Peptides, telehealth & MSO

MSO structuring and management services agreements

An MSO structure is two entities and one agreement, and the agreement does most of the work: scope of services, term, termination rights, ownership of the records, and how the management fee is calculated. A fee set as a percentage of collections needs particular care, because a fee that moves with clinical revenue can read as a share of the practice rather than payment for administration. North Carolina has a published position on it: the Medical Board’s statement on referral fees and fee splitting, amended September 2021, treats revenue sharing on a percentage basis between a licensee and a non-licensee as fee splitting unless state law permits it. A fee set at fair market value for defined services, documented before it is charged, is the usual alternative.

Non-physician-owned CPOM-compliant structures

Every share of a North Carolina medical professional corporation must be held by a physician licensed to render the same services and connected to the corporation as an officer, director, shareholder or employee (G.S. 55B-2(2), 55B-4, 55B-6). The Act's limited exceptions for non-licensee holders reach certain design and accountancy firms, not medicine. A non-clinical owner therefore sits outside the clinical entity and takes its economics through contract.

Friendly-PC and physician partnership agreements

The clinical entity is owned by a licensed physician, which raises a practical question: what happens when that physician resigns, dies, loses a license, or falls out with the business. An issuance or transfer of shares in violation of G.S. 55B-6 is void, and the corporation must hold a current certificate of registration from its licensing board under G.S. 55B-10. Succession is handled by transfer restrictions agreed in advance.

Multi-state telehealth licensure

Care is treated as delivered where the patient is located, so each new state is a licensing question before the first consultation rather than after it. North Carolina was authorized to join the Interstate Medical Licensure Compact under S.L. 2025-37, effective 1 January 2026, giving eligible physicians an expedited route to licenses in other member states. The compact covers physicians only and does not reach every state.

Peptide and longevity practice compliance

Where a practice depends on compounded drugs, what it may offer follows what a pharmacy may lawfully compound, and that is a question of federal drug law rather than clinical preference. Under section 503A of the Federal Food, Drug, and Cosmetic Act a bulk drug substance qualifies only if it meets an applicable USP or National Formulary monograph, is a component of an approved drug, or appears on the FDA’s 503A bulks list (21 U.S.C. 353a(b)(1)(A)(i)).

The position on several peptides moved twice this year. In April 2026 the FDA announced that twelve substances, BPC-157 among them, would come out of Category 2 of its interim bulks policy. On 23 and 24 July 2026 the Pharmacy Compounding Advisory Committee recommended six of them for the 503A bulks list. Neither step places a substance on the list; that requires notice-and-comment rulemaking, which the FDA had not completed as of August 2026. Sourcing, the pharmacy agreement, prescribing protocols and patient records are built around where a substance actually sits, and revisited each time it moves.

FDA and compounding pharmacy guidance

Two regimes sit behind the pharmacy relationship. Section 503A covers compounding against a prescription for an identified patient. Section 503B covers FDA-registered outsourcing facilities, which may supply office stock without a patient-specific prescription but must compound under current good manufacturing practice and may use a bulk substance only where the FDA has identified a clinical need for it or the drug appears on the shortage list (21 U.S.C. 353b). Both restrict compounding a drug essentially a copy of a commercially available product (503A) or of an approved drug (503B), subject to exceptions for shortages and a prescriber-documented clinical difference. Which regime applies belongs in the supply agreement, in writing, before the first order.

Anti-kickback and Stark review

The Anti-Kickback Statute reaches remuneration knowingly and willfully offered, paid, solicited or received to induce referrals, or the purchase, lease or ordering of items or services, payable by a federal health care program. Stark separately bars Medicare-payable physician referrals for designated health services where a financial relationship exists, regardless of intent. North Carolina adds its own layer: G.S. 90-401 bars a provider from compensating anyone for recommending or securing the provider’s employment by a patient, and from taking payment from another provider solely or primarily for a referral, while the self-referral article at G.S. 90-405 and following reaches designated health care services covered by a Chapter 58 health benefit plan, an ERISA plan, a state or federal employee program, Medicare or Medicaid. A cash-pay practice is not automatically outside any of it; test marketing commissions, medical director stipends and lead-generation charges.

Marketing and advertising compliance

Website copy, funnels, before-and-after images and affiliate content all count as advertising, including advertising the MSO places on the practice's behalf. Health claims need substantiation held before publication rather than assembled afterwards. Subscription checkouts carry their own rules: North Carolina's automatic renewal statute requires the renewal clause and the means of canceling to be disclosed clearly and conspicuously, and a non-compliant clause is unenforceable.