| 1 | 1 | | II |
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| 2 | 2 | | 119THCONGRESS |
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| 3 | 3 | | 1 |
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| 4 | 4 | | STSESSION S. 526 |
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| 5 | 5 | | To prevent unfair and deceptive acts or practices and the dissemination |
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| 6 | 6 | | of false information related to pharmacy benefit management services |
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| 7 | 7 | | for prescription drugs, and for other purposes. |
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| 8 | 8 | | IN THE SENATE OF THE UNITED STATES |
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| 9 | 9 | | FEBRUARY11, 2025 |
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| 10 | 10 | | Mr. G |
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| 11 | 11 | | RASSLEY(for himself, Ms. CANTWELL, Ms. ERNST, Mr. WELCH, Mrs. |
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| 12 | 12 | | C |
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| 13 | 13 | | APITO, Mrs. SHAHEEN, Mr. MARSHALL, Mr. HEINRICH, Mr. MORAN, |
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| 14 | 14 | | Mrs. H |
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| 15 | 15 | | YDE-SMITH, Mr. TILLIS, and Mr. ROUNDS) introduced the fol- |
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| 16 | 16 | | lowing bill; which was read twice and referred to the Committee on Com- |
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| 17 | 17 | | merce, Science, and Transportation |
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| 18 | 18 | | A BILL |
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| 19 | 19 | | To prevent unfair and deceptive acts or practices and the |
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| 20 | 20 | | dissemination of false information related to pharmacy |
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| 21 | 21 | | benefit management services for prescription drugs, and |
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| 22 | 22 | | for other purposes. |
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| 23 | 23 | | Be it enacted by the Senate and House of Representa-1 |
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| 24 | 24 | | tives of the United States of America in Congress assembled, 2 |
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| 25 | 25 | | SECTION 1. SHORT TITLE. 3 |
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| 26 | 26 | | This Act may be cited as the ‘‘Pharmacy Benefit 4 |
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| 27 | 27 | | Manager Transparency Act of 2025’’. 5 |
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| 29 | 29 | | ssavage on LAPJG3WLY3PROD with BILLS 2 |
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| 30 | 30 | | •S 526 IS |
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| 31 | 31 | | SEC. 2. PROHIBITION ON UNFAIR OR DECEPTIVE PRE-1 |
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| 32 | 32 | | SCRIPTION DRUG PRICING PRACTICES. 2 |
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| 33 | 33 | | (a) C |
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| 34 | 34 | | ONDUCTPROHIBITED.—Except as provided in 3 |
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| 35 | 35 | | subsection (b), it shall be unlawful for any pharmacy ben-4 |
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| 36 | 36 | | efit manager (or affiliate, subsidiary, or agent of a phar-5 |
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| 37 | 37 | | macy benefit manager), directly or indirectly, to engage 6 |
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| 38 | 38 | | in any of the following activities related to pharmacy ben-7 |
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| 39 | 39 | | efit management services: 8 |
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| 40 | 40 | | (1) Charge a health plan or payer a different 9 |
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| 41 | 41 | | amount for a prescription drug’s ingredient cost or 10 |
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| 42 | 42 | | dispensing fee than the amount the pharmacy ben-11 |
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| 43 | 43 | | efit manager reimburses a pharmacy for the pre-12 |
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| 44 | 44 | | scription drug’s ingredient cost or dispensing fee 13 |
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| 45 | 45 | | where the pharmacy benefit manager retains the 14 |
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| 46 | 46 | | amount of any such difference. 15 |
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| 47 | 47 | | (2) Arbitrarily, unfairly, or deceptively, by con-16 |
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| 48 | 48 | | tract or any other means, reduce, rescind, or other-17 |
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| 49 | 49 | | wise claw back any reimbursement payment, in 18 |
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| 50 | 50 | | whole or in part, to a pharmacist or pharmacy for 19 |
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| 51 | 51 | | a prescription drug’s ingredient cost or dispensing 20 |
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| 52 | 52 | | fee, unless— 21 |
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| 53 | 53 | | (A) the original claim was submitted 22 |
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| 54 | 54 | | fraudulently; 23 |
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| 55 | 55 | | (B) the original claim payment was incon-24 |
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| 56 | 56 | | sistent with the reimbursement terms in the 25 |
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| 57 | 57 | | contract; or 26 |
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| 60 | 60 | | •S 526 IS |
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| 61 | 61 | | (C) the pharmacist services were not ren-1 |
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| 62 | 62 | | dered by the pharmacy or pharmacist. 2 |
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| 63 | 63 | | (3) Arbitrarily, unfairly, or deceptively, by con-3 |
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| 64 | 64 | | tract or any other means, increase fees or lower re-4 |
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| 65 | 65 | | imbursement to a pharmacy in order to offset reim-5 |
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| 66 | 66 | | bursement changes instructed by the Federal Gov-6 |
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| 67 | 67 | | ernment under any health plan funded by the Fed-7 |
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| 68 | 68 | | eral Government. 8 |
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| 69 | 69 | | (b) E |
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| 70 | 70 | | XCEPTIONS.—A pharmacy benefit manager 9 |
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| 71 | 71 | | shall not be in violation of paragraph (1) or (3) of sub-10 |
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| 72 | 72 | | section (a) if the pharmacy benefit manager meets the fol-11 |
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| 73 | 73 | | lowing conditions: 12 |
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| 74 | 74 | | (1) The pharmacy benefit manager, affiliate, 13 |
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| 75 | 75 | | subsidiary, or agent passes along or returns 100 per-14 |
