42 U.S.C. § 1395rr — End stage renal disease program

Page 3753 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr 1 See References in Text note below. and conditions as would apply if the services were furnished in or at the direction of such a hospital or clinic that was not operated by such Service, tribe, or organization. (B) Payment shall not be made for services under subparagraph (A) to the extent that pay- ment is otherwise made for such services under this subchapter. (2) The services described in this paragraph are the following: (A) Services for which payment is made under section 1395w–4 of this title. (B) Services furnished by a practitioner de- scribed in section 1395u(b)(18)(C) of this title for which payment under part B is made under a fee schedule. (C) Services furnished by a physical thera- pist or occupational therapist as described in section 1395x(p) of this title for which payment under part B is made under a fee schedule. (3) Subsection (c) shall not apply to payments made under this subsection. (f) Cross reference For provisions relating to the authority of cer- tain Indian tribes, tribal organizations, and Alaska Native health organizations to elect to directly bill for, and receive payment for, health care services provided by a hospital or clinic of such tribes or organizations and for which pay- ment may be made under this subchapter, see section 1645 of title 25.1 (Aug. 14, 1935, ch. 531, title XVIII, § 1880, as added Pub. L. 94–437, title IV, § 401(b), Sept. 30, 1976, 90 Stat. 1408; amended Pub. L. 102–573, title VII, § 701(d), Oct. 29, 1992, 106 Stat. 4572; Pub. L. 106–417, § 3(b)(1), Nov. 1, 2000, 114 Stat. 1815; Pub. L. 106–554, § 1(a)(6) [title IV, § 432(a)], Dec. 21, 2000, 114 Stat. 2763, 2763A–525; Pub. L. 108–173, title VI, § 630, Dec. 8, 2003, 117 Stat. 2321; Pub. L. 111–148, title II, § 2902(a), title X, § 10221(a), (b)(4), Mar. 23, 2010, 124 Stat. 333, 935, 936.) Editorial Notes REFERENCES IN TEXT Section 1645 of title 25, referred to in subsec. (f), was amended generally by section 10221(a) of title X of Pub. L. 111–148, Mar. 23, 2010, 124 Stat. 935, and, as so amend- ed, no longer contains provisions relating to direct bill- ing of medicare, medicaid, and other third party payors. CODIFICATION Pub. L. 111–148, § 10221(a), enacted into law S. 1790, One Hundred Eleventh Congress, as reported by the Committee on Indian Affairs of the Senate in Dec. 2009, ‘‘[e]xcept as provided in’’ section 10221(b) of Pub. L. 111–148. Section 201(a) of S. 1790 would have amended this section but was stricken out by section 10221(b)(4) of Pub. L. 111–148. AMENDMENTS 2010—Subsec. (e)(1)(A). Pub. L. 111–148, § 2902(a), sub- stituted ‘‘on or after’’ for ‘‘during the 5-year period be- ginning on’’. 2003—Subsec. (e)(1)(A). Pub. L. 108–173 inserted ‘‘(and for items and services furnished during the 5-year pe- riod beginning on January 1, 2005, all items and serv- ices for which payment may be made under part B)’’ after ‘‘for services described in paragraph (2)’’. 2000—Subsec. (e). Pub. L. 106–554, § 1(a)(6) [title IV, § 432(a)(2)], added subsec. (e). Former subsec. (e) redesig- nated (f). Pub. L. 106–417 added subsec. (e). Subsec. (f). Pub. L. 106–554, § 1(a)(6) [title IV, § 432(a)(1)], redesignated subsec. (e) as (f). 1992—Subsec. (d). Pub. L. 102–573 made technical amendment to the reference to section 1671 of title 25 to reflect renumbering of corresponding section of original act. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2010 AMENDMENT Pub. L. 111–148, title II, § 2902(b), Mar. 23, 2010, 124 Stat. 333, provided that: ‘‘The amendments made by this section [amending this section] shall apply to items or services furnished on or after January 1, 2010.’’ EFFECTIVE DATE OF 2000 AMENDMENT Amendment by section 1(a)(6) [title IV, § 432(a)] of Pub. L. 106–554 applicable to services furnished on or after July 1, 2001, see section 1(a)(6) [title IV, § 432(c)] of Pub. L. 106–554, set out as a note under section 1395u of this title. Amendment by Pub. L. 106–417 effective Oct. 1, 2000, see section 3(c) of Pub. L. 106–417, set out as a note under section 1645 of Title 25, Indians. MEDICARE PAYMENTS NOT CONSIDERED IN DETERMINING APPROPRIATIONS FOR INDIAN HEALTH CARE Pub. L. 94–437, title IV, § 401(c), Sept. 30, 1976, 90 Stat. 1409, provided that any payments received for services provided to beneficiaries under this section were not to be considered in determining appropriations for health care and services to Indians, prior to the general amendment of section 401 of Pub. L. 94–437 by Pub. L. 102–573, title IV, § 401(a), Oct. 29, 1992, 106 Stat. 4565. Similar provisions are contained in section 401(a) of Pub. L. 94–437, which is classified to section 1641(a) of Title 25, Indians. PREFERENCE IN SERVICES FOR INDIANS WITH MEDICARE COVERAGE NOT AUTHORIZED Pub. L. 94–437, title IV, § 401(d), Sept. 30, 1976, 90 Stat. 1409, which provided that nothing in this section au- thorized the Secretary to provide services to an Indian beneficiary with coverage under this subchapter, in preference to an Indian beneficiary without such cov- erage, prior to the general amendment of section 401 of Pub. L. 94–437 by Pub. L. 102–573, title IV, § 401(a), Oct. 29, 1992, 106 Stat. 4565. Similar provisions are contained in section 401(b) of Pub. L. 94–437, which is classified to section 1641(b) of Title 25, Indians. § 1395rr. End stage renal disease program (a) Type, duration, and scope of benefits The benefits provided by parts A and B of this subchapter shall include benefits for individuals who have been determined to have end stage renal disease as provided in section 426–1 of this title, and benefits for kidney donors as provided in subsection (d) of this section. Notwith- standing any other provision of this subchapter, the type, duration, and scope of the benefit pro- vided by parts A and B with respect to individ- uals who have been determined to have end stage renal disease and who are entitled to such benefits without regard to section 426–1 of this title shall in no case be less than the type, dura- tion, and scope of the benefits so provided for in- dividuals entitled to such benefits solely by rea- son of that section. Page 3754 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr 1 See References in Text note below. (b) Payments with respect to services; dialysis; regulations; physicians’ services; target reim- bursement rates; home dialysis supplies and equipment; self-care home dialysis support services; self-care dialysis units; hepatitis B vaccine (1) Payments under this subchapter with re- spect to services, in addition to services for which payment would otherwise be made under this subchapter, furnished to individuals who have been determined to have end stage renal disease shall include (A) payments on behalf of such individuals to providers of services and renal dialysis facilities which meet such re- quirements as the Secretary shall by regulation prescribe for institutional dialysis services and supplies (including self-dialysis services in a self-care dialysis unit maintained by the pro- vider or facility), transplantation services, self- care home dialysis support services which are furnished by the provider or facility, and rou- tine professional services performed by a physi- cian during a maintenance dialysis episode if payments for his other professional services fur- nished to an individual who has end stage renal disease are made on the basis specified in para- graph (3)(A)(i) of this subsection, (B) payments to or on behalf of such individuals for home di- alysis supplies and equipment, and (C) payments to a supplier of home dialysis supplies and equipment that is not a provider of services, a renal dialysis facility, or a physician for self-ad- ministered erythropoietin as described in sec- tion 1395x(s)(2)(P) 1 of this title if the Secretary finds that the patient receiving such drug from such a supplier can safely and effectively admin- ister the drug (in accordance with the applicable methods and standards established by the Sec- retary pursuant to such section). The require- ments prescribed by the Secretary under sub- paragraph (A) shall include requirements for a minimum utilization rate for transplantations. Beginning 180 days after February 9, 2018, an ini- tial survey of a provider of services or a renal di- alysis facility to determine if the conditions and requirements under this paragraph are met shall be initiated not later than 90 days after such date on which both the provider enrollment form (without regard to whether such form is submitted prior to or after such date of enact- ment) has been determined by the Secretary to be complete and the provider’s enrollment sta- tus indicates approval is pending the results of such survey. (2)(A) With respect to payments for dialysis services furnished by providers of services and renal dialysis facilities to individuals deter- mined to have end stage renal disease for which payments may be made under part B of this sub- chapter, such payments (unless otherwise pro- vided in this section) shall be equal to 80 percent of the amounts determined in accordance with subparagraph (B); and with respect to payments for services for which payments may be made under part A of this subchapter, the amounts of such payments (which amounts shall not exceed, in respect to costs in procuring organs attrib- utable to payments made to an organ procure- ment agency or histocompatibility laboratory, the costs incurred by that agency or laboratory) shall be determined in accordance with section 1395x(v) of this title or section 1395ww of this title (if applicable). Payments shall be made to a renal dialysis facility only if it agrees to ac- cept such payments as payment in full for cov- ered services, except for payment by the indi- vidual of 20 percent of the estimated amounts for such services calculated on the basis estab- lished by the Secretary under subparagraph (B) and the deductible amount imposed by section 1395l(b) of this title. (B) The Secretary shall prescribe in regula- tions any methods and procedures to (i) deter- mine the costs incurred by providers of services and renal dialysis facilities in furnishing cov- ered services to individuals determined to have end stage renal disease, and (ii) determine, on a cost-related basis or other economical and equi- table basis (including any basis authorized under section 1395x(v) of this title) and con- sistent with any regulations promulgated under paragraph (7), the amounts of payments to be made for part B services furnished by such pro- viders and facilities to such individuals. (C) Such regulations, in the case of services furnished by proprietary providers and facilities (other than hospital outpatient departments) may include, if the Secretary finds it feasible and appropriate, provision for recognition of a reasonable rate of return on equity capital, pro- viding such rate of return does not exceed the rate of return stipulated in section 1395x(v)(1)(B) of this title. (D) For purposes of section 1395oo of this title, a renal dialysis facility shall be treated as a pro- vider of services. (3)(A) With respect to payments for physi- cians’ services furnished to individuals deter- mined to have end stage renal disease, the Sec- retary shall pay 80 percent of the amounts cal- culated for such services— (i) on a reasonable charge basis (but may, in such case, make payment on the basis of the prevailing charges of other physicians for comparable services or, for services furnished on or after January 1, 1992, on the basis de- scribed in section 1395w–4 of this title) except that payment may not be made under this sub- paragraph for routine services furnished dur- ing a maintenance dialysis episode, or (ii) subject to subparagraph (B), on a com- prehensive monthly fee or other basis (which effectively encourages the efficient delivery of dialysis services and provides incentives for the increased use of home dialysis) for an ag- gregate of services provided over a period of time (as defined in regulations). (B)(i) For purposes of subparagraph (A)(ii), subject to clauses (ii) and (iii), an individual de- termined to have end stage renal disease receiv- ing home dialysis may choose to receive month- ly end stage renal disease-related clinical as- sessments furnished on or after January 1, 2019, via telehealth. (ii) Except as provided in clause (iii), clause (i) shall apply to an individual only if the indi- vidual receives a face-to-face clinical assess- ment, without the use of telehealth— (I) in the case of the initial 3 months of home dialysis of such individual, at least monthly; and Page 3755 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr (II) after such initial 3 months, at least once every 3 consecutive months. (iii) The Secretary may waive the provisions of clause (ii) during the emergency period de- scribed in section 1320b–5(g)(1)(B) of this title. (4)(A) Pursuant to agreements with approved providers of services and renal dialysis facili- ties, the Secretary may make payments to such providers and facilities for the cost of home di- alysis supplies and equipment and self-care home dialysis support services furnished to pa- tients whose self-care home dialysis is under the direct supervision of such provider or facility, on the basis of a target reimbursement rate (as defined in paragraph (6)) or on the basis of a method established under paragraph (7). (B) The Secretary shall make payments to a supplier of home dialysis supplies and equip- ment furnished to a patient whose self-care home dialysis is not under the direct supervision of an approved provider of services or renal di- alysis facility only in accordance with a written agreement under which— (i) the patient certifies that the supplier is the sole provider of such supplies and equip- ment to the patient, (ii) the supplier agrees to receive payment for the cost of such supplies and equipment only on an assignment-related basis, and (iii) the supplier certifies that it has entered into a written agreement with an approved provider of services or renal dialysis facility under which such provider or facility agrees to furnish to such patient all self-care home di- alysis support services and all other necessary dialysis services and supplies, including insti- tutional dialysis services and supplies and emergency services. (5) An agreement under paragraph (4) shall re- quire, in accordance with regulations prescribed by the Secretary, that the provider or facility will— (A) assume full responsibility for directly obtaining or arranging for the provision of— (i) such medically necessary dialysis equipment as is prescribed by the attending physician; (ii) dialysis equipment maintenance and repair services; (iii) the purchase and delivery of all nec- essary medical supplies; and (iv) where necessary, the services of trained home dialysis aides; (B) perform all such administrative func- tions and maintain such information and rec- ords as the Secretary may require to verify the transactions and arrangements described in subparagraph (A); (C) submit such cost reports, data, and infor- mation as the Secretary may require with re- spect to the costs incurred for equipment, sup- plies, and services furnished to the facility’s home dialysis patient population; and (D) provide for full access for the Secretary to all such records, data, and information as he may require to perform his functions under this section. (6) The Secretary shall establish, for each cal- endar year, commencing with January 1, 1979, a target reimbursement rate for home dialysis which shall be adjusted for regional variations in the cost of providing home dialysis. In estab- lishing such a rate, the Secretary shall include— (A) the Secretary’s estimate of the cost of providing medically necessary home dialysis supplies and equipment; (B) an allowance, in an amount determined by the Secretary, to cover the cost of pro- viding personnel to aid in home dialysis; and (C) an allowance, in an amount determined by the Secretary, to cover administrative costs and to provide an incentive for the effi- cient delivery of home dialysis; but in no event (except as may be provided in regulations under paragraph (7)) shall such tar- get rate exceed 75 percent of the national aver- age payment, adjusted for regional variations, for maintenance dialysis services furnished in approved providers and facilities during the pre- ceding fiscal year. Any