MD
Maryland House Bill HB785

Maryland 2023 Regular Session

Maryland House Bill HB785 Compare Versions

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1- WES MOORE, Governor Ch. 365
21
3-– 1 –
4-Chapter 365
5-(House Bill 785)
62
7-AN ACT concerning
3+EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTING LA W.
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+ *hb0785*
89
9-Health Insurance – Step Therapy or Fail–First Protocol and Prior Authorization
10-– Revisions
10+HOUSE BILL 785
11+J5, J4 3lr1212
12+ CF SB 515
13+By: Delegates S. Johnson and White, White, Alston, Bagnall, Bhandari, Chisholm,
14+Cullison, Guzzone, Hill, Hutchinson, Kaiser, Kerr, R. Lewis, Lopez,
15+Martinez, M. Morgan, Pena–Melnyk, Reilly, Rosenberg, Szeliga, Taveras,
16+and Woods
17+Introduced and read first time: February 8, 2023
18+Assigned to: Health and Government Operations
19+Committee Report: Favorable with amendments
20+House action: Adopted
21+Read second time: March 10, 2023
1122
12-FOR the purpose of prohibiting certain insurers, nonprofit health service plans, and health
13-maintenance organizations from imposing a step therapy or fail–first protocol on an
14-insured or an enrollee for certain prescription drugs used to treat a certain mental
15-disorder or condition; requiring certain insurers, nonprofit health service plans, or
16-health maintenance organizations to establish a certain process for requesting an
17-exception to a step therapy or fail–first protocol; prohibiting certain insurers,
18-nonprofit health service plans, health maintenance organizations, and pharmacy
19-benefits managers from requiring more than a certain number of prior
20-authorizations for a prescription for different dosages of the same prescription drug;
21-requiring a private review agent to make a determination on a step therapy
22-exception request or prior authorization request submitted electronically within a
23-certain period of time; and generally relating to step therapy or fail–first protocols
24-and prior authorizations and health insurance.
23+CHAPTER ______
2524
26-BY repealing and reenacting, with amendments,
27- Article – Insurance
28-Section 15–142 and 15–10B–06(a)
29- Annotated Code of Maryland
30- (2017 Replacement Volume and 2022 Supplement)
25+AN ACT concerning 1
3126
32-BY repealing and reenacting, without amendments,
33- Article – Insurance
34- Section 15–854(a)
35- Annotated Code of Maryland
36- (2017 Replacement Volume and 2022 Supplement)
27+Health Insurance – Step Therapy or Fail–First Protocol and Prior Authorization 2
28+– Revisions 3
3729
38-BY adding to
39- Article – Insurance
40- Section 15–854(g)
41- Annotated Code of Maryland
42- (2017 Replacement Volume and 2022 Supplement)
30+FOR the purpose of prohibiting certain insurers, nonprofit health service plans, and health 4
31+maintenance organizations from imposing a step therapy or fail–first protocol on an 5
32+insured or an enrollee for certain prescription drugs used to treat a certain mental 6
33+disorder or condition; requiring certain insurers, nonprofit health service plans, or 7
34+health maintenance organizations to establish a certain process for requesting an 8
35+exception to a step therapy or fail–first protocol; prohibiting certain insurers, 9
36+nonprofit health service plans, health maintenance organizations, and pharmacy 10
37+benefits managers from requiring more than a certain number of prior 11
38+authorizations for a prescription for different dosages of the same prescription drug; 12
39+requiring a private review agent to make a determination on a step therapy 13
40+exception request or prior authorization request submitted electronically within a 14
41+certain period of time; and generally relating to step therapy or fail–first protocols 15
42+and prior authorizations and health insurance. 16
4343
44- SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY O F MARYLAND,
45-That the Laws of Maryland read as follows:
44+BY repealing and reenacting, with amendments, 17
45+ Article – Insurance 18
46+Section 15–142 and 15–10B–06(a) 19
47+ Annotated Code of Maryland 20
48+ (2017 Replacement Volume and 2022 Supplement) 21 2 HOUSE BILL 785
4649
47-Article – Insurance
4850
49-15–142. Ch. 365 2023 LAWS OF MARYLA ND
5051
51-– 2 –
52+BY repealing and reenacting, without amendments, 1
53+ Article – Insurance 2
54+ Section 15–854(a) 3
55+ Annotated Code of Maryland 4
56+ (2017 Replacement Volume and 2022 Supplement) 5
5257
53- (a) (1) In this section the following words have the meanings indicated.
58+BY adding to 6
59+ Article – Insurance 7
60+ Section 15–854(g) 8
61+ Annotated Code of Maryland 9
62+ (2017 Replacement Volume and 2022 Supplement) 10
5463
55- (2) “Step therapy drug” means a prescription drug or sequence of
56-prescription drugs required to be used under a step therapy or fail–first protocol.