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| 76 | 76 | | cent of any price concession to a health plan or 15 |
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| 77 | 77 | | payer, including any rebate, discount, or other price 16 |
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| 78 | 78 | | concession. 17 |
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| 79 | 79 | | (2) The pharmacy benefit manager, affiliate, 18 |
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| 80 | 80 | | subsidiary, or agent provides full and complete dis-19 |
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| 81 | 81 | | closure of— 20 |
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| 82 | 82 | | (A) the cost, price, and reimbursement of 21 |
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| 83 | 83 | | a prescription drug to each health plan, payer, 22 |
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| 84 | 84 | | and pharmacy with which the pharmacy benefit 23 |
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| 85 | 85 | | manager, affiliate, subsidiary, or agent has a 24 |
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| 87 | 87 | | ssavage on LAPJG3WLY3PROD with BILLS 4 |
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| 88 | 88 | | •S 526 IS |
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| 89 | 89 | | contract or agreement to provide pharmacy ben-1 |
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| 90 | 90 | | efit management services; 2 |
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| 91 | 91 | | (B) each fee, markup, and discount 3 |
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| 92 | 92 | | charged or imposed by the pharmacy benefit 4 |
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| 93 | 93 | | manager, affiliate, subsidiary, or agent to each 5 |
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| 94 | 94 | | health plan, payer, and pharmacy with which 6 |
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| 95 | 95 | | the pharmacy benefit manager, affiliate, sub-7 |
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| 96 | 96 | | sidiary, or agent has a contract or agreement 8 |
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| 97 | 97 | | for pharmacy benefit management services; or 9 |
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| 98 | 98 | | (C) the aggregate amount of all remunera-10 |
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| 99 | 99 | | tion the pharmacy benefit manager receives 11 |
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| 100 | 100 | | from a prescription drug manufacturer for a 12 |
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| 101 | 101 | | prescription drug, including any rebate, dis-13 |
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| 102 | 102 | | count, administration fee, and any other pay-14 |
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| 103 | 103 | | ment or credit obtained or retained by the phar-15 |
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| 104 | 104 | | macy benefit manager, or affiliate, subsidiary, 16 |
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| 105 | 105 | | or agent of the pharmacy benefit manager, pur-17 |
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| 106 | 106 | | suant to a contract or agreement for pharmacy 18 |
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| 107 | 107 | | benefit management services to a health plan, 19 |
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| 108 | 108 | | payer, or any Federal agency (upon the request 20 |
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| 109 | 109 | | of the agency). 21 |
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| 110 | 110 | | SEC. 3. PROHIBITION ON FALSE INFORMATION. 22 |
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| 111 | 111 | | It shall be unlawful for any person to report informa-23 |
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| 112 | 112 | | tion related to pharmacy benefit management services to 24 |
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| 113 | 113 | | a Federal department or agency if— 25 |
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| 116 | 116 | | •S 526 IS |
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| 117 | 117 | | (1) the person knew, or reasonably should have 1 |
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| 118 | 118 | | known, the information to be false or misleading; 2 |
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| 119 | 119 | | (2) the information was required by law to be 3 |
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| 120 | 120 | | reported; and 4 |
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| 121 | 121 | | (3) the false or misleading information reported 5 |
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| 122 | 122 | | by the person would affect analysis or information 6 |
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| 123 | 123 | | compiled by the Federal department or agency for 7 |
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| 124 | 124 | | statistical or analytical purposes with respect to the 8 |
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| 125 | 125 | | market for pharmacy benefit management services. 9 |
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| 126 | 126 | | SEC. 4. TRANSPARENCY. 10 |
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| 127 | 127 | | (a) R |
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| 128 | 128 | | EPORTING BY PHARMACYBENEFITMAN-11 |
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| 129 | 129 | | AGERS.—Subject to subsection (d), not later than 1 year 12 |
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| 130 | 130 | | after the date of enactment of this Act, and annually 13 |
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| 131 | 131 | | thereafter, each pharmacy benefit manager (or affiliate, 14 |
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| 132 | 132 | | subsidiary, or agent of a pharmacy benefit manager) shall 15 |
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| 133 | 133 | | report to the Commission and the Secretary of Health and 16 |
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| 134 | 134 | | Human Services the following information: 17 |
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| 135 | 135 | | (1) The aggregate amount of the difference be-18 |
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| 136 | 136 | | tween the amount the pharmacy benefit manager 19 |
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| 137 | 137 | | was paid by each health plan and the amount that 20 |
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| 138 | 138 | | the pharmacy benefit manager paid each pharmacy 21 |
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| 139 | 139 | | on behalf of the health plan for prescription drugs. 22 |
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| 140 | 140 | | (2) The aggregate amount of any— 23 |
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| 141 | 141 | | (A) generic effective rate fee charged to 24 |
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| 142 | 142 | | each pharmacy; 25 |
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| 145 | 145 | | •S 526 IS |
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| 146 | 146 | | (B) direct and indirect remuneration fee 1 |
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| 147 | 147 | | charged or other price concession to each phar-2 |
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| 148 | 148 | | macy; and 3 |
