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Maryland House Bill HB1274

Maryland 2022 Regular Session

Maryland House Bill HB1274 Compare Versions

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1- LAWRENCE J. HOGAN, JR., Governor Ch. 365
21
3-– 1 –
4-Chapter 365
5-(House Bill 1274)
62
7-AN ACT concerning
3+EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G 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+ *hb1274*
89
9-Prescription Drugs – Pharmacy Benefits Managers and Purchasers – Federal
10-340B Program
10+HOUSE BILL 1274
11+J5 2lr2276
1112
12-FOR the purpose of establishing requirements and prohibitions on pharmacy benefits
13-managers and purchasers related to the federal 340B Program, including
14-requirements related to coverage and reimbursement for drugs purchased under the
15-Program; and generally relating to prescription drugs, purchasers, and pharmacy
16-benefits managers.
13+By: Delegate Kipke
14+Introduced and read first time: February 11, 2022
15+Assigned to: Health and Government Operations
16+Committee Report: Favorable with amendments
17+House action: Adopted
18+Read second time: March 26, 2022
1719
18-BY adding to
19- Article – Insurance
20-Section 15–1611.2
21- Annotated Code of Maryland
22- (2017 Replacement Volume and 2021 Supplement)
20+CHAPTER ______
2321
24- SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
25-That the Laws of Maryland read as follows:
22+AN ACT concerning 1
2623
27-Article – Insurance
24+Prescription Drugs – Pharmacy Benefits Managers and Purchasers – Federal 2
25+340B Program 3
2826
29-15–1611.2.
27+FOR the purpose of establishing requirements and prohibitions on pharmacy benefits 4
28+managers and purchasers related to the federal 340B Program, including 5
29+requirements related to coverage and reimbursement for drugs purchased under the 6
30+Program; and generally relating to prescription drugs, purchasers, and pharmacy 7
31+benefits managers. 8
3032
31- (A) (1) IN THIS SECTION, THE FOLLOWING WORDS HAVE THE MEANINGS
32-INDICATED.
33+BY adding to 9
34+ Article – Insurance 10
35+Section 15–1611.2 11
36+ Annotated Code of Maryland 12
37+ (2017 Replacement Volume and 2021 Supplement) 13
3338
34- (2) “COVERED ENTITY ” HAS THE MEANING STAT ED IN § 602 OF THE
35-FEDERAL VETERANS HEALTH CARE ACT OF 1992.
39+ SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 14
40+That the Laws of Maryland read as follows: 15
3641
37- (3) “PHARMACIES OR PHARMAC ISTS THAT PARTICIPAT E IN THE 340B
38-PROGRAM” MEANS:
42+Article – Insurance 16
3943
40- (I) A PHARMACY OWNED OR OPERATED BY A COVERE D ENTITY
41-THAT IS ELIGIBLE TO OR IS ACTIVELY PAR TICIPATING IN THE 340B PROGRAM; OR
44+15–1611.2. 17
4245
43- (II) A PHARMACY OR PHARMA CIST UNDER CONTRACT WITH A
44-COVERED ENTITY TO DI SPENSE DRUGS PURCHAS ED UNDER THE 340B PROGRAM TO
45-PATIENTS OF THE COVE RED ENTITY.
46- Ch. 365 2022 LAWS OF MARYLAND
46+ (A) (1) IN THIS SECTION, THE FOLLOWING WORDS HAVE THE MEANINGS 18
47+INDICATED. 19
48+ 2 HOUSE BILL 1274
4749
48-– 2 –
49- (4) “340B PROGRAM” MEANS THE DRUG PRICI NG PROGRAM
50-ESTABLISHED UNDER § 602 OF THE FEDERAL VETERANS HEALTH CARE ACT OF
51-1992.
5250
53- (B) BEFORE ALLOWING A BEN EFICIARY TO USE A MA IL–ORDER PHARMACY
54-THAT PARTICIPATES IN THE 340B PROGRAM, A PHARMACY BENEFITS MANAGER OR
55-A PURCHASER SHALL OB TAIN A SIGNED WAIVER FROM THE BENEFICIA RY STATING
56-THAT THE BENEFICIARY IS NOT REQUIRED TO U SE THE MAIL–ORDER PHARMACY .
