Us Congress 2025-2026 Regular Session

Us Congress House Bill HB2214 Compare Versions

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11 I
22 119THCONGRESS
33 1
44 STSESSION H. R. 2214
55 To improve services provided by pharmacy benefit managers.
66 IN THE HOUSE OF REPRESENTATIVES
77 MARCH18, 2025
88 Mrs. M
99 ILLER-MEEKS(for herself, Ms. BARRAGA´N, Ms. MALLIOTAKIS, Mr.
1010 S
1111 CHNEIDER, Mr. ALLEN, and Mr. NORCROSS) introduced the following
1212 bill; which was referred to the Committee on Energy and Commerce, and
1313 in addition to the Committees on Ways and Means, and Education and
1414 Workforce, for a period to be subsequently determined by the Speaker,
1515 in each case for consideration of such provisions as fall within the juris-
1616 diction of the committee concerned
1717 A BILL
1818 To improve services provided by pharmacy benefit managers.
1919 Be it enacted by the Senate and House of Representa-1
2020 tives of the United States of America in Congress assembled, 2
2121 SECTION 1. SHORT TITLE. 3
2222 This Act may be cited as the ‘‘Delinking Revenue 4
2323 from Unfair Gouging Act’’ or the ‘‘DRUG Act’’. 5
2424 SEC. 2. IMPROVING PHARMACY BENEFIT MANAGER SERV-6
2525 ICES. 7
2626 (a) P
2727 UBLICHEALTHSERVICEACT.—Part D of title 8
2828 XXVII of the Public Health Service Act (42 U.S.C. 9
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3131 •HR 2214 IH
3232 300gg–111 et seq.) is amended by adding at the end the 1
3333 following: 2
3434 ‘‘SEC. 2799A–11. IMPROVING PHARMACY BENEFIT MANAGER 3
3535 SERVICES. 4
3636 ‘‘(a) I
3737 NGENERAL.—Beginning on January 1, 2027, 5
3838 except as provided in subsection (b), a pharmacy benefit 6
3939 manager shall derive no remuneration from any entity for 7
4040 services, benefit administration, or any other activities re-8
4141 lated to prescription drug benefits under a group health 9
4242 plan or group or individual health insurance coverage. 10
4343 ‘‘(b) E
4444 XCEPTION FORBONAFIDESERVICEFEES.— 11
4545 ‘‘(1) I
4646 N GENERAL.—A pharmacy benefit man-12
4747 ager may charge an entity a bona fide service fee for 13
4848 the provision of services to such entity only if such 14
4949 fee is set forth in an agreement between the phar-15
5050 macy benefit manager and such entity and the 16
5151 amount of any bona fide service fee— 17
5252 ‘‘(A) is a flat dollar amount; and 18
5353 ‘‘(B) is not directly or indirectly based on, 19
5454 or contingent upon— 20
5555 ‘‘(i) a drug price (such as wholesale 21
5656 acquisition cost) or drug benchmark price 22
5757 (such as average wholesale price); 23
5858 ‘‘(ii) the amount of discounts, rebates, 24
5959 fees, or other direct or indirect remunera-25
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6262 •HR 2214 IH
6363 tion with respect to prescription drugs pre-1
6464 scribed to the participants, beneficiaries, or 2
6565 enrollees in the group health plan or health 3
6666 insurance coverage involved; or 4
6767 ‘‘(iii) any other amounts specified by 5
6868 the Secretary, the Secretary of Labor, and 6
6969 the Secretary of the Treasury; 7
7070 ‘‘(2) D
7171 EFINITIONS.—In this section— 8
7272 ‘‘(A) the term ‘bona fide service fee’ means 9
7373 a fee that is equal to the fair market value of 10
7474 a bona fide, itemized service that is actually 11
7575 performed on behalf of an entity, that the enti-12
7676 ty would otherwise perform (or contract for) in 13
7777 the absence of the service arrangement, and 14
7878 that is not passed on in whole or in part to a 15
7979 client or customer, whether or not the entity 16
8080 takes title to the drug; and 17
8181 ‘‘(B) the term ‘pharmacy benefit manager’ 18
8282 means any person, business, or other entity, 19
8383 such as a third-party administrator, regardless 20
8484 of whether it identifies itself as a pharmacy 21
8585 benefit manager, that, either directly or 22
8686 through an intermediary (including an affiliate, 23
8787 subsidiary, or agent) or an arrangement with a 24
8888 third-party— 25
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9191 •HR 2214 IH
9292 ‘‘(i) acts a price negotiator for pre-1
9393 scription drugs on behalf of a group health 2
9494 plan or health insurance issuer offering 3