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| 149 | 149 | | (C) payment rescinded or otherwise clawed 4 |
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| 150 | 150 | | back from a reimbursement made to each phar-5 |
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| 151 | 151 | | macy. 6 |
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| 152 | 152 | | (3) If, during the reporting year, the pharmacy 7 |
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| 153 | 153 | | benefit manager moved or reassigned a prescription 8 |
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| 154 | 154 | | drug to a formulary tier that has a higher cost, 9 |
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| 155 | 155 | | higher copayment, higher coinsurance, or higher de-10 |
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| 156 | 156 | | ductible to a consumer, or a lower reimbursement to 11 |
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| 157 | 157 | | a pharmacy, an explanation of the reason why the 12 |
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| 158 | 158 | | drug was moved or reassigned from 1 tier to an-13 |
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| 159 | 159 | | other, including whether the move or reassignment 14 |
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| 160 | 160 | | was determined or requested by a prescription drug 15 |
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| 161 | 161 | | manufacturer or other entity. 16 |
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| 162 | 162 | | (4) With respect to any pharmacy benefit man-17 |
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| 163 | 163 | | ager that owns, controls, or is affiliated with a phar-18 |
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| 164 | 164 | | macy, a report regarding any difference in reim-19 |
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| 165 | 165 | | bursement rates or practices, direct and indirect re-20 |
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| 166 | 166 | | muneration fees or other price concessions, and 21 |
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| 167 | 167 | | clawbacks between a pharmacy that is owned, con-22 |
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| 168 | 168 | | trolled, or affiliated with the pharmacy benefit man-23 |
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| 169 | 169 | | ager and any other pharmacy. 24 |
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| 170 | 170 | | (b) R |
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| 171 | 171 | | EPORT TOCONGRESS.— 25 |
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| 174 | 174 | | •S 526 IS |
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| 175 | 175 | | (1) IN GENERAL.—Not later than 1 year after 1 |
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| 176 | 176 | | the date of enactment of this Act, and annually 2 |
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| 177 | 177 | | thereafter, the Commission shall submit to the Com-3 |
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| 178 | 178 | | mittee on Commerce, Science, and Transportation of 4 |
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| 179 | 179 | | the Senate and the Committee on Energy and Com-5 |
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| 180 | 180 | | merce of the House of Representatives a report that 6 |
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| 181 | 181 | | addresses, at a minimum— 7 |
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| 182 | 182 | | (A) the number actions brought by the 8 |
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| 183 | 183 | | Commission during the reporting year to en-9 |
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| 184 | 184 | | force this Act and the outcome of each such en-10 |
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| 185 | 185 | | forcement action; 11 |
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| 186 | 186 | | (B) the number of open investigations or 12 |
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| 187 | 187 | | inquiries into potential violations of this Act as 13 |
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| 188 | 188 | | of the time the report is submitted; 14 |
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| 189 | 189 | | (C) the number and nature of complaints 15 |
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| 190 | 190 | | received by the Commission relating to an alle-16 |
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| 191 | 191 | | gation of a violation of this Act during the re-17 |
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| 192 | 192 | | porting year; 18 |
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| 193 | 193 | | (D) an anonymized summary of the re-19 |
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| 194 | 194 | | ports filed with the Commission pursuant to 20 |
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| 195 | 195 | | subsection (a) for the reporting year; 21 |
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| 196 | 196 | | (E) an analysis of the requirements of this 22 |
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| 197 | 197 | | Act and whether the implementation of such re-23 |
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| 198 | 198 | | quirements leads to mergers (including hori-24 |
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| 199 | 199 | | zontal mergers or vertical mergers) amongst 25 |
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| 201 | 201 | | ssavage on LAPJG3WLY3PROD with BILLS 8 |
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| 202 | 202 | | •S 526 IS |
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| 203 | 203 | | any pharmacy benefit managers, or any phar-1 |
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| 204 | 204 | | macy benefit manager that owns, controls, or is 2 |
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| 205 | 205 | | affiliated with a pharmacy, or any pharmacy 3 |
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| 206 | 206 | | benefit manager that owns, controls, or is affili-4 |
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| 207 | 207 | | ated with a health plan, and the effect of such 5 |
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| 208 | 208 | | merger (including the likelihood of a substantial 6 |
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| 209 | 209 | | decrease in competition or the potential for a 7 |
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| 210 | 210 | | monopoly); and 8 |
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| 211 | 211 | | (F) policy or legislative recommendations 9 |
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| 212 | 212 | | to strengthen any enforcement action relating 10 |
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| 213 | 213 | | to a violation of this Act, including rec-11 |
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| 214 | 214 | | ommendations to include additional prohibited 12 |
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| 215 | 215 | | conduct in section 2(a), and recommendations 13 |
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| 216 | 216 | | to encourage more competition and decrease the 14 |
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| 217 | 217 | | likelihood of a monopoly in the pharmaceutical 15 |
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| 218 | 218 | | supply chain. 16 |
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| 219 | 219 | | (2) F |
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| 220 | 220 | | ORMULARY DESIGN OR PLACEMENT PRAC -17 |
