evekhm/cms_iom_500 huggingface dataset:
Social Security Act §1833
(C)Limit on aggregate outlier adjustments.(i)Ingeneral.The total of the additionalpayments made under this paragraph for covered OPD services furnishedin a year (as estimated by the Secretary before the beginning of theyear) may not exceed the applicable percentage (specified in clause(ii)) of the total program payments estimated to be made under thissubsection for all covered OPD services furnished in that year. Ifthis paragraph is first applied to less than a full year, the previoussentence shall apply only to the portion of such year.(ii)Applicablepercentage.For purposes of clause (i),the term applicable percentage means a percentage specifiedby the Secretary up to (but not to exceed)(I)for a year(or portion of a year) before 2004, 2.5 percent; and(II)for 2004and thereafter, 3.0 percent.(D)Transitional authority.In applyingsubparagraph (A) for covered OPD services furnished before January1, 2002, the Secretary may(i)apply such subparagraphto a bill for such services related to an outpatient encounter (ratherthan for a specific service or group of services) using OPD fee scheduleamounts and transitional passthrough payments covered underthe bill; and(ii)use an appropriatecost-to-charge ratio for the hospital involved (as determined by theSecretary), rather than for specific departments within the hospital.(E)Exclusion of separate drug and biological apcs from outlier payments.No additional payment shall be made under subparagraph (A) inthe case of ambulatory payment classification groups established separatelyfor drugs or biologicals.(6)Transitionalpassthrough for additional costs of innovative medical devices,drugs, and biologicals.(A)In general.The Secretary shall providefor an additional payment under this paragraph for any of the followingthat are provided as part of a covered OPD service (or group of services):(i)Currentorphan drugs.A drug or biological thatis used for a rare disease or condition with respect to which thedrug or biological has been designated as an orphan drug under section526 of the Federal Food, Drug and Cosmetic Act if payment for thedrug or biological as an outpatient hospital service under this partwas being made on the first date that the system under this subsectionis implemented.(ii)
Social Security Act §1833
(ii)Currentcancer therapy drugs and biologicals and brachytherapy.A drug or biological that is used in cancer therapy, including(but not limited to) a chemotherapeutic agent, an antiemetic, a hematopoieticgrowth factor, a colony stimulating factor, a biological responsemodifier, a bisphosphonate, and a device of brachytherapy or temperaturemonitored cryoablation, if payment for such drug, biological, or deviceas an outpatient hospital service under this part was being made onsuch first date.(iii)Current radiopharmaceutical drugs and biological products.A radiopharmaceutical drug or biological product used in diagnostic,monitoring, and therapeutic nuclear medicine procedures if paymentfor the drug or biological as an outpatient hospital service underthis part was being made on such first date.(iv)Newmedical devices, drugs, and biologicals.A medical device, drug, or biological not described in clause (i),(ii), or (iii) if(I)paymentfor the device, drug, or biological as an outpatient hospital serviceunder this part was not being made as of December 31, 1996; and(II)the costof the drug or biological or the average cost of the category of devicesis not insignificant in relation to the OPD fee schedule amount (ascalculated under paragraph (3)(D)) payable for the service (or groupof services) involved.(B)Use of categories in determining eligibility of a device for passthroughpayments.The following provisions applyfor purposes of determining whether a medical device qualifies foradditional payments under clause (ii) or (iv) of subparagraph (A):(i)Establishmentof initial categories.(I)In general.The Secretary shall initiallyestablish under this clause categories of medical devices based ontype of device by April 1, 2001. Such categories shall be establishedin a manner such that each medical device that meets the requirementsof clause (ii) or (iv) of subparagraph (A) as of January 1, 2001,is included in such a category and no such device is included in morethan one category. For purposes of the preceding sentence, whethera medical device meets such requirements as of such date shall bedetermined on the basis of the program memoranda issued before suchdate.(II)
Social Security Act §1833
