Healthcare today is especially complex. In addition to ever-changing laws and regulations surrounding licensing, reimbursement and compliance, private equity healthcare is on the rise, bringing FTC scrutiny with it. Unforgiving laws bring criminal charges and lawsuits on one end of the spectrum, while new types of medicine and wellness practices create ambiguity and liability. In the alphabet soup of healthcare providers and opportunities, learn how a healthcare attorney can help practitioners navigate the challenging legal landscape.
1) Assist with Licensing
For physicians practicing medicine in a large healthcare network, licensing requirements are highly regulated and managed through numerous governmental agencies including the PA Department of Health. In-house compliance professionals help ensure licenses are maintained. But what about solo practitioners and evolving areas of health, like mobile IV therapists, weight loss clinics, or non-invasive medical aesthetic practices like those found in med spas? 
Especially if you’re launching a business in a relatively up-and-coming industry, a healthcare attorney can provide invaluable guidance and support, ensuring practitioners understand the licensing requirements specific to their respective jurisdictions and potentially aiding in the completion of applications and documentation. (Business attorneys can also aid in business licensing requirements, which also vary greatly). Some important distinctions to consider include:
- Medicine vs. health care – while medical care focuses on treating illness and injury and can only be administered by physicians and trained medical professionals, health care centers around illness prevention and promotion of health and includes a broader array of care professionals, many even falling under today’s broader umbrella sector of the wellness industry. It’s important to distinguish and define your company’s practices and ensure that your services and practices comply with the law.
- Corporate Practice of Medicine (“CPOM”) laws – if you are practicing medicine, you may be subject to your state’s Corporate Practice of Medicine laws, which typically dictate ownership by a licensed practitioner such as a physician to ensure patient health is prioritized over profits. Sometimes, establishing a Management Services Organization (MSO) may be an opportunity for non-physician ownership while maintaining compliance.
- Boards – various medical boards like dental, cosmetology, and nursing entities are jurisdictional governmental agencies that have the ability to regulate your practice and license your professionals. Be sure to renew and maintain licenses accordingly.
Maintaining licenses and complying with regulations – while minimal for some practices – is imperative to safeguard your professional standing, career, and reputation in the business and medical community. Additionally, should licensing complications arise, a healthcare attorney can represent you, helping you present your case before licensing boards.
2) Review and Complete Insurance Contracts
Beyond licensing, your healthcare practice will also need to consider whether or not to accept health insurance on behalf of your patients. While utilizing insurance coverage often has many benefits like increased caseload and a potentially larger referral network, it also means being prepared to review stacks of paperwork and is subject to increased compliance and auditing requirements.
As advocates for their clients, healthcare attorneys meticulously review insurance contracts, deciphering complex clauses and terms that may impact the physician’s practice and ensuring their interests are protected and agreements are fair and favorable. Provider credentialing services can be intense and include many legal requirements that a healthcare attorney can support.
3) Ensure Compliance with Federal Fraud & Abuse Law
Medical providers especially need to be mindful of any referral practices or behaviors that may broach financial relationships in favor of a physician, as dictated by state and federal fraud and abuse laws such as the Stark Law. Beyond physicians, federal law extends to a myriad of healthcare companies and service providers when it comes to:
- Anti-Kickback Statute (AKS) – the AKS prohibits the knowing and willful payment of “remuneration” to induce or reward the generation of business for any item or service payable by any federal healthcare programs, not just Medicare/Medicaid. Remuneration broadly covers compensation, including anything of value, such as exorbitant hotel stays and meals, entertainment, and excessive compensation for medical consulting.
- False Claims Act – submitting fraudulent Medicare or Medicaid payment claims may result in fines of up to three times the programs’ loss plus $11,000 per claim filed, with each instance of an item or a service billed to Medicare or Medicaid counting as a claim.
- State Fraud and Abuse Laws – many states including Pennsylvania have anti-fraud laws at the state level imposing additional regulatory and compliance requirements.
Regardless of intent, even unknowingly violating statutes can be costly. A healthcare attorney can address your practice’s business relationships and activities to ensure compliance.
4) Reduce Risk
Lastly, and perhaps most importantly, healthcare attorneys help businesses reduce risk. Let’s say you’re a kinesiologist who wants to offer in-home stretching services and athletic training. Beyond having your degree, you are not governed or licensed by a medical organization, nor are you protected by one. What happens if a client tears a muscle while engaging in your services?
With understanding of operations and delivery of health services, a healthcare attorney can advise you on best practices for your business when it comes to:
- Recordkeeping and documentation – for something like the kinesiology business mentioned above, it’s wise to have patients sign service agreements and intake documents acknowledging when a business is not providing medical advice and that it’s the patient’s responsibility to consult with a physician prior to taking any course of exercise. Similar to business waivers, this limits some liability for the business. Establish clear protocols for notices, consent, and contracts between you and your patients.
- Business structure – how you structure your business impacts what level of liability you’re subject to. Setting up an LLC is a recommended way for solo practitioners to shield themselves and their personal assets from any debts and claims made against your business. Liability insurance is also recommended for most businesses.
- Marketing – depending on the area of healthcare, you may be limited by various laws for how you may word or promote your services. If you don’t employ marketing personnel, you may wish to consult with your attorney to avoid making false or unsubstantiated claims.
Experienced healthcare attorneys
Whether you’re new or seasoned in the healthcare industry, laws are constantly being added, changed, and expanded, creating significant endeavors for businesses. FLB is actively and thoughtfully engaged on the issues that matter to our clients. Our attorneys remain up-to-date regarding emerging trends and new regulatory requirements. We also understand that healthcare is frequently impacted by employment law, real estate law and corporate law so we regularly collaborate with professionals in other practice areas to meet your needs.
Connect with our healthcare team to discuss your challenges today.