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| 221 | 221 | | TICES.—Not later than 1 year after the date of en-18 |
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| 222 | 222 | | actment of this Act, the Commission shall submit to 19 |
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| 223 | 223 | | the Committee on Commerce, Science, and Trans-20 |
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| 224 | 224 | | portation of the Senate, the Committee on Finance 21 |
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| 225 | 225 | | of the Senate, the Committee on Health, Education, 22 |
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| 226 | 226 | | Labor, and Pensions of the Senate, the Committee 23 |
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| 227 | 227 | | on Ways and Means of the House of Representa-24 |
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| 228 | 228 | | tives, and the Committee on Energy and Commerce 25 |
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| 231 | 231 | | •S 526 IS |
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| 232 | 232 | | of the House of Representatives a report that ad-1 |
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| 233 | 233 | | dresses the policies, practices, and role of pharmacy 2 |
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| 234 | 234 | | benefit managers (including their affiliates, subsidi-3 |
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| 235 | 235 | | aries, and agents) regarding formulary design or 4 |
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| 236 | 236 | | placement, including— 5 |
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| 237 | 237 | | (A) whether pharmacy benefit managers 6 |
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| 238 | 238 | | (including their affiliates, subsidiaries, and 7 |
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| 239 | 239 | | agents) use formulary design or placement to 8 |
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| 240 | 240 | | increase their gross revenue without an accom-9 |
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| 241 | 241 | | panying increase in patient access or decrease 10 |
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| 242 | 242 | | in patient cost; or 11 |
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| 243 | 243 | | (B) recommendations to Congress for leg-12 |
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| 244 | 244 | | islative action addressing such policies, prac-13 |
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| 245 | 245 | | tices, and role of pharmacy benefit managers 14 |
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| 246 | 246 | | (including their affiliates, subsidiaries, and 15 |
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| 247 | 247 | | agents). 16 |
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| 248 | 248 | | (3) C |
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| 249 | 249 | | ONSTRUCTION.—Nothing in this section 17 |
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| 250 | 250 | | shall be construed as authorizing the Commission to 18 |
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| 251 | 251 | | disclose any information that is a trade secret or 19 |
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| 252 | 252 | | confidential information described in section 20 |
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| 253 | 253 | | 552(b)(4) of title 5, United States Code, except as 21 |
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| 254 | 254 | | necessary to enforce this Act. 22 |
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| 255 | 255 | | (4) C |
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| 256 | 256 | | ONFIDENTIALITY.—The Commission may 23 |
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| 257 | 257 | | disclose the information in a form which does not 24 |
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| 258 | 258 | | disclose the identity of a specific pharmacy benefit 25 |
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| 260 | 260 | | ssavage on LAPJG3WLY3PROD with BILLS 10 |
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| 261 | 261 | | •S 526 IS |
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| 262 | 262 | | manager, pharmacy, or health plan for the following 1 |
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| 263 | 263 | | purposes: 2 |
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| 264 | 264 | | (A) To permit the Comptroller General of 3 |
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| 265 | 265 | | the United States to review the information 4 |
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| 266 | 266 | | provided to carry out this Act. 5 |
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| 267 | 267 | | (B) To permit the Director of the Congres-6 |
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| 268 | 268 | | sional Budget Office to review the information 7 |
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| 269 | 269 | | provided. 8 |
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| 270 | 270 | | (c) GAO S |
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| 271 | 271 | | TUDY.—Not later than 1 year after the 9 |
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| 272 | 272 | | date of enactment of this Act, the Comptroller General 10 |
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| 273 | 273 | | of the United States shall submit to the Committee on 11 |
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| 274 | 274 | | Commerce, Science, and Transportation, the Committee 12 |
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| 275 | 275 | | on Finance, and the Committee on Health, Education, 13 |
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| 276 | 276 | | Labor, and Pensions of the Senate and to the Committee 14 |
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| 277 | 277 | | on Ways and Means and the Committee on Energy and 15 |
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| 278 | 278 | | Commerce of the House of Representatives a report 16 |
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| 279 | 279 | | that— 17 |
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| 280 | 280 | | (1) addresses, at minimum— 18 |
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| 281 | 281 | | (A) the role that pharmacy benefit man-19 |
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| 282 | 282 | | agers play in the pharmaceutical supply chain; 20 |
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| 283 | 283 | | (B) the state of competition among phar-21 |
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| 284 | 284 | | macy benefit managers, including the market 22 |
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| 285 | 285 | | share for the Nation’s 10 largest pharmacy 23 |
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| 286 | 286 | | benefit managers; 24 |
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| 289 | 289 | | •S 526 IS |
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| 290 | 290 | | (C) the use of rebates and fees by phar-1 |
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| 291 | 291 | | macy benefit managers, including data for each 2 |
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| 292 | 292 | | of the 10 largest pharmacy benefit managers 3 |
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| 293 | 293 | | that reflects, for each drug in the formulary of 4 |
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| 294 | 294 | | each such pharmacy benefit manager— 5 |
