National Renal Administrators Association Issues Public Comment on Centers for Medicare & Medicaid Services Rule

WASHINGTON, Nov. 4 -- Maria Regnier, president of the National Renal Administrators Association, Mount Royal, New Jersey, has issued a public comment on the Centers for Medicare and Medicaid Services rule entitled "Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments, and Patient Protection and Affordable Care Act: Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency". The comment was written and posted on Oct. 29, 2020:

* * *

The National Renal Administrators Association (NRAA) is a voluntary organization representing dialysis providers throughout the United States. Our membership primarily includes small and independent for-profit and not-for-profit providers serving patients in urban, rural, and suburban areas in both free-standing and hospital-based facilities. We strongly support efforts by the Centers for Medicare and Medicaid Services (CMS) to improve patient quality of care and health outcomes for Medicare beneficiaries with Chronic Kidney Disease (CKD) of all stages. We appreciate the ongoing recognition by CMS of the unique challenges posed to small and medium facilities providing high quality care to these vulnerable pediatric and adult patient populations.

The NRAA wishes to thank you and members of your team for your critically important work in confronting the COVID-19 public health crisis. We very much appreciate the temporary regulatory flexibilities that have been extended to dialysis providers caring for Medicare beneficiaries with end-stage renal disease (ESRD) during the public health emergency (PHE). Unfortunately, ESRD patients typically suffer from multiple underlying conditions beyond ESRD that place them at especially serious risk for contracting COVID-19 and experiencing severe adverse health outcomes, including death, from the virus. The risk of COVID-19 exposure is especially high for these patients and their healthcare providers, as the vast majority of ESRD patients receive treatment three times per week in dialysis facilities - with frequent patient entry and exit into facilities significantly increasing the risk for contracting and spreading the virus for patients and their care team members. Temporary regulatory relief during the pandemic critically has enabled providers to remain solely focused on safely delivering dialysis treatment in a manner that protects both patients and their providers.

With this background, the NRAA appreciates the opportunity to comment on the agency's interim final rule with comment entitled "Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency" (CMS-3401-IFC). In sum, the NRAA strongly shares the agency's concern that any data collected during the 2020 performance year of the ESRD Quality Incentive Program (QIP) will be highly limited due to the COVID-19 PHE and therefore make calculating reliable measure results for scoring purposes impossible. The NRAA thus respectfully urges CMS to suspend prospective application of QIP penalties and payment adjustments based on the 2020 performance year.

The ongoing challenges of the pandemic require dialysis facilities to remain laser-focused on ensuring that ESRD patients can access the life-sustaining treatment they need in a safe way that minimizes virus exposure for patients and providers. As such, the NRAA very much appreciates the Extraordinary Circumstances Exception (ECE) flexibility CMS has granted to dialysis facilities for reporting QIP data during the COVID-19 PHE. This flexibility has enabled dialysis facilities to solely focus on maintaining patient safety and minimizing COVID-19 exposure during the PHE rather than redirecting attention and resources toward QIP reporting and avoiding program penalties.

The NRAA strongly shares the concerns raised by CMS that any data collected during the 2020 QIP performance year will not lead to reliable measure scoring because of the pandemic. First, we share the agency's concern that, despite the best efforts of providers to safely deliver dialysis to patients throughout the COVID-19 PHE, patients in certain cases have not received treatment out of fear of virus exposure. Patients not receiving prescribed dialysis treatment will impact facility performance on multiple measures in the QIP and lead to unfair program penalties for reasons outside of the facility's control. Indeed, we agree with CMS:

"Regardless of protocols in place at facilities, dialysis patients concerned about being exposed to COVID-19 at a facility may decide to skip their treatment sessions. This could be reflected in quality metrics captured for the facility when the patients return to treatment."/1

Such an outcome is not appropriate and does not align with the shared goal of CMS and dialysis providers to first and foremost protect patient safety - particularly during a pandemic in which ESRD beneficiaries are at risk for severe outcomes, including death, from contracting COVID-19.

