| Old | New | Differences | |
|---|---|---|---|
| 1 | 1 | ||
| 2 | 2 | ||
| 3 | 3 | EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW. | |
| 4 | 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 | 5 | *hb0357* | |
| 9 | 6 | ||
| 10 | 7 | HOUSE BILL 357 | |
| 11 | 8 | C3 3lr0778 | |
| 12 | - | HB 1014/22 – HGO CF SB 898 | |
| 13 | - | By: Delegate Kipke Delegates Kipke, Alston, Bagnall, Bhandari, Chisholm, | |
| 14 | - | Cullison, Guzzone, Hill, Hutchinson, S. Johnson, Kaiser, Kerr, R. Lewis, | |
| 15 | - | Lopez, Martinez, M. Morgan, Pena–Melnyk, Reilly, Rosenberg, Szeliga, | |
| 16 | - | Taveras, White, and Woods | |
| 9 | + | HB 1014/22 – HGO | |
| 10 | + | By: Delegate Kipke | |
| 17 | 11 | Introduced and read first time: January 26, 2023 | |
| 18 | 12 | Assigned to: Health and Government Operations | |
| 19 | - | Committee Report: Favorable with amendments | |
| 20 | - | House action: Adopted | |
| 21 | - | Read second time: March 5, 2023 | |
| 22 | 13 | ||
| 23 | - | ||
| 14 | + | A BILL ENTITLED | |
| 24 | 15 | ||
| 25 | 16 | AN ACT concerning 1 | |
| 26 | 17 | ||
| 27 | - | Pharmacy Benefits Managers – Definitions Definition of Carrier, ERISA, and 2 | |
| 28 | - | Purchaser and Alteration of Application of Law 3 | |
| 18 | + | Pharmacy Benefits Managers – Definitions of Carrier, ERISA, and Purchaser 2 | |
| 29 | 19 | ||
| 30 | - | FOR the purpose of repealing the definitions of “carrier” and “ERISA” and altering the 4 | |
| 31 | - | definition altering the definition of “purchaser” for the purpose of applying certain 5 | |
| 32 | - | provisions of State insurance law governing pharmacy benefits managers to certain 6 | |
| 33 | - | persons that provide prescription drug coverage or benefits in the State through 7 | |
| 34 | - | plans or programs subject to the federal Employee Retirement Income Security Act 8 | |
| 35 | - | of 1974 (ERISA) exclude certain nonprofit health maintenance organizations; 9 | |
| 36 | - | repealing a certain provision provisions that restricts restrict the applicability of 10 | |
| 37 | - | certain provisions of law to pharmacy benefits managers that provide pharmacy 11 | |
| 38 | - | benefits management services on behalf of a carrier; and generally relating to 12 | |
| 39 | - | pharmacy benefits managers. 13 | |
| 20 | + | FOR the purpose of repealing the definitions of “carrier” and “ERISA” and altering the 3 | |
| 21 | + | definition of “purchaser” for the purpose of applying certain provisions of State 4 | |
| 22 | + | insurance law governing pharmacy benefits managers to certain persons that 5 | |
| 23 | + | provide prescription drug coverage or benefits in the State through plans or 6 | |
| 24 | + | programs subject to the federal Employee Retirement Income Security Act of 1974 7 | |
| 25 | + | (ERISA); repealing a certain provision that restricts applicability of certain 8 | |
| 26 | + | provisions of law to pharmacy benefits managers that provide pharmacy benefits 9 | |
| 27 | + | management services on behalf of a carrier; and generally relating to pharmacy 10 | |
| 28 | + | benefits managers. 11 | |
| 40 | 29 | ||
| 41 | - | BY repealing and reenacting, with amendments, | |
| 42 | - | Article – Insurance | |
| 43 | - | Section 15–1601, 15–1606, 15–1611, 15–1611.1, 15–1612, 15–1613, 15–1622, | |
| 44 | - | 15–1628(a), 15–1628.3, 15–1629, | |
| 45 | - | Annotated Code of Maryland | |
| 46 | - | (2017 Replacement Volume and 2022 Supplement) | |
| 30 | + | BY repealing and reenacting, with amendments, 12 | |
| 31 | + | Article – Insurance 13 | |
| 32 | + | Section 15–1601, 15–1606, 15–1611, 15–1611.1, 15–1612, 15–1613, 15–1622, 14 | |
| 33 | + | 15–1628(a), 15–1628.3, 15–1629, 15–1630, and 15–1633.1 15 | |
| 34 | + | Annotated Code of Maryland 16 | |
| 35 | + | (2017 Replacement Volume and 2022 Supplement) 17 | |
| 47 | 36 | ||
| 48 | - | BY repealing 20 2 HOUSE BILL 357 | |
| 37 | + | BY repealing 18 | |
| 38 | + | Article – Insurance 19 | |
| 39 | + | Section 15–1633 20 | |
| 40 | + | Annotated Code of Maryland 21 | |
| 41 | + | (2017 Replacement Volume and 2022 Supplement) 22 | |
| 49 | 42 | ||
| 43 | + | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 23 | |
| 44 | + | That the Laws of Maryland read as follows: 24 | |
| 50 | 45 | ||
| 51 | - | Article – Insurance 1 | |
| 52 | - | Section 15–1633 2 | |
| 53 | - | Annotated Code of Maryland 3 | |
| 54 | - | (2017 Replacement Volume and 2022 Supplement) 4 | |
| 46 | + | Article – Insurance 25 | |
| 55 | 47 | ||
| 56 | - | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 5 | |
| 57 | - | That the Laws of Maryland read as follows: 6 | |
| 58 | - | ||
| 59 | - | Article – Insurance 7 | |
| 60 | - | ||
| 61 | - | 15–1601. 8 | |
| 62 | - | ||
| 63 | - | (a) In this subtitle the following words have the meanings indicated. 9 | |
| 64 | - | ||
| 65 | - | (b) “Agent” means a pharmacy, a pharmacist, a mail order pharmacy, or a 10 | |
| 66 | - | nonresident pharmacy acting on behalf or at the direction of a pharmacy benefits manager. 11 | |
| 67 | - | ||
| 68 | - | (c) “Beneficiary” means an individual who receives prescription drug coverage or 12 | |
| 69 | - | benefits from a purchaser. 13 | |
| 70 | - | ||
| 71 | - | (d) [(1) “Carrier” means the State Employee and Retiree Health and Welfare 14 | |
| 72 | - | Benefits Program, an insurer, a nonprofit health service plan, or a health maintenance 15 | |
| 73 | - | organization that: 16 | |
| 74 | - | ||
| 75 | - | (i) provides prescription drug coverage or benefits in the State; and 17 | |
| 76 | - | ||
| 77 | - | (ii) enters into an agreement with a pharmacy benefits manager for 18 | |
| 78 | - | the provision of pharmacy benefits management services. 19 | |
| 79 | - | ||
| 80 | - | (2) “Carrier” does not include a person that provides prescription drug 20 | |
| 81 | - | coverage or benefits through plans subject to ERISA and does not provide prescription drug 21 | |
| 82 | - | coverage or benefits through insurance, unless the person is a multiple employer welfare 22 | |
| 83 | - | arrangement as defined in § 514(b)(6)(A)(ii) of ERISA. 23 | |
| 84 | - | ||
| 85 | - | (e)] “Compensation program” means a program, policy, or process through which 24 | |
| 86 | - | sources and pricing information are used by a pharmacy benefits manager to determine the 25 | |
| 87 | - | terms of payment as stated in a participating pharmacy contract. 26 | |
| 88 | - | ||
| 89 | - | [(f)] (E) “Contracted pharmacy” means a pharmacy that participates in the 27 | |
| 90 | - | network of a pharmacy benefits manager through a contract with: 28 | |
| 91 | - | ||
| 92 | - | (1) the pharmacy benefits manager; or 29 | |
| 93 | - | ||
| 94 | - | (2) a pharmacy services administration organization or a group purchasing 30 | |
| 95 | - | organization. 31 | |
| 96 | - | ||
| 97 | - | [(g) “ERISA” has the meaning stated in § 8–301 of this article.] 32 HOUSE BILL 357 3 | |
| 48 | + | 15–1601. 26 2 HOUSE BILL 357 | |
| 98 | 49 | ||
| 99 | 50 | ||
| 100 | 51 | ||
| 101 | - | ||
| 52 | + | (a) In this subtitle the following words have the meanings indicated. 1 | |
| 102 | 53 | ||
| 103 | - | [(i)] (G) (1) “Manufacturer payments” means any compensati on or 2 | |
| 104 | - | remuneration a pharmacy benefits manager receives from or on behalf of a pharmaceutical 3 | |
| 105 | - | manufacturer. 4 | |
| 54 | + | (b) “Agent” means a pharmacy, a pharmacist, a mail order pharmacy, or a 2 | |
| 55 | + | nonresident pharmacy acting on behalf or at the direction of a pharmacy benefits manager. 3 | |
| 106 | 56 | ||
| 107 | - | (2) “Manufacturer payments” includes: 5 | |
| 57 | + | (c) “Beneficiary” means an individual who receives prescription drug coverage or 4 | |
| 58 | + | benefits from a purchaser. 5 | |
| 108 | 59 | ||
| 109 | - | (i) payments received in accordance with agreements with 6 | |
| 110 | - | pharmaceutical manufacturers for formulary placement and, if applicable, drug utilization; 7 | |