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| 295 | 295 | | (i) the amount of the rebate passed on 6 |
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| 296 | 296 | | to patients; 7 |
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| 297 | 297 | | (ii) the amount of the rebate passed 8 |
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| 298 | 298 | | on to payors; 9 |
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| 299 | 299 | | (iii) the amount of the rebate kept by 10 |
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| 300 | 300 | | the pharmacy benefit manager; and 11 |
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| 301 | 301 | | (iv) the role of fees charged by the 12 |
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| 302 | 302 | | pharmacy benefit manager; 13 |
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| 303 | 303 | | (D) whether pharmacy benefit managers 14 |
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| 304 | 304 | | structure their formularies in favor of high-re-15 |
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| 305 | 305 | | bate prescription drugs over lower-cost, lower- 16 |
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| 306 | 306 | | rebate alternatives; 17 |
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| 307 | 307 | | (E) the average prior authorization ap-18 |
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| 308 | 308 | | proval time for each of the 10 largest pharmacy 19 |
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| 309 | 309 | | benefit managers; 20 |
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| 310 | 310 | | (F) factors affecting the use of step ther-21 |
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| 311 | 311 | | apy in each of the 10 largest pharmacy benefit 22 |
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| 312 | 312 | | managers; 23 |
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| 313 | 313 | | (G) the extent to which the price that 24 |
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| 314 | 314 | | pharmacy benefit managers charge payors, such 25 |
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| 317 | 317 | | •S 526 IS |
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| 318 | 318 | | as the Medicare program under title XXVIII of 1 |
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| 319 | 319 | | the Social Security Act (42 U.S.C. 1395 et 2 |
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| 320 | 320 | | seq.), State Medicaid programs under title XIX 3 |
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| 321 | 321 | | of the Social Security Act (42 U.S.C. 1396 et 4 |
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| 322 | 322 | | seq.), the Federal Employees Health Benefits 5 |
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| 323 | 323 | | Program under chapter 89 of title 5, United 6 |
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| 324 | 324 | | States Code, or private payors, for a drug is 7 |
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| 325 | 325 | | more than such pharmacy benefit managers pay 8 |
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| 326 | 326 | | the pharmacy for the drug; and 9 |
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| 327 | 327 | | (H) the competitive impact of pharmacy 10 |
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| 328 | 328 | | benefit managers’ business practices, including 11 |
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| 329 | 329 | | the impact that such business practices have on 12 |
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| 330 | 330 | | the cost of health plan premiums or prescrip-13 |
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| 331 | 331 | | tion drugs for consumers; and 14 |
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| 332 | 332 | | (2) provides recommendations for legislative ac-15 |
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| 333 | 333 | | tion to lower the cost of prescription drugs for con-16 |
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| 334 | 334 | | sumers and payors, improve the efficiency of the 17 |
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| 335 | 335 | | pharmaceutical supply chain by lowering inter-18 |
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| 336 | 336 | | mediary costs, improve competition in pharmacy 19 |
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| 337 | 337 | | benefit management, and provide transparency in 20 |
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| 338 | 338 | | pharmacy benefit management. 21 |
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| 339 | 339 | | (d) P |
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| 340 | 340 | | RIVACYREQUIREMENTS.—Any entity shall pro-22 |
|---|
| 341 | 341 | | vide information under subsection (a) in a manner con-23 |
|---|
| 342 | 342 | | sistent with the privacy, security, and breach notification 24 |
|---|
| 343 | 343 | | regulations promulgated under section 264(c) of the 25 |
|---|
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| 346 | 346 | | •S 526 IS |
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| 347 | 347 | | Health Insurance Portability and Accountability Act of 1 |
|---|
| 348 | 348 | | 1996 (42 U.S.C. 1320d–2 note) (or any successor regula-2 |
|---|
| 349 | 349 | | tion), and shall restrict the use and disclosure of such in-3 |
|---|
| 350 | 350 | | formation according to such regulations. 4 |
|---|
| 351 | 351 | | SEC. 5. WHISTLEBLOWER PROTECTIONS. 5 |
|---|
| 352 | 352 | | (a) I |
|---|
| 353 | 353 | | NGENERAL.—A pharmacy benefit manager, 6 |
|---|
| 354 | 354 | | health plan, pharmaceutical manufacturer, pharmacy, or 7 |
|---|
| 355 | 355 | | any affiliate, subsidiary, or agent thereof shall not, directly 8 |
|---|
| 356 | 356 | | or indirectly, discharge, demote, suspend, diminish, or 9 |
|---|
| 357 | 357 | | withdraw benefits from, threaten, harass, or in any other 10 |
|---|
| 358 | 358 | | manner discriminate against or adversely impact a covered 11 |
|---|
| 359 | 359 | | individual because— 12 |
|---|
| 360 | 360 | | (1) the covered individual, or anyone perceived 13 |
|---|
| 361 | 361 | | as assisting the covered individual, takes (or is sus-14 |
|---|
| 362 | 362 | | pected to have taken or will take) a lawful action in 15 |
|---|
| 363 | 363 | | providing to Congress, an agency of the Federal 16 |
|---|
| 364 | 364 | | Government, the attorney general of a State, a State 17 |
|---|
| 365 | 365 | | regulator with authority over the distribution or in-18 |
|---|
| 366 | 366 | | surance coverage of prescription drugs, or a law en-19 |
|---|
| 367 | 367 | | forcement agency relating to any act or omission 20 |
|---|
| 368 | 368 | | that the covered individual reasonably believes to be 21 |
|---|
| 369 | 369 | | a violation of this Act; 22 |
|---|
| 370 | 370 | | (2) the covered individual provides information 23 |
|---|
| 371 | 371 | | that the covered individual reasonably believes evi-24 |
|---|
| 372 | 372 | | dences such a violation to— 25 |
|---|
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| 374 | 374 | | ssavage on LAPJG3WLY3PROD with BILLS 14 |
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| 375 | 375 | | •S 526 IS |
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| 376 | 376 | | (A) a person with supervisory authority 1 |
|---|
| 377 | 377 | | over the covered individual at the pharmacy 2 |
|---|
| 378 | 378 | | benefit manager, health plan, pharmaceutical 3 |
|---|
| 379 | 379 | | manufacturer, pharmacy, or any affiliate, sub-4 |
|---|
| 380 | 380 | | sidiary, or agent thereof; or 5 |
|---|