51+ (2) “COVERED ENTITY ” HAS THE MEANING STAT ED IN § 602 OF THE 1
52+FEDERAL VETERANS HEALTH CARE ACT OF 1992. 2
5753
58- (C) (B) A PHARMACY BENEFITS MA NAGER OR A PURCHASER SHALL:
54+ (3) “PHARMACIES OR PHARMAC ISTS THAT PARTICIPAT E IN THE 340B 3
55+PROGRAM” MEANS: 4
5956
60- (1) MAKE FORMULARY AND C OVERAGE DECISIONS FO R A PHARMACY
61-OR PHARMACIST THAT P ARTICIPATES IN THE 340B PROGRAM BASED ON THE
62-NORMAL COURSE OF BUS INESS OF THE PHARMAC Y BENEFITS MANAGER OR
63-PURCHASER ; AND
57+ (I) A PHARMACY OWNED OR OPERATED BY A COVERE D ENTITY 5
58+THAT IS ELIGIBLE TO OR IS ACTIVELY PAR TICIPATING IN THE 340B PROGRAM; OR 6
6459
65- (2) ALLOW A BENEFICIARY TO USE ANY IN–NETWORK PHARMACY OR
66-PHARMACIST THAT THE BENEFICIARY CHOOSES , WITHOUT REGARD TO WH ETHER
67-THE PHARMACY OR PHAR MACIST PARTICIPATES IN 340B PROGRAM.
60+ (II) A PHARMACY OR PHARMA CIST UNDER CONTRACT WITH A 7
61+COVERED ENTITY TO DI SPENSE DRUGS PURCHAS ED UNDER THE 340B PROGRAM TO 8
62+PATIENTS OF THE COVE RED ENTITY. 9
6863
69- (D) (C) A PHARMACY BENEFITS MA NAGER OR A PURCHASER MAY NOT:
64+ (4) “340B PROGRAM” MEANS THE DRUG PRICI NG PROGRAM 10
65+ESTABLISHED UNDER § 602 OF THE FEDERAL VETERANS HEALTH CARE ACT OF 11
66+1992. 12
7067
71- (1) TRANSFER 340B PROGRAM SAVINGS FROM A PHARMACY OR
72-PHARMACIST THAT PARTI CIPATES IN THE 340B PROGRAM TO A PHARMACY
73-BENEFITS MANAGER OR PURCHASER ;
68+ (B) BEFORE ALLOWING A BEN EFICIARY TO USE A MA IL–ORDER PHARMACY 13
69+THAT PARTICIPATES IN THE 340B PROGRAM, A PHARMACY BENEFITS MANAGER OR 14
70+A PURCHASER SHALL OB TAIN A SIGNED WAIVER FROM THE BENEFICIA RY STATING 15
71+THAT THE BENEFICIARY IS NOT REQUIRED TO U SE THE MAIL–ORDER PHARMACY . 16
7472
75- (2) OFFER LOWER REIMBURS EMENT FOR A PRESCRIP TION DRUG
76-PURCHASED UNDER THE 340B PROGRAM THAN THE REIM BURSEMENT IT OFFERS
77-FOR THE SAME PRESCRI PTION DRUG IF IT IS NOT PURCHASED UNDER THE 340B
78-PROGRAM;
73+ (C) (B) A PHARMACY BENEFITS MA NAGER OR A PURCHASER SHALL: 17
7974
80- (3) REFUSE TO COVER PRES CRIPTION DRUGS PURCH ASED UNDER
81-THE 340B PROGRAM;
75+ (1) MAKE FORMULARY AND C OVERAGE DECISIONS FO R A PHARMACY 18
76+OR PHARMACIST THAT P ARTICIPATES IN THE 340B PROGRAM BASE D ON THE 19
77+NORMAL COURSE OF BUS INESS OF THE PHARMAC Y BENEFITS MANAGER OR 20
78+PURCHASER ; AND 21
8279
83- (4) REFUSE TO ALLOW PHAR MACIES OR PHARMACIST S THAT
84-PARTICIPATE IN THE 340B PROGRAM TO PARTICIPAT E IN THE PHARMACY BE NEFITS
85-MANAGER’S PURCHASER’S NETWORK ON THE SOLE BASIS TH AT THE PHARMACY OR
86-PHARMACIST PARTICIPA TES IN THE 340B PROGRAM;
