MD
Maryland Senate Bill SB515

Maryland 2023 Regular Session

Maryland Senate Bill SB515 Compare Versions

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1- WES MOORE, Governor Ch. 364
21
3-– 1 –
4-Chapter 364
5-(Senate Bill 515)
62
7-AN ACT concerning
3+EXPLANATION: CAPITALS INDICATE MATTER ADDED TO EXIS TING LAW.
4+ [Brackets] indicate matter deleted from existing law.
5+ Underlining indicates amendments to bill.
6+ Strike out indicates matter stricken from the bill by amendment or deleted from the law by
7+amendment.
8+ *sb0515*
89
9-Health Insurance – Step Therapy or Fail–First Protocol – Revisions
10+SENATE BILL 515
11+J5, J4 3lr1591
12+ CF HB 785
13+By: Senator Lam
14+Introduced and read first time: February 3, 2023
15+Assigned to: Finance
16+Committee Report: Favorable with amendments
17+Senate action: Adopted
18+Read second time: March 11, 2023
1019
11-FOR the purpose of prohibiting certain insurers, nonprofit health service plans, and health
12-maintenance organizations from imposing a step therapy or fail–first protocol on an
13-insured or an enrollee for certain prescription drugs used to treat a certain mental
14-disorder or condition; requiring certain insurers, nonprofit health service plans, or
15-health maintenance organizations to establish a certain process for requesting an
16-exception to a step therapy or fail–first protocol; prohibiting certain insurers,
17-nonprofit health service plans, health maintenance organizations, and pharmacy
18-benefits managers from requiring more than a certain number of prior
19-authorizations for a prescription for different dosages of the same prescription drug;
20-requiring a private review agent to make a determination on a step therapy
21-exception request or prior authorization request submitted electronically within a
22-certain period of time; and generally relating to step therapy or fail–first protocols
23-and prior authorizations and health insurance.
20+CHAPTER ______
2421
25-BY repealing and reenacting, with amendments,
26- Article – Insurance
27-Section 15–142 and 15–10B–06(a)
28- Annotated Code of Maryland
29- (2017 Replacement Volume and 2022 Supplement)
22+AN ACT concerning 1
3023
31-BY repealing and reenacting, without amendments,
32- Article – Insurance
33- Section 15–854(a)
34- Annotated Code of Maryland
35- (2017 Replacement Volume and 2022 Supplement)
24+Health Insurance – Step Therapy or Fail–First Protocol – Revisions 2
3625
37-BY adding to
38- Article – Insurance
39- Section 15–854(g)
40- Annotated Code of Maryland
41- (2017 Replacement Volume and 2022 Supplement)
26+FOR the purpose of prohibiting certain insurers, nonprofit health service plans, and health 3
27+maintenance organizations from imposing a step therapy or fail–first protocol on an 4
28+insured or an enrollee for certain prescription drugs used to treat a certain mental 5
29+disorder or condition; requiring certain insurers, nonprofit health service plans, or 6
30+health maintenance organizations to establish a certain process for requesting an 7
31+exception to a step therapy or fail–first protocol; prohibiting certain insurers, 8
32+nonprofit health service plans, health maintenance organizations, and pharmacy 9
33+benefits managers from requiring more than a certain number of prior 10
34+authorizations for a prescription for different dosages of the same prescription drug; 11
35+requiring a private review agent to make a determination on a step therapy 12
36+exception request or prior authorization request submitted electronically within a 13
37+certain period of time; and generally relating to step therapy or fail–first protocols 14
38+and prior authorizations and health insurance. 15
4239
43- SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
44-That the Laws of Maryland read as follows:
40+BY repealing and reenacting, with amendments, 16
41+ Article – Insurance 17
42+Section 15–142 and 15–10B–06(a) 18
43+ Annotated Code of Maryland 19
44+ (2017 Replacement Volume and 2022 Supplement) 20
4545
46-Article – Insurance
46+BY repealing and reenacting, without amendments, 21
47+ Article – Insurance 22
48+ Section 15–854(a) 23 2 SENATE BILL 515
4749
48-15–142.
49- Ch. 364 2023 LAWS OF MARYLAND
5050
51-– 2 –
52- (a) (1) In this section the following words have the meanings indicated.
51+ Annotated Code of Maryland 1
52+ (2017 Replacement Volume and 2022 Supplement) 2
5353
54- (2) “Step therapy drug” means a prescription drug or sequence of
55-prescription drugs required to be used under a step therapy or fail–first protocol.
