Nation’s Kidney Community Expresses Deep Disappointment on CMS Proposed Rules on Prospective Payment System and ESRD Quality Incentive Program

 Kidney Care Partners (KCP) – the nation’s largest non-profit, non-partisan kidney care coalition dedicated to protecting access and comprised of more than 30 organizations, including patients, dialysis professionals, physicians, nurses, researchers, therapeutic innovators, transplant coordinators, and manufacturers – today issued the following statement expressing disappointment with the Centers for Medicare & Medicaid Services (CMS) proposed rule on End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury (AKI), End-Stage Renal Disease Quality Incentive Program (QIP), and End-Stage Renal Disease Treatment Choices Model (ETC):

KCP is extremely concerned the CMS ESRD PPS proposed rule fails to heed calls from the kidney care community for meaningful relief to address the ongoing workforce crisis. The lack of attention and action on these labor issues, which impact the availability of vital healthcare services, is dismaying and short-sighted. With ESRD inflation-related labor costs around four percent nationally, CMS flatly rejected calls from providers, patients, and bipartisan Members of Congress to provide resources necessary to keep dialysis clinics open and ensure access to care for the individuals with ESRD, who, in the rule’s preamble, CMS, itself, recognized as among the most vulnerable of all beneficiaries.

Further, CMS’s rule doesn’t address policies that result in insufficient payment and instead proposes inadequate reimbursement for innovative treatment options, contributing to significant barriers to patient access and exacerbating already existing health equity concerns. Together, these provisions widen disparities for individuals living with kidney disease or failure, who are disproportionately from communities of color.

Due to a number of factors that make transplant – the ideal treatment – difficult to obtain, most individuals with kidney failure rely upon life-sustaining home or in-center dialysis sessions three or more times each week. Providing these services requires a highly trained and skilled healthcare workforce consisting of a diverse and knowledgeable team to develop and implement an individualized plan of care. These care teams include nephrologists, advanced practitioners (such as nurse practitioners or physician assistants), nephrology nurses, renal nutritionists, nephrology social workers, patient care technicians, renal technologists, administrative support, and financial counselors. Unfortunately, because of the ongoing healthcare labor crisis, many facilities cannot hire sufficient staff needed to support individuals receiving dialysis. Reductions in treatment capacity and closures of facilities altogether are some of the grave risks presented by the proposed rule’s policy choices.

Federal data from the Bureau of Labor Statistics (BLS) showed an 8.3 percent increase in the cost of labor between the first quarter of 2020 and the first quarter of 2022.[1] In contrast, the Medicare rates were increased by only 3.0 percent for Calendar Year 2023, which is more than 5 percentage points less than the Administration’s own labor statistics. By statute, the annual Medicare payment increase is supposed to capture not only increases in labor costs, but also increased costs related to equipment, supplies, medication, and devices.

KCP is disappointed that CMS has refused to adopt the forecast error policies that it applies in other Medicare payment systems for the ESRD PPS. While this policy might not solve the payment adequacy problems in its entirety, it is an important step to help make sure that patients have access to the life-sustaining services they need.

Patient advocate Lori Hartwell of Renal Support Network said, “We can’t expect the kidney care treatment landscape to improve without access to innovation and a kidney care professional workforce. This rule doesn’t consider that without a workforce, people with kidney failure are denied access to care. It’s disappointing that this rule inadequately addresses these issues, as it’s ultimately people living with kidney disease who will suffer.”

KCP continued,

Given the options outlined in the Request for Information (RFI) and strong community and Congressional comments submitted as a result of that RFI in 2022, KCP is particularly disappointed in the proposed payment methodology for post-transitional drug add-on payment adjustment (TDAPA) drugs. We applaud CMS for recognizing that additional resources should be added to the payment rate for innovative drugs or biologicals that received TDAPA when the TDAPA period ends and for understanding the need to update the add-on amounts to reflect inflationary costs.

However, the proposal to add funding across all treatments will create significant access concerns for patients when the drug or biologic is medically needed for only a small percentage of patients. This approach simply will not provide adequate reimbursement to facilities when the product is used. Moreover, the proposal to limit the new funding only to three years creates a payment cliff that provides no sustainable pathway for the continued use of the product after the post-TDAPA period ends. These policies, coupled with limitations in utilization and the proposal to pay 65 percent of total drug expenditures rather than to use a more accurate offset calculation, result in a payment rate of a mere nine cents per treatment to the payment for the only TDAPA drug currently in use. Particularly concerning is that despite the agency’s assertion that it seeks to address health inequity for underserved communities, underfunding these treatments post-TDAPA will continue to expand the divide between those who can access new innovations and who cannot.