(II)Authorization of implementation other than through regulations.The categories may be established under this clause by programmemorandum or otherwise, after consultation with groups representinghospitals, manufacturers of medical devices, and other affected parties.(ii)Establishingcriteria for additional categories.(I)In general.The Secretary shall establishcriteria that will be used for creation of additional categories (otherthan those established under clause (i)) through rulemaking (whichmay include use of an interim final rule with comment period).(II)Standard.Such categories shall beestablished under this clause in a manner such that no medical deviceis described by more than one category. Such criteria shall includea test of whether the average cost of devices that would be includedin a category and are in use at the time the category is establishedis not insignificant, as described in subparagraph (A)(iv)(II).(III)Deadline.Criteria shall first be establishedunder this clause by July 1, 2001. The Secretary may establish incompelling circumstances categories under this clause before the datesuch criteria are established.(IV)Adding categories.The Secretary shallpromptly establish a new category of medical devices under this clausefor any medical device that meets the requirements of subparagraph(A)(iv) and for which none of the categories in effect (or that werepreviously in effect) is appropriate.(iii)Period for which category is in effect.A category of medical devices established under clause (i) or (ii)shall be in effect for a period of at least 2 years, but not morethan 3 years, that begins(I)in thecase of a category established under clause (i), on the first dateon which payment was made under this paragraph for any device describedby such category (including payments made during the period beforeApril 1, 2001); and(II)in thecase of any other category, on the first date on which payment ismade under this paragraph for any medical device that is describedby such category.(iv)Requirementstreated as met.A medical device shallbe treated as meeting the requirements of subparagraph (A)(iv), regardlessof whether the device meets the requirement of subclause (I) of suchsubparagraph, if(I)the deviceis described by a category established and in effect under clause(i); or
Social Security Act §1833
(I)the deviceis described by a category established and in effect under clause(i); or(II)the deviceis described by a category established and in effect under clause(ii) and an application under section 515 of the Federal Food, Drug,and Cosmetic Act has been approved with respect to the device, orthe device has been cleared for market under section 510(k) of suchAct, or the device is exempt from the requirements of section 510(k)of such Act pursuant to subsection (l) or (m) of section 510 of suchAct or section 520(g) of such Act.Nothing in this clause shall be construed as requiring an applicationor prior approval (other than that described in subclause (II)) inorder for a covered device described by a category to qualify forpayment under this paragraph.(C)Limited period of payment.(i)Drugsand biologicals.Subject to subparagraph(G), the payment under this paragraph with respect to a drug or biologicalshall only apply during a period of at least 2 years, but not morethan 3 years, that begins[114](I)on the firstdate this subsection is implemented in the case of a drug or biologicaldescribed in clause (i), (ii), or (iii) of subparagraph (A) and inthe case of a drug or biological described in subparagraph (A)(iv)and for which payment under this part is made as an outpatient hospitalservice before such first date; or(II)in thecase of a drug or biological described in subparagraph (A)(iv) notdescribed in subclause (I), on the first date on which payment ismade under this part for the drug or biological as an outpatient hospitalservice.(ii)Medicaldevices.Payment shall be made underthis paragraph with respect to a medical device only if such device(I)is describedby a category of medical devices established and in effect under subparagraph(B); and(II)is providedas part of a service (or group of services) paid for under this subsectionand provided during the period for which such category is in effectunder such subparagraph.(D)
Social Security Act §1833