| 60 | + | (d) [(1) “Carrier” means the State Employee and Retiree Health and Welfare 6 | |
| 61 | + | Benefits Program, an insurer, a nonprofit health service plan, or a health maintenance 7 | |
| 62 | + | organization that: 8 | |
| 111 | 63 | ||
| 112 | - | ( | |
| 64 | + | (i) provides prescription drug coverage or benefits in the State; and 9 | |
| 113 | 65 | ||
| 114 | - | (iii) market share incentives; 9 | |
| 66 | + | (ii) enters into an agreement with a pharmacy benefits manager for 10 | |
| 67 | + | the provision of pharmacy benefits management services. 11 | |
| 115 | 68 | ||
| 116 | - | (iv) commissions; 10 | |
| 69 | + | (2) “Carrier” does not include a person that provides prescription drug 12 | |
| 70 | + | coverage or benefits through plans subject to ERISA and does not provide prescription drug 13 | |
| 71 | + | coverage or benefits through insurance, unless the person is a multiple employer welfare 14 | |
| 72 | + | arrangement as defined in § 514(b)(6)(A)(ii) of ERISA. 15 | |
| 117 | 73 | ||
| 118 | - | (v) fees under products and services agreements; 11 | |
| 74 | + | (e)] “Compensation program” means a program, policy, or process through which 16 | |
| 75 | + | sources and pricing information are used by a pharmacy benefits manager to determine the 17 | |
| 76 | + | terms of payment as stated in a participating pharmacy contract. 18 | |
| 119 | 77 | ||
| 120 | - | ( | |
| 121 | - | ||
| 78 | + | [(f)] (E) “Contracted pharmacy” means a pharmacy that participates in the 19 | |
| 79 | + | network of a pharmacy benefits manager through a contract with: 20 | |
| 122 | 80 | ||
| 123 | - | ( | |
| 81 | + | (1) the pharmacy benefits manager; or 21 | |
| 124 | 82 | ||
| 125 | - | ( | |
| 126 | - | ||
| 83 | + | (2) a pharmacy services administration organization or a group purchasing 22 | |
| 84 | + | organization. 23 | |
| 127 | 85 | ||
| 128 | - | [(j)] (H) “Nonprofit health maintenance organization” has the meaning stated 17 | |
| 129 | - | in § 6–121(a) of this article. 18 | |
| 86 | + | [(g) “ERISA” has the meaning stated in § 8–301 of this article.] 24 | |
| 130 | 87 | ||
| 131 | - | [(k)] (I) “Nonresident pharmacy” has the meaning stated in § 12–403 of the 19 | |
| 132 | - | Health Occupations Article. 20 | |
| 88 | + | [(h)] (F) “Formulary” means a list of prescription drugs used by a purchaser. 25 | |
| 133 | 89 | ||
| 134 | - | [(l)] (J) “Participating pharmacy contract” means a contract filed with the 21 | |
| 135 | - | Commissioner in accordance with § 15–1628(b) of this subtitle. 22 | |
| 90 | + | [(i)] (G) (1) “Manufacturer payments” means an y compensation or 26 | |
| 91 | + | remuneration a pharmacy benefits manager receives from or on behalf of a pharmaceutical 27 | |
| 92 | + | manufacturer. 28 | |
| 136 | 93 | ||
| 137 | - | [(m)] (K) “Pharmacist” has the meaning stated in § 12–101 of the Health 23 | |
| 138 | - | Occupations Article. 24 | |
| 94 | + | (2) “Manufacturer payments” includes: 29 | |
| 139 | 95 | ||
| 140 | - | [(n)] (L) “Pharmacy” has the meaning stated in § 12 –101 of the Health 25 | |
| 141 | - | Occupations Article. 26 | |
| 96 | + | (i) payments received in accordance with agreements with 30 HOUSE BILL 357 3 | |
| 142 | 97 | ||
| 143 | - | [(o)] (M) “Pharmacy and therap eutics committee” means a committee 27 | |
| 144 | - | established by a pharmacy benefits manager to: 28 | |
| 98 | + | ||
| 99 | + | pharmaceutical manufacturers for formulary placement and, if applicable, drug utilization; 1 | |
| 100 | + | ||
| 101 | + | (ii) rebates, regardless of how categorized; 2 | |
| 102 | + | ||
| 103 | + | (iii) market share incentives; 3 | |
| 104 | + | ||
| 105 | + | (iv) commissions; 4 | |
| 106 | + | ||
| 107 | + | (v) fees under products and services agreements; 5 | |
| 108 | + | ||
| 109 | + | (vi) any fees received for the sale of utilization data to a 6 | |
| 110 | + | pharmaceutical manufacturer; and 7 | |
| 111 | + | ||
| 112 | + | (vii) administrative or management fees. 8 | |
| 113 | + | ||
| 114 | + | (3) “Manufacturer payments” does not include purchase discounts based on 9 | |
| 115 | + | invoiced purchase terms. 10 | |
| 116 | + | ||
| 117 | + | [(j)] (H) “Nonprofit health maintenance organization” has the meaning stated 11 | |
| 118 | + | in § 6–121(a) of this article. 12 | |
| 119 | + | ||
| 120 | + | [(k)] (I) “Nonresident pharmacy” has the meaning stated in § 12–403 of the 13 | |
| 121 | + | Health Occupations Article. 14 | |
| 122 | + | ||
| 123 | + | [(l)] (J) “Participating pharmacy contract” means a contract filed with the 15 | |
| 124 | + | Commissioner in accordance with § 15–1628(b) of this subtitle. 16 | |
| 125 | + | ||
| 126 | + | [(m)] (K) “Pharmacist” has the meaning stated in § 12–101 of the Health 17 | |
| 127 | + | Occupations Article. 18 | |
| 128 | + | ||
| 129 | + | [(n)] (L) “Pharmacy” has the meaning stated in § 12 –101 of the Health 19 | |
| 130 | + | Occupations Article. 20 | |
| 131 | + | ||
| 132 | + | [(o)] (M) “Pharmacy and therapeutics committee” means a committee 21 | |
| 133 | + | established by a pharmacy benefits manager to: 22 | |
| 134 | + | ||
| 135 | + | (1) objectively appraise and evaluate prescription drugs; and 23 | |
| 136 | + | ||
| 137 | + | (2) make recommendations to a purchaser regarding the selection of drugs 24 | |
| 138 | + | for the purchaser’s formulary. 25 | |
| 139 | + | ||
| 140 | + | [(p)] (N) (1) “Pharmacy benefits management services” means: 26 | |
| 141 | + | ||
| 142 | + | (i) the procurement of prescription drugs at a negotiated rate for 27 | |
| 143 | + | dispensation within the State to beneficiaries; 28 | |
| 145 | 144 | 4 HOUSE BILL 357 | |
| 146 | 145 | ||
| 147 | 146 | ||
| 148 | - | (1) objectively appraise and evaluate prescription drugs; and 1 | |
| 147 | + | (ii) the administration or management of prescription drug coverage 1 | |
| 148 | + | provided by a purchaser for beneficiaries; and 2 | |
| 149 | 149 | ||
| 150 | - | ( | |
| 151 | - | ||
| 150 | + | (iii) any of the following services provided with regard to the 3 | |
| 151 | + | administration of prescription drug coverage: 4 | |
| 152 | 152 | ||
| 153 | - | | |
| 153 | + | 1. mail service pharmacy; 5 | |
| 154 | 154 | ||
| 155 | - | | |
| 156 | - | ||
| 155 | + | 2. claims processing, retail network management, a nd 6 | |
| 156 | + | payment of claims to pharmacies for prescription drugs dispensed to beneficiaries; 7 | |
| 157 | 157 | ||
| 158 | - | (ii) the administration or management of prescription drug coverage 7 | |
| 159 | - | provided by a purchaser for beneficiaries; and 8 | |
| 158 | + | 3. clinical formulary development and management services; 8 | |
| 160 | 159 | ||
| 161 | - | (iii) any of the following services provided with regard to the 9 | |
| 162 | - | administration of prescription drug coverage: 10 | |
| 160 | + | 4. rebate contracting and administration; 9 | |
| 163 | 161 | ||
| 164 | - | 1. mail service pharmacy; 11 | |
| 162 | + | 5. patient compliance, therapeutic intervention, and generic 10 | |
| 163 | + | substitution programs; or 11 | |
| 165 | 164 | ||
| 166 | - | 2. claims processing, retail network management, and 12 | |
| 167 | - | payment of claims to pharmacies for prescription drugs dispensed to beneficiaries; 13 | |
| 165 | + | 6. disease management programs. 12 | |
| 168 | 166 | ||
| 169 | - | 3. clinical formulary development and management services; 14 | |
| 167 | + | (2) “Pharmacy benefits management services” does not include any service 13 | |
| 168 | + | provided by a nonprofit health maintenance organization that operates as a group model, 14 | |
| 169 | + | provided that the service: 15 | |
| 170 | 170 | ||
| 171 | - | 4. rebate contracting and administration; 15 | |
| 171 | + | (i) is provided solely to a member of the nonprofit health 16 | |
| 172 | + | maintenance organization; and 17 | |
| 172 | 173 | ||
