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The 2009 Proposed Rule for Prospective ESRD Payment: Perspectives

From the Forum of ESRD Networks

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he Forum of ESRD Networks welcomes theopportunity to comment on the proposed

ule for the end-stage renal disease (ESRD) pro-pective payment system (PPS). The Forum is aot-for-profit organization that advocates on be-alf of the 18 regional ESRD Networks, coordi-ates projects and activities of mutual interest tohe Networks, and facilitates the flow of informa-ion to and between the Networks. This editorialeflects the consensus of Forum leadership, in-luding Network Executive Directors and neph-ologists from all 18 Networks. The Networksnd Forum are not involved with reimbursementolicy except as it affects quality of care.It is the opinion of the Forum that implementa-

ion of the PPS in its current form will uninten-ionally degrade ESRD care. The proposed PPSould undermine quality goals established by

he Centers for Medicare & Medicaid ServicesCMS) itself to ensure patient safety and indepen-ence, and to improve patients’ experience ofare. The proposal furthermore runs counter tohe Institute of Medicine’s 2001 recommenda-ions in Crossing the Quality Chasm, that wetrive to make health care safe, effective, patient-entered, timely, efficient, and equitable.1 Eco-omic incentives in the proposed PPS will frag-ent care, compromising each of these goals.pecific items of concern are summarized point-y-point below.

. The PPS will compromise patient access toESRD services. Hemodialysis patientstreated twice weekly and patients who misstreatments will become financially undesir-able, because dialysis facilities will be respon-sible for laboratory and medication costs forthe entire month, but will be reimbursed onlyfor treatments delivered. Accordingly, some

This article is part of a series in the February 2010 issuef AJKD that explores the 2009 proposed rule for theedicare ESRD prospective payment system.Address correspondence to Cynthia Kristensen, MD, Den-

er Nephrology, 130 Rampart Way, Ste 300B, Denver, CO0230. E-mail: ckristensen@denverneph.net© 2010 by the National Kidney Foundation, Inc.0272-6386/10/5502-0010$36.00/0

doi:10.1053/j.ajkd.2009.12.008

American Journal of Kid34

“undesirable” patients who miss treatmentsmay be discharged involuntarily. Further-more, facilities treating transient patientswill have an incentive not to perform labora-tory tests or to administer medications, andthe quality of dialysis services received bytransient patients will be difficult to monitor.Therefore, we are concerned that patienttravel and emergent treatments away fromthe patient’s permanent facility may be se-verely curtailed unless facilities have finan-cial agreements with each other. Patients nottreated by large dialysis organizations will beparticularly disadvantaged.

. Additional payment for home training ses-sions and/or self-training sessions will ceaseand Method II will be eliminated. Withoutadditional payment for training, facilitieswill offer home treatment to fewer patients;in particular, facilities will be less likely tooffer home therapies to elderly, less able, andless educated patients anticipated to requiremore prolonged training, thereby increasingdisparities in care. Facilities that accept thesemore work-intensive patients from other fa-cilities specifically for home training pur-poses will be disadvantaged. Additionally,the loss of the Method II option will particu-larly affect small dialysis organizations andindependent providers, both of which lackthe corporate infrastructure needed to estab-lish secondary reimbursement relationshipsto allow billing for durable medical equip-ment goods. Finally, this policy could pro-foundly impair the ability of pediatric dialy-sis facilities to provide peritoneal dialysis, asmost now use Method II to support theirhome peritoneal dialysis programs.

. The per treatment unit of payment willremain, with 3 treatments per week al-lowed (more based on medical necessity).Maintaining the traditional form of reimburse-ment does not address the delivery of innova-tive therapies, including shortened daily di-alysis or nocturnal dialysis, and discouragesdevelopment and implementation of futureimprovements in the delivery of dialysis

care. Facilities that strive to optimize treat-

ney Diseases, Vol 55, No 2 (February), 2010: pp 234-236

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Editorial 235

ment options for their patients must billunder a per unit treatment which may not fitthe way in which the treatment is actuallydelivered.

. Proposed case-mix payment adjusters donot align with incentives for high-qualitycare. For example, adjustment for recentbacteremia creates a perverse incentive toprolong catheter use, and adjustment forrecent bacterial pneumonia creates a per-verse incentive not to administer pneumococ-cal vaccine.

. All laboratory tests ordered by nephrolo-gists billing for outpatient dialysis will beincluded in the bundled payment. Preserv-ing veins by minimizing venipuncture isessential to our national effort to promotenative vein fistulas. ESRD patients routinelyrequire measurement of lipid levels, glycosy-lated hemoglobin, prothrombin time, andanticonvulsant levels at hemodialysis, aswell as tests required in preparation fortransplant. Sampling for these tests at hemo-dialysis improves adherence to testing ordersand allows tests to be performed more quicklythan if patients are required to visit outpa-tient phlebotomy facilities. However, underthe new PPS, these tests will be reimbursedoutside the bundle only if ordered by physi-cians who do not bill for outpatient dialysis.To protect patients’ veins and assure that thenephrology team receives the test results,many facilities will be required to credentialeach patient’s primary and specialty carephysicians so that the tests may be drawn athemodialysis. Reflecting such an administra-tive burden, dialysis facilities may requirenon–dialysis unit physician providers to or-der such tests at outpatient laboratories.Transplant evaluations and routine care couldbe delayed, and, in the absence of consoli-dated medical records systems, treating neph-rologists may not know patients’ drug levels.Similarly, non–dialysis unit physicians whoorder such tests may adjust treatment withoutregard for the implications of kidney failureand dialysis treatment.