54+BY adding to 3
55+ Article – Insurance 4
56+ Section 15–854(g) 5
57+ Annotated Code of Maryland 6
58+ (2017 Replacement Volume and 2022 Supplement) 7
5659
57- (3) “STEP THERAPY EXCEPTIO N REQUEST” MEANS A REQUEST TO
58-OVERRIDE A STEP THER APY OR FAIL–FIRST PROTOCOL .
60+ SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 8
61+That the Laws of Maryland read as follows: 9
5962
60- [(3)] (4) (I) “Step therapy or fail–first protocol” means a protocol
61-established by an insurer, a nonprofit health service plan, or a health maintenance
62-organization that requires a prescription drug or sequence of prescription drugs to be used
63-by an insured or an enrollee before a prescription drug ordered by a prescriber for the
64-insured or the enrollee is covered.
63+Article – Insurance 10
6564
66- (II) “STEP THERAPY OR FAIL –FIRST PROTOCOL ” INCLUDES A
67-PROTOCOL THAT MEETS THE DEFINITION UNDER SUBPARAGRAPH (I) OF THIS
68-PARAGRAPH REGARDLESS OF THE NAME , LABEL, OR TERMINOLOGY USED BY THE
69-INSURER, NONPROFIT HEALTH SER VICE PLAN, OR HEALTH MAINTENAN CE
70-ORGANIZATION TO IDEN TIFY THE PROTOCOL .
65+15–142. 11
7166
72- [(4)] (5) “Supporting medical information” means:
67+ (a) (1) In this section the following words have the meanings indicated. 12
7368
74- (i) a paid claim from an entity subject to this section for an insured
75-or an enrollee;
69+ (2) “Step therapy drug” means a prescription drug or sequence of 13
70+prescription drugs required to be used under a step therapy or fail–first protocol. 14
7671
77- (ii) a pharmacy record that documents that a prescription has been
78-filled and delivered to an insured or an enrollee, or a representative of an insured or an
79-enrollee; or
72+ (3) “STEP THERAPY EXCEPTIO N REQUEST” MEANS A REQUEST TO 15
73+OVERRIDE A STEP THER APY OR FAIL–FIRST PROTOCOL . 16
8074
81- (iii) other information mutually agreed on by an entity subject to this
82-section and the prescriber of an insured or an enrollee.
75+ [(3)] (4) (I) “Step therapy or fail–first protocol” means a protocol 17
76+established by an insurer, a nonprofit health service plan, or a health maintenance 18
77+organization that requires a prescription drug or sequence of prescription drugs to be used 19
78+by an insured or an enrollee before a prescription drug ordered by a prescriber for the 20
79+insured or the enrollee is covered. 21
8380
84- (b) (1) This section applies to:
81+ (II) “STEP THERAPY OR FAIL –FIRST PROTOCOL ” INCLUDES A 22
82+PROTOCOL THAT MEETS THE DEFINITION UNDER SUBPARAGRAPH (I) OF THIS 23
83+PARAGRAPH REGARDLESS OF THE NAME , LABEL, OR TERMINOLOGY USED BY THE 24
84+INSURER, NONPROFIT HEALTH SER VICE PLAN, OR HEALTH MAINTENANC E 25
85+ORGANIZATION TO I DENTIFY THE PROTOCOL . 26
8586
86- (i) insurers and nonprofit health service plans that provide hospital,
87-medical, or surgical benefits to individuals or groups on an expense–incurred basis under
88-health insurance policies or contracts that are issued or delivered in the State; and
87+ [(4)] (5) “Supporting medical information” means: 27
8988
90- (ii) health maintenance organizations that provide hospital,
91-medical, or surgical benefits to individuals or groups under contracts that are issued or
92-delivered in the State.
89+ (i) a paid claim from an entity subject to this section for an insured 28
90+or an enrollee; 29
9391
94- (2) An insurer, a nonprofit health service plan, or a health maintenance
95-organization that provides coverage for prescription drugs through a pharmacy benefits
96-manager is subject to the requirements of this section. WES MOORE, Governor Ch. 364
92+ (ii) a pharmacy record that documents that a prescription has been 30
93+filled and delivered to an insured or an enrollee, or a representative of an insured or an 31
94+enrollee; or 32
95+ SENATE BILL 515 3
9796
98-– 3 –
9997
100- (c) An entity subject to this section may not impose a step therapy or fail–first
101-protocol on an insured or an enrollee if:
98+ (iii) other information mutually agreed on by an entity subject to this 1
99+section and the prescriber of an insured or an enrollee. 2
102100
103- (1) the step therapy drug has not been approved by the U.S. Food and Drug
104-Administration for the medical condition being treated; or
101+ (b) (1) This section applies to: 3
105102
106- (2) a prescriber provides supporting medical information to the entity that
107-a prescription drug covered by the entity:
103+ (i) insurers and nonprofit health service plans that provide hospital, 4
104+medical, or surgical benefits to individuals or groups on an expense–incurred basis under 5
105+health insurance policies or contracts that are issued or delivered in the State; and 6
108106
109- (i) was ordered by a prescriber for the insured or enrollee within the
110-past 180 days; and
107+ (ii) health maintenance organizations that provide hospital, 7
108+medical, or surgical benefits to individuals or groups under contracts that are issued or 8
109+delivered in the State. 9
111110
112- (ii) based on the professional judgment of the prescriber, was
113-effective in treating the insured’s or enrollee’s disease or medical condition.
