The voice for pharmacy compounding • September 4, 2020 |
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Shawn Hodges
APC President
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Dear friend,
If you’re like me, work is so hectic lately that you’re liable to miss important news about your compounding business unless it smacks you upside the head.
Consider the short list below a timely head-smack from me and APC, and give it your attention (please!):
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Compounders on Capitol Hill is FAST APPROACHING! In fact, it’s this coming Thursday. We’ll have a virtual briefing on the issues you and members like you will be sharing with key members of Congress in 55 virtual visits through September and October. PLEASE SUPPORT THIS EFFORT. Read details below and register. Remember to tell us which of the 55 virtual visits you’d like to be a part of!
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USP is LISTENING! USP is hosting an open forum on beyond-use dates – a direct result of APC’s successful appeal of the new USP <795> and <797> chapters – and you need to participate. Read details below and register.
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Meet the Compounder headed to Congress – AND HELP ELECT MORE LIKE HER! We’re hosting a CompPAC virtual fundraiser September 10 to help replenish our funding so we can support pro-compounding candidates for Congress in the November elections. Our guest for the fundraiser will be APC member and Republican nominee for Congress from Tennessee’s first district, Diana Harshbarger. It’s $250 per person. Help us elect candidates who think like you do: Register here.
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Let’s change the narrative! APC has a new Code of Ethics, and you need to pay attention to both the ‘why’ and the ‘what’ of it. Read more below, and look for me to have more to say about it in coming weeks.
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Pets have needs too! Have you contacted your member of Congress to ask them to sign on to the Yoho joint letter to FDA urging withdrawal of draft GFI #256 that restricts animal compounding? Do it here. Takes two minutes, tops.
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APC partners with OPA! We’re a sponsor of the Ohio Pharmacists Association’s Midwest Independent Pharmacy Expo and Compound Conference in Columbus, Ohio (or virtual, if you prefer) on October 4. Check it out here.
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Prescribers and patients believe in what we do! Don’t forget to share our cBHT testimonial portal with your patients and prescribers. More about that below, too.
Read on for this week’s 5 BIG THINGS, and stay tuned to more head-smacking APC email updates and social media posts. We’ll keep you in the know.
Best,
Shawn
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September 29 -- Live CE webinar:
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2020 OSHA Training:
Bloodborne Pathogens
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1. THIS THURSDAY: Get briefed for Hill visits |
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- Want to continue to compound hormone therapy?
- Want to be there for veterinarians and their patients?
- Want to avoid the next Tricare clawback?
You need to get off the sidelines.
The rules can stifle your business, and they're not going to change if we -- that is, you -- don't speak up.
At Compounders on Capitol Hill VIRTUAL you'll get the chance to coordinate with hundreds of other compounders, because together our voice is a lot louder.
Our experts will brief you on the issues and how to present them. We'll organize you with virtual visits to 55 members of Congress. We'll have you 100% ready to make your case.
But it's YOUR voice that counts — and you need to take that first step. Join us at Compounders on Capitol Hill VIRTUAL on September 10.
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2. Board approves new Code of Ethics, will require members to subscribe to it |
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The APC Board of Directors this week approved a reinvigorated Compounder Code of Ethics and a requirement that APC members indicate that they will abide by the tenets of the code as a condition of membership in APC.
“This new code and the commitment we’re asking our members to make to it is an essential step in rebuilding the reputation of our profession in the wake of serial scandals by bad actors,” said APC President Shawn Hodges of Kennesaw, Georgia. “The fact is, the overwhelming majority of us are consummate professionals. This new Code of Ethics is meant to be a North Star for compounders, and APC will promote it and inculcate it via our communication and education offerings.”
The new code of ethics was recommended by a special APC Ethics Working Group chaired by Dr. Loyd Allen of Edmund, Oklahoma. The impetus for the new code is inferred in the preamble of the working group report:
Seldom a month goes by without at least one report in news media somewhere in America of unethical or illegal behavior – and the legal consequences of that behavior – related to pharmacy compounding. Pain cream scams, Medicaid fraud, and worst of all, occasional patient harm, have come to be mainstays of healthcare reporting. While it’s true that the reported unethical behavior is limited to a relatively few bad actors – almost never APC members – the image and reputation of all compounding pharmacists and pharmacies have been harmed and continue to be affected by those ongoing disclosures of indictments, convictions, fines, sentencings, license revocations, and patient lawsuits.
Unethical behavior in pharmacy compounding amounts to an existential threat to compounding pharmacists and pharmacies and to patients’ access to compounded medications in America. It is not enough to note that pharmacy compounders help literally millions of Americans live better, healthier lives if the public perceives them as unethical and unsafe as a result of the behaviors reported in the news.
The new code includes 10 commitments focused clinical practice, professional development, business practices, serving as ambassadors for the compounding profession.
The requirement that APC members subscribe to the Code of Ethics will take effect for new members starting January 1, 2021, and for renewing members upon their renewal date thereafter.
In addition to Dr. Allen, Ethics Working Group members included A.J. Day, Houston, TX; Stacy Hightower, Aubrey, TX.; Phung Matthews, Woods Cross, UT; Gary McCrory, Sugar Land, TX.; Jon Pritchett, Cary, NC; Renee McCarthy, Annapolis, MD; and Joe Navarra, Woodbury, NY.
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3. USP's holding an open forum on <795> and <797>
USP has announced its next step as it reconsiders the BUD provisions in General Chapters <795> and <797>, following APC's successful appeal last year.
Next up: An all-day virtual public forum on Tuesday, September 15 where USP will share its current findings, then take questions, comments, recommendations from participants that will inform the 2020 – 2025 Compounding Expert Committee, chaired by APC member Brenda Jensen.
Got questions? Contact the USP Healthcare Quality and Safety staff at [email protected]. |
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4. We heard back from Tricare on the recoupment. Here’s the scoop.
Tricare is refusing to back down. We’re still fighting, don’t worry — and we’ve added new information to our resources page (and available to both members and non-members).
The most important points: First, because of the confusion about the dates on the original letters, Tricare is resetting the 90-day period to file an appeal. You now have 90 days from September 1, 2020, to appeal.
Second, in the APC conference call, our attorneys said that rather than having to prove a physician/patient relationship existed for the prescriptions in question, you can instead prove medical necessity.
And remember: Regardless of how small a recoupment may be, compounders must appeal or be saddled with having committed fraud.
- A video of the August 27 briefing session with our attorney friends (for those who couldn’t attend live).
- A new white paper from those attorneys explaining Tricare’s response.
Fighting these clawbacks will probably require Congress’s help. That’s why we need to make sure we have friends there — and that’s why we need you to invest in CompPAC, our political action committee. Come to the September 10 fundraiser (and meet future compounder and congresswoman Diana Harshbarger). It’s part of the 2020 Compounders on Capitol Hill – Virtual! |
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5. cBHT testimonials pour in
Since we made a call for people -- patients, compounders, prescribers -- to share their stories of how cBHT has changed their lives, we've been inundated with responses from across the country. People have shared how much cBHT has meant to them, and how devastated they would be to lost this life-changing therapy.
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If you have patients who are taking or have taken compounded hormone therapy, ask them to take a few minutes to share their experiences.
Cool idea: Prompt them at the bottom of your cash register receipts!
If you have received patient testimonials, please share those, too (minus identifying information). And if you work with cBHT prescribers, share the link with them for sharing with their patients.
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APC is committed to addressing any concerns or complaints within one business day. Please send them — and, of course, any compliments — to [email protected].
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