evekhm/cms_iom_500 huggingface dataset:
Social Security Act §1833
(B)[90]In the case of outpatient therapy servicesfor which an exception is requested under the first sentence of subparagraph(A), the claim for such services shall contain an appropriate modifier(such as the KX modifier used as of the date of the enactment of thissubparagraph) indicating that such services are medically necessaryas justified by appropriate documentation in the medical record involved.(C)[91](i)In applying thisparagraph with respect to a request for an exception with respectto expenses that would be incurred for outpatient therapy services(including services described in subsection (a)(8)(B)) that wouldexceed the threshold described in clause (ii) for a year, the requestfor such an exception, for services furnished on or after October1, 2012, shall be subject to a manual medical review process that,subject to subparagraph (E), is similar to the manual medical reviewprocess used for certain exceptions under this paragraph in 2006.[92](ii)The thresholdunder this clause for a year is $3,700. Such threshold shall be appliedseparately(I)for physicaltherapy services and speech-language pathology services; and(II)for occupationaltherapy services.(E)(i)In place of themanual medical review process under subparagraph (C)(i), the Secretaryshall implement a process for medical review under this subparagraphunder which the Secretary shall identify and conduct medical reviewfor services described in subparagraph (C)(i) furnished by a providerof services or supplier (in this subparagraph referred to as a therapy provider) using such factors as the Secretary determinesto be appropriate.(ii)Such factorsmay include the following:(I)The therapyprovider has had a high claims denial percentage for therapy servicesunder this part or is less compliant with applicable requirementsunder this title.(II)The therapyprovider has a pattern of billing for therapy services under thispart that is aberrant compared to peers or otherwise has questionablebilling practices for such services, such as billing medically unlikelyunits of services in a day.(III)Thetherapy provider is newly enrolled under this title or has not previouslyfurnished therapy services under this part.(IV)The servicesare furnished to treat a type of medical condition.
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(III)Thetherapy provider is newly enrolled under this title or has not previouslyfurnished therapy services under this part.(IV)The servicesare furnished to treat a type of medical condition.(V)The therapyprovider is part of group that includes another therapy provider identifiedusing the factors determined under this subparagraph.(iii)For purposesof carrying out this subparagraph, the Secretary shall provide forthe transfer, from the Federal Supplementary Medical Insurance TrustFund under section 1841, of $5,000,000 to the Centers for Medicare& Medicaid Services Program Management Account for fiscal years2015 and 2016, to remain available until expended. Such funds maynot be used by a contractor under section 1893(h) for medical reviewsunder this subparagraph.(iv)[94]The targeted review process under this subparagraphshall not apply to services for which expenses are incurred beyondthe period for which the exceptions process under subparagraph (A)is implemented, except as such process is applied under paragraph(7)(B).(6)(A)[95]In applying paragraphs (1) and (3) to servicesfurnished during the period beginning not later than October 1, 2012,and ending on December 31, 2017, the exclusion of services describedin subsection (a)(8)(B) from the uniform dollar limitation specifiedin paragraph (2) shall not apply to such services furnished during2012 through 2017.(B)(i)[96]With respect to outpatient therapy services furnishedbeginning on or after January 1, 2013, and before January 1, 2014,for which payment is made under section 1834(g), the Secretary shall count toward the uniform dollarlimitations described in paragraphs (1) and (3) and the thresholddescribed in paragraph (5)(C) the amount that would be payable underthis part if such services were paid under section 1834(k)(1)(B) instead of being paidunder section 1834(g).(ii)Nothing in clause(i) shall be construed as changing the method of payment for outpatienttherapy services under section 1834(g).(7)[97]For purposes of paragraphs (1)(B) and (3)(B),with respect to services described in such paragraphs, the requirementsdescribed in this paragraph are as follows:(A)
