Private Direct/Concierge Medicine: Complying with Medicare Regulations, State Laws, and Business Regulations

Recording of a 90-minute CLE webinar with Q&A

Conducted on Tuesday, March 24, 2020

Recorded event now available

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Course Materials

This CLE course will provide a review of critical legal issues involved in organizing and operating various models of private direct healthcare practices (often referred to as concierge, direct care, integrative/Functional Medicine and connected care practices) and affiliated business models, including a discussion of compliance challenges and solutions.


The popularity of private direct healthcare practices and affiliated business models are highlighted by the recent public offering of OneMedical. As primary care remains an area of concern for the US healthcare system, and with the increase of reported primary care physician burnout, private direct practice models (often partnered with affiliated businesses, such as OneMedical) continues to garner interest. Uncertainties and provider frustration regarding healthcare plan primary care reimbursement has also contributed to increased interest in private direct healthcare.

Hospitals, businesses (such as Amazon), and large retail healthcare businesses (CVS, Walmart, and others) have implemented or are in the process of creating innovative primary care solutions that frequently combine plan-reimbursed services with private fee amenities beyond plan coverage. Some models incorporate employer funding and package these services as employment benefits. All these models share common compliance challenges relating to federal and state laws applicable to private fee healthcare services.

Private direct practices, where the healthcare professionals wish or need to remain Medicare participatory, must carefully organize their fees and offerings as outside of Medicare coverage (and outside Medicaid coverage if Medicaid eligible are involved). Some private direct practices involve healthcare professionals formally opting out of Medicare to address the Medicare compliance risk. But is that Medicare compliance risk overrated? And what are the downsides to formally opting out of Medicare? Does that mitigate all risks?

Businesses and employers are collaborating to help create innovative primary care offerings. Most U.S. states have laws or ethical prohibitions against a business practicing medicine or owning/controlling a healthcare practice (referred to as the corporate practice of medicine or CPOM).

Federal and state laws prohibiting referral compensation/kickbacks also must be considered with business/healthcare practice models. Federal tax and employment laws impact how healthcare services can be packaged and delivered to employees. State insurance and consumer protection laws may impact whether private fee offerings constitute "insurance" without compliance with state insurance laws or may overpromise services relative to capacity.

Finally, federal and state data privacy laws are nearly always triggered with innovative practice models that deliver expanded electronic communication and related heath data services. Can private direct practice fees be packaged such that they may qualify as a "medical expense" such that they are eligible for HSA/HRA/FSA funds? While the variety and complexity of federal and state laws may seem formidable, there are time-tested compliance solutions for all these legal challenges.

Listen as our authoritative presenter, Jim Eischen of Eischen Law Office (and the owner of an online learning platform provides an authoritative presentation that addresses all of the referenced private direct practice challenges and alternative compliance solutions for these challenges. Given the lack of published treatises or official safe harbors for these challenges, come listen to the author of the 2018 California Medical Association’s physician legal handbook on private direct practice laws. Gain improved confidence in navigating these fascinating legal compliance issues that US primary care innovations will continue to navigate.



  1. Private direct medicine practice and business models: Updated market trends
  2. Practice/business model variations
    1. Concierge practice models/businesses
    2. Integrative/functional healthcare
    3. Direct primary care/DPC
    4. Primary care innovation models: Updated business models
    5. Employer-funded models
    6. The future: Health data tracking, behavioral modification, and AI
  3. Legal considerations
    1. Medicare/Medicaid and private plan integration: The fork in the road
    2. State insurance and consumer protection laws
    3. State/Medical Board CPOM Issues
    4. Anti-kickback/anti-referral/improper remuneration
    5. IRC eligibility as "medical expenses" and HSA/HRA/FSA funds
    6. Employer funding: IRC & ERISA challenges
    7. Navigating data privacy & best practices
    8. Future regulatory trends: The rise of telehealth reimbursement and the need for private direct medicine compliance solution evolution


The panelist will review these and other noteworthy questions:

  • What are primary compliance challenges relating to federal and state laws applicable to private fee healthcare services?
  • How do federal tax and employment laws impact the packaging and delivery of healthcare services to employees?
  • Can private direct practice fees be packaged such that they may qualify as a "medical expense" such that they are eligible for HSA/HRA/FSA funds?
  • What are the risks for Medicare compliance with private direct healthcare practices? What are the downsides to formally opting out of Medicare? Does opting out mitigate all risks?


Eischen, James
James J. Eischen, Jr.

Eischen Law Office & Lofty Learning

Mr. Eischen is a licensed California attorney with over 32 years of experience handling complex corporate,...  |  Read More

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