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In 2025, regulators, manufacturers and the press all had their say about cash-pay GLP-1 telehealth. The year started with a supply story. It ended with a price story and an advertising story.
This is the Telehealth Growth Desk's year-end review for cash-pay operators. It covers what happened, what it taught, and how I would set up 2026. It is educational, not legal advice. Anything that touches your claims, products or licenses belongs with counsel who knows your state.
Here is the whole year on one list, before we go through it.
- February 21: the FDA determines the semaglutide shortage is resolved.
- March 5: Novo Nordisk launches NovoCare Pharmacy with Wegovy at $499 per month for cash payers.
- March to May: shortage-era compounding leeway ends in stages.
- June 23: Novo Nordisk ends its collaboration with Hims & Hers.
- July 8: the Eighth Circuit vacates the FTC's click-to-cancel rule.
- September 9: the FDA and HHS announce the drug-advertising crackdown.
- October 1: Medicare telehealth flexibilities lapse as the government shuts down.
- November 6: the White House announces GLP-1 pricing agreements with Lilly and Novo Nordisk.
How did 2025 start? The shortage ends
On February 21, 2025, the FDA determined that the semaglutide shortage was resolved (the note I wrote at the time). Tirzepatide had been declared resolved earlier, on October 2, 2024, and again after litigation on December 19, 2024.1 That mattered because the shortage list was what gave compounders their wider leeway.
Three weeks later, on March 5, Novo Nordisk announced NovoCare Pharmacy, pricing every Wegovy dose at $499 a month for cash payers, with home delivery and case manager support.2 For the first time a manufacturer put a clear, branded cash number on the table, and it became the anchor that every clinic had to answer.
$499
What happened to compounding in spring and summer?
The FDA's published timeline shows the leeway ending in stages. Enforcement discretion for compounding pharmacies ended after the court denied a preliminary injunction on March 5 for tirzepatide and on April 24 for semaglutide. For outsourcing facilities, the FDA's no-action date was March 19 for tirzepatide and May 22 for semaglutide.1 The FDA also explained that a compounded drug is generally considered "essentially a copy" if it has the same active ingredient, in the same or easily substitutable strength, as a commercially available product, with narrow exceptions for a documented significant difference for an identified patient.1
Then came the public fight. Novo Nordisk ended its collaboration with Hims & Hers on June 23, less than two months after the companies announced it, saying Hims sold "illegitimate, knockoff versions of Wegovy" that put patient safety at risk. Hims' shares fell about 31% that day.3 Those are Novo's claims, not rulings, but the lesson for operators was plain: manufacturers will contrast brand and compounded offers in public, and the language you use will be read in that light.
Why was September the turn from supply to speech?
On September 9, 2025 the FDA and HHS announced a crackdown on misleading drug advertising: thousands of letters warning companies to remove misleading ads, about 100 cease-and-desist letters, and a move to begin rulemaking on the "adequate provision" loophole.4 The FDA noted that it once sent more than 100 warning letters a year to drug companies, a number that fell to one in 2023 and zero in 2024.4
The part that landed on telehealth: Holland & Knight reports that, unlike earlier actions, the FDA sent warning letters to telehealth providers and companies, including several GLP-1 providers, saying the products were misbranded because of misleading ads. Examples flagged included "Semaglutide (the same ingredient in Wegovy & Ozempic)" and "TIRZEPATIDE (GENERIC MOUNJARO)."5
The conversation moved from "can we supply it" to "what are we saying about it." That is the shift I would underline for 2026. (My read at the time: The FDA's Drug Ad Crackdown Reaches Telehealth.) Supply problems end. Claims problems follow you.
What happened to Medicare telehealth and prescribing rules?
On October 1, as the federal government shut down, Medicare's telehealth flexibilities lapsed: geographic restrictions returned, patients could no longer receive covered telehealth at home, and audio-only services expired.6 A cash-pay clinic is not paid differently, but the headlines can confuse patients.
Later, a CMS FAQ summarized by the American Hospital Association said CMS will retroactively pay claims for telehealth services furnished during the shutdown through January 30. The same FAQ warned that the flexibilities expire at the end of January if government funding is not extended.10
Telehealth flexibilities will expire at the end of January if government funding is not extended.
On prescribing controlled substances by telehealth, the DEA and HHS had extended their flexibilities through December 31, 2025 in a November 2024 rule.11 I could not verify any newer action as of this writing, so if you prescribe controlled medications by telehealth, check for updates before the year turns.
How did prices change by November?