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(7)[97]For purposes of paragraphs (1)(B) and (3)(B),with respect to services described in such paragraphs, the requirementsdescribed in this paragraph are as follows:(A)Inclusion of appropriate modifier.Theclaim for such services contains an appropriate modifier (such asthe KX modifier described in paragraph (5)(B)) indicating that suchservices are medically necessary as justified by appropriate documentationin the medical record involved.(B)Targeted medical review for certain services above threshold.(i)In general.In the case where expenses that would be incurred for such serviceswould exceed the threshold described in clause (ii) for the year,such services shall be subject to the process for medical review implementedunder paragraph (5)(E).(ii)Threshold.The threshold under this clause for(I)a year before2028, is $3,000;(II)2028,is the amount specified in subclause (I) increased by the percentageincrease in the MEI (as defined in section 1842(i)(3)) for 2028; and(III)a subsequentyear, is the amount specified in this clause for the preceding yearincreased by the percentage increase in the MEI (as defined in section1842(i)(3)) for such subsequent year; except that if an increase undersubclause (II) or (III) for a year is not a multiple of $10, it shallbe rounded to the nearest multiple of $10.(iii)Application.The threshold under clause(ii) shall be applied separately(I)for physicaltherapy services and speech-language pathology services; and(II)for occupationaltherapy services.(iv)Funding.For purposes of carrying out this subparagraph, the Secretaryshall provide for the transfer, from the Federal Supplementary MedicalInsurance Trust Fund under section 1841 to the Centers for Medicare& Medicaid Services Program Management Account, of $5,000,000for each fiscal year beginning with fiscal year 2018, to remain availableuntil expended. Such funds may not be used by a contractor under section1893(h) for medical reviews under this subparagraph.
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(8)With respect toservices furnished on or after January 1, 2013, where payment maynot be made as a result of application of paragraphs (1) and (3), section 1879 shall apply in the same manner as such sectionapplies to a denial that is made by reason of section 1862(a)(1).[98](h)(1)(A)Subject tosection 1834(d)(1), the Secretary shall establish fee schedules for clinical diagnosticlaboratory tests (including prostate cancer screening tests undersection 1861(oo) consisting of prostate-specific antigen blood tests) for which paymentis made under this part, other than such tests performed by a providerof services for an inpatient of such provider.(B)In the caseof clinical diagnostic laboratory tests performed by a physician orby a laboratory (other than tests performed by a qualified hospitallaboratory (as defined in subparagraph (D)) for outpatients of suchhospital), the fee schedules established under subparagraph (A) shallbe established on a regional, statewide, or carrier service area basis(as the Secretary may determine to be appropriate) for tests furnishedon or after July 1, 1984.(C)In the caseof clinical diagnostic laboratory tests performed by a qualified hospitallaboratory (as defined in subparagraph (D)) for outpatients of suchhospital, the fee schedules established under subparagraph (A) shallbe established on a regional, statewide, or carrier service area basis(as the Secretary may determine to be appropriate) for tests furnishedon or after July 1, 1984.(D)In this subsection,the term qualified hospital laboratory means a hospitallaboratory, in a sole community hospital (as defined in section 1886(d)(5)(D)(iii)), which provides some clinical diagnostic laboratory tests 24 hoursa day in order to serve a hospital emergency room which is availableto provide services 24 hours a day and 7 days a week.
