Us Congress 2023-2024 Regular Session

Us Congress House Bill HB8 Compare Versions

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11 I
22 118THCONGRESS
33 1
44 STSESSION H. R. 198
55 To increase reporting requirements and transparency requirements in the
66 340B Drug Pricing Program, and for other purposes.
77 IN THE HOUSE OF REPRESENTATIVES
88 JANUARY9, 2023
99 Mr. R
1010 OSENDALEintroduced the following bill; which was referred to the Com-
1111 mittee on Energy and Commerce, and in addition to the Committee on
1212 Ways and Means, for a period to be subsequently determined by the
1313 Speaker, in each case for consideration of such provisions as fall within
1414 the jurisdiction of the committee concerned
1515 A BILL
1616 To increase reporting requirements and transparency require-
1717 ments in the 340B Drug Pricing Program, and for other
1818 purposes.
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 ‘‘Drug Pricing Trans-4
2323 parency and Accountability Act’’. 5
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2727 SEC. 2. MORATORIUM ON REGISTRATION OF NEW NON- 1
2828 RURAL SECTION 340B HOSPITALS. 2
2929 Section 340B(a) of the Public Health Service Act (42 3
3030 U.S.C. 256b(a)) is amended— 4
3131 (1) in paragraph (4)(L), by striking ‘‘A sub-5
3232 section (d) hospital’’ and inserting ‘‘Subject to para-6
3333 graph (11), a subsection (d) hospital’’; and 7
3434 (2) by adding at the end the following: 8
3535 ‘‘(11) M
3636 ORATORIUM ON REGISTRATION OF CER -9
3737 TAIN HOSPITALS.—During the 2-year period begin-10
3838 ning on the date of the enactment of this para-11
3939 graph— 12
4040 ‘‘(A) an entity described in paragraph 13
4141 (4)(L) shall not be considered a covered entity 14
4242 under this section unless such entity was a cov-15
4343 ered entity on such date (as evidenced by the 16
4444 entity having been identified as a covered entity 17
4545 as of such date under the covered entity identi-18
4646 fication system established under subsection 19
4747 (d)(2)(B)(iv)); and 20
4848 ‘‘(B) no site shall be added to the covered 21
4949 entity identification system established under 22
5050 subsection (d)(2)(B)(iv) or be permitted to 23
5151 begin participating in the drug discount pro-24
5252 gram under this section, as a ‘child site’ or oth-25
5353 erwise, on the basis of association with a cov-26
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5757 ered entity described in paragraph (4)(L) un-1
5858 less such site was identified as a child site as 2
5959 of December 31, 2020, under the system estab-3
6060 lished under subsection (d)(2)(B)(iv). 4
6161 ‘‘(12) R
6262 EGULATIONS TO BE ISSUED DURING 5
6363 THE MORATORIUM PERIOD TO IMPLEMENT STATU -6
6464 TORY REQUIREMENTS CLARIFYING HOSPITAL ELIGI -7
6565 BILITY CRITERIA AND HOSPITAL CHILD SITE STAND -8
6666 ARDS AND ENHANCING HOSPITAL TRANSPARENCY .— 9
6767 ‘‘(A) I
6868 SSUANCE OF REGULATIONS .— 10
6969 ‘‘(i) I
7070 N GENERAL.—During the mora-11
7171 torium period under paragraph (11), the 12
7272 Secretary shall promulgate regulations 13
7373 through notice and comment rulemaking to 14
7474 implement the standards and requirements 15
7575 described in subparagraph (B). 16
7676 ‘‘(ii) D
7777 EADLINE.—Such final regula-17
7878 tions shall be promulgated and take ef-18
7979 fect— 19
8080 ‘‘(I) before the end date of the 20
8181 moratorium described in paragraph 21
8282 (11); or 22
8383 ‘‘(II) in the event that any of 23
8484 such regulations have not taken effect 24
8585 by such end date, the moratorium 25
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8989 under subparagraph (11) shall be ex-1
9090 tended until such regulations are final 2
9191 and effective. 3
9292 ‘‘(iii) L
9393 IMITATION.—The authority to 4
9494 promulgate regulations under this para-5
9595 graph is limited to setting forth the details 6
9696 necessary and appropriate to carry out the 7
9797 requirements of subparagraph (B) effi-8
9898 ciently, effectively, and in conformity with 9
