Concierge & Direct Primary Care
Medical & Compliance Guidance
Medical & Compliance Guidance
Concierge medicine (also known as retainer medicine or boutique medicine) involves charging patients (or clients) a subscription (or access) fee for medical and other health care services. Frequently, physician entrepreneurs will create a model of high-end, primary care through concierge medicine, but be unaware of the legal pitfalls from laws relating to insurance, contracts, and so on.
Concierge or boutique medical practices raise legal issues requiring knowledge of insurance laws, contract legal issues, ethical rules applicable to medical doctors and other clinicians, anti-kickback and fee-splitting laws, and many other regulatory arenas.
The legal and regulatory issues are tied together, requiring expert care, and they can apply to clinicians in both conventional medicine and the complementary and alternative medicine or wellness sphere. Sometimes our clients start out thinking they have a concierge medicine model of care, but it’s a wellness care model in which the patient contracts for specified services.
Our expertise includes drafting agreements between doctor and patient, whether the physician is offering true concierge, VIP care, or a wellness program.
These legal and regulatory compliance challenges include:
Insurance Conflicts
Regulatory Classification as Insurance
Patient Termination & Ethical Duties
Kickbacks & Fee-Splitting Risks
Contractual Violations with Insurers
Advertising & Marketing Compliance
Navigating the legal landscape of concierge medicine requires careful attention to laws around insurance, fee structures, and patient agreements. Our team helps clinicians structure their practices to stay compliant and minimize risk. If you’re building or managing a concierge or wellness model, consider a legal review to ensure you’re on solid ground.
Concierge & Direct Primary Care Medical Lawyers’ Advice
Any concierge medicine or wellness program must be structured carefully by an attorney well-versed in corporate practice of medicine, fee-splitting and kickback laws, insurance law, and other legal rules, so that the transaction passes legal muster and is legally compliant. Our experienced concierge medicine attorneys can help you craft an appropriate concierge or wellness program, as well as all the legal documentation to help manage your regulatory and legal risk.
Core Legal Issues
- One of the key legal issues is the extent to which the access or retainer fee for the concierge medical practice includes services that are routinely covered by insurance, such as physical exams, routine medical office visits, and routine diagnostic tests.
- A second issue that arises is that of illegal kickbacks and fee-splitting legal rules. When concierge practices offer “free” services, this raises concerns under the federal anti-kickback statute (AKS) if Medicare is involved, and otherwise and additionally under state antikickback laws. The “free” service can be viewed by enforcement authorities as an illegal inducement for clinical services.
- The third issue is whether the access fee could be considered the practice of insurance, and therefore subject the entity or medical practice offering the pre-paid medical service to state regulation as an insurer. Fee-for-service arrangements may be viewed as outside insurance regulations; however, access fees for prepaid services raise legal issues.
- Fourth, the arrangement must comply with any contractual arrangements the entity or provider has with private insurance companies or third-party payers. For example, the private insurance company may have a clause that prohibits balance billing — i.e., billing the patient for a service after or instead of the rate of reimbursement allowed by the insurance agreement. The prohibition on balance billing usually only applies to covered services, so there may be an “out” here. Once again, the contract should be carefully reviewed by an attorney familiar with insurance contracts in the medical arena. Deciding not to accept insurance is one option, although that may reduce overall revenues.
- Another concern is how to terminate patients after a set level of services has been provided. State laws and ethical rules prohibit patient abandonment. The patient must be given enough time to find a new and satisfactory physician.
Structuring a Compliant and Sustainable Concierge Model
- Another concern is how to terminate patients after a set level of services has been provided. State laws and ethical rules prohibit patient abandonment. The patient must be given enough time to find a new and satisfactory physician.
- Concierge medical practices must also be aware of advertising laws applicable to physicians and non-physician providers (both allied health and complementary and alternative medicine practitioners), and also refrain from claims of effectiveness, results, and cures that cannot be realized and may only accelerate potential liability. An experienced attorney can review marketing materials for compliance with relevant laws and help minimize potential liability exposure.
- In general, the concierge practice would benefit not only from clear legal review by an experienced health care and contracts attorney, but also by having the lawyer draft a contract between the practice and the patient that specifies the services to be covered by the access or subscription fee; the Medicare status of the physicians involved; whether those providers accept insurance; how the billing will be done; and what will happen when the patient is terminated from the program. Medicare/Medicaid, for example, may already cover some of the services, thereby prohibiting the participating or non-par physician from offering them.
