Whalatane
6 días hace
Also beginning Jan. 1, 2025, the bundled payment will include oral-only renal dialysis drugs and biologics — a move initially set to begin in 2014 but delayed until now by several laws and court challenges.
“In response to comments that we received on the proposed rule [released in July], we are finalizing a policy to pay the [transitional drug add-on payment adjustment] for phosphate binders based on 100% of the average sales price, increased by a fixed amount of $36.41 for incremental costs such as dispensing and storage of phosphate binders, which will be added to any monthly claim for which there is a [transitional drug add-on payment adjustment] payment for phosphate binders. We expect that incorporating oral-only drugs and biological products into the [End-stage Renal Disease Prospective Payment System] will increase access to these drugs,” CMS stated in the release.
In a response statement, Kidney Care Partners (KPC), a non-profit coalition of stakeholder organizations, expressed concern that “the base rate is insufficient to support adding new treatment options without adding new money.”
“We applaud CMS’s efforts both in recognizing that providing oral-only medications as part of the bundle requires additional funding, as well as creating access for AKI patients to home dialysis,” Mahesh Krishnan, MD, MPH, MBA, chair of Kidney Care Partners, said in the statement. “However, KCP has consistently raised concerns that significant changes are needed to the ESRD PPS system to maintain an appropriate level of care, access and reimbursement for the more than 557,000 Americans who rely on regular dialysis treatment.”
KPC urged support of the Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 (H.R. 5027/S. 4469) to provide a permanent reimbursement pathway for innovative drugs and devices.
Kiwi
ErnieBilco
6 días hace
Ardelyx (NASDAQ:ARDX) plunged 17% after a court dismissed a lawsuit the company filed against the Centers for Medicare and Medicaid Services (CMS) over its proposal to bundle its kidney disease therapy Xphozah in the Medicare payment system applicable for dialysis services.
"Defendants’ motion to dismiss is therefore granted, and plaintiffs’ motion for a preliminary injunction or expedited summary judgment is denied as moot," US District Judge Beryl Howell wrote in an opinion.
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In October, the FDA approved Xphozah as a late-line add-on therapy to cut serum phosphorus in adults with chronic kidney disease on dialysis.
The issue relates to Medicare’s plan to include Xphozah, along with all other oral-only phosphate-lowering therapies (PLTs), in its End-Stage Renal Disease Prospective Payment System (ESRD PPS), a bundled payment system for dialysis services.
Ardelyx (ARDX) didn't immediately respond to Seeking Alpha email request for comment.
The decision, which will take effect on January 1, 2025, can potentially eliminate Part D coverage for Xphozah.
The plaintiffs alleged that the Medicare proposal violates U.S. law, noting that dialysis providers do not administer Xphozah and other PLTs, currently offered under outpatient pharmacy benefit plans such as Medicare Part D.
Whalatane
1 semana hace
Thx. So they have increased the payment per dialysis to $273 and state the following
In response to comments that we received on the proposed rule, we are finalizing a policy to pay the TDAPA for phosphate binders based on 100% of the Average Sales Price (ASP), increased by a fixed amount of $36.41 for incremental costs such as dispensing and storage of phosphate binders, which will be added to any monthly claim for which there is a TDAPA payment for phosphate binders.
I believe the dialysis centers can keep any money saved below the $273 paid per dialysis ...so the incentive is to push the existing generics not new brand Oral drugs even if the new drugs are more effective for some
The CMS payment system for dialysis services uses a bundled prospective payment system (PPS). Under this system, facilities receive a set payment amount per treatment, regardless of their actual costs3.
If a facility's actual costs are below the bundled payment amount, they likely can retain those savings. The PPS is designed to incentivize efficiency in providing care.
Kiwi
Whalatane
4 semanas hace
From Rose on X
Rose Han
@itsrosehan1
$ARDX
Ardelyx gains bipartisan support for potential kidney disease legislation
Ardelyx, a biopharmaceutical company focused on developing innovative treatments for kidney and cardiorenal diseases, may see increased interest following recent legislative developments. A bill related to kidney patient care, H.R.5074 - the Kidney PATIENT Act of 2023, has gained additional bipartisan cosponsors in Congress.
The bill, initially introduced by Rep. Carter, Earl L. Buddy [R-GA-1] on July 28, 2023, has now attracted 4 new cosponsors, bringing the total to 37. The new cosponsors, all added on October 18, 2024, include:
1. Rep. Meeks, Gregory W. [D-NY-5]
2. Rep. Velázquez, Nydia M. [D-NY-7]
3. Rep. Gonzalez, Vicente [D-TX-34]
4. Rep. Horsford, Steven [D-NV-4]
This growing bipartisan support for kidney patient-focused legislation could potentially benefit companies like Ardelyx that are developing treatments for kidney-related conditions. While the bill's specifics and its potential impact on Ardelyx's business are not detailed here, increased congressional attention to kidney health issues could create a more favorable regulatory and market environment for Ardelyx's pipeline products.
Investors in Ardelyx may want to monitor the progress of this legislation, as it could have implications for the company's future prospects in the kidney disease treatment space.
Current view is that we need 50 cosponsors or more ...bipartisan ...for this to pass
Kiwi
Whalatane
1 mes hace
Why access to these new serum phosphorous lowering drugs is so important
Patients receiving maintenance dialysis for chronic kidney failure have a high mortality rate, with 5-year survival of less than 50% after dialysis initiation in the US.3
Cardiovascular complications are the leading cause of death, with 40% of deaths attributed to arrhythmia or cardiac arrest.3
Systemic complications of chronic kidney failure include anemia, hypertension, and mineral bone disorders, such as hyperphosphatemia and hyperparathyroidism.
Dialysis treatment–related complications, such as vascular access dysfunction, infections, and hemodynamic instability during dialysis, are common and may cause distressing symptoms, including cramping, post-dialysis fatigue, and poor quality of life.4
Kiwi