medicine, dentistry , or podiatry , or veterinary medicine only for use
40 in animals, or the practice of optometry in accordance with and as provided in sections
41 195.070 and 336.220 in the compounding, administering, prescribing, or dispensing of his or
42 her own prescriptions.
43 5. A pharmacist with a certificate of medication therapeutic plan authority may
44 provide medication therapy services pursuant to a written protocol from a physician licensed
45 under chapter 334 to patients who have established a physician-patient relationship, as
46 described in subdivision (1) of subsection 1 of section 191.1 146, with the protocol physician.
47 The written protocol authorized by this section shall come only from the physician and shall
48 not come from a nurse engaged in a collaborative practice arrangement under section
49 334.104, or from a physician assistant engaged in a collaborative practice arrangement under
50 section 334.735.
51 6. Nothing in this section shall be construed as to prevent any person, firm or
52 corporation from owning a pharmacy regulated by sections 338.210 to 338.315, provided that
53 a licensed pharmacist is in char ge of such pharmacy .
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54 7. Nothing in this section shall be construed to apply to or interfere with the sale of
55 nonprescription drugs and the ordinary household remedies and such drugs or medicines as
56 are normally sold by those engaged in the sale of general merchandise.
57 8. No health carrier as defined in chapter 376 shall require any physician with which
58 they contract to enter into a written protocol with a pharmacist for medication therapeutic
59 services.
60 9. This section shall not be construed to allow a pharmacist to diagnose or
61 independently prescribe pharmaceuticals except to the extent described under section
62 338.740 .
63 10. The state board of registration for the healing arts, under section 334.125, and the
64 state board of pharmacy , under section 338.140, shall jointly promulgate rules regulating the
65 use of protocols for medication therapy services. Such rules shall require protocols to include
66 provisions allowing for timely communication between the pharmacist and the protocol
67 physician or similar body authorized by this section, and any other patient protection
68 provisions deemed appropriate by both boards. In order to take ef fect, such rules shall be
69 approved by a majority vote of a quorum of each board. Neither board shall separately
70 promulgate rules regulating the use of protocols for medication therapy services. Any rule or
71 portion of a rule, as that term is defined in section 536.010, that is created under the authority
72 delegated in this section shall become effectiv e only if it complies with and is subject to all of
73 the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter
74 536 are nonseverable and if any of the powers vested with the general assembly pursuant to
75 chapter 536 to review , to delay the ef fective date, or to disapprove and annul a rule are
76 subsequently held unconstitutional, then the grant of rulemaking authority and any rule
77 proposed or adopted after August 28, 2007, shall be invalid and void.
78 1 1. The state board of pharmacy may grant a certificate of medication therapeutic
79 plan authority to a licensed pharmacist who submits proof of successful completion of a
80 board-approved course of academic clinical study beyond a bachelor of science in pharmacy ,
81 including but not limited to clinical assessment skills, from a nationally accredited college or
82 university , or a certification of equivalence issued by a nationally recognized professional
83 or ganization and approved by the board of pharmacy .
84 12. Any pharmacist who has received a certificate of medication therapeutic plan
85 authority may engage in the designing, initiating, implementing, and monitoring of a
86 medication therapeutic plan as defined by a written protocol from a physician that may be
87 specific to each patient for care by a pharmacist.
88 13. Nothing in this section shall be construed to allow a pharmacist to make a
89 therapeutic substitution of a pharmaceutical prescribed by a physician unless authorized by
90 the written protocol or the physician's prescription order .
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91 14. "V eterinarian", "doctor of veterinary medicine", "practitioner of veterinary
92 medicine", "DVM", "VMD", "BVSe", "BVMS", "BSe (V et Science)", "VMB", "MRCVS", or
93 an equivalent title means a person who has received a doctor's degree in veterinary medicine
94 from an accredited school of veterinary medicine or holds an Educational Commission for
95 Foreign V eterinary Graduates (EDFVG) certificate issued by the American V eterinary
96 Medical Association (A VMA).
97 15. In addition to other requirements established by the joint promulgation of rules by
98 the board of pharmacy and the state board of registration for the healing arts:
99 (1) A pharmacist shall administer vaccines by protocol in accordance with treatment
100 guidelines established by the Centers for Disease Control and Prevention (CDC);
101 (2) A pharmacist who is administering a vaccine shall request a patient to remain in
102 the pharmacy a safe amount of time after administering the vaccine to observe any adverse
103 reactions. Such pharmacist shall have adopted emer gency treatment protocols.