80+ (2) ALLOW A BENEFICIARY TO USE ANY IN–NETWORK PHARMACY OR 22
81+PHARMACIST THAT THE BENEFICIARY CHOOSES , WITHOUT REGARD TO WH ETHER 23
82+THE PHARMACY OR PHAR MACIST PARTICIPATES IN 340B PROGRAM. 24
8783
88- (5) CHARGE MORE THAN FAI R MARKET VALUE OR SE EK PROFIT
89-SHARING IN EXCHANGE FOR COVERAGE OF SERV ICES FOR A PHARMACY OR
90-PHARMACIST THAT PART ICIPATES IN THE 340B PROGRAM;
91- LAWRENCE J. HOGAN, JR., Governor Ch. 365
84+ (D) (C) A PHARMACY BENEFITS MA NAGER OR A PURCHASER MAY NOT: 25
9285
93-– 3 –
94- (6) REQUIRE, AS A CONDITION OF CO VERAGE, THAT A BENEFICIARY
95-USE A SPECIFIED MAIL –ORDER PHARMACY OR PH ARMACIST THAT PARTIC IPATES IN
96-THE 340B PROGRAM OR OTHERWISE COERCE A BENEFICIARY INTO USING A
97-SPECIFIC MAIL–ORDER PHARMACY OR PH ARMACIST THAT PARTICIPATES IN THE
98-340B PROGRAM;
86+ (1) TRANSFER 340B PROGRAM SAVINGS FROM A PHARMACY OR 26
87+PHARMACIST THAT PARTI CIPATES IN THE 340B PROGRAM TO A PHARMACY 27
88+BENEFITS MANAGER OR PURCHASER ; 28
9989
100- (7) (5) IMPOSE DIFFERENT REIMBURSEMENT OR NET WORK
101-PARTICIPATION CONTRACT TERMS ON PH ARMACIES OR PHARMACI STS THAT
102-PARTICIPATE IN A PHA RMACY BENEFITS MANAG ER’S OR PURCHASER ’S NETWORK
103-BASED ON WHETHER A P HARMACY OR PH ARMACIST PARTICIPATE S IN THE 340B
104-PROGRAM;
90+ (2) OFFER LOWER REIMBURS EMENT FOR A PRESCRIP TION DRUG 29
91+PURCHASED UNDER THE 340B PROGRAM THAN THE REIM BURSEMENT IT OFFERS 30
92+FOR THE SAME PRESCRI PTION DRUG IF IT IS NOT PURCHASED UNDER THE 340B 31
93+PROGRAM; 32
94+ HOUSE BILL 1274 3
10595
106- (8) REQUIRE A PHARMACY O R PHARMACIST TO REVE RSE, RESUBMIT,
107-OR CLARIFY A 340B PROGRAM CLAIM AFTER T HE INITIAL ADJUDICAT ION, UNLESS
108-THE ACTIONS ARE IN T HE NORMAL COURSE OF BUSINESS OF THE PHAR MACY
109-BENEFITS MANAGER OR PURCHASER AND ARE NOT RELATED TO WHETHER THE
110-PHARMACY OR PHARMACI ST PARTICIPATES IN T HE 340B PROGRAM;
11196
112- (9) REQUIRE A BILLING MO DIFIER TO INDICATE T HAT THE CLAIM FOR
113-A PRESCRIPTION DRUG IS A 340B PROGRAM CLAIM , UNLESS THE PRESCRIPT ION
114-DRUG IS BEING BILLED TO THE MARYLAND MEDICAL ASSISTANCE PROGRAM OR A
115-MANAGED CARE ORGANIZ ATION;
97+ (3) REFUSE TO COVER PRES CRIPTION DRUGS PURCH ASED UNDER 1
98+THE 340B PROGRAM; 2
11699
117- (6) IMPOSE DIFFERENT FEE S, CHARGEBACKS , OR OTHER
118-ADJUSTMENTS ON PHARM ACIES OR PHARMACISTS BASED ON WHETHER A
119-PHARMACY OR PHARMACI ST PARTICIPATES IN T HE 340B PROGRAM;
100+ (4) REFUSE TO ALLOW PHAR MACIES OR PHARMACIST S THAT 3
101+PARTICIPATE IN THE 340B PROGRAM TO PARTICIPAT E IN THE PHARMACY BE NEFITS 4
102+MANAGER’S PURCHASER ’S NETWORK ON THE SOLE BASIS TH AT THE PHARMACY OR 5
