April 7, 2026
By: Matt Wilmot & Edgar Bueno
Declining reimbursements, mounting paperwork, and shrinking time with patients have pushed a lot of physicians, nurse practitioners (NPs), and physician assistants (PAs) to explore concierge medicine. It offers providers more autonomy, more direct relationships with patients, and a practice model built around care rather than billing cycles.
However, transitioning to a concierge or “direct care” model is both a legal and strategic undertaking. Before focusing on operational considerations such as pricing structures or vendor contracts, the first question should be: is this the right model for you, and if so, what are the core decisions you need to make before you build anything?
This article covers the strategic considerations of this question. Part Two will address the operational details, including service delivery considerations, pricing models, and the documentation and contracts you will need to run a compliant practice.
Who the Concierge Model Is For
While concierge medicine started with primary care physicians, it has expanded across a wide range of providers and specialties. The common thread is that it works best where time, access, and personalized attention are central to the value you are delivering.
That includes:
- Primary Care & Internal Medicine, offering comprehensive, relationship-based care
- Specialty Care, particularly for specialties managing complex chronic conditions that require frequent monitoring and proactive coordination
- Wellness, Longevity & Functional Medicine, whereservices are generally not covered by payers, which puts them largely outside the regulatory framework discussed below
- In-Home Aesthetic & Luxury Services, where dermatologists and aesthetics-focused NPs/PAs are increasingly offering services like Botox, fillers, and medical-grade skincare directly in patients’ homes
- Telemedicine-Only Practices, where services are delivered entirely online
The Medicare Question: A Critical Strategic Decision
For providers focused on wellness or aesthetics, Medicare is largely not a factor. Those services are typically not covered, which means you can charge patients directly without involving any government payer.
For primary and specialty care providers, it is the first significant decision you will face. Do the services you plan to offer qualify as “covered services” under Medicare, and if so, what do you want to do about that? There are two paths:
- Opting Out: You enter into private contracts with patients. Medicare is not billed, and patients cannot seek Medicare reimbursement. This requires filing a specific affidavit with Medicare, which is renewed every two years.
- Staying In: If you remain a participating or non-participating Medicare provider, covered services must be charged in line with the Medicare fee-for-service schedule. You can charge separately for non-covered services, like certain wellness coordination or non-clinical amenities, but not for anything Medicare would otherwise cover.
Opting out is a two-year commitment. The decision should be made deliberately, accounting for your target patient demographic and whether you intend to provide services to Medicare beneficiaries in other clinical contexts (such as a hospital setting, moonlighting, or other professional arrangements). Both paths are viable; the key is making the decision deliberately and understanding the practical implications.
The Regulatory Landscape: What Applies to You
While concierge medicine relieves certain administrative and regulatory burdens, it brings its own compliance considerations, and it is important to understand which ones apply to your specific situation.
Federal and State Law
Any concierge practice needs to be mindful of the federal Anti-Kickback Statute (AKS) and the physician self-referral law (a/k/a the Stark Law) as well as their state analogues. Whether and how these apply depends largely on whether your practice participates in federal health care programs. The federal AKS and Stark Law generally apply when patients are covered by a federal health care program. But analogous state regulations often reach further, covering privately insured and self-pay patients as well.
Telemedicine adds another dimension. Treating patients across state lines means you are subject to the laws and regulations of each state where those patients are located. Even with a license to practice in a given state, your practice model needs to comply with that state’s specific rules, which may look quite different from your home state.
These are the decisions that shape everything downstream. Getting clarity here, especially on Medicare status and the regulatory framework that applies to your specific services and patient population, puts you in a much stronger position before you start building the practice itself.
Part Two will cover the operational side:
- How service delivery works across telehealth and home visits
- How to think about pricing
- The documentation and contracts every concierge practice needs to have in place
For guidance on any of the considerations discussed above, please contact Matt Wilmot, Edgar Bueno, or a member of HunterMaclean’s Health Care Compliance & Regulation practice group at (912) 236-0261.