104 16. In addition to other requirements by the board, a pharmacist shall receive
105 additional training as required by the board and evidenced by receiving a certificate from the
106 board upon completion, and shall display the certification in his or her pharmacy where
107 vaccines are delivered.
108 17. A pharmacist shall inform the patient that the administration of a vaccine will be
109 entered into the ShowMeV ax system, as administered by the department of health and senior
110 services. The patient shall attest to the inclusion of such information in the system by signing
111 a form provided by the pharmacist. If the patient indicates that he or she does not want such
112 information entered into the ShowMeV ax system, the pharmacist shall provide a written
113 report within fourteen days of administration of a vaccine to the patient's health care provider ,
114 if provided by the patient, containing:
115 (1) The identity of the patient;
116 (2) The identity of the vaccine or vaccines administered;
117 (3) The route of administration;
118 (4) The anatomic site of the administration;
119 (5) The dose administered; and
120 (6) The date of administration.
121 18. A pharmacist licensed under this chapter may order and administer vaccines
122 approved or authorized by the U.S. Food and Drug Administration to address a public health
123 need, as lawfully authorized by the state or federal government, or a department or agency
124 thereof, during a state or federally declared public health emer gency .
338.740. 1. Notwithstanding any other provi sion of law , a pharmacist may
2 dispense an emergency supply of insulin to a patient without a curr ent, valid
3 pr escription if:
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4 (1) The pharmacist makes every r easonable attempt but is unable to obtain
5 authorization to r efill the prescription fr om the prescribi ng health care prov ider or
6 another health car e pr ovider r esponsible for the patient's care;
7 (2) Either:
8 (a) The pharmacist has a record of a pr escription at the pharmacy or has been
9 pr esented pr oof of a r ecent prescrip tion for the insulin in the name of the patient who is
10 r equesting the emergency supply; or
11 (b) In the pharmacist's profession al judgment, the ref usal to dispense an
12 emergency supply of the insulin will endanger the patient's health or disrupt essential
13 drug therapy for a chron ic condition of the patient;
14 (3) The amount of insulin dispensed does not exceed the amount of the most
15 r ecent pr escription or the standard quantity or unit-of-use package of the drug; and
16 (4) The pre scriber of the drug has not indicated that no emergency ref ills are
17 authorized.
18 2. A pharmacist, the pharmacist's employer , and the original pr escriber of the
19 drug ar e not civilly liable for an act or omission in connection with the dispensing of
20 insulin under this section unless the act or omission constitutes negligence, rec klessness,
21 or willful or wanton misconduct.
22 3. The board of pharmacy shall adopt rules, in consultation with the state board
23 of reg istration for the healing arts and the state board of nursing, to establish standard
24 pr ocedur es for pharmacists to follow in dispensing insulin under this section. The rules
25 adopted shall include documentation re quir ements for a pharmacist to complete when
26 dispensing insulin without a curren t prescrip tion. Any rule or portion of a rule, as that
27 term is defined in section 536.010, that is creat ed under the authority delegated in this
28 section shall become effective only if it complies with and is subject to all of the
29 pr ovisions of chapter 536 and, if applicable, section 536.028. This section and chapter
30 536 are nonseverable and if any of the powers vested with the general assembly
31 pursuant to chapter 536 to revi ew , to delay the effective date, or to disappr ove and annul
32 a rule are subsequently held unconstitutional, then the grant of rulemaking authority
33 and any rule prop osed or adopted after August 28, 2026, shall be invalid and void.
376.681. 1. As used in this section, the terms "pharmacy" and "pharmacy
2 benefits manager" shall have the same meanings given to the terms in section 376.388.
3 2. A pharmacy benefits manager shall not r eimburse a pharmacy for each
4 dispensed drug in an amount less than the actual acquisition cost of the drug. In
5 addition to the reim bursement amount for the drug, the pharmacy benefits manager
6 shall pay the pharmacy a dispensing fee of at least fifteen dollars for each pr escription
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7 drug dispensed to fairly compensate for profes sional services, operational costs, and
8 patient counseling.