such target rate so es- tablished shall be utilized, without renegoti- ation of the rate, throughout the calendar year for which it is established. During the last quar- ter of each calendar year, the Secretary shall es- tablish a home dialysis target reimbursement rate for the next calendar year based on the most recent data available to the Secretary at the time. In establishing any rate under this paragraph, the Secretary may utilize a competi- tive-bid procedure, a prenegotiated rate proce- dure, or any other procedure (including methods established under paragraph (7)) which the Sec- retary determines is appropriate and feasible in order to carry out this paragraph in an effective and efficient manner. (7) Subject to paragraph (12), the Secretary shall provide by regulation for a method (or methods) for determining prospectively the amounts of payments to be made for dialysis services furnished by providers of services and renal dialysis facilities to individuals in a facil- ity and to such individuals at home. Such meth- od (or methods) shall provide for the prospective determination of a rate (or rates) for each mode of care based on a single composite weighted for- mula (which takes into account the mix of pa- tients who receive dialysis services at a facility or at home and the relative costs of providing such services in such settings) for hospital-based facilities and such a single composite weighted formula for other renal dialysis facilities, or based on such other method or combination of methods which differentiate between hospital- based facilities and other renal dialysis facili- ties and which the Secretary determines, after detailed analysis, will more effectively encour- age the more efficient delivery of dialysis serv- ices and will provide greater incentives for in- creased use of home dialysis than through the single composite weighted formulas. The amount of a payment made under any method other than a method based on a single composite weighted formula may not exceed the amount (or, in the case of continuous cycling peritoneal dialysis, 130 percent of the amount) of the me- dian payment that would have been made under the formula for hospital-based facilities. Subject to section 422(a)(2) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protec- tion Act of 2000, the Secretary shall provide for Page 3756 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr such exceptions to such methods as may be war- ranted by unusual circumstances (including the special circumstances of sole facilities located in isolated, rural areas and of pediatric facili- ties). Each application for such an exception shall be deemed to be approved unless the Sec- retary disapproves it by not later than 60 work- ing days after the date the application is filed. The Secretary may provide that such method will serve in lieu of any target reimbursement rate that would otherwise be established under paragraph (6). The Secretary shall reduce the amount of each composite rate payment under this paragraph for each treatment by 50 cents (subject to such adjustments as may be required to reflect modes of dialysis other than hemo- dialysis) and provide for payment of such amount to the organizations (designated under subsection (c)(1)(A)) for such organizations’ nec- essary and proper administrative costs incurred in carrying out the responsibilities described in subsection (c)(2). The Secretary shall provide that amounts paid under the previous sentence shall be distributed to the organizations de- scribed in subsection (c)(1)(A) to ensure equi- table treatment of all such network organiza- tions. The Secretary in distributing any such payments to network organizations shall take into account— (A) the geographic size of the network area; (B) the number of providers of end stage renal disease services in the network area; (C) the number of individuals who are enti- tled to end stage renal disease services in the network area; and (D) the proportion of the aggregate adminis- trative funds collected in the network area. The Secretary shall increase the amount of each composite rate payment for dialysis services furnished during 2000 by 1.2 percent above such composite rate payment amounts for such serv- ices furnished on December 31, 1999, for such services furnished on or after January 1, 2001, and before January 1, 2005, by 2.4 percent above such composite rate payment amounts for such services furnished on December 31, 2000, and for such services furnished on or after January 1, 2005, by 1.6 percent above such composite rate payment amounts for such services furnished on December 31, 2004. (8) For purposes of this subchapter, the term ‘‘home dialysis supplies and equipment’’ means medically necessary supplies and equipment (in- cluding supportive equipment) required by an individual suffering from end stage renal disease in connection with renal dialysis carried out in his home (as defined in regulations), including obtaining, installing, and maintaining such equipment. (9) For purposes of this subchapter, the term ‘‘self-care home dialysis support services’’, to the extent permitted in regulation, means— (A) periodic monitoring of the patient’s home adaptation, including visits by qualified provider or facility personnel (as defined in regulations), so long as this is done in accord- ance with a plan prepared and periodically re- viewed by a professional team (as defined in regulations) including the individual’s physi- cian; (B) installation and maintenance of dialysis equipment; (C) testing and appropriate treatment of the water; and (D) such additional supportive services as the Secretary finds appropriate and desirable. (10) For purposes of this subchapter, the term ‘‘self-care dialysis unit’’ means a renal dialysis facility or a distinct part of such facility or of a provider of services, which has been approved by the Secretary to make self-dialysis services, as defined by the Secretary in regulations, available to individuals who have been trained for self-dialysis. A self-care dialysis unit must, at a minimum, furnish the services, equipment and supplies needed for self-care dialysis, have patient-staff ratios which are appropriate to self-dialysis (allowing for such appropriate less- er degree of ongoing medical supervision and as- sistance of ancillary personnel than is required for full care maintenance dialysis), and meet such other requirements as the Secretary may prescribe with respect to the quality and cost-ef- fectiveness of services. (11)(A) Hepatitis B vaccine and its administra- tion, when provided to a patient determined to have end stage renal disease, shall not be in- cluded as dialysis services for purposes of pay- ment under any prospective payment amount or comprehensive fee established under this sec- tion. Payment for such vaccine and its adminis- tration shall be made separately in accordance with section 1395l of this title. (B) Erythropoietin, when provided to a patient determined to have end stage renal disease, shall not be included as a dialysis service for purposes of payment under any prospective pay- ment amount or comprehensive fee established under this section, and subject to paragraphs (12) and (13) payment for such item shall be made separately— (i) in the case of erythropoietin provided by a physician, in accordance with section 1395l of this title; and (ii) in the case of erythropoietin provided by a provider of services, renal dialysis facility, or other supplier of home dialysis supplies and equipment— (I) for erythropoietin provided during 1994, in an amount equal to $10 per thousand units (rounded to the nearest 100 units), and (II) for erythropoietin provided during a subsequent year, in an amount determined to be appropriate by the Secretary, except that such amount may not exceed the amount determined under this clause for the previous year increased by the percentage increase (if any) in the implicit price deflator for gross national product (as pub- lished by the Department of Commerce) for the second quarter of the preceding year over the implicit price deflator for the sec- ond quarter of the second preceding year. (C) The amount payable to a supplier of home dialysis supplies and equipment that is not a provider of services, a renal dialysis facility, or a physician for erythropoietin shall be deter- mined in the same manner as the amount pay- able to a renal dialysis facility for such item. (12)(A) Subject to paragraph (14), in lieu of payment under paragraph (7) beginning with services furnished on January 1, 2005, the Sec- Page 3757 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr retary shall establish a basic case-mix adjusted prospective payment system for dialysis services furnished by providers of services and renal di- alysis facilities in a year to individuals in a fa- cility and to such individuals at home. The case- mix under such system shall be for a limited number of patient characteristics. Under such system, the payment rate for dialysis services furnished on or after January 1, 2009, by pro- viders of services shall be the same as the pay- ment rate (computed without regard to this sen- tence) for such services furnished by renal dialy- sis facilities, and in applying the geographic index under subparagraph (D) to providers of services, the labor share shall be based on the labor share otherwise applied for renal dialysis facilities. (B) The system described in subparagraph (A) shall include— (i) the services comprising the composite rate established under paragraph (7); and (ii) the difference between payment amounts under this subchapter for separately billed drugs and biologicals (including erythro- poietin) and acquisition costs of such drugs and biologicals, as determined by the Inspec- tor General reports to the Secretary as re- quired by section 623(c) of the Medicare Pre- scription Drug, Improvement, and Moderniza- tion Act of 2003— (I) beginning with 2005, for such drugs and biologicals for which a billing code exists prior to January 1, 2004; and (II) beginning with 2007, for such drugs and biologicals for which a billing code does not exist prior to January 1, 2004, adjusted to 2005, or 2007, respectively, as deter- mined to be appropriate by the Secretary. (C)(i) In applying subparagraph (B)(ii) for 2005, such payment amounts under this subchapter shall be determined using the methodology spec- ified in paragraph (13)(A)(i). (ii) For 2006, the Secretary shall provide for an adjustment to the payments under clause (i) to reflect the difference between the payment amounts using the methodology under para- graph (13)(A)(i) and the payment amount deter- mined using the methodology applied by the Secretary under paragraph (13)(A)(iii) of such paragraph, as estimated by the Secretary. (D) The Secretary shall adjust the payment rates under such system by a geographic index as the Secretary determines to be appropriate. If the Secretary applies a geographic index under this paragraph that differs from the index ap- plied under paragraph (7) the Secretary shall phase-in the application of the index under this paragraph over a multiyear period. (E)(i) Such system shall be designed to result in the same aggregate amount of expenditures for such services, as estimated by the Secretary, as would have been made for 2005 if this para- graph did not apply. (ii) The adjustment made under subparagraph (B)(ii)(II) shall be done in a manner to result in the same aggregate amount of expenditures after such adjustment as would otherwise have been made for such services for 2006 or 2007, re- spectively, as estimated by the Secretary, if this paragraph did not apply. (F) Beginning with 2006, the Secretary shall annually increase the basic case-mix adjusted payment amounts established under this para- graph, by an amount determined by— (i) applying the estimated growth in expend- itures for drugs and biologicals (including erythropoietin) that are separately billable to the component of the basic case-mix adjusted system described in subparagraph (B)(ii); and (ii) converting the amount determined in clause (i) to an increase applicable to the basic case-mix adjusted payment amounts estab- lished under subparagraph (B). Except as provided in subparagraph (G), nothing in this paragraph or paragraph (14) shall be con- strued as providing for an update to the com- posite rate component of the basic case-mix ad- justed system under subparagraph (B) or under the system under paragraph (14). (G) The Secretary shall increase the amount of the composite rate component of the basic case-mix adjusted system under subparagraph (B) for dialysis services— (i) furnished on or after January 1, 2006, and before April 1, 2007, by 1.6 percent above the amount of such composite rate component for such services furnished on December 31, 2005; (ii) furnished on or after April 1, 2007, and be- fore January 1, 2009, by 1.6 percent above the amount of such composite rate component for such services furnished on March 31, 2007; (iii) furnished on or after January 1, 2009, and before January 1, 2010, by 1.0 percent above the amount of such composite rate com- ponent for such services furnished on Decem- ber 31, 2008; and (iv) furnished on or after January 1, 2010, by 1.0 percent above the amount of such com- posite rate component for such services fur- nished on December 31, 2009. (H) There shall be no administrative or judi- cial review under section 1395ff of this title, sec- tion 1395oo of this title, or otherwise, of the case-mix system, relative weights, payment amounts, the geographic adjustment factor, or the update for the system established under this paragraph, or the determination of the dif- ference between medicare payment amounts and acquisition costs for separately billed drugs and biologicals (including erythropoietin) under this paragraph and paragraph (13). (13)(A) Subject to paragraph (14), the payment amounts under this subchapter for separately billed drugs and biologicals furnished in a year, beginning with 2004, are as follows: (i) For such drugs and biologicals (other than erythropoietin) furnished in 2004, the amount determined under section 1395u(o)(1)(A)(v) of this title for the drug or bi- ological. (ii) For such drugs and biologicals (including erythropoietin) furnished in 2005, the acquisi- tion cost of the drug or biological, as deter- mined by the Inspector General reports to the Secretary as required by section 623(c) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Insofar as the Inspector General has not determined the ac- quisition cost with respect to a drug or bio- logical, the Secretary shall determine the pay- ment amount for such drug or biological. Page 3758 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr (iii) For such drugs and biologicals (includ- ing erythropoietin) furnished in 2006 and sub- sequent years, such acquisition cost or the amount determined under section 1395w–3a of this title for the drug or biological, as the Sec- retary may specify. (B) Drugs and biologicals (including erythro- poietin) which were separately billed under this subsection on the day before December 8, 2003, shall continue to be separately billed on and after such date, subject to paragraph (14). (14)(A)(i) Subject to subparagraph (E), for serv- ices furnished on or after January 1, 2011, the Secretary shall implement a payment system under which a single payment is made under this subchapter to a provider of services or a renal dialysis facility for renal dialysis services (as defined in subparagraph (B)) in lieu of any other payment (including a payment adjustment under paragraph (12)(B)(ii)) and for such services and items furnished pursuant to paragraph (4). (ii) In implementing the system under this paragraph the Secretary shall ensure that the estimated total amount of payments under this subchapter for 2011 for renal dialysis services shall equal 98 percent of the estimated total amount of payments for renal dialysis services, including payments under paragraph (12)(B)(ii), that would have been made under this sub- chapter with respect to services furnished in 2011 if such system had not been implemented. In making the estimation under subclause (I), the Secretary shall use per patient utilization data from 2007, 2008, or 2009, whichever has the lowest per patient utilization. (B) For purposes of this paragraph, the term ‘‘renal dialysis services’’ includes— (i) items and services included in the com- posite rate