In a Highly Regulated Healthcare Environment Ad Hoc Legal Simply Will Not Do: Secure Outside General Counsel in Your Corner


Owning a medical practice is hard work. From patient care, to overseeing staff, to complying with healthcare laws, you have got your share of challenges every day. If the first three items are not difficult enough to manage, throw a pandemic in the mix affecting your life, your staff, your patients, and your livelihood in the mix.  Healthcare law is complex and always evolving. And it informs everything you do.

You surely consulted with a healthcare attorney when you formed your practice. And, you may have periodically turned to an attorney when you had questions requiring specific expertise in a practice related matter. You may have even scrambled to untangle a situation that may have unintentionally gone awry – hopefully not, but, at the very least, infrequently. But what about your day-to-day operations? These days, even they can have legal ramifications.

Without a doubt, the healthcare landscape has changed dramatically, and so have the legal needs of the industry. Even if you are a solo practitioner, an ad hoc legal approach may no longer serve your best interests.  In fact, your medical practice cannot afford to operate in a vacuum.

“After-the-Fact-Legal” No Longer

Integrating a continuous and more proactive legal process into your practice can provide tremendous risk protection. The time has passed when legal gets called in after-the-fact. Now you must get skilled counsel involved early in every discussion relating to your practice.

The thought of hiring a full-time general counsel to ensure best practices may make your head spin. But consider retaining an outside advisor to serve as your general counsel. It’s an alternative that may seem more palatable.  This fractional general counsel, to borrow a term from other industry sectors, can provide continuous legal advisement but without the costs, responsibilities and benefits attached to an in-house general counsel. Beyond dollars, you save time. Plus, no more being under the gun with time constraints and having to research and retain an attorney on a piecemeal basis for different one-time occurrences.

Institutional Memory Builds a Relationship

An outside advisor, or consigliere, who works with you and your medical practice regularly gets to know and understand your goals, challenges, strengths, and Achilles heels.  Establishing this familiarity creates a solid institutional memory, which results in faster situation analysis and decision-making and puts you on a path to an outcome that is reasoned and right the first time around.

Gone are the days when general counsel were exclusively on hand to review and draft contracts and other important documents. Especially in the highly regulated healthcare industry, outside general counsel provides business counseling and advisement on strategic planning, negotiates deals with third parties, and is oftentimes the liaison with legislators to inform policy. Great general counsel are leaders and communicators who evaluate each situation with the objectivity that enables them to ask the tough questions that your subjectivity may prevent you from asking. They are connectors to peers and associates with specialized skills in this sophisticated practice area. They remain continually abreast of the changes in healthcare laws and measure the unique needs and goals of your practice against the larger context of the highly regulated healthcare landscape.

Compliance: The Watchdog of Every Move You Make

It is nearly impossible to overstate the complexity of healthcare compliance.It is somewhat of a moving target as the landscape changes from volume-based to value-based medicine and health consumers are developing more of a voice. Plus,each state has its own healthcare rules and laws. Some parallel federal laws, while others are completely different. You are required to simultaneously comply with both sets of laws and regulations and identify all the laws and regulations that apply to your specific organization. That is a formidable task when your mission is to help and heal patients.

As a solo practitioner, you may not need an extensive compliance department, but you will need a compliance program just the same. In most instances, smaller medical practices are held to the same high standards as larger ones.  HIPAA and OSHA, Anti-Harassment & Anti-Discrimination, and Stark & Anti-Kickback are just a few examples of why even the smallest medical practice faces the same risks as larger ones in the event of deficiencies. 

The wraparound effect of compliance and healthcare law in general impacts practically every practice decision and action you take. One unintentional misstep, and you could be in hot water. Consider the intricacies of the issues you face daily in several areas:

  • Telehealth – Telehealth, which has been around for years, has gained significant traction to provide convenience and expanded access to care for a busy, on-the-go patient population. Now with COVID-19, it has become a must for most practices. As telehealth continues to grow in scope so do the federal and state requirements for its quality assurance.  As a result, it remains an evolving and elusive area, not only for effective care delivery but also for standardized legal and/or regulatory frameworks.