KCP Chair, John P. Butler noted, “It is crucial to ensure that changes in the payment system reflect the needs of the kidney care community and support the delivery of high-quality care. We urge CMS to thoroughly consider the community’s concerns and look forward to providing more specific feedback in our forthcoming comments.”

[1] BLS. “Employment Cost Index: Wages and salaries for All Civilian workers in Hospitals (2004-2022).” BLS.gov, https://fred.stlouisfed.org/series/CIS1026220000000I#0.

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Kidney Community Submits to CMS Comments on ESRD Proposed Payment System, Quality Incentive Program and ESRD Treatment Choices Model

 Kidney Care Partners (KCP) – the nation’s largest non-profit, non-partisan coalition of more than 30 organizations representing patients, professional care providers, and a wide range of kidney care stakeholders – thanks the Centers for Medicare & Medicaid Services (CMS) for proposing new policies in the CY 2023 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program Proposed Rule that seek to address recommendations KCP has made related to both the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and the End-Stage Renal Disease Quality Incentive Program (QIP)

“We appreciate this opportunity to work with the Administration to improve access to high-quality kidney care and address health inequities too often seen in this population,” said John P. Butler, chair of KCP. “Our comments address policies that will greatly impact access to innovations and the quality of care for the approximately 37 million Americans living with kidney disease.”

In its comments, KCP asks CMS to implement policy changes to help address the workforce crisis – which has a direct impact on the quality of care – that is threatening access to dialysis facilities and ensure that current policies do not make it more difficult for dialysis patients to obtain phosphate binders and phosphate lowering drugs.

In the context of the ESRD quality program, KCP requests that CMS suspend the penalties in the value-based purchasing program, given the ongoing impact on the ability to report quality data and the problems created by the pandemic.

Moreover, KCP applauds CMS for including a Request for Information (RFI) that recognizes the problems with the current “no new money” policy related to adding a new product to the bundle. Under the current policy, CMS would not adjust the payment rate when certain new, innovative products are added to the bundle. Given the chronic underfunding of this program, protecting patient access to innovative treatment options means that CMS should assess the payment rate and add new dollars even if the product being added to the bundle comes within what CMS has designated as an “existing functional category.” KCP also asks CMS to review the RFI comments and propose a policy for CY 2024 that will adjust the payment rate to support the long-term sustainable adoption of innovative products.

The comments also call on CMS to ensure incentives to adopt innovation apply to patients enrolled in Medicare Advantage plans, targeting case-mix and facility-level adjustors, outlier policies, addressing concerns about oral-only drugs potentially coming into the bundle in 2025, and similar policies to prevent millions of dollars from being trapped within the federal government and not spent on patient care. KCP also supports providing flexibilities that support care coordination among those who provide services to individuals living with kidney disease and kidney failure.

On quality, KCP notes that the ESRD QIP value-based purchasing program provides important quality performance information that promotes patient-driven decision-making. However, the pandemic has disrupted data reporting and skewed measure outcomes, making it inappropriate to apply penalties to facilities still battling the pandemic. KCP asks CMS to suspend the penalties for these facilities, just as it has done for hospitals and other Medicare providers with value-based purchasing programs. Given that individuals living with kidney disease are particularly at-risk for COVID-19 infection, re-infection, and experiencing complications from the disease, the kidney care community asks CMS to consider the public health emergency’s impact on the dialysis population and on reporting.

Finally, KCP notes its support for streamlining the QIP and ensuring that performance evaluation measures are meaningful to individuals who require dialysis and reflect the actual performance of dialysis facilities. While KCP recognizes and appreciates the efforts CMS has made to address some of the ongoing concerns the kidney care community shares with regard to the use of certain measures, the group also highlighted recommendations that have not been resolved. This includes the release of specific measures, universal rate measures, addressing health inequities, and promoting transparency.

“As a community, we look forward to continued work with CMS and applaud its recognition that there is a real need to increase funding for innovative kidney care. We hope the end policy result will provide for continued and sustainable, high-quality care for every American living with kidney disease and kidney failure,” Butler concluded.

