In This Issue
1.IACP Prepares for PCAC Meeting
2. Escalating Compounding Costs in Tricare
3. Credentialing or Phishing?
4. Military Times: Agency to Act on Compound Med Reimbursements
5. IACP Supports Pharmacists' Provider Legislation - Companion Senate Bill for Federal Provider Status Introduced
6. IACP Co-Signs Pharmacy Letter to CMS on Open Pharmacy Provider Networks and Payment for Pharmacist Services
7. IACP Welcomes New Corporate Partner: GRX Marketing
8. Corporate Partner Spotlight: PCE
9. Less Than 2 Weeks for the Educational Conference!
10. CCH Registration is Open!
|Capitol Connections is a biweekly newsletter for IACP Members Only.
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IACP Prepares for PCAC Meeting
The FDA’s recently appointed Pharmacy Compounding Advisory Committee (PCAC) will hold its first formal meeting on Monday and Tuesday, February 23-24, 2015 at the agency’s main headquarters in White Oak, Maryland. The PCAC will be responsible for determining lists of “do not compound” drugs as well as which APIs may be used for compounding when no monograph nor FDA-approved drug containing that particular active ingredient is available.
Six drugs will be considered for inclusion on the API bulk ingredient list for §503A traditional compounders. Those are: Cantharidin, Diphenylcyclopropenone, Piracetam, silver protein mild, squaric acid dibutyl ester (dibutyl squarate), and Thymol iodide. Additionally, the PCAC is expected to review and approve the list of 25 drugs withdrawn from the market to be added to the “do not compound” list for safety and efficacy reasons.
“Our primary concern is that the FDA solicited lists of drugs even before the Committee was formed. That raises questions as to whether Congressional intent is being followed by the agency,” says IACP Vice President of Government Affairs Cynthia Blankenship. “The language in §§503A and 503B is clear that compounding experts from the medical and pharmacy community are to be engaged in executing what Congress wanted. How is it possible to have the agency establish criteria, obtain lists of drugs, set up an agenda, select which drugs are to be considered first… without first having the Committee in place and benefiting from its recommendations?”
IACP Submits Formal Comments to FDA
Yesterday, IACP submitted formal comments to FDA on the questionable process which has been put into place. Please click here to read the letter.
Escalating Compounding Costs in TriCare
This week, International Academy of Compounding Pharmacists (IACP) representatives met with TriCare pharmacy benefit administrators to discuss possible solutions to the ever increasing costs of compounded preparations that the agency is seeing. As reported in a recent GAO study, TriCare is now paying more than $6 million per day for compounded preparations, an amount that is almost equivalent to what was being paid on a monthly basis just a few years ago although overall utilization by beneficiaries has remained static. As with other public and private plans, increasing costs for compounded drugs are raising heightened scrutiny within TriCare and will continue to do so.
IACP’s Reimbursement and Third Party Committee, chaired by Vice-President Baylor Rice, RPh, FIACP, is working directly with other stakeholders in the pharmacy community including NCPA and APhA. “Our greatest concern is that TriCare and other payors would make a draconian decision to eliminate all compounds from coverage, thereby not only denying patients access to the most appropriate medications for their particular health needs but also unintentionally increasing costs in other areas of the system when additional medical visits are necessary.”
What are your thoughts on what the “ideal” third-party payment system would be for compounded preparations? As IACP continues dialogues with PBMs, insurers, and payors, the voice of individual compounding practitioners will be important. Let us know your ideas by emailing firstname.lastname@example.org.
Credentialing or Phishing?
If you received an e-mail asking for personal financial information like your social security number, your credit card number, or your mother’s maiden name, you’d think twice, right? You’d try and verify whether the request was legitimate. Of course you would.
“Phishing” is claiming to be a company or person needing personal or proprietary financial details and hoping that you’ll react before thinking and supply it to them. Usually that’s done with a sense of urgency or a provided deadline or a “if you don’t act now your account will be suspended.” Most of us know about phishing scams on the internet.
