August 23, 2016
Centers for Medicare and Medicaid Services
Hubert H. Humphrey Building,
200 Independence Avenue, SW
Washington, DC 20201
RE: Medicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model
Dear Acting Administrator Slavitt:
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 comments on selected portions of the 2017 End-Stage Renal Disease Prospective Payment System Proposed Rule.
RPA’s comments focus on the following issues:
• Payment for Hemodialysis When More Than 3 Treatments Are Furnished per Week
• Payment for Dialysis Services Furnished to Individuals with Acute Kidney Injury
• Questions Regarding the Comprehensive End-Stage Renal Disease Care Model and Future Payment Models
Payment for Hemodialysis When More Than 3 Treatments Are Furnished per Week
In the proposed rule, CMS reiterates its policy to provide payment for more than three hemodialysis sessions in a weeks’ time when medically justified. RPA supports the Agency’s policy in this area and believes that it facilitates appropriate care for the subset of ESRD patients whose condition merits the additional treatments. The proposed rule goes on to note that:
Additional conventional HD treatments are reimbursed at the full ESRD PPS payment if the facility’s Medicare Administrative Contractor (MAC) determines the treatments are
medically justified based on a patient condition, such as congestive heart failure or pregnancy. MACs have developed local coverage determinations and automated processes to pay for all the treatments reported on the claim if the ESRD facility reports diagnoses determined by the MAC to medically justify treatments beyond 3 times per week.
While RPA recognizes the benefits of heterogeneous coverage policy development at the MAC level, we are concerned about how the medical justification policy for additional dialysis treatments is developed and applied at the local level since some MACs have LCDs, others do not, and none are comprehensive in the list of diagnoses of chronic conditions that warrant more frequent dialysis on a routine basis. In fact, of the approximately 35 diagnoses listed in at least one LCD and one billing article, only 3 are for chronic conditions. In contrast to those indications that address acute conditions and are symptom-driven (e.g., acute fluid overload, hyperkalemia), the indications for more frequent hemodialysis include diagnoses that foster prevention of such acute conditions (e.g., chronic volume overload refractory to thrice weekly dialysis, hypertension) as well as those which address complications that, for some patients, are not adequately treated (e.g., hyperphosphatemia) by thrice weekly dialysis. Criteria for medical justification should thus include and represent chronic (in addition to acute) conditions that affect the ESRD patient, many of which may not be threatening in the short-term but rather are negatively impactful in the long-term. In addition, more frequent dialysis would allow the quality of life benefits that result from taking fewer medications, having less fluctuant volume status, and for patients whose symptoms are not controlled by thrice weekly treatments, more frequent dialysis could lower the risk of interdialytic complications. In short, more frequent dialysis may be needed acutely to sustain life because of an emergent life-threatening complication, but also chronically, to preempt situations of high acuity and to maximize dialytic management of the chronic complications attendant to ESRD, particularly those that increase in likelihood with longer interdialytic intervals.
Additionally, given that a preponderance of commercial insurers cover dialysis sessions for ESRD patients at frequencies of greater than the conventional thrice weekly, RPA is concerned that implementation of a justification policy that substantially disadvantages Medicare beneficiaries with ESRD versus their counterparts in the private pay arena will create two tiers of coverage for these services (with Medicare beneficiaries clearly in the lesser tier). We are mindful of a MAC’s obligation to fulfill its fiduciary responsibility in administering the Medicare Trust Fund, but we would argue that a parallel charge is to ensure that Medicare beneficiaries receive optimal health care including that which fosters prevention of avoidable acute events whether these are new or an acute exacerbation of chronic conditions. RPA recognizes that the creation of a disparity between the care that individuals with private insurance receive in comparison to that of Medicare beneficiaries is completely unintended, but we do believe that such a disparity has and will continue to occur as a result of implementation of the policy as currently written.
