FDA Develops Drug Facts Label for Over-the-Counter Versions of Naloxone
The Food and Drug Administration (FDA) this week announced it has developed a model Drug Facts label (DFL) with easy-to-understand, “pictogram” instructions on how to use over-the-counter (OTC) versions of the opioid antidote naloxone.
FDA Commissioner Scott Gottlieb said in a statement that while FDA-approved prescription naloxone formulations have instructions for use in product labeling, they don’t have the consumer-friendly DFL that is required for OTC products.
“Before submitting a new drug application or supplement for an OTC drug product, companies must develop a DFL and conduct studies to show that consumers can understand how to use the product without the supervision of a healthcare professional,” Gottlieb said. “Some stakeholders have identified the requirement to perform these studies as a barrier to development of OTC naloxone products.”
Along with the announcement, the FDA posted two model DFLs—one for using with a nasal spray and one for using with an auto injector—and the supporting FDA review. Gottlieb noted that the agency expects these efforts to “jumpstart” development of OTC naloxone products to promote wider access to this medicine.
CMS Uses Social Media to Regulate Hospital Price Transparency Rule
CMS Administrator Seema Verma used Twitter this week to encourage the public to help oversee compliance with the agency’s new price transparency rules.
Since Jan. 1, all hospitals, including psychiatric hospitals, have been required to establish, update, and publish publicly online a list of the hospital’s “standard charges” for services the hospital provides. CMS included this Affordable Care Act requirement in its final FY 2019 inpatient prospective payment system (IPPS) rule.
In her tweet this week, Verma said, “[W]e’re asking the Twitterverse to help us make sure patients have access to the basic hospital pricing information (called the chargemaster) that is now required to be posted online.”
The final rule did not include a definition of “standard charge,” but CMS noted that hospitals can make public a chargemaster “or another form of the hospital’s choice.”
CMS has released two FAQ (here and here) documents on the requirement also said the form must be in a “machine-readable” format and added that PDF documents are not considered permissible under that definition.
Quality Reporting Center to Host IPFQR Webinar on January 22
The Quality Reporting Center will host a webinar on Tuesday, January 22 to review updates to the latest version of the Inpatient Psychiatric Facility Quality Reporting Program manual and other tools for inpatient psychiatric facilities to meet IPFQR program requirements.
The hourlong webinar will start at 2 p.m. ET. Click here to register.
MACPAC to Examine Utilization Management of MAT Next Week
The Medicaid and CHIP Payment and Access Commission will discuss utilization management of medication assisted treatment (MAT) in two separate sessions at its meeting next Friday, January 25 in Washington, DC.
Panelists include Anika Alvanzo, medical director with Johns Hopkins Substance Use Disorders Consultation Service and assistant professor in the university’s division of general internal medicine;
Kristin Hoover, clinical pharmacy manager at the Pennsylvania Human Services Department; and
Mario San Bartolome, medical director in substance use disorders at Molina Healthcare
Click here to see the agenda for the commission’s two-day meeting, which starts on Thursday, January 24.
Register for the Rx Drug Abuse and Heroin Summit in April
2019 NABH Exhibitor & Sponsor Guide Ad Deadline is Today!
The deadline to place an ad about your organization in the 2019 NABH Exhibitor & Sponsor Guide is today, Friday, January 18.
Download the 2019 Advertising Opportunities form and reserve space now. For questions, please contact Maria Merlie at 202.393.6700 (ext. 104), or (email@example.com). And for more details about the 2019 NABH Annual Meeting, please visit NABH’s Annual Meeting homepage.
NABH to Welcome HHS Deputy Secretary Eric Hargan at Annual Meeting on March 19
NABH is pleased to announce that HHS Secretary Eric D. Hargan will serve as the keynote speaker during the 2019 NABH Annual Meeting on Tuesday, March 19.
As the department’s deputy secretary, Mr. Hargan serves as the chief operating officer of the federal government’s largest department, which has an annual budget of more than $1.3 trillion and more than 80,000 employees in 26 divisions.
From 2003 to 2007, Mr. Hargan served at HHS in a variety of capacities before he eventually held the position of acting deputy secretary. During his tenure there, Mr. Hargan has also served as the department’s regulatory policy officer, where he oversaw the development and approval of all HHS, CMS, and FDA regulations and significant guidance.
Hargan is from Mounds, Ill.—a town with a population of about 800 people—where his mother worked at rural hospital for 58 years. He received his B.A. cum laude from Harvard University, and his J.D. from Columbia University Law School, where he was senior editor of the Columbia Law Review. In between his tours at HHS, Mr. Hargan taught at Loyola Law School in Chicago, focusing on administrative law and healthcare regulations.
2019 NABH Annual Meeting Online Preliminary Program Now Available!
The online preliminary program for the 2019 NABH Annual Meeting is now available on NABH’s Annual Meeting homepage. Please take a moment to review the sessions and speakers, and revisit the page regularly for updates about our speakers, exhibitors, and sponsors.
We look forward to seeing you at the Mandarin Oriental Washington, D.C. from March 18-20, 2019!
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