The US government recently filed a brief in opposition to Sutter Health's motion to dismiss the Department of Justice's (DOJ's) complaint in intervention in a False Claims Act suit alleging that Sutter had knowingly submitted and caused the submission of unsupported diagnosis codes for Medicare Advantage organisation patients in order to inflate Medicare reimbursement. The brief reinforces the DOJ's increasingly aggressive enforcement of the Medicare Advantage space under the False Claims Act.
The Federal Council recently adopted new measures to combat rising costs in the public healthcare sector. With this first set of measures, the Federal Council intends to provide all stakeholders with the instruments needed to reduce costs and expects to save several hundred million Swiss francs annually.
Technology is developing rapidly and it generally takes the legislature years to catch up. This is particularly true in the healthcare industry, where regulations are struggling to keep up with the development of health-related technology. This situation has put Mexico in a difficult position. On the one hand, health-related technology is widely available to the general population. However, Mexico also faces numerous challenges, as it cannot quickly and efficiently regulate the use of emerging technologies.
The Federal Council recently approved a draft of the Social Security and Health Commission of the Council of States in order to improve the legal basis for the transfer of data of insured persons. The Federal Council intends to collect personal data from insured persons while guaranteeing the protection of personal data and upholding the principle of proportionality.
Patients who are beyond treatment under the standards of conventional medicine often seek help from alternative medical treatments; however, these methods pose not only medical risks for patients, but also legal risks for doctors. A recent Supreme Administrative Court decision appears to favour a liberal approach to new therapies and compassionate use and enhances the possibilities for developing new therapies and alternative medicines in future.
The Federal Supreme Court recently clarified that although certain provisions of the Health Insurance Act and the Health Insurance Ordinance are based on patent protection (or expiration), the Health Insurance Ordinance sets out no pricing rules for generics if the original's exclusivity is only partially lost. Further, protected indications of a multi-indication pharmaceutical, of which some indications have lost exclusivity, cannot be exchanged by a generic.
The long-awaited amendments to the Patented Medicines Regulations were recently published in Part II of the Canada Gazette. Major changes include the introduction of three new price regulatory factors and a revised schedule of reference countries. Although the new law will not be in force until 1 July 2020, there are immediate implications.
The Department of Health and Human Services (HHS), the Department of Labour and the Treasury have jointly announced that they will not enforce the HHS's recently finalised policy that limits private health plans' use of accumulator programmes to prescription brand drugs for which a medically appropriate generic equivalent is available. Stakeholders should remain alert to any changes in state enforcement policies and consider opportunities to engage with the administration on future revisions.
The Canadian Agency for Drugs and Technologies in Health (CADTH) recently released Issue 8 of its Pharmaceutical Reviews Update announcing revisions to its Procedure and Submission Guidelines for the CADTH Common Drug Review, among other things. The update also announced that the CADTH will no longer review biosimilars through the Common Drug Review or the pan-Canadian Oncology Drug Review.
The Federal Council recently submitted a draft amendment to the Narcotics Act for consultation that aims to facilitate patients' access to cannabis-based treatments. The revised act would allow patients to obtain direct medical prescriptions for cannabis-based treatments with a tetrahydrocannabinol content of more than 1% without having to obtain an exceptional licence from the Federal Office of Public Health.
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.
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.
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.
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.
To safeguard against potential liability claims under the EU Product Liability Directive, the EU Medical Device Regulation stipulates that medical device manufacturers must have measures in place to provide sufficient financial coverage. However, as medical software can hardly be considered a 'product' under the German Act on Product Liability and the EU Product Liability Directive, it is conceivable that no liability applies under the respective provisions and, therefore, there is no need for financial coverage.
The Federal Council intends to improve access to psychotherapy, especially for children and adolescents, as well as adults in crisis situations. In order to facilitate such access and ensure adequate care, the Federal Council has proposed a change to the existing system which will allow, among other things, psychotherapists to provide their services independently within the compulsory healthcare insurance framework.
Health Canada has announced a consultation on its new draft guidance: The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products. The guidance is intended to clarify and outline the factors and circumstances that contribute to rendering a message or activity non-promotional.
Health Canada recently published an annual highlights report for 2018. The report provides information regarding Health Canada drug (for human or veterinary use) and medical device approvals, as well as published safety issues in 2018. Moreover, the Therapeutic Products Directorate and the Biologics and Genetic Therapies Directorate released their Drug Submission Performance Annual Reports for the 2018-2019 fiscal year.
The EU Medical Device Regulation (MDR) was introduced in May 2017 and sets out the legal framework for medical devices in Germany. However, the MDR provides no definition of 'medical software' and limited rules on liability. Medical software liability under the existing regulatory framework requires that medical software be classified as a product; however, this classification is highly controversial and has been widely debated.
Advanced therapeutic products have been the topic of much debate recently. First, Bill C-97 – which includes amendments to the Food and Drugs Act, including a new framework for advanced therapeutic products – received royal assent. Second, Health Canada opened a consultation to seek feedback on what it should consider when developing new clinical trial regulations as well as implementing the pathway for advanced therapeutic products.