(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.(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(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),(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(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.(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);(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).