HR.
3162 (version July 25, 2007)
Children's Health and Medicare Protection Act of 2007 (Introduced in House)
Subtitle C--End Stage Renal Disease Program
SEC. 631. CHRONIC KIDNEY DISEASE DEMONSTRATION PROJECTS.
SEC. 632. MEDICARE COVERAGE OF KIDNEY DISEASE PATIENT EDUCATION SERVICES.
`Kidney Disease Education Services
SEC. 633. REQUIRED TRAINING FOR PATIENT CARE DIALYSIS TECHNICIANS.
SEC. 634. MEDPAC REPORT ON TREATMENT MODALITIES FOR PATIENTS WITH KIDNEY FAILURE.
SEC. 635. ADJUSTMENT FOR ERYTHROPOIETIN STIMULATING AGENTS (ESAS).
SEC. 636. SITE NEUTRAL COMPOSITE RATE.
SEC. 637. DEVELOPMENT OF ESRD BUNDLING SYSTEM AND QUALITY INCENTIVE PAYMENTS.
SEC. 638. MEDPAC REPORT ON ESRD BUNDLING SYSTEM.
SEC. 639. OIG STUDY AND REPORT ON ERYTHROPOIETIN
SEC. 703. EXTENSION OF MEDICARE SECONDARY PAYER FOR BENEFICIARIES WITH END STAGE RENAL DISEASE FOR LARGE GROUP PLANS.
SEC. 631. CHRONIC KIDNEY DISEASE DEMONSTRATION PROJECTS.
(a) In General- The Secretary of Health and Human Services (in this section referred to as the `Secretary'), acting through the Director of the National Institutes of Health, shall establish demonstration projects to--
(1) increase public and medical community awareness (particularly of those who treat patients with diabetes and hypertension) about the factors that lead to chronic kidney disease, how to prevent it, how to diagnose it, and how to treat it;
(2) increase screening and use of prevention techniques for chronic kidney disease for Medicare beneficiaries and the general public (particularly among patients with diabetes and hypertension, where prevention techniques are well established and early detection makes prevention possible); and
(3) enhance surveillance systems and expand research to better assess the prevalence and incidence of chronic kidney disease, (building on work done by Centers for Disease Control and Prevention).
(b) Scope and Duration-
(1) SCOPE- The Secretary shall select at least 3 States in which to conduct demonstration projects under this section. In selecting the States under this paragraph, the Secretary shall take into account the size of the population of individuals with end-stage renal disease who are enrolled in part B of title XVIII of the Social Security Act and ensure the participation of individuals who reside in rural and urban areas.
(2) DURATION- The demonstration projects under this section shall be conducted for a period that is not longer than 5 years and shall begin on January 1, 2009.
(c) Evaluation and Report-
(1) EVALUATION- The Secretary shall conduct an evaluation of the demonstration projects conducted under this section.
(2) REPORT- Not later than 12 months after the date on which the demonstration projects under this section are completed, the Secretary shall submit to Congress a report on the evaluation conducted under paragraph (1) together with recommendations for such legislation and administrative action as the Secretary determines appropriate.
SEC. 632. MEDICARE COVERAGE OF KIDNEY DISEASE PATIENT EDUCATION SERVICES.
(a) Coverage of Kidney Disease Education Services-
(1) COVERAGE- Section 1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)) is amended--
(A) in subparagraph (Z), by striking `and' after the semicolon at the end;
(B) in subparagraph (AA), by adding `and' after the semicolon at the end; and
(C) by adding at the end the following new subparagraph: `(BB) kidney disease education services (as defined in subsection (ccc));'.