Further, it is RPA’s opinion that the justification policy does not account for the importance of Medicare beneficiaries’ patient experience. The availability of coverage for additional dialysis sessions increases the likelihood of an ESRD patient’s ability to dialyze at home, which in turn enhances the possibility of an ESRD patient resuming normal life activities and even returning to work when applicable. In these cases a more flexible policy would not only improve the care that a dialysis patient receives but would also likely have financial benefit for the health system broadly. RPA believes that any MAC’s medical justification policy should not pose a barrier to this positive potential.
In summary, RPA fully recognizes the importance of medical justification in administering the Medicare program, as well as the need for the MACs to be mindful stewards of Medicare’s finite fiscal resources. However, we also believe that overly restrictive medical justification policies can be harmful to the subset of Medicare ESRD beneficiaries with legitimate medical reasons for requiring additional dialysis and thus are prescribed treatments beyond the typical thrice weekly threshold. Therefore,
RPA urges CMS to promote the adoption of medical justification policies at the MAC level that are comprehensive and applicable to the ESRD patient and have sufficient flexibility to foster the prescription of additional dialysis sessions for all patients for whom it is medically justified.
Payment for Dialysis Services Furnished to Individuals with Acute Kidney Injury
This year’s proposed rule includes for the first time coverage policies for dialysis services provided in outpatient dialysis facilities to Medicare beneficiaries with acute kidney injury (AKI), and RPA commends CMS for its straightforward interpretation of the underlying statute authorizing the coverage policies. However, there are several issues within the AKI section of the rulemaking that either require clarification from CMS or solicit input from stakeholder organizations. These issues are addressed below.
Additionally, appended to this letter is RPA’s relevant position paper on Acute Kidney Injury Patients Requiring Outpatient Dialysis, published in May 2016. This paper describes the unique characteristics of the AKI patient population, identifies areas in which application of the ESRD care model may create barriers to optimal dialysis care for these patients, and offers recommendations for how the ESRD care model can be revised to reflect the needs of AKI patients to facilitate their transition from AKI to recovery or ESRD.
In-Center Peritoneal Dialysis
In the proposed rule the Agency notes that it does not expect that beneficiaries with AKI will receive dialysis in their homes due to the duration of treatment and the unique needs of AKI, and therefore is proposing not to extend the home dialysis benefit to beneficiaries with AKI. We do not disagree with this proposal. However, we do believe that in-center peritoneal dialysis should be available as a treatment modality for AKI patients for several reasons. In light of the increased emphasis on expanding access to home dialysis in general and the increasing number of programs utilizing emergent or urgent peritoneal dialysis as opposed to hemodialysis as rescue therapy for patients presenting in urgent need, excluding such patients from coverage seems counter to the shared goal. Further, peritoneal dialysis may be utilized for purposes of vein preservation in the event that the patient does become end-stage and vascular access must be created and maintained. Our concern stems from the fact that in other contexts within the kidney disease payment realm (such as the monthly capitated payment for ESRD patients), CMS does not appear to differentiate between peritoneal and home hemodialysis, and combines these services under the more general term of home dialysis.
RPA believes that in-center peritoneal dialysis should be an available option in the treatment of AKI patients, and we urge CMS to clarify that in-center PD would be a covered service for AKI patients.
AKI and the ESRD Conditions for Coverage
In the proposed rule CMS inquires about the applicability of the ESRD Conditions for Coverage (CfC) to the treatment of AKI patients, and we concur with the Agency that issues such as water quality and infection control protocols would be the same for an ESRD patient receiving maintenance dialysis and an AKI patient. In contrast, issues such as development and review of long term care plans would be inappropriate to apply to the care of an AKI patient who is expected to regain renal function. Thus, as a general rule RPA would suggest that Conditions pertaining to the operation of the dialysis facility broadly should be applicable in the care of AKI patients but that those Conditions related to care planning should either not apply or be given additional consideration before policy is developed. We are supportive of the Agency’s decision to address these issues in future rulemaking rather than for the 2017 final rule.