    The lack of clarity in the telemedicine laws and insurance regulations create many pitfalls for medical practices as well as inconsistent reimbursement. Also significant: the law gets more complicated when telemedicine is practiced interstate, and the patient and doctor live across state lines. Professional licensing and liability coverage for telemedicine practitioners can also be a daunting problem task. 

    HIPAA privacy and security measures also come into play when practicing telemedicine. Failure to properly secure protected health information engage in telemedicine can result in fines, penalties, disciplinary actions, and/or loss of license.

  • Employment Issues – Employment begins with employment contracts that outline the job description, work-week time requirements, compensation, and benefits as well as clearly detail incentives and how they are reliant on productivity and contribution to practice growth. These contracts must also spell out professional liability and practice protections.

    In addition to traditional employment law considerations, you cannot overlook considerations surrounding employee discipline. For example, termination with or without cause can result in disgruntled employees who can put your practice at reputational risk or who are quite adept at reporting you to healthcare and employment agencies. Strict compliance specifications dictate employee termination and the exit interview process. HIPAA mandates may require documentation of disciplinary actions and the reasonable provision of a probationary remediation period if the alleged wrongdoing involved the handling or mishandling of protected health information.  COBRA also comes into play when an employee is terminated. If the terminated employee is a physician within your practice, non-competes or restrictive covenants may also be necessary, including properly enforcing them.

  • Difficult Patient Issues – Difficult patients can also be a concern for your practice. While you do have the right to terminate your relationship with a particular patient in accordance with your state licensing board regulations, you must be very careful about the way you manage the issue. You want to avoid patient abandonment allegations or breach of provider agreements with payors. Plus, correspondence with the patient must be carefully managed so that you do not give a disgruntled patient a reason to complain to government regulatory entities or to stir up publicity that could damage your reputation or online persona.

  • Vendor and Contract Arrangements – As reimbursement rates shift and the industry moves to a value-based system, you are likely considering strategies to maximize market share and practice growth.  As discussed, telehealth is certainly one effective growth strategy. Joining forces with other providers may be another. This can occur through small mergers and acquisitions or be as large-scale as developing clinically integrated networks. Regulatory considerations weigh heavily in forming these networks and defining the working relationships, uniform policies, and protocols that address both employment matters and patient care, and oftentimes space leasing arrangements.

  • Real Estate Ventures and Obligations – Beyond the question of whether you own or lease your space, you may be considering real estate as an investment that will also foster growth. It can be leveraged to grow your business, or for the creation of long-term wealth. There is no one-size-fits-all approach to this investing, especially because there are liability considerations under the Anti-Kickback Statutes and the Stark Laws. Making sure your real estate ventures, transaction, and leases comply with these overarching laws or fall within their safe harbors is critical and must be done carefully and methodically.

A Dynamic Landscape

The demands imposed upon healthcare providers are intensifying.  As a provider you join the mega providers like hospitals and health systems in a need to re-envision patient care and pursue new channels to provide it. Amid this environment, the law also changes rapidly, and healthcare lawyers are required to address new expectations in terms of the breadth of expertise they bring to health care professionals.

One last thought. Not all healthcare attorneys are created equal. Research and interview carefully to find the professional that meshes well with your practice and aligns with your values. Find someone who melds well with you and your practice administrators, personalizes their approach, and makes your challenges their one.  Select a consigliere whospecializes in healthcare, business, and employment law.  But do consider the outside general counsel option to adhere to healthcare regulations and laws and to follow best practices. Then go out and do what you do best: serve patients and build your practice.

At The Nan Gallagher Law Group we are committed to helping you develop your practice by providing the guidance to navigate all the intricacies of the legal healthcare environment.  Call us at 973.998.8494 and explore advisement and collaboration that will enable you to operate with maximum efficiency, provide your patients with quality care, and grow a thriving practice.