(2) SERVICES DESCRIBED- Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended by adding at the end the following new subsection:
`Kidney Disease Education Services
`(ccc)(1) The term `kidney disease education services' means educational services that are--
`(A) furnished to an individual with stage IV chronic kidney disease who, according to accepted clinical guidelines identified by the Secretary, will require dialysis or a kidney transplant;
`(B) furnished, upon the referral of the physician managing the individual's kidney condition, by a qualified person (as defined in paragraph (2)); and
`(C) designed--
`(i) to provide comprehensive information (consistent with the standards developed under paragraph (3)) regarding--
`(I) the management of comorbidities, including for purposes of delaying the need for dialysis;
`(II) the prevention of uremic complications; and
`(III) each option for renal replacement therapy (including hemodialysis and peritoneal dialysis at home and in-center as well as vascular access options and transplantation);
`(ii) to ensure that the individual has the opportunity to actively participate in the choice of therapy; and
`(iii) to be tailored to meet the needs of the individual involved.
`(2) The term `qualified person' means a physician, physician assistant, nurse practitioner, or clinical nurse specialist who furnishes services for which payment may be made under the fee schedule established under section 1848. Such term does not include a renal dialysis facility.
`(3) The Secretary shall set standards for the content of such information to be provided under paragraph (1)(C)(i) after consulting with physicians, other health professionals, health educators, professional organizations, accrediting organizations, kidney patient organizations, dialysis facilities, transplant centers, network organizations described in section 1881(c)(2), and other knowledgeable persons. To the extent possible the Secretary shall consult with a person or entity described in the previous sentence, other than a dialysis facility, that has not received industry funding from a drug or biological manufacturer or dialysis facility.
`(4) In promulgating regulations to carry out this subsection, the Secretary shall ensure that each individual who is eligible for benefits for kidney disease education services under this title receives such services in a timely manner to maximize the benefit of those services.
`(5) The Secretary shall monitor the implementation of this subsection to ensure that individuals who are eligible for benefits for kidney disease education services receive such services in the manner described in paragraph (4).
`(6) No individual shall be eligible to be provided more than 6 sessions of kidney disease education services under this title.'.
(3) PAYMENT UNDER THE PHYSICIAN FEE SCHEDULE- Section 1848(j)(3) of the Social Security Act (42 U.S.C. 1395w-4(j)(3)) is amended by inserting `(2)(BB),' after `(2)(AA),'.
(4) LIMITATION ON NUMBER OF SESSIONS- Section 1862(a)(1) of the Social Security Act (42 U.S.C. 1395y(a)(1)) is amended--
(A) in subparagraph (M), by striking `and' at the end;
(B) in subparagraph (N), by striking the semicolon at the end and inserting `, and'; and
(C) by adding at the end the following new subparagraph:
`(O) in the case of kidney disease education services (as defined in section 1861(ccc)), which are furnished in excess of the number of sessions covered under such section;'.
(5) GAO REPORT- Not later than September 1, 2010, the Comptroller General of the United States shall submit to Congress a report on the following:
(A) The number of Medicare beneficiaries who are eligible to receive benefits for kidney disease education services (as defined in section 1861(ccc) of the Social Security Act, as added by paragraph (2)) under title XVIII of such Act and who receive such services.
(B) The extent to which there is a sufficient amount of physicians, physician assistants, nurse practitioners, and clinical nurse specialists to furnish kidney disease education services (as so defined) under such title and whether or not renal dialysis facilities (and appropriate employees of such facilities) should be included as an entity eligible under such section to furnish such services.
(C) Recommendations, if appropriate, for renal dialysis facilities (and appropriate employees of such facilities) to structure kidney disease education services (as so defined) in a manner that is objective and unbiased and that provides a range of options and alternative locations for renal replacement therapy and management of co-morbidities that may delay the need for dialysis.
(b) Effective Date- The amendments made by this section shall apply to services furnished on or after January 1, 2009.
SEC. 633. REQUIRED TRAINING FOR PATIENT CARE DIALYSIS TECHNICIANS.
Section 1881 of the Social Security Act (42 U.S.C. 1395rr) is amended by adding the following new subsection:
`(h)(1) Except as provided in paragraph (2), a provider of services or a renal dialysis facility may not use, for more than 12 months during 2009, or for any period beginning on January 1, 2010, any individual as a patient care dialysis technician unless the individual--
`(A) has completed a training program in the care and treatment of an individual with chronic kidney failure who is undergoing dialysis treatment; and
`(B) has been certified by a nationally recognized certification entity for dialysis technicians.