Monitoring of Beneficiaries with AKI Receiving Dialysis in ESRD Facilities
RPA strongly commends CMS for its recognition and acknowledgement in the proposed rule of the “unique acute medical needs of the AKI population”. As noted in our above-referenced and attached position paper:
Acute kidney injury requiring dialysis (AKI-D) patients differ from ESRD patients in key ways. AKI-D patients are by definition in a transitory state, heading toward either renal recovery or ESRD, with weak predictive markers and no finite time frame to a decision point. In addition, many AKI-D patients are recovering from critical illness and multi-organ system failure; the functioning of various non-renal organs is also in transition, and their overall clinical care needs are substantial. They require close monitoring to determine if renal recovery is developing, to avoid nephrotoxic medications and diagnostic studies, and to assure that as renal and other organ functions change, the necessary adjustments in medications, nutrition and clinical care are continuously implemented.
Accordingly, CMS’ proposal to separately pay for drugs, biologicals, laboratory services, and supplies that ESRD facilities are certified to furnish and that would otherwise be furnished to a beneficiary with AKI in a hospital outpatient setting is completely appropriate, and we fully agree with this decision. Additionally, the importance of monitoring for recovered renal function (RRF), and preserving RRF, cannot be overemphasized; CMS policy development in this area should account for that circumstance.
RPA urges CMS to take a similar approach in the consideration, development, and implementation of quality of care measures as they will apply to the care, monitoring and treatment of Medicare beneficiaries with AKI. RPA recognizes that quality of care measures are an essential component of an optimized care delivery system; however, there are currently insufficient data and limited consensus related to the treatment of AKI to form the basis for specific quality metrics.
RPA believes that new quality measures are appropriate for AKI patients; however, new measures should not be implemented until relevant data have been obtained and validated, and consensus on appropriate measures developed.
Comprehensive End-Stage Renal Disease Care Model and Future Payment Models
Listed below are RPA’s responses to the 10 questions CMS posed in the proposed rule with regard to innovative approaches to care delivery and financing for beneficiaries with ESRD.
1. How could participants in alternative payment models (APMs) and advanced alternative payment models (AAPMs) coordinate care for beneficiaries with chronic kidney disease (CKD) and improve their transition into dialysis?
When the economic incentives are meaningful and aligned to promote improved transition to dialysis, and there is flexibility for nephrologists to participate in a model based on their own risk tolerance, RPA believes that the healthcare delivery marketplace will respond with investment and innovation. One way to do that is by making APMs accountable for the full cost and clinical quality associated with ESRD populations’ start on dialysis, possibly by utilizing a bundled payment for the first three or six months of dialysis. Additionally, these APMs should be able to work with other upstream and/or downstream providers without significant legal risk exposure of doing so for the patient’s benefit. These programs will then incentivize providers to innovate in CKD to capture the clinical and financial benefits of a smooth start on dialysis.
Aligning incentives with optimal starts (such as peritoneal dialysis, home hemodialysis, in-center hemodialysis with a fistula or graft, and preemptive transplant), physicians will likely be able to drive down catheter rates and reduce costs associated with the transition to dialysis.
Specific incentives could include:
• Payment incentives for all optimal starts
• Bundled payment for first 3 or 6 months of dialysis
• Care coordination payments for CKD 4/5 education
• Outpatient dialysis starts without hospital admission
RPA also believes that these care models should account for the use of palliative care and/or comprehensive conservative care for CKD patients who wish to forego dialysis and pursue non-dialytic management, accounting for the reality that dialysis is not the best treatment option for all late stage CKD patients.
2. How could participants in APMs and AAPMs target key interventions for beneficiaries at different stages of chronic kidney disease?
Stage 3 estimated Glomerular Filtration Rate (eGFR) 30-60: Provide documented general education regarding CKD, including what a patient can do to help prevent or slow progression of CKD. Educational points could include: (1) examples of good blood glucose control in the diabetes population that will help slow progression of CKD and prevent diabetes related hospitalizations; (2) understanding the value of blood pressure control and what medications may slow progression of CKD; (3) discussion of treatment needs and control of phosphorus, anemia and metabolic abnormalities such as metabolic acidosis; (4) identification of those patients at high risk of transition from CKD to ESRD by the best means possible, including the use of predictive analytics; and (5) avoidance of known nephrotoxic agents.