for renal dialysis services as of De- cember 31, 2010; (ii) erythropoiesis stimulating agents and any oral form of such agents that are fur- nished to individuals for the treatment of end stage renal disease; (iii) other drugs and biologicals that are fur- nished to individuals for the treatment of end stage renal disease and for which payment was (before the application of this paragraph) made separately under this subchapter, and any oral equivalent form of such drug or bio- logical; and (iv) diagnostic laboratory tests and other items and services not described in clause (i) that are furnished to individuals for the treat- ment of end stage renal disease. Such term does not include vaccines. (C) The system under this paragraph may pro- vide for payment on the basis of services fur- nished during a week or month or such other ap- propriate unit of payment as the Secretary specifies. (D) Such system— (i) shall include a payment adjustment based on case mix that may take into account pa- tient weight, body mass index, comorbidities, length of time on dialysis, age, race, ethnicity, and other appropriate factors; (ii) shall include a payment adjustment for high cost outliers due to unusual variations in the type or amount of medically necessary care, including variations in the amount of erythropoiesis stimulating agents necessary for anemia management; (iii) shall include a payment adjustment that reflects the extent to which costs in- curred by low-volume facilities (as defined by the Secretary) in furnishing renal dialysis services exceed the costs incurred by other fa- cilities in furnishing such services, and for payment for renal dialysis services furnished on or after January 1, 2011, and before January 1, 2014, such payment adjustment shall not be less than 10 percent; and (iv) may include such other payment adjust- ments as the Secretary determines appro- priate, such as a payment adjustment— (I) for pediatric providers of services and renal dialysis facilities; (II) by a geographic index, such as the index referred to in paragraph (12)(D), as the Secretary determines to be appropriate; and (III) for providers of services or renal di- alysis facilities located in rural areas. The Secretary shall take into consideration the unique treatment needs of children and young adults in establishing such system. (E)(i) The Secretary shall provide for a four- year phase-in (in equal increments) of the pay- ment amount under the payment system under this paragraph, with such payment amount being fully implemented for renal dialysis serv- ices furnished on or after January 1, 2014. (ii) A provider of services or renal dialysis fa- cility may make a one-time election to be ex- cluded from the phase-in under clause (i) and be paid entirely based on the payment amount under the payment system under this paragraph. Such an election shall be made prior to January 1, 2011, in a form and manner specified by the Secretary, and is final and may not be re- scinded. (iii) The Secretary shall make an adjustment to the payments under this paragraph for years during which the phase-in under clause (i) is ap- plicable so that the estimated total amount of payments under this paragraph, including pay- ments under this subparagraph, shall equal the estimated total amount of payments that would otherwise occur under this paragraph without such phase-in. (F)(i)(I) Subject to subclauses (II) and (III) and clause (ii), beginning in 2012, the Secretary shall annually increase payment amounts established under this paragraph by an ESRD market bas- ket percentage increase factor for a bundled payment system for renal dialysis services that reflects changes over time in the prices of an ap- propriate mix of goods and services included in renal dialysis services. In order to accomplish the purposes of subparagraph (I) with respect to 2016, 2017, and 2018, after determining the in- crease factor described in the preceding sentence for each of 2016, 2017, and 2018, the Secretary shall reduce such increase factor by 1.25 percent- age points for each of 2016 and 2017 and by 1 per- centage point for 2018. (II) Subject to subclause (III), for 2012 and each subsequent year, after determining the increase factor described in subclause (I), the Secretary shall reduce such increase factor by the produc- tivity adjustment described in section Page 3759 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr 2 So in original. Probably should be ‘‘biologicals’’. 1395ww(b)(3)(B)(xi)(II) of this title. The applica- tion of the preceding sentence may result in such increase factor being less than 0.0 for a year, and may result in payment rates under the payment system under this paragraph for a year being less than such payment rates for the pre- ceding year. (III) Notwithstanding subclauses (I) and (II), in order to accomplish the purposes of subpara- graph (I) with respect to 2015, the increase factor described in subclause (I) for 2015 shall be 0.0 percent pursuant to the regulation issued by the Secretary on December 2, 2013, entitled ‘‘Medi- care Program; End-Stage Renal Disease Pro- spective Payment System, Quality Incentive Program, and Durable Medical Equipment, Pros- thetics, Orthotics, and Supplies; Final Rule’’ (78 Fed. Reg. 72156). (ii) For years during which a phase-in of the payment system pursuant to subparagraph (E) is applicable, the following rules shall apply to the portion of the payment under the system that is based on the payment of the composite rate that would otherwise apply if the system under this paragraph had not been enacted: (I) The update under clause (i) shall not apply. (II) Subject to clause (i)(II), the Secretary shall annually increase such composite rate by the ESRD market basket percentage increase factor described in clause (i)(I). (G) There shall be no administrative or judi- cial review under section 1395ff of this title, sec- tion 1395oo of this title, or otherwise of the de- termination of payment amounts under subpara- graph (A), the establishment of an appropriate unit of payment under subparagraph (C), the identification of renal dialysis services included in the bundled payment, the adjustments under subparagraph (D), the application of the phase- in under subparagraph (E), and the establish- ment of the market basket percentage increase factors under subparagraph (F). (H) Erythropoiesis stimulating agents and other drugs and biologicals shall be treated as prescribed and dispensed or administered and available only under part B if they are— (i) furnished to an individual for the treat- ment of end stage renal disease; and (ii) included in subparagraph (B) for pur- poses of payment under this paragraph. (I) For services furnished on or after January 1, 2014, and before January 1, 2015, the Secretary shall, by comparing per patient utilization data from 2007 with such data from 2012, make reduc- tions to the single payment that would other- wise apply under this paragraph for renal dialy- sis services to reflect the Secretary’s estimate of the change in the utilization of drugs and biologicals described in clauses (ii), (iii), and (iv) of subparagraph (B) (other than oral-only ESRD- related drugs, as such term is used in the final rule promulgated by the Secretary in the Fed- eral Register on August 12, 2010 (75 Fed. Reg. 49030)). In making reductions under the pre- ceding sentence, the Secretary shall take into account the most recently available data on av- erage sales prices and changes in prices for drugs and biological 2 reflected in the ESRD market basket percentage increase factor under subparagraph (F). (c) Renal disease network areas; coordinating councils, executive committees, and medical review boards; national end stage renal dis- ease medical information system; functions of network organizations (1)(A)(i) For the purpose of assuring effective and efficient administration of the benefits pro- vided under this section, the Secretary shall, in accordance with such criteria as he finds nec- essary to assure the performance of the respon- sibilities and functions specified in paragraph (2)— (I) establish at least 17 end stage renal dis- ease network areas, and (II) for each such area, designate a network administrative organization which, in accord- ance with regulations of the Secretary, shall establish (aa) a network council of renal dialy- sis and transplant facilities located in the area and (bb) a medical review board, which has a membership including at least one patient rep- resentative and physicians, nurses, and social workers engaged in treatment relating to end stage renal disease. The Secretary shall publish in the Federal Reg- ister a description of the geographic area that he determines, after consultation with appro- priate professional and patient organizations, constitutes each network area and the criteria on the basis of which such determination is made. (ii)(I) In order to determine whether the Sec- retary should enter into, continue, or terminate an agreement with a network administrative or- ganization designated for an area established under clause (i), the Secretary shall develop and publish in the Federal Register standards, cri- teria, and procedures to evaluate an applicant organization’s capabilities to perform (and, in the case of an organization with which such an agreement is in effect, actual performance of) the responsibilities described in paragraph (2). The Secretary shall evaluate each applicant based on quality and scope of services and may not accord more than 20 percent of the weight of the evaluation to the element of price. (II) An agreement with a network administra- tive organization may be terminated by the Sec- retary only if he finds, after applying such standards and criteria, that the organization has failed to perform its prescribed responsibilities effectively and efficiently. If such an agreement is to be terminated, the Secretary shall select a successor to the agreement on the basis of com- petitive bidding and in a manner that provides an orderly transition. (B) At least one patient representative shall serve as a member of each network council and each medical review board. (C) The Secretary shall, in regulations, pre- scribe requirements with respect to membership in network organizations by individuals (and the relatives of such individuals) (i) who have an ownership or control interest in a facility or provider which furnishes services referred to in section 1395x(s)(2)(F) of this title, or (ii) who have received remuneration from any such facil- ity or provider in excess of such amounts as con- Page 3760 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr stitute reasonable compensation for services (in- cluding time and effort relative to the provision of professional medical services) or goods sup- plied to such facility or provider; and such re- quirements shall provide for the definition, dis- closure, and, to the maximum extent consistent with effective administration, prevention of po- tential or actual financial or professional con- flicts of interest with respect to decisions con- cerning the appropriateness, nature, or site of patient care. (2) The network organizations of each network shall be responsible, in addition to such other duties and functions as may be prescribed by the Secretary, for— (A) encouraging, consistent with sound med- ical practice, the use of those treatment set- tings most compatible with the successful re- habilitation of the patient and the participa- tion of patients, providers of services, and renal disease facilities in vocational rehabili- tation programs; (B) developing criteria and standards relat- ing to the quality and appropriateness of pa- tient care and with respect to working with patients, facilities, and providers in encour- aging participation in vocational rehabilita- tion programs; and network goals with respect to the placement of patients in self-care set- tings and undergoing or preparing for trans- plantation; (C) evaluating the procedure by which facili- ties and providers in the network assess the appropriateness of patients for proposed treat- ment modalities; (D) implementing a procedure for evaluating and resolving patient grievances; (E) conducting on-site reviews of facilities and providers as necessary (as determined by a medical review board or the Secretary), uti- lizing standards of care established by the net- work organization to assure proper medical care; (F) collecting, validating, and analyzing such data as are necessary to prepare the re- ports required by subparagraph (H) and to as- sure the maintenance of the registry estab- lished under paragraph (7); (G) identifying facilities and providers that are not cooperating toward meeting network goals and assisting such facilities and pro- viders in developing appropriate plans for cor- rection and reporting to the Secretary on fa- cilities and providers that are not providing appropriate medical care; and (H) submitting an annual report to the Sec- retary on July 1 of each year which shall in- clude a full statement of the network’s goals, data on the network’s performance in meeting its goals (including data on the comparative performance of facilities and providers with respect to the identification and placement of suitable candidates in self-care settings and transplantation and encouraging participation in vocational rehabilitation programs), identi- fication of those facilities that have consist- ently failed to cooperate with network goals, and recommendations with respect to the need for additional or alternative services or facili- ties in the network in order to meet the net- work goals, including self-dialysis training, transplantation, and organ procurement facili- ties. (3) Where the Secretary determines, on the basis of the data contained in the network’s an- nual report and such other relevant data as may be available to him, that a facility or provider has consistently failed to cooperate with net- work plans and goals or to follow the rec- ommendations of the medical review board, he may terminate or withhold certification of such facility or provider (for purposes of payment for services furnished to individuals with end stage renal disease) until he determines that such pro- vider or facility is making reasonable and appro- priate efforts to cooperate with the network’s plans and goals. If the Secretary determines that the facility’s or provider’s failure to co- operate with network plans and goals does not jeopardize patient health or safety or justify termination of certification, he may instead, after reasonable notice to the provider or facil- ity and to the public, impose such other sanc- tions as he determines to be appropriate, which sanctions may include denial of reimbursement with respect to some or all patients admitted to the facility after the date of notice to the facil- ity or provider, and graduated reduction in re- imbursement for all patients. (4) The Secretary shall, in determining wheth- er to certify additional facilities or expansion of existing facilities within a network, take into account the network’s goals and performance as reflected in the network’s annual report. (5) The Secretary, after consultation with ap- propriate professional and planning organiza- tions, shall provide such guidelines with respect to the planning and delivery of renal disease services as are necessary to assist network orga- nizations in their development of their respec- tive networks’ goals to promote the optimum use of self-dialysis and transplantation by suit- able candidates for such modalities. (6) It is the intent of the Congress that the maximum practical number of patients who are medically, socially, and psychologically suitable candidates for home dialysis or transplantation should be so treated and that the maximum practical number of patients who are suitable candidates for vocational rehabilitation services be given access to such services and encouraged to return to gainful employment. The Secretary shall consult with appropriate professional and network organizations and consider available evidence relating to developments in research, treatment methods, and technology for home di- alysis and transplantation. (7) The Secretary shall establish a national end stage renal disease registry the purpose of which shall be to assemble and analyze the data reported by network organizations, transplant centers, and other sources on all end stage renal disease patients in a