111+ (2) An insurer, a nonprofit health service plan, or a health maintenance 10
112+organization that provides coverage for prescription drugs through a pharmacy benefits 11
113+manager is subject to the requirements of this section. 12
114114
115- (d) Subsection (c) of this section may not be construed to require coverage for a
116-prescription drug that is not:
115+ (c) An entity subject to this section may not impose a step therapy or fail–first 13
116+protocol on an insured or an enrollee if: 14
117117
118- (1) covered by the policy or contract of an entity subject to this section; or
118+ (1) the step therapy drug has not been approved by the U.S. Food and Drug 15
119+Administration for the medical condition being treated; or 16
119120
120- (2) otherwise required by law to be covered.
121+ (2) a prescriber provides supporting medical information to the entity that 17
122+a prescription drug covered by the entity: 18
121123
122- (e) An entity subject to this section may not impose a step therapy or fail–first
123-protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and
124-Drug Administration if:
124+ (i) was ordered by a prescriber for the insured or enrollee within the 19
125+past 180 days; and 20
125126
126- (1) (I) the prescription drug is used to treat the insured’s or enrollee’s
127-stage four advanced metastatic cancer; and
127+ (ii) based on the professional judgment of the prescriber, was 21
128+effective in treating the insured’s or enrollee’s disease or medical condition. 22
128129
129- [(2)] (II) use of the prescription drug is:
130+ (d) Subsection (c) of this section may not be construed to require coverage for a 23
131+prescription drug that is not: 24
130132
131- [(i)] 1. consistent with the U.S. Food and Drug
132-Administration–approved indication or the National Comprehensive Cancer Network
133-Drugs & Biologics Compendium indication for the treatment of stage four advanced
134-metastatic cancer; and
133+ (1) covered by the policy or contract of an entity subject to this section; or 25
135134
136- [(ii)] 2. supported by peer–reviewed medical literature; OR
135+ (2) otherwise required by law to be covered. 26
137136
138- (2) THE PRESCRIPTION DRU G IS USED TO TREAT T HE INSURED’S OR
139-ENROLLEE’S MENTAL DISORDER OR CONDITION, AS DEFINED IN THE CU RRENT
140-DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS PUBLISHED B Y
141-THE AMERICAN PSYCHIATRIC ASSOCIATION, THAT RESULTS IN A SE RIOUS
142-FUNCTIONAL IMPAIRMEN T THAT SUBSTANTIALLY INTERFERES WITH OR L IMITS ONE
143-OR MORE MAJOR LIFE A CTIVITIES.
144- Ch. 364 2023 LAWS OF MARYLAND
137+ (e) An entity subject to this section may not impose a step therapy or fail–first 27
138+protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 28
139+Drug Administration if: 29
145140
146-– 4 –
147- (F) (1) AN ENTITY SUBJECT TO THIS SECTION SHALL E STABLISH A
148-PROCESS FOR REQUESTI NG AN EXCEPTION TO A STEP THERAPY OR FAIL –FIRST
149-PROTOCOL THAT IS :
141+ (1) (I) the prescription drug is used to treat the insured’s or enrollee’s 30
142+stage four advanced metastatic cancer; and 31
150143
151- (I) CLEARLY DESCRIBED , INCLUDING THE SPECIF IC
152-INFORMATION AND DOCU MENTATION, IF NEEDED, THAT MUST BE SUBMITTED BY
153-THE PRESCRIBER TO BE CON SIDERED A COMPLETE S TEP THERAPY EXCEPTIO N
154-REQUEST;
144+ [(2)] (II) use of the prescription drug is: 32 4 SENATE BILL 515
155145
156- (II) EASILY ACCESSIBLE TO THE PRESCRIBER ; AND
157146
158- (III) POSTED ON THE ENTITY ’S WEBSITE.