9999 such subparagraph. 10
100100 ‘‘(B) S
101101 TANDARDS AND REQUIREMENTS .— 11
102102 ‘‘(i) H
103103 OSPITAL CHILD SITE STAND -12
104104 ARDS.— 13
105105 ‘‘(I) I
106106 N GENERAL.—Hospitals de-14
107107 scribed in subparagraphs (L) and (M) 15
108108 of paragraph (4) may register off- 16
109109 campus outpatient facilities associated 17
110110 with the hospital (also known as ‘child 18
111111 sites’) to participate in the drug dis-19
112112 count program under this section (be-20
113113 ginning after the moratorium under 21
114114 paragraph (11) ends), if— 22
115115 ‘‘(aa) the site is listed on the 23
116116 hospital’s most recently filed 24
117117 Medicare cost report on a line 25
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121121 that is reimbursable under the 1
122122 Medicare program (or, if the hos-2
123123 pital is a children’s hospital that 3
124124 does not file a Medicare cost re-4
125125 port, the hospital submits to the 5
126126 Secretary a signed statement cer-6
127127 tifying that the facility would be 7
128128 correctly included on a reimburs-8
129129 able line of a Medicare cost re-9
130130 port if the hospital filed a cost 10
131131 report); 11
132132 ‘‘(bb) such cost report dem-12
133133 onstrates that the services pro-13
134134 vided at the facility have associ-14
135135 ated costs and charges for hos-15
136136 pital outpatient department serv-16
137137 ices under title XVIII of the So-17
138138 cial Security Act (or, if the hos-18
139139 pital is a children’s hospital that 19
140140 does not file a Medicare cost re-20
141141 port, the hospital submits to the 21
142142 Secretary a signed statement cer-22
143143 tifying that the services provided 23
144144 at the facility include or consist 24
145145 solely of outpatient services); 25
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149149 ‘‘(cc) the facility is wholly 1
150150 owned by the covered entity; 2
151151 ‘‘(dd) the Secretary has 3
152152 made a determination, under the 4
153153 process described in section 5
154154 413.65(b) of title 42, Code of 6
155155 Federal Regulations (or any suc-7
156156 cessor regulations), that the facil-8
157157 ity meets the Medicare provider- 9
158158 based standards under section 10
159159 413.65 of title 42, Code of Fed-11
160160 eral Regulations (or any suc-12
161161 cessor regulations); 13
162162 ‘‘(ee) the facility provides a 14
163163 full range of outpatient services, 15
164164 in addition to drugs; and 16
165165 ‘‘(ff) the facility adheres to 17
166166 the charity care policy and any 18
167167 sliding fee scale policy of the par-19
168168 ent hospital. 20
169169 ‘‘(II) D
170170 E-REGISTRATION.—If at 21
171171 any time following registration one or 22
172172 more of the standards listed above are 23
173173 no longer satisfied, a registered hos-24
174174 pital shall immediately notify the Sec-25
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178178 retary, de-register the facility, and 1
179179 keep the facility from making any 2
180180 purchases under the drug discount 3
181181 program under this section or rep-4
182182 resenting to third parties that it may 5
183183 purchase under such program. 6
184184 ‘‘(ii) H
185185 OSPITAL ELIGIBILITY STAND -7
186186 ARDS FOR HOSPITALS NOT OWNED OR OP -8
187187 ERATED BY A UNIT OF STATE OR LOCAL 9
188188 GOVERNMENT.—For purposes of subpara-10
189189 graph (L)(i) of paragraph (4): 11
190190 ‘‘(I) A private hospital has been 12
191191 formally granted governmental powers 13
192192 by a unit of State or local government 14
193193 if the Secretary receives a certification 15
194194 from a State or local governmental 16
195195 entity that such governmental entity 17
196196 has formally delegated, through State 18
197197 or local statute or regulation or, if 19
198198 permitted by applicable State or local 20
199199 law, through a contract with a State 21
200200 or local government, to the hospital 22
201201 such a power, described in detail in 23
202202 the certification. 24