64+ SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 11
65+That the Laws of Maryland read as follows: 12
5766
58- (3) “STEP THERAPY EXCEPTIO N REQUEST” MEANS A REQUEST TO
59-OVERRIDE A STEP THER APY OR FAIL–FIRST PROTOCOL .
67+Article – Insurance 13
6068
61- [(3)] (4) (I) “Step therapy or fail–first protocol” means a protocol
62-established by an insurer, a nonprofit health service plan, or a health maintenance
63-organization that requires a prescription drug or sequence of prescription drugs to be used
64-by an insured or an enrollee before a prescription drug ordered by a prescriber for the
65-insured or the enrollee is covered.
69+15–142. 14
6670
67- (II) “STEP THERAPY OR FAIL –FIRST PROTOCOL ” INCLUDES A
68-PROTOCOL THAT MEETS THE DEFINITION UNDER SUBPARAGRAPH (I) OF THIS
69-PARAGRAPH REGARDLESS OF THE NAME , LABEL, OR TERMINOLOGY USED BY THE
70-INSURER, NONPROFIT HEALTH SER VICE PLAN, OR HEALTH MAINTENANC E
71-ORGANIZATION TO IDEN TIFY THE PROTOCOL .
71+ (a) (1) In this section the following words have the meanings indicated. 15
7272
73- [(4)] (5) “Supporting medical information” means:
73+ (2) “Step therapy drug” means a prescription drug or sequence of 16
74+prescription drugs required to be used under a step therapy or fail–first protocol. 17
7475
75- (i) a paid claim from an entity subject to this section for an insured
76-or an enrollee;
76+ (3) “STEP THERAPY EXCEPTIO N REQUEST” MEANS A REQUEST TO 18
77+OVERRIDE A STEP THER APY OR FAIL–FIRST PROTOCOL . 19
7778
78- (ii) a pharmacy record that documents that a prescription has been
79-filled and delivered to an insured or an enrollee, or a representative of an insured or an
80-enrollee; or
79+ [(3)] (4) (I) “Step therapy or fail–first protocol” means a protocol 20
80+established by an insurer, a nonprofit health service plan, or a health maintenance 21
81+organization that requires a prescription drug or sequence of prescription drugs to be used 22
82+by an insured or an enrollee before a prescription drug ordered by a prescriber for the 23
83+insured or the enrollee is covered. 24
8184
82- (iii) other information mutually agreed on by an entity subject to this
83-section and the prescriber of an insured or an enrollee.
85+ (II) “STEP THERAPY OR FAIL –FIRST PROTOCOL ” INCLUDES A 25
86+PROTOCOL THAT MEETS THE DEFINITION UNDER SUBPARAGRAPH (I) OF THIS 26
87+PARAGRAPH REGARDLESS OF THE NAME , LABEL, OR TERMINOLOGY USED BY THE 27
88+INSURER, NONPROFIT HEALTH SER VICE PLAN, OR HEALTH MAINTENANCE 28
89+ORGANIZATION TO IDEN TIFY THE PROTOCOL . 29
8490
85- (b) (1) This section applies to:
91+ [(4)] (5) “Supporting medical information” means: 30
8692
87- (i) insurers and nonprofit health service plans that provide hospital,
88-medical, or surgical benefits to individuals or groups on an expense–incurred basis under
89-health insurance policies or contracts that are issued or delivered in the State; and
93+ (i) a paid claim from an entity subject to this section for an insured 31
94+or an enrollee; 32
95+ HOUSE BILL 785 3
9096
91- (ii) health maintenance organizations that provide hospital,
92-medical, or surgical benefits to individuals or groups under contracts that are issued or
93-delivered in the State.
94- WES MOORE, Governor Ch. 365
9597
96-– 3 –
97- (2) An insurer, a nonprofit health service plan, or a health maintenance
98-organization that provides coverage for prescription drugs through a pharmacy benefits
99-manager is subject to the requirements of this section.
