Illinois 2023-2024 Regular Session

Illinois House Bill HB5462 Compare Versions

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11 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB5462 Introduced , by Rep. Anna Moeller SYNOPSIS AS INTRODUCED: 215 ILCS 5/356z.63225 ILCS 85/3225 ILCS 85/20 from Ch. 111, par. 4140225 ILCS 85/24 from Ch. 111, par. 4144305 ILCS 5/5-5.12 from Ch. 23, par. 5-5.12225 ILCS 85/9.6 rep. Amends the Pharmacy Practice Act. Provides that it is the practice of pharmacy to order and administer vaccines to patients 7 years of age and older for COVID-19 or influenza subcutaneously, intramuscularly, or orally as authorized, approved, or licensed by the United States Food and Drug Administration or in accordance with the United States Centers for Disease Control and Prevention's Recommended Immunization Schedule or the United States Centers for Disease Control and Prevention's Health Information for International Travel (rather than as authorized, approved, or licensed by the United States Food and Drug Administration). Provides that a pharmacist who is exercising his or her professional judgment may change the quantity of medication prescribed if specified conditions are satisfied. Provides that a pharmacist may change the dosage form of a prescription if it is in the best interest of patient care, so long as the prescriber's directions are also modified to equate to an equivalent amount of drug dispensed as prescribed. Provides that a pharmacist may complete missing information on a prescription if there is evidence to support the change. Repeals provisions concerning the administration of vaccines, tests, and therapeutics by registered pharmacy technicians and student pharmacists. Makes other changes. Amends the Illinois Insurance Code and the Medical Assistance Article of the Illinois Public Aid Code. Provides that the ordering and administration of vaccines by a pharmacist as part of the practice of pharmacy shall be covered and reimbursed under the medical assistance program and by other insurers at no less than the rate that the vaccine is reimbursed at when ordered and administered by a licensed physician. LRB103 38877 RTM 69014 b A BILL FOR 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB5462 Introduced , by Rep. Anna Moeller SYNOPSIS AS INTRODUCED: 215 ILCS 5/356z.63225 ILCS 85/3225 ILCS 85/20 from Ch. 111, par. 4140225 ILCS 85/24 from Ch. 111, par. 4144305 ILCS 5/5-5.12 from Ch. 23, par. 5-5.12225 ILCS 85/9.6 rep. 215 ILCS 5/356z.63 225 ILCS 85/3 225 ILCS 85/20 from Ch. 111, par. 4140 225 ILCS 85/24 from Ch. 111, par. 4144 305 ILCS 5/5-5.12 from Ch. 23, par. 5-5.12 225 ILCS 85/9.6 rep. Amends the Pharmacy Practice Act. Provides that it is the practice of pharmacy to order and administer vaccines to patients 7 years of age and older for COVID-19 or influenza subcutaneously, intramuscularly, or orally as authorized, approved, or licensed by the United States Food and Drug Administration or in accordance with the United States Centers for Disease Control and Prevention's Recommended Immunization Schedule or the United States Centers for Disease Control and Prevention's Health Information for International Travel (rather than as authorized, approved, or licensed by the United States Food and Drug Administration). Provides that a pharmacist who is exercising his or her professional judgment may change the quantity of medication prescribed if specified conditions are satisfied. Provides that a pharmacist may change the dosage form of a prescription if it is in the best interest of patient care, so long as the prescriber's directions are also modified to equate to an equivalent amount of drug dispensed as prescribed. Provides that a pharmacist may complete missing information on a prescription if there is evidence to support the change. Repeals provisions concerning the administration of vaccines, tests, and therapeutics by registered pharmacy technicians and student pharmacists. Makes other changes. Amends the Illinois Insurance Code and the Medical Assistance Article of the Illinois Public Aid Code. Provides that the ordering and administration of vaccines by a pharmacist as part of the practice of pharmacy shall be covered and reimbursed under the medical assistance program and by other insurers at no less than the rate that the vaccine is reimbursed at when ordered and administered by a licensed physician. LRB103 38877 RTM 69014 b LRB103 38877 RTM 69014 b A BILL FOR
22 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB5462 Introduced , by Rep. Anna Moeller SYNOPSIS AS INTRODUCED:
33 215 ILCS 5/356z.63225 ILCS 85/3225 ILCS 85/20 from Ch. 111, par. 4140225 ILCS 85/24 from Ch. 111, par. 4144305 ILCS 5/5-5.12 from Ch. 23, par. 5-5.12225 ILCS 85/9.6 rep. 215 ILCS 5/356z.63 225 ILCS 85/3 225 ILCS 85/20 from Ch. 111, par. 4140 225 ILCS 85/24 from Ch. 111, par. 4144 305 ILCS 5/5-5.12 from Ch. 23, par. 5-5.12 225 ILCS 85/9.6 rep.
44 215 ILCS 5/356z.63
55 225 ILCS 85/3
66 225 ILCS 85/20 from Ch. 111, par. 4140
77 225 ILCS 85/24 from Ch. 111, par. 4144
88 305 ILCS 5/5-5.12 from Ch. 23, par. 5-5.12
99 225 ILCS 85/9.6 rep.
1010 Amends the Pharmacy Practice Act. Provides that it is the practice of pharmacy to order and administer vaccines to patients 7 years of age and older for COVID-19 or influenza subcutaneously, intramuscularly, or orally as authorized, approved, or licensed by the United States Food and Drug Administration or in accordance with the United States Centers for Disease Control and Prevention's Recommended Immunization Schedule or the United States Centers for Disease Control and Prevention's Health Information for International Travel (rather than as authorized, approved, or licensed by the United States Food and Drug Administration). Provides that a pharmacist who is exercising his or her professional judgment may change the quantity of medication prescribed if specified conditions are satisfied. Provides that a pharmacist may change the dosage form of a prescription if it is in the best interest of patient care, so long as the prescriber's directions are also modified to equate to an equivalent amount of drug dispensed as prescribed. Provides that a pharmacist may complete missing information on a prescription if there is evidence to support the change. Repeals provisions concerning the administration of vaccines, tests, and therapeutics by registered pharmacy technicians and student pharmacists. Makes other changes. Amends the Illinois Insurance Code and the Medical Assistance Article of the Illinois Public Aid Code. Provides that the ordering and administration of vaccines by a pharmacist as part of the practice of pharmacy shall be covered and reimbursed under the medical assistance program and by other insurers at no less than the rate that the vaccine is reimbursed at when ordered and administered by a licensed physician.