To view KCP’s QIP comment letter, click here.

To view KCP’s PPS comment letter, click here.

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Nation’s Kidney Community Deeply Disappointed with Supreme Court Ruling in Marietta Memorial Hospital Employee Benefit Health Plan v. DaVita

 Kidney Care Partners (KCP) – the nation’s largest non-profit, non-partisan coalition of more than 30 organizations, comprising patients, dialysis professionals, physicians, nurses, researchers, therapeutic innovators, transplant coordinators, and manufacturers – today, expressed deep disappointment in the Supreme Court ruling on Marietta Memorial Hospital Employee Benefit Health Plan v. DaVita, citing concern about discrimination in accessing affordable quality care for individuals living with end-stage renal disease (ESRD) and its impact on growing health inequities.

“The insurer practice at issue – shifting patients prematurely to Medicare – will exacerbate inequalities in access and quality care for an already vulnerable population. This ruling is a blow to promoting affordable patient choice and instead unfairly shifts costs to the American taxpayer. We feel this decision leaves patients with ESRD vulnerable to discriminatory and inequitable insurer practices, and in fact, is not consistent with the Administration’s own goals on health equity,” said John P. Butler, Chair of KCP.

Premature loss of private group health coverage can be devastating for some patients living with ESRD. Often, private insurance plans offer more coverage options than Medicare does. Some of these services, such as dental coverage, can be essential in controlling infections that, if not caught early, can exclude a patient from transplant waitlists. More comprehensive disease management services can provide better outcomes by helping to manage other chronic diseases common in patients requiring dialysis. Private insurance may, in some cases, also provide lower copays and deductibles and limits on out-of-pocket costs than Medicare. When a patient living with ESRD loses private insurance coverage, the consequences can also extend to other family members under that policy who do not qualify for Medicare and may face substantially higher costs, deductibles, and other cost requirements resulting from that loss of coverage.

“Despite this ruling, KCP remains steadfast in our commitment to ensuring equitable, affordable access to quality care for the millions of individuals living with or at risk for kidney disease,” said Butler. “We stand ready and willing to work with Congress and other policymakers to address the gap created by today’s ruling and clarify the intent of the Medicare Secondary Payor Act to better protect patients from exclusionary measures like this. More must be done to ensure that no one is denied or discriminated against because of the treatment they need because of their disease.”

The issue in the case was whether a group health insurance plan that limited access to outpatient dialysis treatments violated the Medicare Secondary Payer statute by discriminating against patients based on their need for dialysis. In January, KCP filed an amicus brief that argued that the health plan discriminated against those with ESRD by limiting coverage for life-sustaining treatment, thereby forcing patients to drop private group coverage, and financial protections, in favor of Medicare. The recent Supreme Court opinion disagreed with that argument.

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Kidney Care Community Outlines Policy Priorities for 2022

 Kidney Care Partners (KCP) – the nation’s largest non-profit kidney care coalition of more than 30 organizations, comprising patients, physicians, nurses, researchers, transplant coordinators, dialysis professionals, therapeutic innovators and manufacturers– recently announced the community’s policy priorities for 2022.

KCP is dedicated to working on issues ranging across the full spectrum of the kidney disease continuum from education and prevention to early intervention to dialysis and, finally, to transplant and post-transplant care. The recently released policy priorities document outlines four key areas of focus:

· Supporting patient choice in treatment options;

· Reforming the Medicare ESRD Benefit;

· Advancing kidney care quality; and

· Addressing issues related to COVID-19.

“Every individual living with kidney disease, end stage renal disease (ESRD), and kidney transplant must have access to a variety of appropriate, innovative treatment modalities and coverage options, regardless of their age or location,” said Michele Kimball, executive director of KCP. “This includes expanded home dialysis choice, access to innovative products and services, removing barriers for donor waitlists, living donor education, and ensuring those living with kidney disease have the same insurance options as other Americans.”

KCP notes in its policy priorities that the organization is also committed to reforming the Medicare ESRD Benefit to support innovative care options, promote patient choice, and eliminate barriers to care by seeking new payment models and preventing Congress from using ESRD-specific offsets for other policies.

Additionally, the coalition is working to advance kidney care quality by seeking to streamline the quality programs and ensure appropriate implementation for the Quality Incentive Program (QIP) and Five Star, as well as seeking the passage of the bipartisan, bicameral Chronic Kidney Disease Improvement in Research and Treatment Act (S. 1971/H.R. 4065).