Many pharmacies have received requests for extensive documentation about their compounding practices, ostensibly for “credentialing” purposes in order to remain CVS/Caremark network providers. Those requests include such things as providing complete copies of the pharmacy’s compounding Standard Operating Procedures (SOPs), schematics of the compounding lab, and months’ worth of invoices from suppliers. These requests have come from PSAOs and from wholesalers but, to date, IACP has yet to find a single member who has actually received this request from CVS/Caremark. In fact, the only change to the CVS/Caremark provider manual – issued last May – requires that compounding pharmacies be able to provide citations from the medical and scientific literature to support the dispensing of a particular compound when requested to do so by the PBM. There have been no changes to the provider manual requiring any additional documentation.
Please click here to read more.
Military Times: Agency to Act on Compound Med Reimbursements
Military Times is reporting that two advisory committees to the Defense Health Agency are at odds over whether Tricare should reimburse for compounded medications.
The Defense Department Pharmacy and Therapeutics Committee in December recommended strict guidelines on compounded medication prescriptions — rules that would allow Tricare to reimburse for the medicines even through its own regulations don't require the defense health system to do so.
Jay McEniry, Executive Director of Patients and Physicians for Rx Access, says, "This is first time I've seen such a reaction in health care — let's just cut [the benefit]. Let's not cut it. A lot of people need compounds. They have no other options, no other medications they can tolerate. It's interesting we are having this discussion. It's a disservice to a lot of people who need it and deserve it."
Click here to read more including the Military Times article.
IACP Supports Pharmacists' Provider Legislation - Companion Senate Bill for Federal Provider Status Introduced
The Pharmacy and Medically Underserved Areas Enhancement Act (S. 314) was introduced by Sens. Charles Grassley (R-IA), Sherrod Brown (D-OH), Mark Kirk (R-IL) and Bob Casey (D-PA) on Thursday, January 29th. Senate Bill 314, and its companion bill - H.R. 592, will provide access to pharmacist provided patient care services to Medicare beneficiaries in medically underserved communities.
The International Academy of Compounding Pharmacists (IACP) has been a part of the Patient Access to Pharmacists' Care Coalition (PAPCC) -- a large group of pharmacy associations -- since 2012.
Our long-term goal is to not only provide for payment for the consultation and formulation work that compounding pharmacists provide but also to obtain complete coverage of all compounded preparations within Medicare Part D.
IACP Co-Signs Pharmacy Letter to CMS on Open Pharmacy Provider Networks and Payment for Pharmacist Services
"Collectively, our organizations represent more than 100,000 practicing pharmacists in the United States. We write today regarding the new requirements for prescribers of Part D covered drugs CMS adopted in the Final Rule for Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (the “Final Rule”). Specifically, we are concerned that enacting § 423.120(c)(5) and (6) (referred to hereinafter as the “policy”) as currently written will severely compromise patient access to both care and medications and may generate substantial costs and inefficiencies to patients, Medicare, and the health care system generally."
Click here to read the entire letter.
New State Legislation Tracker on Pharmacy Provider Status
IACP Members: Check out the brand-new feature on our Compounders Stateside page. We've added a new State Legislation Tracker on Pharmacy Provider Status. Click here to view!
Location of Additional Meningitis Outbreak Victims Remains a Mystery
Federal investigators say they have identified 27 more victims of a deadly 2012 fungal meningitis outbreak but with one single exception, state health officials across the country say they don't know about any additional cases.
In an affidavit filed in U.S. District Court in Boston, Joseph Ridgley, an investigator for the U.S. Food and Drug Administration stated that not only were there 27 more victims, 12 of them eventually died.
That pushed the death toll for the outbreak from 64 to 76 and the total number of victims from 751 to 778. Click here to read more.
IACP Prepares New Compounding Fact Sheet for Members
To help our members address questions from their patients, practitioners, media and others in their community, IACP has prepared a new Compounding Fact Sheet for your use.
It includes a compounding profession overview, message points in response to the NECC tragedy, current oversight info, and IACP concerns regarding DQSA. Please click here to access.
