GLP-1 / Peptide / Telehealth Platform

MSO and professional entity design, friendly PC formation, fifty-state corporate practice mapping, and multi-tier holding architectures with separated network, management, and technology functions.

Management services agreements drafted and negotiated from single-brand groups to enterprise, multi-entity platforms: fair-market-value fee structures, scope and control boundaries, intercompany and collection agreements, and successor mechanics for a future transaction.

The complete integrated contract stack that makes a system sellable: management agreements, platform licenses, network subcontractor agreements, intercompany agreements, brand onboarding frameworks, deployable partner templates, and joinder mechanics for scale.

Entity selection by seat and by state, professional entity rules, foreign qualification everywhere services run, and launch sequencing that keeps every state lawful before it goes live.

Every dollar traced from patient through platform, MSO, medical group, pharmacy, and marketing partners, tested against the Anti-Kickback Statute, state fee-splitting, patient brokering, and CPOM fee restrictions. Broken flows rebuilt.

Compliant payment structures for the whole model: merchant and payment processor agreements, including with Stripe and other major processors; merchant-of-record structuring; collection agent and collections agreements, including MSO-to-PC billing and collection; subscription and recurring billing terms; reserve, chargeback, and MATCH exposure; and KYC onboarding that keeps a high-risk healthcare merchant bankable.

Fulfillment and 3PL agreements, cold chain and shipping terms, supplier and API sourcing agreements, service-level and liability allocation, and the nonresident and cross-state considerations that ride along with them.

503A and 503B analysis, establishing and documenting the clinically significant difference exception product by product, prescriber attestation infrastructure, formulary-wide product legality review, and post-shortage strategy. We advise every party in the model on how FDA rulings and recent advisory panel (PCAC) recommendations change what can be compounded and offered.

Advising on where and how to expand product offerings compliantly across GLP-1, peptides, hair loss, hormones, ED, and adjacent categories: the regulatory basis for each new product, the visit modality and consent it requires, the compounding or sourcing path, and the marketing and payment implications, mapped against the states you serve before you launch it.

Pre-publication review of every ad on every channel, full website audits with deploy-ready copy, influencer and testimonial systems, LegitScript strategy, media buy redlines, and the internal approval workflow that documents it.

Building affiliate and influencer programs that drive growth without crossing into paying for patients: CPA, CPL, revenue-share, and per-signup structures analyzed against the line between advertising and referrals, affiliate and influencer agreements with disclosure and substantiation obligations built in, network and sub-affiliate terms, and restructuring of arrangements that read as fee-splitting into fair-market-value advertising deals.

We draft the site, not just audit it: product pages, checkout flows, Terms of Service, Privacy Policy, notice of privacy practices, SMS and text consent (TCPA), email consent (CAN-SPAM), cookie and tracking disclosures, auto-renewal and refund policies, and tracking technology exposure on health data pages.

Synchronous (live video) versus asynchronous (store-and-forward) visit structuring by state and by treatment category, physician supervision requirements, autonomous and independent nurse practitioner practice states, collaborative practice agreements, delegation, protocols, and standing orders, and the modality and prescribing rules that differ across GLP-1, hormone, ED, and controlled-substance categories.

Consent developed for every party that needs it, not just the medical group: state-specific telehealth informed consent, treatment- and category-specific consent for GLP-1, hormones, ED, and peptides, compounding and significant-difference consent addenda, and the data, SMS, and marketing consent the storefront relies on. Built to match the intake, the structure, and the states you serve.

Network access agreements, provider network agreements, fulfillment terms, vendor and technology agreements, and the multi-party fee architecture that connects them.

Who needs a business associate agreement and why, subcontractor chains, breach response, state consumer health data laws including Washington’s My Health My Data Act, and Security Rule readiness.

Written policy suites, audit protocols, partner file audits, KYC frameworks, and attestation and consent capture systems; insurance guidance, including coverage requirements drafted into every agreement; and the security posture a scaling company needs, meaning administrative, physical, and technical safeguards, employee offboarding that revokes access on day one, and secured network configuration.

