Wednesday, October 30, 2013

WellPoint Excluding Some Compounded Drugs From Coverage



As of November 1, 2013, WellPoint will no longer pay for compounded medications that are made from bulk ingredients. WellPoint plans include Anthem Blue Cross and Anthem Blue Cross Blue Shield.
For a compound drug to be covered it must contain at least one ingredient/drug that requires a prescription to obtain. Additionally, that ingredient/drug must also be approved by the Food and Drug Administration (FDA). Drugs impacted include:
  • Compounded bulk powders (not FDA approved)
  • Pharmaceutical Adjuvants (compounding vehicles, not FDA approved)
Letters were mailed to all groups and individuals that will be affected by this change. Individuals that are impacted by this change will need to talk with their doctor about changing to a covered medication, or pay the entire cost.

Interesting article says drug safety bill puts urgent treatment in jeopardy. I thought bad compounders like necc who refuse to follow the rules cause far greater jeopardy


There are a lot of illness for which there are no treatments or cures so I am not sure I am completely convinced with this argument although I am sure there will be some such cases.  What is the solution if not what is proposed?  Is there a way to fix the current draft without having to start over?  There have been issues with the eye med named in article. I guess it comes down to a balancing and weighing. No legislation will be perfect.  Just as there never has been  assess to meds for every person for every illness... harsh but true.

 HomepageNon-mobile version

Drug Safety Bill Puts Urgent Treatment in Jeopardy

By Craig H. KligerOct. 30, 2013, 3:30 p.m.We all remember the scenes in the film “Willy Wonka & the Chocolate Factory” where Gene Wilder nonchalantly warns, “Stop. Don’t,” as various characters try unknown products and experience unanticipated effects. Of course, each instance ends with predictably unfortunate results.Congress’ attempt to regulate compounded medications poses a Wonka-esque scenario in which potentially well-intentioned legislation may have the unintentional side effect of harming patients and adding unnecessary costs to the health care system.

read here

Fourth Question of the Day October 30, 2013 Once the Federal Drug Quality and Security Act becomes law how will this effect insurance polices and cost? Will there be a new category for outsourcing facilities?


BREAKING NEWS URGENT MUST READ--SENATE IS WORKING ON DEAL TO CONSIDER Federal Compounding Legislation TODAY, October 30, 2013!!! stay tuned for more info as it becomes available!!!

We are also working on an agreement to consider H.R.3204, a bill to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, as early as today

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10/29/13 - PDA/FDA Joint Regulatory Conference: Great Place to Learn From Regulators

10/29/13 - PDA/FDA Joint Regulatory Conference: Great Place to Learn From Regulators
BETHESDA, Md., Oct. 29, 2013 /PRNewswire-USNewswire/ Many of the nearly 1,000 people who attended the 23rd Annual PDA/FDA Joint Regulatory Conference said the event provided them the opportunity to hear directly from regulators on the issues that affect them most, and from industry experts on how they are responding to these same issues.
(Logo:http://photos.prnewswire.com/prnh/20130226/DC66667LOGO)
Co-sponsored and co-planned by the PDA and the FDA, and held in Washington, D.C., the annual conference has become the place where those working in the pharmaceutical industry can join in discussions with representatives of the Food and Drug Administration to gain their perspectives. There were more than 45 FDA speakers, including Janet Woodcock, M.D., Director, CDER, FDA.
Attendees come from across the globe. Many say the conference gives them more than in depth knowledge to take back to their firms.
"In addition, for me as a lawyer, the many opportunities to hear directly from the FDA officials on what their current line of thinking is and what their visions on their expected policy changes are," said Daike Van de Putte, from GSK. "It was very insightful for me to learn the reasons behind such changes."
Other attendees, who supply the pharmaceutical industry, said the conference helped them better understand their customers.
"I came away with a deeper understanding of our customers' needs and challenges, along with critical information that enables us to become a better partner," said Ross. W. Acucena of EMD Millipore.
"The 2013 PDA/FDA Joint Regulatory Conference was, as always, a priceless venue to connect with colleagues and FDA representatives," said Veronica Cruz, Ph.D., of Johnson & Johnson.
The 2014 PDA/FDA Joint Regulatory Conference is scheduled for September 8-10. There is a workshop, entitled2014 PDA Drug Shortage Workshop on September 10-11. Courses from the renowned PDA Training and Research Institute will follow.
About PDAThe Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide. PDA's Annual Meeting will be held April 7-9, 2014 in San Antonio, Texas. For information, visit www.pda.org and follow PDA on LinkedIn.
Press ContactAmelia Townsend Director of Marketing Services, Parenteral Drug Association (PDA), townsend@pda.org, 301-656-5900, ext. 153
SOURCE Parenteral Drug Association

quoted from here