Sec. 1301. REVISIONS TO PASS-THROUGH PERIOD AND PAYMENT RULES UNDER OPPS FOR CERTAIN NEW DRUGS AND BIOLOGICALS
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## SEC. 1301 REVISIONS TO PASS-THROUGH PERIOD AND PAYMENT RULES UNDER OPPS FOR CERTAIN NEW DRUGS AND BIOLOGICALS ###
(a)Revisions to Pass-through Period and Payment Rules ####
(1)In general Section 1833(t)(6) of the Social Security Act (42 U.S.C. 1395l(t)(6)) is amended— #####
(A)in subparagraph (C)(i), in the matter preceding subclause (I), by striking “The payment” and inserting “Subject to subparagraph (G), the payment”; #####
(B)in subparagraph (D)(i), by inserting “subject to subparagraph (H),” before “in the case”; and #####
(C)by adding at the end the following new subparagraphs: > > ##### “(G) Pass-through extension for certain drugs and biologicals > > In the case of a drug or biological whose period of pass-through status under this paragraph ended on December 31, 2017, and for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) furnished beginning January 1, 2018, such pass-through status shall be extended for a 2-year period beginning on October 1, 2018. > > > ##### “(H) Temporary payment rule for certain drugs and biologicals > > In the case of a drug or biological whose period of pass-through status under this paragraph ended on December 31, 2017, and for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) furnished beginning January 1, 2018, the payment amount for such drug or biological under this subsection that is furnished during the period beginning on October 1, 2018, and ending on March 31, 2019, shall be the greater of— > > > ###### “(i) > > the payment amount that would otherwise apply under subparagraph (D)(i) for such drug or biological during such period; or > > > ###### “(ii) > > the payment amount that applied under such subparagraph (D)(i) for such drug or biological on December 31, 2017. > > > ##### “(I) Special payment adjustment rules for last quarter of 2018 > > In the case of a drug or biological whose period of pass-through status under this paragraph ended on December 31, 2017, and for which payment under this subsection was packaged into a payment amount for a covered OPD service (or group of services) beginning January 1, 2018, the following rules shall apply with respect to payment amounts under this subsection for covered a OPD service (or group of services) furnished during the period beginning on October 1, 2018, and ending on December 31, 2018: > > > ###### “(i) > > The Secretary shall remove the packaged costs of such drug or biological (as determined by the Secretary) from the payment amount under this subsection for the covered OPD service (or group of services) with which it is packaged. > > > ###### “(ii) > > The Secretary shall not make any adjustments to payment amounts under this subsection for a covered OPD service (or group of services) for which no costs were removed under clause (i).” > . ####
(2)Nonapplication of limit on aggregate annual adjustment for 2018 Section 1833(t)(6)(E)(i) of the Social Security Act (42 U.S.C. 1395l(t)(6)(E)(i)) is amended by adding at the end the following new sentence: “This clause shall not apply for 2018.”. ####
(3)Implementation **[**[42 U.S.C. 1395l note](/us/usc/t42/s1395l)**]** Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by paragraphs
(1)and
(2)by program instruction or otherwise. ###
(b)GAO Study and Report ####
(1)In general The Comptroller General of the United States (in this subsection referred to as the “Comptroller General”) shall conduct a study on the policy for packaging high cost drugs and biologicals after their pass-through status under subsection (t)(6) of section 1833 of the Social Security Act (42 U.S.C. 1395l) has expired under the payment systems for hospital outpatient department services under section subsection
(t)of such section and for surgical services furnished in an ambulatory surgical center under subsection
(i)of such section. Such study shall include an analysis of— #####
(A)the impact of such policy on— ######
(i)the utilization of such drugs and biologicals; ######
(ii)the availability of treatment options, including consultations with physicians and hospitals; and ######
(iii)to the extent practicable, the health outcomes of Medicare beneficiaries; and #####
(B)the impact of the amendments made by subsection (a), including the impact on price competition and cost-sharing. ####
(2)Report Not later than March 1, 2021, the Comptroller General shall submit to Congress a report containing the results of the study conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate. ### DIVISION T REVENUE PROVISIONS
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Sec. 1301
REVISIONS TO PASS-THROUGH PERIOD AND PAYMENT RULES UNDER OPPS FOR CERTAIN NEW DRUGS AND BIOLOGICALS
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