Creation/Revision Date: November 17, 2015
August 28, 2015
James Cosgrove, PhD
Director, Health Care
U.S. Government Accountability Office
441 G St., NW, Room 5021
Washington, DC 20548
[View the full GAO Report on Home Dialysis (GAO-16-125)]
Dear Director Cosgrove:
The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with kidney disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with kidney disease. We are writing to provide input on the GAO’s draft report to Congress on Medicare Payment Policies for Home Dialysis.
Not only do we appreciate the opportunity to provide input on the report, we also appreciate the GAO staff’s ongoing professionalism and competence in our interactions with them. Regarding the report itself, we generally believe that it reflects the performance of an exhaustive degree of research by GAO staff on the potential causes of the compromised use of home dialysis among U.S. end-stage renal disease (ESRD) patients, and thus its conclusions are largely accurate. However, RPA believes that the scope of the issues resulting in the underuse of home dialysis in the Medicare program is much wider than the ostensible charge of the GAO’s project (the extent to which Medicare payment policies are the source of the underuse). Accordingly, our comments not only provide input on the draft recommendations (paraphrased) in the report, but also highlight the broader issues limiting more widespread use of home dialysis in the U.S.
We believe that the three most important factors affecting use of home therapies are not tied to the Medicare payment system but rather relate to the following:
• Patient Centered Care: Patients must have all treatment options available to them so they can choose which option works best for them. This requires greatly improved patient education and access to dialysis centers offering all modalities of renal replacement therapy.
• Nephrologist Preparedness: Processes for providing nephrologists with adequate training and experience with home therapies must be identified, or incentives should be developed to refer appropriate candidates to other centers offering home therapies.
• Infrastructure for Home Dialysis Care: There must be appropriate staff support and supplies available to enable effective delivery of home therapies.
Comments on GAO Report Recommendations
CMS Should Improve the Reliability of Dialysis Facility Cost Data for the Treatment and Training Associated with Home Dialysis
RPA completely concurs with this recommendation. In fact, while we recognize that the report itself notes the shortcomings of self-reported dialysis facility cost data, it is our belief that dependence on self-reported data can be presented in ways beneficial to the source of the information. Further, the difficulty in segregating cost report and staff time data specific to home dialysis from overall dialysis facility cost data renders the informational foundation of the report less than optimal. RPA realizes that (in the report’s defense) at this time there are no other methods to obtain such data, but this fact only serves to underscore the critical importance of improving the reliability of this data.
CMS Should Examine and Revise if Necessary Medicare Physician Payment Policies Affecting Home Dialysis
RPA strongly urges the GAO to reconsider this recommendation and proceed cautiously with due deliberation for several reasons. First, we do not agree with the physician groups quoted in the report who believe that the current payment methodology (setting reimbursement in the physician fee schedule at the mid-level of the tiered payment structure for the ESRD monthly capitated payment—MCP) is a primary disincentive for the use of home dialysis. It is one among numerous factors (discussed in detail below) that may result in a determination to forego home dialysis as a treatment option, but typically it is hardly the primary driver of such a decision (as we do not envision that many nephrologists are mentally calculating the differences between home and in-center MCP payments as treatment modality decisions are being discussed).
Secondly, we are concerned that absent specific direction to CMS on how to revise these policies, payment for Medicare Part B services related to home dialysis will be substantially reduced. If CMS were to administratively set the payment rate for the home dialysis MCP at either the average payment for all MCP services or at the upper payment level (figures noted in the report), this would provide a healthy Part B payment increase for home dialysis services, and probably enhance the incentives to provide this care. RPA would be supportive of such a change as we believe that the current reimbursement does not consider the substantially increased burden of caring for a home- based patient, where there is more ‘hands-on’ care required by the nephrologist versus dialysis facility personnel. However, we believe that the more likely scenario is that CMS would refer this issue to the AMA’s Relative Value Update Committee (RUC), and while RPA is a participant in and supporter of the RUC’s activities, it is a highly unpredictable process, and thus it is quite possible that RUC review would result in a recommended payment cut for home dialysis in the physician fee schedule. Given that the evident theme of the GAO report is to determine ways of promoting use of home dialysis, a reduction in payment for those services would obviously be counterproductive.
Finally, we urge the GAO to consider an alternate recommendation that mirrors the direction outlined in the recently passed Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and embraces a value-based model of care delivery. Use of performance metrics that incent home dialysis utilization, whether for the dialysis facility or the nephrologist, could be established to promote this modality, and would be more reflective of the value-based future of health care delivery rather than the volume-based models of the past.