159147
160- (2) A STEP THERAPY EXCEPTI ON REQUEST SHALL BE GRANTED IF,
161-BASED O N THE PROFESSIONAL J UDGMENT OF THE PRESC RIBER AND ANY
162-INFORMATION AND DOCU MENTATION REQUIRED U NDER PARAGRAPH (1)(I) OF THIS
163-SUBSECTION:
148+ [(i)] 1. consistent with the U.S. Food and Drug 1
149+Administration–approved indication or the National Comprehensive Cancer Network 2
150+Drugs & Biologics Compendium indication for the treatment of stage four advanced 3
151+metastatic cancer; and 4
164152
165- (I) THE STEP THERAPY DRU G IS CONTRAINDICATED OR WILL
166-LIKELY CAUSE AN ADVE RSE REACTION, PHYSICAL HARM , OR MENTAL HARM TO THE
167-INSURED OR ENROLLEE ;
153+ [(ii)] 2. supported by peer–reviewed medical literature; OR 5
168154
169- (II) THE STEP THERAPY DRU G IS EXPECTED TO BE INEFFECTIVE
170-BASED ON THE KNOWN C LINICAL CHARACTERIST ICS OF THE INSURED O R ENROLLEE
171-AND THE KNOWN CHARAC TERISTICS OF THE PRE SCRIPTION DRUG REGIM EN;
155+ (2) THE PRESCRIPTION DRU G IS USED TO TREAT T HE INSURED’S OR 6
156+ENROLLEE’S MENTAL DISORDER OR CONDITION, AS DEFINED IN THE CURRE NT 7
157+DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS PUBLISHED B Y 8
158+THE AMERICAN PSYCHIATRIC ASSOCIATION, THAT RESULTS IN A SE RIOUS 9
159+FUNCTIONAL IMPAIRMEN T THAT SUBSTANTIALLY INTERFERES WITH OR L IMITS ONE 10
160+OR MORE MAJOR LIFE A CTIVITIES. 11
172161
173- (III) THE INSURED OR ENROL LEE IS STABLE ON A PR ESCRIPTION
174-DRUG PRESCRIBED FOR THE MEDICAL CONDITIO N UNDER CONSIDERATIO N WHILE
175-COVERED UNDER THE PO LICY OR CONTRACT OF THE ENTITY OR UNDER A PREVIOUS
176-SOURCE OF COVERAGE ; OR
162+ (F) (1) AN ENTITY SUBJECT TO THIS SECTION SHALL E STABLISH A 12
163+PROCESS FOR REQUESTI NG AN EXCEPTION TO A STEP THERAPY OR FAIL –FIRST 13
164+PROTOCOL THAT IS : 14
177165
178- (IV) WHILE COVERED UNDER THE POLICY OR CONTRA CT OF THE
179-ENTITY OR A PREVIOUS SOU RCE OF COVERAGE , THE INSURED OR ENROL LEE HAS
180-TRIED A PRESCRIPTION DRUG THAT:
166+ (I) CLEARLY DESCRIBED , INCLUDING THE SPECIF IC 15
167+INFORMATION AND DOCU MENTATION, IF NEEDED, THAT MUST BE SUBMITTED BY 16
168+THE PRESCRIBER TO BE CON SIDERED A COMPLETE S TEP THERAPY EXCEPTIO N 17
169+REQUEST; 18
181170
182- 1. IS IN THE SAME PHARM ACOLOGIC CLASS OR HA S THE
183-SAME MECHANISM OF AC TION AS THE STEP THE RAPY DRUG; AND
171+ (II) EASILY ACCESSIBLE TO THE PRESCRIBER ; AND 19
184172
185- 2. WAS DISCONTINUED BY THE PRESCRIBER DUE T O
186-LACK OF EFFICACY OR EFFECTIVENESS , DIMINISHED EFFECT , OR AN ADVERSE
187-EVENT.
188- WES MOORE, Governor Ch. 364
173+ (III) POSTED ON THE ENTITY ’S WEBSITE. 20
189174
190-– 5 –
191- (3) AN INSURED OR ENROLLE E MAY APPEAL THE DEC ISION TO DENY
192-A STEP THERAPY EXCEP TION REQUEST UNDER T HIS SECTION.
