The voice for pharmacy compounding • July 10, 2020
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Enjoy our latest edition. Send your suggestions and questions to
info@a4pc.org
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Shawn Hodges
APC President
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Dear friend,
1. Thank you!
2. Don’t stop.
Two weeks ago in this space, I alerted you to the revenue shortfall APC is facing, the result of the pandemic’s impact on our events and operations. I asked you to step up and invest in OneFund so that we can avoid any reduction in services between now and year-end. (OneFund fuels APC’s entire advocacy operation, because member dues alone aren’t enough to support our work.)
And boy, did some of you do so! Over the past two weeks, about 60 APC members have invested collectively almost $50,000 in OneFund. That means we’re one-third of the way to our $150,000 goal.
To those of you who have invested: We’re grateful to you.
If you’ve been meaning to invest but haven’t gotten around to it yet, here’s a bit of added incentive -- a quick list of APC’s impressive accomplishments
in the past six weeks alone
:
- As you’ll read below, we marshalled resources and relationships and helped challenge an outrageous Tricare clawback from compounders. On June 25, Tricare blinked and suspended the recoupment.
- Working with related associations, we urged FDA to extend the comment period on its flawed draft animal compounding GFI -- and it did.
- We’ve gotten traction in our push for OMB to remand back to FDA a flawed “final” MOU on interstate shipments of compounded drugs because FDA failed to comply with the Paperwork Reduction Act. It’s not over yet, but we know we’ve been heard.
- We created three new member task forces to identify research and patient outcomes data we’ll use to challenge recently released studies on compounded pain creams and cBHRT. A third task force has been formed to look into third party reimbursement issues impacting our members.
- As a result of interest in cash-only business models -- spurred by that ESI/Tricare recoupment – we’re offering a free webinar exploring the pros and cons of the cash model. Read about that below, too.
That’s an impressive short-term return on your APC dues investment -- and I hope it’s enough to persuade you now to invest in OneFund -- for the good of your patients and your business … and for your association’s future.
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Now, read on about the five big things you need to know this week!
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2020 OSHA Training:
Bloodborne Pathogens
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1. NASEM released its cBHT report, and something seems awfully familiar.
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For pharmacy compounders,
the release of NASEM’s FDA-funded Compounded Bioidentical Hormone Therapy study feels a lot like the movie Groundhog Day, only without Bill Murray for laughs. Which is to say: We’ve seen this sort of thing before.
In May, NASEM released the first of two FDA-funded studies — one focused on compounded pain creams. In that report, it managed to come up with recommendations that — surprise! — almost perfectly reflected FDA’s stated concerns about compounded pain creams.
On July 1, NASEM released the second of the two FDA-funded studies — one focused on cBHT. In that report, it managed to come up with recommendations that — surprise! — almost perfectly reflected FDA’s stated concerns about cBHT.
It's
deja vu all over again.
Back in May
we pointed out the flaws in the pain cream study … and here we go again. That's not to say all NASEM's recommendations about cBHT are unreasonable, just that they're not all based on a thorough exploration of evidence and, critically, outcomes.
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2.
Tricare has retracted its claws. For now.
Hopefully it's permanent.
As you know, APC pulled out all the stops and, working with NCPA, we were all over Congress, the Defense Health Agency, and ESI about that sudden recoupment in June.
Those efforts payed off, and compounders affected by the Tricare/ESI clawback have received messages from Express Scripts: Not only are the recoupments "suspended until further notice," but so is the 90-day time period to request an administrative review.
Sounds like a win. But (and there's always a 'but'): We haven’t had final word from DHA or Tricare that the clawbacks are cancelled permanently. Nor do we know what will happen to the pharmacists who have already had their reimbursements unjustly recouped from them by ESI.
All that said, we're tracking this closely, and we've kept our member resources updated. Our Web page on the issue,
A4PC.org/tricareclawbacks, now includes a new summary from attorneys Brown & Fortunato (PDF) and a conversation with attorney Hunter Jamerson discussing those "suspension" letters (11 minute MP3 audio).
We'll continue to keep you updated as we learn more, of course.
This is not a battle we should have had to fight in the first place. The staggering lack of logic, due process, and basic fairness was obvious to everyone. And even if the suspension is permanent, it was not without costs to the many compounding pharmacy owners who had to engage and pay attorneys to help them challenge the absurd clawback effort in the first place.
On the other hand, the entire affair is a textbook example of how critical professional associations are.
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3. Thinking of going cash-only? We’ve got a free webinar.
It's a common option among compounders, and maybe you're thinking of doing it yourself, especially after the Tricare debacle -- going to a cash-only model. So APC put together a free informational webinar (sorry, no CE) with a group of experts: "Cash-Only Compounding: Pros, Cons, and Caveats." (Here at APC we don't favor one model over another; that's obviously an individual decision. We just want to help you make the right one for your practice.)
It's next week:
Thursday, July 16, from 2:00–3:00 PM EDT, and it will answer all your questions (well, probably) about going cash-only. And yes, there will be time for live Q&A.
The presenter lineup:
Hunter W. Jamerson, Esq.
Macaulay & Jamerson, P.C., Richmond, Va.
Tenille Davis, PharmD
Pharmacist-in-Charge, PCCA Hormone Specialist, Board Certified Sterile Compounding Pharmacist
Civic Center Pharmacy, Scottsdale, Ariz.
Austin B. Tull PharmD
Cherokee Custom Script Pharmacy, Holly Springs, Ga.
Michelle Moser, RPh
Owner/Pharmacist
Makers Compounding Pharmacy, Mt Vernon, Wash.
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4. If you m
issed EduCon 2020 Virtual, you can now enjoy it on demand.
We had to convert the spring EduCon event into EduCon 2020 Virtual (thanks, Covid), but that's definitely not the end of it. You can still "attend" thanks to the magic of the Internet.
- All seven continuing ed courses, available on demand (with discounted prices for members)
- The special presentation on animal compounding from Dr. Steven Solomon, director of the FDA Center for Veterinary Medicine
- The virtual Expo Hall where you can visit exhibitors, see presentations, and reach out to vendors
- The 2020 State of the Alliance Report
Head there now for a look, take one of those great CE classes, and be sure to pop in on an exhibitor — no mask necessary!
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5. We've got two new CE courses for you (sponsored by the Pharmacy Compounding Foundation).
The
Pharmacy Compounding Foundation is a great supporter of APC's education, and its grants have helped expand our continuing ed courses — we've added two more to the lineup:
It takes a village ... or at least a support team. It's always good to know what goes on behind the scenes, and this live webinar will give you a look.
Tuesday, July 21, 2020
2:00–3:00 pm EDT
- $55 for Pharmacist Members
- $30 for Technician or Student Members
- $75 for Non-Members
Featuring Eric Tosh, vice president for professional services, Letco Medical.
Is it safe? It better be. We'll help you get there with both the big picture and the operational details of keeping safety at the center of your compounding practice. (The folks at APMS support APC, and we support them.
Give their safety program a look!)
Tuesday, August 11, 2020
2:00–3:00 pm EDT
- $55 for Pharmacist Members
- $30 for Technician or Student Members
- $75 for Non-Members
Featuring John M. Kessler, chief medication safety officer, Alliance for Patient Medication Safety.
Both programs are made possible through unrestricted educational grants-in-aid from the Pharmacy Compounding Foundation.
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