The Daily Scan

July 23, 2018

Last Updated: 8:50 AM EST

Medicaid

  • The Kentucky Cabinet for Health and Family Services (CHFS) released the following statement on Kentucky HEALTH, the state's Medicaid program: "We had hoped for a quick federal re-approval that would allow the transformative Kentucky HEALTH program to start August 1, avoiding delayed access to services for beneficiaries and costly system changes...Unfortunately, changing benefits and coverage is not as easy as flipping a single switch. As Cabinet officials testified, system changes are risky and cannot be made overnight. The Cabinet has spent the last few weeks working on a temporary solution for restored benefits to be implemented by August 1. In addition, while dental, vision, and non-emergency medical transportation eligibility for those in the Alternative Benefit Plan will not show in the system until August 1, the Cabinet is close to completing a manual system work-around that will allow payment of claims incurred by any eligible Medicaid beneficiary for dental, vision, and nonemergency transportation services incurred during the month of July." (Kentucky.gov)

Regulation

  • HHS Assistant Secretary for Health, ADM Brett P. Giroir, M.D., and USAID’s Deputy Assistant Administrator, Alma Crumm Golden, M.D released a statement in The New York Post this weekend clarifying the Trump administration's views on breastfeeding: "As pediatricians, US representatives at this year’s World Health Assembly in Geneva and supporters of breastfeeding throughout our professional careers, we were shocked to read recent headlines, in the New York Times  and elsewhere, claiming that the Trump administration has somehow called into question the importance of breastfeeding for infants. The administration fully endorses breastfeeding, and the agencies where we work — Health and Human Services and USAID — communicate this unequivocally. That’s why the US government supported unanimous consensus on the resolution on breastfeeding at the World Health Assembly , which plainly states that breastfeeding is optimal 'for child survival, nutrition and development.'" (HHS.gov)

 

  • FDA Commissioner Scott Gottlieb, M.D. released a statement on Friday commenting on Bayer's decision to stop manufacturing the controversial Essure birth control device: The U.S. Food and Drug Administration was notified by Bayer that the Essure permanent birth control device will no longer be sold or distributed after December 31, 2018. This decision follows the FDA’s patient safety action in April, in which the agency issued an order restricting the sale and distribution of Essure; it was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device’s safety and effectiveness.The decision today to halt Essure sales also follows a series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use.For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. We expect Bayer to meet its postmarket obligations concerning this device." (FDA.gov)

 

  • On Friday, the U.S. Food and Drug Administration approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with AML. “Tibsovo is a targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH1 mutation,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The use of Tibsovo is associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions.” (FDA.gov)

 

  • The FDA issued guidance last week intended to clarify the agency’s expectations when electronic health records are used as a source of data in clinical investigations. The guidance applies to clinical investigations of human drugs and biological products, medical devices and combination products, including investigations conducted in clinical practice settings. (AHA.org)

 

 

 

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