Welcome to the first issue of The Clinic Brief.
Here's the deal: every week, we read the regulatory feeds — FDA, Federal Register, state boards, the enforcement letters — so you don't have to, and we translate what actually moved into what it means for a small cash-pay practice. Then one operator lesson from people who run clinics in this market, with the numbers attached. Four minutes, once a week. That's the whole product.
📡 The Radar
1. The compounded-GLP-1 era is officially closing — both doors.
FDA resolved the tirzepatide and semaglutide shortages (Dec 2024 / Feb 2025), ending the legal basis for mass compounding, and in April proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list — closing the second pathway (FDA statement · Orrick analysis). The comment period closed in June.
What it means for your clinic: if any revenue line still assumes compounded GLP-1 economics, that line has a countdown attached. Compounded product is narrowing to specific documented clinical need — not cost, not convenience. Reprice around the program, not the drug.
2. The manufacturers are now your discount competitor.
LillyDirect sells Zepbound at $299–449/month by dose; NovoCare's self-pay Wegovy runs $199; oral Wegovy launched at $149 — the lowest price ever for an FDA-approved GLP-1 (source).
What it means: your patients can now get a cash quote from the manufacturer before they call you. If your premium isn't justified by the program — monitoring, titration, access, accountability — it isn't justified.
3. Med spas are being examined like surgical centers.
An FDA warning letter to a Texas med spa signaled federal enforcement reaching aesthetic practices directly (AmSpa); state boards in Kansas, Texas, California, and Oregon are running random audits of wellness centers; and states have opened investigations into clinics buying peptides from unlicensed suppliers (Frier Levitt).
What it means: "where did this vial come from?" is now the first question in an investigation. If your answer isn't "a licensed pharmacy, here's the paper," fix that before you fix anything else this quarter.
🔭 The Watchlist
The 503B exclusion proposal moves toward a final rule — final text and effective dates are the items to watch. State boards keep moving independently; if you operate multi-state, your compliance bar is your strictest state's. We'll flag movement here weekly.
🔧 The Operator Lesson: your EMR is lying to you about revenue
We ran a twelve-month reconciliation at a practice we operate: the payment gateway's settled revenue against the EMR's billing reports. The EMR was understating collected revenue roughly eightfold — not fraud, not a bug. Cash-pay visits documented under $0-fee encounter codes; memberships and medication charges billed by the gateway without ever touching an encounter. Every service-line and provider-productivity decision made on the EMR's numbers inherited that distortion.
The same pass surfaced something better: ~$58,000 in declined charges across the year — expired cards, failed subscription retries — sitting in a gateway report nobody had ever opened. Patients who received service, wanted to pay, and simply never successfully did. That's not lost revenue. That's a call list.
The fix is a monthly discipline, not software: pull both totals for the same month, classify the gateway transactions (a simple price-point map covers most cash-pay volume), read three numbers — coverage ratio, decline volume, subscription drift — and end with three named actions. First pass takes an afternoon. After that, an hour a month.
We turned the exercise into a worksheet — the same structure we use, genericized. It's free for subscribers: Download the Reconciliation Worksheet →
Before you go
Two things coming: the full Clinic Operator's Toolkit (every template behind these lessons) and a book. More soon.
Was this useful? Reply and tell us what's confusing you most about running your clinic right now — replies literally set the editorial calendar.
— Devin & Ryan
The Clinic Brief is business and regulatory information, not legal or medical advice. Talk to qualified healthcare counsel about your specific situation.