Physicians & Healthcare Startups: Don’t Mess with Alphabet-Soup Lettered Government Agencies

Federal Trade Commission seal sign and logo in downtown

Dr. Heart, Fat-Burning Hero and Resolver of Complex Chronic Medical Conditions has a Business Idea

Dr. Seymour Heart, the perennial hero of our blog, has once again come up with a fantastic healthcare startup opportunity.

Dr. Heart received his medical license from a prestigious medical school and has a niche practice in functional medicine, integrative medicine, stem cell therapies, anti-aging medicine, and he has also teamed up with chiropractors, acupuncturists, massage therapists, naturopathic medical doctors, and a team of nurse practitioners, physician assistants, medical assistants, and other healthcare providers to create a world-famous center for holistic health care.

Day in and day out, Dr. Heart resolves chronic conditions, debilitating diseases, and serious health crises for a multitude of patients, many of whom fly in from other states or other countries due to Dr. Heart’s enormous success in treating complex healthcare situations—and the amazing marketing and sales machine he has built over many years.

Dr. Heart’s best friend from high school and current business partner, Jiggling Coins Joe, has purchased this fat-burning, fat-melting, love handle incinerating, medical device from a company that shows “investors” how to make some cool millions (or hundreds of thousands).

Jiggling Joe has found a way to tap the many patients and customers interested in weight loss and sell sessions with this incredible medical product as part of Dr. Heart’s practice and clinic.

Dr. Heart is scheduled to appear on a major, national talk show next month.  He’s worried about a blog post he recently read about kickbacks, Stark law, and fee-splitting.

And he’s also concerned about whether Jiggling Joe has taken the business idea too far.  After all, the product that incinerates love handles is a Class 2 prescription medical device, and it’s the cosmetologists and estheticians that are using the medical device on patients.

All of this is, supposedly, “under” the umbrella or supervision of Dr. Heart, the medical doctor … and a friend of Joe’s consulted someone who heard it from another lawyer who got in on authority from a really great healthcare lawyer that everything would be “ok if ….” And then again, what is an umbrella, what does it mean to be “under,” and is there anything that is required in order to meet the definition of “physician supervision?”

MedSpa: Physician Supervision of RNs—Do You Need It?

THERE CAN BE A LOT OF CONFUSION IN THE INDUSTRY—AND MEDICAL SPA TREATMENT BY RNS UNDER PHYSICIAN SUPERVISION IS AN ENFORCEMENT HOT BOTTOM. How Much Treatment Can RNs Do in a Medical Spa?

What about a “good faith exam” or appropriate prior exam – is this required?

Does HIPAA matter?  What about state laws governing data breaches and patient privacy and security?

Dr. Heart is particularly concerned about the implication of these blog posts that he may be missing some steps, or perhaps doing some illegal … and he doesn’t want this to come up on the talk show.

Is using this medical device for weight loss a different problem than profiting from dietary supplements, or the same – and does it matter whether he uses an LLC, C, or S corporation, or is the issue that he has a side business generating income where the referral comes from the medical practice?

Are physician online dietary supplement sales, kickbacks or fee-splitting?

Are physician online dietary supplement sales, kickbacks or fee-splitting?

How can he choose from the list of healthcare and FDA lawyers out there?  Should he trust “Dr. Google?”

Is there a quick answer to his now growing list of legal questions?

What about the federal Food and Drug Administration (FDA) and Federal Trade Commission (FTC)?  If this is a prescription medical device, is Dr. Heart at risk from either federal agency?

The Healthcare and FDA/FTC Business Law Firm of the Future

Dr. Heart needs the Healthcare and FDA/FTC Business Law Firm of the Future.

Because FDA and FTC are three letters no one in the medical industry wants to mess with.  And Medical Board investigation spells a possible disciplinary action which could mean the end of Dr. Heart’s heartfelt medical career.  He doesn’t have the time, energy or bandwidth to defend against his cutting-edge medical practices – which might or might not be standard of care; certainly, he feels he is practicing the medicine of the future and while today’s evidence for his specific therapies might not necessarily have the same level of support as more “cookbook, conventional” medical therapies, he sees a lot of evidentiary support in the medical literature for the therapeutic approaches he favors.

Dr. Heart requires the kind of legal understanding that crosses various arenas of law, even if they are all focused on the multi-trillion-dollar industry for health and wellness.  He isn’t just asking about medical malpractice liability risk with respect to his medical practice.  He isn’t only asking about how to create the best ever informed consent form.  He wants an inclusive, holistic, systems-friendly, all-around robust legal strategy and solution to his pressing legal questions.

How to choose a healthcare lawyer or FDA attorney and regulatory consultant

The best way to select a healthcare lawyer or FDA attorney (or FDA regulatory consultant) for legal advice about your health and wellness service, practice, facility, or product, is to follow […]

A Business Savvy Approach to Legal Strategy in the Health and Wellness Market

Our Ideal Client has a healthcare product (dietary supplement, cosmetic, medical device, OTC drug, biologic) and needs FDA advice to get to market and/or make compliant claims in their marketing.