. All intravenous medications administered inthe dialysis facility will be included in thebundled payment. The Medicare Improve-

ments for Patients and Providers Act of 2008

mandates that all ESRD-related intravenousmedications and their oral equivalents beincluded in the bundled payment.2 Accord-ingly, dialysis providers may decline to ad-minister intravenous medications not di-rectly related to kidney failure, such asantibiotics for infected diabetic foot ulcers orother infections. Personnel administeringthese drugs outside the dialysis unit will needalternate intravenous access, often via aperipherally inserted central catheter line,which imperils sites for future hemodialysisvascular access.

. ESRD-specific oral drugs will be includedin the bundle. Out of fiscal necessity, dialy-sis providers will turn to the most economi-cal alternatives when deciding upon oralmedications. For example, it is likely thatdialysis providers will abandon the use ofcinacalcet hydrochloride to control hyperpara-thyroidism, increasing the parathyroidec-tomy rate, without regard to patient choice.Nephrologists may be placed in the unten-able position of determining not which medi-cations are most appropriate for a patient, butrather which patients within the facility aremost deserving or have the greatest need forcertain medications.

The necessity for contractual arrangementsbetween facilities and pharmacies to provideESRD-related oral medications may affectpatient safety as well as medication access.While the larger dialysis providers have inter-nal pharmacy options, smaller providers gener-ally do not. In areas with multiple pharmacyoptions, the facility may not be able to contractwith all pharmacies, and patients may resortto obtaining ESRD medications from onepharmacy and non-ESRD medications fromanother due to insurance or geographic rea-sons, resulting in concerns regarding medica-tion interactions, reconciliation, and tracking.

. The PPS will establish a Quality IncentiveProgram (QIP) by the year 2012. Theimplementation of reimbursement based onthe QIP in the dialysis provider setting mayaffect quality of care in unanticipated ways.For example, with the initial emphasis beingplaced on adequacy and anemia manage-

ment, other aspects of treatment may be

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Kristensen and Wish236

ignored as facilities intensify efforts to meetpayment for performance (P4P) goals. Withthe current momentum in increasing thepercentages of prevalent arteriovenous fistu-las, it would be more desirable to include thisindicator in any first round of P4P. It is ourunderstanding that CMS will use claims datafrom the year 2010 to assess quality when theQIP begins in 2012. To assess quality on2-year old data is counter to the fundamen-tals of quality improvement, which demandtimely data analysis. Further, to withholdreimbursement based on 2-year old data willhave the effect of punishing facilities whichhave made advancements in quality between2010 and 2012. Finally, the establishment ofQIP benchmarks based on national averagesrather than on best practices perpetuatesmediocrity and removes incentives for perfor-mance improvement among providers whoare achieving average but suboptimal out-comes.

. Initial outcomes analysis will be based onlimited claims data. It will be critical for theNetworks to detect and evaluate the conse-quences of the reimbursement changes; how-ever, unintended consequences may be diffi-cult to measure even with a robust datasystem. The Networks need to appropriatelyassess quality of care, access to care, anddisparity issues through the analysis of timely,accurate, validated, and complete patient-level data. Unfortunately, the informationsystems that are required to address theseissues may not be available and, to date, the

level of Network access to CROWNWeb 2

data is unclear. Claims data are incomplete,are not timely, and will not provide anaccurate assessment of the quality of careprovided by a dialysis facility.

In conclusion, the Forum of ESRD Networksupports CMS’ overarching goals in the PPS torovide more cost-effective care, eliminate waste,nd create a culture of value-based purchasing.owever, the Forum is concerned that the provi-

ions of the PPS summarized above neither sup-ort several goals of the ESRD Network Pro-ram nor several goals delineated by the Institutef Medicine to cross the quality chasm. Weppeal to CMS to reassess the proposed rule forPS to focus on the establishment of a dialysisare system that is more patient-centered, lessragmented, and more comprehensive.

Cynthia Kristensen, MDJay Wish, MD

Forum of ESRD Networks

ACKNOWLEDGEMENTSDrs Kristensen and Wish are current and former President

f the Forum of ESRD Networks, respectively.Financial Disclosure: Dr Kristensen is a partner in a joint

enture of dialysis facility ownership with DaVita, Inc. Drish declares that he has no relevant financial interests.

REFERENCES1. Institute of Medicine. Crossing the Quality Chasm: A

ew Health System for the 21st Century. Washington, DC:ational Academy Press; 2001.2. Medicare Improvements for Patients and Providers Act

f 2008. Medicare, Provisions Relating to Part B, Otherayment and Coverage Improvements. Public L No. 110-

75, §153(a).