`(2)(A) A provider of services or a renal dialysis facility may permit an individual enrolled in a training program described in paragraph (1)(A) to serve as a patient care dialysis technician while they are so enrolled.
`(B) The requirements described in subparagraphs (A), (B), and (C) of paragraph (1) do not apply to an individual who has performed dialysis-related services for at least 5 years.
`(3) For purposes of paragraph (1), if, since the most recent completion by an individual of a training program described in paragraph (1)(A), there has been a period of 24 consecutive months during which the individual has not furnished dialysis-related services for monetary compensation, such individual shall be required to complete a new training program or become recertified as described in paragraph (1)(B).
`(4) A provider of services or a renal dialysis facility shall provide such regular performance review and regular in-service education as assures that individuals serving as patient care dialysis technicians for the provider or facility are competent to perform dialysis-related services.'.
SEC. 634. MEDPAC REPORT ON TREATMENT MODALITIES FOR PATIENTS WITH KIDNEY FAILURE.
(a) Evaluation-
(1) IN GENERAL- Not later than March 1, 2009, the Medicare Payment Advisory Commission (established under section 1805 of the Social Security Act) shall submit to the Secretary and Congress a report evaluating the barriers that exist to increasing the number of individuals with end-stage renal disease who elect to receive home dialysis services under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.).
(2) REPORT DETAILS- The report shall include the following:
(A) A review of Medicare home dialysis demonstration projects initiated before the date of the enactment of this Act, and the results of such demonstration projects and recommendations for future Medicare home dialysis demonstration projects or Medicare program changes that will test models that can improve Medicare beneficiary access to home dialysis.
(B) A comparison of current Medicare home dialysis costs and payments with current in-center and hospital dialysis costs and payments.
(C) An analysis of the adequacy of Medicare reimbursement for patient training for home dialysis (including hemodialysis and peritoneal dialysis) and recommendations for ensuring appropriate payment for such home dialysis training.
(D) A catalogue and evaluation of the incentives and disincentives in the current reimbursement system that influence whether patients receive home dialysis services or other treatment modalities.
(E) An evaluation of patient education services and how such services impact the treatment choices made by patients.
(F) Recommendations for implementing incentives to encourage patients to elect to receive home dialysis services or other treatment modalities under the Medicare program
(3) SCOPE OF REVIEW- In preparing the report under paragraph (1), the Medicare Payment Advisory Commission shall consider a variety of perspectives, including the perspectives of physicians, other health care professionals, hospitals, dialysis facilities, health plans, purchasers, and patients.
SEC. 635. ADJUSTMENT FOR ERYTHROPOIETIN STIMULATING AGENTS (ESAS).
(a) In General- Subsection (b)(13) of section 1881 of the Social Security Act (42 U.S.C. 1395rr) is amended--
(1) in subparagraph (A)(iii), by striking `For such drugs' and inserting `Subject to subparagraph (C), for such drugs'; and
(2) by adding at the end the following new subparagraph:
`(C)(i) The payment amounts under this title for erythropoietin furnished during 2008 or 2009 to an individual with end stage renal disease by a large dialysis facility (as defined in subparagraph (D)) (whether to individuals in the facility or at home), in an amount equal to $8.75 per thousand units (rounded to the nearest 100 units) or, if less, 102 percent of the average sales price (as determined under section 1847A) for such drug or biological.
`(ii) The payment amounts under this title for darbepoetin alfa furnished during 2008 or 2009 to an individual with end stage renal disease by a large dialysis facility (as defined in clause
(iii)) (whether to individuals in the facility or at home), in an amount equal to $2.92 per microgram or, if less, 102 percent of the average sales price (as determined under section 1847A) for such drug or biological. `(iii) For purposes of this subparagraph, the term `large dialysis facility' means a provider of services or renal dialysis facility that is owned or managed by a corporate entity that, as of July 24, 2007, owns or manages 300 or more such providers or facilities, and includes a successor to such a corporate entity'.