9595 group or individual health insurance cov-4
9696 erage; or 5
9797 ‘‘(ii) manages or administers the pre-6
9898 scription drug benefits provided by a group 7
9999 health plan or health insurance issuer of-8
100100 fering group or individual health insurance 9
101101 coverage, including creating formularies, 10
102102 the processing and payment of claims for 11
103103 prescription drugs, arranging alternative 12
104104 access to or funding for prescription drugs, 13
105105 the performance of drug utilization review, 14
106106 the processing of drug prior authorization 15
107107 requests, the adjudication of appeals or 16
108108 grievances related to the prescription drug 17
109109 benefit, contracting with network phar-18
110110 macies (including retail and mail phar-19
111111 macies), controlling the cost of covered 20
112112 prescription drugs, or the provision of re-21
113113 lated services. 22
114114 ‘‘(c) E
115115 NFORCEMENT.— 23
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118118 •HR 2214 IH
119119 ‘‘(1) IN GENERAL.—The Secretary, in consulta-1
120120 tion with the Secretary of Labor and the Secretary 2
121121 of the Treasury, shall enforce this section. 3
122122 ‘‘(2) D
123123 ISGORGEMENT.—The pharmacy benefit 4
124124 manager shall disgorge to a group health plan or 5
125125 health insurance issuer offering group or individual 6
126126 health insurance coverage any payment, remunera-7
127127 tion, or other amount received by the pharmacy ben-8
128128 efit manager or an affiliate of such pharmacy benefit 9
129129 manager from such plan or issuer in violation of 10
130130 subsection (a) or, pursuant to subsection (b), the 11
131131 agreement entered into with such plan or issuer for 12
132132 bona fide service fees. 13
133133 ‘‘(3) P
134134 ENALTIES.—A pharmacy benefit man-14
135135 ager that violates subsection (a) or (b) shall be sub-15
136136 ject to a civil monetary penalty in the amount of 16
137137 $10,000 for each day during which such violation 17
138138 continues. 18
139139 ‘‘(4) P
140140 ROCEDURE.—Notwithstanding section 19
141141 2723, the provisions of section 1128A of the Social 20
142142 Security Act, other than subsection (a) and (b) and 21
143143 the first sentence of subsection (c)(1) of such sec-22
144144 tion, shall apply to civil monetary penalties under 23
145145 this subsection in the same manner as such provi-24
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148148 •HR 2214 IH
149149 sions apply to a penalty or proceeding under section 1
150150 1128A of the Social Security Act. 2
151151 ‘‘(d) R
152152 EGULATIONS.—Notwithstanding any other 3
153153 provision of law, the Secretary, in consultation with the 4
154154 Secretary of Labor and the Secretary of the Treasury, 5
155155 shall implement this section through interim final regula-6
156156 tions. 7
157157 ‘‘(e) R
158158 ULES OFCONSTRUCTION.—Nothing in this 8
159159 section shall be construed— 9
160160 ‘‘(1) as prohibiting payments related to reim-10
161161 bursement for ingredient costs to entities that ac-11
162162 quire prescription drugs or pharmacy dispensing 12
163163 fees; and 13
164164 ‘‘(2) to prohibit rebates, discounts, or other 14
165165 price concessions from being fully passed through to 15
166166 a group health plan or health insurance issuer offer-16
167167 ing group or individual health insurance coverage to 17
168168 lower net costs for prescription drugs.’’. 18
169169 (b) ERISA.— 19
170170 (1) I
171171 N GENERAL.—Subpart B of part 7 of sub-20
172172 title B of title I of the Employee Retirement Income 21
173173 Security Act of 1974 (29 U.S.C. 1185 et seq.) is 22
174174 amended by inserting after section 725 the fol-23
175175 lowing: 24
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178178 •HR 2214 IH
179179 ‘‘SEC. 726. IMPROVING PHARMACY BENEFIT MANAGER 1
180180 SERVICES. 2
181181 ‘‘(a) G
182182 ENERAL.—Beginning on January 1, 2027, ex-3
183183 cept as provided in subsection (b), a pharmacy benefit 4
184184 manager shall derive no remuneration from any entity for 5
185185 services, benefit administration, or any other activities re-6
186186 lated to prescription drug benefits under a group health 7
