Federal and state layers
At the federal level, the Centers for Medicare & Medicaid Services sets the rules for providers that bill those programs, the FDA regulates drugs, devices, and many other products, and the HHS Office for Civil Rights enforces HIPAA. In New York, the State Education Department licenses physicians and most other health professionals, while discipline of physicians runs through the Department of Health's Office of Professional Medical Conduct. The Department of Health also licenses hospitals, nursing homes, and many clinics. Insurance coverage questions often involve the Department of Financial Services. A single business decision can touch several of these agencies at once, which is why knowing the map comes before reading any particular rule.
Rules that surprise newcomers
New York generally does not allow businesses owned by non-licensees to practice medicine or to employ physicians to do so, apart from licensed facilities such as hospitals, and that rule shapes how practices and management companies are structured. Many facilities need state approval before they open, expand, or change ownership, and that process can take considerable time. Telehealth across state lines usually requires a license in the state where the patient is located. Referral arrangements and fee-splitting are regulated far more tightly than in most industries. Founders coming from technology or other fields often learn these healthcare regulations after they have already built around them.
Starting from your plan
Rules in this area make more sense when they are read against a specific plan. In a first conversation we ask what services will be offered, who will provide them, who will own the business, where patients will be, and how the services will be paid for. From that, we can identify which approvals, licenses, and enrollments are likely to be needed and roughly in what order. We also flag the arrangements that tend to draw scrutiny, so they can be designed properly from the beginning rather than repaired later. Changes to the plan can change the answer, so we revisit it as the business develops.