Fast (the details are in GLP-1 Prices Are Falling). On November 6, the White House announced pricing agreements with Eli Lilly and Novo Nordisk. The fact sheet lists TrumpRx cash prices of $350 for Ozempic and Wegovy and an average of $346 for Zepbound, a $245 Medicare and Medicaid price and a $50 Medicare copay, with no start dates given.8 Lilly separately set Zepbound self-pay at $299 for the lowest dose and up to $449, with Medicare coverage starting as early as April 1, 2026.9
Meanwhile the business of telehealth kept growing. Hims & Hers reported Q3 revenue of about $599 million, up 49% from a year earlier, with 2.47 million subscribers, up 21%, and monthly online revenue per average subscriber of $80, up 19%.7
The same release said the company was in active discussions with Novo Nordisk to make Wegovy available on its platform, with no definitive agreement executed.7
| The 2024 playbook | The end of 2025 reality |
|---|---|
| Win on price vs the brand | Brand cash prices are falling toward the compounder's range |
| Claims like "same ingredient as" | Those exact claims drew FDA letters |
| Margin from the drug | Margin from the service and the relationship |
| Regulators focus on supply | Regulators focus on advertising |
| Ads built on speed | Ads built on substantiation |
What did the year teach cash-pay operators?
Four lessons, in the order I would learn them.
Lesson one: language is infrastructure. The words on your pages are not decoration. They are the thing regulators and competitors read first. Keep a claims ledger with the evidence behind each claim and the exact approved wording.
Lesson two: do not build a business on a temporary rule. The shortage list gave compounders room. When it ended, so did the room. Anything that exists because of a loophole, a shortage or a gray area needs a plan B.
Lesson three: price is a story, and the story changes. A clinic built on "cheaper" loses its pitch when the benchmark moves. A clinic built on access, follow-up and clarity keeps it.
Lesson four: subscriptions need honest terms. Losing the click-to-cancel rule in court on July 8 did not free anyone from ROSCA, the FTC Act or state auto-renewal statutes.12 (Build the easy exit anyway.) Clear price, renewal and cancellation terms protect patients and you.
Where cash-pay clinics sat in the middle
Most cash-pay clinics are small. They do not have a legal department or a regulatory team, and they often learn about a rule change from a patient or a competitor. That is the structural problem of this category: the compliance burden is the same as it is for a national brand and the resources are not. The practical answer is a short, written system. A one-page ledger, a quarterly review and a counsel relationship cost far less than a single corrected campaign.
What should you set up for 2026?
- Build the claims ledger. Every claim, its proof, the approved wording, a banned list, an owner.
- Rewrite the value story. Five things a patient gets from your clinic that a mail-order channel does not.
- Audit sameness and comparison language across ads, pages, emails and social posts.
- Clean up the subscription flow. Price, term, renewal, cancellation and refund terms visible before purchase.
- Map your data. Know what your tools, pixels and vendors receive, and keep health details out of ad platforms.
- Make a watch list with dates: TrumpRx availability, oral drug approvals, Medicare telehealth funding after January, and DEA prescribing rules.
- Review quarterly, with counsel in the room for anything on the ledger.
Which watch-list item matters most?
If I had to pick one, it is pricing, because it changes your story and your margin at the same time. Prices announced in November were not all live, and several depend on programs that had not launched or drugs that had not been approved.89 That means the next few months will be a stretch of announcements, partial rollouts and competitors advertising prices that do not yet exist. Your edge is to wait for facts, update your pages when they are true and tell patients plainly what you offer.
The second is advertising enforcement. I would treat the September letters as a first wave, not a finish line. A clinic that fixes its pages in December is in a different position from one that waits to be asked.
The year in one sentence
In 2025 the easy edge in telehealth, supply and price, got competed away or regulated, and the lasting edge turned out to be trust: clear claims, honest terms and care patients can feel.
Telehealth stopped being a supply game in 2025. It became a trust game, and trust is built one honest sentence at a time.
I have seen this pattern in every category that grows fast and then meets its regulators. The operators who survive the transition are boring in the right places and distinctive in the right ones. They keep their claims clean and their care excellent. My telehealth page explains how I help clinics build that way.
Keep building.Ekai
Questions people ask
What were the biggest telehealth events of 2025?
The FDA declared the semaglutide shortage resolved in February, shortage-era compounding leeway wound down in spring, Novo Nordisk ended its collaboration with Hims & Hers in June, the FDA and HHS announced an advertising crackdown in September, Medicare telehealth flexibilities lapsed on October 1, and the White House announced GLP-1 pricing agreements on November 6.
Is compounded semaglutide still allowed?
Under the FDA's published timeline, shortage-era leeway for compounding semaglutide ended in spring 2025. Compounding is now limited under standard rules, and the FDA and HHS have focused on telehealth advertising that implies sameness with brand drugs. Get qualified counsel before making any compounding claim.
What happened to Medicare telehealth in 2025?
The flexibilities lapsed on October 1, 2025 as the government shut down. Per a CMS FAQ summarized by the American Hospital Association, CMS will retroactively pay claims for telehealth services during the shutdown through January 30, and the flexibilities expire at the end of January if funding is not extended.
What should a cash-pay telehealth clinic prioritize for 2026?
Build a claims ledger, rewrite your value story around care rather than drug price, document consent and data flows, plan for subscription disclosures, and set a watch list for pricing programs, oral drug approvals and telehealth rules. Educational, not legal advice.
Did Hims & Hers keep growing in 2025?
In its Q3 2025 results, Hims & Hers reported revenue of about $599 million, up 49% year over year, with 2.47 million subscribers, up 21%.
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