S. 1971/H.R. 4065 – The Chronic Kidney Disease Improvement in Research and Treatment Act of 2021

This bipartisan bill can save lives and improve quality of life for millions.

On June 8, 2021, S. 1971 The Chronic Kidney Disease Improvement and Research Treatment Act of 2021 was proposed into legislation “to improve the understanding of, and promote access to treatment for, chronic kidney disease.” Originally introduced to the 2017-2018 legislative session by Rep Tom Marino (R-PA), this is the third incarnation of this bill, reintroduced to the 2021-2022 session by Senators Ben Cardin (D-MD) and Roy Blunt (R-MO). Each Congressional session bills must be reintroduced and receive updated Senate and House numbers for that session (S. bills correspond to the Senate and H.R. to the House of Representatives). So, if you feel like you’ve read about this Act on RSN’s website before, you have!

Passing this Act would be a significant step toward improving care for people who have kidney disease. Here are the major points that RSN believes will help the kidney community and why they will lead to optimal outcomes.

Guarantee access to Medigap policies for all ESRD Medicare recipients

To date, there is currently no “all-inclusive” provision for access to Medigap or supplemental insurance to encompass items and services not fully covered by Medicare for end-stage renal disease (ESRD) patients under the age of 65. Only 31 of the 50 states offer some kind of Medigap coverage. Because the ESRD program provides Medicare to people affected by and receiving treatment for renal failure, this leaves people under the age of 65 choosing either to pay potentially huge out-of-pocket costs or to compromise their treatment by picking and choosing what they can afford. This obstacle can often financially cripple people living with kidney disease. A federal requirement that all Medicare recipients have access to Medigap coverage in every state, would guarantee that the full range of services required to maintain their health is available to them.

Require HHS to list dialysis service providers available in all MA Networks

Congress expanded patient access to Medicare Advantage (MA) plans effective January 2021; meaning people with ESRD who have access to Medicare are allowed to enroll in MA plans. When managed care plans like MA were developed in the 90s, Congress had the foresight to write policy that disallowed people who have ESRD and also qualify for Medicare from joining. This was a very compassionate move as network adequacy wasn’t readily available and Congress knew patients could die or be harmed waiting for a referral or authorization to receive care.

Network adequacy standards determine how many types of providers must be in a plan’s network, based on factors like travel time or the number of miles a beneficiary must travel to reach a provider’s office or facility. Network adequacy is still the foundation of managed care, but dialysis facilities were removed in 2020 which creates a big problem for people living with kidney disease for multiple reasons. This “all-in-one managed care” system that precludes geographic considerations as long as your plan providers are “in-network,” is not conducive to guaranteeing treatment 3 times per week.  For instance, 15 miles can mean a drive time of 15 minutes in one area and 90 minutes in another area with heavy traffic.

It also means dialysis facilities are not listed when patients choose potential MA plans. So patients have no way of knowing if their current care facility is in that Network, which could potentially result in dangerous consequences if the patient must change and adapt to a new facility and care team.  All of this may prevent informed decision-making for people who need dialysis when seeking to enroll in MA plans.

Add Chronic Kidney Disease (CKD) screening to the annual wellness benefit

Kidney disease is a silent illness. The two main causes of kidney failure are diabetes and high blood pressure. Often people don’t realize they have kidney disease until they reach ESRD and the kidneys fail. Adding a chronic kidney disease (CKD) screening to the annual wellness benefit will allow Medicare beneficiaries at-risk for kidney disease and kidney failure, to find out if they have the disease, help determine what stage they’re in, and allow them to seek treatment to slow the progression of the disease or even prevent it.  People can be better equipped for what’s ahead and know what options they have to care for themselves with preparation, education and access to proper medical information and specialists.

Allow Medicare beneficiaries with Stage 5 CKD who are not yet on dialysis to have access to the ESRD Kidney Disease Education benefit

The ESRD Kidney Disease Education (KDE) benefit is a vehicle to access critical knowledge about navigating kidney disease, but currently has multiple barriers preventing potential beneficiaries from being able to access it.

It would be valuable for patients if the benefit would be expanded to allow dialysis facilities to provide kidney disease education services. Also, due to the shortage of nephrologists, it would be advantageous to allow physician assistants, nurse practitioners, and clinical nurse specialists to serve as referral sources for the benefit. Education is particularly vital when you are in the last stage of kidney failure. Allowing Medicare beneficiaries with Stage 5 CKD who are not yet on dialysis to have access to the benefit would be extremely helpful to them, as well as to the Medicare program, because it will help patients make the best choices for care.