| 173 | - | | |
| 174 | - | ||
| 174 | + | (ii) is furnished through the internal pharmacy operations of the 18 | |
| 175 | + | nonprofit health maintenance organization. 19 | |
| 175 | 176 | ||
| 176 | - | 6. disease management programs. 18 | |
| 177 | + | [(q)] (O) “Pharmacy benefits manager” means a person that performs pharmacy 20 | |
| 178 | + | benefits management services. 21 | |
| 177 | 179 | ||
| 178 | - | (2) “Pharmacy benefits management services” does not include any service 19 | |
| 179 | - | provided by a nonprofit health maintenance organization that operates as a group model, 20 | |
| 180 | - | provided that the service: 21 | |
| 180 | + | [(r)] (P) “Proprietary information” means: 22 | |
| 181 | 181 | ||
| 182 | - | (i) is provided solely to a member of the nonprofit health 22 | |
| 183 | - | maintenance organization; and 23 | |
| 182 | + | (1) a trade secret; 23 | |
| 184 | 183 | ||
| 185 | - | (ii) is furnished through the internal pharmacy operations of the 24 | |
| 186 | - | nonprofit health maintenance organization. 25 | |
| 184 | + | (2) confidential commercial information; or 24 | |
| 187 | 185 | ||
| 188 | - | [(q)] (O) “Pharmacy benefits manager” means a person that performs pharmacy 26 | |
| 189 | - | benefits management services. 27 | |
| 186 | + | (3) confidential financial information. 25 | |
| 190 | 187 | ||
| 191 | - | [(r)] (P) “Proprietary information” means: 28 | |
| 192 | - | ||
| 193 | - | (1) a trade secret; 29 | |
| 188 | + | [(s)] (Q) (1) “Purchaser” means a person that offers a plan or program in the 26 | |
| 189 | + | State, including the State Employee and Retiree Health and Welfare Benefits Program, AN 27 | |
| 190 | + | INSURER, A NONPROFIT HEALTH S ERVICE PLAN , OR A HEALTH MAINTENA NCE 28 | |
| 191 | + | ORGANIZATION , that: 29 | |
| 194 | 192 | HOUSE BILL 357 5 | |
| 195 | 193 | ||
| 196 | 194 | ||
| 197 | - | ( | |
| 195 | + | [(1)] (I) provides prescription drug coverage or benefits in the State; and 1 | |
| 198 | 196 | ||
| 199 | - | (3) confidential financial information. 2 | |
| 197 | + | [(2)] (II) enters into an agreement with a pharmacy benefits manager for 2 | |
| 198 | + | the provision of pharmacy benefits management services. 3 | |
| 200 | 199 | ||
| 201 | - | [(s)] (Q) (1) “Purchaser” means a person that offers a plan or program in the 3 | |
| 202 | - | State, including the State Employee and Retiree Health and Welfare Benefits Program, AN 4 | |
| 203 | - | INSURER, A NONPROFIT HEALTH S ERVICE PLAN , OR A HEALTH MAINTENA NCE 5 | |
| 204 | - | ORGANIZATION , that: 6 | |
| 200 | + | (2) “PURCHASER” DOES NOT INCLUDE A N ONPROFIT HEALTH 4 | |
| 201 | + | MAINTENANCE ORGANIZA TION THAT: 5 | |
| 205 | 202 | ||
| 206 | - | ||
| 203 | + | (I) OPERATES AS A GROUP MODEL; 6 | |
| 207 | 204 | ||
| 208 | - | ||
| 209 | - | the | |
| 205 | + | (II) PROVIDES SERVICES SO LELY TO MEMBER S OR PATIENTS OF 7 | |
| 206 | + | THE NONPROFIT HEALTH MAINTENANCE ORGANIZA TION; AND 8 | |
| 210 | 207 | ||
| 211 | - | ( | |
| 212 | - | ||
| 208 | + | (III) FURNISHES SERVICES T HROUGH THE INTERNAL PHARMACY 9 | |
| 209 | + | OPERATIONS OF THE NO NPROFIT HEALTH MAINT ENANCE ORGANIZATION . 10 | |
| 213 | 210 | ||
| 214 | - | (I) OPERATES AS A GROUP MODEL; 12 | |
| 211 | + | [(t)] (R) “Rebate sharing contract” means a contract between a pharmacy 11 | |
| 212 | + | benefits manager and a purchaser under which the pharmacy benefits manager agrees to 12 | |
| 213 | + | share manufacturer payments with the purchaser. 13 | |
| 215 | 214 | ||
| 216 | - | ( | |
| 217 | - | ||
| 215 | + | [(u)] (S) (1) “Therapeutic interchange” means any change from one 14 | |
| 216 | + | prescription drug to another. 15 | |
| 218 | 217 | ||
| 219 | - | (III) FURNISHES SERVICES T HROUGH THE INTERNAL PHARMACY 15 | |
| 220 | - | OPERATIONS OF THE NO NPROFIT HEALTH MAINT ENANCE ORG ANIZATION. 16 | |
| 218 | + | (2) “Therapeutic interchange” does not include: 16 | |
| 221 | 219 | ||
| 222 | - | [(t)] (R) “Rebate sharing contract” means a contract between a pharmacy 17 | |
| 223 | - | benefits manager and a purchaser under which the pharmacy benefits manager agrees to 18 | |
| 224 | - | share manufacturer payments with the purchaser. 19 | |
| 220 | + | (i) a change initiated pursuant to a drug utilization review; 17 | |
| 225 | 221 | ||
| 226 | - | [(u)] (S) (1) “Therapeutic interchange” means any change from one 20 | |
| 227 | - | prescription drug to another. 21 | |
| 222 | + | (ii) a change initiated for patient safety reasons; 18 | |
| 228 | 223 | ||
| 229 | - | (2) “Therapeutic interchange” does not include: 22 | |
| 224 | + | (iii) a change required due to market unavailability of the currently 19 | |
| 225 | + | prescribed drug; 20 | |
| 230 | 226 | ||
| 231 | - | (i) a change initiated pursuant to a drug utilization review; 23 | |
| 227 | + | (iv) a change from a brand name drug to a generic drug in accordance 21 | |
| 228 | + | with § 12–504 of the Health Occupations Article; or 22 | |
| 232 | 229 | ||
| 233 | - | (ii) a change initiated for patient safety reasons; 24 | |
| 230 | + | (v) a change required for coverage reasons because the originally 23 | |
| 231 | + | prescribed drug is not covered by the beneficiary’s formulary or plan. 24 | |
| 234 | 232 | ||
| 235 | - | ( | |
| 236 | - | ||
| 233 | + | [(v)] (T) “Therapeutic interchange solicitation” means any communication by a 25 | |
| 234 | + | pharmacy benefits manager for the purpose of requesting a therapeutic interchange. 26 | |
| 237 | 235 | ||
| 238 | - | ( | |
| 239 | - | ||
| 236 | + | [(w)] (U) “Trade secret” has the meaning stated in § 11–1201 of the Commercial 27 | |
| 237 | + | Law Article. 28 | |
| 240 | 238 | ||
| 241 | - | ||
| 242 | - | ||
| 239 | + | 15–1606. 29 | |
| 240 | + | 6 HOUSE BILL 357 | |
| 243 | 241 | ||
| 244 | 242 | ||
| 243 | + | A [carrier] PURCHASER may not enter into an agreement with a pharmacy benefits 1 | |
| 244 | + | manager that has not registered with the Commissioner. 2 | |
| 245 | 245 | ||
| 246 | - | [(v)] (T) “Therapeutic interchange solicitation” means any communication by a 1 | |
| 247 | - | pharmacy benefits manager for the purpose of requesting a therapeutic interchange. 2 | |
| 246 | + | 15–1611. 3 | |
| 248 | 247 | ||
| 249 | - | [ | |
| 250 | - | ||
| 248 | + | (a) [This section applies only to a pharmacy benefits manager that provides 4 | |
| 249 | + | pharmacy benefits management services on behalf of a carrier. 5 | |
| 251 | 250 | ||
| 252 | - | 15–1606. 5 | |
| 251 | + | (b)] A pharmacy benefits manager may not prohibit a pharmacy or pharmacist 6 | |
| 252 | + | from: 7 | |
| 253 | 253 | ||
| 254 | - | A [carrier] PURCHASER may not enter into an agreement with a pharmacy benefits 6 | |
| 255 | - | manager that has not registered with the Commissioner. 7 | |
| 254 | + | (1) providing a beneficiary with information regarding the retail price for 8 | |
| 255 | + | a prescription drug or the amount of the cost share for which the beneficiary is responsible 9 | |
| 256 | + | for a prescription drug; 10 | |
| 256 | 257 | ||
| 257 | - | 15–1611. 8 | |
| 258 | + | (2) discussing with a beneficiary information regarding the retail price for 11 | |
| 259 | + | a prescription drug or the amount of the cost share for which the beneficiary is responsible 12 | |
| 260 | + | for a prescription drug; or 13 | |
| 258 | 261 | ||
| 259 | - | (a) [This section applies only to a pharmacy benefits manager that provides 9 | |
| 260 | - | pharmacy benefits management services on behalf of a carrier. 10 | |
| 262 | + | (3) if a more affordable drug is available than one on the purchaser’s 14 | |
| 263 | + | formulary and the requirements for a therapeutic interchange under §§ [15–1633.1] 15 | |
| 264 | + | 15–1633 through 15–1639 of this subtitle are met, selling the more affordable alternative 16 | |
| 265 | + | to the beneficiary. 17 | |
| 261 | 266 | ||
| 262 | - | (b) | |