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1616 1 AN ACT concerning regulation.
1717 2 Be it enacted by the People of the State of Illinois,
1818 3 represented in the General Assembly:
1919 4 Section 5. The Illinois Insurance Code is amended by
2020 5 changing Section 356z.63 as follows:
2121 6 (215 ILCS 5/356z.63)
2222 7 Sec. 356z.63 356z.61. Coverage of pharmacy testing,
2323 8 screening, vaccinations, and treatment.
2424 9 (a) A group or individual policy of accident and health
2525 10 insurance or a managed care plan that is amended, delivered,
2626 11 issued, or renewed on or after January 1, 2025 shall provide
2727 12 coverage for health care or patient care services provided by
2828 13 a pharmacist if:
2929 14 (1) the pharmacist meets the requirements and scope of
3030 15 practice described in paragraph (15), (16), or (17) of
3131 16 subsection (d) of Section 3 of the Pharmacy Practice Act;
3232 17 (2) the health plan provides coverage for the same
3333 18 service provided by a licensed physician, an advanced
3434 19 practice registered nurse, or a physician assistant;
3535 20 (3) the pharmacist is included in the health benefit
3636 21 plan's network of participating providers; and
3737 22 (4) reimbursement has been successfully negotiated in
3838 23 good faith between the pharmacist and the health plan.
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4242 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB5462 Introduced , by Rep. Anna Moeller SYNOPSIS AS INTRODUCED:
4343 215 ILCS 5/356z.63225 ILCS 85/3225 ILCS 85/20 from Ch. 111, par. 4140225 ILCS 85/24 from Ch. 111, par. 4144305 ILCS 5/5-5.12 from Ch. 23, par. 5-5.12225 ILCS 85/9.6 rep. 215 ILCS 5/356z.63 225 ILCS 85/3 225 ILCS 85/20 from Ch. 111, par. 4140 225 ILCS 85/24 from Ch. 111, par. 4144 305 ILCS 5/5-5.12 from Ch. 23, par. 5-5.12 225 ILCS 85/9.6 rep.
4444 215 ILCS 5/356z.63
4545 225 ILCS 85/3
4646 225 ILCS 85/20 from Ch. 111, par. 4140
4747 225 ILCS 85/24 from Ch. 111, par. 4144
4848 305 ILCS 5/5-5.12 from Ch. 23, par. 5-5.12
4949 225 ILCS 85/9.6 rep.
5050 Amends the Pharmacy Practice Act. Provides that it is the practice of pharmacy to order and administer vaccines to patients 7 years of age and older for COVID-19 or influenza subcutaneously, intramuscularly, or orally as authorized, approved, or licensed by the United States Food and Drug Administration or in accordance with the United States Centers for Disease Control and Prevention's Recommended Immunization Schedule or the United States Centers for Disease Control and Prevention's Health Information for International Travel (rather than as authorized, approved, or licensed by the United States Food and Drug Administration). Provides that a pharmacist who is exercising his or her professional judgment may change the quantity of medication prescribed if specified conditions are satisfied. Provides that a pharmacist may change the dosage form of a prescription if it is in the best interest of patient care, so long as the prescriber's directions are also modified to equate to an equivalent amount of drug dispensed as prescribed. Provides that a pharmacist may complete missing information on a prescription if there is evidence to support the change. Repeals provisions concerning the administration of vaccines, tests, and therapeutics by registered pharmacy technicians and student pharmacists. Makes other changes. Amends the Illinois Insurance Code and the Medical Assistance Article of the Illinois Public Aid Code. Provides that the ordering and administration of vaccines by a pharmacist as part of the practice of pharmacy shall be covered and reimbursed under the medical assistance program and by other insurers at no less than the rate that the vaccine is reimbursed at when ordered and administered by a licensed physician.
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5959 215 ILCS 5/356z.63
6060 225 ILCS 85/3
6161 225 ILCS 85/20 from Ch. 111, par. 4140
6262 225 ILCS 85/24 from Ch. 111, par. 4144
6363 305 ILCS 5/5-5.12 from Ch. 23, par. 5-5.12
6464 225 ILCS 85/9.6 rep.
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8383 1 (b) Vaccines ordered and administered by a pharmacist as
8484 2 described in subsection (d) of Section 3 of the Pharmacy
8585 3 Practice Act shall be covered and reimbursed at no less than
8686 4 the rate that the vaccine is reimbursed at when ordered and
8787 5 administered by a physician licensed to practice medicine in
8888 6 all its branches.
8989 7 (Source: P.A. 103-1, eff. 4-27-23; revised 8-29-23.)
9090 8 Section 10. The Pharmacy Practice Act is amended by
9191 9 changing Sections 3, 20, and 24 as follows:
9292 10 (225 ILCS 85/3)
9393 11 (Section scheduled to be repealed on January 1, 2028)
9494 12 Sec. 3. Definitions. For the purpose of this Act, except
9595 13 where otherwise limited therein:
9696 14 (a) "Pharmacy" or "drugstore" means and includes every
9797 15 store, shop, pharmacy department, or other place where
9898 16 pharmacist care is provided by a pharmacist (1) where drugs,
9999 17 medicines, or poisons are dispensed, sold or offered for sale
100100 18 at retail, or displayed for sale at retail; or (2) where
101101 19 prescriptions of physicians, dentists, advanced practice
102102 20 registered nurses, physician assistants, veterinarians,
103103 21 podiatric physicians, or optometrists, within the limits of
104104 22 their licenses, are compounded, filled, or dispensed; or (3)
105105 23 which has upon it or displayed within it, or affixed to or used
106106 24 in connection with it, a sign bearing the word or words
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117117 1 "Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical Care",
118118 2 "Apothecary", "Drugstore", "Medicine Store", "Prescriptions",
119119 3 "Drugs", "Dispensary", "Medicines", or any word or words of
120120 4 similar or like import, either in the English language or any
121121 5 other language; or (4) where the characteristic prescription
122122 6 sign (Rx) or similar design is exhibited; or (5) any store, or
123123 7 shop, or other place with respect to which any of the above
124124 8 words, objects, signs or designs are used in any
125125 9 advertisement.