376.687. 1. As used in this section, the following terms mean:
2 (1) "Diabetes device", a pr escribed device used to cure , diagnose, mitigate,
3 pr event, or tr eat diabetes or low blood sugar . The term "diabetes device" includes, but
4 is not limited to, a blood glucose monitor , continuous glucose monitor , or insulin pump;
5 (2) "Epinephrine delivery device", a pr escribed, single-use device used for the
6 delivery of a premeas ur ed dose of epinephrine into the human body;
7 (3) "Pres cription insulin drug", a pr escription drug that contains insulin and is
8 used to control blood glucose levels to tr eat diabetes but does not include an insulin drug
9 that is administered to a patient intravenously .
10 2. This section applies to any grou p or individual policy of accident and health
11 insurance amended, deliver ed, issued, or renewed on or after August 28, 2026.
12 3. (1) An insur er that pr ovides coverage for prescription insulin drugs under the
13 terms of a health coverage plan the insurer offers shall limit the total amount that an
14 insur ed is requ ired to pay for a thirty-day supply of cover ed pr escription insulin drugs
15 at an amount not to exceed thirty-five dollars, regard less of the quantity or type of
16 cover ed pr escription insulin drug used to fill the insure d's pr escription.
17 (2) An insur er that pro vides coverage for diabetes devices under the terms of a
18 health coverage plan the insur er offers shall limit the total amount that an insur ed is
19 r equir ed to pay for one cover ed diabetes device at an amount not to exceed one hundr ed
20 dollars, re gardless of the type of covered diabetes device used to fill the insur ed's
21 pr escription.
22 (3) An insur er that provi des coverage for epinephrine delivery devices under the
23 terms of a health coverage plan the insurer offers shall limit the total amount that an
24 insur ed is r equir ed to pay for one covered epinephrine delivery device at an amount not
25 to exceed one hundred dollars, reg ardless of the type of cover ed epinephrine delivery
26 device used to fill the insur ed's prescrip tion.
27 4. On January first of each year , the limit on the amount that an insur ed is
28 r equir ed to pay for one cover ed diabetes device or epinephrine delivery device or for a
29 thirty-day supply of a covered pr escription insulin drug shall incr ease by a per centage
30 equal to the percen tage change fr om the pr eceding year in the medical car e component
31 of the Consumer Price Index for All Urban Consumers for the United States as r eported
32 by the Bureau of Labor Statistics of the United States Department of Labor .
33 5. If, under federal law , application of any requi rem ent under this section would
34 r esult in health savings account ineligibility under Section 223 of the Internal Revenue
35 Code of 1986, as amended, the requi rem ents of this section shall apply to health savings
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36 account-qualified high deductible health plans with respect to any cost-sharing of such a
37 plan after the enr ollee has satisfied the minimum deductible under Section 223, except
38 with res pect to items or services that ar e prev entive care under Section 223(c)(2)(C) of
39 the Internal Revenue Code of 1986, as amended, in which case the r equir ements of this
40 section shall apply regard less of whether the minimum deductible under Section 223 has
41 been satisfied.
42 6. The dir ector of the department of commerc e and insurance may pr omulgate
43 all necessary rules and r egulations for the administration of this section. Any rule or
44 portion of a rule, as that term is defined in section 536.010, that is creat ed under the
45 authority delegated in this section shall become effective only if it complies with and is
46 subject to all of the pr ovisions of chapter 536 and, if applicable, section 536.028. This
47 section and chapter 536 are nonseverable and if any of the powers vested with the
48 general assembly pursuant to chapter 536 to revie w , to delay the effective date, or to
49 disappr ove and annul a rule ar e subsequently held unconstitutional, then the grant of
50 rulemaking authority and any rule pr oposed or adopted after August 28, 2026, shall be
51 invalid and void.
376.689. 1. Befor e November 1, 2026, the department of commer ce and
2 insurance, in conjunction with the department of health and senior services and the
3 department of social services, shall make available to the public a report that details
4 each department's findings for the following:
5 (1) A summary of pricing practices for insulin, diabetes devices, and epinephrine
6 delivery devices and variables that contribute to the pricing of health coverage plans;
7 (2) Public policy recomm endations to contr ol and prev ent overpricing of
8 pr escription insulin drugs, diabetes devices, and epinephrine delivery devices made
9 available to Missouri consumers; and
10 (3) Any other information that the department of commer ce and insurance finds
11 necessary .
12 2. The pr ovisions of this section terminate on January 1, 2027.
✔
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