manner that will permit— (A) the preparation of the annual report to the Congress required under subsection (g); 1 (B) an identification of the economic im- pact, cost-effectiveness, and medical efficacy of alternative modalities of treatment; (C) an evaluation with respect to the most appropriate allocation of resources for the treatment and research into the cause of end stage renal disease; Page 3761 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr (D) the determination of patient mortality and morbidity rates, and trends in such rates, and other indices of quality of care; and (E) such other analyses relating to the treat- ment and management of end stage renal dis- ease as will assist the Congress in evaluating the end stage renal disease program under this section. The Secretary shall provide for such coordina- tion of data collection activities, and such con- solidation of existing end stage renal disease data systems, as is necessary to achieve the pur- pose of such registry, shall determine the appro- priate location of the registry, and shall provide for the appointment of a professional advisory group to assist the Secretary in the formulation of policies and procedures relevant to the man- agement of such registry. (8) The provisions of sections 1320c–6 and 1320c–9 of this title shall apply with respect to network administrative organizations (including such organizations as medical review boards) with which the Secretary has entered into agreements under this subsection. (d) Donors of kidney for transplant surgery Notwithstanding any provision to the con- trary in section 426 of this title any individual who donates a kidney for transplant surgery shall be entitled to benefits under parts A and B of this subchapter with respect to such dona- tion. Reimbursement for the reasonable ex- penses incurred by such an individual with re- spect to a kidney donation shall be made (with- out regard to the deductible, premium, and coin- surance provisions of this subchapter), in such manner as may be prescribed by the Secretary in regulations, for all reasonable preparatory, operation, and postoperation recovery expenses associated with such donation, including but not limited to the expenses for which payment could be made if he were an eligible individual for pur- poses of parts A and B of this subchapter with- out regard to this subsection. Payments for postoperation recovery expenses shall be limited to the actual period of recovery. (e) Reimbursement of providers, facilities, and nonprofit entities for costs of artificial kid- ney and automated dialysis peritoneal ma- chines for home dialysis (1) Notwithstanding any other provision of this subchapter, the Secretary may, pursuant to agreements with approved providers of services, renal dialysis facilities, and nonprofit entities which the Secretary finds can furnish equipment economically and efficiently, reimburse such providers, facilities, and nonprofit entities (without regard to the deductible and coinsur- ance provisions of this subchapter) for the rea- sonable cost of the purchase, installation, main- tenance and reconditioning for subsequent use of artificial kidney and automated dialysis peri- toneal machines (including supportive equip- ment) which are to be used exclusively by enti- tled individuals dialyzing at home. (2) An agreement under this subsection shall require that the provider, facility, or other enti- ty will— (A) make the equipment available for use only by entitled individuals dialyzing at home; (B) recondition the equipment, as needed, for reuse by such individuals throughout the use- ful life of the equipment, including modifica- tion of the equipment consistent with ad- vances in research and technology; (C) provide for full access for the Secretary to all records and information relating to the purchase, maintenance, and use of the equip- ment; and (D) submit such reports, data, and informa- tion as the Secretary may require with respect to the cost, management, and use of the equip- ment. (3) For purposes of this section, the term ‘‘sup- portive equipment’’ includes blood pumps, hep- arin pumps, bubble detectors, other alarm sys- tems, and such other items as the Secretary may determine are medically necessary. (f) Experiments, studies, and pilot projects (1) The Secretary shall initiate and carry out, at selected locations in the United States, pilot projects under which financial assistance in the purchase of new or used durable medical equip- ment for renal dialysis is provided to individuals suffering from end stage renal disease at the time home dialysis is begun, with provision for a trial period to assure successful adaptation to home dialysis before the actual purchase of such equipment. (2) The Secretary shall conduct experiments to evaluate methods for reducing the costs of the end stage renal disease program. Such experi- ments shall include (without being limited to) reimbursement for nurses and dialysis techni- cians to assist with home dialysis, and reim- bursement to family members assisting with home dialysis. (3) The Secretary shall conduct experiments to evaluate methods of dietary control for reducing the costs of the end stage renal disease program, including (without being limited to) the use of protein-controlled products to delay the neces- sity for, or reduce the frequency of, dialysis in the treatment of end stage renal disease. (4) The Secretary shall conduct a comprehen- sive study of methods for increasing public par- ticipation in kidney donation and other organ donation programs. (5) The Secretary shall conduct a full and com- plete study of the reimbursement of physicians for services furnished to patients with end stage renal disease under this subchapter, giving par- ticular attention to the range of payments to physicians for such services, the average amounts of such payments, and the number of hours devoted to furnishing such services to pa- tients at home, in renal disease facilities, in hospitals, and elsewhere. (6) The Secretary shall conduct a study of the number of patients with end stage renal disease who are not eligible for benefits with respect to such disease under this subchapter (by reason of this section or otherwise), and of the economic impact of such noneligibility of such individ- uals. Such study shall include consideration of mechanisms whereby governmental and other health plans might be instituted or modified to permit the purchase of actuarially sound cov- erage for the costs of end stage renal disease. (7)(A) The Secretary shall establish protocols on standards and conditions for the reuse of dia- Page 3762 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr lyzer filters for those facilities and providers which voluntarily elect to reuse such filters. (B) With respect to dialysis services furnished on or after January 1, 1988 (or July 1, 1988, with respect to protocols that relate to the reuse of bloodlines), no dialysis facility may reuse dialy- sis supplies (other than dialyzer filters) unless the Secretary has established a protocol with re- spect to the reuse of such supplies and the facil- ity follows the protocol so established. (C) The Secretary shall incorporate protocols established under this paragraph, and the re- quirement of subparagraph (B), into the require- ments for facilities prescribed under subsection (b)(1)(A) and failure to follow such a protocol or requirement subjects such a facility to denial of participation in the program established under this section and to denial of payment for dialy- sis treatment not furnished in compliance with such a protocol or in violation of such require- ment. (8) The Secretary shall submit to the Congress no later than October 1, 1979, a full report on the experiments conducted under paragraphs (1), (2), (3), and (7), and the studies under paragraphs (4), (5), (6), and (7). Such report shall include any recommendations for legislative changes which the Secretary finds necessary or desirable as a result of such experiments and studies. (g) Conditional approval of dialysis facilities; re- striction-of-payments notice to public and fa- cility; notice and hearing; judicial review (1) In any case where the Secretary— (A) finds that a renal dialysis facility is not in substantial compliance with requirements for such facilities prescribed under subsection (b)(1)(A), (B) finds that the facility’s deficiencies do not immediately jeopardize the health and safety of patients, and (C) has given the facility a reasonable oppor- tunity to correct its deficiencies, the Secretary may, in lieu of terminating ap- proval of the facility, determine that payment under this subchapter shall be made to the facil- ity only for services furnished to individuals who were patients of the facility before the ef- fective date of the notice. (2) The Secretary’s decision to restrict pay- ments under this subsection shall be made effec- tive only after such notice to the public and to the facility as may be prescribed in regulations, and shall remain in effect until (A) the Sec- retary finds that the facility is in substantial compliance with the requirements under sub- section (b)(1)(A), or (B) the Secretary terminates the agreement under this subchapter with the facility. (3) A facility dissatisfied with a determination by the Secretary under paragraph (1) shall be entitled to a hearing thereon by the Secretary (after reasonable notice) to the same extent as is provided in section 405(b) of this title, and to judicial review of the Secretary’s final decision after such hearing as is provided in section 405(g) of this title, except that, in so applying such sections and in applying section 405(l) of this title thereto, any reference therein to the Commissioner of Social Security or the Social Security Administration shall be considered a reference to the Secretary or the Department of Health and Human Services, respectively. (h) Quality incentives in the end-stage renal dis- ease program (1) Quality incentives (A) In general With respect to renal dialysis services (as defined in subsection (b)(14)(B)) furnished on or after January 1, 2012, in the case of a pro- vider of services or a renal dialysis facility that does not meet the requirement de- scribed in subparagraph (B) with respect to the year, payments otherwise made to such provider or facility under the system under subsection (b)(14) for such services shall be reduced by up to 2.0 percent, as determined appropriate by the Secretary. (B) Requirement The requirement described in this subpara- graph is that the provider or facility meets (or exceeds) the total performance score under paragraph (3) with respect to perform- ance standards established by the Secretary with respect to measures specified in para- graph (2). (C) No effect in subsequent years The reduction under subparagraph (A) shall apply only with respect to the year in- volved, and the Secretary shall not take into account such reduction in computing the single payment amount under the system under paragraph (14) in a subsequent year. (2) Measures (A) In general The measures specified under this para- graph with respect to the year involved shall include— (i) measures on anemia management that reflect the labeling approved by the Food and Drug Administration for such management and measures on dialysis ade- quacy; (ii) to the extent feasible, such measure (or measures) of patient satisfaction as the Secretary shall specify; (iii) for 2016 and subsequent years, meas- ures described in subparagraph (E)(i); and (iv) such other measures as the Sec- retary specifies, including, to the extent feasible, measures on— (I) iron management; (II) bone mineral metabolism; and (III) vascular access, including for maximizing the placement of arterial ve- nous fistula. (B) Use of endorsed measures (i) In general Subject to clause (ii), any measure speci- fied by the Secretary under subparagraph (A)(iv) must have been endorsed by the en- tity with a contract under section 1395aaa(a) of this title. (ii) Exception In the case of a specified area or medical topic determined appropriate by the Sec- retary for which a feasible and practical Page 3763 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr measure has not been endorsed by the enti- ty with a contract under section 1395aaa(a) of this title, the Secretary may specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. (C) Updating measures The Secretary shall establish a process for updating the measures specified under sub- paragraph (A) in consultation with inter- ested parties. (D) Consideration In specifying measures under subpara- graph (A), the Secretary shall consider the availability of measures that address the unique treatment needs of children and young adults with kidney failure. (E) Measures specific to the conditions treat- ed with oral-only drugs (i) In general The measures described in this subpara- graph are measures specified by the Sec- retary that are specific to the conditions treated with oral-only drugs. To the extent feasible, such measures shall be outcomes- based measures. (ii) Consultation In specifying the measures under clause (i), the Secretary shall consult with inter- ested stakeholders. (iii) Use of endorsed measures (I) In general Subject to subclause (I), any measures specified under clause (i) must have been endorsed by the entity with a contract under section 1395aaa(a) of this title. (II) Exception If the entity with a contract under sec- tion 1395aaa(a) of this title has not en- dorsed a measure for a specified area or topic related to measures described in clause (i) that the Secretary determines appropriate, the Secretary may specify a measure that is endorsed or adopted by a consensus organization recognized by the Secretary that has expertise in clinical guidelines for kidney disease. (3) Performance scores (A) Total performance score (i) In general Subject to clause (ii), the Secretary shall develop a methodology for assessing the total performance of each provider of serv- ices and renal dialysis facility based on performance standards with respect to the measures selected under paragraph (2) for a performance period established under paragraph (4)(D) (in this subsection re- ferred to as the ‘‘total performance score’’). (ii) Application For providers of services and renal dialy- sis facilities that do not meet (or exceed) the total performance score established by the Secretary, the Secretary shall ensure that the application of the methodology developed under clause (i) results in an ap- propriate distribution of reductions in payment under paragraph (1) among pro- viders and facilities achieving different levels of total performance scores, with providers and facilities achieving the low- est total performance scores receiving the largest reduction in payment under para- graph (1)(A). (iii) Weighting of measures In calculating the total performance score, the Secretary shall weight the scores with respect to individual measures calculated under subparagraph (B) to re- flect priorities for quality improvement, such as weighting scores to ensure that providers of services and renal dialysis fa- cilities have strong incentives to meet or exceed anemia management and dialysis adequacy performance standards, as deter- mined appropriate by the Secretary. (B) Performance score with respect to indi- vidual measures The Secretary shall also calculate sepa- rate performance scores for each measure, including for dialysis adequacy and anemia management. (4) Performance standards (A) Establishment Subject to subparagraph (E), the Secretary shall establish performance standards with respect to measures selected under para- graph (2) for a performance period with re- spect to a year (as established under sub- paragraph (D)). (B) Achievement and improvement The performance standards established under subparagraph (A) shall include levels of achievement and improvement, as deter- mined appropriate by the Secretary. (C) Timing The Secretary shall establish the perform- ance standards under subparagraph (A) prior to the beginning of the performance period for the year involved. (D) Performance period The Secretary shall establish the perform- ance period with respect to a year. Such per- formance period shall occur prior to the be- ginning of such year. (E) Special rule The Secretary shall initially use as the performance standard for the measures spec- ified under paragraph (2)(A)(i) for a provider of services or a renal