175+ (2) A STEP THERAPY EXCEPTI ON REQUEST SHALL BE GRANTED IF, 21
176+BASED ON THE PR OFESSIONAL JUDGMENT OF THE PRESCRIBER AND ANY 22
177+INFORMATION AND DOCU MENTATION REQUIRED U NDER PARAGRAPH (1)(I) OF THIS 23
178+SUBSECTION: 24
193179
194- (4) (I) A STEP THERAPY EXCEPTION REQUES T OR APPEAL SHALL
195-BE GRANTED:
180+ (I) THE STEP THERAPY DRU G IS CONTRAINDICATED OR WILL 25
181+LIKELY CAUSE AN ADVE RSE REACTION, PHYSICAL HARM , OR MENTAL HARM TO THE 26
182+INSURED OR ENROLLEE ; 27
196183
197- 1. IN REAL TIME IF NO A DDITIONAL INFORMATIO N IS
198-NEEDED BY THE ENTITY TO PROCESS THE REQUE ST AND THE REQUEST M EETS THE
199-ENTITY’S CRITERIA FOR APPRO VAL; OR
184+ (II) THE STEP THERAPY DRU G IS EXPECTED TO BE INEFFECTIVE 28
185+BASED ON THE KNOWN C LINICAL CHARACTERIST ICS OF THE INSURED O R ENROLLEE 29
186+AND THE KNOWN CHARAC TERISTICS OF THE PRE SCRIPTION DRUG REGIM EN; 30
200187
201- 2. IF ADDITIONAL INFORM ATION IS NEEDED BY T HE
202-ENTITY TO PROCESS TH E REQUEST AND THE RE QUEST IS NOT URGENT , WITHIN 1
203-BUSINESS DAY AFTER T HE ENTITY RECEIVES A LL RELEVANT INFORMAT ION NEEDED
204-TO PROCESS THE REQUE ST.
188+ (III) THE INSURED OR ENROL LEE IS STABLE ON A PRESCRIP TION 31
189+DRUG PRESCRIBED FOR THE MEDICAL CONDITIO N UNDER CONSIDERATIO N WHILE 32 SENATE BILL 515 5
205190
206- (II) IF AN ENTITY SUBJECT TO THIS SECTION DOES NOT GRANT
207-OR DENY A STEP THERA PY EXCEPTION REQUEST OR AN APPEAL WITHIN THE TIME
208-PERIOD REQUIRED UNDE R SUBPARAGRAPH (I) OF THIS PARAGRAPH , THE REQUEST
209-OR APPEAL SHALL BE T REATED AS GRANTED .
210191
211- (3) ON GRANTING A STEP TH ERAPY EXCEPTION REQU EST, AN ENTITY
212-SUBJECT TO THIS SECT ION SHALL AUTHORIZE COVERAGE F OR THE PRESCRIPTION
213-DRUG ORDERED BY THE PRESCRIBER FOR AN IN SURED OR ENROLLEE .
192+COVERED UNDER THE PO LICY OR CONTRACT OF THE ENTITY OR UNDER A PREVIOUS 1
193+SOURCE OF COVERAGE ; OR 2
214194
215- (4) AN ENROLLEE OR INSURE D MAY APPEAL A STEP THERAPY
216-EXCEPTION REQUEST DE NIAL IN ACCORDANCE W ITH SUBTITLE 10A OR SUBTITLE
217-10B OF THIS TITLE.
195+ (IV) WHILE COVERED UNDER THE POLICY OR CONTRA CT OF THE 3
196+ENTITY OR A PREVIOUS SOURCE OF COVERAGE, THE INSURED OR ENROL LEE HAS 4
197+TRIED A PRESCRIPTION DRUG THAT: 5
218198
219- (5) THIS SUBSECTION MAY NOT B E CONSTRUED TO PREVENT:
199+ 1. IS IN THE SAME PHARM ACOLOGIC CLASS OR HA S THE 6
200+SAME MECHANISM OF AC TION AS THE STEP THE RAPY DRUG; AND 7
220201
221- (I) PREVENT:
202+ 2. WAS DISCONTINUED BY THE PRESCRIBER DUE T O 8
203+LACK OF EFFICACY OR EFFECT IVENESS, DIMINISHED EFFECT , OR AN ADVERSE 9
204+EVENT. 10
222205
223- 1. AN ENTITY SUBJECT TO THIS SECTION FROM
224-REQUIRING AN INSURED OR ENROLLEE TO TRY A N AB–RATED GENERIC
225-EQUIVALENT OR INTERC HANGEABLE BIOLOGICAL PRODUCT BEFORE PROVI DING
226-COVERAGE FOR THE EQUIVALENT BRANDED P RESCRIPTION DRUG ; OR
206+ (3) AN INSURED OR ENROLLE E MAY APPEAL THE DEC ISION TO DENY 11
207+A STEP THERAPY EXCEP TION REQUEST UNDER T HIS SECTION. 12
227208
228- (II) 2. A HEALTH CARE PROVID ER FROM PRESCRIBING A
229-PRESCRIPTION DRUG TH AT IS DETERMINED TO BE MEDICALLY APPROPR IATE; OR
209+ (4) (I) A STEP THERAPY EXCEPTI ON REQUEST OR APPEAL SHALL 13
210+BE GRANTED: 14
230211
231- (II) REQUIRE AN ENTITY SU BJECT TO THIS SECTIO N TO
232-PROVIDE COVERAGE FOR A PRESCRIPTION DR UG THAT IS NOT COVER ED BY A
233-POLICY OR CONTRACT O F THE ENTITY.