IACP Welcomes New Corporate Partner: GRX Marketing
The IACP Corporate Partner Program engages corporate leaders in the pharmacy compounding community by connecting them with IACP’s more than 4,000 members who are focused upon the specialty practice of pharmacy compounding. We encourage all IACP members to support IACP’s 68 corporate partners who are instrumental in our joint effort to protect and grow this vital part of quality healthcare.
To learn more about GRX Marketing, please visit www.grxmarketing.com.
USP Announces Revised <800> Chapter Available for Viewing
The United States Pharmacopeial Convention (USP) announces that the revised chapter of the proposed <800> is now posted on the USP website. Please click here to review.
The chapter will still be proposed in the Pharmacopeial Forum 41(2) in Mar/April 2015. The comment period for this chapter will end on May 31st, 2015.
Registration for the Open Mic web meeting about the proposed new general chapter <800> is due by 5pm on February 19th. Please click here for more information.
What's New on the FDA Drugs Site
Drug Firm Annual Registration Status (updated)
Drug Firm Annual Registration Status Download File (updated)
The FDA Drug Shortage Report
Please click here for the most recent Drug Shortage information.
Dr. Margaret Hamburg to Step Down in March
Click here for a Wall Street Journal story.
Please send your news to email@example.com!
Congratulations to IACP Vice President Baylor Rice, RPh, FIACP, for his news coverage in the Chesterfield Observer! Click here to read.
IACP Corporate Partner MEDISCA is hosting its annual SPCC Nationals, March 21-22, 2015 in Gainesville, Fla.! Please click here to view their 2014-2015 SPCC Nationals Booklet, highlighting their prestigious selection of guest speakers and judges.
IACP Member Q&A
Every week, IACP members contact our offices for questions about practice, business, legislation and other issues. In every issue of Capitol Connections, we'll highlight a question we've been asked that affects many of our members. If you have a question you'd like answered, please send to firstname.lastname@example.org.
Does IACP have a list of attorneys for member reference?
Yes. Please visit our Members-only Site - click here.
Corporate Partner Spotlight: PCE Investment Bankers
When you’re navigating the critical, and sometimes challenging phases of the business life cycle, nothing is more important than getting the right advice at the right time. At PCE, that’s our specialty.
Whether you’re merging, selling, buying or expanding, PCE will identify the best capital strategies and solutions for your personal and corporate goals. When it comes to assessing the value of your business, our valuation reports are thorough, accurate and wholly defensible. Looking to maximize the value of your business, but not sure where to start? As business owners ourselves, we love helping fellow entrepreneurs figure out their next move.
Please click here to read more.
Less Than 2 Weeks for the 2015 Educational Conference Kick-off!
Connect and network with fellow colleagues. #EduCon2015
Don’t miss this one-of-a-kind, 3-in-1 conference that brings the pharmacy profession together in paradise. The American College of Apothecaries (ACA), the International Academy of Compounding Pharmacists (IACP) and the American College of Veterinary Pharmacists (ACVP) are joining forces again to bring you an extraordinary Educational Conference, February 25-28, 2015, at the ocean front property, the Harbor Beach Marriott Resort & Spa in Fort Lauderdale, Florida. Click here for more!
Advocate: Why You Should Attend #EduCon2015!
Take advantage of the Educational Conference 2015 Justification Letter and explain to your supervisor all the benefits you’ll receive from attending the ACA, IACP, ACVP Educational Conference!
The justification letter template includes how the conference will make you a better employee and what you and the pharmacy can expect to receive from attending. Click here to access the Educational Conference 2015 Justification Letter.
ACA, IACP, ACVP Educational Conference Graphic Toolkit Now Available!
This is an opportunity to let your patient and prescriber communities know that you will be attending the Educational Conference this year! Promote the Conference on your pharmacy or company website, Facebook page and even in print! Attendees, Corporate Partners and Exhibiting Companies are all encouraged to promote their support by using the Graphic Toolkit. The Educational Conference Graphic Toolkit includes a logo/web banner, Facebook Cover Image, “I’m Attending” e-mail signature as well as full page, ¼-page, and ½-page print ads.
Share that you’re attending! Click here to download the Graphic Toolkit.
The 2015 Educational Conference E- brochure is Now Available!