| 381 | 381 | | (B) another individual working for the 6 |
|---|
| 382 | 382 | | pharmacy benefit manager, health plan, phar-7 |
|---|
| 383 | 383 | | maceutical manufacturer, pharmacy, or any af-8 |
|---|
| 384 | 384 | | filiate, subsidiary, or agent thereof who the cov-9 |
|---|
| 385 | 385 | | ered individual reasonably believes has the au-10 |
|---|
| 386 | 386 | | thority to investigate, discover, or terminate the 11 |
|---|
| 387 | 387 | | violation or to take any other action to address 12 |
|---|
| 388 | 388 | | the violation; 13 |
|---|
| 389 | 389 | | (3) the covered individual testifies (or it is sus-14 |
|---|
| 390 | 390 | | pected that the covered individual will testify) in an 15 |
|---|
| 391 | 391 | | investigation or judicial or administrative proceeding 16 |
|---|
| 392 | 392 | | concerning such a violation; or 17 |
|---|
| 393 | 393 | | (4) the covered individual assists or participates 18 |
|---|
| 394 | 394 | | (or it is expected that the covered individual will as-19 |
|---|
| 395 | 395 | | sist or participate) in such an investigation or judi-20 |
|---|
| 396 | 396 | | cial or administrative proceeding. 21 |
|---|
| 397 | 397 | | (b) E |
|---|
| 398 | 398 | | NFORCEMENT.—An individual who alleges any 22 |
|---|
| 399 | 399 | | adverse action in violation of subsection (a) may bring an 23 |
|---|
| 400 | 400 | | action for a jury trial in the appropriate district court of 24 |
|---|
| 401 | 401 | | the United States for the following relief: 25 |
|---|
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| 403 | 403 | | ssavage on LAPJG3WLY3PROD with BILLS 15 |
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| 404 | 404 | | •S 526 IS |
|---|
| 405 | 405 | | (1) Temporary relief while the case is pending. 1 |
|---|
| 406 | 406 | | (2) Reinstatement with the same seniority sta-2 |
|---|
| 407 | 407 | | tus that the individual would have had, but for the 3 |
|---|
| 408 | 408 | | discharge or discrimination. 4 |
|---|
| 409 | 409 | | (3) Twice the amount of back pay otherwise 5 |
|---|
| 410 | 410 | | owed to the individual, with interest. 6 |
|---|
| 411 | 411 | | (4) Consequential and compensatory damages, 7 |
|---|
| 412 | 412 | | and compensation for litigation costs, expert witness 8 |
|---|
| 413 | 413 | | fees, and reasonable attorneys’ fees. 9 |
|---|
| 414 | 414 | | (c) W |
|---|
| 415 | 415 | | AIVER OFRIGHTS ANDREMEDIES.—The rights 10 |
|---|
| 416 | 416 | | and remedies provided for in this section shall not be 11 |
|---|
| 417 | 417 | | waived by any policy form or condition of employment, in-12 |
|---|
| 418 | 418 | | cluding by a predispute arbitration agreement. 13 |
|---|
| 419 | 419 | | (d) P |
|---|
| 420 | 420 | | REDISPUTEARBITRATIONAGREEMENTS.—No 14 |
|---|
| 421 | 421 | | predispute arbitration agreement shall be valid or enforce-15 |
|---|
| 422 | 422 | | able if the agreement requires arbitration of a dispute 16 |
|---|
| 423 | 423 | | arising under this section. 17 |
|---|
| 424 | 424 | | SEC. 6. ENFORCEMENT. 18 |
|---|
| 425 | 425 | | (a) E |
|---|
| 426 | 426 | | NFORCEMENT BY THE COMMISSION.— 19 |
|---|
| 427 | 427 | | (1) U |
|---|
| 428 | 428 | | NFAIR AND DECEPTIVE ACTS OR PRAC -20 |
|---|
| 429 | 429 | | TICES.—A violation of this Act shall be treated as 21 |
|---|
| 430 | 430 | | a violation of a rule defining an unfair or deceptive 22 |
|---|
| 431 | 431 | | act or practice under section 18(a)(1)(B) of the Fed-23 |
|---|
| 432 | 432 | | eral Trade Commission Act (15 U.S.C. 24 |
|---|
| 433 | 433 | | 57a(a)(1)(B)). 25 |
|---|
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| 435 | 435 | | ssavage on LAPJG3WLY3PROD with BILLS 16 |
|---|
| 436 | 436 | | •S 526 IS |
|---|
| 437 | 437 | | (2) POWERS OF THE COMMISSION .— 1 |
|---|
| 438 | 438 | | (A) I |
|---|
| 439 | 439 | | N GENERAL.—Except as provided in 2 |
|---|
| 440 | 440 | | subparagraph (C), the Commission shall enforce 3 |
|---|
| 441 | 441 | | this Act in the same manner, by the same 4 |
|---|
| 442 | 442 | | means, and with the same jurisdiction, powers, 5 |
|---|
| 443 | 443 | | and duties as though all applicable terms and 6 |
|---|
| 444 | 444 | | provisions of the Federal Trade Commission 7 |
|---|
| 445 | 445 | | Act (15 U.S.C. 41 et seq.) were incorporated 8 |
|---|
| 446 | 446 | | into and made a part of this Act. 9 |
|---|
| 447 | 447 | | (B) P |
|---|
| 448 | 448 | | RIVILEGES AND IMMUNITIES .—Sub-10 |
|---|
| 449 | 449 | | ject to paragraph (3), any person who violates 11 |
|---|
| 450 | 450 | | this Act shall be subject to the penalties and 12 |
|---|
| 451 | 451 | | entitled to the privileges and immunities pro-13 |
|---|
| 452 | 452 | | vided in the Federal Trade Commission Act (15 14 |
|---|
| 453 | 453 | | U.S.C. 41 et seq.). 15 |
|---|
| 454 | 454 | | (C) N |
|---|
| 455 | 455 | | ONPROFIT ORGANIZATIONS AND IN -16 |
|---|
| 456 | 456 | | SURANCE.—Notwithstanding section 4 or 6 of 17 |
|---|
| 457 | 457 | | the Federal Trade Commission Act (15 U.S.C. 18 |
|---|
| 458 | 458 | | 44, 46), section 2 of McCarran-Ferguson Act 19 |
|---|
| 459 | 459 | | (15 U.S.C. 1012), or any other jurisdictional 20 |
|---|
| 460 | 460 | | limitation of the Commission, the Commission 21 |
|---|
| 461 | 461 | | shall also enforce this Act, in the same manner 22 |
|---|
| 462 | 462 | | provided in subparagraphs (A) and (B) of this 23 |
|---|
| 463 | 463 | | paragraph, with respect to— 24 |
|---|
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| 465 | 465 | | ssavage on LAPJG3WLY3PROD with BILLS 17 |
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| 466 | 466 | | •S 526 IS |
|---|
| 467 | 467 | | (i) organizations not organized to 1 |
|---|
| 468 | 468 | | carry on business for their own profit or 2 |
|---|
| 469 | 469 | | that of their members; and 3 |
|---|
| 470 | 470 | | (ii) the business of insurance, and 4 |
|---|
| 471 | 471 | | persons engaged in such business. 5 |
|---|
| 472 | 472 | | (D) A |
|---|
| 473 | 473 | | UTHORITY PRESERVED .—Nothing in 6 |
|---|
| 474 | 474 | | this section shall be construed to limit the au-7 |
|---|
| 475 | 475 | | thority of the Commission under any other pro-8 |
|---|
| 476 | 476 | | vision of law. 9 |
|---|
| 477 | 477 | | (3) P |
|---|
| 478 | 478 | | ENALTIES.— 10 |
|---|
| 479 | 479 | | (A) A |
|---|
| 480 | 480 | | DDITIONAL CIVIL PENALTY .—In ad-11 |
|---|
| 481 | 481 | | dition to any penalty applicable under the Fed-12 |
|---|
| 482 | 482 | | eral Trade Commission Act (15 U.S.C. 41 et 13 |
|---|
| 483 | 483 | | seq.), any person that violates this Act shall be 14 |
|---|
| 484 | 484 | | liable for a civil penalty of not more than 15 |
|---|
| 485 | 485 | | $1,000,000. 16 |
|---|
| 486 | 486 | | (B) M |
|---|
| 487 | 487 | | ETHOD.—The penalties provided by 17 |
|---|
| 488 | 488 | | subparagraph (A) shall be obtained in the same 18 |
|---|
| 489 | 489 | | manner as civil penalties imposed under section 19 |
|---|
| 490 | 490 | | 18(a)(1)(B) of the Federal Trade Commission 20 |
|---|
| 491 | 491 | | Act (15 U.S.C. 57a(a(1)(B). 21 |
|---|
| 492 | 492 | | (C) M |
|---|
| 493 | 493 | | ULTIPLE OFFENSES ; MITIGATING 22 |
|---|
| 494 | 494 | | FACTORS.—In assessing a penalty under sub-23 |
|---|
| 495 | 495 | | paragraph (A)— 24 |
|---|
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| 498 | 498 | | •S 526 IS |
|---|
| 499 | 499 | | (i) each day of a continuing violation 1 |
|---|
| 500 | 500 | | shall be considered a separate violation; 2 |
|---|
| 501 | 501 | | and 3 |
|---|
| 502 | 502 | | (ii) the court shall take into consider-4 |
|---|
| 503 | 503 | | ation, among other factors— 5 |
|---|
| 504 | 504 | | (I) the seriousness of the viola-6 |
|---|
| 505 | 505 | | tion; 7 |
|---|
| 506 | 506 | | (II) the efforts of the person 8 |
|---|
| 507 | 507 | | committing the violation to remedy 9 |