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206206 ‘‘(II) A private hospital has a 1
207207 contract with a State or local govern-2
208208 ment to provide health care services to 3
209209 low-income individuals who are not 4
210210 entitled to benefits under Medicare or 5
211211 Medicaid if— 6
212212 ‘‘(aa) the hospital submits a 7
213213 copy of the contract to the Sec-8
214214 retary for review; 9
215215 ‘‘(bb) the Secretary deter-10
216216 mines that the contract creates 11
217217 an enforceable obligation for the 12
218218 hospital to provide direct medical 13
219219 care to low-income individuals in-14
220220 eligible for Medicare and Med-15
221221 icaid in an amount that rep-16
222222 resents at least 15 percent of the 17
223223 hospital’s total costs for all items 18
224224 and services furnished at such 19
225225 hospital; and 20
226226 ‘‘(cc) the contract is avail-21
227227 able to the public as part of the 22
228228 information describing the hos-23
229229 pital in the covered entity identi-24
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233233 fication system established under 1
234234 subsection (d)(2)(B)(iv). 2
235235 ‘‘(III) If at any time a hospital 3
236236 not owned or operated by a unit of 4
237237 State or local government no longer 5
238238 meets one or more requirements 6
239239 under subclause (I) or (II), the hos-7
240240 pital shall immediately notify the Sec-8
241241 retary, dis-enroll from the drug dis-9
242242 count program under this section, and 10
243243 stop making purchases under such 11
244244 program and representing to third 12
245245 parties that it may purchase under 13
246246 such program. 14
247247 ‘‘(iii) H
248248 OSPITAL TRANSPARENCY RE -15
249249 QUIREMENTS.— 16
250250 ‘‘(I) H
251251 OSPITAL REQUIREMENTS 17
252252 TO IDENTIFY SECTION 340B DRUGS .— 18
253253 In the case of covered entity hospitals 19
254254 described in subparagraph (L) of 20
255255 paragraph (4): 21
256256 ‘‘(aa) Claims for covered 22
257257 outpatient drugs purchased 23
258258 under the drug discount program 24
259259 under this section shall be sub-25
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263263 mitted to public and private 1
264264 payors using the 340B modifier 2
265265 established by the Secretary 3
266266 under the prospective payment 4
267267 system for hospital outpatient de-5
268268 partment services, in conform-6
269269 ance with paragraph (22) of sec-7
270270 tion 1833(t) of the Social Secu-8
271271 rity Act, subsection (h) of 9
272272 1847A, subparagraph (F) of sec-10
273273 tion 1927(a)(5), and paragraph 11
274274 (5) of section 1857(g), that is 12
275275 ‘JG’. 13
276276 ‘‘(bb) Such hospitals shall 14
277277 report to the Secretary on an an-15
278278 nual basis, in a form and manner 16
279279 specified by the Secretary— 17
280280 ‘‘(AA) the hospital’s ag-18
281281 gregate annual revenue from 19
282282 drugs purchased under the 20
283283 program under this section, 21
284284 minus its aggregate annual 22
285285 acquisition costs for such 23
286286 drugs, broken out by hos-24
287287 pital and by each child site; 25
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291291 ‘‘(BB) any dispensing 1
292292 fees paid by the hospital or 2
293293 child site to contract phar-3
294294 macies for such drugs; 4
295295 ‘‘(CC) the patient mix, 5
296296 broken down by expected 6
297297 payment source (including 7
298298 at least the Medicare pro-8
299299 gram under title XVIII of 9
300300 the Social Security Act, a 10
301301 State plan under the Med-11
302302 icaid program under title 12
303303 XIX of such Act, private in-13
304304 surance, and uninsured indi-14
305305 viduals), for each such hos-15
306306 pital, and each child site of 16
307307 the hospital listed in the 17
308308 covered entity information 18
309309 system established under 19
310310 subsection (d)(2)(B)(iv), and 20
311311 the costs incurred at each 21
312312 such hospital and site for 22
313313 charity care (as described in 23
314314 line 23 of Worksheet S– 24