| 263 | - | ||
| 267 | + | [(c)] (B) This section may not be construed to alter the requirements for a 18 | |
| 268 | + | therapeutic interchange under §§ [15–1633.1] 15–1633 through 15–1639 of this subtitle. 19 | |
| 264 | 269 | ||
| 265 | - | (1) providing a beneficiary with information regarding the retail price for 13 | |
| 266 | - | a prescription drug or the amount of the cost share for which the beneficiary is responsible 14 | |
| 267 | - | for a prescription drug; 15 | |
| 270 | + | 15–1611.1. 20 | |
| 268 | 271 | ||
| 269 | - | (2) discussing with a beneficiary information regarding the retail price for 16 | |
| 270 | - | a prescription drug or the amount of the cost share for which the beneficiary is responsible 17 | |
| 271 | - | for a prescription drug; or 18 | |
| 272 | + | (a) [This section applies only to a pharmacy benefits manager that provides 21 | |
| 273 | + | pharmacy benefits management services on behalf of a carrier. 22 | |
| 272 | 274 | ||
| 273 | - | (3) if a more affordable drug is available than one on the purchaser’s 19 | |
| 274 | - | formulary and the requirements for a therapeutic interchange under §§ [15–1633.1] 20 | |
| 275 | - | 15–1633 through 15–1639 of this subtitle are met, selling the more affordable alternative 21 | |
| 276 | - | to the beneficiary. 22 | |
| 275 | + | (b)] Except as provided in subsection [(c)] (B) of this section, a pharmacy benefits 23 | |
| 276 | + | manager may not require that a beneficiary use a specific pharmacy or entity to fill a 24 | |
| 277 | + | prescription if: 25 | |
| 277 | 278 | ||
| 278 | - | ||
| 279 | - | ||
| 279 | + | (1) the pharmacy benefits manager or a corporate affiliate of the pharmacy 26 | |
| 280 | + | benefits manager has an ownership interest in the pharmacy or entity; or 27 | |
| 280 | 281 | ||
| 281 | - | 15–1611.1. 25 | |
| 282 | + | (2) the pharmacy or entity has an ownership interest in the pharmacy 28 | |
| 283 | + | benefits manager or a corporate affiliate of the pharmacy benefits manager. 29 | |
| 282 | 284 | ||
| 283 | - | ( | |
| 284 | - | pharmacy | |
| 285 | + | [(c)] (B) A pharmacy benefits manager may require a beneficiary to use a 30 | |
| 286 | + | specific pharmacy or entity for a specialty drug as defined in § 15–847 of this title. 31 | |
| 285 | 287 | ||
| 286 | - | (b)] Except as provided in subsection [(c)] (B) of this section, a pharmacy benefits 28 | |
| 287 | - | manager may not require that a beneficiary use a specific pharmacy or entity to fill a 29 | |
| 288 | - | prescription if: 30 | |
| 289 | - | HOUSE BILL 357 7 | |
| 288 | + | 15–1612. 32 HOUSE BILL 357 7 | |
| 290 | 289 | ||
| 291 | - | ||
| 292 | - | (1) the pharmacy benefits manager or a corporate affiliate of the pharmacy 1 | |
| 293 | - | benefits manager has an ownership interest in the pharmacy or entity; or 2 | |
| 294 | - | ||
| 295 | - | (2) the pharmacy or entity has an ownership interest in the pharmacy 3 | |
| 296 | - | benefits manager or a corporate affiliate of the pharmacy benefits manager. 4 | |
| 297 | - | ||
| 298 | - | [(c)] (B) A pharmacy benefits manager may require a beneficiary to use a 5 | |
| 299 | - | specific pharmacy or entity for a specialty drug as defined in § 15–847 of this title. 6 | |
| 300 | - | ||
| 301 | - | 15–1612. 7 | |
| 302 | - | ||
| 303 | - | (a) [This section applies only to a pharmacy benefits manager that provides 8 | |
| 304 | - | pharmacy benefits management services on behalf of a carrier. 9 | |
| 305 | - | ||
| 306 | - | (b)] This section does not apply to reimbursement: 10 | |
| 307 | - | ||
| 308 | - | (1) for specialty drugs; 11 | |
| 309 | - | ||
| 310 | - | (2) for mail order drugs; or 12 | |
| 311 | - | ||
| 312 | - | (3) to a chain pharmacy with more than 15 stores or a pharmacist who is 13 | |
| 313 | - | an employee of the chain pharmacy. 14 | |
| 314 | - | ||
| 315 | - | [(c)] (B) A pharmacy benefits manager may n ot reimburse a pharmacy or 15 | |
| 316 | - | pharmacist for a pharmaceutical product or pharmacist service in an amount less than the 16 | |
| 317 | - | amount that the pharmacy benefits manager reimburses itself or an affiliate for providing 17 | |
| 318 | - | the same product or service. 18 | |
| 319 | - | ||
| 320 | - | 15–1613. 19 | |
| 321 | - | ||
| 322 | - | A pharmacy and therapeutics committee established by a pharmacy benefits 20 | |
| 323 | - | manager performing pharmacy benefits management services [on behalf of a carrier] shall 21 | |
| 324 | - | meet the requirements of this part. 22 | |
| 325 | - | ||
| 326 | - | 15–1622. 23 | |
| 327 | - | ||
| 328 | - | [(a) Except as provided for in subsection (b) of this section, the provisions of §§ 24 | |
| 329 | - | 15–1623 and 15–1624 of this subtitle apply only to a pharmacy benefits manager that 25 | |
| 330 | - | provides pharmacy benefits management services on behalf of a carrier. 26 | |
| 331 | - | ||
| 332 | - | (b)] The provisions of §§ 15–1623 and 15–1624 of this part do not apply to a 27 | |
| 333 | - | pharmacy benefits manager when providing pharmacy benefits management services to a 28 | |
| 334 | - | purchaser that is affiliated with the pharmacy benefits manager through common 29 | |
| 335 | - | ownership within an insurance holding company. 30 | |
| 336 | - | ||
| 337 | - | 15–1628. 31 8 HOUSE BILL 357 | |
| 338 | - | ||
| 339 | - | ||
| 340 | - | ||
| 341 | - | (a) (1) At the time of entering into a contract with a pharmacy or a pharmacist, 1 | |
| 342 | - | and at least 30 working days before any contract change, a pharmacy benefits manager 2 | |
| 343 | - | shall disclose to the pharmacy or pharmacist: 3 | |
| 344 | - | ||
| 345 | - | (i) the applicable terms, conditions, and reimbursement rates; 4 | |
| 346 | - | ||
| 347 | - | (ii) the process and procedures for verifying pharmacy benefits and 5 | |
| 348 | - | beneficiary eligibility; 6 | |
| 349 | - | ||
| 350 | - | (iii) the dispute resolution and audit appeals process; and 7 | |
| 351 | - | ||
| 352 | - | (iv) the process and procedures for verifying the prescription drugs 8 | |
| 353 | - | included on the formularies used by the pharmacy benefits manager. 9 | |
| 354 | - | ||
| 355 | - | (2) (i) This paragraph does not apply to a requirement that a specialty 10 | |
| 356 | - | pharmacy obtain national certification to be considered a specialty pharmacy in a pharmacy 11 | |
| 357 | - | benefits manager’s or [carrier’s] PURCHASER ’S network. 12 | |
| 358 | - | ||
| 359 | - | (ii) For purposes of credentialing a pharmacy or a pharmacist as a 13 | |
| 360 | - | condition for participating in a pharmacy benefits manager’s OR PURCHASER ’S network 14 | |
| 361 | - | [for a carrier], the pharmacy benefits manager OR PURCHASER may not: 15 | |
| 362 | - | ||
| 363 | - | 1. require a pharmacy or pharmacist to renew credentialing 16 | |
| 364 | - | more frequently than once every 3 years; or 17 | |
| 365 | - | ||
| 366 | - | 2. charge a pharmacy or pharmacist a fee for the initial 18 | |
| 367 | - | credentialing or renewing credentialing. 19 | |
| 368 | - | ||
| 369 | - | 15–1628.3. 20 | |
| 370 | - | ||
| 371 | - | (a) A pharmacy benefits manager or a [carrier] PURCHASER may not directly or 21 | |
| 372 | - | indirectly charge a contracted pharmacy, or hold a contracted pharmacy responsible for, a 22 | |
| 373 | - | fee or performance–based reimbursement related to the adjudication of a claim or an 23 | |
| 374 | - | incentive program. 24 | |
| 375 | - | ||
| 376 | - | (b) A pharmacy benefits manager or [carrier] PURCHASER may not make or 25 | |
| 377 | - | allow any reduction in payment for pharmacy services by a pharmacy benefits manager or 26 | |
| 378 | - | [carrier] PURCHASER or directly or indirectly reduce a payment for a pharmacy service 27 | |
| 379 | - | under a reconciliation process to an effective rate of reimbursement, including generic 28 | |