98+ (ii) a pharmacy record that documents that a prescription has been 1
99+filled and delivered to an insured or an enrollee, or a representative of an insured or an 2
100+enrollee; or 3
100101
101- (c) An entity subject to this section may not impose a step therapy or fail–first
102-protocol on an insured or an enrollee if:
102+ (iii) other information mutually agreed on by an entity subject to this 4
103+section and the prescriber of an insured or an enrollee. 5
103104
104- (1) the step therapy drug has not been approved by the U.S. Food and Drug
105-Administration for the medical condition being treated; or
105+ (b) (1) This section applies to: 6
106106
107- (2) a prescriber provides supporting medical information to the entity that
108-a prescription drug covered by the entity:
107+ (i) insurers and nonprofit health service plans that provide hospital, 7
108+medical, or surgical benefits to individuals or groups on an expense–incurred basis under 8
109+health insurance policies or contracts that are issued or delivered in the State; and 9
109110
110- (i) was ordered by a prescriber for the insured or enrollee within the
111-past 180 days; and
111+ (ii) health maintenance organizations that provide hospital, 10
112+medical, or surgical benefits to individuals or groups under contracts that are issued or 11
113+delivered in the State. 12
112114
113- (ii) based on the professional judgment of the prescriber, was
114-effective in treating the insured’s or enrollee’s disease or medical condition.
115+ (2) An insurer, a nonprofit health service plan, or a health maintenance 13
116+organization that provides coverage for prescription drugs through a pharmacy benefits 14
117+manager is subject to the requirements of this section. 15
115118
116- (d) Subsection (c) of this section may not be construed to require coverage for a
117-prescription drug that is not:
119+ (c) An entity subject to this section may not impose a step therapy or fail–first 16
120+protocol on an insured or an enrollee if: 17
118121
119- (1) covered by the policy or contract of an entity subject to this section; or
122+ (1) the step therapy drug has not been approved by the U.S. Food and Drug 18
123+Administration for the medical condition being treated; or 19
120124
121- (2) otherwise required by law to be covered.
125+ (2) a prescriber provides supporting medical information to the entity that 20
126+a prescription drug covered by the entity: 21
122127
123- (e) An entity subject to this section may not impose a step therapy or fail–first
124-protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and
125-Drug Administration if:
128+ (i) was ordered by a prescriber for the insured or enrollee within the 22
129+past 180 days; and 23
126130
127- (1) (I) the prescription drug is used to treat the insured’s or enrollee’s
128-stage four advanced metastatic cancer; and
131+ (ii) based on the professional judgment of the prescriber, was 24
132+effective in treating the insured’s or enrollee’s disease or medical condition. 25
129133
130- [(2)] (II) use of the prescription drug is:
134+ (d) Subsection (c) of this section may not be construed to require coverage for a 26
135+prescription drug that is not: 27
131136
132- [(i)] 1. consistent with the U.S. Food and Drug
133-Administration–approved indication or the National Comprehensive Cancer Network
134-Drugs & Biologics Compendium indication for the treatment of stage four advanced
135-metastatic cancer; and
137+ (1) covered by the policy or contract of an entity subject to this section; or 28
136138
137- [(ii)] 2. supported by peer–reviewed medical literature; OR
139+ (2) otherwise required by law to be covered. 29
138140
139- (2) THE PRESCRIPTION DRU G IS USED TO TREAT T HE INSURED’S OR
140-ENROLLEE’S MENTAL DISORDER OR C ONDITION, AS DEFINED IN THE CU RRENT
141-DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS PUBLISHED B Y
142-THE AMERICAN PSYCHIATRIC ASSOCIATION, THAT RESULTS IN A SE RIOUS Ch. 365 2023 LAWS OF MARYLA ND
141+ (e) An entity subject to this section may not impose a step therapy or fail–first 30
142+protocol on an insured or an enrollee for a prescription drug approved by the U.S. Food and 31
143+Drug Administration if: 32
144+ 4 HOUSE BILL 785
143145
144-– 4 –
145-FUNCTIONAL IMPAIRMEN T THAT SUBSTANTIALLY INTERFERES WITH OR L IMITS ONE
146-OR MORE MAJOR LIFE A CTIVITIES.
147146
148- (F) (1) AN ENTITY SUBJECT TO THIS SECTION SHALL E STABLISH A
149-PROCESS FOR REQUESTI NG AN EXCEPTION TO A STEP THERAPY OR FAIL –FIRST
150-PROTOCOL THAT IS :
147+ (1) (I) the prescription drug is used to treat the insured’s or enrollee’s 1
148+stage four advanced metastatic cancer; and 2
151149
152- (I) CLEARLY DESCRIBED , INCLUDING THE SPECIF IC
153-INFORMATION AND DOCUMENTATION , IF NEEDED, THAT MUST BE SUBMITT ED BY
154-THE PRESCRIBER TO BE CON SIDERED A COMPLETE S TEP THERAPY EXCEPTIO N
155-REQUEST;
150+ [(2)] (II) use of the prescription drug is: 3
156151
157- (II) EASILY ACCESSIBLE TO THE PRESCRIBER ; AND
152+ [(i)] 1. consistent with the U.S. Food and Drug 4
153+Administration–approved indication or the National Comprehensive Cancer Network 5
154+Drugs & Biologics Compendium indication for the treatment of stage four advanced 6
155+metastatic cancer; and 7
158156
159- (III) POSTED ON THE ENTITY ’S WEBSITE.