Review the complete meeting agenda; learn what's new in 2015; why pharmacy students should attend, and much more!
Click here to download the 2015 Educational Conference E-brochure, sponsored by ACA & IACP Corporate Partner Humco Compounding. The Flipbook technology for the E-brochure was generously provided by RXinsider.
IACP Members: Don't Miss the Only Political Action Committee for Compounders
Plan to Join our EVP CEO David G. Miller and VP of Government Affairs Cynthia Blankenship at IACP’s COMP PAC Breakfast Saturday, February 28, 2015 during the 2015 ACA, IACP, ACVP Educational Conference.
Why is a political action committee and COMP PAC important?
COMP PAC uses its funds to support those legislators that have demonstrated a commitment to compounding pharmacy and have expressed interest in advancing our legislative goals.
When the 114th Congress takes its oath of office on January 3, IACP will already have three major legislative priorities in the works that directly address YOUR needs. Please click here to read more!
CCH Registration is Open!
The 21st Annual Compounders on Capitol Hill (CCH) will be held June 6-9, 2015 at the Renaissance Washington, in Washington D.C. With more than 400 expected attendees in 2015, Compounders on Capitol Hill brings together the top-level compounding pharmacists and technicians from across the country with the same goal – to protect pharmacy compounding. Don’t miss the only pharmacy compounding event that takes our issues directly to Washington, D.C.’s doorstep.
CCH returns to Downtown Washington, D.C.! Conveniently situated in the Penn Quarter district, this premier location is surrounded by shops, a variety of dining options, the Spy Museum, Chinatown, the National Portrait Gallery, the Smithsonian American Art Museum, and world-famous National Mall monuments. Click here to read more!
Save the Date for Rx Mixer!
Lots of blue eye shadow, acid washed jeans with popped-up shirt collars, fingerless lace gloves, giant hair bows, and layers of beaded necklaces are totally tubular once again for Rewind: Back to the 80s— the theme for IACP Foundation’s 11th Annual Rx Mixer, a fundraising event to be held in conjunction with IACP’s 21st Annual Compounders on Capitol Hill (CCH), Sunday, June 7, 2015!
Travel back to the place where you uttered slang phrases like “gag me with a spoon,” “like, totally,” “gnarly,” “grody,” “grody to the max,” “rad,” “awesome,” or any combination of these words excessively. If your hairdresser couldn’t stop laughing long enough to actually give you the Flock of Seagulls haircut you wanted. And, if you still know all the dance moves to “Thriller.” You know you belong to the 80s.
Click here for more!
The Compound Conference is the only conference annually partnering with a state pharmacy association, bringing together the leaders in the pharmacy compounding profession. At the Compound Conference, attendees have an unprecedented opportunity to meet face-to-face with compounding pharmacists, technicians, and marketing representatives in their home state.
Offering a variety of Continuing Education sessions focused on understanding the essentials in building a compounding practice, the 2015 Compound Conference is a joint meeting with the Ohio Pharmacists Association (OPA) and the International Academy of Compounding Pharmacists (IACP). Don’t miss this unique conference bringing together two leading pharmacy associations, August 15, 2015 at the Hilton Columbus at Easton in Columbus, Ohio.
Click here for more.
Ensuring Patient Safety and Quality Products: The Most Critical First Step - This Thursday!
In the interest of ensuring the purity and safety of formulations, a compounding pharmacy does not have to be doing something “wrong” or be out of “compliance” to change current practices. For many years hands-washing of vials or using some sort of a “dishwasher” has been the standard practice in most compounding pharmacies. However, washing vials manually is not only time consuming, it is inconsistent, it often fails to remove contaminants and yields results that cannot be validated. How does one achieve a validatable process? Automate it. This is the only way. Machines are consistent, they repeat the same process over and over again and they guarantee that vials have been cleaned not only for the safety of patients, but within the FDA standards and requirements.
Click here for more information, and to register!
Need CE ASAP? Check out the IACP AdvanCE On-Demand Library!
If you need CE credit, check out IACP's AdvanCE's on-demand library, which houses more than 100 programs on various pharmacy topics. Please click here to access the self-paced programs.
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