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Several patient groups and renal associations responded to the proposed rules. Here is a sampling of comments from the National Kidney Foundation and the Renal Physicians Association:
National Kidney Foundation
In their Nov. 1 letter to Charles Haley, MD, MS, FACP, medical director for the MAC for Noridian Healthcare Solutions, National Kidney Foundation President Michael Choi, MD, and CEO Kevin Longino questioned Haley’s use of the foundation’s Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines on dialysis adequacy in his rationale to limit more frequent dialysis.
“The KDOQI guidelines are intended to help guide practitioner decision making and promote improvements in care delivery by providing recommendations based on a rigorous and thorough review of the available evidence. This clinical practice guideline document [cited in the proposed rule] is based upon the best information available as of June 2015. It is designed to provide information and assist decision-making. It is not intended to define a standard of care, and should not be construed as one, nor should it be interpreted as prescribing an exclusive course of management. Variations in practice will inevitably and appropriately occur when clinicians take into account the needs of individual patients, available resources, and limitations unique to an institution or type of practice.
“The guidelines are not intended to be used to drive policy that significantly limits the shared decision making between practitioners and patients,” Choi and Longino wrote. “In fact, the 2015 updated Hemodialysis Adequacy Guideline, cited as the basis for this LCD, promote shared-decision making more than ever before, as many of the recommendations call for considering different durations of dialysis, including more frequent dialysis, and informing patients of the risks and benefits of the different types of dialysis available.
“Engaging patients in their care and developing care plans is a key goal that CMS has championed, and that this LCD would undermine. Care planning should begin with patients’ individual life goals and values in mind and treatment options available to best help patients meet those goals. This should not simply be dismissed as unnecessary care, in fact it may be vital for patients to achieve optimal outcomes.
“However, we also recognize that reasonable limitations are needed to ensure appropriate payments are made, but this draft LCD goes too far in implementing restrictions, making it less likely that patients will truly have the opportunity to participate in shared decision making when it comes to frequency of dialysis treatments. For these reasons we highlight the overburdensome barriers that this policy creates in achieving individualized, patient-centered care and suggest that CMS work with patients and health care practitioners to develop a more reasonable policy.”
Choi and Longino also wrote in the letter that Haley was “misquoting” the KDOQI guidelines.
“This LCD states, ‘Efforts to increase the dose of dialysis administration above three times per week have not improved survival, indicating that something else needs to be addressed.’”
The word “above” has been added to the actual quote from the KDOQI Clinical Practice Guideline for Hemodialysis Adequacy 2015 Update, which is found in the executive summary and actually reads, “Efforts to increase the dose of dialysis administered three times weekly have not improved survival, indicating that something else needs to be addressed.” The KDOQI statement is referring to the dose of dialysis delivered during a traditional dialysis schedule of three times per week. It is not referring to the number of treatments delivered as this LCD implies. Furthermore, the KDOQI Hemodialysis Adequacy workgroup notes a paucity of research conducted on outcomes related to more frequent dialysis, particularly for home hemodialysis. This is not to say that there is not clinical benefit of additional dialysis sessions, but instead highlights a lack of significantly powered randomized control trial studies.
“The guideline recommends consideration of additional treatments for specific acute and chronic conditions based on observational data and practitioner judgement in conjunction with patients’ individual goals.”
Choi and Longino concluded by urging Haley to “not move forward with this policy as written.”
Renal Physicians Association
In their Nov. 1 letter to Haley, the Renal Physicians Association said there was value in Noridian’s efforts to build a physician payment code set to categorize patients who needed more frequent dialysis.
“We appreciate the addition of ICD-10 codes to the list of diagnosis codes that support medical necessity for more frequent dialysis and applaud the MACs for recognizing the breadth of comorbid conditions that impact the treatment of kidney failure,” Michael D. Shapiro, MD, MBA, FACP, RPA president, wrote.
However, the nephrologist argued that more frequent dialysis is a treatment option for patients who need more dialysis on a routine basis.