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(2)(A)(i)Except as providedin clause (v), subparagraph (B), and paragraph (4)[99], the Secretaryshall set the fee schedules at 60 percent (or, in the case of a testperformed by a qualified hospital laboratory (as defined in paragraph(1)(D)) for outpatients of such hospital, 62 percent) of the prevailingcharge level determined pursuant to the third and fourth sentencesof section 1842(b)(3) for similar clinical diagnostic laboratory tests for the applicableregion, State, or area for the 12-month period beginning July 1, 1984,adjusted annually (to become effective on January 1 of each year)by, subject to clause (iv), subject to a percentage increase or decreaseequal to the percentage increase or decrease in the Consumer PriceIndex for All Urban Consumers (United States city average minus, foreach of the years 2009 and 2010, 0.5 percentage points), and, fortests furnished before the date of enactment of section 1834A, subjectto[100]such other adjustments as theSecretary determines are justified by technological changes.(ii)Notwithstandingclause (i)(I)any changein the fee schedules which would have become effective under thissubsection for tests furnished on or after January 1, 1988, shallnot be effective for tests furnished during the 3-month period beginningon January 1, 1988,(II)the Secretaryshall not adjust the fee schedules under clause (i) to take into accountany increase in the consumer price index for 1988,(III)theannual adjustment in the fee schedules determined under clause (i)for each of the years 1991, 1992, and 1993 shall be 2 percent, and(IV)the annualadjustment in the fee schedules determined under clause (i) for eachof the years 1994 and 1995, 1998 through 2002, and 2004 through 2008shall be 0 percent.(iii)In establishingfee schedules under clause (i) with respect to automated tests andtests (other than cytopathology tests) which before July 1, 1984,the Secretary made subject to a limit based on lowest charge levelsunder the sixth sentence of section 1842(b)(3) performed after March 31,1988, the Secretary shall reduce by 8.3 percent the fee schedulesotherwise established for 1988, and such reduced fee schedules shallserve as the base for 1989 and subsequent years.
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(iv)After determiningthe adjustment to the fee schedules under clause (i), the Secretaryshall reduce such adjustment(I)for 2011and each subsequent year, by the productivity adjustment describedin section 1886(b)(3)(B)(xi)(II); and.(II)for eachof 2011 through 2015, by 1.75 percentage points.Subclause (I) shall not apply in a year where the adjustmentto the fee schedules determined under clause (i) is 0.0 or a percentagedecrease for a year. The application of the productivity adjustmentunder subclause (I) shall not result in an adjustment to the fee schedulesunder clause (i) being less than 0.0 for a year. The application ofsubclause (II) may result in an adjustment to the fee schedules underclause (i) being less than 0.0 for a year, and may result in paymentrates for a year being less than such payment rates for the precedingyear.(v)[101]The Secretary shall reduce by 2 percent thefee schedules otherwise determined under clause (i) for 2013, andsuch reduced fee schedules shall serve as the base for 2014 and subsequentyears.(B)The Secretarymay make further adjustments or exceptions to the fee schedules toassure adequate reimbursement of (i) emergency laboratory tests neededfor the provision of bona fide emergency services, and (ii) certainlow volume high-cost tests where highly sophisticated equipment orextremely skilled personnel are necessary to assure quality.(3)In addition tothe amounts provided under the fee schedules (for tests furnishedbefore January 1, 2017) or under section 1834A (for tests furnishedon or after January 1, 2017), subject to subsection (b)(5) of suchsection[102], the Secretary shall provide for and establish(A)a nominalfee to cover the appropriate costs in collecting the sample on whicha clinical diagnostic laboratory test was performed and for whichpayment is made under this part, except that not more than one suchfee may be provided under this paragraph with respect to samples collectedin the same encounter, and
Social Security Act §1833
(B)a fee tocover the transportation and personnel expenses for trained personnelto travel to the location of an individual to collect the sample,except that such a fee may be provided only with respect to an individualwho is homebound or an inpatient in an inpatient facility (other thana hospital). In establishing a fee to cover the transportation andpersonnel expenses for trained personnel to travel to the locationof an individual to collect a sample, the Secretary shall providea method for computing the fee based on the number of miles traveledand the personnel costs associated with the collection of each individualsample, but the Secretary shall only be required to apply such methodin the case of tests furnished during the period beginning on April1, 1989, and ending on December 31, 1990, by a laboratory that establishesto the satisfaction of the Secretary (based on data for the 12-monthperiod ending June 30, 1988) that(i)  the laboratory is dependent upon paymentsunder this title for at least 80 percent of its collected revenuesfor clinical diagnostic laboratory tests,(ii)  at least 85 percent of its gross revenuesfor such tests are attributable to tests performed with respect toindividuals who are homebound or who are residents in a nursing facility,and(iii)  the laboratory provided such testsfor residents in nursing facilities representing at least 20 percentof the number of such facilities in the State in which the laboratoryis located.