| 380 | - | effective rates, brand effective rates, direct and indirect remuneration fees, or any other 29 | |
| 381 | - | reduction or aggregate reduction of payments. 30 | |
| 382 | - | ||
| 383 | - | 15–1629. 31 | |
| 384 | - | HOUSE BILL 357 9 | |
| 385 | 290 | ||
| 386 | 291 | ||
| 387 | 292 | (a) [This section applies only to a pharmacy benefits manager that provides 1 | |
| 388 | 293 | pharmacy benefits management services on behalf of a carrier. 2 | |
| 389 | 294 | ||
| 390 | - | (b)] This section does not apply to an audit that involves probable or potential 3 | |
| 391 | - | fraud or willful misrepresentation by a pharmacy or pharmacist. 4 | |
| 295 | + | (b)] This section does not apply to reimbursement: 3 | |
| 392 | 296 | ||
| 393 | - | [(c)] (B) A pharmacy benefits manager shall conduct an audit of a pharmacy or 5 | |
| 394 | - | pharmacist under contract with the pharmacy benefits manager in accordance with this 6 | |
| 395 | - | section. 7 | |
| 297 | + | (1) for specialty drugs; 4 | |
| 396 | 298 | ||
| 397 | - | [(d)] (C) A pharmacy benefits manager may not schedule an onsite audit to begin 8 | |
| 398 | - | during the first 5 calendar days of a month unless requested by the pharmacy or 9 | |
| 399 | - | pharmacist. 10 | |
| 299 | + | (2) for mail order drugs; or 5 | |
| 400 | 300 | ||
| 401 | - | [(e)] (D) When conducting an audit, a pharmacy benefits manager shall: 11 | |
| 301 | + | (3) to a chain pharmacy with more than 15 stores or a pharmacist who is 6 | |
| 302 | + | an employee of the chain pharmacy. 7 | |
| 402 | 303 | ||
| 403 | - | (1) if the audit is onsite, provide written notice to the pharmacy or 12 | |
| 404 | - | pharmacist at least 2 weeks before conducting the initial onsite audit for each audit cycle; 13 | |
| 304 | + | [(c)] (B) A pharmacy benefits manager may not reimburse a pharmacy or 8 | |
| 305 | + | pharmacist for a pharmaceutical product or pharmacist service in an amount less than the 9 | |
| 306 | + | amount that the pharmacy benefits manager reimburses itself or an affiliate for providing 10 | |
| 307 | + | the same product or service. 11 | |
| 405 | 308 | ||
| 406 | - | (2) employ the services of a pharmacist if the audit requires the clinical or 14 | |
| 407 | - | professional judgment of a pharmacist; 15 | |
| 309 | + | 15–1613. 12 | |
| 408 | 310 | ||
| 409 | - | (3) permit its auditors to enter the prescription area of a pharmacy only 16 | |
| 410 | - | when accompanied by or authorized by a member of the pharmacy staff; 17 | |
| 311 | + | A pharmacy and therapeutics committee established by a pharmacy benefits 13 | |
| 312 | + | manager performing pharmacy benefits management services [on behalf of a carrier] shall 14 | |
| 313 | + | meet the requirements of this part. 15 | |
| 411 | 314 | ||
| 412 | - | (4) allow a pharmacist or pharmacy to use any prescription, or authorized 18 | |
| 413 | - | change to a prescription, that meets the requirements of COMAR 10.34.20.02 to validate 19 | |
| 414 | - | claims submitted for reimbursement for dispensing of original and refill prescriptions; 20 | |
| 315 | + | 15–1622. 16 | |
| 415 | 316 | ||
| 416 | - | ( | |
| 417 | - | ||
| 418 | - | ||
| 317 | + | [(a) Except as provided for in subsection (b) of this section, the provisions of §§ 17 | |
| 318 | + | 15–1623 and 15–1624 of this subtitle apply only to a pharmacy benefits manager that 18 | |
| 319 | + | provides pharmacy benefits management services on behalf of a carrier. 19 | |
| 419 | 320 | ||
| 420 | - | (i) written; or 24 | |
| 321 | + | (b)] The provisions of §§ 15–1623 and 15–1624 of this part do not apply to a 20 | |
| 322 | + | pharmacy benefits manager when providing pharmacy benefits management services to a 21 | |
| 323 | + | purchaser that is affiliated with the pharmacy benefits manager through common 22 | |
| 324 | + | ownership within an insurance holding company. 23 | |
| 421 | 325 | ||
| 422 | - | (ii) transmitted electronically or by any other means of 25 | |
| 423 | - | communication authorized by contract between the pharmacy and the pharmacy benefits 26 | |
| 424 | - | manager; 27 | |
| 326 | + | 15–1628. 24 | |
| 425 | 327 | ||
| 426 | - | ( | |
| 427 | - | ||
| 428 | - | pharmacy | |
| 328 | + | (a) (1) At the time of entering into a contract with a pharmacy or a pharmacist, 25 | |
| 329 | + | and at least 30 working days before any contract change, a pharmacy benefits manager 26 | |
| 330 | + | shall disclose to the pharmacy or pharmacist: 27 | |
| 429 | 331 | ||
| 430 | - | (7) only audit claims submitted or adjudicated within the 2–year period 31 | |
| 431 | - | immediately preceding the audit, unless a longer period is authorized under federal or State 32 | |
| 432 | - | law; 33 | |
| 433 | - | 10 HOUSE BILL 357 | |
| 332 | + | (i) the applicable terms, conditions, and reimbursement rates; 28 | |
| 333 | + | ||
| 334 | + | (ii) the process and procedures for verifying pharmacy benefits and 29 | |
| 335 | + | beneficiary eligibility; 30 | |
| 336 | + | 8 HOUSE BILL 357 | |
| 434 | 337 | ||
| 435 | 338 | ||
| 436 | - | (8) deliver the preliminary audit report to the pharmacy or pharmacist 1 | |
| 437 | - | within 120 calendar days after the completion of the audit, with reasonable extensions 2 | |
| 438 | - | allowed; 3 | |
| 339 | + | (iii) the dispute resolution and audit appeals process; and 1 | |
| 439 | 340 | ||
| 440 | - | (9) in accordance with subsection [(k)] (J) of this section, allow a pharmacy 4 | |
| 441 | - | or pharmacist to produce documentation to address any discrepancy found during the audit; 5 | |
| 442 | - | and 6 | |
| 341 | + | (iv) the process and procedures for verifying the prescription drugs 2 | |
| 342 | + | included on the formularies used by the pharmacy benefits manager. 3 | |
| 443 | 343 | ||
| 444 | - | (10) deliver the final audit report to the pharmacy or pharmacist: 7 | |
| 344 | + | (2) (i) This paragraph does not apply to a requirement that a specialty 4 | |
| 345 | + | pharmacy obtain national certification to be considered a specialty pharmacy in a pharmacy 5 | |
| 346 | + | benefits manager’s or [carrier’s] PURCHASER ’S network. 6 | |
| 445 | 347 | ||
| 446 | - | ( | |
| 447 | - | ||
| 448 | - | ||
| 348 | + | (ii) For purposes of credentialing a pharmacy or a pharmacist as a 7 | |
| 349 | + | condition for participating in a pharmacy benefits manager’s OR PURCHASER ’S network 8 | |
| 350 | + | [for a carrier], the pharmacy benefits manager OR PURCHASER may not: 9 | |
| 449 | 351 | ||
| 450 | - | (ii) within 30 days after the conclusion of the internal appeals 11 | |
| 451 | - | process under subsection [(k)] (J) of this section if the pharmacy or pharmacist requests 12 | |
| 452 | - | an internal appeal. 13 | |
| 352 | + | 1. require a pharmacy or pharmacist to renew credentialing 10 | |
| 353 | + | more frequently than once every 3 years; or 11 | |
| 453 | 354 | ||
| 454 | - | [(f)] (E) If a contract between a pharmacy or pharmacist and a pharmacy 14 | |
| 455 | - | benefits manager specifies a period of time in which a pharmacy or pharmacist is allowed 15 | |
| 456 | - | to withdraw and resubmit a claim and that period of time expires before the pharmacy 16 | |
| 457 | - | benefits manager delivers a preliminary audit report that identifies discrepancies, the 17 | |
| 458 | - | pharmacy benefits manager shall allow the pharmacy or pharmacist to withdraw and 18 | |
| 459 | - | resubmit a claim within 30 days after: 19 | |
| 355 | + | 2. charge a pharmacy or pharmacist a fee for the initial 12 | |
| 356 | + | credentialing or renewing credentialing. 13 | |
| 460 | 357 | ||
| 461 | - | (1) the preliminary audit report is delivered if the pharmacy or pharmacist 20 | |
| 462 | - | does not request an internal appeal under subsection [(k)] (J) of this section; or 21 | |
| 358 | + | 15–1628.3. 14 | |
| 463 | 359 | ||
| 464 | - | (2) the conclusion of the internal appeals process under subsection [(k)] (J) 22 | |