|---|
| 508 | 508 | | the harm caused by the violation in a 10 |
|---|
| 509 | 509 | | timely manner; and 11 |
|---|
| 510 | 510 | | (III) whether the violation was 12 |
|---|
| 511 | 511 | | intentional. 13 |
|---|
| 512 | 512 | | (b) E |
|---|
| 513 | 513 | | NFORCEMENT BY STATES.— 14 |
|---|
| 514 | 514 | | (1) I |
|---|
| 515 | 515 | | N GENERAL.—If the attorney general of a 15 |
|---|
| 516 | 516 | | State has reason to believe that an interest of the 16 |
|---|
| 517 | 517 | | residents of the State has been or is being threat-17 |
|---|
| 518 | 518 | | ened or adversely affected by a practice that violates 18 |
|---|
| 519 | 519 | | this Act, the attorney general of the State may bring 19 |
|---|
| 520 | 520 | | a civil action on behalf of the residents of the State 20 |
|---|
| 521 | 521 | | in an appropriate district court of the United States 21 |
|---|
| 522 | 522 | | to obtain appropriate relief. 22 |
|---|
| 523 | 523 | | (2) R |
|---|
| 524 | 524 | | IGHTS OF THE COMMISSION .— 23 |
|---|
| 525 | 525 | | (A) N |
|---|
| 526 | 526 | | OTICE TO THE COMMISSION .— 24 |
|---|
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| 529 | 529 | | •S 526 IS |
|---|
| 530 | 530 | | (i) IN GENERAL.—Except as provided 1 |
|---|
| 531 | 531 | | in clause (iii), the attorney general of a 2 |
|---|
| 532 | 532 | | State, before initiating a civil action under 3 |
|---|
| 533 | 533 | | paragraph (1), shall provide written notifi-4 |
|---|
| 534 | 534 | | cation to the Commission that the attorney 5 |
|---|
| 535 | 535 | | general intends to bring such civil action. 6 |
|---|
| 536 | 536 | | (ii) C |
|---|
| 537 | 537 | | ONTENTS.—The notification re-7 |
|---|
| 538 | 538 | | quired under clause (i) shall include a copy 8 |
|---|
| 539 | 539 | | of the complaint to be filed to initiate the 9 |
|---|
| 540 | 540 | | civil action. 10 |
|---|
| 541 | 541 | | (iii) E |
|---|
| 542 | 542 | | XCEPTION.—If it is not feasible 11 |
|---|
| 543 | 543 | | for the attorney general of a State to pro-12 |
|---|
| 544 | 544 | | vide the notification required under clause 13 |
|---|
| 545 | 545 | | (i) before initiating a civil action under 14 |
|---|
| 546 | 546 | | paragraph (1), the attorney general shall 15 |
|---|
| 547 | 547 | | notify the Commission immediately upon 16 |
|---|
| 548 | 548 | | instituting the civil action. 17 |
|---|
| 549 | 549 | | (B) I |
|---|
| 550 | 550 | | NTERVENTION BY THE COMMIS -18 |
|---|
| 551 | 551 | | SION.—The Commission may— 19 |
|---|
| 552 | 552 | | (i) intervene in any civil action 20 |
|---|
| 553 | 553 | | brought by the attorney general of a State 21 |
|---|
| 554 | 554 | | under paragraph (1); and 22 |
|---|
| 555 | 555 | | (ii) upon intervening— 23 |
|---|
| 556 | 556 | | (I) be heard on all matters aris-24 |
|---|
| 557 | 557 | | ing in the civil action; and 25 |
|---|
| 558 | 558 | | VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 |
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|---|
| 560 | 560 | | •S 526 IS |
|---|
| 561 | 561 | | (II) file petitions for appeal of a 1 |
|---|
| 562 | 562 | | decision in the civil action. 2 |
|---|
| 563 | 563 | | (3) C |
|---|
| 564 | 564 | | ONSTRUCTION.— 3 |
|---|
| 565 | 565 | | (A) P |
|---|
| 566 | 566 | | OWERS CONFERRED ON THE ATTOR -4 |
|---|
| 567 | 567 | | NEY GENERAL OF A STATE .—Nothing in this 5 |
|---|
| 568 | 568 | | subsection may be construed to prevent the at-6 |
|---|
| 569 | 569 | | torney general of a State from exercising the 7 |
|---|
| 570 | 570 | | powers conferred on the attorney general by the 8 |
|---|
| 571 | 571 | | laws of the State to conduct investigations, to 9 |
|---|
| 572 | 572 | | administer oaths or affirmations, or to compel 10 |
|---|
| 573 | 573 | | the attendance of witnesses or the production of 11 |
|---|
| 574 | 574 | | documentary or other evidence. 12 |
|---|
| 575 | 575 | | (B) ERISA.—No civil action brought pur-13 |
|---|
| 576 | 576 | | suant to this subsection shall conflict with the 14 |
|---|
| 577 | 577 | | Employee Retirement Income Security Act of 15 |
|---|
| 578 | 578 | | 1974 (29 U.S.C. 1001 et seq.). 16 |
|---|
| 579 | 579 | | (4) V |
|---|
| 580 | 580 | | ENUE; SERVICE OF PROCESS.— 17 |
|---|
| 581 | 581 | | (A) V |
|---|
| 582 | 582 | | ENUE.—Any action brought under 18 |
|---|
| 583 | 583 | | paragraph (1) may be brought in— 19 |
|---|
| 584 | 584 | | (i) the district court of the United 20 |
|---|
| 585 | 585 | | States that meets applicable requirements 21 |
|---|
| 586 | 586 | | relating to venue under section 1391 of 22 |
|---|
| 587 | 587 | | title 28, United States Code; or 23 |
|---|
| 588 | 588 | | (ii) another court of competent juris-24 |
|---|
| 589 | 589 | | diction. 25 |
|---|
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| 592 | 592 | | •S 526 IS |
|---|
| 593 | 593 | | (B) SERVICE OF PROCESS.—In an action 1 |
|---|
| 594 | 594 | | brought under paragraph (1), process may be 2 |
|---|
| 595 | 595 | | served in any district in which— 3 |
|---|
| 596 | 596 | | (i) the defendant is an inhabitant, 4 |
|---|
| 597 | 597 | | may be found, or transacts business; or 5 |
|---|
| 598 | 598 | | (ii) venue is proper under section 6 |
|---|
| 599 | 599 | | 1391 of title 28, United States Code. 7 |
|---|
| 600 | 600 | | (5) A |
|---|
| 601 | 601 | | CTIONS BY OTHER STATE OFFICIALS .— 8 |
|---|
| 602 | 602 | | (A) I |
|---|
| 603 | 603 | | N GENERAL.—If an attorney general 9 |
|---|
| 604 | 604 | | lacks appropriate jurisdiction to bring a civil ac-10 |
|---|
| 605 | 605 | | tion under paragraph (1), any other officer of 11 |
|---|
| 606 | 606 | | a State who is authorized by the State to do so 12 |
|---|
| 607 | 607 | | may bring a civil action under paragraph (1), 13 |
|---|
| 608 | 608 | | subject to the same requirements and limita-14 |
|---|
| 609 | 609 | | tions that apply under this subsection to civil 15 |
|---|
| 610 | 610 | | actions brought by attorneys general. 16 |
|---|
| 611 | 611 | | (B) C |
|---|
| 612 | 612 | | LARIFICATION OF AUTHORITY .—The 17 |
|---|
| 613 | 613 | | authority provided by subparagraph (A) shall 18 |
|---|
| 614 | 614 | | supplant, and not supplement, the authorities of 19 |
|---|
| 615 | 615 | | State attorneys general under paragraph (1). 20 |
|---|
| 616 | 616 | | (C) S |
|---|
| 617 | 617 | | AVINGS PROVISION.—Nothing in this 21 |
|---|
| 618 | 618 | | subsection may be construed to prohibit an au-22 |
|---|
| 619 | 619 | | thorized official of a State from initiating or 23 |
|---|
| 620 | 620 | | continuing any proceeding in a court of the 24 |
|---|
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|---|
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| 623 | 623 | | •S 526 IS |
|---|
| 624 | 624 | | State for a violation of any civil or criminal law 1 |
|---|
| 625 | 625 | | of the State. 2 |
|---|
| 626 | 626 | | (c) A |
|---|
| 627 | 627 | | FFIRMATIVEDEFENSE.— 3 |
|---|
| 628 | 628 | | (1) I |
|---|
| 629 | 629 | | N GENERAL.—In an action brought under 4 |
|---|
| 630 | 630 | | this section to enforce section 2, it shall be an af-5 |
|---|
| 631 | 631 | | firmative defense, on which the defendant has the 6 |
|---|
| 632 | 632 | | burden of persuasion by a preponderance of the evi-7 |
|---|
| 633 | 633 | | dence, that the conduct alleged to be a violation of 8 |
|---|
| 634 | 634 | | section 2 was nonpretextual and reasonably nec-9 |
|---|
| 635 | 635 | | essary to— 10 |
|---|
| 636 | 636 | | (A) prevent a violation of, or comply with, 11 |
|---|
| 637 | 637 | | Federal or State law; 12 |
|---|
| 638 | 638 | | (B) protect patient safety; or 13 |
|---|
| 639 | 639 | | (C) protect patient access. 14 |
|---|
| 640 | 640 | | (2) C |
|---|
| 641 | 641 | | LARIFICATION.—Nothing in this sub-15 |
|---|