(4)(A)In establishingany fee schedule under this subsection, the Secretary may providefor an adjustment to take into account, with respect to the portionof the expenses of clinical diagnostic laboratory tests attributableto wages, the relative difference between a regions or localareas wage rates and the wage rate presumed in the data onwhich the schedule is based.(B)For purposesof subsections (a)(1)(D)(i) and (a)(2)(D)(i), the limitation amountfor a clinical diagnostic laboratory test performed(i)on or after July1, 1986, and before April 1, 1988, is equal to 115 percent of themedian of all the fee schedules established for that test for thatlaboratory setting under paragraph (1),(ii)after March31, 1988, and before January 1, 1990, is equal to the median of allthe fee schedules established for that test for that laboratory settingunder paragraph (1),
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(ii)after March31, 1988, and before January 1, 1990, is equal to the median of allthe fee schedules established for that test for that laboratory settingunder paragraph (1),(iii)after December31, 1989, and before January 1, 1991, is equal to 93 percent of themedian of all the fee schedules established for that test for thatlaboratory setting under paragraph (1),(iv)after December31, 1990, and before January 1, 1994, is equal to 88 percent of suchmedian,(v)after December31, 1993, and before January 1, 1995, is equal to 84 percent of suchmedian,(vi)after December31, 1994, and before January 1, 1996, is equal to 80 percent of suchmedian,(vii)after December31, 1995, and before January 1, 1998, is equal to 76 percent of suchmedian, and(viii)after December31, 1997, is equal to 74 percent of such median (or 100 percent ofsuch median in the case of a clinical diagnostic laboratory test performedon or after January 1, 2001, that the Secretary determines is a newtest for which no limitation amount has previously been establishedunder this subparagraph).(5)(A)In the caseof a bill or request for payment for a clinical diagnostic laboratorytest for which payment may otherwise be made under this part on anassignment-related basis or under a provider agreement under section 1866, payment may bemade only to the person or entity which performed or supervised theperformance of such test; except that(i)if a physicianperformed or supervised the performance of such test, payment maybe made to another physician with whom he shares his practice,(ii)in the caseof a test performed at the request of a laboratory by another laboratory,payment may be made to the referring laboratory but only if(I)the referringlaboratory is located in, or is part of, a rural hospital,(II)the referringlaboratory is wholly owned by the entity performing such test, thereferring laboratory wholly owns the entity performing such test,or both the referring laboratory and the entity performing such testare wholly-owned by a third entity, or
Social Security Act §1833
(II)the referringlaboratory is wholly owned by the entity performing such test, thereferring laboratory wholly owns the entity performing such test,or both the referring laboratory and the entity performing such testare wholly-owned by a third entity, or(III)notmore than 30 percent of the clinical diagnostic laboratory tests forwhich such referring laboratory (but not including a laboratory describedin subclause (II)), receives requests for testing during the yearin which the test is performed are performed by another laboratory,and(iii)in the caseof a clinical diagnostic laboratory test provided under an arrangement(as defined in section 1861(w)(1)) made by a hospital, critical access hospital orskilled nursing facility, payment shall be made to the hospital orskilled nursing facility.(B)In the caseof such a bill or request for payment for a clinical diagnostic laboratorytest for which payment may otherwise be made under this part, andwhich is not described in subparagraph (A), payment may be made tothe beneficiary only on the basis of the itemized bill of the personor entity which performed or supervised the performance of the test.(C)Payment fora clinical diagnostic laboratory test, including a test performedin a physicians office but excluding a test performed by arural health clinic may only be made on an assignment-related basisor to a provider of services with an agreement in effect under section 1866.(D)A personmay not bill for a clinical diagnostic laboratory test, includinga test performed in a physicians office but excluding a testperformed by a rural health clinic, other than on an assignment-relatedbasis. If a person knowingly and willfully and on a repeated basisbills for a clinical diagnostic laboratory test in violation of theprevious sentence, the Secretary may apply sanctions against the personin the same manner as the Secretary may apply sanctions against aphysician in accordance with paragraph (2) of section 1842(j) in the samemanner such paragraphs apply with respect to a physician. Paragraph(4) of such section shall apply in this subparagraph in the same manneras such paragraph applies to such section.