dialysis facility the lesser of— (i) the performance of such provider or facility for such measures in the year se- lected by the Secretary under the second sentence of subsection (b)(14)(A)(ii); or (ii) a performance standard based on the national performance rates for such meas- ures in a period determined by the Sec- retary. Page 3764 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr (5) Limitation on review There shall be no administrative or judicial review under section 1395ff of this title, sec- tion 1395oo of this title, or otherwise of the fol- lowing: (A) The determination of the amount of the payment reduction under paragraph (1). (B) The establishment of the performance standards and the performance period under paragraph (4). (C) The specification of measures under paragraph (2). (D) The methodology developed under paragraph (3) that is used to calculate total performance scores and performance scores for individual measures. (6) Public reporting (A) In general The Secretary shall establish procedures for making information regarding perform- ance under this subsection available to the public, including— (i) the total performance score achieved by the provider of services or renal dialy- sis facility under paragraph (3) and appro- priate comparisons of providers of services and renal dialysis facilities to the national average with respect to such scores; and (ii) the performance score achieved by the provider or facility with respect to in- dividual measures. (B) Opportunity to review The procedures established under subpara- graph (A) shall ensure that a provider of services and a renal dialysis facility has the opportunity to review the information that is to be made public with respect to the pro- vider or facility prior to such data being made public. (C) Certificates (i) In general The Secretary shall provide certificates to providers of services and renal dialysis facilities who furnish renal dialysis serv- ices under this section to display in pa- tient areas. The certificate shall indicate the total performance score achieved by the provider or facility under paragraph (3). (ii) Display Each facility or provider receiving a cer- tificate under clause (i) shall prominently display the certificate at the provider or facility. (D) Web-based list The Secretary shall establish a list of pro- viders of services and renal dialysis facilities who furnish renal dialysis services under this section that indicates the total per- formance score and the performance score for individual measures achieved by the pro- vider and facility under paragraph (3). Such information shall be posted on the Internet website of the Centers for Medicare & Med- icaid Services in an easily understandable format. (Aug. 14, 1935, ch. 531, title XVIII, § 1881, as added Pub. L. 95–292, § 2, June 13, 1978, 92 Stat. 308; amended Pub. L. 96–499, title IX, § 957, Dec. 5, 1980, 94 Stat. 2648; Pub. L. 97–35, title XXI, § 2145(a), Aug. 13, 1981, 95 Stat. 799; Pub. L. 98–21, title VI, § 602(i), Apr. 20, 1983, 97 Stat. 165; Pub. L. 98–369, div. B, title III, §§ 2323(c), 2352(a), 2354(b)(41), July 18, 1984, 98 Stat. 1086, 1099, 1102; Pub. L. 98–617, § 3(b)(8), Nov. 8, 1984, 98 Stat. 3296; Pub. L. 99–509, title IX, § 9335(a)(2), (d)(1), (e)–(i)(1), (j)(1), (k)(1), Oct. 21, 1986, 100 Stat. 2029–2033; Pub. L. 100–93, § 12, Aug. 18, 1987, 101 Stat. 697; Pub. L. 100–203, title IV, §§ 4036(b), (c)(2), (d)(5), 4065(b), Dec. 22, 1987, 101 Stat. 1330–79, 1330–80, 1330–112; Pub. L. 101–239, title VI, §§ 6102(e)(8), 6203(b)(1), (2), 6219(a), (b), Dec. 19, 1989, 103 Stat. 2188, 2235, 2254; Pub. L. 101–508, title IV, § 4201(c)(1), (d)(2), formerly (d)(2), (3), Nov. 5, 1990, 104 Stat. 1388–103, 1388–104, renum- bered Pub. L. 103–432, title I, § 160(d)(3), Oct. 31, 1994, 108 Stat. 4444; Pub. L. 103–66, title XIII, § 13566(a), Aug. 10, 1993, 107 Stat. 607; Pub. L. 103–296, title I, § 108(c)(5), Aug. 15, 1994, 108 Stat. 1485; Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 222(a)], Nov. 29, 1999, 113 Stat. 1536, 1501A–352; Pub. L. 106–554, § 1(a)(6) [title IV, § 422(a)(1)], Dec. 21, 2000, 114 Stat. 2763, 2763A–516; Pub. L. 108–173, title VI, § 623(a), (b)(2), (d), Dec. 8, 2003, 117 Stat. 2312, 2313; Pub. L. 109–171, title V, § 5106, Feb. 8, 2006, 120 Stat. 42; Pub. L. 109–432, div. B, title I, § 103(a), Dec. 20, 2006, 120 Stat. 2981; Pub. L. 110–275, title I, § 153(a), (b)(1), (3)(A), (c), July 15, 2008, 122 Stat. 2553, 2556; Pub. L. 111–148, title III, § 3401(h), Mar. 23, 2010, 124 Stat. 485; Pub. L. 112–240, title VI, § 632(a), Jan. 2, 2013, 126 Stat. 2354; Pub. L. 113–93, title II, § 217(b), (d), Apr. 1, 2014, 128 Stat. 1061, 1062; Pub. L. 115–123, div. E, title III, § 50302(a), (d), title IV, § 50403(b), Feb. 9, 2018, 132 Stat. 190, 192, 218; Pub. L. 116–136, div. A, title III, § 3705, Mar. 27, 2020, 134 Stat. 418.) Editorial Notes REFERENCES IN TEXT Section 1395x(s)(2)(P) of this title, referred to in sub- sec. (b)(1), was redesignated section 1395x(s)(2)(O) of this title by Pub. L. 103–432, title I, § 147(f)(6)(B)(iii)(II), Oct. 31, 1994, 108 Stat. 4432. Section 422(a)(2) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, referred to in subsec. (b)(7), is section 1(a)(6) [title IV, § 422(a)(2)] of Pub. L. 106–554, which is set out as a note under this section. Section 623(c) of the Medicare Prescription Drug, Im- provement, and Modernization Act of 2003, referred to in subsec. (b)(12)(B)(ii), (13)(A)(ii), is section 623(c) of Pub. L. 108–173, which is set out as a note under this section. Subsection (g), referred to in subsec. (c)(7)(A), was re- pealed, and subsec. (h) was redesignated (g), by Pub. L. 100–203, title IV, §§ 4036(d)(5)(C), (D), Dec. 22, 1987, 101 Stat. 1330–80. AMENDMENTS 2020—Subsec. (b)(3)(B)(i). Pub. L. 116–136, § 3705(1), sub- stituted ‘‘clauses (ii) and (iii)’’ for ‘‘clause (ii)’’. Subsec. (b)(3)(B)(ii). Pub. L. 116–136, § 3705(2), sub- stituted ‘‘Except as provided in clause (iii), clause (i)’’ for ‘‘Clause (i)’’ in introductory provisions. Subsec. (b)(3)(B)(iii). Pub. L. 116–136, § 3705(3), added cl. (iii). 2018—Subsec. (b)(1). Pub. L. 115–123, § 50403(b), inserted at end: ‘‘Beginning 180 days after February 9, 2018, an initial survey of a provider of services or a renal dialy- sis facility to determine if the conditions and require- ments under this paragraph are met shall be initiated Page 3765 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr not later than 90 days after such date on which both the provider enrollment form (without regard to wheth- er such form is submitted prior to or after such date of enactment) has been determined by the Secretary to be complete and the provider’s enrollment status indi- cates approval is pending the results of such survey.’’ Pub. L. 115–123, § 50302(d), substituted ‘‘paragraph (3)(A)(i)’’ for ‘‘paragraph (3)(A)’’. Subsec. (b)(3). Pub. L. 115–123, § 50302(a), inserted sub- par. (A) designation before ‘‘With respect to’’, redesig- nated former subpars. (A) and (B) as cls. (i) and (ii), re- spectively, of subpar. (A), substituted ‘‘subject to sub- paragraph (B), on a comprehensive’’ for ‘‘on a com- prehensive’’ in cl. (ii), and added subpar. (B). 2014—Subsec. (b)(14)(F)(i)(I). Pub. L. 113–93, § 217(b)(2)(A), substituted ‘‘subclauses (II) and (III)’’ for ‘‘subclause (II)’’ and inserted at end ‘‘In order to ac- complish the purposes of subparagraph (I) with respect to 2016, 2017, and 2018, after determining the increase factor described in the preceding sentence for each of 2016, 2017, and 2018, the Secretary shall reduce such in- crease factor by 1.25 percentage points for each of 2016 and 2017 and by 1 percentage point for 2018.’’ Subsec. (b)(14)(F)(i)(II). Pub. L. 113–93, § 217(b)(2)(B), substituted ‘‘Subject to subclause (III), for 2012’’ for ‘‘For 2012’’. Subsec. (b)(14)(F)(i)(III). Pub. L. 113–93, § 217(b)(2)(C), added subcl. (III). Subsec. (b)(14)(I). Pub. L. 113–93, § 217(b)(1), inserted ‘‘and before January 1, 2015,’’ after ‘‘January 1, 2014,’’. Subsec. (h)(2)(A)(iii), (iv). Pub. L. 113–93, § 217(d)(1), added cl. (iii) and redesignated former cl. (iii) as (iv). Subsec. (h)(2)(B)(i). Pub. L. 113–93, § 217(d)(2), sub- stituted ‘‘(A)(iv)’’ for ‘‘(A)(iii)’’. Subsec. (h)(2)(E). Pub. L. 113–93, § 217(d)(3), added sub- par. (E). 2013—Subsec. (b)(14)(I). Pub. L. 112–240 added subpar. (I). 2010—Subsec. (b)(14)(F)(i). Pub. L. 111–148, § 3401(h)(1), designated existing provisions as subcl. (I), substituted ‘‘subclause (II) and clause (ii)’’ for ‘‘clause (ii)’’ and struck out ‘‘minus 1.0 percentage point’’ before period at end, and added subcl. (II). Subsec. (b)(14)(F)(ii)(II). Pub. L. 111–148, § 3401(h)(2), substituted ‘‘Subject to clause (i)(II), the’’ for ‘‘The’’ and ‘‘clause (i)(I)’’ for ‘‘clause (i) minus 1.0 percentage point’’. 2008—Subsec. (b)(12)(A). Pub. L. 110–275, § 153(a)(2), (b)(3)(A)(i), substituted ‘‘Subject to paragraph (14), in lieu of payment’’ for ‘‘In lieu of payment’’ and inserted at end ‘‘Under such system, the payment rate for dialy- sis services furnished on or after January 1, 2009, by providers of services shall be the same as the payment rate (computed without regard to this sentence) for such services furnished by renal dialysis facilities, and in applying the geographic index under subparagraph (D) to providers of services, the labor share shall be based on the labor share otherwise applied for renal di- alysis facilities.’’ Subsec. (b)(12)(F). Pub. L. 110–275, § 153(b)(3)(A)(ii), in concluding provisions, inserted ‘‘or paragraph (14)’’ after ‘‘this paragraph’’ and ‘‘or under the system under paragraph (14)’’ after ‘‘subparagraph (B)’’. Subsec. (b)(12)(G). Pub. L. 110–275, § 153(a)(1), inserted ‘‘and before January 1, 2009,’’ after ‘‘April 1, 2007,’’ in cl. (ii) and added cls. (iii) and (iv). Subsec. (b)(13)(A). Pub. L. 110–275, § 153(b)(3)(A)(iii)(I), substituted ‘‘Subject to paragraph (14), the payment amounts’’ for ‘‘The payment amounts’’ in introductory provisions. Subsec. (b)(13)(B). Pub. L. 110–275, § 153(b)(3)(A)(iii)(II), redesignated cl. (i) as subpar. (B), inserted ‘‘, subject to paragraph (14)’’ before period at end, and struck out cl. (ii) which read as follows: ‘‘Nothing in this paragraph, section 1395u(o) of this title, section 1395w–3a of this title, or section 1395w–3b of this title shall be construed as requiring or authorizing the bundling of payment for drugs and biologicals into the basic case-mix adjusted payment system under this paragraph.’’ Subsec. (b)(14). Pub. L. 110–275, § 153(b)(1), added par. (14). Subsec. (h). Pub. L. 110–275, § 153(c), added subsec. (h). 2006—Subsec. (b)(12)(F). Pub. L. 109–171, § 5106(1), sub- stituted ‘‘Except as provided in subparagraph (G), noth- ing’’ for ‘‘Nothing’’ in concluding provisions. Subsec. (b)(12)(G). Pub. L. 109–432 amended subpar. (G) generally. Prior to amendment, subpar. (G) read as fol- lows: ‘‘The Secretary shall increase the amount of the composite rate component of the basic case-mix ad- justed system under subparagraph (B) for dialysis serv- ices furnished on or after January 1, 2006, by 1.6 percent above the amount of such composite rate component for such services furnished on December 31, 2005.’’ Pub. L. 109–171, § 5106(3), added subpar. (G). Former subpar. (G) redesignated (H). Subsec. (b)(12)(H). Pub. L. 109–171, § 5106(2), redesig- nated subpar. (G) as (H). 2003—Subsec. (b)(7). Pub. L. 108–173, § 623(a), (b)(2), (d)(2), in first sentence substituted ‘‘Subject to para- graph (12), the Secretary’’ for ‘‘The Secretary’’, in fourth sentence substituted ‘‘Subject to section 422(a)(2) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, the Sec- retary’’ for ‘‘The Secretary’’, and, in concluding provi- sions, struck out ‘‘and’’ before ‘‘for such services fur- nished on or after January 1, 2001,’’, inserted ‘‘and be- fore January 1, 2005,’’ after ‘‘January 1, 2001,’’, and in- serted ‘‘, and for such services furnished on or after January 1, 2005, by 1.6 percent above such composite rate payment amounts for such services furnished on December 31, 2004’’ before period at end. Subsec. (b)(11)(B). Pub. L. 108–173, § 623(d)(3), inserted ‘‘subject to paragraphs (12) and (13)’’ before ‘‘payment for such item’’ in introductory provisions. Subsec. (b)(12), (13). Pub. L. 108–173, § 623(d)(1), added pars. (12) and (13). 2000—Subsec. (b)(7). Pub. L. 106–554 substituted ‘‘for such services furnished on or after January 1, 2001, by 2.4 percent’’ for ‘‘for such services furnished on or after January 1, 2001, by 1.2 percent’’ in concluding provi- sions. 1999—Subsec. (b)(7). Pub. L. 106–113 inserted con- cluding provisions. 1994—Subsec. (g)(3). Pub. L. 103–296 inserted before pe- riod at end ‘‘, except that, in so applying such sections and in applying section 405(l) of this title thereto, any reference therein to the Commissioner of Social Secu- rity or the Social Security Administration shall be considered a reference to the Secretary or the Depart- ment of Health and Human Services, respectively’’. 1993—Subsec. (b)(1)(C). Pub. L. 103–66, § 13566(a)(1), substituted ‘‘section 1395x(s)(2)(P)’’ for ‘‘section 1395x(s)(2)(Q)’’. Subsec. (b)(11)(B)(ii)(I). Pub. L. 103–66, § 13566(a)(2), substituted ‘‘1994’’ for ‘‘1991’’ and ‘‘$10’’ for ‘‘$11’’. 1990—Subsec. (b)(1). Pub. L. 101–508, § 4201(d)(2)(A), for- merly § 4201(d)(2), as renumbered by Pub. L. 103–432, § 160(d)(3), added cl. (C). Subsec. (b)(11). Pub. L. 101–508, § 4201(d)(2)(B), for- merly § 4201(d)(3), as renumbered by Pub. L. 103–432, § 160(d)(3), added subpar. (C). Pub. L. 101–508, § 4201(c)(1), designated existing provi- sions as subpar. (A) and added subpar. (B). 1989—Subsec. (b)(3)(A). Pub. L. 101–239, § 6102(e)(8), in- serted ‘‘or, for services furnished on or after January 1, 1992, on the basis described in section 1395w–4 of this title’’ after ‘‘comparable services’’. Subsec. (b)(4). Pub. L. 101–239, § 6203(b)(2), designated existing provisions as subpar. (A) and added subpar. (B). Subsec. (b)(7). Pub. L. 101–239, § 6219(a), substituted ‘‘organizations (designated under subsection (c)(1)(A)) for such organizations’ necessary and proper adminis- trative costs incurred in carrying out the responsibil- ities described in subsection (c)(2). The Secretary shall provide that amounts paid under the previous sentence shall be distributed to the organizations described in subsection (c)(1)(A) to ensure equitable treatment of all such network organizations. The Secretary in distrib- uting any such payments to network organizations shall take into account—’’ and subpars. (A) to (D) for ‘‘network administrative organization (designated Page 3766 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr under subsection (c)(1)(A) for the network area in which the treatment is provided) for its necessary and proper administrative costs incurred in carrying out its responsibilities under subsection (c)(2).’’ in last sen- tence. Pub. L. 101–239, § 6203(b)(1), inserted after second sen- tence ‘‘The amount of a payment made under any method other than a method based on a single com- posite weighted formula may not exceed the amount (or, in the case of continuous cycling peritoneal dialy- sis, 130 percent of the amount) of the median payment that would have been made under the formula for hos- pital-based facilities.’’ Subsec. (c)(8). Pub. L. 101–239, § 6219(b), added par. (8). 1987—Subsec. (b)(1). Pub. L. 100–203, § 4036(b), sub- stituted ‘‘transplantations’’ for ‘‘covered procedures and for self-dialysis training programs’’. Subsec. (b)(2)(C). Pub. L. 100–203, § 4065(b), substituted ‘‘facilities (other than hospital outpatient depart- ments)’’ for ‘‘facilities’’. Subsec. (c)(2)(F). Pub. L. 100–203, § 4036(d)(5)(A), struck out ‘‘and subsection (g) of this section’’ after ‘‘required by subparagraph (H)’’. Subsec. (c)(6). Pub. L. 100–203, § 4036(d)(5)(B), struck out at end ‘‘The Secretary shall periodically submit to the Congress such legislative recommendations as the Secretary finds warranted on the basis of such con- sultation and evidence to further the national objective of maximizing the use of home dialysis and transplan- tation consistent with good medical practice.’’ Subsec. (f)(7)(B). Pub. L. 100–203, § 4036(c)(2), inserted ‘‘(or July 1, 1988, with respect to protocols that relate to the reuse of bloodlines)’’ after ‘‘January 1, 1988’’. Subsec. (g). Pub. L. 100–203, § 4036(d)(5)(C), (D), redes- ignated subsec. (h) as (g) and struck out former subsec. (g) which directed the Secretary to submit to Congress on July 1, 1979, and on July 1 of each year thereafter a report on end stage renal disease program. Subsec. (h). Pub. L. 100–203, § 4036(d)(5)(D), redesig- nated subsec. (h) as (g). Pub. L. 100–93 added subsec. (h). 