The Sherman Food, Drug, and Cosmetic Law, among other things, prohibits a person from conducting a home medical device retail facility business in the state without a valid license from the State Department of Public Health. Existing law requires the department to inspect each place of business prior to issuing a license, and further requires the department to inspect each licensee at least annually.
This bill would modify, until January 1, 2023, the requirement for the department to inspect a licensed home medical device retail facility business if it is accredited, as specified, by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services. If so accredited, the bill would authorize the department to conduct an inspection only upon a complaint made to the department regarding the licensee. For a licensee that is not so accredited, the bill would continue to require the department to conduct an inspection at least annually.
Section 4040.5 of the Business and Professions Code is amended to read:
4040.5. “Reverse distributor” means every person who acts as an agent for pharmacies, drug wholesalers, third-party logistics providers, manufacturers, and other entities by receiving, inventorying, warehousing, and managing the disposition of outdated or nonsaleable dangerous drugs or dangerous devices.
Section 4022.6 is added to the Business and Professions Code, to read:
4022.6. “Designated representative-reverse distributor” means an individual to whom a license has been granted pursuant to Section 4053.2, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor. A pharmacist fulfilling the duties of Section 4053.2 shall not be required to obtain a license as a designated representative-reverse distributor.
“Another data point shows just how greatly Medicare’s importance as a revenue driver for HME has dropped. In addition to Medicare’s 16 percent share, Medicaid accounted for 15 percent of HME spending, and all other sources, such as private payer and retail sales, represented 68 percent of HME spending.”
“According to research AAHomecare had been performing using Medicare data, the number of traditional suppliers of home medical equipment to Medicare beneficiaries has dropped 40.9 percent since July 2013. In addition, the number of unique locations (commonly referred to as rooftops) serving Medicare beneficiaries has declined by 38.7 percent during the same period.”
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“One of the major changes in the medical device sector is the continuously growing emphasis on home health care through wearable device and remote monitoring devices. Technology now allows patients a much more flexible approach to therapy, one that does not diminish their life styles as previously. A recent research report by Meticulous Research estimates that the global home medical devices market is expected to reach $48.47 billion by 2022 with a CAGR of 7.8% over the period of 2016 to 2022.”
“Medicare reimbursement rates for home medical equipment cover just 88 percent of overall costs for companies providing this service, raising concerns about the future viability of the home medical equipment industry under the current Medicare model, according to an American Association for Homecare study.
The report’s conclusions show the current Medicare competitive bidding program for home medical equipment is producing financially unsustainable rates, and faults the program for its lack of transparency.”
“AAHomecare has received confirmation that H.R. 5210, the Patient Access to Durable Medical Equipment Act, did not successfully clear through the Senate before adjournment last night thanks to a hold placed by an unidentified Senator. This means the July 1 round of cuts for rural and non-bid area suppliers will remain in effect unless Congress takes action when they return in September.”