2022: The Ever-Changing Healthcare Regulatory Landscape


 

As we look ahead in 2022, it's a good opportunity to re-visit key regulatory challenges from 2021 and what potentially lies ahead in each of these key areas.

Telehealth

It's no secret that the number of physicians offering telehealth increased dramatically during the COVID-19 pandemic in 2020 -- jumping from 25 percent of physicians in 2018 to almost 80 percent of physicians in 2020, according to the American Medical Association.

While some industry observers heralded the trend as a new day in healthcare, a closer look shows that telehealth use may continue to flourish in some limited areas, such as mental health or chronic care management, but usage rates may settle back into historical levels overall. A recent study by Trilliant Health found that even with dramatic increases in telehealth use in 2020, less than 15 percent of the U.S. population used telehealth services in 2020. The study also found that telehealth usage was already waning in most states in 2021.

Additionally, many of the emergency telehealth rules put in place during the pandemic have expired--meaning that many states will need to make regulatory changes to allow for widespread use of telehealth services.

NON-COMPETES

An executive order from President Biden called for increased antitrust enforcement, with a "focus" on healthcare as one of four key industries. While the potential implications for merger and acquisition activity are obvious, there could also be secondary ramifications for physicians and other healthcare providers. These consequences may be significant--and often unintended.

The executive order encourages the FTC to use its regulatory authority to curtail the unfair use of non-compete provisions. By issuing a blanket instruction to promote antitrust enforcement without an exception for the sale of a business, the order marks a dramatic federal intervention into policy traditionally within the purview of state law.

Before Biden's order, the FTC had already embarked on a path of aggressive enforcement concerning rulemaking and enforcement activity that goes well beyond M&A -- though that is certainly a significant part. Recently, the Commission took the position that it is unconstrained by conventional antitrust precepts like the "rule of reason" and the consumer welfare principle. Many observers believe that the FTC is likely to seek the expansion of its Section 5 authority to investigate practices that have been commonly accepted under other federal and state antitrust statutes and case law. The FTC will likely attempt to outlaw such practices through regulation, litigation or both.

Now, with the empowerment and mandate from Biden's order, the FTC will take a deep look at what it can do to restrict the enforcement of non-compete provisions.

CARE AT HOME

Providers, operators, investors and policymakers agree that home-based healthcare options are transforming how healthcare is delivered and the economics that drive it. Regardless of the specialty, care at home implicates a discrete set of local, state and federal legal issues, including corporate practice of medicine limitations, site-of-service restrictions, scope of practice, professional considerations, supervision requirements, reimbursement issues, telehealth regulations and traditional home health licensure requirements.

At the same time, the regulations have not fully caught up with the various business models being adopted, and CMS and various states are actively experimenting with waivers, pilot programs and new reimbursement methodologies. Anticipating this trend, we have seen increased investment by providers, payors and private equity firms into both provider platforms and technology companies that facilitate care at home.

SURPRISE BILLING

The No Surprises Act -- which took effect in January 2022 -- was intended to address the persistent problem of balance billing patients for the cost of services provided by facilities and providers that are not in their health plan network, often with no prior notice. The No Surprises Act bans balance billing for emergency services and prohibits out-of-network charges in most circumstances without notice to and consent from the patient.

Surprise billing also creates problems for payors and providers. Payors are often required to spend additional time helping unhappy employees or enrollees understand why the services they received were not covered under their health plans. For providers, the disparities in payment rates may lead to uncollected fees and patient dissatisfaction. In response, multiple states have passed legislation aimed at addressing this practice. The Act is the first comprehensive effort at the federal level, and it affects health plans, hospitals, physicians and air ambulance transportation companies.

The end of surprise billing is expected to be a blessing for patients, but for providers, insurers and employers, it could result in significant compliance hassles.

MaryEllen Pickrell is a partner with Waller where she advises healthcare providers on complex M&A transactions.

Jesse Neil is a partner with Waller who advises providers on healthcare operations and public policy.

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