157+ [(ii)] 2. supported by peer–reviewed medical literature; OR 8
160158
161- (2) A STEP THERAPY EXCEPTI ON REQUE ST SHALL BE GRANTED IF,
162-BASED ON THE PROFESS IONAL JUDGMENT OF TH E PRESCRIBER AND ANY
163-INFORMATION AND DOCU MENTATION REQUIRED U NDER PARAGRAPH (1)(I) OF THIS
164-SUBSECTION:
159+ (2) THE PRESCRIPTION DRU G IS USED TO TREAT T HE INSURED’S OR 9
160+ENROLLEE’S MENTAL DISORDER OR CONDI TION, AS DEFINED IN THE CU RRENT 10
161+DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS PUBLISHED B Y 11
162+THE AMERICAN PSYCHIATRIC ASSOCIATION, THAT RESULTS IN A SE RIOUS 12
163+FUNCTIONAL IMPAIRMEN T THAT SUBSTANTIALLY INTERFERES WITH OR L IMITS ONE 13
164+OR MORE MAJOR LIFE ACTI VITIES. 14
165165
166- (I) THE STEP THERAPY DRU G IS CONTRAINDICATED OR WILL
167-LIKELY CAUSE AN ADVE RSE REACTION, PHYSICAL HARM , OR MENTAL HARM TO THE
168-INSURED OR ENROLLEE ;
166+ (F) (1) AN ENTITY SUBJECT TO THIS SECTION SHALL E STABLISH A 15
167+PROCESS FOR REQUESTI NG AN EXCEPTION TO A STEP THERAPY OR FAIL –FIRST 16
168+PROTOCOL THAT IS : 17
169169
170- (II) THE STEP THERAPY DRU G IS EXPECTED TO BE INEFFECTIVE
171-BASED ON THE KNOWN C LINICAL CHARACTERIST ICS OF THE INSURED O R ENROLLEE
172-AND THE KNOWN CHARAC TERISTICS OF THE PRE SCRIPTION DRUG REGIM EN;
170+ (I) CLEARLY DESCRIBED , INCLUDING THE SPECIF IC 18
171+INFORMATION AND DOCU MENTATION, IF NEEDED, THAT MUST BE SUBMITT ED BY 19
172+THE PRESCRIBER TO BE CON SIDERED A COMPLETE S TEP THERAPY EXCEPTIO N 20
173+REQUEST; 21
173174
174- (III) THE INSURED OR ENROL LEE IS STABLE ON A P RESCRIPTION
175-DRUG PRESCRIBED FOR THE MEDICAL CONDITIO N UNDER CONSIDERATIO N WHILE
176-COVERED UNDER THE PO LICY OR CONTRACT OF THE ENTITY OR UNDER A PREVIOUS
177-SOURCE OF COVERAGE ; OR
175+ (II) EASILY ACCESSIBLE TO THE PRESCRIBER ; AND 22
178176
179- (IV) WHILE COVERED UNDER THE POLICY OR CONTRACT O F THE
180-ENTITY OR A PREVIOUS SOURCE OF COVERAGE , THE INSURED OR ENROL LEE HAS
181-TRIED A PRESCRIPTION DRUG THAT:
177+ (III) POSTED ON THE ENTITY ’S WEBSITE. 23
182178
183- 1. IS IN THE SAME PHARM ACOLOGIC CLASS OR HA S THE
184-SAME MECHANISM OF AC TION AS THE STEP THE RAPY DRUG; AND
185- WES MOORE, Governor Ch. 365
179+ (2) A STEP THERAPY EXCEPTI ON REQUEST SHALL BE GRANTED IF, 24
180+BASED ON THE PROFESS IONAL JUDGMENT OF TH E PRESCRIBER AND ANY 25
181+INFORMATION AND DOCU MENTATION REQUIRED U NDER PARAGRAPH (1)(I) OF THIS 26
182+SUBSECTION: 27
186183
187-– 5 –
188- 2. WAS DISCONTINUED BY THE PRESCRIBER DUE T O
189-LACK OF EFFICACY OR EFFECTIVENESS , DIMINISHED EFFECT , OR AN ADVERSE
190-EVENT.
184+ (I) THE STEP THERAPY DRU G IS CONTRAINDICATED OR WILL 28
185+LIKELY CAUSE AN ADVE RSE REACTION, PHYSICAL HA RM, OR MENTAL HARM TO THE 29
186+INSURED OR ENROLLEE ; 30
191187
192- (3) AN INSURED OR ENROLLE E MAY APPEAL THE DEC ISION TO DENY
193-A STEP THERAPY EXCEP TION REQUEST UNDER T HIS SECTION.
