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The FDA recently granted approval to Harvoni and Sovaldi for the treatment of pediatric patients with hepatitis C virus (HCV). Unlike ongoing access challenges for adults with HCV, experts say insurance coverage for these high price drugs may be less problematic for children. According to Kaiser Health News, state Medicaid programs are required to cover early and periodic screening, diagnostics, and treatment services that are necessary to correct physical and mental illnesses in children younger than 21 years. “The short answer is that [Medicaid] will likely require coverage for all kids regardless of whatever the coverage policies for adults may be,” Matt Salo, executive director of the National Association of Medicaid Directors, told KHN. Currently, many state Medicaid programs restrict access to HCV drugs for adults, often requiring the patient to have significant liver damage and/or prove they had been drug- and alcohol-free for several months before approving treatment. But for pediatric patients, the federal standard is broader, meaning medical necessity could not be linked to severity of the illness/liver disease. It remains unclear how private insurers will handle coverage for kids, KHN reported. “Given these are recently approved drugs, we expect plans will follow their normal practices,” Kristine Grow, spokeswoman for America’s Health Insurance Plans, told KHN. “This included evaluating the evidence, systematic review of the medication’s effectiveness, considering any federal or state mandates, and updating their policies as new evidence is available.”
Findings from a new study raise a new concern for smokers: thirdhand smoke. The term refers to the nicotine and chemical residue left behind from cigarette and cigar smoke that sticks to skin, hair, clothes, rugs and walls, according to KHN. The thin film can be picked up by touch or released into the air when disturbed. In a study published in Tobacco Control, investigators examined 25 children admitted to an emergency room with breathing problems associated with exposure to secondhand smoke. The findings revealed that the average level of nicotine on the children’s hands was more than 3 times greater than nicotine levels found on the hands of non-smoking adults who live with smokers. Additionally, the investigators found that all but 1 of the children had detectable levels in their saliva of cotinine. All of the participants had parents who smoked, but did not smoke themselves.
Theranos Inc has reached an agreement with CMS that pledges the company and its founder will stay away from the blood-testing business for a minimum of 2 years in exchange for reduced penalties. The agreement resolves a year-long regulatory block, The Wall Street Journal reported. In March 2016, the main lab regulator first proposed barring CEO and Founder Elizabeth Holmes from the medical-lab business for 2 years after Theranos failed to correct testing issues at its main lab in Newark, CA. Inspectors had said that the testing problems had put patients in “immediate jeopardy,” according to the WSJ.