Buy-side and sell-side transactions, diligence questionnaires purpose-built for telehealth and GLP-1 targets, pre-transaction readiness, and structure cleanup before a buyer sees the data room.

FDA warning letter and Form 483 responses, FTC inquiries and CIDs, LegitScript revocations, ad platform appeals, processor terminations, board complaints, state AG inquiries, regulator and payor audit responses, manufacturer demands, and counterparty disputes.

Governance and capital raises, multi-state employment and contractor classification, trademarks and IP, commercial and logistics contracts, text and email marketing compliance, and franchise law screening for turnkey models.

Compounding did not become illegal, but the shortage-based pathway that allowed large-scale compounding of copies ended in 2025. What remains lawful is patient-specific compounding supported by a documented clinical determination that the compounded product differs significantly from the approved drug for that patient. Price is not a significant difference. Neither is convenience or availability. The question is not whether compounded GLP-1 exists, it is whether the file behind each prescription would survive being read by someone looking for a problem.

If a non-physician owns economic interest in a business that delivers medical care, then in most states, yes, in some form. The harder question is whether the structure you have works in the states you actually serve. Single-state structures applied nationally are the most common defect we see, and the 2025 and 2026 legislative wave in states including California and Oregon narrowed the room considerably.

This is the most consequential question in the industry and the answer is usually no. A payment that scales with prescription volume is tied to referrals, which is the core of anti-kickback and patient brokering analysis. Some state patient brokering statutes, including Florida’s, are not limited to federal program patients, so a cash-pay model does not by itself remove the exposure. The workable path is compensation for identifiable services at fair market value, set in advance, and not varying with referral volume. That restructuring has to happen before execution, not after a subpoena.

Yes. We review and negotiate merchant and payment processor agreements, including with major processors, along with merchant-of-record structures, subscription and recurring billing terms, reserve and chargeback provisions, and the know-your-customer onboarding that keeps a high-risk healthcare merchant bankable. Where a processor has terminated an account, we handle the response and the re-underwriting.

Yes. We paper fulfillment, 3PL, cold chain, and supplier agreements, pharmacy network access and dispensing terms, and the payment and processor relationships that move the money. These are drafted to fit the structure, so the fulfillment and payment layers do not quietly create referral, fee-splitting, or corporate-practice exposure.

This is one of the most common situations we are brought in for. A company scales faster than anyone planned, and the base never gets built to match: the compliance program, vendor diligence, HR and employment, licensing and registrations, governance, data practices, and financial controls all fall behind the growth at once. We build the whole-company operational and compliance foundation, not only the healthcare-regulatory piece, and we do it on a standing cadence, weekly or several times a week, with an assessment, a prioritized roadmap, assigned owners, and deadlines, until the company is current and staying current is routine.

It is established one patient at a time, by the prescriber, and recorded in documentation that reflects a real clinical judgment rather than a policy applied to everyone. The determination is that the compounded product is significantly different from the approved drug for that particular patient, for a clinical reason. Price, convenience, and availability do not count. We advise the medical group and the pharmacy on how to establish the exception, builds the attestation so it can be answered both ways, and structures the intake so the prescriber is deciding on real information. Done correctly, the file behind each prescription tells a coherent, patient-specific story.

They change what can lawfully be compounded, offered, and marketed, and they affect every party in the model, not only the pharmacy. FDA shortage resolutions and bulks proposals narrowed the GLP-1 compounding pathways, while the July 2026 advisory committee recommended several peptides for the 503A bulks list, a recommendation that is not yet a rule. We advise each party on what these developments actually mean for its formulary, its marketing, and its structure, and separates what has legally changed from what has only been proposed or recommended, because acting on the second as if it were the first is how businesses get ahead of the law.

Yes. Before you add a product, whether it is a new peptide, a hormone, an ED or hair loss offering, or an adjacent category, we map the regulatory basis for it, the visit modality and consent it requires, the compounding or sourcing path, and the marketing and payment implications, against every state you serve. Product expansion is where fast-growing platforms most often add exposure without realizing it, because a new SKU can carry a different modality rule, a different compounding basis, and a different advertising constraint than the one it sits next to.