187187 plan or group health insurance coverage. 8
188188 ‘‘(b) E
189189 XCEPTION FORBONAFIDESERVICEFEES.— 9
190190 ‘‘(1) I
191191 N GENERAL.—A pharmacy benefit man-10
192192 ager may charge an entity a bona fide service fee for 11
193193 the provision of services to an entity only if such fee 12
194194 is set forth in an agreement between the pharmacy 13
195195 benefit manager and such entity and the amount of 14
196196 any bona fide service fee— 15
197197 ‘‘(A) is a flat dollar amount; and 16
198198 ‘‘(B) is not directly or indirectly based on, 17
199199 or contingent upon— 18
200200 ‘‘(i) a drug price (such as wholesale 19
201201 acquisition cost) or drug benchmark price 20
202202 (such as average wholesale price); 21
203203 ‘‘(ii) the amount of discounts, rebates, 22
204204 fees, or other direct or indirect remunera-23
205205 tion with respect to prescription drugs pre-24
206206 scribed to the participants, beneficiaries, or 25
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209209 •HR 2214 IH
210210 enrollees in the group health plan or health 1
211211 insurance coverage involved; or 2
212212 ‘‘(iii) any other amounts specified by 3
213213 the Secretary, the Secretary of Health and 4
214214 Human Services, and the Secretary of the 5
215215 Treasury. 6
216216 ‘‘(2) D
217217 EFINITIONS.—In this section— 7
218218 ‘‘(A) the term ‘bona fide service fee’ means 8
219219 a fee that is equal to the fair market value of 9
220220 a bona fide, itemized service that is actually 10
221221 performed on behalf of an entity, that the enti-11
222222 ty would otherwise perform (or contract for) in 12
223223 the absence of the service arrangement, and 13
224224 that is not passed on in whole or in part to a 14
225225 client or customer, whether or not the entity 15
226226 takes title to the drug; and 16
227227 ‘‘(B) the term ‘pharmacy benefit manager’ 17
228228 means any person, business, or other entity, 18
229229 such as a third-party administrator, regardless 19
230230 of whether it identifies itself as a pharmacy 20
231231 benefit manager, that, either directly or 21
232232 through an intermediary (including an affiliate, 22
233233 subsidiary, or agent) or an arrangement with a 23
234234 third-party— 24
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237237 •HR 2214 IH
238238 ‘‘(i) acts a price negotiator for pre-1
239239 scription drugs on behalf of a group health 2
240240 plan or health insurance issuer offering 3
241241 group health insurance coverage; or 4
242242 ‘‘(ii) manages or administers the pre-5
243243 scription drug benefits provided by a group 6
244244 health plan or health insurance issuer of-7
245245 fering group health insurance coverage, in-8
246246 cluding creating formularies, the proc-9
247247 essing and payment of claims for prescrip-10
248248 tion drugs, arranging alternative access to 11
249249 or funding for prescription drugs, the per-12
250250 formance of drug utilization review, the 13
251251 processing of drug prior authorization re-14
252252 quests, the adjudication of appeals or 15
253253 grievances related to the prescription drug 16
254254 benefit, contracting with network phar-17
255255 macies (including retail and mail phar-18
256256 macies), controlling the cost of covered 19
257257 prescription drugs, or the provision of re-20
258258 lated services. 21
259259 ‘‘(c) E
260260 NFORCEMENT.—The Secretary shall enforce 22
261261 this section as provided for in section 502(c)(13). 23
262262 ‘‘(d) R
263263 EGULATIONS.—Notwithstanding any other 24
264264 provision of law, the Secretary, in consultation with the 25
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267267 •HR 2214 IH
268268 Secretary of Health and Human Services and the Sec-1
269269 retary of the Treasury, shall implement this section 2
270270 through interim final regulations. 3
271271 ‘‘(e) R
272272 ULES OFCONSTRUCTION.—Nothing in this 4
273273 section shall be construed— 5
274274 ‘‘(1) as prohibiting payments related to reim-6
275275 bursement for ingredient costs to entities that ac-7
276276 quire prescription drugs or pharmacy dispensing 8
277277 fees; and 9
278278 ‘‘(2) to prohibit rebates, discounts, or other 10