188+ (II) THE STEP THERAPY DRU G IS EXPECTED TO BE INEFFECTIVE 31
189+BASED ON THE KNOWN C LINICAL CHARACTERIST ICS OF THE INSURED O R ENROLLEE 32
190+AND THE KNOWN CHARAC TERISTICS OF THE PRE SCRIPTION DRUG REGIM EN; 33
191+ HOUSE BILL 785 5
194192
195- (4) (I) A STEP THERAPY EXCEPTION REQUES T OR APPEAL SHALL
196-BE GRANTED:
197193
198- 1. IN REAL TIME IF NO A DDITIONAL INFORMATIO N IS
199-NEEDED BY THE ENTITY TO PROCESS THE REQUE ST AND THE REQUEST M EETS THE
200-ENTITY’S CRITERIA FOR APPRO VAL; OR
194+ (III) THE INSURED OR ENROLLEE IS STABLE ON A PRESC RIPTION 1
195+DRUG PRESCRIBED FOR THE MEDICAL CONDITIO N UNDER CONSIDERATIO N WHILE 2
196+COVERED UNDER THE PO LICY OR CONTRACT OF THE ENTITY OR UNDER A PREVIOUS 3
197+SOURCE OF COVERAGE ; OR 4
201198
202- 2. IF ADDITIONAL INFORM ATION IS NEEDED BY T HE
203-ENTITY TO PROCESS TH E REQUEST AND THE RE QUEST IS NOT URGENT , WITHIN 1
204-BUSINESS DAY AFTER T HE ENTITY RECEIVES A LL RELEVANT INFORMAT ION NEEDED
205-TO PROCESS THE REQUE ST.
199+ (IV) WHILE COVERED UNDER THE POLICY OR CO NTRACT OF THE 5
200+ENTITY OR A PREVIOUS SOURCE OF COVERAGE , THE INSURED OR ENROL LEE HAS 6
201+TRIED A PRESCRIPTION DRUG THAT: 7
206202
207- (II) IF AN ENTITY SUBJECT TO THIS SECTION DOES NOT GRANT
208-OR DENY A STEP THERA PY EXCEPTION REQUEST OR AN APPEAL WITHIN THE TIME
209-PERIOD REQUIRED UNDE R SUBPARAGRAPH (I) OF THIS PARAGRAPH , THE REQUEST
210-OR APPEAL SHALL BE T REATED AS GRANTED .
203+ 1. IS IN THE SAME PHARM ACOLOGIC CLASS OR HA S THE 8
204+SAME MECHANISM OF AC TION AS THE STEP THE RAPY DRUG; AND 9
211205
212- (3) ON GRANTING A STEP TH ERAPY EXCEPTION REQU EST, AN ENTITY
213-SUBJECT TO THIS SECT ION SHALL AUTHORIZE COVERAGE F OR THE PRESCRIPTION
214-DRUG ORDERED BY THE PRESCRIBER FOR AN IN SURED OR ENROLLEE .
206+ 2. WAS DISCONTINUED BY THE PRESCRIBER DUE T O 10
207+LACK OF EFFICACY OR EFFECTIVENESS , DIMINISHED EFFECT , OR AN ADVERSE 11
208+EVENT. 12
215209
216- (4) AN ENROLLEE OR INSURE D MAY APPEAL A STEP THERAPY
217-EXCEPTION REQUEST DE NIAL IN ACCORDANCE W ITH SUBTITLE 10A OR SUBTITLE
218-10B OF THIS TITLE.
