CAMPS is sponsoring AB 1387 (Arambula) which would exempt an HMDRF from annual inspections if they are accredited by an accrediting body approved by CMS/ Medicare. Upon initial licensure a HMDRF would be inspected but after that would only be inspected based upon a complaint to CDPH. Non- accredited HMDRFs would continue to be subject to annual inspections.
CAMPS sponsored legislation to create HMDRF licensing in 2000 to allow non-pharmacies to dispense legend stamped or dangerous devices. The requirements for compliance have largely been developed by CDPH staff and inspectors with few elements detailed in regulation or statute. In 2006 Medicare established a requirement that all providers of DME and medical supplies must be accredited by one of 10 recognized accrediting bodies. The accreditation process is a rigorous with a procedure and process driven program to assure both quality and patient protections. It is a more extensive oversight process than state inspections.
In addition under current law an HMDRF located outside California that provides services to California residents is required to be licensed but is not subject to initial or annual inspections. There are approximately 1,100 HMDRFs in California and over 300 out of state HMDRFs. In state HMDRFs are subject to an additional burden and uncertain state requirements while out of state HMDRFs are not held to the same standards. SB 1387 has been referred to the Assembly Health Committee and will likely be heard in April.