234- Ch. 364 2023 LAWS OF MARYLAND
212+ 1. IN REAL TIME IF NO A DDITIONAL INFORMATIO N IS 15
213+NEEDED BY THE ENTITY TO PROCESS THE REQUE ST AND THE REQUEST M EETS THE 16
214+ENTITY’S CRITERIA FOR APPRO VAL; OR 17
235215
236-– 6 –
237- (6) AN ENTITY SUBJECT TO THIS SECTION MAY USE AN EXISTING STEP
238-THERAPY EXCEPTION PR OCESS THAT SATISFIES THE REQUIREMENTS UND ER THIS
239-SUBSECTION.
216+ 2. IF ADDITIONAL INFORM ATION IS NEEDED BY T HE 18
217+ENTITY TO PROCESS TH E REQUEST AND THE REQUEST IS NOT URGEN T, WITHIN 1 19
218+BUSINESS DAY AFTER T HE ENTITY RECEIVES A LL RELEVANT INFORMAT ION NEEDED 20
219+TO PROCESS THE REQUE ST. 21
240220
241-15–854.
221+ (II) IF AN ENTITY SUBJECT TO THIS SECTION DOES NOT GRANT 22
222+OR DENY A STEP THERA PY EXCEPTION REQUEST OR AN APPEAL WITHIN THE TIME 23
223+PERIOD REQUIRED UNDE R SUBPARAGRAPH (I) OF THIS PARAGRAPH , THE REQUEST 24
224+OR APPEAL SHALL BE T REATED AS GRANTED . 25
242225
243- (a) (1) This section applies to:
226+ (3) ON GRANTING A STEP TH ERAPY EXCEPTION REQU EST, AN ENTITY 26
227+SUBJECT TO THIS SECT ION SHALL AUTHORIZE COVERAGE FOR THE PRE SCRIPTION 27
228+DRUG ORDERED BY THE PRESC RIBER FOR AN INSURED OR ENROLLEE . 28
244229
245- (i) insurers and nonprofit health service plans that provide coverage
246-for prescription drugs through a pharmacy benefit under individual, group, or blanket
247-health insurance policies or contracts that are issued or delivered in the State; and
230+ (4) AN ENROLLEE OR INSURE D MAY APPEAL A STEP THERAPY 29
231+EXCEPTION REQUEST DE NIAL IN ACCORDANCE W ITH SUBTITLE 10A OR SUBTITLE 30
232+10B OF THIS TITLE. 31
248233
249- (ii) health maintenance organizations that provide coverage for
250-prescription drugs through a pharmacy benefit under individual or group contracts that
251-are issued or delivered in the State.
234+ (5) THIS SUBSECTION MAY N OT BE CONSTRUED TO PREVENT: 32
235+ 6 SENATE BILL 515
252236
253- (2) An insurer, a nonprofit health service plan, or a health maintenance
254-organization that provides coverage for prescription drugs through a pharmacy benefits
255-manager or that contracts with a private review agent under Subtitle 10B of this article is
256-subject to the requirements of this section.
257237
258- (3) This section does not apply to a managed care organization as defined
259-in § 15–101 of the Health – General Article.
238+ (I) PREVENT: 1
260239
261- (G) (1) EXCEPT AS PROVIDED IN PARAGRAPH (2) OF THIS SUBSECTION ,
262-AN ENTITY SUBJECT TO THIS SECTION MAY NOT REQUIRE MORE THAN ON E PRIOR
263-AUTHORIZATION IF T WO OR MORE TABLETS O F DIFFERENT DOSAGE S TRENGTHS OF
264-THE SAME PRESCRIPTIO N DRUG ARE:
240+ 1. AN ENTITY SUBJECT TO THIS SECTION FROM 2
241+REQUIRING AN INSURED OR ENROLLEE TO TRY A N AB–RATED GENERIC 3
242+EQUIVALENT OR INTERC HANGEABLE BIOLOGICAL PRODUCT BEFORE PROVI DING 4
243+COVERAGE FOR THE EQU IVALENT BRANDED PRES CRIPTION DRUG ; OR 5
265244
266- (I) PRESCRIBED AT THE SA ME TIME AS PART OF A N INSURED’S
267-TREATMENT PLAN ; AND
245+ (II) 2. A HEALTH CARE PROVID ER FROM PRESCRIBING A 6
246+PRESCRIPTION DRUG TH AT IS DETERMINED TO BE MEDICALLY APPROPR IATE; OR 7
268247
269- (II) MANUFACTURED BY THE SAME MANUFACTURER .
