This bill refines Medicare payment systems to improve patient access to new kidney care treatments, adjusts payment updates based on forecast accuracy, and expands Medicare coverage for kidney disease screening and education.
Carol Miller
Representative
WV-1
The Kidney Care Access Protection Act aims to improve patient access to innovative kidney care treatments by reforming Medicare payment systems for new drugs and devices. It also addresses payment stability by adjusting for forecast errors in dialysis service updates and enhances prevention efforts. Finally, the Act expands Medicare coverage for chronic kidney disease screening and education services starting in 2026.
Medicare Set to Guarantee Non-Stop Payments for New Dialysis Drugs Starting 2026, Expanding Kidney Care Access and Costs
The “Kidney Care Access Protection Act” is here to shake up how Medicare pays for dialysis, aiming to bring new drugs and equipment to patients faster. This isn't just about better care; it’s a major restructuring of the payment system, specifically designed to incentivize innovation in the kidney care market, effective mostly in 2026.
The Cost of Innovation: Guaranteed Payments for New Drugs
Title I is the big one, focusing on getting new technology to patients with End-Stage Renal Disease (ESRD). Currently, when a new dialysis drug or biological product hits the market, it gets a temporary payment bump called TDAPA (Transitional Drug Add-on Payment Adjustment). This bill (Sec. 101) extends that temporary payment for new drugs approved since 2020 to at least three years and, crucially, creates a permanent add-on payment adjustment after the temporary period ends. This means that once a new drug qualifies, Medicare is essentially guaranteeing a long-term revenue stream for it, starting January 1, 2026.
Here’s the part that impacts the Medicare budget: this permanent payment is explicitly mandated not to be implemented in a budget-neutral manner. Translation: Medicare is guaranteed to spend more money on these new drugs without offsetting those costs elsewhere. For taxpayers and general Medicare beneficiaries, this means higher overall program expenditures. The payment amount is calculated using a formula based on drug use and average sales price data, but if that sales data is zero or negative, the calculation defaults to 100% of the drug’s wholesale acquisition cost (WAC). If WAC is used, it could potentially lead to higher payments than if the drug had established market sales, which is something to watch closely.
Equipment, MA Plans, and Staffing Adjustments
It’s not just drugs getting the golden ticket. The bill also extends the transitional payment for new and innovative equipment and supplies (TPNIES) to at least three years (Sec. 101). More importantly, it removes the rule that excluded capital-related assets—think expensive, large-scale dialysis machines—from receiving this transitional payment. This change could be a big win for manufacturers of high-tech dialysis equipment, ensuring their new, costly devices get covered by Medicare quicker.
Furthermore, the bill ensures that Medicare Advantage (MA) plans can’t lag behind. Starting in 2026, MA plans must make direct payment adjustments to providers for these new drugs and equipment, matching the payment rates set by the traditional Medicare system (Sec. 102). This removes a potential barrier for MA enrollees trying to access the latest treatments.
Separately, Title II addresses payment accuracy by requiring the Secretary of HHS to adjust annual payment updates for dialysis services starting in 2026 to account for forecast errors (Sec. 201). If the government incorrectly forecasts the cost of providing dialysis services by more than 0.5 percentage points, they have to correct it in the following year’s payment update. This aims to bring stability and fairness to providers who rely on accurate annual payment adjustments.
Catching Kidney Disease Early
Title III is focused on prevention and education, which is a major benefit for patients. Starting January 1, 2026, the Medicare Annual Wellness Visit will now include Chronic Kidney Disease (CKD) screening as a covered component (Sec. 301). This is a smart move. Catching CKD early—before it progresses to ESRD—can significantly improve a patient’s quality of life and reduce the long-term, astronomical costs of dialysis treatment.
The bill also expands access to kidney disease education for those already diagnosed with late-stage CKD (Stage IV or V) (Sec. 302). It widens the pool of professionals who can provide this education, including physician assistants, nurse practitioners, and clinical nurse specialists, making it easier for patients to get the crucial information they need to manage their condition before needing dialysis. For dialysis facilities that provide this education, the bill ensures they get paid separately for it, instead of having the cost buried in the standard dialysis payment bundle. This should incentivize facilities to prioritize patient education.