Stage 4 estimated Glomerular Filtration Rate (eGFR) 15-30: (1) Enhanced patient education on Stage 3 recommendations outlined above plus beginning education about ESRD and all modality options as well as the option for some patients to pursue conservative non-dialytic management; (2) defined modality education and discussion of those options by the nephrologists and other members of the multidisciplinary renal team; (3) established plan in place for type of dialysis, including appropriate referral to surgeon; (4) referral to transplant center if appropriate; and (5) initiation of palliative care discussion, if appropriate.
For those patients with hemodialysis as their modality choice, the APM should begin the access process of vein mapping, referral to a surgeon and placement of the appropriate vascular access.
Incentive payments could be made for:
• A successful outpatient start on hemodialysis
• A start with a functioning vascular access
• A preemptive transplant (thus avoiding the patient ever going on dialysis)
• A successful home dialysis start
Further, CMS in conjunction with CDC should consider the creation of a Stage 4B code for CKD, for patients with a GFR < 25 or those identified at high risk by a predicative model.
Additionally, accurate patient attribution is critically important to avoid patient de-selection (i.e., cherry-picking/lemon-dropping).
3. How could participants in APMs and AAPMs better promote increased rates of renal transplantation?
Similar to above, formal documentation of discussions and referral to appropriate educational options could serve as a surrogate for renal transplant information in CKD 4; this should be a required discussion. The addition of a Stage 4B for CKD would give better direction on early referral to a transplant center. It should be noted that according to UNOS regulations patients can be listed for transplant when their eGFR is < 20, so development by APMs and AAPMs of structured processes that advance transplant evaluation and referral for appropriate patients would likely promote increased rates of renal transplantation.
4. How could CMS build on the CEC Model or develop alternative approaches for improving the quality of care and reducing costs for ESRD beneficiaries?
Appropriate incentives for optimal start dialysis is paramount. Use of shared decision making and establishment of advance directives that guide end-of-life care are key to reducing the high numbers of ESRD patients who die in hospital after aggressive and intensive care. Identification of patients who choose palliative care/medical management instead of dialysis could also be important to lowering overall costs by avoiding aggressive and intensive care in those who do not wish it. In this area, it is important to note that patients that choose non-dialysis options do not show up in an APM’s value denominator, so it is difficult to judge the impact this has on overall costs. Incentives for innovative approaches in this area would be beneficial. The CEC model is difficult to scale because it is difficult for many physician groups to take risk, so a more flexible approach to pay for outcomes and create innovative programs would be worthwhile. Facilitating access to dialysis units by non-nephrologist health care providers (e.g. podiatrists, vascular surgeons, and endocrinologists) would enhance patient access to such specialists, presenting an innovative approach to treatment of other comorbid illnesses. Advanced use of telemedicine in the facilities could help address many of the patient needs that require other office visits. Additionally, greater emphasis should be placed on behavioral health.
5. Are there specific innovations that are most appropriate for smaller dialysis organizations?
While smaller dialysis organizations may have difficulty engaging in APMs requiring risk, a payment model focused on incentivizing optimal starts into ESRD as described above would be scalable to smaller organizations and more rural settings, as all dialysis facilities and nephrologists nationwide have patients who are transitioning to ESRD and dialysis. Additionally, the development of structures similar to group purchasing organizations (GPOs) among allied small dialysis organizations could facilitate their participation in APMs.
6. How could primary-care based models better integrate with APMs or AAPMs focused on kidney care to help prevent development of CKD in patients and progression to ESRD? Primary-care based models may include patient-centered medical homes or other APMs.
