(II)Recommendations.Upon the completionof such surveys, the Comptroller General shall recommend to the Secretarythe frequency and methodology of subsequent surveys to be conductedby the Secretary under clause (ii).(ii)Subsequentsecretarial surveys.The Secretary, takinginto account such recommendations, shall conduct periodic subsequentsurveys to determine the hospital acquisition cost for each specifiedcovered outpatient drug for use in setting the payment rates undersubparagraph (A).(iii)Survey requirements.The surveys conductedunder clauses (i) and (ii) shall have a large sample of hospitalsthat is sufficient to generate a statistically significant estimateof the average hospital acquisition cost for each specified coveredoutpatient drug. With respect to the surveys conducted under clause(i), the Comptroller General shall report to Congress on the justificationfor the size of the sample used in order to assure the validity ofsuch estimates.(iv)Differentiationin cost.In conducting surveys underclause (i), the Comptroller General shall determine and report toCongress if there is (and the extent of any) variation in hospitalacquisition costs for drugs among hospitals based on the volume ofcovered OPD services performed by such hospitals or other relevantcharacteristics of such hospitals (as defined by the Comptroller General).(v)Commenton proposed rates.Not later than 30days after the date the Secretary promulgated proposed rules settingforth the payment rates under subparagraph (A) for 2006, the ComptrollerGeneral shall evaluate such proposed rates and submit to Congressa report regarding the appropriateness of such rates based on thesurveys the Comptroller General has conducted under clause (i).(E)Adjustment in payment rates for overhead costs.(i)Medpacreport on drug apc design.The MedicarePayment Advisory Commission shall submit to the Secretary, not laterthan July 1, 2005, a report on adjustment of payment for ambulatorypayment classifications for specified covered outpatient drugs totake into account overhead and related expenses, such as pharmacyservices and handling costs. Such report shall include(I)a descriptionand analysis of the data available with regard to such expenses;(II)a recommendationas to whether such a payment adjustment should be made; and(III)ifsuch adjustment should be made, a recommendation regarding the methodologyfor making such an adjustment.(ii)Adjustmentauthorized.The Secretary may adjustthe weights for ambulatory payment classifications for specified coveredoutpatient drugs to take into account the recommendations containedin the report submitted under clause (i).(F)Classes of drugs.For purposes of thisparagraph:(i)Solesource drugs.The term sole sourcedrug means(I)a biologicalproduct (as defined under section 1861(t)(1)); or(II)a singlesource drug (as defined in section 1927(k)(7)(A)(iv)).(ii)Innovatormultiple source drugs.The term innovator multiple source drug has the meaning given suchterm in section 1927(k)(7)(A)(ii).(iii)Noninnovator multiple source drugs.The term noninnovator multiple source drug has themeaning given such term in section 1927(k)(7)(A)(iii).(G)Reference average wholesale price.The term reference average wholesale price means,with respect to a specified covered outpatient drug, the average wholesaleprice for the drug as determined under section 1842(o) as of May 1, 2003.(H)Inapplicability of expenditures in determining conversion, weighting,and other adjustment factors.Additionalexpenditures resulting from this paragraph shall not be taken intoaccount in establishing the conversion, weighting, and other adjustmentfactors for 2004 and 2005 under paragraph (9), but shall be takeninto account for subsequent years.(15)Paymentfor new drugs and biologicals until hcpcs code assigned.With respect to payment under this part for an outpatient drugor biological that is covered under this part and is furnished aspart of covered OPD services for which a HCPCS code has not been assigned,the amount provided for payment for such drug or biological underthis part shall be equal to 95 percent of the average wholesale pricefor the drug or biological.(16)Miscellaneousprovisions.(A)Application of reclassification of certain hospitals.If a hospital is being treated as being located in a rural areaunder section 1886(d)(8)(E), that hospital shall be treated under this subsection as being locatedin that rural area.(B)Threshold for establishment of separate apcs for drugs.The Secretary shall reduce the threshold for the establishmentof separate ambulatory payment classification groups (APCs) with respectto drugs or biologicals to $50 per administration for drugs and biologicalsfurnished in 2005 and 2006.(C)Payment for devices of brachytherapy and therapeutic radiopharmaceuticalsat charges adjusted to cost.Notwithstandingthe preceding provisions of this subsection, for a device of brachytherapyconsisting of a seed or seeds (or radioactive source) furnished onor after January 1, 2004, and before July 1, 2008, and for therapeuticradiopharmaceuticals furnished on or after January 1, 2008, and beforeJuly 1, 2008, the payment basis for the device or therapeutic radiopharmaceuticalunder this subsection shall be equal to the hospitals chargesfor each deviceor therapeutic radiopharmaceutical furnished, adjustedto cost. Charges for such devices or therapeutic radiopharmaceuticalsshall not be included in determining any outlier payment under thissubsection.(D)[126]Special paymentrule.(i)Ingeneral.In the case of covered OPD servicesfurnished on or after April 1, 2013, in a hospital described in clause(ii), if(I)  the payment rate that would otherwiseapply under this subsection for stereotactic radiosurgery, completecourse of treatment of cranial lesion(s) consisting of 1 session thatis multisource Cobalt 60 based (identified as of January 1, 2013,by HCPCS code 77371 (and any succeeding code) and reimbursed as ofsuch date under APC 0127 (and any succeeding classification group));exceeds(II)  the payment rate that would otherwiseapply under this subsection for linear accelerator based stereotacticradiosurgery, complete course of therapy in one session (identifiedas of January 1, 2013, by HCPCS code G0173 (and any succeeding code)and reimbursed as of such date under APC 0067 (and any succeedingclassification group)),the payment rate for the servicedescribed in subclause (I) shall be reduced to an amount equal tothe payment rate for the service described in subclause (II).