On July 13, 2016, the Senate passed by 92-2 vote the Comprehensive Addiction and Recovery Act of 2016 (S. 524), a comprehensive set of 18 bills targeting the opioid crisis, which bill the U.S. House of Representatives approved in a 407-5 vote on July 8, 2016.
Last week, CMS posted the 2015 Open Payments data to its website, as well as updated payment records for 2013 and 2014. Overall, manufacturers reported $7.52 billion in payments and ownership interests to 618,931 physicians and 1,116 teaching hospitals in 2015. Nearly 1,500 companies reported making payments in 2015, comprising a total 11.9 million records. Although the total number of records and amounts of payment are comparable from 2014 to 2015, there are shifts in the reporting of the nature of payments.
On June 27, 2016, the OIG posted Advisory Opinion No. 16-07 stating that an erectile dysfunction (ED) drug manufacturer would not face sanctions for a planned discount-card promotion for the drug.
On June 13, 2016, the American Medical Association (AMA) at its annual meeting approved new ethical guidelines for physicians providing telemedicine services, which will be incorporated in the full publication of the AMA Code of Medical Ethics this fall. Although the ethical guidelines do not place legal limitations on the provision of telemedicine for any individual physician or State, they are designed to guide a physician in his or her practice. Allegations of any violations of the Code of Medical Ethics, after a disciplinary hearing, could ultimately result in suspension or revocation of a physician’s AMA membership. Individual State agencies are responsible for issuing licenses and enforcing State law governing the practice of medicine, including ramifications of unethical behavior.
On March 30, 2016, the Secretary of the Department of Health and Human Services (HHS) published a proposed rule to expand access to medication-assisted treatment (MAT) by allowing certain eligible practitioners to treat up to 200 patients, as authorized under the Controlled Substances Act. MAT involves the use of medication in combination with certain behavioral health interventions to provide a comprehensive, individualized approach to opioid use disorder treatment.
On May 26, 2016, the Food and Drug Administration (FDA) approved Probuphine as part of a targeted initiative by the U.S. Department of Health and Human Services (HHS) and the FDA to reduce prescription opioid and heroin-related overdose, death and dependence.
On 25 April 2015, the Minister for Health announced a review of the Guidelines (Guidelines) for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC), the body that recommends which products should be reimbursed by Government, and for how much. The Minister said the review sought to ensure that the PBAC Guidelines are “consistent and transparent, while incorporating international best practice and removing any unnecessary regulatory burden on the pharmaceutical industry”. The review is being carried out by Adelaide Health Technology Assessment (AHTA) in conjunction with PBAC.
During the week ending May 13, 2016, the U.S. House of Representatives approved a comprehensive set of 18 bills aimed at curbing the opioid epidemic. The largest of these bills, the Comprehensive Opioid Abuse Reduction Act of 2016 (H.R. 5046), passed by a 413-5 vote in the House on May 12, 2016. This bill authorizes US $103 million dollars in grant funding for fiscal years 2017 through 2021, and makes the U.S. Department of Justice (DOJ) responsible for administering grants to state, local, and tribal governments to provide a range of opioid abuse services. These services include developing and expanding existing programs to combat opioid abuse, training first responders in administering opioid overdose reversal medication, and providing dedicated opioid treatment and prevention services for veterans. In March 2016, the Senate passed a similar measure, titled the Comprehensive Addiction and Recovery Act of 2016 (S. 524), which authorizes the Attorney General to award similar grants.
A recent Australian case (https://www.austlii.edu.au/au/cases/cth/FCA/2016/394.html) has touched on the tricky area of nicotine containing products, this time in the guise of product known as the Voke Inhalator, which contained 0.43mg of nicotine in a pressurised inhalation can. The supplier of the product was seeking to register the product as an OTC product, but our regulator, the Therapeutic Goods Administration (TGA), refused to consider the application, on the basis that the wrong form had been used.
The Australian Labor Party has flagged the data exclusivity provisions of the Trans Pacific Partnership Agreement (TPP) as a major issue ahead of our now confirmed July date for an Australian election.