August 23, 2016
Centers for Medicare & Medicaid Services
Department of Health & Human Services
P.O. Box 8010
Baltimore, MD 21244–8010
Submitted electronically to: www.regulations.gov
To Whom It May Concern:
The Center for Medicare Advocacy (the Center) is pleased to provide the Centers for Medicare & Medicaid Services (CMS) comments on the proposed rule concerning Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, 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 (CMS-1651-P).
The Center, founded in 1986, is a national, non-partisan law organization that works to ensure fair access to Medicare and to quality health care. We draw upon our direct experience with thousands of individuals to educate policy makers about how decisions affect the lives of real people. Additionally, we provide legal representation to ensure that people receive the Medicare coverage for which they qualify, and the quality health care they need.
Access to Care Issues for Durable Medical Equipment (DME) for Dually-Eligible Beneficiaries
The Center for Medicare Advocacy, along with nearly 80 other organizations, submitted a separate letter in response to the request for information on Access to Care Issues for Durable Medical Equipment (DME) for dually eligible beneficiaries. Please include that letter as part of the Center’s comments.
Coverage of Acute Kidney Injuries
Given the clinical links between Acute Kidney Injuries (AKI) and Chronic Kidney Disease (CKD) and given the requirement to do so in the Trade Preferences Extension Act of
2015, the Center welcomes CMS’s proposal to cover the dialysis of AKI patients. The Center would like clarification concerning how CMS intends to ensure access to dialysis treatment for Acute Kidney Injury patients given that patients may have trouble scheduling dialysis treatment appointments in light of the dialysis clinician shortage. Given this barrier to care, the Center recommends convening a technical expert panel of dialysis clinicians, nephrologists, and beneficiary organizations to discuss how AKI patients can have guaranteed access to this new benefit.
Outcome-Based Clinical Measures
The Center and CMS both recognize the importance of including meaningful measures that capture patient goals over time in patient outcome measures. CMS has taken a number of steps to weigh these measures more heavily; Increasing the weight of the clinical measures from 50 to 75 percent of the total performance score as well as moving the safety measure from its clinical measure component status (as part of the clinical score) to its own domain status separate from the clinical score gives the outcome measures within the clinical score greater weight within the total performance score. This outcome measure proposal should, however, proceed with caution concerning documenting “improvement.” The Screening for Clinical Depression and Follow-Up Reporting Measure that became part of the 2014 End-Stage Renal Disease Prospective Payment System Final Rule (CMS-1614-F), for instance, collects data that can be used to “calculate achievement and improvement scores.” The Center supports outcome-based measures if they are also used to calculate achievement and generally meet patient goals—but not all patients, especially those with chronic conditions such as ESRD, have the ability, however, to improve, so there should not be an improvement standard within this or any other particular measure. The Center points to the following language from the 2016 proposed ESRD rule when it can be applied to appropriate outcome measures: “It is important to prioritize measures of patient experience because high performance on these measures improves clinical outcomes and patient retention.”
Sometimes the condition of a kidney disease patient can improve; Other patients with kidney disease cannot. A patient who has an AKI may improve with treatment, but another person with End-Stage-Renal Failure—someone who is not likely to improve and actually benefits from treatments—may need maintenance care or other solutions that slow their decline. Therefore, outcome-based clinical measures should be diagnosis specific, not overly broad, and not encompassing several potentially-conflicting diagnoses. It may also be appropriate to have some improvement-based outcome measures that reward providers that are successful in treating acute renal conditions and preventing further decline, while also avoiding penalizing providers caring for AKI patients if renal failure becomes imminent and for whom improvement is no longer possible.
Measure Data Validation
Given the danger for gamesmanship inherent in self-reported data, the Center agrees with CMS’s proposal to set up a useful mechanism for validating the data submitted by providers. The Center supports the proposal for FY 2019 that requires 35 randomly-selected facilities to participate in a dialysis event study in which 10 patient records would be submitted. Providers do not always report dialysis events or do not usually report them in accordance with the Centers for Disease Control and Prevention (CDC’s) National Healthcare Safety Network (NHSN) Dialysis Event Protocol. Given this, the Center for Medicare Advocacy feels that such a review, if done correctly, can better hold accountable providers who would otherwise have provided a quality of care that did not meet patient needs. We also support CMS’s proposal to hold providers accountable by deducting points from the facility’s total performance score if they do not respond to a request for dialysis event records within a certain period of time; Audits when coupled with meaningful accountability are better able to guarantee that the dialysis events of ESRD patients are reported accurately and appropriately. Furthermore, regarding the validation of all measures that make up the ESRD Total Performance Score, the Center also sees the wisdom of the continuation of the previous practice of sampling one out of 30 randomly-selected records as well as the continued existence of a provider penalty (10 points from the total performance score) should records not be submitted within 60 days after receiving a request for records.
Comprehensive End-Stage Renal Disease Care Model and Future Payment Models
In the proposed rule, CMS states that it will ask nephrologists, dialysis clinicians, and other providers to design new Alternate Payment Model (APM) entities for ESRD patients within a dialysis-specific Accountable Care Organization (ACO) model know as an End-Stage Renal Disease Seamless Care Organization (ESCO). Conspicuously missing from this list of stakeholders are health consumer organizations that are well-positioned to discuss patient access to care, the importance of auditing self-reported measures, the importance of outcome measures that meet individual patient needs, and other issues important to consumers. The Center requests that CMS consider including beneficiary advocates and ESRD beneficiaries in such a design of an Alternate Payment Model. Further, given the complexity of certain APMs, we encourage CMS to require these prospective entities to provide linguistically and culturally appropriate materials for patients. We also ask CMS to provide prototypes of these materials to patient advocates to review before they are finalized.
The Center for Medicare Advocacy greatly appreciates the opportunity to provide comments on the proposed rule on the proposed Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, 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 (CMS-1651-P).
For additional information, please contact David Lipschutz at 202-298-5760 or DLipschutz@MedicareAdvocacy.org. Thank you.
 Prasad Devarajan and John Lynn Jefferies. “Progression of Chronic Kidney Disease After Acute Kidney Injury.” Progress in Pediatric Cardiology. 28 December 2015. P. 33.
 CMS. “CY 2017 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, and Quality Incentive Program.” 30 June 2016. https://www.gpo.gov/fdsys/pkg/FR-2016-06-30/pdf/2016-15188.pdf (site visited August 23, 2016). P. 42806.
 Ibid. P. 42820, 42822.
 Ibid. P. 42826.
 CMS. “Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies.” 06 November 2014. https://www.gpo.gov/fdsys/pkg/FR-2014-11-06/pdf/2014-26182.pdf (site visited July 15, 2016). P. 66200.
 CMS. “CY 2017 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, and Quality Incentive Program.” P. 42826.
 Ibid. P. 42833.
 Ibid. P. 42865