- Another concern that arises is when non-physician practices try to package clinical services (such as, for example, acupuncture) and non-clinical spa services. Conflating clinical and non-clinical services not only raises kickback or fee-splitting issues but also subjects the clinician to potential charges of exceeding the scope of practice. For example, suppose the only arrangement is one in which the patient pre-purchases acupuncture visits, but can see any acupuncturist in the practice. The question is whether this involves fee-splitting or a kickback, in that the discount could potentially be viewed as an illegal inducement(or incentive) from acupuncturist A to see acupuncturist B (especially if A owns the clinic).
- CPM, the corporate practice of medicine, may also be triggered if state law applies this legal rule to professions outside of medicine and views the arrangement as the entity itself interfering with clinical practice. Still another potential area of law is that applicable to gift cards, since state law may have specific regulations regarding discounts and packaged services.
FAQ
Great! Let us know and we’ll do a conflicts check and then send you an engagement letter. Typically we want to know if we are going to represent you as an individual, or your entity (corporation or LLC); we’ll also want to know your website and some basic contact information.
Review our legal services to see some of the areas we like to work in; check our testimonials, client roster, and experience; read some of our blog posts; check out our Linked In community; or just call or email us to explore. Put simply, we represent health and wellness products, technologies, practices and ventures that accelerate health and healing.
We are very comfortable working with clients via phone and email. You can sign, scan and email the engagement letter, and submit the advance by check or online.
The answer depends on the complexity of the project. Each client’s situation is different. We want every client to receive the best possible advice, and so we want to be in a position to devote as much time as is required to do that. Look to our testimonials, client roster, and experience. We work with our clients effectively and efficiently and build long-term relationships based on mutual trust. We bill hourly and do not offer project or flat fees. Lawyering is an art, not a science – we’re intuitive as well as skilled lawyers.
Yes, like most law firms, we require an advance against fees and costs. Our typical advance ranges from $3,500 – $10,000. We offer our expertise and savvy and work hand-in-hand with you toward your goals. Occasionally, we will offer you a one-hour consult as a way to jump-start our work together, and give you an overview of critical issues, with guidance on the critical business cross-roads you’re facing. We do not take equity or deferred compensation.
Our Firm doesn’t quite “quotes” or answer “how much does it cost.” Through long experience, we’ve found that the answer is pretty much meaningless. Some lawyers and law firms give quotes, but if you read the accompanying disclaimer, you’ll see that the disclaimer basically says that you can’t depend on the quote for anything. In our long experience, “how much it costs” depends on a lot of variables, including:
- What the client is asking for
- What the client really needs
- What the client doesn’t know they don’t know
- What we discover as we dive into the legal research and analysis
- How complicated the problem really turns out to be
- How much client will want to do on their own
- Whether we can find some elegantly simple solutions to sub-parts of the puzzle
- What decisions we make together, and separately, as we explore the puzzle and put solutions and strategies together
In many cases, we might think a project is very complex but then as dig in, we can make executive decisions and recommendations that save the client dozens of hours of lawyer time and tens of thousands of dollars. This happens a lot with our clients. In other cases, the client might think the problem is simple but as we start to review it, the puzzle is much larger; sometimes the client throws in extra facts and complications at the last minute, and that will increase the expense and work; sometimes we’ll give the client “homework” so they can DIY a piece, taking it outside the need for lawyer time.
One thing we do is get our clients frequently on the phone. We find that the Legal Strategy Session often cuts through the fog. Where we need to do a chunk of written legal work, we’ll do so and let you know that’s what we think is needed. Where we can be more efficient with a call, we’ll tell you that as well.
Many clients come us after having wasted tens of thousands of dollars with other lawyers. Read our testimonials. We’re here to provide a lot more value than the retainer—our business model and Firm policy is to provide at least 3-5 times the value back to you. That’s our model and we’re sticking to it. We’re not trying to sell you on a “cheap retainer” or promise of discounts. We’re here to solve a big hairy problem and get you where you need to go, as efficiently and productively as we can.
Typically, assessing feasibility involves legal and strategic advice, which we provide in the 45-minute consult, in a way that is appropriate to the time we have together there.
The only way to know is to jump into the process. If you want to know more about us and how we work, browse our testimonials, look at our client rolodex, or review our experience on our website.
Work with us and find out how efficient and engaged we are with your business. We like to work with clients for life. It is a deep and trusting relationship.
Michael’s bio is online here. He has written books on healthcare law and policy, taught healthcarelaw as a faculty member at Harvard Medical School, garnered NIH and other medical research grants, and published over 100 articles in legal and medical journals. Michael speaks all over the world on healthcare topics.
