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Around the nation: FDA approves first nasal spray for depression


FDA has approved a nasal spray to treat depression, the first medicine of its kind for the condition, in today's bite-sized hospital and health industry news from Illinois, Maryland, and Massachusetts. 

  • Illinois: The Department of Justice (DOJ) has filed a lawsuit against Walgreens, accusing the company of filling millions of potentially illegitimate prescriptions, including for opioids, since 2012. In the complaint, which was filed in the U.S. District Court for the Northern District of Illinois, DOJ said Walgreens pharmacists filled prescriptions for controlled substances that had clear red flags indicating they were likely unlawful. DOJ also argued that Walgreens systematically pressured its pharmacists to fill the prescriptions without first confirming their validity. According to DOJ, Walgreens violated the federal Controlled Substances Act and the False Claims Act by filling the "unlawful" prescriptions and seeking reimbursement for them through federal healthcare programs. In response to the lawsuit, Walgreens said it stands by its pharmacists, who fill legitimate prescriptions for FDA-approved medications in accordance with all applicable laws and regulations. "We will not stand by and allow the government to put our pharmacists in a no-win situation, trying to comply with 'rules' that simply do not exist," the company said in a statement. According to the Associated Press/MedPage Today, DOJ filed a similar lawsuit against CVS in December, which the company said was a "false narrative." (Associated Press/MedPage Today, 1/21; Hart, Wall Street Journal, 1/17)
  • Maryland: FDA has approved a new nasal spray called Spravato to treat depression. Spravato, which is manufactured by Johnson & Johnson (J&J), is a first-of-its-kind treatment for depression and can be given to patients who have not seen their depression improve after taking at least two oral medications. The main ingredient in Spravato is esketamine hydrochloride, a "chemical cousin" of ketamine, which has been used to treat depression, anxiety, and post-traumatic stress disorder. According to J&J, the treatment can only be administered by healthcare professionals, and patients must be monitored for two hours after administration. So far, the treatment has been given to 140,000 patients worldwide, and J&J said patients could start to see results within 24 hours. Some side effects of Spravato include sleepiness, fainting, dizziness, anxiety, feeling disconnected, and breathing problems. (Pflaumer, The Hill, 1/22)
  • Massachusetts: The Lancet Diabetes & Endocrinology Commission, which includes 56 experts in nutrition, endocrinology, internal medicine, and public health, has proposed a new way to define and diagnose obesity. Currently, physicians use body mass index (BMI) to determine whether a person is obese. However, since BMI is based only on height and weight, it does not provide detailed information about a person's health. In a report, the commission recommended that obesity no longer be defined solely by BMI. Instead, they recommend that physicians also measure a person's excess body fat, in addition to BMI, to determine obesity. The commission also recommended two new categories of obesity: clinical obesity and preclinical obesity. Clinical obesity indicates that a person already has a chronic disease associated with obesity, and preclinical obesity indicates that a person has a higher risk of developing a health condition due to the level of body fat. "Our reframing acknowledges the nuanced reality of obesity and allows for personalized care," said Francesco Rubino, chair of the commission from King's College London. (Aubrey, "Shots," NPR, 1/15)

Growing your organization's behavioral health strategic function

Overview

Demand for mental health and substance use care is on the rise. Unmet behavioral health needs interfere with today's biggest priorities for provider organizations and health plans: reducing total cost of care, meeting quality standards for patients or members, and improving workforce retention and resilience. Use this tool to assess the maturity of your behavioral health strategic function and identify near-term focus areas. 


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