UniCycive Therapeutics Inc (UNCY)

[Whalatane]

The dialysis bundle explained and its relevance to UNCY ( and ARDX )

The dialysis bundle in the United States is a comprehensive payment system implemented by Medicare for end-stage renal disease (ESRD) treatment. Here's an explanation of the key aspects:
Purpose and Implementation:
The dialysis bundle, officially known as the End Stage Renal Disease (ESRD) Prospective Payment System (PPS), was implemented on January 1, 2011. Its purpose is to provide a single, bundled payment to dialysis facilities for renal dialysis services provided to Medicare beneficiaries.
What's Included in the Bundle:
The bundled per-treatment payment covers:
Dialysis treatment
Drugs and injectable medications
Laboratory services
Supplies
Capital-related costs
Equipment and supplies used for home dialysis
Oral drugs with injectable equivalents
Payment Structure:
The payment is made on a per-treatment basis and is adjusted for patient-level and facility-level factors. It includes provisions for:
A base rate
Adjustments for patient demographics and comorbidities
Quality incentives through the Medicare Quality Improvement Program (QIP)
Oral-Only Drugs:
Currently, oral-only drugs (those without injectable equivalents) are not included in the bundle. However, CMS plans to incorporate these, specifically phosphate binders, into the bundled payment starting January 1, 2025.
Innovative Treatments:
The system includes provisions for new treatments:
Transitional Drug Add-on Payment Adjustment (TDAPA) for new renal dialysis drugs and biologicals
Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES)
Impact on Clinical Care:
The bundled payment system has led to changes in clinical algorithms and quality improvement activities. For example, Fresenius Kidney Care reported optimizing the use of erythropoiesis-stimulating agents (ESAs) and vitamin D treatments while maintaining or improving quality outcomes.
Quality Metrics:
The bundle is tied to quality metrics through the QIP, which examines factors such as dialysis adequacy and management of complications like hypercalcemia.
Drug Designation Process:
CMS uses a drug designation process to determine how new renal dialysis drugs and biological products are incorporated into the bundled payment.
The dialysis bundle aims to incentivize efficient care delivery while maintaining or improving quality outcomes for ESRD patients. It has led to changes in clinical practices and resource allocation within dialysis facilities, with ongoing adjustments to incorporate new treatments and medications into the payment system.

Note high lighted area .
If included in the bundle , price caps would limit any use of OLC ( UNCY ) or Xphazoh (ARDX )

Outside the bundle the MD can get Medicare to cover 75% of the cost and the Co can issue coupons to reduce the copay to the patient

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