The 2009 Proposed Rule for Prospective ESRD Payment: Perspectives From the Forum of ESRD Networks

Article Outline

The Forum of ESRD Networks welcomes the opportunity to comment on the proposed rule for the end-stage renal disease (ESRD) prospective payment system (PPS). The Forum is a not-for-profit organization that advocates on behalf of the 18 regional ESRD Networks, coordinates projects and activities of mutual interest to the Networks, and facilitates the flow of information to and between the Networks. This editorial reflects the consensus of Forum leadership, including Network Executive Directors and nephrologists from all 18 Networks. The Networks and Forum are not involved with reimbursement policy except as it affects quality of care.

It is the opinion of the Forum that implementation of the PPS in its current form will unintentionally degrade ESRD care. The proposed PPS would undermine quality goals established by the Centers for Medicare & Medicaid Services (CMS) itself to ensure patient safety and independence, and to improve patients' experience of care. The proposal furthermore runs counter to the Institute of Medicine's 2001 recommendations in Crossing the Quality Chasm, that we strive to make health care safe, effective, patient-centered, timely, efficient, and equitable.1 Economic incentives in the proposed PPS will fragment care, compromising each of these goals. Specific items of concern are summarized point-by-point below.

1. The PPS will compromise patient access to ESRD services. Hemodialysis patients treated twice weekly and patients who miss treatments will become financially undesirable, because dialysis facilities will be responsible for laboratory and medication costs for the entire month, but will be reimbursed only for treatments delivered. Accordingly, some “undesirable” patients who miss treatments may be discharged involuntarily. Furthermore, facilities treating transient patients will have an incentive not to perform laboratory tests or to administer medications, and the quality of dialysis services received by transient patients will be difficult to monitor. Therefore, we are concerned that patient travel and emergent treatments away from the patient's permanent facility may be severely curtailed unless facilities have financial agreements with each other. Patients not treated by large dialysis organizations will be particularly disadvantaged.

2. Additional payment for home training sessions and/or self-training sessions will cease and Method II will be eliminated. Without additional payment for training, facilities will offer home treatment to fewer patients; in particular, facilities will be less likely to offer home therapies to elderly, less able, and less educated patients anticipated to require more prolonged training, thereby increasing disparities in care. Facilities that accept these more work-intensive patients from other facilities specifically for home training purposes will be disadvantaged. Additionally, the loss of the Method II option will particularly affect small dialysis organizations and independent providers, both of which lack the corporate infrastructure needed to establish secondary reimbursement relationships to allow billing for durable medical equipment goods. Finally, this policy could profoundly impair the ability of pediatric dialysis facilities to provide peritoneal dialysis, as most now use Method II to support their home peritoneal dialysis programs.

3. The per treatment unit of payment will remain, with 3 treatments per week allowed (more based on medical necessity). Maintaining the traditional form of reimbursement does not address the delivery of innovative therapies, including shortened daily dialysis or nocturnal dialysis, and discourages development and implementation of future improvements in the delivery of dialysis care. Facilities that strive to optimize treatment options for their patients must bill under a per unit treatment which may not fit the way in which the treatment is actually delivered.

4. Proposed case-mix payment adjusters do not align with incentives for high-quality care. For example, adjustment for recent bacteremia creates a perverse incentive to prolong catheter use, and adjustment for recent bacterial pneumonia creates a perverse incentive not to administer pneumococcal vaccine.

5. All laboratory tests ordered by nephrologists billing for outpatient dialysis will be included in the bundled payment. Preserving veins by minimizing venipuncture is essential to our national effort to promote native vein fistulas. ESRD patients routinely require measurement of lipid levels, glycosylated hemoglobin, prothrombin time, and anticonvulsant levels at hemodialysis, as well as tests required in preparation for transplant. Sampling for these tests at hemodialysis improves adherence to testing orders and allows tests to be performed more quickly than if patients are required to visit outpatient phlebotomy facilities. However, under the new PPS, these tests will be reimbursed outside the bundle only if ordered by physicians who do not bill for outpatient dialysis. To protect patients' veins and assure that the nephrology team receives the test results, many facilities will be required to credential each patient's primary and specialty care physicians so that the tests may be drawn at hemodialysis. Reflecting such an administrative burden, dialysis facilities may require non–dialysis unit physician providers to order such tests at outpatient laboratories. Transplant evaluations and routine care could be delayed, and, in the absence of consolidated medical records systems, treating nephrologists may not know patients' drug levels. Similarly, non–dialysis unit physicians who order such tests may adjust treatment without regard for the implications of kidney failure and dialysis treatment.