126126 10 (b) "Drugs" means and includes (1) articles recognized in
127127 11 the official United States Pharmacopoeia/National Formulary
128128 12 (USP/NF), or any supplement thereto and being intended for and
129129 13 having for their main use the diagnosis, cure, mitigation,
130130 14 treatment or prevention of disease in man or other animals, as
131131 15 approved by the United States Food and Drug Administration,
132132 16 but does not include devices or their components, parts, or
133133 17 accessories; and (2) all other articles intended for and
134134 18 having for their main use the diagnosis, cure, mitigation,
135135 19 treatment or prevention of disease in man or other animals, as
136136 20 approved by the United States Food and Drug Administration,
137137 21 but does not include devices or their components, parts, or
138138 22 accessories; and (3) articles (other than food) having for
139139 23 their main use and intended to affect the structure or any
140140 24 function of the body of man or other animals; and (4) articles
141141 25 having for their main use and intended for use as a component
142142 26 or any articles specified in clause (1), (2) or (3); but does
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153153 1 not include devices or their components, parts or accessories.
154154 2 (c) "Medicines" means and includes all drugs intended for
155155 3 human or veterinary use approved by the United States Food and
156156 4 Drug Administration.
157157 5 (d) "Practice of pharmacy" means:
158158 6 (1) the interpretation and the provision of assistance
159159 7 in the monitoring, evaluation, and implementation of
160160 8 prescription drug orders;
161161 9 (2) the dispensing of prescription drug orders;
162162 10 (3) participation in drug and device selection;
163163 11 (4) drug administration limited to the administration
164164 12 of oral, topical, injectable, and inhalation as follows:
165165 13 (A) in the context of patient education on the
166166 14 proper use or delivery of medications;
167167 15 (B) vaccination of patients 7 years of age and
168168 16 older pursuant to a valid prescription or standing
169169 17 order, by a physician licensed to practice medicine in
170170 18 all its branches, except for vaccinations covered by
171171 19 paragraph (15), upon completion of appropriate
172172 20 training, including how to address contraindications
173173 21 and adverse reactions set forth by rule, with
174174 22 notification to the patient's physician and
175175 23 appropriate record retention, or pursuant to hospital
176176 24 pharmacy and therapeutics committee policies and
177177 25 procedures. Eligible vaccines are those listed on the
178178 26 U.S. Centers for Disease Control and Prevention (CDC)
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189189 1 Recommended Immunization Schedule, the CDC's Health
190190 2 Information for International Travel, or the U.S. Food
191191 3 and Drug Administration's Vaccines Licensed and
192192 4 Authorized for Use in the United States. As applicable
193193 5 to the State's Medicaid program and other payers,
194194 6 vaccines ordered and administered in accordance with
195195 7 this subsection shall be covered and reimbursed at no
196196 8 less than the rate that the vaccine is reimbursed when
197197 9 ordered and administered by a physician;
198198 10 (B-5) following the initial administration of
199199 11 long-acting or extended-release form opioid
200200 12 antagonists by a physician licensed to practice
201201 13 medicine in all its branches, administration of
202202 14 injections of long-acting or extended-release form
203203 15 opioid antagonists for the treatment of substance use
204204 16 disorder, pursuant to a valid prescription by a
205205 17 physician licensed to practice medicine in all its
206206 18 branches, upon completion of appropriate training,
207207 19 including how to address contraindications and adverse
208208 20 reactions, including, but not limited to, respiratory
209209 21 depression and the performance of cardiopulmonary
210210 22 resuscitation, set forth by rule, with notification to
211211 23 the patient's physician and appropriate record
212212 24 retention, or pursuant to hospital pharmacy and
213213 25 therapeutics committee policies and procedures;
214214 26 (C) administration of injections of
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225225 1 alpha-hydroxyprogesterone caproate, pursuant to a
226226 2 valid prescription, by a physician licensed to
227227 3 practice medicine in all its branches, upon completion
228228 4 of appropriate training, including how to address
229229 5 contraindications and adverse reactions set forth by
230230 6 rule, with notification to the patient's physician and
231231 7 appropriate record retention, or pursuant to hospital
232232 8 pharmacy and therapeutics committee policies and
233233 9 procedures; and
234234 10 (D) administration of injections of long-term
235235 11 antipsychotic medications pursuant to a valid
236236 12 prescription by a physician licensed to practice
237237 13 medicine in all its branches, upon completion of
238238 14 appropriate training conducted by an Accreditation
239239 15 Council of Pharmaceutical Education accredited
240240 16 provider, including how to address contraindications
241241 17 and adverse reactions set forth by rule, with
242242 18 notification to the patient's physician and
243243 19 appropriate record retention, or pursuant to hospital
244244 20 pharmacy and therapeutics committee policies and
245245 21 procedures.