315315 10—Hospital Uncompen-25
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319319 sated and Indigent Care 1
320320 Data to the Medicare cost 2
321321 report or as reported in any 3
322322 successor form); 4
323323 ‘‘(DD) the percent of 5
324324 total revenues (net of any 6
325325 discounts) at each site de-7
326326 rived from infusion or injec-8
327327 tion of physician-adminis-9
328328 tered drugs, including any 10
329329 associated items or services 11
330330 furnished incident-to the ad-12
331331 ministration of such drugs; 13
332332 and 14
333333 ‘‘(EE) with respect to 15
334334 such hospital and each child 16
335335 site of the hospital, the 17
336336 names of all third-party ven-18
337337 dors or other similar entities 19
338338 (including split fee vendors 20
339339 and contract pharmacies) 21
340340 that the covered entity con-22
341341 tracts with to provide serv-23
342342 ices associated with the pro-24
343343 gram under this section 25
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347347 (broken down by covered en-1
348348 tity and by each child site). 2
349349 ‘‘(II) P
350350 UBLIC AVAILABILITY.— 3
351351 The Secretary shall make the infor-4
352352 mation reported to the Secretary 5
353353 under subclause (I)(bb) available to 6
354354 the public (with redactions of any in-7
355355 formation the Secretary determines to 8
356356 be proprietary or confidential) in an 9
357357 annual compilation of the reported in-10
358358 formation available on the internet 11
359359 website of the Department of Health 12
360360 and Human Services, and as part of 13
361361 the information describing the hos-14
362362 pital and the relevant child site in the 15
363363 covered entity identification system 16
364364 established under subsection 17
365365 (d)(2)(B)(iv).’’. 18
366366 SEC. 3. 340B CLAIMS MODIFIER. 19
367367 (a) M
368368 EDICAID.—Section 1927(a)(5) of the Social Se-20
369369 curity Act (42 U.S.C. 1396r–8(a)(5)) is amended by add-21
370370 ing at the end the following: 22
371371 ‘‘(F) 340B
372372 CLAIMS MODIFIER.— 23
373373 ‘‘(i) I
374374 N GENERAL.—All claims sub-24
375375 mitted to a Medicaid fee-for-service pro-25
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379379 gram or a medicaid managed care organi-1
380380 zation (as defined in section 2
381381 1903(m)(1)(A)) for reimbursement of a 3
382382 unit of a covered outpatient drug subject 4
383383 to an agreement under section 340B of the 5
384384 Public Health Service Act shall include the 6
385385 340B modifier established by the Secretary 7
386386 under the prospective payment system for 8
387387 hospital outpatient department services 9
388388 under section 1833(t) that is ‘JG’ or the 10
389389 Submission Clarification Code of ‘20’ de-11
390390 veloped by the National Council for Pre-12
391391 scription Drug Programs (NCPDP). 13
392392 ‘‘(ii) D
393393 ATA SHARING.—Each single 14
394394 State agency shall make available to a 15
395395 manufacturer of a covered outpatient drug 16
396396 any fee-for-service or managed care claim 17
397397 for reimbursement for a unit of such drug 18
398398 for the purpose of verifying the propriety 19
399399 of any claim for a rebate payment under 20
400400 an agreement under subsection (b) with re-21
401401 spect to such drug. At the manufacturer’s 22
402402 request, in lieu of making such a claim 23
403403 available to the manufacturer, the single 24
404404 State agency may instead provide a list of 25
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408408 claims (and relevant data concerning each 1
409409 claim) for covered outpatient drugs that 2
410410 were purchased under an agreement under 3
411411 section 340B of the Public Health Service 4
412412 Act or other summary data specified by 5
413413 the manufacturer. 6
414414 ‘‘(iii) R
415415 EPORT.—Each single State 7
416416 agency shall publish an annual report on 8
417417 utilization of covered outpatient drugs sub-9
418418 ject to an agreement under section 340B 10