(b) No Impact on Drug Add-On Payment- Nothing in the amendments made by subsection (a) shall be construed to affect the amount of any payment adjustment made under section 1881(b)(12)(B)(ii) of the Social Security Act (42 U.S.C. 1395rr(b)(12)(B)(ii)).
SEC. 636. SITE NEUTRAL COMPOSITE RATE.
Subsection (b)(12)(A) of section 1881 of the Social Security Act (42 U.S.C. 1395rr) is amended by adding at the end the following new sentence: `Under such system the payment rate for dialysis services furnished on or after January 1, 2008, by providers of such services for hospital-based facilities shall be the same as the payment rate (computed without regard to this sentence) for such services furnished by renal dialysis facilities that are not hospital-based, except that in applying the geographic index under subparagraph (D) to hospital-based facilities, the labor share shall be based on the labor share otherwise applied for such facilities.'.
SEC. 637. DEVELOPMENT OF ESRD BUNDLING SYSTEM AND QUALITY INCENTIVE PAYMENTS.
(a) Development of ESRD Bundling System- Subsection (b) of section 1881 of the Social Security Act (42 U.S.C. 1395rr) is further amended--
(1) in paragraph (12)(A), by striking `In lieu of payment' and inserting `Subject to paragraph (14), in lieu of payment';
(2) in the second sentence of paragraph (12)(F)--
(A) by inserting `or paragraph (14)' after `this paragraph'; and
(B) by inserting `or under the system under paragraph (14)' after `subparagraph (B)';
(3) in paragraph (12)(H)--
(A) by inserting `or paragraph (14)' after `under this paragraph' the first place it appears; and
(B) by inserting before the period at the end the following: `or, under paragraph (14), the identification of renal dialysis services included in the bundled payment, the adjustment for outliers, the identification of facilities to which the phase-in may apply, and the determination of payment amounts under subparagraph (A) under such paragraph, and the application of paragraph (13)(C)(iii))';
(4) in paragraph (13)--
(A) in subparagraph (A), by striking `The payment amounts' and inserting `subject to paragraph (14), the payment amounts'; and
(B) in subparagraph (B)--
(i) in clause (i), by striking `(i)' after `(B)' and by inserting `, subject to paragraph (14)' before the period at the end; and
(ii) by striking clause (ii); and
(5) by adding at the end the following new paragraph:
`(14)(A) Subject to subparagraph (E), for services furnished on or after January 1, 2010, the Secretary shall implement a payment system under which a single payment is made under this title for renal dialysis services (as defined in subparagraph (B)) in lieu of any other payment (including a payment adjustment under paragraph (12)(B)(ii)) for such services and items furnished pursuant to paragraph (4). In implementing the system the Secretary shall ensure that the estimated total amount of payments under this title for 2010 for renal dialysis services shall equal 96 percent of the estimated amount of payments for such services, including payments under paragraph (12)(B)(ii), that would have been made if such system had not been implemented.
`(B) For purposes of this paragraph, the term `renal dialysis services' includes--
`(i) items and services included in the composite rate for renal dialysis services as of December 31, 2009;
`(ii) erythropoietin stimulating agents furnished to individuals with end stage renal disease;
`(iii) other drugs and biologicals and diagnostic laboratory tests, that the Secretary identifies as commonly used in the treatment of such patients and for which payment was (before the application of this paragraph) made separately under this title, and any oral equivalent form of such drugs and biologicals or of drugs and biologicals described in clause (ii); and
`(iv) home dialysis training for which payment was (before the application of this paragraph) made separately under this section.
Such term does not include vaccines.
`(C) The system under this paragraph may provide for payment on the basis of services furnished during a week or month or such other appropriate 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 patient 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 erythropoietin stimulating agents necessary for anemia management; and
`(iii) may include such other payment adjustments as the Secretary determines appropriate, such as a payment adjustment--
`(I) by a geographic index, such as the index referred to in paragraph (12)(D), as the Secretary determines to be appropriate;
`(II) for pediatric providers of services and renal dialysis facilities;
`(III) for low volume providers of services and renal dialysis facilities;
`(IV) for providers of services or renal dialysis facilities located in rural areas; and
`(V) for providers of services or renal dialysis facilities that are not large dialysis facilities.