1986—Subsec. (b)(7). Pub. L. 99–509, § 9335(j)(1), inserted at end ‘‘The Secretary shall reduce the amount of each composite rate payment under this paragraph for each treatment by 50 cents (subject to such adjustments as may be required to reflect modes of dialysis other than hemodialysis) and provide for payment of such amount to the network administrative organization (designated under subsection (c)(1)(A) for the network area in which the treatment is provided) for its necessary and proper administrative costs incurred in carrying out its responsibilities under subsection (c)(2).’’ Pub. L. 99–509, § 9335(a)(2), inserted ‘‘and of pediatric facilities’’ after ‘‘isolated rural areas’’ in third sen- tence, and inserted after third sentence ‘‘Each applica- tion for such an exception shall be deemed to be ap- proved unless the Secretary disapproves it by not later than 60 working days after the date the application is filed.’’ Subsec. (c)(1)(A). Pub. L. 99–509, § 9335(d)(1), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: ‘‘For the purpose of assuring effective and efficient administration of the benefits provided under this section, the Secretary shall establish, in ac- cordance with such criteria as he finds appropriate, renal disease network areas, such network organiza- tions (including a coordinating council, an executive committee of such council, and a medical review board, for each network area) as he finds necessary to accom- plish such purpose, and a national end stage renal dis- ease medical information system. The Secretary may by regulations provide for such coordination of net- work planning and quality assurance activities and such exchange of data and information among agencies with responsibilities for health planning and quality assurance activities under Federal law as is consistent with the economical and efficient administration of this section and with the responsibilities established for network organizations under this section.’’ Subsec. (c)(1)(B). Pub. L. 99–509, § 9335(e), amended subpar. (B) generally, substituting ‘‘network council and each medical review board’’ for ‘‘coordinating council and executive committee’’. Subsec. (c)(2)(A). Pub. L. 99–509, § 9335(f)(1), inserted ‘‘and the participation of patients, providers of serv- ices, and renal disease facilities in vocational rehabili- tation programs’’ before the semicolon. Subsec. (c)(2)(B). Pub. L. 99–509, § 9335(f)(2), inserted ‘‘and with respect to working with patients, facilities, and providers in encouraging participation in voca- tional rehabilitation programs’’ before first semicolon. Subsec. (c)(2)(D) to (F). Pub. L. 99–509, § 9335(f)(5), added subpars. (D) to (F). Former subpars. (D) and (E) redesignated (G) and (H), respectively. Subsec. (c)(2)(G). Pub. L. 99–509, § 9335(f)(3), (5), redes- ignated former subpar. (D) as (G) and inserted ‘‘and re- porting to the Secretary on facilities and providers that are not providing appropriate medical care’’ before the semicolon. Subsec. (c)(2)(H). Pub. L. 99–509, § 9335(f)(4), (5), redes- ignated former subpar. (E) as (H) and inserted ‘‘and en- couraging participation in vocational rehabilitation programs’’ after ‘‘and transplantation’’. Subsec. (c)(3). Pub. L. 99–509, § 9335(g), inserted ‘‘or to follow the recommendations of the medical review board’’ after ‘‘network plans and goals’’. Subsec. (c)(6). Pub. L. 99–509, § 9335(h), inserted ‘‘and that the maximum practical number of patients who are suitable candidates for vocational rehabilitation services be given access to such services and encour- aged to return to gainful employment’’ at end of first sentence. Subsec. (c)(7). Pub. L. 99–509, § 9335(i)(1), added par. (7). Subsec. (f)(7). Pub. L. 99–509, § 9335(k)(1), amended par. (7) generally. Prior to amendment, par. (7) read as fol- lows: ‘‘The Secretary shall conduct a study of the med- ical appropriateness and safety of cleaning and reusing dialysis filters by home dialysis patients. In such cases in which the Secretary determines that such home cleaning and reuse of filters is a medically sound proce- dure, the Secretary shall conduct experiments to evalu- ate such home cleaning and reuse as a method of reduc- ing the costs of the end stage renal disease program.’’ 1984—Subsecs. (a), (b)(1), (2)(A), (B), (3), (8). Pub. L. 98–369, § 2354(b)(41), substituted ‘‘end stage’’ for ‘‘end- stage’’ wherever appearing. Subsec. (b)(11). Pub. L. 98–617 realigned margin of par. (11). Pub. L. 98–369, § 2323(c), added par. (11). Subsec. (c)(3). Pub. L. 98–369, § 2352(a), inserted provi- sion that if the Secretary determines that the facility’s or provider’s failure to cooperate with network plans and goals does not jeopardize patient health or safety or justify termination of certification, he may instead, after reasonable notice to the provider or facility and to the public, impose such other sanctions as he deter- mines to be appropriate, which sanctions may include denial of reimbursement with respect to some or all pa- tients admitted to the facility after the date of notice to the facility or provider, and graduated reduction in reimbursement for all patients. 1983—Subsec. (b)(2)(A). Pub. L. 98–21 inserted ‘‘or sec- tion 1395ww of this title (if applicable)’’ after ‘‘section 1395x(v) of this title’’. 1981—Subsec. (b)(2)(B). Pub. L. 97–35, § 2145(a)(1), (2), substituted ‘‘section 1395x(v) of this title) and con- sistent with any regulations promulgated under para- graph (7)’’ for ‘‘section 1395x(v) of this title)’’ and struck out provisions that such regulations provide for the implementation of appropriate incentives for en- couraging more efficient and effective delivery of serv- ices, and include a system for classifying comparable providers and facilities, and prospectively set rates or target rates with arrangements for sharing such reduc- tions in costs as may be attributable to more efficient and effective delivery of services. Subsec. (b)(3)(B). Pub. L. 97–35, § 2145(a)(3), substituted ‘‘or other basis (which effectively encourages the effi- cient delivery of dialysis services and provides incen- tives for the increased use of home dialysis)’’ for ‘‘or other basis’’. Page 3767 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr Subsec. (b)(4). Pub. L. 97–35, § 2145(a)(4), inserted ref- erence to alternative basis of a method established under par. (7). Subsec. (b)(6). Pub. L. 97–35, § 2145(a)(5), (6), sub- stituted ‘‘(except as may be provided in regulations under paragraph (7)) shall such target rate exceed 75 percent’’ and ‘‘any other procedure (including methods established under paragraph (7)) which the Secretary’’ for ‘‘shall such target rate exceed 70 percent’’ and ‘‘any other procedure which the Secretary’’, respectively. Subsec. (b)(7) to (10). Pub. L. 97–35, § 2145(a)(7), (8), added par. (7) and redesignated former pars. (7) to (9) as (8) to (10), respectively. 1980—Subsec. (e)(1). Pub. L. 96–499, § 957(a)(1)–(3), sub- stituted ‘‘services, renal dialysis facilities, and non- profit entities which the Secretary finds can furnish equipment economically and efficiently,’’ for ‘‘services and renal dialysis facilities’’ and ‘‘such providers, fa- cilities, and nonprofit entities’’ for ‘‘such providers and facilities’’. Subsec. (e)(2). Pub. L. 96–499, § 957(a)(4), substituted ‘‘, facility, or other entity will’’ for ‘‘or facility will’’. Subsec. (g). Pub. L. 96–499, § 957(b), substituted ‘‘July’’ for ‘‘April’’ in two places. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1994 AMENDMENT Amendment by Pub. L. 103–296 effective Mar. 31, 1995, see section 110(a) of Pub. L. 103–296, set out as a note under section 401 of this title. EFFECTIVE DATE OF 1993 AMENDMENT Amendment by Pub. L. 103–66 applicable to erythro- poietin furnished on or after Jan. 1, 1994, see section 13566(c) of Pub. L. 103–66, set out as a note under section 1395x of this title. EFFECTIVE DATE OF 1990 AMENDMENT Pub. L. 101–508, title IV, § 4201(c)(2), Nov. 5, 1990, 104 Stat. 1388–104, provided that: ‘‘The amendments made by paragraph (1) [amending this section] shall apply to erythropoietin furnished on or after January 1, 1991.’’ Amendment by section 4201(d)(2) of Pub. L. 101–508 ap- plicable to items and services furnished on or after July 1, 1991, see section 4201(d)(3)[(4)] of Pub. L. 101–508, set out as a note under section 1395x of this title. EFFECTIVE DATE OF 1989 AMENDMENT Pub. L. 101–239, title VI, § 6203(b)(3), Dec. 19, 1989, 103 Stat. 2235, provided that: ‘‘The amendments made by this subsection [amending this section] shall apply with respect to dialysis services, supplies, and equip- ment furnished on or after February 1, 1990.’’ EFFECTIVE DATE OF 1987 AMENDMENT Amendment by section 4065(b) of Pub. L. 100–203 effec- tive Jan. 1, 1988, see section 4065(c) of Pub. L. 100–203, set out as a note under section 1395x of this title. Amendment by Pub. L. 100–93 effective at end of four- teen-day period beginning Aug. 18, 1987, and inappli- cable to administrative proceedings commenced before end of such period, see section 15(a) of Pub. L. 100–93, set out as a note under section 1320a–7 of this title. EFFECTIVE DATE OF 1986 AMENDMENT Pub. L. 99–509, title IX, § 9335(a)(3), Oct. 21, 1986, 100 Stat. 2029, provided that: ‘‘The amendments made by paragraph (2) [amending this section] shall apply to ap- plications filed on or after the date of the enactment of this Act [Oct. 21, 1986].’’ Pub. L. 99–509, title IX, § 9335(j)(2), Oct. 21, 1986, 100 Stat. 2032, as amended by Pub. L. 100–203, title IV, § 4085(i)(21)(C), Dec. 22, 1987, 101 Stat. 1330–133, provided that: ‘‘The amendment made by paragraph (1) [amend- ing this section] shall apply to treatment furnished on or after January 1, 1987[,] except that, until network administrative organizations are established under sec- tion 1881(c)(1)(A) of the Social Security Act [42 U.S.C. 1395rr(c)(1)(A)] (as amended by subsection (d)(1) of this section), the distribution of payments described in the last sentence of section 1881(b)(7) of such Act shall be made based on the distribution of payments under sec- tion 1881 of such Act to network administrative organi- zations for fiscal year 1986.’’ [Pub. L. 100–203, title IV, § 4085(i)(21), Dec. 22, 1987, 101 Stat. 1330–133, provided that the amendment of section 9335(j)(2) of Pub. L. 99–509, set out above, by section 4085(i)(21)(C) of Pub. L. 100–203 is effective as if included in the enactment of Pub. L. 99–509.] Pub. L. 99–509, title IX, § 9335(l), Oct. 21, 1986, 100 Stat. 2033, provided that: ‘‘The amendments made by sub- sections (e), (f), and (g) [amending this section] shall apply to network administrative organizations des- ignated for network areas established under the amend- ment made by subsection (d)(1) [amending this sec- tion].’’ EFFECTIVE DATE OF 1984 AMENDMENT Amendment by Pub. L. 98–617 effective as if originally included in the Deficit Reduction Act of 1984, Pub. L. 98–369, see section 3(c) of Pub. L. 98–617, set out as a note under section 1395f of this title. Amendment by section 2323(c) of Pub. L. 98–369 appli- cable to services furnished on or after Sept. 1, 1984, see section 2323(d) of Pub. L. 98–369, set out as a note under section 1395l of this title. Pub. L. 98–369, div. B, title III, § 2352(b), July 18, 1984, 98 Stat. 1099, provided that: ‘‘The amendment made by this section [amending this section] shall apply to de- terminations made by the Secretary on or after the date of the enactment of this Act [July 18, 1984].’’ Amendment by section 2354(b)(41) of Pub. L. 98–369 ef- fective July 18, 1984, but not to be construed as chang- ing or affecting any right, liability, status, or interpre- tation which existed (under the provisions of law in- volved) before that date, see section 2354(e)(1) of Pub. L. 98–369, set out as a note under section 1320a–1 of this title. EFFECTIVE DATE OF 1983 AMENDMENT Amendment by Pub. L. 98–21 applicable to items and services furnished by or under arrangement with a hos- pital beginning with its first cost reporting period that begins on or after Oct. 1, 1983, any change in a hos- pital’s cost reporting period made after November 1982 to be recognized for such purposes only if the Secretary finds good cause therefor, see section 604(a)(1) of Pub. L. 98–21, set out as a note under section 1395ww of this title. EFFECTIVE DATE OF 1981 AMENDMENT Pub. L. 97–35, title XXI, § 2145(b), Aug. 13, 1981, 95 Stat. 800, provided that: ‘‘The amendments made by sub- section (a) [amending this section] apply to services furnished on or after October 1, 1981, and the Secretary of Health and Human Services shall first promulgate regulations to carry out section 1881(b)(7) of the Social Security Act [42 U.S.C. 1395rr(b)(7)] not later than Octo- ber 1, 1981.’’ EFFECTIVE DATE Section effective with respect to services, supplies, and equipment furnished after the third calendar month beginning after June 13, 1978, except that provi- sions for the implementation of an incentive reim- bursement system for dialysis services furnished in fa- cilities and providers to become effective with respect to a facility’s or provider’s first accounting period be- ginning after the last day of the twelfth month fol- lowing the month of June 1978, and except that provi- sions for reimbursement rates for home dialysis to be- come effective on Apr. 1, 1979, see section 6 of Pub. L. 95–292, set out as an Effective Date of 1978 Amendment note under section 426 of this title. CONSTRUCTION OF 2008 AMENDMENT Pub. L. 110–275, title I, § 153(b)(4), July 15, 2008, 122 Stat. 2556, provided that: ‘‘Nothing in this subsection Page 3768 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr [amending this section and sections 1395x and 1395y of this title and repealing provisions set out as a note under this section] or the amendments made by this subsection shall be construed as authorizing or requir- ing the Secretary of Health and Human Services to make payments under the payment system imple- mented under paragraph (14)(A)(i) of section 1881(b) of the Social Security Act (42 U.S.C. 1395rr(b)), as added by paragraph (1), for any unrecovered amount for any bad debt attributable to deductible and coinsurance on items and services not included in the basic case-mix adjusted composite rate under paragraph (12) of such section as in effect before the date of the enactment of this Act [July 15, 2008].’’ DRUG DESIGNATIONS Pub. L. 113–93, title II, § 217(c), Apr. 1, 2014, 128 Stat. 1062, provided that: ‘‘As part of the promulgation of an- nual rule for the Medicare end stage renal disease pro- spective payment system under section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) for cal- endar year 2016, the Secretary of Health and Human Services (in this subsection referred to as the ‘Sec- retary’) shall establish a process for— ‘‘(1) determining when a product is no longer an oral-only drug; and ‘‘(2) including new injectable and intravenous prod- ucts into the bundled payment under such system.’’ AUDITS OF COST REPORTS OF ESRD PROVIDERS AS RECOMMENDED BY MEDPAC Pub. L. 113–93, title II, § 217(e), Apr. 1, 2014, 128 Stat. 1063, provided that: ‘‘(1) IN GENERAL.—The Secretary of Health and Human Services shall conduct audits of Medicare cost reports beginning during 2012 for a representative sam- ple of providers of services and renal dialysis facilities furnishing renal dialysis services. ‘‘(2) FUNDING.—For purposes of carrying out para- graph (1), the Secretary of Health and Human Services shall provide for the transfer from the Federal Supple- mentary Medical Insurance Trust Fund established under section 1841 of the Social Security Act (42 U.S.C. 1395t) to the Centers for Medicare & Medicaid Services Program Management Account of $18,000,000 for fiscal year 2014. Amounts transferred under this paragraph for a fiscal year shall be available until expended.’’ DELAY OF IMPLEMENTATION OF ORAL-ONLY ESRD-RE- LATED DRUGS IN THE ESRD PROSPECTIVE PAYMENT SYSTEM; MONITORING Pub. L. 112–240, title VI, § 632(b), Jan. 2, 2013, 126 Stat. 2354, as amended by Pub. L. 113–93, title II, § 217(a), Apr. 1, 2014, 128 Stat. 1061; Pub. L. 113–295, div. B, title II, § 204, Dec. 19, 2014, 128 Stat. 4065, provided that: ‘‘(1) DELAY.