Modifications/Additions to CR 3730, Frequent Hemodialysis Network (FHN) Payments for Approved Clinical Trial Costs The Centers for Medicare & Medicaid Services (CMS) is jointly sponsoring, with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), two clinical trials that will evaluate the effectiveness of more frequent hemodialysis sessions compared with conventional three times weekly hemodialysis. One of these trials compares daily in-center hemodialysis (six times per week) with conventional in-center hemodialysis (three times per week). The other compares nocturnal hemodialysis (six times per week in the home) with conventional in-center hemodialysis (three times per week). CMS has agreed to pay for covered patient care-related expenses for Medicare beneficiaries enrolled in these trials. For patients enrolled in the experimental arms of these trials (more frequent in-center or nocturnal hemodialysis), CMS also authorizes payment for one additional composite rate per week for the duration of the trial. The duration of the daily in-center hemodialysis trial will be 12 months after patient enrollment. The duration of the nocturnal hemodialysis trial will be 14 months after patient enrollment. For patients enrolled in the experimental arm of the nocturnal hemodialysis trial, CMS also authorizes additional home dialysis training payment at the composite payment rate plus $20 for each training session incurred not to exceed 30 training session payments per patient. The standard Medicare deductible and copayments will apply to both composite rate payments and training session payments. Authority to enter into this agreement is contained in Section 601 of the Economy Act of 1932 as amended (31 USC 1535). CMS’s program authority is CFR 42 USC 1310. The program authority for NIDDK is the Economy Act, as amended (31 USC 1535). Providers may view the entire text of this transmittal with its attachment at http://www.cms.hhs.gov/transmittals/downloads/R206OTN.pdf . Pub. 100-20 Transmittal# 206, CR# 4138 |