246246 22 (5) (blank);
247247 23 (6) drug regimen review;
248248 24 (7) drug or drug-related research;
249249 25 (8) the provision of patient counseling;
250250 26 (9) the practice of telepharmacy;
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261261 1 (10) the provision of those acts or services necessary
262262 2 to provide pharmacist care;
263263 3 (11) medication therapy management;
264264 4 (12) the responsibility for compounding and labeling
265265 5 of drugs and devices (except labeling by a manufacturer,
266266 6 repackager, or distributor of non-prescription drugs and
267267 7 commercially packaged legend drugs and devices), proper
268268 8 and safe storage of drugs and devices, and maintenance of
269269 9 required records;
270270 10 (13) the assessment and consultation of patients and
271271 11 dispensing of hormonal contraceptives;
272272 12 (14) the initiation, dispensing, or administration of
273273 13 drugs, laboratory tests, assessments, referrals, and
274274 14 consultations for human immunodeficiency virus
275275 15 pre-exposure prophylaxis and human immunodeficiency virus
276276 16 post-exposure prophylaxis under Section 43.5;
277277 17 (15) the ordering and administration of vaccines to
278278 18 vaccination of patients 7 years of age and older for
279279 19 COVID-19 or influenza subcutaneously, intramuscularly, or
280280 20 orally as authorized, approved, or licensed by the United
281281 21 States Food and Drug Administration or in accordance with
282282 22 the United States Centers for Disease Control and
283283 23 Prevention's Recommended Immunization Schedule or the
284284 24 United States Centers for Disease Control and Prevention's
285285 25 Health Information for International Travel. , pursuant to
286286 26 the following conditions:
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297297 1 (A) the vaccine must be authorized or licensed by
298298 2 the United States Food and Drug Administration;
299299 3 (B) the vaccine must be ordered and administered
300300 4 according to the Advisory Committee on Immunization
301301 5 Practices standard immunization schedule;
302302 6 (C) the pharmacist must complete a course of
303303 7 training accredited by the Accreditation Council on
304304 8 Pharmacy Education or a similar health authority or
305305 9 professional body approved by the Division of
306306 10 Professional Regulation;
307307 11 (D) the pharmacist must have a current certificate
308308 12 in basic cardiopulmonary resuscitation;
309309 13 (E) the pharmacist must complete, during each
310310 14 State licensing period, a minimum of 2 hours of
311311 15 immunization-related continuing pharmacy education
312312 16 approved by the Accreditation Council on Pharmacy
313313 17 Education;
314314 18 (F) the pharmacist must comply with recordkeeping
315315 19 and reporting requirements of the jurisdiction in
316316 20 which the pharmacist administers vaccines, including
317317 21 informing the patient's primary-care provider, when
318318 22 available, and complying with requirements whereby the
319319 23 person administering a vaccine must review the vaccine
320320 24 registry or other vaccination records prior to
321321 25 administering the vaccine; and
322322 26 (G) the pharmacist must inform the pharmacist's
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333333 1 patients who are less than 18 years old, as well as the
334334 2 adult caregiver accompanying the child, of the
335335 3 importance of a well-child visit with a pediatrician
336336 4 or other licensed primary-care provider and must refer
337337 5 patients as appropriate;
338338 6 (16) the ordering and administration of COVID-19
339339 7 therapeutics subcutaneously, intramuscularly, or orally
340340 8 with notification to the patient's physician and
341341 9 appropriate record retention or pursuant to hospital
342342 10 pharmacy and therapeutics committee policies and
343343 11 procedures for: (i) COVID-19 (SARS-CoV 2) or other
344344 12 respiratory illnesses, conditions, or diseases; (ii)
345345 13 influenza; (iii) group A Streptococcus Pharyngitis; (iv)
346346 14 lice; (v) skin conditions, including ringworm and
347347 15 athlete's foot; (vi) respiratory syncytial virus or RSV;
348348 16 and (vii) other health conditions identified by a
349349 17 statewide public health emergency, as defined in the
350350 18 Illinois Emergency Management Agency Act. Eligible
351351 19 therapeutics are those approved, authorized, or licensed
352352 20 by the United States Food and Drug Administration and must
353353 21 be administered subcutaneously, intramuscularly, or orally
354354 22 in accordance with that approval, authorization, or
355355 23 licensing; and
356356 24 (17) the ordering and administration of tests and
357357 25 screenings for (i) influenza, (ii) SARS-CoV 2 SARS-COV 2,
358358 26 and (iii) group A Streptococcus Pharyngitis, (iv) lice,
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369369 1 (v) skin conditions, including ringworm and athlete's
370370 2 foot, (vi) RSV, and (vii) other health conditions
371371 3 identified by a statewide public health emergency, as
372372 4 defined in the Illinois Emergency Management Agency Act,
373373 5 with notification to the patient's physician and
374374 6 appropriate record retention or pursuant to hospital
375375 7 pharmacy and therapeutics committee policies and
376376 8 procedures. Eligible tests and screenings are those
377377 9 approved, authorized, or licensed by the United States
378378 10 Food and Drug Administration and must be administered in
379379 11 accordance with that approval, authorization, or
380380 12 licensing.
381381 13 A pharmacist who orders or administers tests or
382382 14 screenings for health conditions described in this
383383 15 paragraph may use a test that may guide clinical
384384 16 decision-making for the health condition that is waived
385385 17 under the federal Clinical Laboratory Improvement
386386 18 Amendments of 1988 and regulations promulgated thereunder
387387 19 or any established screening procedure that is established
388388 20 under a statewide protocol.
389389 21 A pharmacist may delegate the administrative and
390390 22 technical tasks of performing a test for the health
391391 23 conditions described in this paragraph to a registered
392392 24 pharmacy technician or student pharmacist acting under the
393393 25 supervision of the pharmacist.
394394 26 A pharmacist who performs any of the acts defined as the
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405405 1 practice of pharmacy in this State must be actively licensed
406406 2 as a pharmacist under this Act.
407407 3 (e) "Prescription" means and includes any written, oral,
408408 4 facsimile, or electronically transmitted order for drugs or
409409 5 medical devices, issued by a physician licensed to practice
410410 6 medicine in all its branches, dentist, veterinarian, podiatric
411411 7 physician, or optometrist, within the limits of his or her
412412 8 license, by a physician assistant in accordance with
413413 9 subsection (f) of Section 4, or by an advanced practice
414414 10 registered nurse in accordance with subsection (g) of Section
415415 11 4, containing the following: (1) name of the patient; (2) date
416416 12 when prescription was issued; (3) name and strength of drug or
417417 13 description of the medical device prescribed; and (4)
418418 14 quantity; (5) directions for use; (6) prescriber's name,
419419 15 address, and signature; and (7) DEA registration number where
420420 16 required, for controlled substances. The prescription may, but
421421 17 is not required to, list the illness, disease, or condition
422422 18 for which the drug or device is being prescribed. DEA
423423 19 registration numbers shall not be required on inpatient drug
424424 20 orders. A prescription for medication other than controlled
425425 21 substances shall be valid for up to 15 months from the date
426426 22 issued for the purpose of refills, unless the prescription
427427 23 states otherwise.
428428 24 (f) "Person" means and includes a natural person,
429429 25 partnership, association, corporation, government entity, or
430430 26 any other legal entity.
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441441 1 (g) "Department" means the Department of Financial and
442442 2 Professional Regulation.
443443 3 (h) "Board of Pharmacy" or "Board" means the State Board
444444 4 of Pharmacy of the Department of Financial and Professional
445445 5 Regulation.
