How helps with legal review of concierge medicine services

The government’s Medicare website is useful in performing a legal and regulatory review of what healthcare services a concierge medical practice might offer. Key concierge medical practice legal issues include:

  • Medicare (or in California, Medi-Cal/Denti-Cal) rules, if the provider is enrolled and billing Medicare (or Medi-Cal or Denti-Cal);
  • The contractual provisions of insurance carriers with whom the provider is enrolled;
  • Other legal rules, such as prohibitions on unlicensed practice of the business of insurance; or, legal rules prohibiting healthcare fraud.

If physicians are Medicare par or non-par (but not opted out), then physicians can only offer Medicare non-covered services on a concierge basis, and enforcement penalties can be stiff if physicians get the coverage decision wrong.

The OIG has initiated several enforcement actions against physicians for charging Medicare beneficiaries for services covered by Medicare. One alleged that R. Douglas Thorsen, M.D., an internist from Minneapolis, violated his Medicare assignment agreement when he presented his patients with a medical care contract with a $600 annual fee. The contract offered patients “coordination of care with other providers,” “a comprehensive assessment and plan for optimum health,” and “extra time” spent on patient care. After looking at the facts and circumstances of the case, the OIG alleged that at least some of these contracted services were already covered and reimbursable under Medicare.

The other involved Lee R. Rocamora, M.D., from North Carolina, who agreed to pay $106,600 to resolve his liability for allegedly violating the Civil Monetary Penalties Law. The OIG alleged that the practitioner requested payments from Medicare beneficiaries in violation of his assignment agreement. Specifically, the practitioner allegedly asked his patients to enter into a membership agreement for his patient care program, under which the patients paid an annual fee. In exchange for the fee, the membership agreement specified that the practitioner would provide members with: (1) an annual comprehensive physical examination; (2) same day or next day appointments; (3) support personnel dedicated exclusively to members; (4) 24 hours a day and 7 days a week physician availability; (5) prescription facilitation; (6) coordination of referrals and expedited referrals, if medically necessary; and (7) other service amenities as determined by the practitioner.

Medicare may allow concierge fees for services that are clearly non-covered, provided that the concierge contract is clear that the fees will be going exclusively to those non-covered services. However, one of the hidden issues is that Medicare-covered services might be expected in, or bundled with, the services provided by the Concierge Membership Fee, even if the services described by the Concierge Membership Agreement appear to be non-Medicare-covered services.

Among other things:

Coordination of care and treatment planning are considered core obligations reimbursed by Evaluation and Management (“E/M” codes). E/M services refer to visits and consultations furnish by physicians and the following qualified non-physician practitioners (“NPPs”): nurse practitioners, clinical nurse specialists, certified nurse midwives, and physician assistants.

In general, the more complex the visit, the higher the level of code the physician or NPP may bill within the appropriate category of E/M services; and, there are three key components when selecting the appropriate level of E/M service provided: history, examination, and medical decision. But for visits that consist predominately of counseling and/or coordination of care, time is the key or controlling factor to qualify for a particular level of E/M services. In addition, coordination of care is one of seven components used in defining the levels of E/M services, as are counseling and time. Thus, for example:

Billing Medicare for a patient visit requires the selection of a CPT code that best represents the level of E/M service performed. For example, there are five CPT codes that may be selected to bill for office or other outpatient visits for a new patient:

99201….Usually the presenting problem(s) are self limited or minor and the physician typically spends 10 minutes face-to-face with the patient and/or family. E/M requires the following key components:

  • Problem focused history.
  • Problem focused examination.
  • Straightforward medical decision making.

99202…. Usually the presenting problem(s) are of low to moderate severity and the physician typically spends 20 minutes face-to-face with the patient and/or family. E/M requires the following three key components:

  • Expanded focused history.
  • Expanded problem focused examination.
  • Straightforward medical decision making.

99203… [30 minutes] …..

99204 …[45 minutes] ….

99205 …[60 minutes] ….

Email ultimately will likely be bundled within EMR/patient portal developments, and thus fall outside non-covered services.

Medicare offers a webpage for patients to ask: “is my test, item, or service covered?” (Your Medicare Coverage) This provides a handy search for: “Is my test, item, or service covered?”

For example, typing in “preventative” brings up many different possibilities, ranging from “preventive & screening services” to “pap tests and pelvic exams.”

One of the important pages to review is the one on preventive visit & yearly wellness exams, which refers to the Initial Preventive Physical Exam (“IPPE”) and the Annual Wellness Visit. This page indicates the following:

  • Welcome to Medicare” preventive visit:You can get this introductory visit only within the first 12 months you have Part B. This visit includes a review of your medical and social history related to your health and education and counseling about preventive services, including certain screenings, shots, and referrals for other care, if needed. It also includes:
    • Height, weight, and blood pressure measurements
    • A calculation of your body mass index
    • A simple vision test
    • A review of your potential risk for depression and your level of safety
    • An offer to talk with you about creating advance directives.
    • A written plan letting you know which screenings, shots, and other preventive services you need.

This visit is covered one time. You don’t need to have this visit to be covered for yearly “Wellness” visits.

  • Yearly “Wellness” visits:If you’ve had Part B for longer than 12 months, you can get this visit to develop or update a personalized prevention help plan to prevent disease and disability based on your current health and risk factors. Your provider will ask you to fill out a questionnaire, called a “Health Risk Assessment,” as part of this visit. Answering these questions can help you and your provider develop a personalized prevention plan to help you stay healthy and get the most out of your visit. It also includes:
    • A review of your medical and family history
    • Developing or updating a list of current providers and prescriptions
    • Height, weight, blood pressure, and other routine measurements
    • Detection of any cognitive impairment
    • Personalized health advice
    • A list of risk factors and treatment options for you
    • A screening schedule (like a checklist) for appropriate preventive services.

This visit is covered once every 12 months (11 full months must have passed since the last visit).

The above list does not appear to include services, such as, for example:

  • Wellness coaching (unless this is considered part of “personalized health advice”
  • Visual screening
  • Beck anxiety index
  • Blood count
  • Comprehensive metabolic profile
  • TSH
  • Urinalysis
  • HgbA1C
  • Certain other tests

At this initial stage of review we are not stating conclusively that the above are non-covered services under Medicare—as we have not checked Medicare manuals and other documentation (such as applicable regulations); but are merely suggesting that there could be screens, diagnostics, and labs that are Medicare non-covered, even within, for example, the general area of preventative, wellness services.


For more information about structuring your concierge medical practice, offering telemedicine services, opening an integrative medicine clinic, Stark / anti-kickback / fee-splitting issues, HIPAA liability, dietary supplement labeling, medical device legal issues, and other healthcare legal and regulatory issues, contact the Cohen Healthcare Law Group. Our healthcare and FDA legal team provides regulatory, transactional, and litigation advice to healthcare companies and service providers.

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