| 642 | 642 | | section shall be construed to prohibit a defendant 16 |
|---|
| 643 | 643 | | from raising any other affirmative defense available. 17 |
|---|
| 644 | 644 | | SEC. 7. PROTECTION OF PERSONAL HEALTH INFORMA-18 |
|---|
| 645 | 645 | | TION. 19 |
|---|
| 646 | 646 | | In making any disclosure or report required by this 20 |
|---|
| 647 | 647 | | Act, a pharmacy benefit manager (including their affili-21 |
|---|
| 648 | 648 | | ates, subsidiaries, and agents) shall not include any infor-22 |
|---|
| 649 | 649 | | mation that would identify a patient or a provider that 23 |
|---|
| 650 | 650 | | issued a prescription. 24 |
|---|
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|---|
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| 653 | 653 | | •S 526 IS |
|---|
| 654 | 654 | | SEC. 8. EFFECT ON STATE LAWS. 1 |
|---|
| 655 | 655 | | Nothing in this Act shall be construed to preempt, 2 |
|---|
| 656 | 656 | | displace, or supplant any State laws, rules, regulations, 3 |
|---|
| 657 | 657 | | or requirements, or the enforcement thereof. 4 |
|---|
| 658 | 658 | | SEC. 9. DEFINITIONS. 5 |
|---|
| 659 | 659 | | In this Act: 6 |
|---|
| 660 | 660 | | (1) C |
|---|
| 661 | 661 | | OMMISSION.—The term ‘‘Commission’’ 7 |
|---|
| 662 | 662 | | means the Federal Trade Commission. 8 |
|---|
| 663 | 663 | | (2) C |
|---|
| 664 | 664 | | OVERED INDIVIDUAL.—The term ‘‘covered 9 |
|---|
| 665 | 665 | | individual’’ means a current or former employee, 10 |
|---|
| 666 | 666 | | contractor, subcontractor, service provider, or agent 11 |
|---|
| 667 | 667 | | of a pharmacy benefit manager, health plan, phar-12 |
|---|
| 668 | 668 | | maceutical manufacturer, pharmacy, or any affiliate, 13 |
|---|
| 669 | 669 | | subsidiary, or agent thereof. 14 |
|---|
| 670 | 670 | | (3) H |
|---|
| 671 | 671 | | EALTH PLAN.—The term ‘‘health plan’’ 15 |
|---|
| 672 | 672 | | means any group or individual health insurance plan 16 |
|---|
| 673 | 673 | | or coverage, including any health insurance plan or 17 |
|---|
| 674 | 674 | | coverage sponsored or funded by the Federal Gov-18 |
|---|
| 675 | 675 | | ernment or the government of any State, Territory, 19 |
|---|
| 676 | 676 | | or subdivision thereof. 20 |
|---|
| 677 | 677 | | (4) P |
|---|
| 678 | 678 | | HARMACY BENEFIT MANAGER .—The term 21 |
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| 679 | 679 | | ‘‘pharmacy benefit manager’’ means any entity that 22 |
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| 680 | 680 | | provides pharmacy benefit management services on 23 |
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| 681 | 681 | | behalf of a health plan, a payer, or health insurance 24 |
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| 682 | 682 | | issuer. 25 |
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| 684 | 684 | | ssavage on LAPJG3WLY3PROD with BILLS 24 |
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| 685 | 685 | | •S 526 IS |
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| 686 | 686 | | (5) PHARMACY BENEFIT MANAGEMENT SERV -1 |
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| 687 | 687 | | ICES.—The term ‘‘pharmacy benefit management 2 |
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| 688 | 688 | | services’’ means, pursuant to a written agreement 3 |
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| 689 | 689 | | with a payer or health plan offering group or indi-4 |
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| 690 | 690 | | vidual health insurance coverage, directly or through 5 |
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| 691 | 691 | | an intermediary, the service of— 6 |
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| 692 | 692 | | (A) negotiating terms and conditions, in-7 |
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| 693 | 693 | | cluding rebates and price concessions, with re-8 |
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| 694 | 694 | | spect to a prescription drug on behalf of the 9 |
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| 695 | 695 | | health plan, coverage, or payer; or 10 |
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| 696 | 696 | | (B) managing the prescription drug bene-11 |
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| 697 | 697 | | fits provided by the health plan, coverage, or 12 |
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| 698 | 698 | | payer, which may include formulary manage-13 |
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| 699 | 699 | | ment the processing and payment of claims for 14 |
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| 700 | 700 | | prescription drugs, the performance of drug uti-15 |
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| 701 | 701 | | lization review, the processing of drug prior au-16 |
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| 702 | 702 | | thorization requests, the adjudication of appeals 17 |
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| 703 | 703 | | or grievances related to the prescription drug 18 |
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| 704 | 704 | | benefit, contracting with network pharmacies, 19 |
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| 705 | 705 | | or the provision of related services. 20 |
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| 706 | 706 | | (6) P |
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| 707 | 707 | | RESCRIPTION DRUG.—The term ‘‘prescrip-21 |
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| 708 | 708 | | tion drug’’ means— 22 |
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| 709 | 709 | | (A) a drug, as that term is defined in sec-23 |
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| 710 | 710 | | tion 201(g) of the Federal Food, Drug, and 24 |
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| 711 | 711 | | Cosmetic Act (21 U.S.C. 321(g)), that is— 25 |
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| 713 | 713 | | ssavage on LAPJG3WLY3PROD with BILLS 25 |
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| 714 | 714 | | •S 526 IS |
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| 715 | 715 | | (i) approved by the Food and Drug 1 |
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| 716 | 716 | | Administration under section 505 of such 2 |
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| 717 | 717 | | Act (21 U.S.C. 355); and 3 |
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| 718 | 718 | | (ii) subject to the requirements of sec-4 |
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| 719 | 719 | | tion 503(b)(1) of such Act (21 U.S.C. 5 |
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| 720 | 720 | | 353(b)(1)); 6 |
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| 721 | 721 | | (B) a biological product as that term is de-7 |
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| 722 | 722 | | fined in section 351 of the Public Health Serv-8 |
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| 723 | 723 | | ice Act (42 U.S.C. 262(i)(1)); or 9 |
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| 724 | 724 | | (C) a product that is biosimilar to, or 10 |
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| 725 | 725 | | interchangeable with, a biologic product under 11 |
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| 726 | 726 | | section 351 of the Public Health Service Act 12 |
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| 727 | 727 | | (42 U.S.C. 262(i)). 13 |
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| 728 | 728 | | Æ |
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| 730 | 730 | | ssavage on LAPJG3WLY3PROD with BILLS |
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