(II)is providedas part of a service (or group of services) paid for under this subsectionand provided during the period for which such category is in effectunder such subparagraph.(D)Amount of additional payment.Subjectto subparagraph (E)(iii), the amount of the payment under this paragraphwith respect to a device, drug, or biological provided as part ofa covered OPD service is(i)subject to subparagraph(H), in the case of a drug or biological, the amount by which theamount determined under section 1842(o) (or if the drug or biologicalis covered under a competitive acquisition contract under section 1847B, an amount determinedby the Secretary equal to the average price for the drug or biologicalfor all competitive acquisition areas and year established under suchsection as calculated and adjusted by the Secretary for purposes ofthis paragraph) for the drug or biological exceeds the portion ofthe otherwise applicable medicare OPD fee schedule that the Secretarydetermines is associated with the drug or biological; or[115](ii)in the caseof a medical device, the amount by which the hospitals chargesfor the device, adjusted to cost, exceeds the portion of the otherwiseapplicable medicare OPD fee schedule that the Secretary determinesis associated with the device.(E)Limit on aggregate annual adjustment.(i)Ingeneral.[116]The total of the additional paymentsmade under this paragraph for covered OPD services furnished in ayear (as estimated by the Secretary before the beginning of the year)may not exceed the applicable percentage (specified in clause (ii))of the total program payments estimated to be made under this subsectionfor all covered OPD services furnished in that year. If this paragraphis first applied to less than a full year, the previous sentence shallapply only to the portion of such year. This clause shall not applyfor 2018.(ii)Applicablepercentage.For purposes of clause (i),the term applicable percentage means(I)for a year(or portion of a year) before 2004, 2.5 percent; and(II)for 2004and thereafter, a percentage specified by the Secretary up to (butnot to exceed) 2.0 percent.(iii)
Social Security Act §1833
(II)for 2004and thereafter, a percentage specified by the Secretary up to (butnot to exceed) 2.0 percent.(iii)Uniform prospective reduction if aggregate limit projected to beexceeded.If the Secretary estimatesbefore the beginning of a year that the amount of the additional paymentsunder this paragraph for the year (or portion thereof) as determinedunder clause (i) without regard to this clause will exceed the limitestablished under such clause, the Secretary shall reduce pro ratathe amount of each of the additional payments under this paragraphfor that year (or portion thereof) in order to ensure that the aggregateadditional payments under this paragraph (as so estimated) do notexceed such limit.(F)Limitation of application of functional equivalence standard.(i)Ingeneral.The Secretary may not publishregulations that apply a functional equivalence standard to a drugor biological under this paragraph.(ii)Application.Clause (i) shall apply to the application of a functional equivalencestandard to a drug or biological on or after the date of enactmentof the Medicare Prescription Drug, Improvement, and ModernizationAct of 2003 unless(I)such applicationwas being made to such drug or biological prior to such date of enactment;and(II)the Secretaryapplies such standard to such drug or biological only for the purposeof determining eligibility of such drug or biological for additionalpayments under this paragraph and not for the purpose of any otherpayments under this title.(iii)Rule of construction.Nothing in thissubparagraph shall be construed to effect the Secretarys authorityto deem a particular drug to be identical to another drug if the 2products are pharmaceutically equivalent and bioequivalent, as determinedby the Commissioner of Food and Drugs.(G)Pass-through extension for certain drugs and biologicals.In the case of a drug or biological whose period of pass-throughstatus under this paragraph ended on December 31, 2017, and for whichpayment under this subsection was packaged into a payment for a coveredOPD service (or group of services) furnished beginning January 1,2018, such pass-through status shall be extended for a 2-year periodbeginning on October 1, 2018.[117](H)
Social Security Act §1833
(H)Temporary payment rule for certain drugs and biologicals.In the case of a drug or biological whose period of pass-throughstatus under this paragraph ended on December 31, 2017, and for whichpayment under this subsection was packaged into a payment for a coveredOPD service (or group of services) furnished beginning January 1,2018, the payment amount for such drug or biological under this subsectionthat is furnished during the period beginning on October 1, 2018,and ending on March 31, 2019, shall be the greater of(i)the payment amountthat would otherwise apply under subparagraph (D)(i) for such drugor biological during such period; or(ii)the paymentamount that applied under such subparagraph (D)(i) for such drug orbiological on December 31, 2017.