248+ (II) REQUIRE AN ENTITY SU BJECT TO THIS SECTIO N TO 8
249+PROVIDE COVERAGE FOR A PRESCRIPTION DRUG THAT IS NOT COVERED BY A 9
250+POLICY OR CONTRACT O F THE ENTITY. 10
270251
271- (2) THIS SUBSECTION DOES NOT PROHIBIT AN ENTITY FROM
272-REQUIRING MORE THAN ONE PRIOR AUTHORIZAT ION IF THE PRESCRIPT ION IS FOR
273-TWO OR MORE TABLETS OF DIFFERENT DOSAGE STRENGTHS OF AN OPIO ID THAT IS
274-NOT AN OPIOID PARTIA L AGONIST.
252+ (6) AN ENTITY SUBJECT TO THIS SECTION MAY USE AN EXISTING STEP 11
253+THERAPY EXCEPTION PR OCESS THAT SATISFIES THE REQUIREMENTS UND ER THIS 12
254+SUBSECTION. 13
275255
276-15–10B–06.
256+15–854. 14
277257
278- (a) (1) [A] EXCEPT AS PROVIDED IN PARAGRAPH (4) OF THIS
279-SUBSECTION, A private review agent shall:
280- WES MOORE, Governor Ch. 364
258+ (a) (1) This section applies to: 15
281259
282-– 7 –
283- (i) make all initial determinations on whether to authorize or certify
284-a nonemergency course of treatment for a patient within 2 working days after receipt of the
285-information necessary to make the determination;
260+ (i) insurers and nonprofit health service plans that provide coverage 16
261+for prescription drugs through a pharmacy benefit under individual, group, or blanket 17
262+health insurance policies or contracts that are issued or delivered in the State; and 18
286263
287- (ii) make all determinations on whether to authorize or certify an
288-extended stay in a health care facility or additional health care services within 1 working
289-day after receipt of the information necessary to make the determination; and
264+ (ii) health maintenance organizations that provide coverage for 19
265+prescription drugs through a pharmacy benefit under individual or group contracts that 20
266+are issued or delivered in the State. 21
290267
291- (iii) promptly notify the health care provider of the determination.
268+ (2) An insurer, a nonprofit health service plan, or a health maintenance 22
269+organization that provides coverage for prescription drugs through a pharmacy benefits 23
270+manager or that contracts with a private review agent under Subtitle 10B of this article is 24
271+subject to the requirements of this section. 25
292272
293- (2) If within 3 calendar days after receipt of the initial request for health
294-care services the private review agent does not have sufficient information to make a
295-determination, the private review agent shall inform the health care provider that
296-additional information must be provided.
273+ (3) This section does not apply to a managed care organization as defined 26
274+in § 15–101 of the Health – General Article. 27
297275
298- (3) If a private review agent requires prior authorization for an emergency
299-inpatient admission, or an admission for residential crisis services as defined in § 15–840
300-of this title, for the treatment of a mental, emotional, or substance abuse disorder, the
301-private review agent shall:
276+ (G) (1) EXCEPT AS PROVIDED IN PARAGRAPH (2) OF THIS SUBSECTION , 28
277+AN ENTITY SUBJECT TO THIS SECTION MAY NOT REQUIRE MORE THAN ON E PRIOR 29
278+AUTHORIZATION IF TWO OR MORE TABLETS OF D IFFERENT DOSAGE STRE NGTHS OF 30
279+THE SAME PRESCRIPTION DRUG AR E: 31
302280
303- (i) make all determinations on whether to authorize or certify an
304-inpatient admission, or an admission for residential crisis services as defined in § 15–840
305-of this title, within 2 hours after receipt of the information necessary to make the
306-determination; and
281+ (I) PRESCRIBED AT THE SA ME TIME AS PART OF A N INSURED’S 32
282+TREATMENT PLAN ; AND 33 SENATE BILL 515 7
307283
308- (ii) promptly notify the health care provider of the determination.
