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Three things moved this quarter. Only one of them lands directly on the revenue of a cash-pay telehealth clinic. This desk exists to tell you which, so you spend October on the right work.
This is an operator's briefing, not legal advice. Bring anything that matters to counsel who knows your state and your products.
What is the signal this quarter?
Start with a simple filter, the change test. For each headline, ask whether it changes what you can say, what you can charge, or what you can legally do. If it changes none of the three, it is noise for your month.
Here is the quarter through that filter.
Does the FDA's September crackdown reach a cash-pay clinic?
Yes, and this is the one to read twice. (I broke down the letters in The FDA's Drug Ad Crackdown Reaches Telehealth.)
On September 9, 2025, the FDA and HHS announced a push against misleading drug advertising. The agency said it was sending thousands of letters warning companies to remove misleading ads, plus about 100 cease-and-desist letters to companies with deceptive ads, and that it would begin rulemaking on a long-standing "adequate provision" loophole.1 The press release itself talks about direct-to-consumer drug advertising and paid influencer promotion.
The telehealth angle came out in the commentary. Holland & Knight reports that, unlike earlier actions, the FDA sent warning letters to telehealth providers and companies, including several GLP-1 providers, and said the products were misbranded because of misleading ads.2 Examples of flagged language included "Semaglutide (the same ingredient in Wegovy & Ozempic)" and "TIRZEPATIDE (GENERIC MOUNJARO)."2
Semaglutide (the same ingredient in Wegovy & Ozempic).
If your site, your ads or your emails use anything like that line, you are the audience for this story. Sameness language is the new red flag.
What to check this week
- Any headline or ad that compares your product to a brand name.
- Any phrase like "generic," "same as," "equivalent to" or "the active ingredient in."
- Influencer or affiliate posts that do not clearly disclose payment. The FDA release specifically calls out undisclosed paid influencer promotion.1
- Before and after claims with no support behind them.
Do the Medicare telehealth changes affect you?
The federal government shut down on October 1, 2025, and the Medicare telehealth flexibilities lapsed. Geographic restrictions returned, patients can no longer receive covered telehealth at home, audio-only services expired, and the hospital-at-home program lapsed.3
For a pure cash-pay clinic, that changes nothing about how you are paid. What it can do is create noise in your inbox and your comments. Patients will read "telehealth ends" headlines and ask if your service is affected. A short, calm line on your FAQ page solves that: say you are a cash-pay service and that these Medicare changes do not apply to your program, if that is true for you.
If you accept Medicare for any service, treat this as a billing issue to review with your biller or counsel.
One more date: controlled substances
If you prescribe any controlled medication by telehealth, note that the DEA and HHS extended their telemedicine prescribing flexibilities through December 31, 2025, as announced in November 2024.8 My earlier note on the extension through 2025 has the background. Check for any new action before year-end.
Where does compounding stand?
The FDA declared the semaglutide shortage resolved on February 21, 2025. Its compounder page then lays out the wind-down: shortage-era enforcement leeway for tirzepatide ended in March 2025, for semaglutide from compounding pharmacies in April 2025, and for outsourcing facilities in May 2025.4
Holland & Knight summarizes the practical effect (the earlier shortage-over note has the history): with the shortage over, standard rules apply, and compounding of these drugs is limited to 503A pharmacies working from valid patient-specific prescriptions.2
- Feb 21, 2025Semaglutide shortage declared resolved
- March 2025Tirzepatide leeway ends
- April 2025Semaglutide leeway ends for compounding pharmacies
- May 2025Semaglutide leeway ends for outsourcing facilities
What price anchor are patients bringing in?
On March 5, 2025, Novo Nordisk launched NovoCare Pharmacy with all Wegovy doses at $499 per month for cash-paying patients.5 That number sits in patients' heads. Your offer is compared with it whether you like it or not.
The pricing picture also got messier in June, when Novo Nordisk ended its collaboration with Hims & Hers, saying the company sold "illegitimate, knockoff versions of Wegovy," according to CBS News. It was less than two months after the partnership was announced.6
The takeaway is not a verdict on any company. It is that brand-name and compounded offers are being publicly contrasted, and regulators are reading the same pages patients are.
How should you talk about price and value right now?
With a $499 brand anchor in the market, "cheaper" is a weak and risky headline. It is weak because someone can always undercut you. It is risky because price comparisons drift into claims about what the cheaper product is.
A stronger story is about what the patient actually gets: the clinician time, the follow-up cadence, the support when something feels off, the clarity about what is in the box and where it came from. Those are facts about your service you can document. They also age better than a price, which can change in a week.
Write that story in plain words on your pricing page, then check each sentence against the question the FDA letters raised: does this imply a sameness or a benefit I cannot support?
What about subscriptions and cancellation?
The Eighth Circuit vacated the FTC's click-to-cancel rule on July 8, 2025. The rule's requirements are gone, but the Restore Online Shoppers' Confidence Act, Section 5 of the FTC Act and state auto-renewal laws still apply.7 If you run a membership, a clear price, a clear renewal term and a simple way to cancel remain the safe path. See Click-to-Cancel Was Vacated for the build-it-anyway case.
Q4 priorities for a cash-pay clinic
- Claims audit. Pull every ad, landing page, email and social post. Flag comparison and sameness language and anything you cannot substantiate.
- Disclosure audit. Check sponsored content, affiliate links and influencer posts.
- Pricing page. State what the patient pays, what is included and what renews.
- Holiday plan. Decide your promotions now, with counsel, rather than the week of Black Friday.
- Calm FAQ. Add a short note on how federal telehealth headlines do or do not affect your program.
- Calendar. Put December 31 on it for any controlled-substance telehealth prescribing.
The noise list
Everything else this quarter is worth knowing and not worth acting on today: opinion pieces on future policy, speculation about drug pricing, and every thread that starts "sources say." Check back when there is a date, a rule or a letter. Until then, your best use of October is fixing the pages you already control. I would rather see a clinic with clean, boring copy than one with a brilliant headline and a warning letter. How I work with clinics on the funnel side is on my telehealth page.
Keep building.Ekai
Questions people ask
Did the FDA's September 2025 crackdown apply to telehealth companies?
Yes. Holland & Knight reports that, unlike earlier actions, the FDA sent warning letters to telehealth providers and companies, including several GLP-1 providers, saying misleading advertising made the products misbranded. Review your ads and site copy now.
Does the Medicare telehealth lapse affect a cash-pay clinic?
Not directly. The lapse that began October 1, 2025 changes what Medicare will pay for. A clinic that does not bill Medicare is not paid differently, but it can affect patient confusion and the competitive picture if you also see Medicare patients.
Can telehealth clinics still compound semaglutide in Q4 2025?
The FDA declared the semaglutide shortage resolved on February 21, 2025, and the shortage-era leeway ended in spring 2025. Compounding is now limited under the normal rules, so get qualified counsel before making any compounding claim.
What should a telehealth ad never say?
Do not imply a compounded product is the same as an FDA-approved brand. Holland & Knight cites FDA letters that flagged lines such as 'the same ingredient in Wegovy & Ozempic' and 'generic Mounjaro'. Educational only, not legal advice.
Sources
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