A big part of our business is strategizing with and advising healthcare startups  (for example, a telemedicine company; a medical spa; the developer of a healthcare app—such as, the app analyzes whether your particular genetic makeup predisposes you for a better result with therapy X vs. therapy Y for condition Z) to devise the most efficient “go to market” strategies that conserve capital, save time and keep them out of hot water with the FDA and believe it or not, what’s even worse is the FTC.

Physicians who need practical legal and business advice to expand their practice also call the FDA/FTC business law firm home.

Our team enjoys working with all three types of clients equally. The FDA work tends to be the most intellectually challenging and requires the most “lawyering”.  Healthcare startups provide opportunities for us to flex our entrepreneurial muscles; And dealing with physicians is almost second nature to us because we excel at translating legalese into medi-speak and then into plain English so practitioners and business associates and investors can fully understand and appreciate how and why slowing down for a bit of smart planning at the beginning can and usually does speed things up overall and saves our clients a lot of time, money and aggravation.

As anyone in the health and wellness industry knows, it’s a bit of a moving target with the FDA and worse, with the FTC, and with any government agency including the medical board.  And undercovers can gather a lot of information during investigative forays into a healthcare practice or business where they pose as harmless “patients.”

That’s why it’s the smart thing to do to engage the services of a law firm that lives and breathes in this space instead of a generalist.  Because your time, your money and your professional reputation are too important to put your future in the hands of a “dabbler.”

We would help Dr. Heart separate out and then tackle the various issues he is facing, whether they involve:

  • Liability risk management (risk mitigation with respect to negligence, informed consent documentation, medical records issues)
  • Medical device – FDA, FTC and other regulatory issues
  • Anti-kickback, self-referral and fee-splitting
  • HIPAA and privacy & security
  • Business legal issues such as corporate formation and use of professional medical corporations
  • Other healthcare industry related legal issues

Kickbacks, Fee-Splitting, Corporate Practice of Medicine, Stark, MSOs: Guiding Healthcare Ventures through the Maze

Fundamentally, you’re worried about legal rules prohibiting kickbacks, fee-splitting, corporate practice of medicine, as well as Stark law; you don’t know whether the MSO or management structure […]

Dr. Heart has a boatload of risk – and opportunity, depending on how he is advised by legal counsel and his propensity for sane vs. not-very-savvy risk-taking.

Dr. Heart tackles the overall Health and Wellness Market: A Moving Target

Savvy healthcare industry businesspeople understand that the market for health and wellness services and products is a moving market.  Therefore, it pays to understand and address the full spectrum of legal and regulatory risk.

One day our team may be working with a physician or medical spa; tomorrow it’s a telemedicine company, then, the latest and greatest trend a healthcare app; next, it’s healthcare-oriented software powered by artificial intelligence (AI); then it’s a revolutionary new product or service with the potential to definitively resolve a health and wellness crisis such as the diabetes epidemic.

As the market is constantly changing, so is the exact mix of clients that come to us. But what nearly all of our clients have in common is full respect for how much they want to stay out of the crosshairs of the FDA, FTC, medical board, or another government agency—or a private plaintiff who is litigation happy.

Except the healthcare practitioners and businesses that didn’t have enough respect for the power of these two federal agencies and then they tell us they wish they’d come to us sooner.

Regardless of whether you’re coming to us ahead of time to avoid a problem or after the FDA or FTC or medical board, DA, AG, or other enforcer of healthcare laws have already come knocking on your door, our daily experience in this highly specialized area of the law and business means our healthcare and FDA lawyers can deploy rapidly and cost effectively to plan, protect and preserve your money, your time and your professional reputation.

Our clients typically have spent a lot of money on other lawyers who gave them wrong or incomplete answers. Normally, business lawyers and litigators don’t have the very specific regulatory knowledge that we have, nor do they have the experience putting together the very complex, multifaceted, “Rubik’s Cube” of legal puzzles that we typically see in the health and wellness industry.

Often our clients have tried other lawyers or non-legal advice, but that doesn’t usually work out too well for them.  Better to solve the legal question and get it right the first time,in order to move the business forward and realize your dream of a viable, profitable, health and wellness business.

Our specific knowledge about deep pockets of law as well as our knowledge across these deep pockets, make us highly competitive nationwide. This very same feature of the practice makes it difficult to summarize while standing on one foot, all the ways we bring value to our clients’ businesses, their careers and their lives too.

That is why we invite you to contact an experienced healthcare lawyer for legal advice to avoid issues with the FDA, or any other regulatory government agencies.

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Michael H Cohen Healthcare & FDA Lawyers

Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.

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