StatLaw – January 2016

New York State Department of Health Announces Online Medical Marijuana System:  The New York State Department of Health (“DOH”) announced the launch of its online Medical Marijuana Patient Certification and Registration System. The online system allows qualified patients to enroll in the Medical Marijuana Program so they will be able to purchase medical marijuana when it becomes available in 2016. In order to obtain medical marijuana, a patient must receive a DOH Medical Marijuana Program certification from a registered physician. The patient must then access the DOH’s online Patient Certification and Registration system to apply for a registry identification card. In order to apply using DOH’s online system, each patient must have a valid DOH Medical Marijuana Program certification form issued and signed by a registered physician, a photographic identification, documentation of his or her temporary or permanent New York State residency, and designated caregiver information, if applicable. A patient under the age of 18 or who is otherwise incapable of consenting must apply through a proxy.

Advocacy Groups Pushing to Require Federal Exchange Health Plans to Cover Medications Used to Treat Opioid Addiction: Physician and consumer advocacy groups are putting pressure on the Center for Medicare and Medicaid Services (“CMS”) to require that health plans sold on the federal exchanges be required to provide coverage for medications used to treat opioid addiction. These groups contend that opioid addiction therapy should be considered an “essential” insurance benefit. According to the Centers for Disease Control and Prevention, more than 28,000 people died from overdoses of prescription pain medication, heroin and other opioids in 2014. The federal government has stated opioid abuse constitutes a “public health crises,” and has requested healthcare experts to offer their opinions on whether coverage for medication-assisted treatment (“MAT”) for opioid addiction should be mandated under the Affordable Care Act. The Act requires health insurers to cover ten essential health benefits, including substance abuse disorder services and prescription drugs, but it is not clear whether this encompasses coverage for the full range of MAT for opioid addiction. However, health insurers and their lobbying groups contend that benefits should be determined by individual insurers in discrete markets, and that mandating coverage for specific treatments will upset the balance between coverage mandates and affordability and lead to increased premiums and market instability, and will also constitute a precedent for mandating essential health benefits in the future.

Senate Committee Suggests Congress Pass Legislation to Better Track Device Medical Device Safety: A recent report revealed that the number of deadly infections associated with the use of contaminated medical scopes far exceeds previous estimates by nearly twice as much as previously reported by regulators. The report, which was authored by the Senate Health, Labor, Education and Pensions Committee, found that as many as 250 patients who had acquired antibiotic-resistant infections in 25 separate incidents between 2012 and 2015 were linked to the same type of contaminated duodenoscopes. The report criticized the FDA’s response to initial reports that there was a possible link between outbreaks of multidrug-resistant infections and contamination of the scopes even after product maker’s cleaning and disinfecting instructions were correctly followed. Particularly damning were assertions that regulators waited months after beginning their investigation on duodenoscopes in September 2013 before taking action to alert the public of a possible risk associated with their use. Going forward, one of the committee staff’s key recommendations called for Congress to require health insurance claims to include the FDA’s unique device identifier codes to improve tracking and monitoring of device safety and efficacy.