`(E) The Secretary may provide for a phase-in of the payment system described in subparagraph (A) for services furnished by a provider of services or renal dialysis facility described in any of subclauses (II) through (V) of subparagraph (D)(iii), but such payment system shall be fully implemented for services furnished in the case of any such provider or facility on or after January 1, 2013.
`(F) The Secretary shall apply the annual increase that would otherwise apply under subparagraph (F) of paragraph (12) to payment amounts established under such paragraph (if this paragraph did not apply) in an appropriate manner under this paragraph.'.
(6) PROHIBITION OF UNBUNDLING- Section 1862(a) of such Act (42 U.S.C. 1395y(a)) is amended--
(A) by striking `or' at the end of paragraph (21);
(B) by striking the period at the end of paragraph (22) and inserting `; or'; and
(C) by inserting after paragraph (22) the following new paragraph:
`(23) where such expenses are for renal dialysis services (as defined in subparagraph (B) of section 1881(b)(14)) for which payment is made under such section (other than under subparagraph (E) of such section) unless such payment is made under such section to a provider of services or a renal dialysis facility for such services.'.
(b) Quality Incentive Payments- Section 1881 of such Act is amended by adding at the end the following new subsection:
`(i) Quality Incentive Payments in the End-Stage Renal Disease Program-
`(1) QUALITY INCENTIVE PAYMENTS FOR SERVICES FURNISHED IN 2008, 2009, AND 2010-
`(A) IN GENERAL- With respect to renal dialysis services furnished during a performance period (as defined in subparagraph (B)) by a provider of services or renal dialysis facility that the Secretary determines meets the applicable performance standard for the period under subparagraph (C) and reports on measures for 2009 and 2010 under subparagraph (D) for such services, in addition to the amount otherwise paid under this section, subject to subparagraph (G), there also shall be paid to the provider or facility an amount equal to the applicable percentage (specified in subparagraph (E) for the period) of the Secretary's estimate (based on claims submitted not later than two months after the end of the performance period) of the amount specified in subparagraph (F) for such period.
`(B) PERFORMANCE PERIOD- In this paragraph, the term `performance period' means each of the following:
`(i) The period beginning on July 1, 2008, and ending on December 31, 2008.
`(ii) 2009.
`(iii) 2010.
`(C) PERFORMANCE STANDARD-
`(i) 2008- For the performance period occurring in 2008, the applicable performance standards for a provider or facility under this subparagraph are--
`(I) 92 percent or more of individuals with end stage renal disease receiving erythopoetin stimulating agents who have an average hematocrit of 33.0 percent or more; and
`(II) less than a percentage, specified by the Secretary, of individuals with end stage renal disease receiving erythopoetin stimulating agents who have an average hematocrit of 39.0 percent or more.
`(ii) 2009 AND 2010- For the 2009 and 2010 performance periods, the applicable performance standard for a provider or facility under this subparagraph is successful performance (relative to national average) on--
`(I) such measures of anemia management as the Secretary shall specify, including measures of hemoglobin levels or hematocrit levels for erythropoietin stimulating agents that are consistent with the labeling for dosage of erythropoietin stimulating agents approved by the Food and Drug Administration for treatment of anemia in patients with end stage renal disease, taking into account variations in hemoglobin ranges or hematocrit levels of patients; and
`(II) such other measures, relating to subjects described in subparagraph (D)(i), as the Secretary may specify.
`(D) REPORTING PERFORMANCE MEASURES- The performance measures under this subparagraph to be reported shall include--
`(i) such measures as the Secretary specifies, before the beginning of the performance period involved and taking into account measures endorsed by the National Quality Forum, including, to the extent feasible measures on--
`(I) iron management;
`(II) dialysis adequacy; and
`(III) vascular access, including for maximizing the placement of arterial venous fistula; and
`(ii) to the extent feasible, such measure (or measures) of patient satisfaction as the Secretary shall specify. The provider or facility submitting information on such measures shall attest to the completeness and accuracy of such information.