[118](I)Special payment adjustment rules for last quarter of 2018.In the case of a drug or biological whose period of pass-throughstatus under this paragraph ended on December 31, 2017, and for whichpayment under this subsection was packaged into a payment amount fora covered OPD service (or group of services) beginning January 1,2018, the following rules shall apply with respect to payment amountsunder this subsection for covered a OPD service (or group of services)furnished during the period beginning on October 1, 2018, and endingon December 31, 2018:(i)The Secretaryshall remove the packaged costs of such drug or biological (as determinedby the Secretary) from the payment amount under this subsection forthe covered OPD service (or group of services) with which it is packaged.(ii)The Secretaryshall not make any adjustments to payment amounts under this subsectionfor a covered OPD service (or group of services) for which no costswere removed under clause (i).[119](J)Additional pass-throughextension and special payment adjustment rule for certain diagnosticradiopharmaceuticals.[120]In the case of a drug or biological furnished in the contextof a clinical study on diagnostic imaging tests approved under a coveragewith evidence development determination whose period of passthroughstatus under this paragraph concluded on December 31, 2018, and forwhich payment under this subsection was packaged into a payment fora covered OPD service (or group of services) furnished beginning January1, 2019, the Secretary shall
Social Security Act §1833
(i) extend such pass-through status forsuch drug or biological for the 9-month period beginning on January1, 2020;(ii) remove, during such period, the packagedcosts of such drug or biological (as determined by the Secretary)from the payment amount under this subsection for the covered OPDservice (or group of services) with which it is packaged; and(iii) not make any adjustments to paymentamounts under this subsection for a covered OPD service (or groupof services) for which no costs were removed under clause (ii).(7)Transitionaladjustment to limit decline in payment.(A)Before 2002.Subject to subparagraph(D), for covered OPD services furnished before January 1, 2002, forwhich the PPS amount (as defined in subparagraph (E)) is(i)at least 90 percent,but less than 100 percent, of the pre-BBA amount (as defined in subparagraph(F)), the amount of payment under this subsection shall be increasedby 80 percent of the amount of such difference;(ii)at least 80percent, but less than 90 percent, of the pre-BBA amount, the amountof payment under this subsection shall be increased by the amountby which (I) the product of 0.71 and the pre-BBA amount, exceeds (II)the product of 0.70 and the PPS amount;(iii)at least70 percent, but less than 80 percent, of the pre-BBA amount, the amountof payment under this subsection shall be increased by the amountby which (I) the product of 0.63 and the pre-BBA amount, exceeds (II)the product of 0.60 and the PPS amount; or(iv)less than 70percent of the pre-BBA amount, the amount of payment under this subsectionshall be increased by 21 percent of the pre-BBA amount.(B)2002.Subjectto subparagraph (D), for covered OPD services furnished during 2002,for which the PPS amount is(i)at least 90 percent,but less than 100 percent, of the pre-BBA amount, the amount of paymentunder this subsection shall be increased by 70 percent of the amountof such difference;
Social Security Act §1833
(i)at least 90 percent,but less than 100 percent, of the pre-BBA amount, the amount of paymentunder this subsection shall be increased by 70 percent of the amountof such difference;(ii)at least 80percent, but less than 90 percent, of the pre-BBA amount, the amountof payment under this subsection shall be increased by the amountby which (I) the product of 0.61 and the pre-BBA amount, exceeds (II)the product of 0.60 and the PPS amount; or(iii)less than80 percent of the pre-BBA amount, the amount of payment under thissubsection shall be increased by 13 percent of the pre-BBA amount.(C)2003.Subjectto subparagraph (D), for covered OPD services furnished during 2003,for which the PPS amount is(i)at least 90 percent,but less than 100 percent, of the pre-BBA amount, the amount of paymentunder this subsection shall be increased by 60 percent of the amountof such difference; or(ii)less than 90percent of the pre-BBA amount, the amount of payment under this subsectionshall be increased by 6 percent of the pre-BBA amount.(D)Hold harmless provisions.(i)Temporarytreatment for certain rural hospitals.(I)In the caseof a hospital located in a rural area and that has not more than 100beds or a sole community hospital (as defined in section 1886(d)(5)(D)(iii)) located in a rural area , for covered OPD services furnished beforeJanuary 1, 2006, for which the PPS amount is less than the pre-BBAamount, the amount of payment under this subsection shall be increasedby the amount of such difference.