CMS Should Examine and Revise if Necessary the Kidney Disease Education (KDE) Benefit
RPA completely concurs with this recommendation. As indicated by the Medicare utilization numbers cited in the draft report, the KDE benefit has been woefully underused since its implementation as part of the 2011 Medicare Fee Schedule. We also agree that the Congressionally-mandated limitation of the benefit to Stage IV chronic kidney disease (CKD) patients and the additional limitation on eligible provider types (physicians, nurse practitioners, physician assistants, and clinical nurse specialists) who can provide the services have served to curtail its widespread use. RPA would thus urge GAO to include recommendations in its report that Congress remove the limitation of the benefit to Stage IV CKD patients, and expand the list of eligible providers to include other personnel such as dieticians, social workers, diabetes educators, and other appropriate provider types.
However, there are other factors that we believe contribute to the underuse of the benefit. First, due to Stark law prohibitions against illegal inducements, nephrology practices are obligated to collect the 20% coinsurance payment for providing these services. In the early years of the KDE benefit’s existence RPA heard from numerous practices that were enthusiastic about providing the KDE services until they realized it would require them to bill patients for the coinsurance.RPA therefore urges the GAO to recommend that the KDE services be added to the list of preventive services for which Medicare will provide 100% payment (in other words, will waive any coinsurance or copayment).
Secondly, RPA believes that the documentation requirements for the KDE benefit are much too onerous and overly prescriptive than is necessary, not constructed to fit with existing educational processes, and therefore serves as a disincentive to practices providing the services. RPA thus urges GAO to recommend that CMS provide greater flexibility with regard to documentation of KDE services, and that rather than maintaining rigid documentation requirements for the service, revise the relevant Medicare regulations to offer recommendations rather than requirements for how to document the types of educational activities that may be included as part of the KDE benefit.
Additional Recommendations to Consider
Nephrology Training in Home Dialysis
In the draft report GAO discusses the gap in nephrology training with regard to home dialysis modalities, and notes that the germane educational bodies are taking steps to address the current shortfall in this area. RPA also acknowledges that these issues are the responsibility of the specialty and profession itself, and do not fall under the purview of the federal government per se. However, the report does note that despite the fact that home dialysis training in many cases is most effective when provided in a site secondary to the hospital setting where most training occurs, hospitals are reluctant to pay for graduate medical education (GME) when provided in a secondary site. Given that GME is funded by the federal government, we encourage GAO to explore ways that Medicare funding of training for home dialysis care can be a greater area of emphasis, regardless of the site of the training.
PD Solution Shortage
Another issue which RPA realizes may be beyond the GAO’s jurisdiction but we believe is underemphasized in the draft report is the current shortage of peritoneal dialysis (PD) solution in the U.S. It is our understanding that the FDA is still designating the availability of PD solution as a shortage situation, but despite this fact the importation of PD solution from foreign manufacturing sources has been discontinued. We know that there are nephrologists who are reluctant to start incident dialysis patients on PD out of concern that as soon as the patient acclimates to their PD regimen, they will be forced to move to in-center dialysis because of the shortage. To the extent that the broader purpose of this report is to discuss why there isn’t greater penetration of home dialysis in the U.S. ESRD population, we believe that the shortage of PD solution should not be downplayed.
One issue not addressed in the GAO report is the possible use of telemedicine technologies to promote the use of home dialysis. RPA believes that easing barriers to utilizing telemedicine and assuring structure for reimbursement of telemedicine would incent both patients (who need the support) and nephrologists (who could more closely monitor patients living distant to care) to choose home dialysis. Use of telemedicine would increase the number of patients who might otherwise not be ‘eligible’ because of distance to care or lack of socioeconomic wherewithal. Unlike some of the other points addressed earlier in RPA’s comments, there are possible changes in Medicare payment policies that could advance the use of telemedicine in home dialysis, such as (1) requiring only a quarterly face-to-face interaction between the home dialysis patient and the nephrologist, and allowing the other two monthly visits in the quarter to be achieved via telemedicine; and (2) expanding the list of approved originating sites for telemedicine to include the patient’s home and perhaps even the dialysis facility. We therefore urge the GAO to address the potential of telemedicine to promote the use of home dialysis modalities in Medicare.
RPA believes that increasing the penetrance of home dialysis requires interplay of multiple interdependent factors. We believe that the intricacies underlying patient choice or desire (which is dependent on awareness), patient understanding (which is dependent on education and knowledge), patient wherewithal (dependent on distance to care and socioeconomic status), and nephrologist comfort level (dependent on training and local facility offerings) cannot be overemphasized. Similarly, importance of availability of support systems and 24/7 resources both for patients and for nephrologists is of paramount importance in increasing the use of home dialysis in the Medicare program.
As always, RPA welcomes the opportunity to work collaboratively with the GAO in its efforts to improve the quality of care provided to the nation’s kidney patients, and we stand ready as a resource to the GAO in its future endeavors. Any questions or comments regarding this correspondence should be directed to RPA’s Director of Public Policy, Rob Blaser, at 301-468-3515, or by email at email@example.com.
Rebecca Schmidt, DO