446446 6 (i) "Secretary" means the Secretary of Financial and
447447 7 Professional Regulation.
448448 8 (j) "Drug product selection" means the interchange for a
449449 9 prescribed pharmaceutical product in accordance with Section
450450 10 25 of this Act and Section 3.14 of the Illinois Food, Drug and
451451 11 Cosmetic Act.
452452 12 (k) "Inpatient drug order" means an order issued by an
453453 13 authorized prescriber for a resident or patient of a facility
454454 14 licensed under the Nursing Home Care Act, the ID/DD Community
455455 15 Care Act, the MC/DD Act, the Specialized Mental Health
456456 16 Rehabilitation Act of 2013, the Hospital Licensing Act, or the
457457 17 University of Illinois Hospital Act, or a facility which is
458458 18 operated by the Department of Human Services (as successor to
459459 19 the Department of Mental Health and Developmental
460460 20 Disabilities) or the Department of Corrections.
461461 21 (k-5) "Pharmacist" means an individual health care
462462 22 professional and provider currently licensed by this State to
463463 23 engage in the practice of pharmacy.
464464 24 (l) "Pharmacist in charge" means the licensed pharmacist
465465 25 whose name appears on a pharmacy license and who is
466466 26 responsible for all aspects of the operation related to the
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477477 1 practice of pharmacy.
478478 2 (m) "Dispense" or "dispensing" means the interpretation,
479479 3 evaluation, and implementation of a prescription drug order,
480480 4 including the preparation and delivery of a drug or device to a
481481 5 patient or patient's agent in a suitable container
482482 6 appropriately labeled for subsequent administration to or use
483483 7 by a patient in accordance with applicable State and federal
484484 8 laws and regulations. "Dispense" or "dispensing" does not mean
485485 9 the physical delivery to a patient or a patient's
486486 10 representative in a home or institution by a designee of a
487487 11 pharmacist or by common carrier. "Dispense" or "dispensing"
488488 12 also does not mean the physical delivery of a drug or medical
489489 13 device to a patient or patient's representative by a
490490 14 pharmacist's designee within a pharmacy or drugstore while the
491491 15 pharmacist is on duty and the pharmacy is open.
492492 16 (n) "Nonresident pharmacy" means a pharmacy that is
493493 17 located in a state, commonwealth, or territory of the United
494494 18 States, other than Illinois, that delivers, dispenses, or
495495 19 distributes, through the United States Postal Service,
496496 20 commercially acceptable parcel delivery service, or other
497497 21 common carrier, to Illinois residents, any substance which
498498 22 requires a prescription.
499499 23 (o) "Compounding" means the preparation and mixing of
500500 24 components, excluding flavorings, (1) as the result of a
501501 25 prescriber's prescription drug order or initiative based on
502502 26 the prescriber-patient-pharmacist relationship in the course
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513513 1 of professional practice or (2) for the purpose of, or
514514 2 incident to, research, teaching, or chemical analysis and not
515515 3 for sale or dispensing. "Compounding" includes the preparation
516516 4 of drugs or devices in anticipation of receiving prescription
517517 5 drug orders based on routine, regularly observed dispensing
518518 6 patterns. Commercially available products may be compounded
519519 7 for dispensing to individual patients only if all of the
520520 8 following conditions are met: (i) the commercial product is
521521 9 not reasonably available from normal distribution channels in
522522 10 a timely manner to meet the patient's needs and (ii) the
523523 11 prescribing practitioner has requested that the drug be
524524 12 compounded.
525525 13 (p) (Blank).
526526 14 (q) (Blank).
527527 15 (r) "Patient counseling" means the communication between a
528528 16 pharmacist or a student pharmacist under the supervision of a
529529 17 pharmacist and a patient or the patient's representative about
530530 18 the patient's medication or device for the purpose of
531531 19 optimizing proper use of prescription medications or devices.
532532 20 "Patient counseling" may include without limitation (1)
533533 21 obtaining a medication history; (2) acquiring a patient's
534534 22 allergies and health conditions; (3) facilitation of the
535535 23 patient's understanding of the intended use of the medication;
536536 24 (4) proper directions for use; (5) significant potential
537537 25 adverse events; (6) potential food-drug interactions; and (7)
538538 26 the need to be compliant with the medication therapy. A
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549549 1 pharmacy technician may only participate in the following
550550 2 aspects of patient counseling under the supervision of a
551551 3 pharmacist: (1) obtaining medication history; (2) providing
552552 4 the offer for counseling by a pharmacist or student
553553 5 pharmacist; and (3) acquiring a patient's allergies and health
554554 6 conditions.
555555 7 (s) "Patient profiles" or "patient drug therapy record"
556556 8 means the obtaining, recording, and maintenance of patient
557557 9 prescription information, including prescriptions for
558558 10 controlled substances, and personal information.
559559 11 (t) (Blank).
560560 12 (u) "Medical device" or "device" means an instrument,
561561 13 apparatus, implement, machine, contrivance, implant, in vitro
562562 14 reagent, or other similar or related article, including any
563563 15 component part or accessory, required under federal law to
564564 16 bear the label "Caution: Federal law requires dispensing by or
565565 17 on the order of a physician". A seller of goods and services
566566 18 who, only for the purpose of retail sales, compounds, sells,
567567 19 rents, or leases medical devices shall not, by reasons
568568 20 thereof, be required to be a licensed pharmacy.
569569 21 (v) "Unique identifier" means an electronic signature,
570570 22 handwritten signature or initials, thumb print, or other
571571 23 acceptable biometric or electronic identification process as
572572 24 approved by the Department.
573573 25 (w) "Current usual and customary retail price" means the
574574 26 price that a pharmacy charges to a non-third-party payor.
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585585 1 (x) "Automated pharmacy system" means a mechanical system
586586 2 located within the confines of the pharmacy or remote location
587587 3 that performs operations or activities, other than compounding
588588 4 or administration, relative to storage, packaging, dispensing,
589589 5 or distribution of medication, and which collects, controls,
590590 6 and maintains all transaction information.