Require the Secretary of HHS to conduct a study to improve care in minority populations with kidney disease

It is well known that there are healthcare disparities in minority communities. This Act would require the Secretary of HHS to conduct a study and submit a report to Congress no later than 12 months after it gets passed, to identify any disincentives in the Medicare payment systems that create barriers to kidney transplants and post-transplant care for beneficiaries with ESRD. It would also outline social, behavior, biological and care factors that lead to kidney disease in minority populations, often disproportionately affected by ESRD, in order to identify best policies and practices to improve care and determine means to slow the progression of kidney disease and increase organ donation rates.

Require that the Secretary of HHS adjust the ESRD PPS bundled   rate so it will cover the cost of adding a new drug, biologic, device, or other technology into the bundle after the transitional payment period ends

ESRD is the only chronic illness that has access to Medicare (regardless of age) based on organ failure. RSN is grateful that Congress made this decision back in the early 70s to reimburse care. The ESRD Prospective Payment System (PPS) is a reimbursement system based on a “bundled” and fixed amount per treatment that Medicare pays to dialysis centers. Some patients have additional comorbidities that raise costs, and it is important that facilities are not disincentivized to care for them. Because payment drives practice, we don’t want to foster ‘cherry picking’. This Act would refine the ESRD payment adjusters to improve the accuracy of facility payments and would require the Secretary of HHS to adjust the ESRD bundled rate to ensure people who require lifesaving dialysis have access to care and get the care they need.

Innovation and technology drive hope for people who have a serious illness and have proven to increase longevity and wellness outcomes. The current ESRD bundled payment program has no sustainable means to incentivize and improve kidney care. Again, payment drives practice. Improved devices and technology are currently not reimbursed at the rate or percentage for kidney disease as they are for other chronic illnesses. So there is no incentive for companies to develop new products or treatments without a clear path for their innovation and research efforts to have a chance in the marketplace.

Currently the traditional payment is for two years. This means that the company has to fully get their product to market to ensure all future payments will be based on utilization within those two years, and it takes a lot of moving parts to make this happen. To force innovation to be reliant on this two-year window is unrealistic and a hindrance to an increase in new innovative therapies and technology to improve care. This Act would require that the Secretary of HHS adjust the ESRD PPS bundled   rate so it will cover the cost of adding a new drug, biologic, device, or other technology into the bundle after the transitional payment period ends.

Modernize the Quality Program to drive quality care

Measuring care in the ESRD Quality program is a new frontier in healthcare. The ESRD Quality Incentive Program (QIP) has a 2 percent withhold of dialysis payment based on the measures in the QIP. The QIP must have measures that are reliable, valid and show room for improvement, thus are frequently reassessed. Too many measures do not incentivize treatment due to the fact that the allowable margin for improvement is too small, or it may be too cumbersome for a facility to try and drive care in that area when the incentive is not worth the time, resources and energy.

The ESRD QIP Five Star programs is a rating system developed by Medicare that assigns 1 to 5 stars to dialysis facilities by comparing the health of the patients in their clinics to patients in other dialysis facilities across the country. This may seem like a good idea, but RSN finds it confusing for patients and doesn’t feel it provides an accurate story for patients and families to make decisions. In this rating system there are always ‘losers,’ as they have to spread the facilities performance across the rating system. For instance, the way the system is structured, a facility that has a 5-star rating that provided good care to a few patients for over 20 years, but those patients passed, are at-risk of getting the lowest rating in the next rating cycle. RSN does not feel this provides an accurate picture nor is it a positive morale booster for the healthcare professionals caring for patients.

In addition, the QIP is a ‘stick versus the carrot’ incentive program. It would be beneficial to provide a QIP bonus payment (carrot) to those who are exceeding performance standards.

Keep up with the progress of this legislation as it moves through the Senate and House of Representatives:
S.1971 – Chronic Kidney Disease Improvement in Research and Treatment Act of 2021

H.R.4065 – Chronic Kidney Disease Improvement in Research and Treatment Act of 2021

RSN will continue to give you the pros and cons of legislation relevant to the kidney community and our Advocacy section can give you direction on how to contact your representatives and have a voice in legislation that directly affects your life.

Web ID: S. 1971/H.R. 4065