`(E) APPLICABLE PERCENTAGE- The applicable percentage specified in this subparagraph for--
`(i) the performance period occurring in 2008, is 1.0 percent;
`(ii) the 2009 performance period, is 2.0 percent; and
`(iii) the 2010 performance period, is 2.0 percent.
In the case of any performance period which is less than an entire year, the applicable percentage specified in this subparagraph shall be multiplied by the ratio of the number of months in the year to the number of months in such performance period. In the case of 2010, the applicable percentage specified in this subparagraph shall be multiplied by the Secretary's estimate of the ratio of the aggregate payment amount described in subparagraph (F)(i) that would apply in 2010 if paragraph (14) did not apply, to the aggregate payment base under subparagraph (F)(ii) for 2010.
`(F) PAYMENT BASE- The payment base described in this subparagraph for a provider or facility is--
`(i) for performance periods before 2010, the payment amount determined under paragraph (12) for services furnished by the provider or facility during the performance period, including the drug payment adjustment described in subparagraph (B)(ii) of such paragraph; and
`(ii) for the 2010 performance period is the amount determined under paragraph (14) for services furnished by the provider or facility during the period.
`(G) LIMITATION ON FUNDING-
`(i) IN GENERAL- If the Secretary determines that the total payments under this paragraph for a performance period is projected to exceed the dollar amount specified in clause (ii) for such period, the Secretary shall reduce, in a pro rata manner, the amount of such payments for each provider or facility for such period to eliminate any such projected excess for the period.
`(ii) DOLLAR AMOUNT- The dollar amount specified in this clause--
`(I) for the performance period occurring in 2008, is $50,000,000;
`(II) for the 2009 performance period is $100,000,000; and
`(III) for the 2010 performance period is $150,000,000.
`(H) FORM OF PAYMENT- The payment under this paragraph shall be in the form of a single consolidated payment.
`(2) QUALITY INCENTIVE PAYMENTS FOR FACILITIES AND PROVIDERS FOR 2011-
`(A) INCREASED PAYMENT- For 2011, in the case of a provider or facility that, for the performance period (as defined in subparagraph (B))--
`(i) meets (or exceeds) the performance standard for anemia management specified in paragraph (1)(C)(ii)(I);
`(ii) has substantially improved performance or exceeds a performance standard (as determined under subparagraph (E)); and
`(iii) reports measures specified in paragraph (1)(D),
with respect to renal dialysis services furnished by the provider or facility during the quality bonus payment period (as specified in subparagraph (C)) the payment amount otherwise made to such provider or facility under subsection (b)(14) shall be increased, subject to subparagraph (F), by the applicable percentage specified in subparagraph (D). Payment amounts under paragraph (1) shall not be counted for purposes of applying the previous sentence.
`(B) PERFORMANCE PERIOD- In this paragraph, the term `performance period' means a multi-month period specified by the Secretary .
`(C) QUALITY BONUS PAYMENT PERIOD- In this paragraph, the term `quality bonus payment period' means, with respect to a performance period, a multi-month period beginning on January 1, 2011, specified by the Secretary that begins at least 3 months (but not more than 9 months) after the end of the performance period.
`(D) APPLICABLE PERCENTAGE- The applicable percentage specified in this subparagraph is a percentage, not to exceed the 2.0 percent, specified by the Secretary consistent with subparagraph (F). Such percentage may vary based on the level of performance and improvement. The applicable percentage specified in this subparagraph shall be multiplied by the ratio applied under the third sentence of paragraph (1)(E) for 2010.
`(E) PERFORMANCE STANDARD- Based on performance of a provider of services or a renal dialysis facility on performance measures described in paragraph (1)(D) for a performance period, the Secretary shall determine a composite score for such period.