210+ (3) AN INSURED OR ENROLLE E MAY APPEAL THE DEC ISION TO DENY 13
211+A STEP THERAPY EXCEP TION REQUEST UNDER T HIS SECTION. 14
219212
220- (5) THIS SUBSECTION MAY NOT B E CONSTRUED TO PREVENT:
213+ (4) (I) A STEP THERAPY EXCEPTION REQUES T OR APPEAL SHALL 15
214+BE GRANTED: 16
221215
222- (I) PREVENT:
216+ 1. IN REAL TIME IF NO A DDITIONAL INFORMATIO N IS 17
217+NEEDED BY THE ENTITY TO PROCESS THE REQUE ST AND THE REQUEST M EETS THE 18
218+ENTITY’S CRITERIA FOR APPRO VAL; OR 19
223219
224- 1. AN ENTITY SUBJECT TO THIS SECTION FROM
225-REQUIRING AN INSURED OR ENROLLEE TO TRY A N AB–RATED GENERIC
226-EQUIVALENT OR INTERC HANGEABLE BIOLOGICAL PRODUCT BEFORE PROVI DING
227-COVERAGE FOR THE EQUIVALENT BRANDED P RESCRIPTION DRUG ; OR
220+ 2. IF ADDITIONAL INFORM ATION IS NEEDED BY T HE 20
221+ENTITY TO PROCESS TH E REQUEST AND THE RE QUEST IS NOT URGENT , WITHIN 1 21
222+BUSINESS DAY AFTER T HE ENTITY RECEIVES A LL RELEVANT INFORMAT ION NEEDED 22
223+TO PROCESS THE REQUE ST. 23
228224
229- (II) 2. A HEALTH CARE PROVID ER FROM PRESCRIBING A
230-PRESCRIPTION DRUG TH AT IS DETERMINED TO BE MEDICALLY APPROPR IATE; OR
231- Ch. 365 2023 LAWS OF MARYLA ND
225+ (II) IF AN ENTITY SUBJECT TO THIS SECTION DOES NOT GRANT 24
226+OR DENY A STEP THERA PY EXCEPTION REQUEST OR AN APPEAL WITHIN THE TI ME 25
227+PERIOD REQUIRED UNDE R SUBPARAGRAPH (I) OF THIS PARAGRAPH , THE REQUEST 26
228+OR APPEAL SHALL BE T REATED AS GRANTED . 27
232229
233-– 6 –
234- (II) REQUIRE AN ENTITY SU BJECT TO THIS SECTIO N TO
235-PROVIDE COVERAGE FOR A PRESCRIPTION DRUG THAT IS NOT COV ERED BY A
236-POLICY OR CONTRACT O F THE ENTITY.
230+ (3) ON GRANTING A STEP TH ERAPY EXCEPTION REQU EST, AN ENTITY 28
231+SUBJECT TO THIS SECT ION SHALL AUTHORIZE COVERAGE FOR THE PRE SCRIPTION 29
232+DRUG ORDERED BY THE PRESCRIBER FOR AN IN SURED OR ENROLLEE . 30
237233
238- (6) AN ENTITY SUBJECT TO THIS SECTION MAY USE AN EXISTING STEP
239-THERAPY EXCEPTION PR OCESS THAT SATISFIES THE REQUIREMENTS UND ER THIS
240-SUBSECTION.
234+ (4) AN ENROLLEE OR INSURE D MAY APPEAL A STEP THERAPY 31
235+EXCEPTION REQUEST DE NIAL IN ACCORDANCE W ITH SUBTITLE 10A OR SUBTITLE 32
236+10B OF THIS TITLE. 33
237+ 6 HOUSE BILL 785
241238
242-15–854.
243239
244- (a) (1) This section applies to:
240+ (5) THIS SUBSECTION MAY NOT BE CONSTRUED TO PREVENT: 1
245241
246- (i) insurers and nonprofit health service plans that provide coverage
247-for prescription drugs through a pharmacy benefit under individual, group, or blanket
248-health insurance policies or contracts that are issued or delivered in the State; and
242+ (I) PREVENT: 2
249243
250- (ii) health maintenance organizations that provide coverage for
251-prescription drugs through a pharmacy benefit under individual or group contracts that
252-are issued or delivered in the State.
244+ 1. AN ENTITY SUBJECT TO THIS SECTION FROM 3
245+REQUIRING AN INSURED OR ENROLLEE TO TRY A N AB–RATED GENERIC 4
246+EQUIVALENT OR INTERC HANGEABLE BIOLOGICAL PRODUCT BEFORE PROVI DING 5
247+COVERAGE FOR THE EQU IVALENT BRANDED PRESCRIPTION DRUG; OR 6
253248
254- (2) An insurer, a nonprofit health service plan, or a health maintenance
255-organization that provides coverage for prescription drugs through a pharmacy benefits
256-manager or that contracts with a private review agent under Subtitle 10B of this article is
257-subject to the requirements of this section.
249+ (II) 2. A HEALTH CARE PROVID ER FROM PRESCRIBING A 7
250+PRESCRIPTION DRUG TH AT IS DETERMINED TO BE MEDICALLY APPROPR IATE; OR 8
258251
259- (3) This section does not apply to a managed care organization as defined
260-in § 15–101 of the Health – General Article.
