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

Description

Private direct healthcare practices and affiliated business models continue to be popular healthcare options. As primary care remains an area of concern for the U.S. healthcare system, and with the increase of reported primary care physician burnout, private direct practice models (often partnered with affiliated businesses) continue 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 health 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 panel addresses the private direct practice challenges and alternative compliance solutions for these challenges. The panel will also offer guidance on evaluating and structuring direct practices.