(ii)Hospital described.A hospital described in this clause is a hospital that is not(I)  located in a rural area (as definedin section 1886(d)(2)(D));(II)  classified as a rural referralcenter under section 1886(d)(5)(C); or(III)  a sole community hospital (asdefined in section 1886(d)(5)(D)(iii)).(iii)Not budget neutral.In making any budget neutrality adjustments under this subsectionfor 2013 (with respect to covered OPD services furnished on or afterApril 1, 2013, and before January 1, 2014) or a subsequent year, theSecretary shall not take into account the reduced expenditures thatresult from the application of this subparagraph.(E)Application of appropriate use criteria for certain imaging services.For provisions relating to the application of appropriate usecriteria for certain imaging services, see section 1834(q).[127](17)QualityReporting.(A)Reduction in update for failure to report.(i)Ingeneral.For purposes of paragraph (3)(C)(iv)for 2009 and each subsequent year, in the case of a subsection (d)hospital (as defined in section 1886(d)(1)(B)) that does not submit,to the Secretary in accordance with this paragraph, data requiredto be submitted on measures selected under this paragraph with respectto such a year, the OPD fee schedule increase factor under paragraph(3)(C)(iv) for such year shall be reduced by 2.0 percentage points.(ii)Non-cumulativeapplication.A reduction under this subparagraphshall apply only with respect to the year involved and the Secretaryshall not take into account such reduction in computing the OPD feeschedule increase factor for a subsequent year.(B)Form and manner of submission.Eachsubsection (d) hospital shall submit data on measures selected underthis paragraph to the Secretary in a form and manner, and at a time,specified by the Secretary for purposes of this paragraph.(C)Development of outpatient measures.(i)Ingeneral.The Secretary shall developmeasures that the Secretary determines to be appropriate for the measurementof the quality of care (including medication errors) furnished byhospitals in outpatient settings and that reflect consensus amongaffected parties and, to the extent feasible and practicable, shallinclude measures set forth by one or more national consensus buildingentities.(ii)Construction.Nothing in this paragraph shall be construed as preventing theSecretary from selecting measures that are the same as (or a subsetof) the measures for which data are required to be submitted undersection 1886(b)(3)(B)(viii).(D)Replacement of measures.For purposesof this paragraph, the Secretary may replace any measures or indicatorsin appropriate cases, such as where all hospitals are effectivelyin compliance or the measures or indicators have been subsequentlyshown not to represent the best clinical practice.(E)Availability of data.The Secretaryshall establish procedures for making data submitted under this paragraphavailable to the public. Such procedures shall ensure that a hospitalhas the opportunity to review the data that are to be made publicwith respect to the hospital prior to such data being made public.The Secretary shall report quality measures of process, structure,outcome, patients perspectives on care, efficiency, and costsof care that relate to services furnished in outpatient settings inhospitals on the Internet website of the Centers for Medicare andMedicaid Services.(18)[128]Authorization of adjustment forcancer hospitals.(A)Study.The Secretary shall conducta study to determine if, under the system under this subsection, costsincurred by hospitals described in section 1886(d)(1)(B)(v) with respectto ambulatory payment classification groups exceed those costs incurredby other hospitals furnishing services under this subsection (as determinedappropriate by the Secretary). In conducting the study under thissubparagraph, the Secretary shall take into consideration the costof drugs and biologicals incurred by such hospitals.(B)Authorization of adjustment.Insofaras the Secretary determines under subparagraph (A) that costs incurredby hospitals described in section 1886(d)(1)(B)(v) exceed those costs incurred by other hospitalsfurnishing services under this subsection, the Secretary shall, subjectto subparagraph (C), provide for an appropriate adjustment under paragraph(2)(E) to reflect those higher costs effective for services furnishedon or after January 1, 2011.(C)Target pcr adjustmentIn applying section 419.43(i) of title 42 of the Code of FederalRegulations to implement the appropriate adjustment under this paragraphfor services furnished on or after January 1, 2018, the Secretaryshall use a target PCR that is 1.0 percentage points less than thetarget PCR that would otherwise apply. In addition to the percentagepoint reduction under the previous sentence, the Secretary may considermaking an additional percentage point reduction to such target PCRthat takes into account payment rates for applicable items and servicesdescribed in paragraph (21)(C) other than for services furnished byhospitals described in section 1886(d)(1)(B)(v). In making any budget neutrality adjustmentsunder this subsection for 2018 or a subsequent year, the Secretaryshall not take into account the reduced expenditures that result fromthe application of this subparagraph.(19)Flooron area wage adjustment factor for hospital outpatient departmentservices in frontier states.(A)In general.Subject to subparagraph(B), with respect to covered OPD services furnished on or after January1, 2011, the area wage adjustment factor applicable under the paymentsystem established under this subsection to any hospital outpatientdepartment which is located in a frontier State (as defined in section 1886(d)(3)(E)(iii)(II)) maynot be less than 1.00. The preceding sentence shall not be appliedin a budget neutral manner.(B)Limitation.This paragraph shall notapply to any hospital outpatient department located in a State thatreceives a non-labor related share adjustment under section 1886(d)(5)(H).(20)Notbudget neutral application of reduced expenditures resulting fromquality incentives for computed tomography.The Secretary shall not take into account the reduced expendituresthat result from the application of section 1834(p) in making anybudget neutrality adjustments this subsection.[129](21)Servicesfurnished by an off-campus outpatient department of a provider[130].(A)