`(F) LIMITATION ON FUNDING- If the Secretary determines that the total amount to be paid under this paragraph for a quality bonus payment period is projected to exceed $200,000,000, the Secretary shall reduce, in a uniform manner, the applicable percentage otherwise applied under subparagraph (D) for services furnished during the period to eliminate any such projected excess.
`(3) APPLICATION-
`(A) IMPLEMENTATION- Notwithstanding any other provision of law, the Secretary may implement by program instruction or otherwise this subsection.
`(B) LIMITATIONS ON REVIEW-
`(i) IN GENERAL- There shall be no administrative or judicial review under section 1869 or 1878 or otherwise of--
`(I) the determination of performance measures and standards under this subsection;
`(II) the determination of successful reporting, including a determination of composite scores; and
`(III) the determination of the quality incentive payments made under this subsection.
`(ii) TREATMENT OF DETERMINATIONS- A determination under this subparagraph shall not be treated as a determination for purposes of section 1869.
`(4) TECHNICAL ASSISTANCE- The Secretary shall identify or establish an appropriately skilled group or organization, such as the ESRD Networks, to provide technical assistance to consistently low-performing facilities or providers that are in the bottom quintile.
`(5) PUBLIC REPORTING-
`(A) ANNUAL NOTICE- The Secretary shall provide an annual written notification to each individual who is receiving renal dialysis services from a provider of services or renal dialysis facility that--
`(i) informs such individual of the composite scores described in subparagraph (A) and other relevant quality measures with respect to providers of services or renal dialysis facilities in the local area;
`(ii) compares such scores and measures to the average local and national scores and measures; and
`(iii) provides information on how to access additional information on quality of such services furnished and options for alternative providers and facilities.
`(B) CERTIFICATES- The Secretary shall provide certificates to facilities and providers who provide services to individuals with end-stage renal disease under this title to display in patient areas. The certificate shall indicate the composite score obtained by the facility or provider under the quality initiative.
`(C) WEB-BASED QUALITY LIST- The Secretary shall establish a web-based list of facilities and providers who furnish renal dialysis services under this section that indicates their composite score of each provider and facility.
`(6) RECOMMENDATIONS FOR REPORTING AND QUALITY INCENTIVE INTITIATIVE FOR PHYSICIANS- The Secretary shall develop recommendations for applying quality incentive payments under this subsection to physicians who receive the monthly capitated payment under this title. Such recommendations shall include the following:
`(A) Recommendations to include pediatric specific measures for physicians with at least 50 percent of their patients with end stage renal disease being individuals under 18 years of age.
`(B) Recommendations on how to structure quality incentive payments for physicians who demonstrate improvements in quality or who attain quality standards, as specified by the Secretary.
`(7) REPORTS-
`(A) INITIAL REPORT- Not later than January 1, 2013, the Secretary shall submit to Congress a report on the implementation of the bundled payment system under subsection (b)(14) and the quality initiative under this subsection. Such report shall include the following information:
`(i) A comparison of the aggregate payments under subsection (b)(14) for items and services to the cost of such items and services.
`(ii) The changes in utilization rates for erythropoietin stimulating agents.
`(iii) The mode of administering such agents, including information on the proportion of such individuals receiving such agents intravenously as compared to subcutaneously.
`(iv) The frequency of dialysis.
`(v) Other differences in practice patterns, such as the adoption of new technology, different modes of practice, and variations in use of drugs other than drugs described in clause (iii).
`(vi) The performance of facilities and providers under paragraph (2).
`(vii) Other recommendations for legislative and administrative actions determined appropriate by the Secretary.
`(B) SUBSEQUENT REPORT- Not later than January 1, 2015, the Secretary shall submit to Congress a report that contains the information described in each of clauses (ii) through (vii) of subparagraph (A) and a comparison of the results of the payment system under subsection (b)(14) for renal dialysis services furnished during the 2-year period beginning on January 1, 2013, and the results of such payment system for such services furnished during the previous two-year period.'.
SEC. 638. MEDPAC REPORT ON ESRD BUNDLING SYSTEM.