“We remain deeply concerned, however, that while this LCD addresses extra treatments for patients who have an infrequent dialysis-requiring event, it does not address care of patients who need more frequent dialysis on a chronic basis for conditions that may be acute and/or life threatening and medically appropriate.
“RPA recognizes that the MACs believe they are constrained in addressing policies that are separately promulgated in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), but we would urge you to seek solutions that allow chronic patients who definitively need extra dialysis treatments within a month to receive them in a covered and compliant manner.
As noted, RPA believes that this LCD, if implemented, will negatively impact the contingent of ESRD kidney patients who require extra dialysis treatments on a routine rather than infrequent basis.”
The RPA spent the remainder of the letter focusing on several key points:
- the need for more frequent dialysis is not limited to acute conditions;
- more frequent dialysis should be a modality choice offered to patients as a treatment covered under the ESRD program; and
- denying more frequent dialysis to patients who need it routinely implies ethical misconduct on the part of the MACs.
“RPA recognizes that a thrice-weekly dialysis regimen will be sufficient for many if not most dialysis patients, but there will still be a subpopulation who experience acute problems that occur on a chronic basis and we believe policy such as set forth in this LCD creates a restriction that is counter to the underlying purpose of the ESRD program,” Shapiro wrote. “ … Coverage by the MACs is medically appropriate for conditions or events that are chronically occurring, in addition to those acute events that infrequently require an extra dialysis treatment.”
Understand the need to treat chronic conditions
In the RPA letter, Shapiro said the proposed LCD will “artificially constrain the nephrologist’s ability to effectively provide high quality and safe patient care.”
He added, “Recent concerns that aggressive ultrafiltration (fluid removal) that negatively impacts the heart has led to efforts to limit the magnitude of ultrafiltration that can occur in a single dialysis treatment. Thus, for patients whose fluid volumes exceed that which is safely removed in a single session (or those who have hemodynamic instability that precludes removal of the needed amount of fluid), additional sessions or extended treatments will be needed. Many patients do not have the physical stamina to undergo an extended dialysis treatment, thus if additional dialysis sessions cannot be covered by Medicare, these beneficiaries will be forced to seek treatment in the emergency department or be hospitalized. The lack of a mechanism for treating these patients with chronically occurring acute problems limits the nephrologist’s options, but more importantly, is a threat to their survival.”
Potential to restrict patient modality choice
The LCD proposed by Noridian and the other contractors also would limit options for patients who need dialysis care.
“At a time when CMS is encouraging the use of home dialysis, RPA believes that the draft LCD will in a real-world, point-of-contact sense create a significant disincentive to the prescribing of home hemodialysis,” Shapiro wrote.
He added, “Indeed, it was originally anticipated that patients with ESRD, if treated, would return to work, and for patients who continue to work, home hemodialysis allows for a more flexible schedule and the opportunity to tailor their treatments in a way that optimizes their well-being. Further, nephrologist medical directors and dialysis providers are evaluated by the ESRD networks and required by the Conditions for Coverage for Dialysis Facilities to educate patients on the advantages and disadvantages of all dialysis treatment options. This LCD would effectively eliminate a major advantage of doing hemodialysis at home – the opportunity to do more frequent dialysis — and could inhibit its use overall by discouraging both nephrologists from offering it and patients from selecting it.
Could limiting patient choice also be costlier for CMS in the long run? “RPA urges Noridian, and CMS, to consider the possible downstream financial impact of the draft LCD. If, for example, a patient with fluid overload experiences a complication that requires an emergency room visit or hospitalization, the expense of that ER visit or hospitalization will far outweigh the cost to the Medicare program compared to that of an ongoing dialysis treatment regimen that could have likely addressed the patient’s condition,” Shapiro noted. “The likelihood of overutilization in this regard is minimal in that patients are generally not interested in increasing the time or number of times they are tethered to a dialysis machine unless they recognize the derived benefit.
“RPA supports the intent of Noridian’s prudent interpretation of medical necessity in order to be fiscally responsible with Medicare resources, but we urge Noridian to not exclude patients with chronically occurring acute complications of kidney failure, and to cover all medically appropriate dialysis treatments, whether isolated or routine,” Shapiro wrote.