Social Security Act §1833
(6)For tests furnishedbefore January 1, 2017, in the case[103]of any diagnostic laboratorytest payment for which is not made on the basis of a fee scheduleunder paragraph (1), the Secretary may establish a payment rate whichis acceptable to the person or entity performing the test and whichwould be considered the full charge for such tests. Such negotiatedrate shall be limited to an amount not in excess of the total paymentthat would have been made for the services in the absence of suchrate.(7)Notwithstandingparagraphs (1) and (4) and section 1834A[104]the Secretary shall establish a national minimum paymentamount under this part for a diagnostic or screening pap smear laboratorytest (including all cervical cancer screening technologies that havebeen approved by the Food and Drug Administration as a primary screeningmethod for detection of cervical cancer) equal to $14.60 for testsfurnished in 2000. For such tests furnished in subsequent years, suchnational minimum payment amount shall be adjusted annually as providedin paragraph (2).(8)(A)The Secretaryshall establish by regulation procedures for determining the basisfor, and amount of, payment under this subsection for any clinicaldiagnostic laboratory test with respect to which a new or substantiallyrevised HCPCS code is assigned on or after January 1, 2005 (in thisparagraph referred to as new tests).(B)Determinationsunder subparagraph (A) shall be made only after the Secretary(i)makes availableto the public (through an Internet website and other appropriate mechanisms)a list that includes any such test for which establishment of a paymentamount under this subsection is being considered for a year;(ii)on the sameday such list is made available, causes to have published in the FederalRegister notice of a meeting to receive comments and recommendations(and data on which recommendations are based) from the public on theappropriate basis under this subsection for establishing payment amountsfor the tests on such list;(iii)not lessthan 30 days after publication of such notice convenes a meeting,that includes representatives of officials of the Centers for Medicareand Medicaid Services involved in determining payment amounts, toreceive such comments and recommendations (and data on which the recommendationsare based);
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(iv)taking intoaccount the comments and recommendations (and accompanying data) receivedat such meeting, develops and makes available to the public (throughan Internet website and other appropriate mechanisms) a list of proposeddeterminations with respect to the appropriate basis for establishinga payment amount under this subsection for each such code, togetherwith an explanation of the reasons for each such determination, thedata on which the determinations are based, and a request for publicwritten comments on the proposed determination; and(v)taking into accountthe comments received during the public comment period, develops andmakes available to the public (through an Internet website and otherappropriate mechanisms) a list of final determinations of the paymentamounts for such tests under this subsection, together with the rationalefor each such determination, the data on which the determinationsare based, and responses to comments and suggestions received fromthe public.(C)Under theprocedures established pursuant to subparagraph (A), the Secretaryshall(i)set forth thecriteria for making determinations under subparagraph (A); and(ii)make availableto the public the data (other than proprietary data) considered inmaking such determinations.(D)The Secretarymay convene such further public meetings to receive public commentson payment amounts for new tests under this subsection as the Secretarydeems appropriate.(E)For purposesof this paragraph:(i)The term HCPCS refers to the Health Care Procedure Coding System.(ii)A code shallbe considered to be substantially revised if thereis a substantive change to the definition of the test or procedureto which the code applies (such as a new analyte or a new methodologyfor measuring an existing analyte-specific test).(9)Notwithstandingany other provision in this part, in the case of any diagnostic laboratorytest for HbA1c that is labeled by the Food and Drug Administrationfor home use and is furnished on or after April 1, 2008, the paymentrate for such test shall be the payment rate established under thispart for a glycated hemoglobin test (identified as of October 1, 2007,by HCPCS code 83036 (and any succeeding codes)).(i)(1)The Secretaryshall, in consultation with appropriate medical organizations