—The Secretary of Health and Human Services may not implement the policy under section 413.174(f)(6) of title 42, Code of Federal Regulations (re- lating to oral-only ESRD-related drugs in the ESRD prospective payment system), prior to January 1, 2025. Notwithstanding section 1881(b)(14)(A)(ii) of the Social Security Act (42 U.S.C. 1395rr(b)(14)(A)(ii)), implemen- tation of the policy described in the previous sentence shall be based on data from the most recent year avail- able. ‘‘(2) MONITORING.—With respect to the implementa- tion of oral-only ESRD-related drugs in the ESRD pro- spective payment system under subsection (b)(14) of section 1881 of the Social Security Act (42 U.S.C. 1395rr(b)(14)), the Secretary of Health and Human Serv- ices shall monitor the bone and mineral metabolism of individuals with end stage renal disease.’’ ANALYSIS OF CASE MIX PAYMENT ADJUSTMENTS Pub. L. 112–240, title VI, § 632(c), Jan. 2, 2013, 126 Stat. 2354, provided that: ‘‘By not later than January 1, 2016, the Secretary of Health and Human Services shall— ‘‘(1) conduct an analysis of the case mix payment adjustments being used under section 1881(b)(14)(D)(i) of the Social Security Act (42 U.S.C. 1395rr(b)(14)(D)(i)); and ‘‘(2) make appropriate revisions to such case mix payment adjustments.’’ INSPECTOR GENERAL STUDIES ON ESRD DRUGS Pub. L. 108–173, title VI, § 623(c), Dec. 8, 2003, 117 Stat. 2312, provided that: ‘‘(1) IN GENERAL.—The Inspector General of the De- partment of Health and Human Services shall conduct two studies with respect to drugs and biologicals (in- cluding erythropoietin) furnished to end-stage renal disease patients under the medicare program which are separately billed by end stage renal disease facilities. ‘‘(2) STUDIES ON ESRD DRUGS.— ‘‘(A) EXISTING DRUGS.—The first study under para- graph (1) shall be conducted with respect to such drugs and biologicals for which a billing code exists prior to January 1, 2004. ‘‘(B) NEW DRUGS.—The second study under para- graph (1) shall be conducted with respect to such drugs and biologicals for which a billing code does not exist prior to January 1, 2004. ‘‘(3) MATTERS STUDIED.—Under each study conducted under paragraph (1), the Inspector General shall— ‘‘(A) determine the difference between the amount of payment made to end stage renal disease facilities under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] for such drugs and biologicals and the ac- quisition costs of such facilities for such drugs and biologicals and which are separately billed by end stage renal disease facilities, and ‘‘(B) estimate the rates of growth of expenditures for such drugs and biologicals billed by such facili- ties. ‘‘(4) REPORTS.— ‘‘(A) EXISTING ESRD DRUGS.—Not later than April 1, 2004, the Inspector General shall report to the Sec- retary [of Health and Human Services] on the study described in paragraph (2)(A). ‘‘(B) NEW ESRD DRUGS.—Not later than April 1, 2006, the Inspector General shall report to the Secretary on the study described in paragraph (2)(B).’’ DEMONSTRATION OF BUNDLED CASE-MIX ADJUSTED PAYMENT SYSTEM FOR ESRD SERVICES Pub. L. 108–173, title VI, § 623(e), Dec. 8, 2003, 117 Stat. 2315, which provided for establishment of a demonstra- tion project, to be conducted for the 3-year period be- ginning on Jan. 1, 2006, of the use of a fully case-mix ad- justed payment system for end stage renal disease serv- ices that bundled into payment rates amounts for drugs and biologicals (including erythropoietin) furnished to end stage renal disease patients under the medicare program which were separately billed by end stage renal disease facilities as of Dec. 8, 2003, and clinical laboratory tests related to such drugs and biologicals, and which authorized appropriations for the dem- onstration project, was repealed by Pub. L. 110–275, title I, § 153(b)(3)(C), July 15, 2008, 122 Stat. 2556. REPORT ON A BUNDLED PROSPECTIVE PAYMENT SYSTEM FOR END STAGE RENAL DISEASE SERVICES Pub. L. 108–173, title VI, § 623(f), Dec. 8, 2003, 117 Stat. 2316, provided that: ‘‘(1) REPORT.— ‘‘(A) IN GENERAL.—Not later than October 1, 2005, the Secretary [of Health and Human Services] shall submit to Congress a report detailing the elements and features for the design and implementation of a bundled prospective payment system for services fur- nished by end stage renal disease facilities including, to the maximum extent feasible, bundling of drugs, clinical laboratory tests, and other items that are separately billed by such facilities. The report shall include a description of the methodology to be used for the establishment of payment rates, including components of the new system described in paragraph (2). Page 3769 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr ‘‘(B) RECOMMENDATIONS.—The Secretary shall in- clude in such report recommendations on elements, features, and methodology for a bundled prospective payment system or other issues related to such sys- tem as the Secretary determines to be appropriate. ‘‘(2) ELEMENTS AND FEATURES OF A BUNDLED PROSPEC- TIVE PAYMENT SYSTEM.—The report required under paragraph (1) shall include the following elements and features of a bundled prospective payment system: ‘‘(A) BUNDLE OF ITEMS AND SERVICES.—A description of the bundle of items and services to be included under the prospective payment system. ‘‘(B) CASE MIX.—A description of the case-mix ad- justment to account for the relative resource use of different types of patients. ‘‘(C) WAGE INDEX.—A description of an adjustment to account for geographic differences in wages. ‘‘(D) RURAL AREAS.—The appropriateness of estab- lishing a specific payment adjustment to account for additional costs incurred by rural facilities. ‘‘(E) OTHER ADJUSTMENTS.—Such other adjustments as may be necessary to reflect the variation in costs incurred by facilities in caring for patients with end stage renal disease. ‘‘(F) UPDATE FRAMEWORK.—A methodology for ap- propriate updates under the prospective payment sys- tem. ‘‘(G) ADDITIONAL RECOMMENDATIONS.—Such other matters as the Secretary determines to be appro- priate.’’ PROHIBITION ON EXCEPTIONS Pub. L. 106–554, § 1(a)(6) [title IV, § 422(a)(2)], Dec. 21, 2000, 114 Stat. 2763, 2763A–516, as amended by Pub. L. 108–173, title VI, § 623(b)(1), Dec. 8, 2003 117 Stat. 2312, provided that: ‘‘(A) IN GENERAL.—Subject to subparagraphs (B), (C), and (D), the Secretary of Health and Human Services may not provide for an exception under section 1881(b)(7) of the Social Security Act (42 U.S.C. 1395rr(b)(7)) on or after December 31, 2000. ‘‘(B) DEADLINE FOR NEW APPLICATIONS.—Subject to subparagraph (D), in the case of a facility that during 2000 did not file for an exception rate under such sec- tion, the facility may submit an application for an ex- ception rate by not later than July 1, 2001. ‘‘(C) PROTECTION OF APPROVED EXCEPTION RATES.—Any exception rate under such section in effect on Decem- ber 31, 2000 (or, in the case of an application under sub- paragraph (B), as approved under such application) shall continue in effect so long as such rate is greater than the composite rate as updated by the amendment made by paragraph (1) [amending this section]. ‘‘(D) INAPPLICABILITY TO PEDIATRIC FACILITIES.—Sub- paragraphs (A) and (B) shall not apply, as of October 1, 2002, to pediatric facilities that do not have an excep- tion rate described in subparagraph (C) in effect on such date. For purposes of this subparagraph, the term ‘pediatric facility’ means a renal facility at least 50 percent of whose patients are individuals under 18 years of age.’’ DEVELOPMENT OF ESRD MARKET BASKET Pub. L. 106–554, § 1(a)(6) [title IV, § 422(b)], Dec. 21, 2000, 114 Stat. 2763, 2763A–516, provided that: ‘‘(1) DEVELOPMENT.—The Secretary of Health and Human Services shall collect data and develop an ESRD market basket whereby the Secretary can esti- mate, before the beginning of a year, the percentage by which the costs for the year of the mix of labor and nonlabor goods and services included in the ESRD com- posite rate under section 1881(b)(7) of the Social Secu- rity Act (42 U.S.C. 1395rr(b)(7)) will exceed the costs of such mix of goods and services for the preceding year. In developing such index, the Secretary may take into account measures of changes in— ‘‘(A) technology used in furnishing dialysis serv- ices; ‘‘(B) the manner or method of furnishing dialysis services; and ‘‘(C) the amounts by which the payments under such section for all services billed by a facility for a year exceed the aggregate allowable audited costs of such services for such facility for such year. ‘‘(2) REPORT.—The Secretary of Health and Human Services shall submit to Congress a report on the index developed under paragraph (1) no later than July 1, 2002, and shall include in the report recommendations on the appropriateness of an annual or periodic update mechanism for renal dialysis services under the medi- care program under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] based on such index.’’ INCLUSION OF ADDITIONAL SERVICES IN COMPOSITE RATE Pub. L. 106–554, § 1(a)(6) [title IV, § 422(c)], Dec. 21, 2000, 114 Stat. 2763, 2763A–517, provided that: ‘‘(1) DEVELOPMENT.—The Secretary of Health and Human Services shall develop a system which includes, to the maximum extent feasible, in the composite rate used for payment under section 1881(b)(7) of the Social Security Act (42 U.S.C. 1395rr(b)(7)), payment for clin- ical diagnostic laboratory tests and drugs (including drugs paid under section 1881(b)(11)(B) of such Act (42 U.S.C. 1395rr(b)(11)(B)) that are routinely used in fur- nishing dialysis services to medicare beneficiaries but which are currently separately billable by renal dialy- sis facilities. ‘‘(2) REPORT.—The Secretary shall include, as part of the report submitted under subsection (b)(2) [set out above], a report on the system developed under para- graph (1) and recommendations on the appropriateness of incorporating the system into medicare payment for renal dialysis services.’’ GAO STUDY ON ACCESS TO SERVICES Pub. L. 106–554, § 1(a)(6) [title IV, § 422(d)], Dec. 21, 2000, 114 Stat. 2763, 2763A–517, directed the Comptroller General of the United States to study access of medi- care beneficiaries to renal dialysis services and re- quired the Comptroller General to submit to Congress a report on the study by not later than Jan. 1, 2003. SPECIAL RULE FOR PAYMENT FOR 2001 Pub. L. 106–554, § 1(a)(6) [title IV, § 422(e)], Dec. 21, 2000, 114 Stat. 2763, 2763A–517, provided that: ‘‘Notwith- standing the amendment made by subsection (a)(1) [amending this section], for purposes of making pay- ments under section 1881(b) of the Social Security Act (42 U.S.C. 1395rr(b)) for dialysis services furnished dur- ing 2001, the composite rate payment under paragraph (7) of such section— ‘‘(1) for services furnished on or after January 1, 2001, and before April 1, 2001, shall be the composite rate payment determined under the provisions of law in effect on the day before the date of the enactment of this Act [Dec. 21, 2000]; and ‘‘(2) for services furnished on or after April 1, 2001, and before January 1, 2002, shall be the composite rate payment (as determined taking into account the amendment made by subsection (a)(1)) increased by a transitional percentage allowance equal to 0.39 per- cent (to account for the timing of implementation of the CPI update).’’ STUDY ON PAYMENT LEVEL FOR HOME HEMODIALYSIS Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 222(c)], Nov. 29, 1999, 113 Stat. 1536, 1501A–352, required the Medicare Payment Advisory Commission to conduct a study on the appropriateness of a differential in pay- ment level for home hemodialysis and to submit a re- port to Congress no later than 18 months after Nov. 29, 1999. RENAL DIALYSIS-RELATED SERVICES Pub. L. 105–33, title IV, § 4558, Aug. 5, 1997, 111 Stat. 463, provided that: ‘‘(a) AUDITING OF COST REPORTS.—Beginning with cost reports for 1996, the Secretary shall audit cost reports Page 3770 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr of each renal dialysis provider at least once every 3 years. ‘‘(b) IMPLEMENTATION OF QUALITY STANDARDS.—The Secretary of Health and Human Services shall develop, by not later than January 1, 1999, and implement, by not later than January 1, 2000, a method to measure and report quality of renal dialysis services provided under the medicare program under title XVIII of the Social Security Act [this subchapter].’’ PROPAC STUDY ON ESRD COMPOSITE RATES Pub. L. 101–508, title IV, § 4201(b), Nov. 5, 1990, 104 Stat. 1388–102, provided that: ‘‘(1) IN GENERAL.— ‘‘(A) STUDY.—The Prospective Payment Assessment Commission (in this subsection referred to as the ‘Commission’) shall conduct a study to determine the costs and services and profits associated with various modalities of dialysis treatments provided to end stage renal disease patients provided under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.]. ‘‘(B) RECOMMENDATIONS.—Based on information col- lected for the study described in subparagraph (A), the Commission shall make recommendations to Con- gress regarding the method or methods and the levels at which the payments made for the facility compo- nent of dialysis services by providers of service and renal dialysis facilities under title XVIII of the So- cial Security Act should be established for dialysis services furnished during fiscal year 1993 and the methodology to be used to update such payments for subsequent fiscal years. In making recommendations concerning the appropriate methodology the Com- mission shall consider— ‘‘(i) hemodialysis and other modalities of treat- ment, ‘‘(ii) the appropriate services to be included in such payments, ‘‘(iii) the adjustment factors to be incorporated including facility characteristics, such as hospital versus free-standing facilities, urban versus rural, size and mix of services, ‘‘(iv) adjustments for labor and nonlabor costs, ‘‘(v) comparative profit margins for all types of renal dialysis providers of service and renal dialysis facilities, ‘‘(vi) adjustments for patient complexity, such as age, diagnosis, case mix, and pediatric services, and ‘‘(vii) efficient costs related to high quality of care and positive outcomes for all treatment mo- dalities. ‘‘(2) REPORT.—Not later than June 1, 1992, the Com- mission shall submit a report to the Committee on Fi- nance of the Senate, and the Committees on Ways and Means and Energy and Commerce of the House of Rep- resentatives on the study conducted under paragraph (1)(A) and shall include in the report the recommenda- tions described in paragraph (1)(B), taking into account the factors described in paragraph (1)(B). ‘‘(3) ANNUAL REPORT.—The Commission, not later than March 1 before the beginning of each fiscal year (beginning with fiscal year 1993) shall report its rec- ommendations to the Committee on Finance of the Senate and the Committees on Ways and Means and Energy and Commerce of the House of Representatives on an appropriate change factor which should be used for updating payments for services rendered in that fis- cal year. The Commission in making such report to Congress shall consider conclusions and recommenda- tions available from the Institute of Medicine.’’ [Prospective Payment Assessment Commission (ProPAC) was terminated and its assets and staff trans- ferred to the Medicare Payment Advisory Commission (MedPAC) by section 4022(c)(2), (3) of Pub. L. 105–33, set out as a note under section 1395b–6 of this title. Section 4022(c)(2), (3) further provided that MedPAC was to be responsible for preparation and submission of reports required by law to be submitted by ProPAC, and that, for that purpose, any reference in law to ProPAC was to be deemed, after the appointment of MedPAC, to refer to MedPAC.] STAFF-ASSISTED HOME DIALYSIS DEMONSTRATION PROJECT Pub. L. 101–508, title IV, § 4202, Nov. 5, 1990, 104 Stat. 1388–104, as amended by Pub. L. 103–432, title I, § 160(b), Oct. 31, 1994, 108 Stat. 4443, provided that: ‘‘(a) ESTABLISHMENT.— ‘‘(1) IN GENERAL.—Not later than 9 months after the date of the enactment of this Act [Nov. 5, 1990], the Secretary of Health and Human Services shall estab- lish and carry out a 3-year demonstration project to determine whether the services of a home dialysis staff assistant providing services to a patient during hemodialysis treatment at the patient’s home may be covered under the medicare program in a cost-effec- tive manner that ensures patient safety. ‘‘(2) NUMBER OF PARTICIPANTS.