The Australasian Sleep Association is making a submission to the Australian Government Therapeutic Goods Authority (similar to USA’s FDA) regarding CPAP supply. World Sleep Society is pleased to publish the results of the survey.
- What are the government rules related to the supply of CPAP to patients? I.e. – does the patient need a prescription from a MD?
- Do CPAP machines need a label stating “For use with prescription only”, or something similar?
- What country or region of the world are you referencing the above two questions?
INTERNATIONAL CPAP SUPPLY RULES
|Country||Does it need a Prescription||Does it need a sign to say Prescription Only|
|Canada||Health care is a provincial responsibility. To my knowledgein all provinces a CPAP prescription is advised but not mandatory||CPAP prescription is advised|
|Canada (2)||In places that fund CPAP a physician prescrition is needed sometimes specifically a sleep physician (Ontario and SK although the latter is losing their funding program). There are also some rules about what service delivery is required (follow up, etc). Choice of testing is also an issue in some places but not all.||Not aware of anything, but believes it would be a good idea|
|USA||Prescription and specific disease documentation criteria, the latter varies between Federal and Non-Federal Insurances. All insurers have formal policy statement of coverage for sleep apnea||Yes – these are available only via prescription. There is also a further category of FDA approved devices where they may (or may not) be sold to durable Medical Equipment providers|
|Germany||A prescription from a physician who has a proven sleep medicine expertise by subspeciality is required||No|
|Germany 2||Yes they need a prescription and a certificate for medical need for CPAP||Yes – all current machines on the German Market have these labels|
|Czech Republic||Yes, patients with sleep breathing disorders need a prescription from MD (specialist in the sleep medicine) and a permission to use CPAP from the Czech health insurances||No – just a number identification|
|Italy||Every region(20) follows local rules. Most supply CPAP free to patients with a diagnosis of moderate – severe OSA. Generally the patient needs a prescription from a sleep specialist||No|
|Brazil||Yes – it does require an MD prescription, no reimbursement for CPAP so far. Reimbursement for CPAP for severe OSA patients are under negotiation||No|