591591 7 (y) "Drug regimen review" means and includes the
592592 8 evaluation of prescription drug orders and patient records for
593593 9 (1) known allergies; (2) drug or potential therapy
594594 10 contraindications; (3) reasonable dose, duration of use, and
595595 11 route of administration, taking into consideration factors
596596 12 such as age, gender, and contraindications; (4) reasonable
597597 13 directions for use; (5) potential or actual adverse drug
598598 14 reactions; (6) drug-drug interactions; (7) drug-food
599599 15 interactions; (8) drug-disease contraindications; (9)
600600 16 therapeutic duplication; (10) patient laboratory values when
601601 17 authorized and available; (11) proper utilization (including
602602 18 over or under utilization) and optimum therapeutic outcomes;
603603 19 and (12) abuse and misuse.
604604 20 (z) "Electronically transmitted prescription" means a
605605 21 prescription that is created, recorded, or stored by
606606 22 electronic means; issued and validated with an electronic
607607 23 signature; and transmitted by electronic means directly from
608608 24 the prescriber to a pharmacy. An electronic prescription is
609609 25 not an image of a physical prescription that is transferred by
610610 26 electronic means from computer to computer, facsimile to
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621621 1 facsimile, or facsimile to computer.
622622 2 (aa) "Medication therapy management services" means a
623623 3 distinct service or group of services offered by licensed
624624 4 pharmacists, physicians licensed to practice medicine in all
625625 5 its branches, advanced practice registered nurses authorized
626626 6 in a written agreement with a physician licensed to practice
627627 7 medicine in all its branches, or physician assistants
628628 8 authorized in guidelines by a supervising physician that
629629 9 optimize therapeutic outcomes for individual patients through
630630 10 improved medication use. In a retail or other non-hospital
631631 11 pharmacy, medication therapy management services shall consist
632632 12 of the evaluation of prescription drug orders and patient
633633 13 medication records to resolve conflicts with the following:
634634 14 (1) known allergies;
635635 15 (2) drug or potential therapy contraindications;
636636 16 (3) reasonable dose, duration of use, and route of
637637 17 administration, taking into consideration factors such as
638638 18 age, gender, and contraindications;
639639 19 (4) reasonable directions for use;
640640 20 (5) potential or actual adverse drug reactions;
641641 21 (6) drug-drug interactions;
642642 22 (7) drug-food interactions;
643643 23 (8) drug-disease contraindications;
644644 24 (9) identification of therapeutic duplication;
645645 25 (10) patient laboratory values when authorized and
646646 26 available;
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657657 1 (11) proper utilization (including over or under
658658 2 utilization) and optimum therapeutic outcomes; and
659659 3 (12) drug abuse and misuse.
660660 4 "Medication therapy management services" includes the
661661 5 following:
662662 6 (1) documenting the services delivered and
663663 7 communicating the information provided to patients'
664664 8 prescribers within an appropriate time frame, not to
665665 9 exceed 48 hours;
666666 10 (2) providing patient counseling designed to enhance a
667667 11 patient's understanding and the appropriate use of his or
668668 12 her medications; and
669669 13 (3) providing information, support services, and
670670 14 resources designed to enhance a patient's adherence with
671671 15 his or her prescribed therapeutic regimens.
672672 16 "Medication therapy management services" may also include
673673 17 patient care functions authorized by a physician licensed to
674674 18 practice medicine in all its branches for his or her
675675 19 identified patient or groups of patients under specified
676676 20 conditions or limitations in a standing order from the
677677 21 physician.
678678 22 "Medication therapy management services" in a licensed
679679 23 hospital may also include the following:
680680 24 (1) reviewing assessments of the patient's health
681681 25 status; and
682682 26 (2) following protocols of a hospital pharmacy and
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693693 1 therapeutics committee with respect to the fulfillment of
694694 2 medication orders.
695695 3 (bb) "Pharmacist care" means the provision by a pharmacist
696696 4 of medication therapy management services, with or without the
697697 5 dispensing of drugs or devices, intended to achieve outcomes
698698 6 that improve patient health, quality of life, and comfort and
699699 7 enhance patient safety.
700700 8 (cc) "Protected health information" means individually
701701 9 identifiable health information that, except as otherwise
702702 10 provided, is:
703703 11 (1) transmitted by electronic media;
704704 12 (2) maintained in any medium set forth in the
705705 13 definition of "electronic media" in the federal Health
706706 14 Insurance Portability and Accountability Act; or
707707 15 (3) transmitted or maintained in any other form or
708708 16 medium.
709709 17 "Protected health information" does not include
710710 18 individually identifiable health information found in:
711711 19 (1) education records covered by the federal Family
712712 20 Educational Right and Privacy Act; or
713713 21 (2) employment records held by a licensee in its role
714714 22 as an employer.
715715 23 (dd) "Standing order" means a specific order for a patient
716716 24 or group of patients issued by a physician licensed to
717717 25 practice medicine in all its branches in Illinois.
718718 26 (ee) "Address of record" means the designated address
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729729 1 recorded by the Department in the applicant's application file
730730 2 or licensee's license file maintained by the Department's
731731 3 licensure maintenance unit.
732732 4 (ff) "Home pharmacy" means the location of a pharmacy's
733733 5 primary operations.
734734 6 (gg) "Email address of record" means the designated email
735735 7 address recorded by the Department in the applicant's
736736 8 application file or the licensee's license file, as maintained
737737 9 by the Department's licensure maintenance unit.
738738 10 (Source: P.A. 102-16, eff. 6-17-21; 102-103, eff. 1-1-22;
739739 11 102-558, eff. 8-20-21; 102-813, eff. 5-13-22; 102-1051, eff.
740740 12 1-1-23; 103-1, eff. 4-27-23.)
741741 13 (225 ILCS 85/20) (from Ch. 111, par. 4140)
742742 14 (Section scheduled to be repealed on January 1, 2028)
743743 15 Sec. 20. Dispensing systems.
744744 16 (a) Two or more pharmacies may establish and use a common
745745 17 electronic file to maintain required dispensing information.
746746 18 (b) Pharmacies using such a common electronic file are not
747747 19 required to physically transfer prescriptions or information
748748 20 for dispensing purposes between or among pharmacies
749749 21 participating in the same common prescription file; provided,
750750 22 however any such common file must contain complete and
751751 23 adequate records of such prescription and refill dispensed as
752752 24 stated in Section 18.