KCP also continues to support and advocate for policies that help to best address the COVID-19 pandemic for those living with kidney disease, individuals receiving dialysis treatments, and kidney transplant recipients.

“These priorities demonstrate KCP’s ongoing commitment to advancing policies that meet patients’ needs at every stage along the care continuum,” said John P. Butler, Chair of KCP. “Our diverse membership is proud to unite around this shared vision for a future of patient-centered, quality-driven kidney care.”

To learn more about KCP’s 2022 policy priorities, Click here.

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Nation’s Largest Kidney Coalition Submits Comments to HHS on Improving Organ Transplant Equity, Home Dialysis Access, Kidney Care Quality

 Kidney Care Partners (KCP) – a non-profit coalition of more than 30 organizations, comprising patients, dialysis professionals, physicians, nurses, researchers, therapeutic innovators, transplant coordinators and manufacturers – has submitted comments through the Centers for Medicare & Medicaid Services (CMS) to the U.S. Department of Health & Human Services (HHS) in response to the Agency’s request for information (RFI) on kidney care improvements. This request focused on how to advance equity and reduce disparities in organ transplantation, improve life-saving donations, provide individuals with CKD with access to more preventative services, promote greater care coordination for individuals receiving dialysis and empower individuals when making decisions about their treatment options, including removing socio-economic barriers to selecting home dialysis.

“We’re very pleased to see HHS and CMS spotlight the unique needs of the more than 37 million Americans living with kidney disease, kidney failure, and kidney transplants by calling on the kidney community to come together with actionable, tangible recommendations to improve care,” said John P. Butler, Chair of KCP. “Given that individuals with kidney disease are disproportionately from communities of color and often experience inequities in the delivery of care, now is the time to investigate, invest in, and implement policies that will improve access and choice to quality care and innovations for all.”

The response letter, written with input from leadership among KCP members from across the kidney care continuum, addresses a broad range of topics, emphasizing improving the organ and transplantation ecosystem and delivering care to individuals with chronic kidney disease (CKD) and end stage renal disease (ESRD). KCP brought together experts in each of the topic areas of the RFI – CKD, dialysis, and transplant – in a series of half-day working sessions to build the consensus recommendations.

Regarding transplants, KCP’s letter notes that “the current processes involved in waitlisting a patient leads to only a fraction of patients being actually listed.” Policy recommendations to address this issue include enhancing education and communication to patients around transplant, increasing transplant data transparency and addressing patient access issues, among others.

KCP specifically calls on HHS and CMS to “eliminate the silos within the health information system and ensure that all providers in the kidney care community can have a 360-degree view of patients’ health data” to improve care coordination and patient outcomes.

KCP also recommended that “HHS work across its agencies and with other stakeholders to slow the progression of CKD and empower patients to select the modality that works best for them” when considering their health care choices.

The comment letter specifically highlights the work of Senators Ben Cardin (D-MD) and Roy Blunt (R-MO) along with Representatives Terri Sewell (D-AL) and Vern Buchanan (R-FL) who have introduced The Chronic Kidney Disease Improvement in Research and Treatment Act of 2021 (H.R. 4065/ S. 1971) that would address shortcomings of the current Kidney Disease Education benefit (KDE) in Medicare and expand it to allow more patients access to KDE services and permit more providers to offer these services. The legislation would also increase awareness among beneficiaries by incorporating CKD screening in the annual Medicare wellness visit.

Additional recommendations in KCP’s response include expanding telehealth access, increasing education and awareness of kidney disease and incentivizing providers to help slow disease progression to delay or avoid ESRD altogether.

KCP also calls on the Administration to remove artificial restrictions that make it difficult for dialysis facilities and nephrologists to support patients whose socio-economic status creates barriers that can prevent them from accessing home dialysis options or receiving a transplant.

“The potential for individuals with kidney diseases to live longer and fuller lives is better than ever, but there’s still much more to be done,” said Michele Kimball, Executive Director of KCP. “KCP has always been a leading advocate for patients and pro-patient policies, and we look forward to working with HHS, CMS, and other stakeholder groups to expand options and choices for patients that drive changes for even better access to quality care and improved outcomes.”

To view the full response from KCP, click here.

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