4 Key Compliance Trends for Physician Practices

Expect to see more and more compliance enforcement actions against physician practices – and also more physician awareness of how they can pro-actively manage liability and follow legal compliance obligations.

4 key compliance trends for physician practice to watch out for include:

• Greater movement toward integrative medicine in ways that also embrace the quantifiable self (i.e., wearable health tech data)
• Concierge medicine / opt-out of Medicare
• HIPAA compliance and privacy / security issues associated with patient information / PHI (protected health information)
• Greater attention to self-referral, anti-kickback and fee-splitting issues as physicians look to include other practitioners in their practices

We‘ve selected these 4 from trends we’ve seen our healthcare and FDA lawyers address over the past year.

Integrative Medicine

Straight conventional medical advice doesn’t sell anymore.

Consumers are informed and empowered. They want to know whether chiropractic is more effective than surgery for low-back pain, for example; or whether homeopathy can help with recurrent child ear infections; or whether acupuncture can treat addictions.

Integrative medicine once was avant-garde and controversial, and physicians who integrated complementary therapies were challenged by medical boards for choosing therapies outside conventional standards; or by other legal and liability obstacles. Now, physicians have to keep up with patient preferences, and the growing body of evidence behind specific treatments – as well as the popularity of mindfulness and mind-body therapies.

Concierge Medicine

With declining Medicare reimbursements and all the bureaucracy and legal jeopardy that attaches to Medicare billing, more physicians are choosing to opt out.

Once opted out, they are no longer bound by Medicare rules that can restrict concierge medical practices. Physicians may also choose to move away from participation in private insurance, and simply offer the myriad number of concierge medical practice business models that can, when properly implemented, afford greater lifestyle freedom.

Concierge medicine is increasingly a preferred model of care for the medical practice.

HIPAA Compliance

With increased federal enforcement of HIPAA, medical doctors are looking to train their staff in HIPAA compliance, and to be more mindful that their practices both have a full complement of HIPAA policies and procedures, and, abide by these HIPAA standards.

Even when HIPAA does not technically apply, it remains a gold standard for privacy and security. And states have their own mirror-HIPAA provisions which require reasonable protection of patient’s medical data and protected health information.

State laws also govern security data breaches, forcing physicians to pay greater attention to having operational policies and procedures in place in case a breach does occur.

Self-Referral, Anti-Kickback, and Fee-Splitting

As physicians look to add-on acupuncturists, chiropractors, or even enter into different arrangements with entrepreneurial ventures, the self-referral / anti-kickback / fee-splitting issues will dictate their compensation arrangements; how they market or manage their ventures; and the extent to which they share revenues with non-physicians.

The corporate practice of medicine rule comes into play here, too, and many states strongly enforce prohibitions against any lay intrusion into the medical domain.

On the federal side, the federal anti-kickback statute prohibits the knowing and willful offer or receipt of remuneration to induce the referral of business or services covered by a federal health care program, including Medicare. Even in the presence of other legitimate purposes, the courts have interpreted the statute to cover any arrangement where one purpose of the payment or offer of payment (albeit not the only purpose) was to obtain money for the referral of services or to induce further referrals. Federal anti-kickback law can apply to all practitioners, not just physicians, where federal reimbursement monies are involved.

Management services organization (MSO) arrangements will be possible, under applicable safe harbors, but physician practices must take care that compensation arrangements are at fair market value, and meet other safe harbor criteria.

Sublease and space equipment rentals must also comply with applicable law.

Our healthcare compliance attorneys track healthcare compliance developments so we can counsel our clients on their compliance legal obligations. Contact our healthcare compliance legal team for laws and updates relevant to your situation.