Not later than March 1, 2012, the Medicare Payment Advisory Commission (established under section 1805 of the Social Security Act) shall submit to Congress a report on the implementation of the payment system under section 1881(b)(14) of the Social Security Act (as added by section 7) for renal dialysis services and related services (defined in subparagraph (B) of such section). Such report shall include, with respect to such payment system for such services, an analysis of each of the following:
(1) An analysis of the overall adequacy of payment under such system for all such services.
(2) An analysis that compares the adequacy of payment under such system for services furnished by--
(A) a provider of services or renal dialysis facility that is described in section 1881(b)(13)(C)(iv) of the Social Security Act;
(B) a provider of services or renal dialysis facility not described in such section;
(C) a hospital-based facility;
(D) a freestanding renal dialysis facility;
(E) a renal dialysis facility located in an urban area; and
(F) a renal dialysis facility located in a rural area.
(3) An analysis of the financial status of providers of such services and renal dialysis facilities, including access to capital, return on equity, and return on capital.
(4) An analysis of the adequacy of payment under such method and the adequacy of the quality improvement payments under section 1881(i) of the Social Security Act in ensuring that payments for such services under the Medicare program are consistent with costs for such services. (5) Recommendations, if appropriate, for modifications to such payment system.
SEC. 639. OIG STUDY AND REPORT ON ERYTHROPOIETIN.
(a) Study- The Inspector General of the Department of Health and Human Services shall conduct a study on the following:
(1) The dosing guidelines, standards, protocols, and alogorithms for erythropoietin stimulating agents recommended or used by providers of services and renal dialysis facilities that are described in section 1881(b)(13)(C)(iv) of the Social Security Act and providers and facilities that are not described in such section.
(2) The extent to which such guidelines, standards, protocols, and algorithms are consistent with the labeling of the Food and Drug Administration for such agents.
(3) The extent to which physicians sign standing orders for such agents that are consistent with such guidelines, standards, protocols, and algorithms recommended or used by the provider or facility involved.
(4) The extent to which the prescribing decisions of physicians, with respect to such agents, are independent of--
(A) such relevant guidelines, standards, protocols, and algorithms; or
(B) recommendations of an anemia management nurse or other appropriate employee of the provider or facility involved.
(5) The role of medical directors of providers of services and renal dialysis facilities and the financial relationships between such providers and facilities and the physicians hired as medical directors of such providers and facilities, respectively.
(b) Report- Not later than January 1, 2009, the Inspector General of the Department of Health and Human Services shall submit to Congress a report on the study conducted under subsection (a), together with such recommendations as the Inspector General determines appropriate.
SEC. 703. EXTENSION OF MEDICARE SECONDARY PAYER FOR BENEFICIARIES WITH END STAGE RENAL DISEASE FOR LARGE GROUP PLANS.
(a) In General- Section 1862(b)(1)(C) of the Social Security Act (42 U.S.C. 1395y(b)(1)(C)) is amended--
(1) by redesignating clauses (i) and (ii) as subclauses (I) and (II), respectively, and indenting accordingly;
(2) by amending the text preceding subclause (I), as so redesignated, to read as follows:
`(C) INDIVIDUALS WITH END STAGE RENAL DISEASE-
`(i) IN GENERAL- A group health plan (as defined in subparagraph (A)(v))--';
(3) in the matter following subclause (II), as so redesignated--
(A) by striking `clause (i)' and inserting `subclause (I)';
(B) by striking `clause (ii)' and inserting `subclause (II)'; and
(C) by striking `clauses (i) and (ii)' and inserting `subclauses (I) and (II)'; and
(D) in the last sentence, by striking `Effective for items' and inserting `Subject to clause (ii), effective for items'; and
(4) by adding at the end the following new clause:
`(ii) SPECIAL RULE FOR LARGE GROUP PLANS- In applying clause (i) to a large group health plan (as defined in subparagraph (B)(iii)). with respect to periods beginning on or after the date that is 30 months prior to January 1, 2008, subclauses (I) and (II) of such clause shall be applied by substituting `42-month' for `12-month' each place it appears.'.