| 465 | - | of this section if the pharmacy or pharmacist requests an internal appeal. 23 | |
| 360 | + | (a) A pharmacy benefits manager or a [carrier] PURCHASER may not directly or 15 | |
| 361 | + | indirectly charge a contracted pharmacy, or hold a contracted pharmacy responsible for, a 16 | |
| 362 | + | fee or performance–based reimbursement related to the adjudication of a claim or an 17 | |
| 363 | + | incentive program. 18 | |
| 466 | 364 | ||
| 467 | - | [(g)] (F) During an audit, a pharmacy benefits manager may not disrupt the 24 | |
| 468 | - | provision of services to the customers of a pharmacy. 25 | |
| 365 | + | (b) A pharmacy benefits manager or [carrier] PURCHASER may not make or 19 | |
| 366 | + | allow any reduction in payment for pharmacy services by a pharmacy benefits manager or 20 | |
| 367 | + | [carrier] PURCHASER or directly or indirectly reduce a payment for a pharmacy service 21 | |
| 368 | + | under a reconciliation process to an effective rate of reimbursement, including generic 22 | |
| 369 | + | effective rates, brand effective rates, direct and indirect remuneration fees, or any other 23 | |
| 370 | + | reduction or aggregate reduction of payments. 24 | |
| 469 | 371 | ||
| 470 | - | ||
| 372 | + | 15–1629. 25 | |
| 471 | 373 | ||
| 472 | - | ( | |
| 473 | - | ||
| 374 | + | (a) [This section applies only to a pharmacy benefits manager that provides 26 | |
| 375 | + | pharmacy benefits management services on behalf of a carrier. 27 | |
| 474 | 376 | ||
| 475 | - | (ii) Except as provided in paragraph (2) of this subsection: 29 | |
| 377 | + | (b)] This section does not apply to an audit that involves probable or potential 28 | |
| 378 | + | fraud or willful misrepresentation by a pharmacy or pharmacist. 29 | |
| 476 | 379 | ||
| 477 | - | 1. share information from an audit with another pharmacy 30 | |
| 478 | - | benefits manager; or 31 | |
| 380 | + | [(c)] (B) A pharmacy benefits manager shall conduct an audit of a pharmacy or 30 | |
| 381 | + | pharmacist under contract with the pharmacy benefits manager in accordance with this 31 | |
| 382 | + | section. 32 | |
| 479 | 383 | ||
| 480 | - | 2. use information from an audit conducted by another 32 | |
| 481 | - | pharmacy benefits manager. 33 HOUSE BILL 357 11 | |
| 384 | + | [(d)] (C) A pharmacy benefits manager may not schedule an onsite audit to begin 33 HOUSE BILL 357 9 | |
| 385 | + | ||
| 386 | + | ||
| 387 | + | during the first 5 calendar days of a month unless requested by the pharmacy or 1 | |
| 388 | + | pharmacist. 2 | |
| 389 | + | ||
| 390 | + | [(e)] (D) When conducting an audit, a pharmacy benefits manager shall: 3 | |
| 391 | + | ||
| 392 | + | (1) if the audit is onsite, provide written notice to the pharmacy or 4 | |
| 393 | + | pharmacist at least 2 weeks before conducting the initial onsite audit for each audit cycle; 5 | |
| 394 | + | ||
| 395 | + | (2) employ the services of a pharmacist if the audit requires the clinical or 6 | |
| 396 | + | professional judgment of a pharmacist; 7 | |
| 397 | + | ||
| 398 | + | (3) permit its auditors to enter the prescription area of a pharmacy only 8 | |
| 399 | + | when accompanied by or authorized by a member of the pharmacy staff; 9 | |
| 400 | + | ||
| 401 | + | (4) allow a pharmacist or pharmacy to use any prescription, or authorized 10 | |
| 402 | + | change to a prescription, that meets the requirements of COMAR 10.34.20.02 to validate 11 | |
| 403 | + | claims submitted for reimbursement for dispensing of original and refill prescriptions; 12 | |
| 404 | + | ||
| 405 | + | (5) for purposes of validating the pharmacy record with respect to orders 13 | |
| 406 | + | or refills of a drug, allow the pharmacy or pharmacist to use records of a hospital or a 14 | |
| 407 | + | physician or other prescriber authorized by law that are: 15 | |
| 408 | + | ||
| 409 | + | (i) written; or 16 | |
| 410 | + | ||
| 411 | + | (ii) transmitted electronically or by any other means of 17 | |
| 412 | + | communication authorized by contract between the pharmacy and the pharmacy benefits 18 | |
| 413 | + | manager; 19 | |
| 414 | + | ||
| 415 | + | (6) audit each pharmacy and pharmacist under the same standards and 20 | |
| 416 | + | parameters as other similarly situated pharmacies or pharmacists audited by the 21 | |
| 417 | + | pharmacy benefits manager; 22 | |
| 418 | + | ||
| 419 | + | (7) only audit claims submitted or adjudicated within the 2–year period 23 | |
| 420 | + | immediately preceding the audit, unless a longer period is authorized under federal or State 24 | |
| 421 | + | law; 25 | |
| 422 | + | ||
| 423 | + | (8) deliver the preliminary audit report to the pharmacy or pharmacist 26 | |
| 424 | + | within 120 calendar days after the completion of the audit, with reasonable extensions 27 | |
| 425 | + | allowed; 28 | |
| 426 | + | ||
| 427 | + | (9) in accordance with subsection [(k)] (J) of this section, allow a pharmacy 29 | |
| 428 | + | or pharmacist to produce documentation to address any discrepancy found during the audit; 30 | |
| 429 | + | and 31 | |
| 430 | + | ||
| 431 | + | (10) deliver the final audit report to the pharmacy or pharmacist: 32 | |
| 432 | + | ||
| 433 | + | (i) within 6 months after delivery of the preliminary audit report if 33 10 HOUSE BILL 357 | |
| 434 | + | ||
| 435 | + | ||
| 436 | + | the pharmacy or pharmacist does not request an internal appeal under subsection [(k)] (J) 1 | |
| 437 | + | of this section; or 2 | |
| 438 | + | ||
| 439 | + | (ii) within 30 days after the conclusion of the internal appeals 3 | |
| 440 | + | process under subsection [(k)] (J) of this section if the pharmacy or pharmacist requests 4 | |
| 441 | + | an internal appeal. 5 | |
| 442 | + | ||
| 443 | + | [(f)] (E) If a contract between a pharmacy or pharmacist and a pharmacy 6 | |
| 444 | + | benefits manager specifies a period of time in which a pharmacy or pharmacist is allowed 7 | |
| 445 | + | to withdraw and resubmit a claim and that period of time expires before the pharmacy 8 | |
| 446 | + | benefits manager delivers a preliminary audit report that identifies discrepancies, the 9 | |
| 447 | + | pharmacy benefits manager shall allow the pharmacy or pharmacist to withdraw and 10 | |
| 448 | + | resubmit a claim within 30 days after: 11 | |
| 449 | + | ||
| 450 | + | (1) the preliminary audit report is delivered if the pharmacy or pharmacist 12 | |
| 451 | + | does not request an internal appeal under subsection [(k)] (J) of this section; or 13 | |
| 452 | + | ||
| 453 | + | (2) the conclusion of the internal appeals process under subsection [(k)] (J) 14 | |
| 454 | + | of this section if the pharmacy or pharmacist requests an internal appeal. 15 | |
| 455 | + | ||
| 456 | + | [(g)] (F) During an audit, a pharmacy benefits manager may not disrupt the 16 | |
| 457 | + | provision of services to the customers of a pharmacy. 17 | |
| 458 | + | ||
| 459 | + | [(h)] (G) (1) A pharmacy benefits manager may not: 18 | |
| 460 | + | ||
| 461 | + | (i) use the accounting practice of extrapolation to calculate 19 | |
| 462 | + | overpayments or underpayments; or 20 | |
| 463 | + | ||
| 464 | + | (ii) Except as provided in paragraph (2) of this subsection: 21 | |
| 465 | + | ||
| 466 | + | 1. share information from an audit with another pharmacy 22 | |
| 467 | + | benefits manager; or 23 | |
| 468 | + | ||
| 469 | + | 2. use information from an audit conducted by another 24 | |
| 470 | + | pharmacy benefits manager. 25 | |
| 471 | + | ||
| 472 | + | (2) Paragraph (1)(ii) of this subsection does not apply to the sharing of 26 | |
| 473 | + | information: 27 | |
| 474 | + | ||
| 475 | + | (i) required by federal or State law; 28 | |
| 476 | + | ||
| 477 | + | (ii) in connection with an acquisition or merger involving the 29 | |
| 478 | + | pharmacy benefits manager; or 30 | |
| 479 | + | ||
