We’ve got some friends in Congress coming to our aid to preserve compounded hormone therapy
Four representatives — Jaime Herrera Beutler, Henry Cuellar, Mark Pocan, and David P. Roe, M.D. — have written a letter to FDA Commissioner Stephen Hahn expressing their concern with the NASEM report. That’s the FDA-commissioned “study” that suggested limiting the availability of cBHT, despite the fact that it is used successfully by millions of people.
“[W]e ask the agency to consider the severely negative impact some of NASEM’s recommendations would have on patients,” they wrote, laying out some of the very issues APC has been pointing out since the NASEM report came out.
Their top point: “Doctors and patients should decide the best therapy.” It’s that simple (although we would add “pharmacists” to that list).
WE NEED YOU: Ask YOUR member of Congress to sign on to the letter. A phone call or message, “Please sign the Pocan letter to FDA about compounded hormone therapy” can make a difference.
Read the Pocan et al letter itself here.
Read APC’s brief on the issue here.
Pharmacists to be allowed to give Covid-19 vaccine
Great news: HHS is preemptively authorizing pharmacists and pharmacy interns across the country to administer any approved Covid-19 vaccine to patients 3 and older. (This follows the agency’s August 19 announcement that it was authorizing pharmacists to provide all CDC-approved vaccines.)
As with the August announcement, this rule applies across the country, and supersedes state laws that may limit pharmacist delivery of vaccines either by vaccine or by age.
The Pharmacy Times news story is here.
Where will you be tomorrow?
You want to be able to ship meds out of state?
You want to continue to supply veterinary compounds?
You want cBHT to stay legal?
THEN SAY SO.
If you don’t add your voice, compounding can lose these fights.
So step up. Defend your business to the members of Congress who will make a difference. You don’t even have to leave your living room.
Tomorrow: Get briefed on the latest at CCH Virtual: https://a4pc.org/cchv
Then: Come to one or more virtual congressional visits with key members of Congress through October.
Change won’t happen unless we MAKE it happen.
Sign up now: A4PC.org/cchv
Help your patients fight Covid-19
“The long muscle fibers that keep hearts beating were diced into short bits” — that’s what even mild cases of Covid-19 can do.
Help your patients protect themselves from Covid-19 and serious, life-long heart and lung damage. Masks and distance are critical, but there are supplements and lifestyle changes that can protect them and their families.
Learn what can help prevent Covid-19, and even what can help treat it with a one-hour virtual CE webinar, “COVID-19 and What You can Do For Your Immune System (and Your Patients)”.
It’s Tuesday, September 29, from 2:00 to 3:00 EDT. $55 for APC pharmacist members, $30 for technician or student members.
Get the details at https://a4pc.org/COVIDimmune.
Board approves new Code of Ethics, will require members to subscribe to it
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.
Read the complete report, which includes the new Code of Ethics, here.
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.
Reminder: 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.
Click here to register for the forum.
Got questions? Contact the USP Healthcare Quality and Safety staff at CompoundingSL@usp.org.
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.
There is more updated information on our Tricare clawbacks info page (https://a4pc.org/tricareclawbacks), including:
- 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!
A compounder is coming to Congress
Meet her at our CompPAC fundraiser reception.
There’s a lot of advocacy work we need to do, from protecting cBHT compounding to stopping the FDA’s crazy MOU with states and more.
We’ll Congress to act, so we need MEMBERS of Congress who support compounding.
And that means CompPAC: APC’s political action committee. But as we head into the heart of the campaign season, CompPAC’s coffers are pretty skimpy. If we’re going to have support in Congress, we need CompPAC to help elect other compounding champions in November.
WE NEED YOU TO REGISTER FOR THE CompPAC FUNDRAISING RECEPTION: 6:45pm on September 10, featuring our special guest: APC member and compounder Diana Harshbarger, who is certain to win the election for Congress in Tennessee’s 1st district.
Admission is $250 per person (PERSONAL contributions only), and every penny goes to CompPAC, and to support candidates who grasp the challenges compounders face.
We’re counting on you!
Make sure your pharmacy can be found
Unlike some other organizations, the folks at Boston Children’s Hospital want to make it easier for kids to get vaccinated. So make sure your pharmacy is on VaccineFinder — a national registry that helps parents find the closest and most convenient place to get their kids the shots they need: Click here to register.