279279 price concessions from being fully passed through to 11
280280 a group health plan or health insurance issuer offer-12
281281 ing group health insurance coverage to lower net 13
282282 costs for prescription drugs.’’. 14
283283 (2) E
284284 NFORCEMENT.—Section 502 of the Em-15
285285 ployee Retirement Income Security Act of 1974 (29 16
286286 U.S.C. 1132) is amended— 17
287287 (A) in subsection (a)(6), by striking ‘‘or 18
288288 (9)’’ and inserting ‘‘(9), or (13)’’; and 19
289289 (B) in subsection (c), by adding at the end 20
290290 the following: 21
291291 ‘‘(13) S
292292 ECRETARIALENFORCEMENTAUTHORITYRE-22
293293 LATING TOPHARMACYBENEFITMANAGERSERVICES.— 23
294294 ‘‘(A) D
295295 ISGORGEMENT.—With respect to a viola-24
296296 tion of section 726 by a pharmacy benefit manager, 25
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300300 such pharmacy benefit manager shall disgorge to a 1
301301 group health plan or health insurance issuer offering 2
302302 group health insurance coverage any payment, remu-3
303303 neration, or other amount received by the pharmacy 4
304304 benefit manager or an affiliate of such pharmacy 5
305305 benefit manager from such plan or issuer in viola-6
306306 tion of subsection (a) of such section or, pursuant to 7
307307 subsection (b) of such section, the agreement en-8
308308 tered into with such plan or issuer for bona fide 9
309309 service fees. 10
310310 ‘‘(B) P
311311 ENALTIES.—A pharmacy benefit man-11
312312 ager that violates subsection (a) or (b) of section 12
313313 726 shall be subject to a civil monetary penalty in 13
314314 the amount of $10,000 for each day during which 14
315315 such violation continues. 15
316316 ‘‘(C) P
317317 ROCEDURE.—Except as provided in this 16
318318 paragraph, the provisions of this section shall apply 17
319319 to civil monetary penalties under this paragraph in 18
320320 the same manner as such provisions apply to other 19
321321 civil penalties under this section. 20
322322 ‘‘(D) R
323323 ULE OF CONSTRUCTION .—Nothing in 21
324324 this paragraph shall effect the authority of the Sec-22
325325 retary under subsection (a)(5).’’. 23
326326 (3) C
327327 LERICAL AMENDMENT .—The table of con-24
328328 tents in section 1 of the Employee Retirement In-25
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331331 •HR 2214 IH
332332 come Security Act of 1974 (29 U.S.C. 1001 et seq.) 1
333333 is amended by inserting after the item relating to 2
334334 section 725 the following new item: 3
335335 Sec. 726. Improving pharmacy benefit manager services.
336336 (c) INTERNALREVENUECODE OF1986.— 4
337337 (1) I
338338 N GENERAL.—Subchapter B of chapter 5
339339 100 of the Internal Revenue Code of 1986 is amend-6
340340 ed by adding at the end the following: 7
341341 ‘‘SEC. 9826. IMPROVING PHARMACY BENEFIT MANAGER 8
342342 SERVICES. 9
343343 ‘‘(a) I
344344 NGENERAL.—Beginning on January 1, 2027, 10
345345 except as provided in subsection (b), a pharmacy benefit 11
346346 manager shall derive no remuneration from any entity for 12
347347 services, benefit administration, or any other activities re-13
348348 lated to prescription drug benefits under a group health 14
349349 plan. 15
350350 ‘‘(b) E
351351 XCEPTION FORBONAFIDESERVICEFEES.— 16
352352 ‘‘(1) I
353353 N GENERAL.—A pharmacy benefit man-17
354354 ager may charge an entity a bona fide service fee for 18
355355 the provision of services to such entity only if such 19
356356 fee is set forth in an agreement between the phar-20
357357 macy benefit manager and such entity and the 21
358358 amount of any bona fide service fee— 22
359359 ‘‘(A) is a flat dollar amount; and 23
360360 ‘‘(B) is not directly or indirectly based on, 24
361361 or contingent upon— 25
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364364 •HR 2214 IH
365365 ‘‘(i) a drug price (such as wholesale 1
366366 acquisition cost) or drug benchmark price 2
367367 (such as average wholesale price); 3
368368 ‘‘(ii) the amount of discounts, rebates, 4
369369 fees, or other direct or indirect remunera-5
370370 tion with respect to prescription drugs pre-6
371371 scribed to the participants, beneficiaries, or 7
372372 enrollees in the group health plan involved; 8