103+PHARMACIST PARTICIPA TES IN THE 340B PROGRAM; 6
120104
121- (10) (7) MODIFY A BENEFICIARY ’S COPAYMENT ON THE B ASIS OF
122-WHETHER A PHARMACY O R PHARMACIST PARTICI PATES IN THE 340B PROGRAM;
105+ (5) CHARGE MORE THAN FAI R MARKET VALUE OR SE EK PROFIT 7
106+SHARING IN EXCHANGE FOR COVERAGE OF SERV ICES FOR A PHARMACY OR 8
107+PHARMACIST THAT PART ICIPATES IN THE 340B PROGRAM; 9
123108
124- (11) (8) ESTABLISH OR SET NET WORK ADEQUACY REQUIR EMENTS
125-BASED ON WHETHER A P HARMACY OR PHARMACIS T PARTICIPATES IN TH E 340B
126-PROGRAM; OR
109+ (6) REQUIRE, AS A CONDITION OF CO VERAGE, THAT A BENEFICIARY 10
110+USE A SPECIFIED MAIL –ORDER PHARMACY OR PH ARMACIST THAT PARTIC IPATES IN 11
111+THE 340B PROGRAM OR OTHERWISE COERCE A BENEFICIARY INTO USING A 12
112+SPECIFIC MAIL–ORDER PHARMACY OR PH ARMACIST THAT PARTICIPATE S IN THE 13
113+340B PROGRAM; 14
127114
128- (12) (9) PROHIBIT AN A COVERED ENTITY AUTHORIZED TO
129-PARTICIPATE IN THE 340B PROGRAM OR A PHARMACY OR PHARMACIST UNDER
130-CONTRACT WITH AN A COVERED ENTITY AUTHORIZED TO PARTICIPATE IN THE 340B
131-PROGRAM FROM PARTICIP ATING IN THE PHARMAC Y BENEFITS MANAGER ’S OR
132-PURCHASER ’S NETWORK ON THE BASIS OF THE COVERED ENTITY’S PARTICIPATION
133-IN THE 340B PROGRAM.
115+ (7) (5) IMPOSE DIFFERENT REIMBURSEMENT OR NET WORK 15
116+PARTICIPATION CONTRACT TERMS ON PH ARMACIES OR PHARMACI STS THAT 16
117+PARTICIPATE IN A PHA RMACY BENEFITS MANAG ER’S OR PURCHASER ’S NETWORK 17
118+BASED ON WHETHER A P HARMACY O R PHARMACIST PARTICI PATES IN THE 340B 18
119+PROGRAM; 19
134120
135- (E) (D) A PHARMACY BENEFITS MA NAGER OR PURCHASER MAY NOT BASE
136-A FORMULARY OR PRESCRI PTION DRUG COVERAGE DECISIONS ON:
137- Ch. 365 2022 LAWS OF MARYLAND
121+ (8) REQUIRE A PHARMACY O R PHARMACIST TO REVE RSE, RESUBMIT, 20
122+OR CLARIFY A 340B PROGRAM CLAIM AFTER T HE INITIAL ADJUDICAT ION, UNLESS 21
123+THE ACTIONS ARE IN T HE NORMAL COURSE OF BUSINESS OF THE PHAR MACY 22
124+BENEFITS MANAGER OR PURCHASER AND ARE NOT RELATED TO WHETHER THE 23
125+PHARMACY OR PHARMACI ST PARTICIPATES IN T HE 340B PROGRAM; 24
138126
139-– 4 –
140- (1) THE PRICE OF THE PRE SCRIPTION DRUG UNDER THE 340B
141-PROGRAM; OR
127+ (9) REQUIRE A BILLING MO DIFIER TO INDICATE T HAT THE CLAIM FOR 25
128+A PRESCRIPTION DRUG IS A 340B PROGRAM CLAIM , UNLESS THE PRESCRIPT ION 26
129+DRUG IS BEING BILLED TO THE MARYLAND MEDICAL ASSISTANCE PROGRAM OR A 27
130+MANAGED CARE ORGANIZ ATION; 28
142131
143- (2) WHETHER THE DISPENSI NG PHARMACY OR PHARM ACIST
144-PARTICIPATES IN THE 340B PROGRAM.
