Health Canada recently announced the final amendments to the Patented Medicines Regulations. The amendments – which represent the first substantive revision to the regulations since their introduction in 1987 – are a significant departure from the existing framework and include new price regulatory factors, updated reference countries and changes in reporting requirements.
Health Canada recently released a revised Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs, which is effective immediately. The revisions include clarifying additions on the requirements for cross-licensed products for an administrative certification form and letter of authorisation, a drug notification form and labelling. Health Canada also recently released an updated Good Label and Package Practices Guide for Prescription Drugs.
The Federal Department of Home Affairs recently decided that measures to preserve the fertility of people suffering from cancer will now be covered by compulsory health insurance. Under the new measures, if cancer patients run the risk that a planned treatment will lead to impaired ovarian or testicular function, sperm, egg cells or ovarian tissue can be frozen (so-called 'cryopreservation') and reused after therapy. Cerebrospinal fluid analyses for diagnosing dementia will also be covered.
Beaver Medical Group LP and an affiliated physician recently agreed to pay a combined total of $5 million to resolve allegations that providers had knowingly submitted diagnosis codes that were not supported by medical records in order to inflate reimbursements from Medicare. The settlement reflects the Department of Justice's continuing efforts to use its enforcement power to pursue fraud in the Medicare Advantage space despite recent setbacks.