Social Security Act §1833
(II)In thecase of a hospital located in a rural area and that has not more than100 beds and that is not a sole community hospital (as defined insection 1886(d)(5)(D)(iii)), for covered OPD services furnished on or after January 1, 2006,and before January 1, 2013[121], for which the PPS amount is less than the pre-BBA amount,the amount of payment under this subsection shall be increased bythe applicable percentage of the amount of such difference. For purposesof the preceding sentence, the applicable percentage shall be 95 percentwith respect to covered OPD services furnished in 2006, 90 percentwith respect to such services furnished in 2007, and 85 percent withrespect to such services furnished in 2008, 2009, 2010, 2011, or 2012[122].(III)In thecase of a sole community hospital (as defined in section 1886(d)(5)(D)(iii)) that has not more than 100 beds, for covered OPD services furnishedon or after January 1, 2009, and before January 1, 2013, for which[123]the PPS amount is less than the pre-BBA amount, the amountof payment under this subsection shall be increased by 85 percentof the amount of such difference. In the case of covered OPD servicesfurnished on or after January 1, 2010, and before January 1, 2013,the preceding[124]sentence shall be applied without regard to the 100-bedlimitation.(ii)Permanenttreatment for cancer hospitals and childrens hospitals.In the case of a hospital described in section clause (iii)or (v) of 1886(d)(1)(B), for covered OPD services for which the PPS amount is less thanthe pre-BBA amount, the amount of payment under this subsection shallbe increased by the amount of such difference.(E)PPS amountdefined.In this paragraph, the term PPS amount means, with respect to covered OPD services, the amount payableunder this title for such services (determined without regard to thisparagraph), including amounts payable as copayment under paragraph(8), coinsurance under section 1866(a)(2)(A)(ii), and the deductibleunder section 1833(b).
Social Security Act §1833
(F)Pre-BBA amount defined.(i)Ingeneral.In this paragraph, the pre-BBA amount means, with respect to covered OPD servicesfurnished by a hospital in a year, an amount equal to the productof the reasonable cost of the hospital for such services for the portionsof the hospitals cost reporting period (or periods) occurringin the year and the base OPD payment-to-cost ratio for the hospital(as defined in clause (ii)).(ii)Basepayment-to-cost-ratio defined.For purposesof this subparagraph, the base payment-to-cost ratio for a hospital means the ratio of(I)the hospitalsreimbursement under this part for covered OPD services furnished duringthe cost reporting period ending in 1996 (or in the case of a hospitalthat did not submit a cost report for such period, during the firstsubsequent cost reporting period ending before 2001 for which thehospital submitted a cost report), including any reimbursement forsuch services through cost-sharing described in subparagraph (E),to (II) the reasonable cost of such services for such period.The Secretary shall determine such ratios as if the amendmentsmade by section 4521 of the Balanced Budget Act of 1997[125]werein effect in 1996.(G)Interim payments.The Secretary shallmake payments under this paragraph to hospitals on an interim basis,subject to retrospective adjustments based on settled cost reports.(H)No effect on copayments.Nothing inthis paragraph shall be construed to affect the unadjusted copaymentamount described in paragraph (3)(B) or the copayment amount underparagraph (8).(I)Application without regard to budget neutrality.The additional payments made under this paragraph(i)shall not beconsidered an adjustment under paragraph (2)(E); and(ii)shall not beimplemented in a budget neutral manner.(8)Copaymentamount.(A)In general.Except as provided in subparagraphs(B) and (C), the copayment amount under this subsection is the amountby which the amount described in paragraph (4)(B) exceeds the amountof payment determined under paragraph (4)(C).(B)