Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments

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FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder - FDA Press Releases

FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder

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Statement by FDA Commissioner Scott Gottlieb, M.D., updating on Puerto Rico related medical product shortages - FDA Press Releases

Statement by FDA Commissioner Scott Gottlieb, M.D. on efforts by the agency to address the impact of IV saline products and amino acids for injection shortages following the hurricane and update on FDA’s work in Puerto Rico

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Virginia Diner, Inc. Issues Allergy Alert on Undeclared Peanut Allergen in Chocolate Covered Cashews 10 oz. cans - FDA Safety Alerts & Drug Recalls

Virginia Diner, Inc. is voluntarily issuing a recall of 10 oz. cans of Plow & Hearth Chocolate Covered Cashews at Plow & Hearth’s locations and nationwide (Mail Order) as a precaution because they may contain peanuts and peanut allergens. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. A label mix up was discovered by a consumer who received and opened a Cashew Tower Set (3 individual cashew cans) of which one can, the 10 oz. Chocolate Covered Cashews, were found to have Salted Peanuts.

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FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers - FDA Press Releases

FDA/CMS parallel review process makes test for efficient identification of multiple targeted therapy options available to health care professionals, patients and eligible Medicare beneficiaries‎ sooner

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CMS releases its Measures Under Consideration List for 2018 pre-rulemaking - CMS Blog

By: Kate Goodrich, M.D., M.H.S., Director, Center for Clinical Standards & Quality, CMS Chief Medical Officer

Medicare and other payers are rapidly moving toward a healthcare system that rewards high quality care while spending more wisely. Foundational to the success of these efforts is having quality measures that are meaningful to patients, consumers, and providers alike.  CMS recently announced the “Meaningful Measures” initiative to identify the most impactful areas for quality measurement and improvement and reflect core issues that are most vital to high quality care and better individual outcomes. Each year, CMS publishes a list of quality and cost measures that are under consideration for Medicare quality reporting and value-based purchasing programs, and collaborates with the National Quality Forum (NQF) to get critical input from multiple stakeholders, including patients, families, caregivers, clinicians, commercial payers and purchasers, on the measures that are best suited for these programs. Ultimately, these measures may help patients choose the nursing home, hospital, or clinician that is best for them, and can help providers to provide the highest quality of care across care settings.

I am happy to announce that CMS posted the Measures under Consideration (MUC) List for 2018 pre-rulemaking on the CMS website and has sent it to NQF in preparation for multi-stakeholder input.

This year’s MUC List contains 32 measures that have the potential to drive improvement in quality across numerous settings of care, including clinician practices, hospitals, and dialysis facilities. CMS is considering new measures to help quantify healthcare outcomes and track the effectiveness, safety and patient-centeredness of the care provided.  At the same time, CMS is taking a new approach to coordinated implementation of meaningful quality measures focused on the most critical, highly impactful areas for improvement while reducing the burden of quality reporting on all providers so they can spend more time with their patients.  In addition to other factors, CMS evaluated the measures on the MUC list to ensure that measures considered for adoption in a CMS program through rulemaking as necessary, focus on clearly defined, meaningful measure priority areas that safeguard public health and improve patient outcomes.  For example, to generate this year’s MUC list, CMS considered 184 measures submitted by stakeholders during an open call for measures.  Considering the meaningful measurement areas, CMS narrowed the list to 32 measures (17% of the original submissions) which focus CMS efforts to achieve goals of high quality healthcare and meaningful outcomes for patients, while minimizing burden. CMS will continue to use the Meaningful Measures approach to strategically assess the development and implementation of quality measure sets that are the most parsimonious and least burdensome, that are well understood by external stakeholders, and are most likely to drive improvement in health outcomes.

This year, approximately 40% of measures on the MUC list are outcome measures, including patient-reported outcome measures, which will help empower patients to make decisions about their own healthcare and help clinicians to make continuous improvements in the care provided. In addition, this year there are eight episode-based cost measures proposed that were developed by incorporating the insight and expertise of clinicians and specialty societies.  CMS is committed to working with clinicians, consumers, and other stakeholders on the development and use of measures that are most meaningful to patients and clinicians and our programs.

We invite you to review the MUC List in detail and to participate in the public process. We believe it is critical to hear a wide range of voices in the selection of quality and efficiency measures that are used for accountability and transparency purposes and look forward to another successful pre-rulemaking season. For more information regarding the NQF Measure Applications Partnership public stakeholder review meeting purpose, meetings, 2017 MUC List deliberations and voting, visit the NQF website at http://ift.tt/IXUWWv.

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Nutra Labs Inc. Issues Voluntary Nationwide Recall of Dietary Supplements Bull and Chao Jimengnan Tablets Due to Undeclared Active Pharmaceutical Ingredients - FDA Safety Alerts & Drug Recalls

Nutra Labs Inc. is voluntarily recalling lots sold by their firm of the male enhancement supplements Bull 1800 mg Capsules with the production date of 05/08/2016, and Chao Jimengnan 150 mg Tablets with Lot # 20151018 to the consumer level. FDA analysis found the products to be tainted with sildenafil, 0.026mg/capsule for Bull, and 70.46mg/tablet for Chao Jimengnan respectively. Sildenafil is the active pharmaceutical ingredient in an FDA approved product used for erectile dysfunction, making Bull capsules and Chao Jimengnan tablets unapproved new drugs.

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