373373 or 9
374374 ‘‘(iii) any other amounts specified by 10
375375 the Secretary, the Secretary of Health and 11
376376 Human Services, and the Secretary of the 12
377377 Labor. 13
378378 ‘‘(2) D
379379 EFINITIONS.—In this section— 14
380380 ‘‘(A) the term ‘bona fide service fee’ means 15
381381 a fee that is equal to the fair market value of 16
382382 a bona fide, itemized service that is actually 17
383383 performed on behalf of an entity, that the enti-18
384384 ty would otherwise perform (or contract for) in 19
385385 the absence of the service arrangement, and 20
386386 that is not passed on in whole or in part to a 21
387387 client or customer, whether or not the entity 22
388388 takes title to the drug; and 23
389389 ‘‘(B) the term ‘pharmacy benefit manager’ 24
390390 means any person, business, or other entity 25
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393393 •HR 2214 IH
394394 such as a third-party administrator, regardless 1
395395 of whether it identifies itself as a pharmacy 2
396396 benefit manager, that, either directly or 3
397397 through an intermediary (including an affiliate, 4
398398 subsidiary, or agent) or an arrangement with a 5
399399 third-party— 6
400400 ‘‘(i) acts as a price negotiator for pre-7
401401 scription drugs on behalf of a group health 8
402402 plan; or 9
403403 ‘‘(ii) manages or administers the pre-10
404404 scription drug benefits provided by a group 11
405405 health plan, including creating formularies, 12
406406 the processing and payment of claims for 13
407407 prescription drugs, arranging alternative 14
408408 access to or funding for prescription drugs, 15
409409 the performance of drug utilization review, 16
410410 the processing of drug prior authorization 17
411411 requests, the adjudication of appeals or 18
412412 grievances related to the prescription drug 19
413413 benefit, contracting with network phar-20
414414 macies, controlling the cost of covered pre-21
415415 scription drugs, or the provision of related 22
416416 services. 23
417417 ‘‘(c) E
418418 NFORCEMENT.— 24
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421421 •HR 2214 IH
422422 ‘‘(1) IN GENERAL.—The Secretary, in consulta-1
423423 tion with the Secretary of Health and Human Serv-2
424424 ices and the Secretary of Labor, shall enforce this 3
425425 section. 4
426426 ‘‘(2) D
427427 ISGORGEMENT.—The pharmacy benefit 5
428428 manager shall disgorge to a group health plan any 6
429429 payment, remuneration, or other amount received by 7
430430 the pharmacy benefit manager or an affiliate of such 8
431431 pharmacy benefit manager from such plan or issuer 9
432432 in violation of subsection (a) or, pursuant to sub-10
433433 section (b), the agreement entered into with such 11
434434 plan for bona fide service fees. 12
435435 ‘‘(3) P
436436 ENALTIES.—A pharmacy benefit man-13
437437 ager that violates subsection (a) or (b) shall be sub-14
438438 ject to a civil monetary penalty in the amount of 15
439439 $10,000 for each day during which such violation 16
440440 continues. 17
441441 ‘‘(4) P
442442 ROCEDURE.—The provisions of section 18
443443 1128A of the Social Security Act, other than sub-19
444444 section (a) and (b) and the first sentence of sub-20
445445 section (c)(1) of such section, shall apply to civil 21
446446 monetary penalties under this subsection in the 22
447447 same manner as such provisions apply to a penalty 23
448448 or proceeding under section 1128A of the Social Se-24
449449 curity Act. 25
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452452 •HR 2214 IH
453453 ‘‘(d) REGULATIONS.—Notwithstanding any other 1
454454 provision of law, the Secretary, in consultation with the 2
455455 Secretary of Health and Human Services and the Sec-3
456456 retary of Labor, shall implement this section through in-4
457457 terim final regulations.’’. 5
458458 (2) C
459459 LERICAL AMENDMENT .—The table of sec-6
460460 tions for subchapter B of chapter 100 of the Inter-7
461461 nal Revenue Code of 1986 is amended by adding at 8
462462 the end the following new item: 9
463463 ‘‘Sec. 9826. Improving pharmacy benefit manager services.’’.
464464 Æ
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