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ACMS Interests Discussed During Alliance for Specialty Medicine Fly-In

ACMS members joined more than 100 specialty physicians from across the country during the Alliance of Specialty Medicine’s annual Legislative Fly-In on Capitol Hill in Washington DC. For three days, specialists from various disciplines heard from and spoke to health policy officials and elected leaders about legislative and regulatory matters affecting their practices and their patients, including drug compounding, narrow networks, and ongoing challenges with quality and integrity programs administered by the Centers for Medicare and Medicaid Services (CMS). Read Fact Sheets on some of the issues discussed during the Fly-In (member login required).

Ironically, the timing of the Fly In coincided with the Senate’s back-and-forth debate on repeal and replacement of the Affordable Care Act. On the very day of some key decision-making on this issue, the Alliance’s speaker roster included Rep. Kevin Brady (R-TX), the Chairman of the House Ways and Means Committee; Senator Rand Paul (R-KY); and Tom Price, Secretary of Health and Human Services. As leaders in the debate on healthcare, each of them brought very distinctive views on the health reform law.

The Alliance was also provided timely updates from Rep. Gene Green (D-TX) the senior Democrat on the House Energy and Commerce Subcommittee on Health; Dr. Jonathan Jarow, a senior medical advisor from the US Food and Drug Administration; and Rick Dearborn, the White House’s Deputy Chief of Staff for Legislative and Governmental Affairs. However, it wasn’t all dry policy discussions as Fox News personality Tucker Carlson entertained everyone with a very colorful and humorous presentation on Washington’s current political climate and culture. 

In conjunction with the speaker presentations, each specialty physician spent an afternoon on Capitol Hill to meet with their Members of Congress and Senators (or their staffs) to advocate for legislative proposals, such as repeal of the Independent Payment Advisory Board, and seek regulatory relief and oversight on key issues. Specialty physicians that couldn't make the trip to Washington participated in the Alliance’s Twitter Town Hall discussion on these issues and both their hashtags #ASMChat and #SpeciatyDocs received a combined ten million impressions on Twitter!

The Alliance Fly-In is an annual event and ACMS looks forward to the next event in summer 2018 - just months before a very important Congressional election!

Compounding and the FDA

July 19, 2017
By Erin S. Gardner, MD, FACMS

I wanted to provide an update from Washington on our ongoing efforts to shape the upcoming guidance for compounding as issued by the FDA. Today was the third and final day for the Alliance of Specialty Medicine’s annual summer fly-in. As many of you know, specialty societies ranging from rheumatology to neurosurgery (and of course ACMS and ASDS) were represented.

Many headline speakers were on the agenda generally. After a (very) entertaining and extemporaneous monologue on healthcare and politics and Washington personalities by television host Tucker Carlson, we were addressed by Secretary of Health and Human Services Tom Price. Dr. Price has been a friend to medicine for greater than a decade, and he offered several encouraging statements about easing the burdens we experience in our daily practices.

Commissioner Scott Gottlieb from the FDA had been scheduled to speak, but had to cancel at the last minute. He sent Jonathan Jarow, MD, the senior medical advisor for the Center for Drug Evaluation and Research, one of the six divisions within the FDA, to speak and represent on his behalf. Dr. Jarow was a friendly sort, as government regulators go, and offered a thorough and rather extended discussion of FDA organization and purview. He discussed five areas of regulation that the FDA is currently particularly focusing on: opioids, prescription drug costs, drug shortages, promoting pharmaceutical innovation, and of course, our own especially pertinent drug compounding.

He emphasized a couple of points, with which we are all familiar. He referenced the 2012 compounding incident from Massachusetts, and the subsequent Drug Quality and Security Act (DQSA, in 2013). He distinguished between 503A (traditional compounding pharmacy that compounds as directed from individual patient prescriptions) and 503B compounding pharmacies (considered outsourcing facilities, where large-batch quantities can be produced, even without an individual prescription). He emphasized that the guidance for compounding issued thus far was only “draft” guidance.

A self-proclaimed theme of his entire talk was the concept of “balance” in the FDA’s mission, and which he explicitly referenced multiple times during our time together. It was using that rhetorical thread that I posed my statement regarding our position on compounding. To wit, we assert that an accommodation should be made (in updated guidelines for drug compounding) to account for the thousands of daily instances of straightforward mixing of medications like bicarbonate with lidocaine/epinephrine solution in the office setting.

I know that both Drs. Coldiron and Moody will be pleased to note that I had my trusted visual aids tucked close in my suit coat, and produced them at that point. Employing the solution bottles in a two-handed flourish, I conceptually demonstrated how the very simple action of mixing a small amount of one with the other makes a dramatic difference in a patient’s experience. I also emphasized that this is overwhelmingly a patient-care issue, rather than a self-serving maneuver.

Dr. Jarow listened in a respectful way, and from all indications a generally open-minded sort of way, but maintained the studied detachment of many of the regulators that one may meet. He parried with two questions of his own. He first asked, is it not possible to have a compounded lidocaine/epinephrine/bicarbonate solution produced at an approved compounding pharmacy and then used for patient care? I responded that the shelf-life of the compounded product is significantly reduced once buffering occurs, thus significantly reducing the utility of such a bulk-produced product. (He didn’t reference individual prescriptions for a product.)

He next asked what I would have him specifically change in the draft guidance. I responded that we needed an explicit accommodation, in the updated (final) guidance, which specifically allows for compounding by physicians within an office setting that occurs in the course of typical patient care (and not with additional certifications, fume hoods, etc). He seemed to receive this in a thoughtful and dispassionate way. I really do believe he left with more to think about than when he arrived in the room.

There were other specialties represented in the room who were sympathetic to our position, and made affirming similar appeals for our own preferred approach. The dermatology folks in the room all agreed that we received a favorable hearing and rationale consideration of our position.

Now, onward with continued efforts to persuade them of the advantage of our position.


Skin Cancer Foundation seeking dermatologists for screening tour stops

This summer, The Skin Cancer Foundation’s Destination: Healthy Skin RV will travel around the United States, providing sun protection information and, with your help, free skin cancer screenings to the public. Join the more than 750 dermatologists who have volunteered to provide screenings in their communities. Screening events will generally be held between 10 am and 4 pm, and you may volunteer for a 3-hour shift in the morning (10 am to 1 pm) or the afternoon (1 pm – 4 pm). You may also volunteer for the entire 6-hour day. If you can only help after your work day, let us know and we may be able to accommodate you. To volunteer, view the tour schedule and contact information for the Skin Cancer Foundation.


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