Medicare program; standards for reuse of hemodialyzer filters and other dialysis supplies--HCFA. Final rule.

This final rule contains standards and conditions for safe and effective hemodialyzer reuse and reprocessing, enforceable as Medicare conditions for coverage. It incorporates by reference voluntary guidelines and standards adopted by the Association for the Advancement of Medical Instrumentation in July 1986 (i.e., "Recommended Practice for Reuse of Hemodialyzers"). In addition, the rule provides standards for reuse of dialyzer caps and prohibits reuse of transducer filters in ESRD facilities. As provided in section 9335(k) of Pub. L. 99-509, the Omnibus Budget reconciliation Act of 1986, failure of facilities to comply with these conditions could result in suspension of payment or removal of the facility from coverage under the Medicare program.