419419 of the Public Health Service Act by the 11
420420 Medicaid fee-for-service program or a med-12
421421 icaid managed care organization (as de-13
422422 fined in section 1903(m)(1)(A)) during the 14
423423 preceding calendar year. The State agency 15
424424 shall not include confidential patient-spe-16
425425 cific, drug-specific, or manufacturer-spe-17
426426 cific information in any such annual re-18
427427 port.’’. 19
428428 (b) M
429429 EDICARE.— 20
430430 (1) M
431431 EDICARE PART B.— 21
432432 (A) H
433433 OSPITAL OUTPATIENT DEPARTMENT 22
434434 SERVICES.—Section 1833(t) of the Social Secu-23
435435 rity Act (42 U.S.C. 1395l) is amended by add-24
436436 ing at the end the following paragraph: 25
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440440 ‘‘(22) 340B CLAIMS MODIFIER.—All claims sub-1
441441 mitted under the system under this subsection for 2
442442 reimbursement of a unit of a covered outpatient 3
443443 drug subject to an agreement under section 340B of 4
444444 the Public Health Service Act shall include the 340B 5
445445 modifier established by the Secretary under such 6
446446 system that is ‘JG’ (or ‘TB’ in the case of a claim 7
447447 for reimbursement under such system submitted by 8
448448 a hospital described in subparagraph (M) or (N) of 9
449449 section 340B(a)(4) of the Public Health Service Act 10
450450 or a rural sole community hospital described in sub-11
451451 paragraph (O) of such section).’’. 12
452452 (B) O
453453 THER PART B CLAIMS .—Section 13
454454 1847A of the Social Security Act (42 U.S.C. 14
455455 1395w–3a) is amended by adding the following 15
456456 new subsection: 16
457457 ‘‘(k) 340B C
458458 LAIMSMODIFIER.—All claims submitted 17
459459 under this part (other than under the prospective payment 18
460460 system for hospital outpatient department services under 19
461461 section 1833(t)) for reimbursement of a unit of a covered 20
462462 outpatient drug subject to an agreement under section 21
463463 340B of the Public Health Service Act shall include the 22
464464 340B modifier established by the Secretary under such 23
465465 payment system that is ‘JG’.’’. 24
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469469 (2) MEDICARE ADVANTAGE AND MEDICARE 1
470470 PART D.—Section 1857(e) of the Social Security Act 2
471471 (42 U.S.C. 1395w–27(e)) is amended by adding at 3
472472 the end the following new paragraph: 4
473473 ‘‘(6) 340B
474474 CLAIMS MODIFIER.—All claims sub-5
475475 mitted to a Medicare Advantage organization or a 6
476476 PDP sponsor under this part and part D, respec-7
477477 tively, for reimbursement of a unit of a covered out-8
478478 patient drug subject to an agreement under section 9
479479 340B of the Public Health Service Act shall include 10
480480 the 340B modifier established by the Secretary 11
481481 under the prospective payment system for hospital 12
482482 outpatient department services under section 13
483483 1833(t) that is ‘JG’ or the Submission Clarification 14
484484 Code of ‘20’ developed by the National Council for 15
485485 Prescription Drug Programs (NCPDP).’’. 16
486486 (3) R
487487 EPORT ON UTILIZATION UNDER MEDICARE 17
488488 PART B.—The Secretary of Health and Human 18
489489 Services shall publish an annual report on utilization 19
490490 under part B of title XVIII of the Social Security 20
491491 Act (42 U.S.C. 1395j et seq.) of covered outpatient 21
492492 drugs purchased subject to an agreement under sec-22
493493 tion 340B of the Public Health Service Act (42 23
494494 U.S.C. 256b) during the preceding calendar year. 24
495495 The Secretary shall not include confidential patient- 25
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499499 specific, drug-specific, or manufacturer-specific in-1
500500 formation in any such annual report. 2
501501 (c) E
502502 FFECTIVEDATE.—The amendments made by 3
503503 this section take effect on the date that is 6 months after 4
504504 the date of enactment of this Act and apply to claims sub-5