753753 25 (c) The Department may formulate such rules, not
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764764 1 inconsistent with law, as may be necessary to carry out the
765765 2 purposes of and to enforce the provisions of this Section
766766 3 within the following exception: The Department shall not
767767 4 impose greater requirements on either common electronic files
768768 5 or a hard copy record system.
769769 6 (d) Drugs shall in no event be dispensed more frequently
770770 7 or in larger amounts than the prescriber ordered without
771771 8 direct prescriber authorization by way of a new prescription
772772 9 order.
773773 10 (e) The dispensing by a pharmacist licensed in this State
774774 11 or another state of a prescription contained in a common
775775 12 database shall not constitute a transfer, provided that (1)
776776 13 all pharmacies involved in the transactions pursuant to which
777777 14 the prescription is dispensed and all pharmacists engaging in
778778 15 dispensing functions are properly licensed, permitted, or
779779 16 registered in this State or another jurisdiction, (2) a policy
780780 17 and procedures manual that governs all participating
781781 18 pharmacies and pharmacists is available to the Department upon
782782 19 request and includes the procedure for maintaining appropriate
783783 20 records for regulatory oversight for tracking a prescription
784784 21 during each stage of the filling and dispensing process, and
785785 22 (3) the pharmacists involved in filling and dispensing the
786786 23 prescription and counseling the patient are identified. A
787787 24 pharmacist shall be accountable only for the specific tasks
788788 25 performed.
789789 26 (f) Nothing in this Section shall prohibit a pharmacist
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800800 1 who is exercising his or her professional judgment from
801801 2 dispensing additional quantities of medication up to the total
802802 3 number of dosage units authorized by the prescriber on the
803803 4 original prescription and any refills.
804804 5 (g) A pharmacist who is exercising his or her professional
805805 6 judgment may change the quantity of medication prescribed if:
806806 7 (1) the prescribed quantity or package size is not
807807 8 commercially available;
808808 9 (2) the change in quantity is related to a change in
809809 10 dosage form, strength, or therapeutic interchange;
810810 11 (3) the change extends a maintenance drug for the
811811 12 limited quantity necessary to coordinate a patient's
812812 13 refills in a medication synchronization program; and
813813 14 (4) the change to add missing non-pharmaceutical
814814 15 devices or durable medical equipment that aid in the
815815 16 appropriate clinical usage of a medication or achieving a
816816 17 positive therapeutic outcome.
817817 18 A pharmacist may change the dosage form of a prescription
818818 19 if it is in the best interest of patient care, so long as the
819819 20 prescriber's directions are also modified to equate to an
820820 21 equivalent amount of drug dispensed as prescribed.
821821 22 A pharmacist may complete missing information on a
822822 23 prescription if evidence supports the change.
823823 24 The change must be documented in the patient's record.
824824 25 (Source: P.A. 100-497, eff. 9-8-17.)
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835835 1 (225 ILCS 85/24) (from Ch. 111, par. 4144)
836836 2 (Section scheduled to be repealed on January 1, 2028)
837837 3 Sec. 24. It shall be unlawful for any manufacturer or
838838 4 distributor of a prescription drug, or any person on behalf of
839839 5 such manufacturer or distributor, to distribute a prescription
840840 6 drug without charge or for less than its fair market value to
841841 7 any person directly or indirectly.
842842 8 Nothing in this Section shall be construed to prohibit the
843843 9 distribution of a prescription drug:
844844 10 (a) at a discount in accordance with the laws of the
845845 11 United States or the State of Illinois;
846846 12 (b) to a person for use in an investigation conducted
847847 13 under Federal Food and Drug Administration regulations;
848848 14 (c) to a patient by a pharmacist in response to a
849849 15 request written and signed by a medical practitioner which
850850 16 designates the quantity to be distributed;
851851 17 (d) to a licensed medical practitioner in response to
852852 18 a request signed by the practitioner which designates the
853853 19 quantity to be distributed;
854854 20 (e) to an agency of the federal government or to a
855855 21 state government or political subdivision for regulatory
856856 22 or enforcement purposes;
857857 23 (f) in an emergency as determined by the laws of the
858858 24 United States or the State of Illinois; or
859859 25 (g) to a bona fide charity authorized to possess and
860860 26 dispense prescription drugs.
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871871 1 It shall be unlawful to require a pharmacist or pharmacy
872872 2 to dispense a prescription drug below fair market value,
873873 3 including the cost of dispensing. Any payor that reimburses a
874874 4 pharmacy below fair market value, including the cost of
875875 5 dispensing, shall not be able to include this pharmacy towards
876876 6 any network adequacy requirements and shall not be in
877877 7 compliance with any willing provider provisions.
878878 8 (Source: P.A. 85-796.)
879879 9 Section 15. The Illinois Public Aid Code is amended by
880880 10 changing Section 5-5.12 as follows:
881881 11 (305 ILCS 5/5-5.12) (from Ch. 23, par. 5-5.12)
882882 12 Sec. 5-5.12. Pharmacy payments.
883883 13 (a) Every request submitted by a pharmacy for
884884 14 reimbursement under this Article for prescription drugs
885885 15 provided to a recipient of aid under this Article shall
886886 16 include the name of the prescriber or an acceptable
887887 17 identification number as established by the Department.
888888 18 (b) Pharmacies providing prescription drugs under this
889889 19 Article shall be reimbursed at a rate which shall include a
890890 20 professional dispensing fee as determined by the Illinois
891891 21 Department, plus the current acquisition cost of the
892892 22 prescription drug dispensed. The Illinois Department shall
893893 23 update its information on the acquisition costs of all
894894 24 prescription drugs no less frequently than every 30 days.
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905905 1 However, the Illinois Department may set the rate of
906906 2 reimbursement for the acquisition cost, by rule, at a
907907 3 percentage of the current average wholesale acquisition cost.
908908 4 (c) (Blank).
909909 5 (d) The Department shall review utilization of narcotic
910910 6 medications in the medical assistance program and impose
911911 7 utilization controls that protect against abuse.
912912 8 (e) When making determinations as to which drugs shall be
913913 9 on a prior approval list, the Department shall include as part
914914 10 of the analysis for this determination, the degree to which a
915915 11 drug may affect individuals in different ways based on factors
916916 12 including the gender of the person taking the medication.