309284
310- (4) FOR A STEP THERAPY EX CEPTION REQUEST SUBM ITTED
311-ELECTRONICALLY IN AC CORDANCE WITH A PROC ESS ESTABLISHED UNDE R §
312-15–142(F) OF THIS TITLE OR A P RIOR AUTHORIZATION R EQUEST SUBMITTED
313-ELECTRONICALLY FOR P HARMACEUTICAL SERVIC ES, A PRIVATE REVIEW AGE NT
314-SHALL MAKE A DETERMI NATION:
315285
316- (I) IN REAL TIME IF:
286+ (II) MANUFACTURED BY THE SAME MANUFACTURER . 1
317287
318- 1. NO ADDITIONAL INFORM ATION IS NEEDED BY T HE
319-PRIVATE REVIEW AGENT TO PROCESS THE REQUE ST; AND
288+ (2) THIS SUBSECTION DOES NOT PROHIBIT AN ENTI TY FROM 2
289+REQUIRING MORE THAN ONE PRIOR AUTHORIZAT ION IF THE PRESCRIPTION IS F OR 3
290+TWO OR MORE TABLETS OF DIFFERENT DOSAGE STRENGTHS OF AN OPIO ID THAT IS 4
291+NOT AN OPIOID PARTIA L AGONIST. 5
320292
321- 2. THE REQUEST MEETS TH E PRIVATE REVIEW AGE NT’S
322-CRITERIA FOR APPROVA L; OR
293+15–10B–06. 6
323294
324- (II) IF A REQUEST IS NOT APPROVED UNDER I TEM (I) OF THIS
325-PARAGRAPH , WITHIN 1 BUSINESS DAY AFTER T HE PRIVATE REVIEW AG ENT
326-RECEIVES ALL OF THE INFORMATION NECESSAR Y TO MAKE THE DETERM INATION.
327- Ch. 364 2023 LAWS OF MARYLAND
295+ (a) (1) [A] EXCEPT AS PROVIDED IN PARAGRAPH (4) OF THIS 7
296+SUBSECTION, A private review agent shall: 8
328297
329-– 8 –
330- SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all
331-policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or
332-after January 1, 2024.
298+ (i) make all initial determinations on whether to authorize or certify 9
299+a nonemergency course of treatment for a patient within 2 working days after receipt of the 10
300+information necessary to make the determination; 11
333301
334- SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect
335-January 1, 2024.
302+ (ii) make all determinations on whether to authorize or certify an 12
303+extended stay in a health care facility or additional health care services within 1 working 13
304+day after receipt of the information necessary to make the determination; and 14
336305
337-Approved by the Governor, May 3, 2023.
306+ (iii) promptly notify the health care provider of the determination. 15
307+
308+ (2) If within 3 calendar days after receipt of the initial request for health 16
309+care services the private review agent does not have sufficient information to make a 17
310+determination, the private review agent shall inform the health care provider that 18
311+additional information must be provided. 19
312+
313+ (3) If a private review agent requires prior authorization for an emergency 20
314+inpatient admission, or an admission for residential crisis services as defined in § 15–840 21
315+of this title, for the treatment of a mental, emotional, or substance abuse disorder, the 22
316+private review agent shall: 23
317+
318+ (i) make all determinations on whether to authorize or certify an 24
319+inpatient admission, or an admission for residential crisis services as defined in § 15–840 25
320+of this title, within 2 hours after receipt of the information necessary to make the 26
321+determination; and 27
322+
323+ (ii) promptly notify the health care provider of the determination. 28
324+
325+ (4) FOR A STEP THERAPY EX CEPTION REQUEST SUBM ITTED 29
326+ELECTRONICALLY IN AC CORDANCE WITH A PROC ESS ESTABLI SHED UNDER § 30
327+15–142(F) OF THIS TITLE OR A P RIOR AUTHORIZATION R EQUEST SUBMITTED 31
328+ELECTRONICALLY FOR P HARMACEUTICAL SERVIC ES, A PRIVATE REVIEW AGE NT 32
329+SHALL MAKE A DETERMI NATION: 33
330+ 8 SENATE BILL 515
331+
332+
333+ (I) IN REAL TIME IF: 1
334+
335+ 1. NO ADDITIONAL INFORM ATION IS NEEDED BY T HE 2
336+PRIVATE REVIEW AGENT TO PROCESS THE REQUE ST; AND 3
337+
338+ 2. THE REQUEST MEETS TH E PRIVATE REVIEW AGE NT’S 4
339+CRITERIA FOR APPROVA L; OR 5
340+
341+ (II) IF A REQUEST IS NOT APPROVED UNDER ITEM (I) OF THIS 6
342+PARAGRAPH , WITHIN 1 BUSINESS DAY AFTER T HE PRIVATE REVIEW AG ENT 7
343+RECEIVES ALL OF THE INF ORMATION NECESSARY T O MAKE THE DETERMINA TION. 8
344+
345+ SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 9
346+policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 10
347+after January 1, 2024. 11
348+
349+ SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take e ffect 12
350+January 1, 2024. 13
351+
352+
353+
354+
355+
356+Approved:
357+________________________________________________________________________________
358+ Governor.
359+________________________________________________________________________________
360+ President of the Senate.
361+________________________________________________________________________________
362+ Speaker of the House of Delegates.