—The total number of eligible patients receiving services under the dem- onstration project established under paragraph (1) may not exceed 800. ‘‘(b) PAYMENTS TO PARTICIPATING PROVIDERS AND FA- CILITIES.— ‘‘(1) SERVICES FOR WHICH PAYMENT MAY BE MADE.— ‘‘(A) IN GENERAL.—Under the demonstration project established under subsection (a), the Sec- retary shall make payments for 3 years under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] to providers of services (other than a skilled nursing facility) or renal dialysis facilities for serv- ices of a qualified home hemodialysis staff assist- ant (as described in subsection (d)) provided to an individual described in subsection (c) during hemo- dialysis treatment at the individual’s home in an amount determined under paragraph (2). ‘‘(B) SERVICES DESCRIBED.—For purposes of sub- paragraph (A), the term ‘services of a home hemo- dialysis staff assistant’ means— ‘‘(i) technical assistance with the operation of a hemodialysis machine in the patient’s home and with such patient’s care during in-home hemo- dialysis; and ‘‘(ii) administration of medications within the patient’s home to maintain the patency of the extra corporeal circuit. ‘‘(2) AMOUNT OF PAYMENT.— ‘‘(A) IN GENERAL.—Payment to a provider of serv- ices or renal dialysis facility participating in the demonstration project established under subsection (a) for the services described in paragraph (1) shall be prospectively determined by the Secretary, made on a per treatment basis, and shall be in an amount determined under subparagraph (B). ‘‘(B) DETERMINATION OF PAYMENT AMOUNT.—(i) The amount of payment made under subparagraph (A) shall be the product of— ‘‘(I) the rate determined under clause (ii) with respect to a provider of services or a renal dialy- sis facility; and ‘‘(II) the factor by which the labor portion of the composite rate determined under section 1881(b)(7) of the Social Security Act [42 U.S.C. 1395rr(b)(7)] is adjusted for differences in area wage levels. ‘‘(ii) The rate determined under this clause, with respect to a provider of services or renal dialysis fa- cility, shall be equal to the difference between— ‘‘(I) two-thirds of the labor portion of the com- posite rate applicable under section 1881(b)(7) of such Act to the provider or facility, and ‘‘(II) the product of the national median hourly wage for a home hemodialysis staff assistant and the national median time expended in the provi- sion of home hemodialysis staff assistant services (taking into account time expended in travel and predialysis patient care). ‘‘(iii) For purposes of clause (ii)(II)— ‘‘(I) the national median hourly wage for a home hemodialysis staff assistant and the na- Page 3771 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr tional median average time expended for home hemodialysis staff assistant services shall be de- termined annually on the basis of the most recent data available, and ‘‘(II) the national median hourly wage for a home hemodialysis staff assistant shall be the sum of 65 percent of the national median hourly wage for a licensed practical nurse and 35 percent of the national median hourly wage for a reg- istered nurse. ‘‘(C) PAYMENT AS ADD-ON TO COMPOSITE RATE.—The amount of payment determined under this para- graph shall be in addition to the amount of pay- ment otherwise made to the provider of services or renal dialysis facility under section 1881(b) of such Act. ‘‘(c) INDIVIDUALS ELIGIBLE TO RECEIVE SERVICES UNDER PROJECT.— ‘‘(1) IN GENERAL.—An individual may receive serv- ices from a provider of services or renal dialysis facil- ity participating in the demonstration project if— ‘‘(A) the individual is not a resident of a nursing facility; ‘‘(B) the individual is an end stage renal disease patient entitled to benefits under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.]; ‘‘(C) the individual’s physician certifies that the individual is confined to a bed or wheelchair and cannot transfer themselves [sic] from a bed to a chair; ‘‘(D) the individual has a serious medical condi- tion (as specified by the Secretary) which would be exacerbated by travel to and from a dialysis facil- ity; ‘‘(E) the individual is eligible for ambulance transportation to receive routine maintenance di- alysis treatments, and, based on the individual’s medical condition, there is reasonable expectation that such transportation will be used by the indi- vidual for a period of at least 6 consecutive months, such that the cost of ambulance transportation can reasonably be expected to meet or exceed the cost of home hemodialysis staff assistance as provided under subsection (b)(2); and ‘‘(F) no family member or other individual is available to provide such assistance to the indi- vidual. ‘‘(2) COVERAGE OF INDIVIDUALS CURRENTLY RECEIVING SERVICES.—Any individual who, on the date of the en- actment of this Act [Nov. 5, 1990], is receiving staff assistance under the experimental authority provided under section 1881(f)(2) of the Social Security Act [42 U.S.C. 1395rr(f)(2)] shall be deemed to be an eligible individual for purposes of this subsection. ‘‘(3) CONTINUATION OF COVERAGE UPON TERMINATION OF PROJECT.—Notwithstanding any provision of title XVIII of the Social Security Act, any individual re- ceiving services under the demonstration project es- tablished under subsection (a) as of the date of the termination of the project shall continue to be eligi- ble for home hemodialysis staff assistance after such date under such title on the same terms and condi- tions as applied under the demonstration project. ‘‘(d) QUALIFICATIONS FOR HOME HEMODIALYSIS STAFF ASSISTANTS.—For purposes of subsection (b), a home di- alysis aide is qualified if the aide— ‘‘(1) meets minimum qualifications as specified by the Secretary; and ‘‘(2) meets any applicable qualifications as specified under the law of the State in which the home hemo- dialysis staff assistant is providing services. ‘‘(e) REPORTS.— ‘‘(1) INTERIM STATUS REPORT.—Not later than De- cember 1, 1992, the Secretary shall submit to Con- gress a preliminary report on the status of the dem- onstration project established under subsection (a). ‘‘(2) FINAL REPORT.—Not later than December 31, 1995, the Secretary shall submit to Congress a final report evaluating the project, and shall include in such report recommendations regarding appropriate eligibility criteria and cost-control mechanisms for medicare coverage of the services of a home dialysis aide providing medical assistance to a patient during hemodialysis treatment at the patient’s home. ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—The Sec- retary shall provide for the transfer from the Federal Supplementary Medical Insurance Trust Fund (estab- lished under section 1841 of the Social Security Act [42 U.S.C. 1395t]) of not more than the following amounts to carry out the demonstration project established under subsection (a) (without regard to amounts appro- priated in advance in appropriation Acts): ‘‘(1) For fiscal year 1991, $4,000,000. ‘‘(2) For fiscal year 1992, $4,000,000. ‘‘(3) For fiscal year 1993, $3,000,000. ‘‘(4) For fiscal year 1994, $2,000,000. ‘‘(5) For fiscal year 1995, $1,000,000.’’ STUDIES OF END-STAGE RENAL DISEASE PROGRAM Pub. L. 100–203, title IV, § 4036(d)(1)–(4), Dec. 22, 1987, 101 Stat. 1330–79, provided that: ‘‘(1) The Secretary of Health and Human Services (in this subsection referred to as the ‘Secretary’) shall ar- range for a study of the end-stage renal disease pro- gram within the medicare program. ‘‘(2) Among other items, the study shall address— ‘‘(A) access to treatment by both individuals eligi- ble for medicare benefits and those not eligible for such benefits; ‘‘(B) the quality of care provided to end-stage renal disease beneficiaries, as measured by clinical indica- tors, functional status of patients, and patient satis- faction; ‘‘(C) the effect of reimbursement on quality of treatment; ‘‘(D) major epidemiological and demographic changes in the end-stage renal disease population that may affect access to treatment, the quality of care, or the resource requirements of the program; and ‘‘(E) the adequacy of existing data systems to mon- itor these matters on a continuing basis. ‘‘(3) The Secretary shall submit to Congress, not later than 3 years after the date of the enactment of this Act [Dec. 22, 1987], a report on the study. ‘‘(4) The Secretary shall request the National Acad- emy of Sciences, acting through the Institute of Medi- cine, to submit an application to conduct the study de- scribed in this section. If the Academy submits an ac- ceptable application, the Secretary shall enter into an appropriate arrangement with the Academy for the conduct of the study. If the Academy does not submit an acceptable application to conduct the study, the Secretary may request one or more appropriate non- profit private entities to submit an application to con- duct the study and may enter into an appropriate ar- rangement for the conduct of the study by the entity which submits the best acceptable application.’’ RATES FOR DIALYSIS SERVICES Pub. L. 99–509, title IX, § 9335(a)(1), Oct. 21, 1986, 100 Stat. 2029, as amended by Pub. L. 101–239, title VI, § 6203(a)(1), Dec. 19, 1989, 103 Stat. 2235; Pub. L. 101–508, title IV, § 4201(a), Nov. 5, 1990, 104 Stat. 1388–102; Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 222(b)], Nov. 29, 1999, 113 Stat. 1536, 1501A–352, provided that: ‘‘Effective with respect to dialysis services provided on or after October 1, 1986, and before December 31, 1990, the Secretary of Health and Human Services shall establish the base rate for routine dialysis treatment in a free-standing facility and in a hospital-based facility under section 1881(b)(7) of the Social Security Act [42 U.S.C. 1395rr(b)(7)] at a level equal to the respective rate in ef- fect as of May 13, 1986, reduced by $2.00. With respect to services furnished on or after January 1, 1991, and be- fore January 1, 2000, such base rate shall be equal to the respective rate in effect as of September 30, 1990 (deter- mined without regard to any reductions imposed pursu- ant to section 6201 of the Omnibus Budget Reconcili- Page 3772 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395rr–1 1 So in original. Probably should not be capitalized. ation Act of 1989 [Pub. L. 101–239, set out as a note under section 904 of Title 2, The Congress]), increased by $1.00. No change may be made in the base rate in ef- fect as of September 30, 1990, unless the Secretary makes such change in accordance with notice and com- ment requirements set forth in section 1871(b)(1) of such Act [42 U.S.C. 1395rr(b)(1)].’’ [Pub. L. 101–239, title VI, § 6203(a)(2), Dec. 19, 1989, 103 Stat. 2235, provided that: ‘‘The amendment made by paragraph (1) [amending section 9335(a)(1) of Pub. L. 99–509, set out above] shall take effect as if included in the enactment of the Omnibus Budget Reconciliation Act of 1986 [Pub. L. 99–509].’’] STUDY AND REPORT ON MEDICARE PAYMENT RATE RE- DUCTIONS FOR PATIENTS WITH END STAGE RENAL DISEASE Pub. L. 99–509, title IX, § 9335(b), Oct. 21, 1986, 100 Stat. 2029, directed Secretary of Health and Human Services to provide for a study to evaluate the effects of reduc- tions in the rates of payment for facility and physi- cians’ services under the medicare program for patients with end stage renal disease on their access to care or on the quality of care, and a report to Congress on re- sults of the study by not later than Jan. 1, 1988, with Secretary to enter into an appropriate arrangement with the National Academy of Sciences or other appro- priate nonprofit private entity for the conduct of the study. DEADLINE FOR ESTABLISHING NEW END STAGE RENAL DISEASE NETWORK AREAS; TRANSITION Pub. L. 99–509, title IX, § 9335(d)(2), (3), Oct. 21, 1986, 100 Stat. 2031, as amended by Pub. L. 100–203, title IV, § 4009(j)(6)(E), Dec. 22, 1987, 101 Stat. 1330–59, provided that: ‘‘(2) DEADLINE FOR ESTABLISHING NEW AREAS.—The Secretary of Health and Human Services shall establish end stage renal disease network areas, pursuant to the amendment made by paragraph (1) [amending this sec- tion], not later than May 1, 1987. The Secretary shall designate network administrative organizations for such areas by not later than July 1, 1987. ‘‘(3) TRANSITION.—If, under the amendment made by paragraph (1), the Secretary designates a network ad- ministrative organization for an area which was not previously designated for that area, the Secretary shall offer to continue to fund the previously designated or- ganization for that area for a period of 30 days after the first date the newly designated organization assumes the duties of a network administrative organization for that area.’’ REPORT ON ESTABLISHMENT OF NATIONAL END STAGE RENAL DISEASE REGISTRY Pub. L. 99–509, title IX, § 9335(i)(2), Oct. 21, 1986, 100 Stat. 2032, provided that: ‘‘The Secretary of Health and Human Services shall submit to the Congress, no later than April 1, 1987, a full report on the progress made in establishing the national end stage renal disease reg- istry under the amendment made by paragraph (1) [amending this section] and shall establish such reg- istry by not later than January 1, 1988.’’ DEADLINE FOR ESTABLISHMENT OF PROTOCOLS ON REUSE OF DIALYZER FILTERS Pub. L. 99–509, title IX, § 9335(k)(2), Oct. 21, 1986, 100 Stat. 2033, as amended by Pub. L. 100–203, title IV, § 4036(c)(1)(A), Dec. 22, 1987, 101 Stat. 1330–79, provided that: ‘‘The Secretary of Health and Human Services shall establish the protocols described in section 1881(f)(7)(A) of the Social Security Act [42 U.S.C. 1395rr(f)(7)(A)] by not later than October 1, 1987 (or July 1, 1988, with respect to protocols that relate to the reuse of bloodlines).’’ [Pub. L. 100–203, title IV, § 4036(c)(1)(B), Dec. 22, 1987, 101 Stat. 1330–79, provided that: ‘‘The amendment made by subparagraph (A) [amending section 9335(k)(2) of Pub. L. 99–509, set out above] shall be effective as if in- cluded in the enactment of section 9335(k)(2) of the Om- nibus Budget Reconciliation Act of 1986 [Pub. L. 99–509].’’] LIMITATION ON MERGER OF END STAGE RENAL DISEASE NETWORKS Pub. L. 99–272, title IX, § 9214, Apr. 7, 1986, 100 Stat. 180, provided that: ‘‘The Secretary of Health and Human Services shall maintain renal disease network organizations as authorized under section 1881(c) of the Social Security Act [42 U.S.C. 1395rr(c)], and may not merge the network organizations into other organiza- tions or entities. The Secretary may consolidate such network organizations, but only if such consolidation does not result in fewer than 14 such organizations being permitted to exist.’’ § 1395rr–1. Medicare coverage for individuals ex- posed to environmental health hazards (a) Deeming of individuals as eligible for medi- care benefits (1) In general For purposes of eligibility for benefits under this subchapter, an individual determined under subsection (c) to be an environmental exposure affected individual described in sub- section (e)(2) shall be deemed to meet the con- ditions specified in section 426(a) of this title. (2) Discretionary deeming For purposes of eligibility for benefits under this subchapter, the Secretary may deem an individual determined under subsection (c) to be an environmental exposure affected indi- vidual described in subsection (e)(3) to meet the conditions specified in section 426(a) of this title. (3) Effective date of coverage An Individual 1 who is deemed eligible for benefits under this subchapter under para- graph (1) or (2) shall be— (A) entitled to benefits under the program under Part 1 A as of the date of such deem- ing; and (B) eligible to enroll in the program under Part 1 B beginning with the month in which such deeming occurs. (b) Pilot program for care of certain individuals residing in emergency declaration areas (1) Program; purpose (A) Primary pilot program The Secretary shall establish a pilot pro- gram in accordance with this subsection to provide innovative approaches to furnishing comprehensive, coordinated, and cost-effec- tive care under this subchapter to individ- uals described in paragraph (2)(A). (B) Optional pilot programs The Secretary may establish a separate pilot program, in accordance with this sub- section, with respect to each geographic area subject to an emergency declaration (other than the declaration of June 17, 2009), in order to furnish such comprehensive, co- ordinated and cost-effective care to individ- uals described in subparagraph (2)(B) who re- side in each such area.