505505 mitted on or after that date. 6
506506 SEC. 4. REPORTS TO CONGRESS. 7
507507 Section 340B of the Public Health Service Act (42 8
508508 U.S.C. 256b) is amended by adding at the end the fol-9
509509 lowing: 10
510510 ‘‘(f) R
511511 EPORTS TOCONGRESS.— 11
512512 ‘‘(1) OIG
513513 REPORT.—Not later than 2 years 12
514514 after the date of the enactment of this subsection, 13
515515 the Office of the Inspector General shall submit to 14
516516 Congress a final report on the level of charity care 15
517517 provided by covered entities described in subpara-16
518518 graph (L) of subsection (a)(4) and separately by 17
519519 child sites of such covered entities. 18
520520 ‘‘(2) GAO
521521 REPORTS.— 19
522522 ‘‘(A) I
523523 NITIAL REPORT.—Not later than 1 20
524524 year after the date of the enactment of this 21
525525 subsection, the Comptroller General of the 22
526526 United States shall submit to Congress a re-23
527527 port— 24
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531531 ‘‘(i) analyzing the State and local gov-1
532532 ernment contracts intended to satisfy the 2
533533 requirement under subsection (a)(4)(L)(i) 3
534534 for a covered entity to qualify as an entity 4
535535 described in subparagraph (L) of sub-5
536536 section (a)(4); 6
537537 ‘‘(ii) assessing the amount of care 7
538538 such contracts obligate such entity to pro-8
539539 vide to low-income individuals ineligible for 9
540540 Medicare under title XVIII of the Social 10
541541 Security Act and Medicaid under title XIX 11
542542 of such Act; and 12
543543 ‘‘(iii) analyzing how these contracts 13
544544 define low-income individuals and whether 14
545545 the Secretary reviews such determinations. 15
546546 ‘‘(B) S
547547 UBSEQUENT REPORT .—Not later 16
548548 than 2 years after the date of the enactment of 17
549549 this subsection, the Comptroller General of the 18
550550 United States shall submit to Congress a final 19
551551 report on the difference between the aggregate 20
552552 gross reimbursement and aggregate acquisition 21
553553 costs received by each such covered entity (in-22
554554 cluding child sites of such entity) for drugs sub-23
555555 ject to an agreement under this section.’’. 24
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558558 •HR 198 IH
559559 SEC. 5. MEDICARE REQUIREMENT FOR HOSPITALS RE-1
560560 GARDING 340B DRUG INFORMATION. 2
561561 (a) I
562562 NGENERAL.—Section 1866(a)(1) of the Social 3
563563 Security Act (42 U.S.C. 1395cc(a)(1)) is amended— 4
564564 (1) in subparagraph (X), by striking ‘‘and’’ at 5
565565 the end; 6
566566 (2) in subparagraph (Y), by striking the period 7
567567 at the end and inserting ‘‘, and’’; and 8
568568 (3) by inserting after subparagraph (Y), the fol-9
569569 lowing new subparagraph: 10
570570 ‘‘(Z) in the case of a hospital that is a covered 11
571571 entity under subsection (a)(4) of section 340B of the 12
572572 Public Health Service Act, to include in any cost re-13
573573 port submitted to the Secretary under this title in-14
574574 formation on— 15
575575 ‘‘(i) the aggregate acquisition costs of the 16
576576 hospital for drugs, the purchase of which were 17
577577 attributed to the hospital, during the period 18
578578 covered by such cost report and for which the 19
579579 hospital received a discount under such section 20
580580 340B; and 21
581581 ‘‘(ii) the aggregate revenues the hospital 22
582582 received from all payors for such drugs, 23
583583 disaggregated by insurance status (including 24
584584 the Medicare program, the Medicaid program, 25
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587587 •HR 198 IH
588588 the Children’s Health Insurance Program, pri-1
589589 vate health insurance, and uninsured).’’. 2
590590 (b) E
591591 FFECTIVEDATE.—The amendments made by 3
592592 subsection (a) shall apply to contracts entered into or re-4
593593 newed on or after the date of the enactment of this Act. 5
594594 Æ
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