Yes. We draft the full website legal layer for telehealth brands: Terms of Service, Privacy Policy, notice of privacy practices, SMS and text message consent built for TCPA, email consent for CAN-SPAM, cookie and tracking disclosures, and auto-renewal, cancellation, and refund policies. For a prescription healthcare storefront these are not generic templates; they have to match the structure, the consent capture, and the state health data laws that apply.

Foundations do not get built by a memo. For buildout and fractional general counsel engagements, we run standing working sessions, weekly or multiple times a week depending on how far behind the growth got, each with a defined agenda, owners, and deadlines. Items move from open to closed on a schedule, documentation is produced as the work happens, and the company reaches a steady state where it is current across every function rather than reacting to problems one at a time.

Yes, and it is one of the more consequential design questions in telehealth. We advise on synchronous (live video) versus asynchronous (store-and-forward) visit structuring, which the states permit differently by treatment category, on physician supervision requirements, on autonomous and independent nurse practitioner practice states, and on collaborative practice agreements, delegation, protocols, and standing orders. The right modality and supervision model depends on the states you serve and the category you are treating, including where controlled substances such as testosterone are involved.

Any vendor that creates, receives, maintains, or transmits protected health information on your behalf. The chain runs further than most operators expect. A management company handling administrative functions for a medical group is typically a business associate of that group, which makes its own data-touching vendors subcontractors, whose obligations must flow down no less protectively. Most platforms discover the gap during a breach, the worst possible moment to map it.

Federal law restricts advertising and promotion of specific compounded drug products, which surprises many pharmacies and nearly every brand partner. Marketing that a platform performs can create exposure on the pharmacy side even though the two are separate businesses. The wall between the pharmacy’s operations and the storefront’s marketing has to be built deliberately, in the contracts and in practice, not assumed.

Yes, and they carry more exposure than most operators assume. The FTC requires material connection disclosures that are actually visible, not truncated, and in video both seen and heard. Outcome claims and before-and-after imagery require typicality disclosure and substantiation. A prescription product adds a layer above the general endorsement rules, and recent FDA enforcement has focused on marketing that implies a compounded product is the same as an approved one.

You have a short window, typically fifteen working days, though the letter itself controls, and what you say shapes everything after it. The instinct to argue is usually wrong and the instinct to over-concede is worse. An effective response acknowledges specifically, corrects verifiably, and documents the correction, written knowing it becomes part of the public record. The remediation is usually broader than the letter: if three product pages are cited, the other forty need the same review before anyone answers.

The medical group. This is not a preference, it is a structural requirement, and getting it wrong undermines the entire corporate practice defense. The management company can provide, host, and support the record system and access records as a business associate to perform its services. It cannot own them, and the agreements have to say so and mean it, including on termination, when the records must follow the practice rather than the platform.

Enough of them that the honest answer is that it depends on your model, and any lawyer who gives you a number without seeing your documents is guessing. Corporate practice doctrines vary from strict prohibition to near-permissiveness, fee restrictions differ independently, and telehealth prescribing and modality requirements form a third overlapping layer. The practical approach is a mapped analysis of your actual structure against every state you serve or intend to serve.

Possibly, and almost nobody screens for it. State franchise and business opportunity statutes generally reach an arrangement combining a trademark license, a prescribed system or marketing plan, and a required fee. A turnkey telehealth offering can contain all three without anyone intending to sell a franchise. The consequences of an unregistered franchise offering are serious and include rescission rights. The screen is inexpensive; the discovery is not.

On the model that fits the engagement, not the one that bills the most. We offer flat fees on a defined scope, so a project carries a number you agree to before it begins; an hourly rate where the work genuinely cannot be scoped in advance; and a hybrid that caps the parts we can define and meters only the parts we cannot. Ongoing support and fractional general counsel run on a standing retainer. Whichever model applies, the fee is agreed at the outset rather than discovered on an invoice.