252+ (II) REQUIRE AN ENTITY SU BJECT TO THIS SECTIO N TO 9
253+PROVIDE COVERAGE FOR A PRESCRIPTION DRUG THAT IS NOT COVERED BY A 10
254+POLICY OR CONTRACT O F THE ENTITY. 11
261255
262- (G) (1) EXCEPT AS PROVIDED IN PARAGRAPH (2) OF THIS SUBSECTION ,
263-AN ENTITY SUBJECT TO THIS SECTION MAY NOT REQUIRE MORE THAN ON E PRIOR
264-AUTHORIZATION IF T WO OR MORE TABLETS O F DIFFERENT DOSAGE S TRENGTHS OF
265-THE SAME PRESCRIPTIO N DRUG ARE:
256+ (6) AN ENTITY SUBJECT TO THIS SECTION MAY USE AN EXISTING STEP 12
257+THERAPY EXCEPTION PR OCESS THAT SATISFIES THE REQUIREMENTS UND ER THIS 13
258+SUBSECTION. 14
266259
267- (I) PRESCRIBED AT THE SA ME TIME AS PART OF A N INSURED’S
268-TREATMENT PLAN ; AND
260+15–854. 15
269261
270- (II) MANUFACTURED BY THE SAME MANUFACTURER .
262+ (a) (1) This section applies to: 16
271263
272- (2) THIS SUBSECTION DOES NOT PROHIBIT AN ENTITY FROM
273-REQUIRING MORE THAN ONE PRIOR AUTHORIZAT ION IF THE PRESCRIPT ION IS FOR
274-TWO OR MORE TABLETS OF DIFFERENT DOSAGE STRENGTHS OF AN OPIO ID THAT IS
275-NOT AN OPIOID PARTIA L AGONIST.
264+ (i) insurers and nonprofit health service plans that provide coverage 17
265+for prescription drugs through a pharmacy benefit under individual, group, or blanket 18
266+health insurance policies or contracts that are issued or delivered in the State; and 19
276267
277-15–10B–06.
278- WES MOORE, Governor Ch. 365
268+ (ii) health maintenance organizations that provide coverage for 20
269+prescription drugs through a pharmacy benefit under individual or group contracts that 21
270+are issued or delivered in the State. 22
279271
280-– 7 –
281- (a) (1) [A] EXCEPT AS PROVIDED IN PARAGRAPH (4) OF THIS
282-SUBSECTION, A private review agent shall:
272+ (2) An insurer, a nonprofit health service plan, or a health maintenance 23
273+organization that provides coverage for prescription drugs through a pharmacy benefits 24
274+manager or that contracts with a private review agent under Subtitle 10B of this article is 25
275+subject to the requirements of this section. 26
283276
284- (i) make all initial determinations on whether to authorize or certify
285-a nonemergency course of treatment for a patient within 2 working days after receipt of the
286-information necessary to make the determination;
277+ (3) This section does not apply to a managed care organization as defined 27
278+in § 15–101 of the Health – General Article. 28
287279
288- (ii) make all determinations on whether to authorize or certify an
289-extended stay in a health care facility or additional health care services within 1 working
290-day after receipt of the information necessary to make the determination; and
280+ (G) (1) EXCEPT AS PROVIDED IN PARAGRAPH (2) OF THIS SUBSECTION , 29
281+AN ENTITY SUBJECT TO THIS SECTION MAY NOT REQUIRE MORE THAN ON E PRIOR 30
282+AUTHORIZATION IF TWO OR MORE TABLETS OF DIFFERENT DOSAGE STRENGTHS OF 31
283+THE SAME PRESCRIPTIO N DRUG ARE: 32
284+ HOUSE BILL 785 7
291285
292- (iii) promptly notify the health care provider of the determination.
293286
294- (2) If within 3 calendar days after receipt of the initial request for health
295-care services the private review agent does not have sufficient information to make a
296-determination, the private review agent shall inform the health care provider that
297-additional information must be provided.
287+ (I) PRESCRIBED AT THE SA ME TIME AS PART OF A N INSURED’S 1
288+TREATMENT PLAN ; AND 2
298289
299- (3) If a private review agent requires prior authorization for an emergency
300-inpatient admission, or an admission for residential crisis services as defined in § 15–840
301-of this title, for the treatment of a mental, emotional, or substance abuse disorder, the
302-private review agent shall:
290+ (II) MANUFACTURED BY THE SAME MANUFACTURER . 3
303291
304- (i) make all determinations on whether to authorize or certify an
305-inpatient admission, or an admission for residential crisis services as defined in § 15–840
306-of this title, within 2 hours after receipt of the information necessary to make the
307-determination; and
292+ (2) THIS SUBSECTION DOES NOT PROHIBIT AN ENTI TY FROM 4
293+REQUIRING MORE THAN ONE PRIOR AUTHORIZAT ION IF THE PRESCRIPT ION IS FOR 5
294+TWO OR MORE TABLETS OF DIFFERENT DOSAGE STRENGTHS OF AN OPIO ID THAT IS 6
295+NOT AN OPIOID PARTIA L AGONIST. 7
308296
309- (ii) promptly notify the health care provider of the determination.