Second, the NRAA very much agrees with the agency's concern that the national comparability of data that would be used for assessing individual facility performance in the QIP in 2020 is not reliable due to the disparate impact of COVID-19 across the U.S.:

"we are concerned about the national comparability of these data due to the geographic differences of COVID-19 incidence rates and hospitalizations, along with different impacts resulting from different state and local law and policy changes implemented in response to COVID-19."/2

We are very concerned that use of unreliable and biased national data has the serious potential to wrongly penalize dialysis facilities in the QIP for performance that may not actually reflect the quality of care delivered. Such a consequence would result in inappropriate negative payment adjustments for facilities - which can have outsized adverse impacts on small and independent dialysis providers with limited resources often treating Medicare beneficiaries with ESRD in rural and underserved areas. In particular, we share the following concerns raised by CMS:

"Furthermore, due to the national nature of the PHE for COVID-19, we believe performance scores for certain measures could be biased and not reflective of nationally comparable performance. Similarly, we are concerned that there may be indirect and unintended consequences of calculating score using potentially biased data that may not reflect the facility's overall quality. Due to facilities having the option to submit or not submit data for this period, the data may not provide a nationally comparable assessment of performance. Thus, reporting bias is possible due to the voluntary submission of data; that is, a bias could be potentially introduced because only high performers and/or facilities not impacted or better resources would choose to submit data, while impacted facilities and/or facilities with fewer resources would choose not to submit data. This would affect comparisons between facilities with different circumstances, and would not be in keeping with the program goal of national comparison (emphasis added)."/3

Therefore, the NRAA respectfully urges CMS to suspend prospective application of QIP payment penalties based on the 2020 performance year. Simply put, dialysis providers have directed all attention to avoiding virus exposure and safely delivering dialysis treatment; they have not had the staff or resources to simultaneously focus on the QIP and COVID-19. This is especially the case for small and independent providers with limited staff and resources that have been under enormous stress for approximately eight months trying their best to safely manage daily COVID-19 routines and procedures with staff members who are experiencing significant physical and mental fatigue. Hence, we respectfully urge CMS to follow through with its consideration of suspending the QIP for the 2020 performance year:

"If circumstances warrant, we may propose to suspend prospective application of program penalties or payment adjustments through the annual PPS proposed rule."/4

Finally, the NRAA further respectfully urges CMS to treat Dialysis Facility Compare (DFC) Five-Star in the same manner as the ESRD QIP with respect to the COVID-19 PHE. The data challenges in both quality programs are the same due to the pandemic. The differences in COVID-19 throughout the U.S. make the data collected for the DFC in 2020 not reliable and not necessarily reflective of the actual quality of care delivered by individual facilities. To avoid patient confusion about the quality of care provided at specific facilities, we urge CMS to not incorporate any data from 2020 in the DFC Star Ratings.

In conclusion, the NRAA thanks you for the opportunity to comment on CMS-3401-IFC. We again wish to express our appreciation for the extensive efforts of you and your team during this unprecedented time. The ongoing significant challenges presented by COVID-19 make safe delivery of life-sustaining dialysis treatment the sole focus of our work as providers treating Medicare beneficiaries with ESRD. We stand ready to work with you as the COVID-19 PHE continues and best ensure that ESRD patients continue to receive high-quality dialysis treatment. If you have any questions concerning our comments, please do not hesitate to call NRAA Executive Director Marc Chow at (831) 234-1299.

Sincerely,

Maria Regnier, RN, MSN, CNN

NRAA President

* * *

Footnotes:

1/ 85 FR 54829

2/ 85 FR 54829

3/ 85 FR 54829

4/ 85 FR 54829

* * *

The rule can be viewed at: https://beta.regulations.gov/document/CMS-2020-0097-0001

TARGETED NEWS SERVICE (founded 2004) features non-partisan 'edited journalism' news briefs and information for news organizations, public policy groups and individuals; as well as 'gathered' public policy information, including news releases, reports, speeches. For more information contact MYRON STRUCK, editor, [email protected], Springfield, Virginia; 703/304-1897; https://targetednews.com