| 480 | + | (iii) at the payor’s request or under the terms of the agreement 31 | |
| 481 | + | between the pharmacy benefits manager and the payor. 32 HOUSE BILL 357 11 | |
| 482 | 482 | ||
| 483 | 483 | ||
| 484 | 484 | ||
| 485 | - | (2) Paragraph (1)(ii) of this subsection does not apply to the sharing of 1 | |
| 486 | - | information: 2 | |
| 485 | + | [(i)] (H) The recoupment of a claims payment from a pharmacy or pharmacist 1 | |
| 486 | + | by a pharmacy benefits manager shall be based on an actual overpayment or denial of an 2 | |
| 487 | + | audited claim unless the projected overpayment or denial is part of a settlement agreed to 3 | |
| 488 | + | by the pharmacy or pharmacist. 4 | |
| 487 | 489 | ||
| 488 | - | (i) required by federal or State law; 3 | |
| 490 | + | [(j)] (I) (1) In this subsection, “overpayment” means a payment by the 5 | |
| 491 | + | pharmacy benefits manager to a pharmacy or pharmacist that is greater than the rate or 6 | |
| 492 | + | terms specified in the contract between the pharmacy or pharmacist and the pharmacy 7 | |
| 493 | + | benefits manager at the time that the payment is made. 8 | |
| 489 | 494 | ||
| 490 | - | (ii) in connection with an acquisition or merger involving the 4 | |
| 491 | - | pharmacy benefits manager; or 5 | |
| 495 | + | (2) A clerical error, record–keeping error, typographical error, or 9 | |
| 496 | + | scrivener’s error in a required document or record may not constitute fraud or grounds for 10 | |
| 497 | + | recoupment of a claims payment from a pharmacy or pharmacist by a pharmacy benefits 11 | |
| 498 | + | manager if the prescription was otherwise legally dispensed and the claim was otherwise 12 | |
| 499 | + | materially correct. 13 | |
| 492 | 500 | ||
| 493 | - | (iii) at the payor’s request or under the terms of the agreement 6 | |
| 494 | - | between the pharmacy benefits manager and the payor. 7 | |
| 501 | + | (3) Notwithstanding paragraph (2) of this subsection, claims remain 14 | |
| 502 | + | subject to recoupment of overpayment or payment of any discovered underpayment by the 15 | |
| 503 | + | pharmacy benefits manager. 16 | |
| 495 | 504 | ||
| 496 | - | [(i)] (H) The recoupment of a claims payment from a pharmacy or pharmacist 8 | |
| 497 | - | by a pharmacy benefits manager shall be based on an actual overpayment or denial of an 9 | |
| 498 | - | audited claim unless the projected overpayment or denial is part of a settlement agreed to 10 | |
| 499 | - | by the pharmacy or pharmacist. 11 | |
| 505 | + | [(k)] (J) (1) A pharmacy benefits manager shall establish an internal appeals 17 | |
| 506 | + | process under which a pharmacy or pharmacist may appeal any disputed claim in a 18 | |
| 507 | + | preliminary audit report. 19 | |
| 500 | 508 | ||
| 501 | - | [(j)] (I) (1) In this subsection, “overpayment” means a payment by the 12 | |
| 502 | - | pharmacy benefits manager to a pharmacy or pharmacist that is greater than the rate or 13 | |
| 503 | - | terms specified in the contract between the pharmacy or pharmacist and the pharmacy 14 | |
| 504 | - | benefits manager at the time that the payment is made. 15 | |
| 509 | + | (2) Under the internal appeals process, a pharmacy benefits manager shall 20 | |
| 510 | + | allow a pharmacy or pharmacist to request an internal appeal within 30 working days after 21 | |
| 511 | + | receipt of the preliminary audit report, with reasonable extensions allowed. 22 | |
| 505 | 512 | ||
| 506 | - | (2) A clerical error, record–keeping error, typographical error, or 16 | |
| 507 | - | scrivener’s error in a required document or record may not constitute fraud or grounds for 17 | |
| 508 | - | recoupment of a claims payment from a pharmacy or pharmacist by a pharmacy benefits 18 | |
| 509 | - | manager if the prescription was otherwise legally dispensed and the claim was otherwise 19 | |
| 510 | - | materially correct. 20 | |
| 513 | + | (3) The pharmacy benefits manager shall include in its preliminary audit 23 | |
| 514 | + | report a written explanation of the internal appeals process, including the name, address, 24 | |
| 515 | + | and telephone number of the person to whom an internal appeal should be addressed. 25 | |
| 511 | 516 | ||
| 512 | - | ( | |
| 513 | - | ||
| 514 | - | ||
| 517 | + | (4) The decision of the pharmacy benefits manager on an appeal of a 26 | |
| 518 | + | disputed claim in a preliminary audit report by a pharmacy or pharmacist shall be reflected 27 | |
| 519 | + | in the final audit report. 28 | |
| 515 | 520 | ||
| 516 | - | ||
| 517 | - | ||
| 518 | - | ||
| 521 | + | (5) The pharmacy benefits manager shall deliver the final audit report to 29 | |
| 522 | + | the pharmacy or pharmacist within 30 calendar days after conclusion of the internal 30 | |
| 523 | + | appeals process. 31 | |
| 519 | 524 | ||
| 520 | - | (2) Under the internal appeals process, a pharmacy benefits manager shall 27 | |
| 521 | - | allow a pharmacy or pharmacist to request an internal appeal within 30 working days after 28 | |
| 522 | - | receipt of the preliminary audit report, with reasonable extensions allowed. 29 | |
| 525 | + | [(l)] (K) (1) A pharmacy benefits manager may not recoup by setoff any 32 | |
| 526 | + | money for an overpayment or denial of a claim until: 33 | |
| 523 | 527 | ||
| 524 | - | (3) The pharmacy benefits manager shall include in its preliminary audit 30 | |
| 525 | - | report a written explanation of the internal appeals process, including the name, address, 31 | |
| 526 | - | and telephone number of the person to whom an internal appeal should be addressed. 32 | |
| 527 | - | ||
| 528 | - | (4) The decision of the pharmacy benefits manager on an appeal of a 33 | |
| 529 | - | disputed claim in a preliminary audit report by a pharmacy or pharmacist shall be reflected 34 | |
| 530 | - | in the final audit report. 35 12 HOUSE BILL 357 | |
| 528 | + | (i) the pharmacy or pharmacist has an opportunity to review the 34 | |
| 529 | + | pharmacy benefits manager’s findings; and 35 | |
| 530 | + | 12 HOUSE BILL 357 | |
| 531 | 531 | ||
| 532 | 532 | ||
| 533 | + | (ii) if the pharmacy or pharmacist concurs with the pharmacy 1 | |
| 534 | + | benefits manager’s findings of overpayment or denial, 30 working days have elapsed after 2 | |
| 535 | + | the date the final audit report has been delivered to the pharmacy or pharmacist. 3 | |
| 533 | 536 | ||
| 534 | - | (5) The pharmacy benefits manager shall deliver the final audit report to 1 | |
| 535 | - | the pharmacy or pharmacist within 30 calendar days after conclusion of the internal 2 | |
| 536 | - | appeals process. 3 | |
| 537 | + | (2) If the pharmacy or pharmacist does not concur with the pharmacy 4 | |
| 538 | + | benefits manager’s findings of overpayment or denial, the pharmacy benefits manager may 5 | |
| 539 | + | not recoup by setoff any money pending the outcome of an appeal under subsection [(k)] 6 | |
| 540 | + | (J) of this section. 7 | |
| 537 | 541 | ||
| 538 | - | [(l)] (K) (1) A pharmacy benefits manager may not recoup by setoff any 4 | |
| 539 | - | money for an overpayment or denial of a claim until: 5 | |
| 542 | + | (3) A pharmacy benefits manager shall remit any money due to a pharmacy 8 | |
| 543 | + | or pharmacist as a result of an underpayment of a claim within 30 working days after the 9 | |
| 544 | + | final audit report has been delivered to the pharmacy or pharmacist. 10 | |
| 540 | 545 | ||
| 541 | - | (i) the pharmacy or pharmacist has an opportunity to review the 6 | |
| 542 | - | pharmacy benefits manager’s findings; and 7 | |
| 546 | + | (4) Notwithstanding the provisions of paragraph (1) of this subsection, a 11 | |
| 547 | + | pharmacy benefits manager may withhold future payments before the date the final audit 12 | |
| 548 | + | report has been delivered to the pharmacy or pharmacist if the identified discrepancy for 13 | |