132+ (6) IMPOSE DIFFERENT FEE S, CHARGEBACKS , OR OTHER 29
133+ADJUSTMENTS ON PHARM ACIES OR PHARMACISTS BASED ON WHETHER A 30
134+PHARMACY OR PHARMACI ST PARTICIPATES IN T HE 340B PROGRAM; 31
145135
146- (F) A 340B PROGRAM CLAIM PROCESS ED BY A PHARMACY OR PHARMACIST
147-THAT PARTICIPATES IN THE 340B PROGRAM IS FINAL AT T HE POINT OF
148-ADJUDICATION .
136+ (10) (7) MODIFY A BENEFICIARY ’S COPAYMENT ON THE B ASIS OF 32
137+WHETHER A PHARMACY O R PHARMACIST PARTICI PATES IN THE 340B PROGRAM; 33
138+ 4 HOUSE BILL 1274
149139
150- (G) THE ADMINISTRATION SHALL ADOPT REGULATIONS TO CARRY OUT
151-THIS SECTION.
152140
153- SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect
154-October 1, 2022.
141+ (11) (8) ESTABLISH OR SET NET WORK ADEQUACY REQUIR EMENTS 1
142+BASED ON WHETHER A P HARMACY OR PHARMACIS T PARTICIPATES IN TH E 340B 2
143+PROGRAM; OR 3
155144
156-Approved by the Governor, May 16, 2022.
145+ (12) (9) PROHIBIT AN A COVERED ENTITY AUTHORIZED TO 4
146+PARTICIPATE IN THE 340B PROGRAM OR A PHARMACY OR PHARMACIST UNDER 5
147+CONTRACT WITH AN A COVERED ENTITY AUTHORIZED TO PARTICIPATE IN THE 340B 6
148+PROGRAM FROM PARTICIP ATING IN THE PHARMAC Y BENEFITS MANAGER ’S OR 7
149+PURCHASER ’S NETWORK ON THE BASIS OF THE COVERED ENTITY’S PARTICIPATION 8
150+IN THE 340B PROGRAM. 9
151+
152+ (E) (D) A PHARMACY BENEFITS MA NAGER OR PURCHASER MAY NOT BASE 10
153+A FORMULARY OR PRESCRI PTION DRUG COVERAGE DECISIONS ON: 11
154+
155+ (1) THE PRICE OF THE PRE SCRIPTION DRUG UNDER THE 340B 12
156+PROGRAM; OR 13
157+
158+ (2) WHETHER THE DISPENSI NG PHARMACY OR PHARM ACIST 14
159+PARTICIPATES IN THE 340B PROGRAM. 15
160+
161+ (F) A 340B PROGRAM CLAIM PROCESS ED BY A PHARMACY OR PHARMACIST 16
162+THAT PARTICIPATES IN THE 340B PROGRAM IS FINAL AT T HE POINT OF 17
163+ADJUDICATION . 18
164+
165+ (G) THE ADMINISTRATION SHALL ADOPT REGULATIONS TO CARRY OUT 19
166+THIS SECTION. 20
167+
168+ SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 21
169+October 1, 2022. 22
170+
171+
172+
173+
174+Approved:
175+________________________________________________________________________________
176+ Governor.
177+________________________________________________________________________________
178+ Speaker of the House of Delegates.
179+________________________________________________________________________________
180+ President of the Senate.