917917 13 (f) The Department shall cooperate with the Department of
918918 14 Public Health and the Department of Human Services Division of
919919 15 Mental Health in identifying psychotropic medications that,
920920 16 when given in a particular form, manner, duration, or
921921 17 frequency (including "as needed") in a dosage, or in
922922 18 conjunction with other psychotropic medications to a nursing
923923 19 home resident or to a resident of a facility licensed under the
924924 20 ID/DD Community Care Act or the MC/DD Act, may constitute a
925925 21 chemical restraint or an "unnecessary drug" as defined by the
926926 22 Nursing Home Care Act or Titles XVIII and XIX of the Social
927927 23 Security Act and the implementing rules and regulations. The
928928 24 Department shall require prior approval for any such
929929 25 medication prescribed for a nursing home resident or to a
930930 26 resident of a facility licensed under the ID/DD Community Care
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941941 1 Act or the MC/DD Act, that appears to be a chemical restraint
942942 2 or an unnecessary drug. The Department shall consult with the
943943 3 Department of Human Services Division of Mental Health in
944944 4 developing a protocol and criteria for deciding whether to
945945 5 grant such prior approval.
946946 6 (g) The Department may by rule provide for reimbursement
947947 7 of the dispensing of a 90-day supply of a generic or brand
948948 8 name, non-narcotic maintenance medication in circumstances
949949 9 where it is cost effective.
950950 10 (g-5) On and after July 1, 2012, the Department may
951951 11 require the dispensing of drugs to nursing home residents be
952952 12 in a 7-day supply or other amount less than a 31-day supply.
953953 13 The Department shall pay only one dispensing fee per 31-day
954954 14 supply.
955955 15 (h) Effective July 1, 2011, the Department shall
956956 16 discontinue coverage of select over-the-counter drugs,
957957 17 including analgesics and cough and cold and allergy
958958 18 medications.
959959 19 (h-5) On and after July 1, 2012, the Department shall
960960 20 impose utilization controls, including, but not limited to,
961961 21 prior approval on specialty drugs, oncolytic drugs, drugs for
962962 22 the treatment of HIV or AIDS, immunosuppressant drugs, and
963963 23 biological products in order to maximize savings on these
964964 24 drugs. The Department may adjust payment methodologies for
965965 25 non-pharmacy billed drugs in order to incentivize the
966966 26 selection of lower-cost drugs. For drugs for the treatment of
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977977 1 AIDS, the Department shall take into consideration the
978978 2 potential for non-adherence by certain populations, and shall
979979 3 develop protocols with organizations or providers primarily
980980 4 serving those with HIV/AIDS, as long as such measures intend
981981 5 to maintain cost neutrality with other utilization management
982982 6 controls such as prior approval. For hemophilia, the
983983 7 Department shall develop a program of utilization review and
984984 8 control which may include, in the discretion of the
985985 9 Department, prior approvals. The Department may impose special
986986 10 standards on providers that dispense blood factors which shall
987987 11 include, in the discretion of the Department, staff training
988988 12 and education; patient outreach and education; case
989989 13 management; in-home patient assessments; assay management;
990990 14 maintenance of stock; emergency dispensing timeframes; data
991991 15 collection and reporting; dispensing of supplies related to
992992 16 blood factor infusions; cold chain management and packaging
993993 17 practices; care coordination; product recalls; and emergency
994994 18 clinical consultation. The Department may require patients to
995995 19 receive a comprehensive examination annually at an appropriate
996996 20 provider in order to be eligible to continue to receive blood
997997 21 factor.
998998 22 (i) On and after July 1, 2012, the Department shall reduce
999999 23 any rate of reimbursement for services or other payments or
10001000 24 alter any methodologies authorized by this Code to reduce any
10011001 25 rate of reimbursement for services or other payments in
10021002 26 accordance with Section 5-5e.
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10131013 1 (j) On and after July 1, 2012, the Department shall impose
10141014 2 limitations on prescription drugs such that the Department
10151015 3 shall not provide reimbursement for more than 4 prescriptions,
10161016 4 including 3 brand name prescriptions, for distinct drugs in a
10171017 5 30-day period, unless prior approval is received for all
10181018 6 prescriptions in excess of the 4-prescription limit. Drugs in
10191019 7 the following therapeutic classes shall not be subject to
10201020 8 prior approval as a result of the 4-prescription limit:
10211021 9 immunosuppressant drugs, oncolytic drugs, anti-retroviral
10221022 10 drugs, and, on or after July 1, 2014, antipsychotic drugs. On
10231023 11 or after July 1, 2014, the Department may exempt children with
10241024 12 complex medical needs enrolled in a care coordination entity
10251025 13 contracted with the Department to solely coordinate care for
10261026 14 such children, if the Department determines that the entity
10271027 15 has a comprehensive drug reconciliation program.
10281028 16 (k) No medication therapy management program implemented
10291029 17 by the Department shall be contrary to the provisions of the
10301030 18 Pharmacy Practice Act.
10311031 19 (l) Any provider enrolled with the Department that bills
10321032 20 the Department for outpatient drugs and is eligible to enroll
10331033 21 in the federal Drug Pricing Program under Section 340B of the
10341034 22 federal Public Health Service Act shall enroll in that
10351035 23 program. No entity participating in the federal Drug Pricing
10361036 24 Program under Section 340B of the federal Public Health
10371037 25 Service Act may exclude fee-for-service Medicaid from their
10381038 26 participation in that program, however, entities defined in
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10491049 1 Section 1905(l)(2)(B) of the Social Security Act are excluded
10501050 2 from this requirement. This subsection does not apply to
10511051 3 outpatient drugs billed to Medicaid managed care
10521052 4 organizations.
10531053 5 (m) Notwithstanding any other provision of this Code to
10541054 6 the contrary, vaccines ordered and administered by a
10551055 7 pharmacist as described in
10561056 subsection (d) of Section 3 of the
10571057 8 Pharmacy Practice Act shall be covered and reimbursed at no
10581058 9 less than the rate that the vaccine is reimbursed at when
10591059 10 ordered and administered by a physician licensed to practice
10601060 11 medicine in all its branches.
10611061 12 (Source: P.A. 102-558, eff. 8-20-21; 102-778, eff. 7-1-22.)
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