| 549 | + | all disputed claims in a preliminary audit report for an individual audit exceeds $25,000. 14 | |
| 543 | 550 | ||
| 544 | - | (ii) if the pharmacy or pharmacist concurs with the pharmacy 8 | |
| 545 | - | benefits manager’s findings of overpayment or denial, 30 working days have elapsed after 9 | |
| 546 | - | the date the final audit report has been delivered to the pharmacy or pharmacist. 10 | |
| 551 | + | [(m)] (L) (1) The Commissioner may adopt regulations regarding: 15 | |
| 547 | 552 | ||
| 548 | - | (2) If the pharmacy or pharmacist does not concur with the pharmacy 11 | |
| 549 | - | benefits manager’s findings of overpayment or denial, the pharmacy benefits manager may 12 | |
| 550 | - | not recoup by setoff any money pending the outcome of an appeal under subsection [(k)] 13 | |
| 551 | - | (J) of this section. 14 | |
| 553 | + | (i) the documentation that may be requested during an audit; and 16 | |
| 552 | 554 | ||
| 553 | - | (3) A pharmacy benefits manager shall remit any money due to a pharmacy 15 | |
| 554 | - | or pharmacist as a result of an underpayment of a claim within 30 working days after the 16 | |
| 555 | - | final audit report has been delivered to the pharmacy or pharmacist. 17 | |
| 555 | + | (ii) the process a pharmacy benefits manager may use to conduct an 17 | |
| 556 | + | audit. 18 | |
| 556 | 557 | ||
| 557 | - | (4) Notwithstanding the provisions of paragraph (1) of this subsection, a 18 | |
| 558 | - | pharmacy benefits manager may withhold future payments before the date the final audit 19 | |
| 559 | - | report has been delivered to the pharmacy or pharmacist if the identified discrepancy for 20 | |
| 560 | - | all disputed claims in a preliminary audit report for an individual audit exceeds $25,000. 21 | |
| 558 | + | (2) On request of the Commissioner or the Commissioner’s designee, a 19 | |
| 559 | + | pharmacy benefits manager shall provide a copy of its audit procedures or internal appeals 20 | |
| 560 | + | process. 21 | |
| 561 | 561 | ||
| 562 | - | ||
| 562 | + | 15–1630. 22 | |
| 563 | 563 | ||
| 564 | - | (i) the documentation that may be requested during an audit; and 23 | |
| 564 | + | (a) [This section applies only to a pharmacy benefits manager that provides 23 | |
| 565 | + | pharmacy benefits management services on behalf of a carrier. 24 | |
| 565 | 566 | ||
| 566 | - | (ii) the process a pharmacy benefits manager may use to conduct an 24 | |
| 567 | - | audit. 25 | |
| 567 | + | (b)] A pharmacy benefits manager shall establish a reasonable internal review 25 | |
| 568 | + | process for a pharmacy to request the review of a failure to pay the contractual 26 | |
| 569 | + | reimbursement amount of a submitted claim. 27 | |
| 568 | 570 | ||
| 569 | - | ( | |
| 570 | - | ||
| 571 | - | ||
| 571 | + | [(c)] (B) A pharmacy may request a pharmacy benefits manager to review a 28 | |
| 572 | + | failure to pay the contractual reimbursement amount of a claim within 180 calendar days 29 | |
| 573 | + | after the date the submitted claim was paid by the pharmacy benefits manager. 30 | |
| 572 | 574 | ||
| 573 | - | 15–1630. 29 | |
| 574 | - | ||
| 575 | - | (a) [This section applies only to a pharmacy benefits manager that provides 30 | |
| 576 | - | pharmacy benefits management services on behalf of a carrier. 31 | |
| 575 | + | [(d)] (C) The pharmacy benefits manager shall give written notice of its review 31 | |
| 576 | + | decision within 90 calendar days after receipt of a request for review from a pharmacy 32 | |
| 577 | + | under this section. 33 | |
| 577 | 578 | HOUSE BILL 357 13 | |
| 578 | 579 | ||
| 579 | 580 | ||
| 580 | - | (b)] A pharmacy benefits manager shall establish a reasonable internal review 1 | |
| 581 | - | process for a pharmacy to request the review of a failure to pay the contractual 2 | |
| 582 | - | reimbursement amount of a submitted claim. 3 | |
| 581 | + | [(e)] (D) If the pharmacy benefits manager determines through the internal 1 | |
| 582 | + | review process established under subsection [(b)] (A) of this section that the pharmacy 2 | |
| 583 | + | benefits manager underpaid a pharmacy, the pharmacy benefits manager shall pay any 3 | |
| 584 | + | money due to the pharmacy within 30 working days after completion of the internal review 4 | |
| 585 | + | process. 5 | |
| 583 | 586 | ||
| 584 | - | [(c)] (B) A pharmacy may request a pharmacy benefits manager to review a 4 | |
| 585 | - | failure to pay the contractual reimbursement amount of a claim within 180 calendar days 5 | |
| 586 | - | after the date the submitted claim was paid by the pharmacy benefits manager. 6 | |
| 587 | + | [(f)] (E) This section may not be construed to limit the ability of a pharmacy and 6 | |
| 588 | + | a pharmacy benefits manager to contractually agree that a pharmacy may have more than 7 | |
| 589 | + | 180 calendar days to request an internal review of a failure of the pharmacy benefits 8 | |
| 590 | + | manager to pay the contractual amount of a submitted claim. 9 | |
| 587 | 591 | ||
| 588 | - | [(d)] (C) The pharmacy benefits manager shall give written notice of its review 7 | |
| 589 | - | decision within 90 calendar days after receipt of a request for review from a pharmacy 8 | |
| 590 | - | under this section. 9 | |
| 592 | + | [15–1633. 10 | |
| 591 | 593 | ||
| 592 | - | [(e)] (D) If the pharmacy benefits manager determines through the internal 10 | |
| 593 | - | review process established under subsection [(b)] (A) of this section that the pharmacy 11 | |
| 594 | - | benefits manager underpaid a pharmacy, the pharmacy benefits manager shall pay any 12 | |
| 595 | - | money due to the pharmacy within 30 working days after completion of the internal review 13 | |
| 596 | - | process. 14 | |
| 594 | + | The provisions of §§ 15–1633.1 through 15–1639 of this subtitle apply only to a 11 | |
| 595 | + | pharmacy benefits manager performing pharmacy benefits management services on behalf 12 | |
| 596 | + | of a carrier.] 13 | |
| 597 | 597 | ||
| 598 | - | [(f)] (E) This section may not be construed to limit the ability of a pharmacy and 15 | |
| 599 | - | a pharmacy benefits manager to contractually agree that a pharmacy may have more than 16 | |
| 600 | - | 180 calendar days to request an internal review of a failure of the pharmacy benefits 17 | |
| 601 | - | manager to pay the contractual amount of a submitted claim. 18 | |
| 598 | + | [15–1633.1.] 15–1633. 14 | |
| 602 | 599 | ||
| 603 | - | [15–1633. 19 | |
| 600 | + | A pharmacy benefits manager or its agent may not request a therapeutic interchange 15 | |
| 601 | + | unless: 16 | |
| 604 | 602 | ||
| 605 | - | The provisions of §§ 15–1633.1 through 15–1639 of this subtitle apply only to a 20 | |
| 606 | - | pharmacy benefits manager performing pharmacy benefits management services on behalf 21 | |
| 607 | - | of a carrier.] 22 | |
| 603 | + | (1) the proposed therapeutic interchange is for medical reasons that benefit 17 | |
| 604 | + | the beneficiary; or 18 | |
| 608 | 605 | ||
| 609 | - | [15–1633.1.] 15–1633. 23 | |
| 606 | + | (2) the proposed therapeutic interchange will result in financial savings 19 | |
| 607 | + | and benefits to the purchaser or the beneficiary. 20 | |
| 610 | 608 | ||
| 611 | - | A pharmacy benefits manager or its agent may not request a therapeutic interchange 24 | |
| 612 | - | unless: 25 | |
| 613 | - | ||
| 614 | - | (1) the proposed therapeutic interchange is for medical reasons that benefit 26 | |
| 615 | - | the beneficiary; or 27 | |
| 616 | - | ||
| 617 | - | (2) the proposed therapeutic interchange will result in financial savings 28 | |
| 618 | - | and benefits to the purchaser or the beneficiary. 29 | |
| 619 | - | ||
| 620 | - | SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 30 | |
| 621 | - | January 1, 2024. 31 | |
| 609 | + | SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 21 | |
| 610 | + | January 1, 2024. 22 | |
| 622 | 611 |