297+15–10B–06. 8
310298
311- (4) FOR A STEP THERAPY EX CEPTION REQUEST SUBM ITTED
312-ELECTRONICALLY IN AC CORDANCE WITH A PROC ESS ESTABLISHED UNDE R §
313-15–142(F) OF THIS TITLE OR A P RIOR AUTHORIZATION R EQUEST SUBMITTED
314-ELECTRONICALLY FOR P HARMACEUTICAL SERVIC ES, A PRIVATE REVIEW AGE NT
315-SHALL MAKE A DETERMINATION :
299+ (a) (1) [A] EXCEPT AS PROVIDED IN PARAGRAPH (4) OF THIS 9
300+SUBSECTION, A private review agent shall: 10
316301
317- (I) IN REAL TIME IF:
302+ (i) make all initial determinations on whether to authorize or certify 11
303+a nonemergency course of treatment for a patient within 2 working days after receipt of the 12
304+information necessary to make the determination; 13
318305
319- 1. NO ADDITIONAL INFORM ATION IS NEEDED BY T HE
320-PRIVATE REVIEW AGENT TO PROCESS THE REQUE ST; AND
306+ (ii) make all determinations on whether to authorize or certify an 14
307+extended stay in a health care facility or additional health care services within 1 working 15
308+day after receipt of the information necessary to make the determination; and 16
321309
322- 2. THE REQUEST MEETS TH E PRIVATE REVIEW AGE NT’S
323-CRITERIA FOR APPROVA L; OR
324- Ch. 365 2023 LAWS OF MARYLA ND
310+ (iii) promptly notify the health care provider of the determination. 17
325311
326-– 8 –
327- (II) IF A REQUEST IS NOT APPROVED UNDER ITEM (I) OF THIS
328-PARAGRAPH , WITHIN 1 BUSINESS DAY AFTER T HE PRIVATE REVIEW AG ENT
329-RECEIVES ALL OF THE INFORMATION NECESSAR Y TO MAKE THE DETERM INATION.
312+ (2) If within 3 calendar days after receipt of the initial request for health 18
313+care services the private review agent does not have sufficient information to make a 19
314+determination, the private review agent shall inform the health care provider that 20
315+additional information must be provided. 21
330316
331- SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all
332-policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or
333-after January 1, 2024.
317+ (3) If a private review agent requires prior authorization for an emergency 22
318+inpatient admission, or an admission for residential crisis services as defined in § 15–840 23
319+of this title, for the treatment of a mental, emotional, or substance abuse disorder, the 24
320+private review agent shall: 25
334321
335- SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect
336-January 1, 2024.
322+ (i) make all determinations on whether to authorize or certify an 26
323+inpatient admission, or an admission for residential crisis services as defined in § 15–840 27
324+of this title, within 2 hours after receipt of the information necessary to make the 28
325+determination; and 29
337326
338-Approved by the Governor, May 3, 2023.
327+ (ii) promptly notify the health care provider of the determination. 30
328+
329+ (4) FOR A STEP THERAPY EX CEPTION REQUEST SUBM ITTED 31
330+ELECTRONICALLY IN ACCOR DANCE WITH A PROCESS ESTABLISHED UNDER § 32
331+15–142(F) OF THIS TITLE OR A P RIOR AUTHORIZATION R EQUEST SUBMITTED 33 8 HOUSE BILL 785
332+
333+
334+ELECTRONICALLY FOR P HARMACEUTICAL SERVIC ES, A PRIVATE REVIEW AGE NT 1
335+SHALL MAKE A DETERMI NATION: 2
336+
337+ (I) IN REAL TIME IF: 3
338+
339+ 1. NO ADDITIONAL INFORM ATION IS NEEDED BY T HE 4
340+PRIVATE REVIEW AGENT TO PROCESS THE REQUE ST; AND 5
341+
342+ 2. THE REQUEST MEETS TH E PRIVATE REVIEW AGE NT’S 6
343+CRITERIA FOR APPROVA L; OR 7
344+
345+ (II) IF A REQUEST IS NOT APPROVED UNDER ITEM (I) OF THIS 8
346+PARAGRAPH , WITHIN 1 BUSINESS DAY AFTER THE PRIVATE REVIEW AGENT 9
347+RECEIVES ALL OF THE INFORMATION NECESSAR Y TO MAKE THE DETERM INATION. 10
348+
349+ SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 11
350+policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 12
351+after January 1, 2024. 13
352+
353+ SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take e ffect 14
354+January 1, 2024. 15
355+
356+
357+
358+
359+Approved:
360+________________________________________________________________________________
361+ Governor.
362+________________________________________________________________________________
363+ Speaker of the House of Delegates.
364+________________________________________________________________________________
365+ President of the Senate.