6. All intravenous medications administered in the dialysis facility will be included in the bundled payment. The Medicare Improvements for Patients and Providers Act of 2008 mandates that all ESRD-related intravenous medications and their oral equivalents be included in the bundled payment.2 Accordingly, dialysis providers may decline to administer intravenous medications not directly related to kidney failure, such as antibiotics for infected diabetic foot ulcers or other infections. Personnel administering these drugs outside the dialysis unit will need alternate intravenous access, often via a peripherally inserted central catheter line, which imperils sites for future hemodialysis vascular access.

7. ESRD-specific oral drugs will be included in the bundle. Out of fiscal necessity, dialysis providers will turn to the most economical alternatives when deciding upon oral medications. For example, it is likely that dialysis providers will abandon the use of cinacalcet hydrochloride to control hyperparathyroidism, increasing the parathyroidectomy rate, without regard to patient choice. Nephrologists may be placed in the untenable position of determining not which medications are most appropriate for a patient, but rather which patients within the facility are most deserving or have the greatest need for certain medications.The necessity for contractual arrangements between facilities and pharmacies to provide ESRD-related oral medications may affect patient safety as well as medication access. While the larger dialysis providers have internal pharmacy options, smaller providers generally do not. In areas with multiple pharmacy options, the facility may not be able to contract with all pharmacies, and patients may resort to obtaining ESRD medications from one pharmacy and non-ESRD medications from another due to insurance or geographic reasons, resulting in concerns regarding medication interactions, reconciliation, and tracking.

8. The PPS will establish a Quality Incentive Program (QIP) by the year 2012. The implementation of reimbursement based on the QIP in the dialysis provider setting may affect quality of care in unanticipated ways. For example, with the initial emphasis being placed on adequacy and anemia management, other aspects of treatment may be ignored as facilities intensify efforts to meet payment for performance (P4P) goals. With the current momentum in increasing the percentages of prevalent arteriovenous fistulas, it would be more desirable to include this indicator in any first round of P4P. It is our understanding that CMS will use claims data from the year 2010 to assess quality when the QIP begins in 2012. To assess quality on 2-year old data is counter to the fundamentals of quality improvement, which demand timely data analysis. Further, to withhold reimbursement based on 2-year old data will have the effect of punishing facilities which have made advancements in quality between 2010 and 2012. Finally, the establishment of QIP benchmarks based on national averages rather than on best practices perpetuates mediocrity and removes incentives for performance improvement among providers who are achieving average but suboptimal outcomes.

9. Initial outcomes analysis will be based on limited claims data. It will be critical for the Networks to detect and evaluate the consequences of the reimbursement changes; however, unintended consequences may be difficult to measure even with a robust data system. The Networks need to appropriately assess quality of care, access to care, and disparity issues through the analysis of timely, accurate, validated, and complete patient-level data. Unfortunately, the information systems that are required to address these issues may not be available and, to date, the level of Network access to CROWNWeb data is unclear. Claims data are incomplete, are not timely, and will not provide an accurate assessment of the quality of care provided by a dialysis facility.

In conclusion, the Forum of ESRD Networks supports CMS' overarching goals in the PPS to provide more cost-effective care, eliminate waste, and create a culture of value-based purchasing. However, the Forum is concerned that the provisions of the PPS summarized above neither support several goals of the ESRD Network Program nor several goals delineated by the Institute of Medicine to cross the quality chasm. We appeal to CMS to reassess the proposed rule for PPS to focus on the establishment of a dialysis care system that is more patient-centered, less fragmented, and more comprehensive.

Acknowledgements

Drs Kristensen and Wish are current and former President of the Forum of ESRD Networks, respectively.

Financial Disclosure: Dr Kristensen is a partner in a joint venture of dialysis facility ownership with DaVita, Inc. Dr Wish declares that he has no relevant financial interests.

References

1. 1Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press; 2001;.

2. 2Medicare Improvements for Patients and Providers Act of 2008. Medicare, Provisions Relating to Part B, Other Payment and Coverage Improvements. Public L No. 110-275, §153(a).

Forum of ESRD Networks

Address correspondence to Cynthia Kristensen, MD, Denver Nephrology, 130 Rampart Way, Ste 300B, Denver, CO 80230

This article is part of a series in the February 2010 issue of AJKD that explores the 2009 proposed rule for the Medicare ESRD prospective payment system.

PII: S0272-6386(09)01577-7

doi:10.1053/j.ajkd.2009.12.008

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