Required use of a flag or ‘trigger’ in primary care models’ electronic health records using clinical indicators for possible CKD as well as risk factors for progressive CKD could promote appropriate and timely referral to a nephrologist. Tools from RPA’s Advanced CKD Patient Management Toolkit were tested among primary care providers (PCPs) as part of a project to improve identification and co-management project between nephrology and primary care practices. The findings were published in the American Journal of Kidney Diseases as Improving Care Coordination Between Nephrology and Primary Care: A Quality Improvement Initiative Using the Renal Physicians Association Toolkit (Haley, William E. et al, American Journal of Kidney Diseases, 2014, Volume 65, Issue 1, 67 – 79, attached).
In the development of the RPA toolkit, the use of specifically tailored tools, such as CKD identification tools and chart flags, a patient diary, and a GFR calculator, led to enhanced awareness and identification of CKD among PCPs, increased communication between practices, and improvement in co-management and cooperation between PCPs and nephrologists.
Creation of incentive payments to primary care physicians for patient education on the risks of CKD could also have substantial benefit.
7. How could APMs and AAPMs help reduce disparities in rates of CKD/ESRD and adverse outcomes among racial/ethnic minorities?
Comprehensive early screening for co-morbid conditions such as diabetes and hypertension as part of broadly based CKD education programs may be the best approach, and this is an area where the federal government could play a key role. It is important to note that identifying the right site of education varies based on the audience being educated. Additionally, sufficient and appropriate incentive payments for optimal starts will go a long way toward reducing these types of disparities. While it would not be wise for the pendulum to fully swing away from patient autonomy to paternalistic care, physicians who are adequately paid to manage the transition from CKD 4/5 to dialysis will likely find creative solutions to increase optimal starts and reduce racial disparities.
8. Are there innovative ways APMs and AAPMs can facilitate changes in care delivery to improve the quality of life for CKD and ESRD patients?
Keeping in mind that patient quality of life is of paramount importance will keep the appropriate focus on the patient and what matters most to them; RPA believes that in some cases the current quality indicators can be a barrier in this area. For example, an 80 year old person may be by choice on dialysis but only wishes to have treatment 3 times a week for 3 hours. Because this isn’t considered adequate dialysis as measured by current standards, the attending physician may be disinclined to adjust the dialysis prescription in a way that could compromise the facility’s performance metrics. A mechanism by which patient preference is recognized as primary and physicians are not held accountable for a patient’s informed decision or choice (however ill-chosen) would be helpful in situations where quality of life is opted for over the need to achieve dialysis adequacy. This is an area where shared decision-making between the patient, nephrologist, and other members of the renal care team is key. RPA’s Clinical Practice Guideline on Shared Decision Making in the Appropriate Initiation of and Withdrawal from Dialysis can be extremely helpful in this process.
9. Are there specific innovations that are most appropriate for evaluating patients for suitability for home dialysis and promoting its use in appropriate populations?
Once again, this is an area where governmental promotion of the structured use of existing, broadly based CKD education programs could be very helpful, and is also another area where the RPA Shared Decision Making Guideline would be useful. In addition, removal of home dialysis originating site restrictions that prohibit the dialysis facility and the patient’s home from serving as originating sites would likely promote the use of home dialysis modalities.
Further, and without restating all of the points made in the first section of this document, RPA believes that innovative thinking and policy flexibility with regard to sufficient reimbursement for more frequent dialysis for those home patients appropriate for such services as determined by the patient and nephrologist will facilitate improved health outcomes for those patients, will advantage the Medicare program broadly via the administration of fewer medications and fewer hospitalizations, and will provide societal benefit by improving the return to work possibilities for some patients.
10. Are there specific innovations that could most effectively be tested in a potential mandatory model?
RPA recommends use of the following:
• Predicative analytics
• More frequent GFR measurements
• Defined clinical pathways in an EHR
• Nurse practitioners and physician assistants managing CKD clinics
• CKD case managers
• Organized multidisciplinary care teams to manage the CKD process
• Advanced care planning early in the course of CKD education
As always, RPA welcomes the opportunity to work collaboratively with CMS in its efforts to improve the quality of care provided to the nation’s kidney patients, and we stand ready as a resource to CMS 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