International CPAP Survey Results

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.

SURVEY QUESTIONS:

  1. What are the government rules related to the supply of CPAP to patients?  I.e. – does the patient need a prescription from a MD?
  2. Do CPAP machines need a label stating “For use with prescription only”, or something similar?
  3. What country or region of the world are you referencing the above two questions?

RESULTS:

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
Hong Kong No 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