The American Health Law Association (AHLA) recently revealed the top 10 health law issues to watch this year as the pandemic rolls on and Congress scrutinizes healthcare legislation.
Full Disclosure - Surprise Billing and Hospital Price Transparency
The "No Surprises Act" for greater transparency in emergency room bills took effect Jan. 1, but several key provisions of the bill remain subject to future rulemaking, including implementation of plan and issuer drug price reporting and implementation of the good faith estimate process and advanced explanation of benefits (EOB) for insured individuals.
For example, on Dec. 9, 2021, the American Hospital Association, American Medical Association, two hospital groups and two physician practices filed a lawsuit challenging a "presumption in favor of the median in-network rate during disputes between providers and health insurers."
"Providers should closely monitor the challenge and its impact on the departments' regulations as litigation moves forward," said Lisa A. Lucido, of Hall Render Killian Health & Lyman PC.
Provider Mergers & Acquisitions Face New Antitrust Headwinds
"The change in administration has brought a more aggressive approach to antitrust enforcement with a sharp focus on the healthcare industry," said Lisl Dunlop of Axinn Veltrop & Harkrider LLP.
Expect investigations with broader scope, new guidelines and changing approaches, more investigations of consummated transactions, and an increased attention to non-hospital provider mergers, said Dunlop.
Pandemic-Related Enforcement and Oversight
"The COVID-19 pandemic ushered in an unprecedented array of measures to provide relief, assistance, and monetary protections for Americans, businesses, and healthcare systems and providers, among others," said Jody Rudman of Husch Blackwell LLP, pointing to the CARES Act availability of $2.2 trillion in relief funds through a number of programs, including the Paycheck Protection Program (PPP) and Provider Relief Fund. "With any funding mechanism of such a substantial size, post-hoc enforcement is inevitable."
Healthcare Workforce Employment Law Issues to Watch
Vaccine mandates, COVID-19 liability, staffing shortages, and whistleblower cases on the rise exemplifies four key employment law issues in play.
"We thought 2020 was unprecedented, but healthcare employers were faced with new challenges in employment law as the world adapted to COVID-19 in 2021," said Shalyn Smith McKitt, a litigation associate lawyer in the Birmingham, Ala. office of Balch & Bingham LLP. "And 2022 won't be any different. The introduction of vaccines in 2021 led to workforce dilemmas and the shift to the new 'normal' called for regulation of the industry regarding the safety and welfare of healthcare employees."
Beware, Ransomware: Considerations When System Access Exceeds the Value of Digital Assets
"Ransomware is a current darling of cybercriminals," said Nathan A. Kottkamp of Williams Mullen. Even though "all entities should have robust cyberinsurance to help mitigate the costs of managing an attack ... it would be helpful if there was straightforward and consistent guidance on what to do in response to an attack. Unfortunately, recommendations and actual experiences vary."
The Healthcare Workforce IDEA (Inclusion, Diversity, Equity & Accessibility)
Defining diversity, unconscious bias and microaggressions, and the use of statistics in diversity initiatives are three areas to watch.
"The conversation around what constitutes diversity and how to achieve it will continue to evolve in 2022," said Tiffany Buckley-Norwood of Trinity Health. "It's important to remain up to date on the laws regulating this area to avoid pitfalls."
Securing the Supply Chain for Healthcare Providers
Challenges with the supply chain of PPEs and ventilators persist, said Michael Herald of Guardian Healthcare.
"While the global marketplace has slowly reopened and manufacturing has resumed, we're still competing for scarce resources with other countries. The U.S. also has experienced an inability to manage the uptick in imports at major shipping ports due largely to a lack of drivers for the trucks that play an important role in carrying goods out of ports for delivery. Critical medical supplies and equipment remain in short supply, potentially jeopardizing patient care or worker safety," said Herald.
Look for FDA guidance and waivers, OSHA enforcement, the Defense Production Act, role of states, supply chain fraud and crisis standards of care issues.
Behavioral Health Transactions Outlook for 2022
A pandemic within a pandemic is a major concern, cautions Purvi Maniar of Norton Rose Fulbright US LLP.
"While rates of childhood mental health concerns and suicide have been rising steadily since 2010, the pandemic also intensified this (mental health) crisis," said Maniar, who suggested looking for increased market activity in significant behavioral health transactions, regulatory advances, current market and consolidation, heightened scrutiny - and silver linings. "Much like the overall acceleration in telemedicine trends that resulted from the pandemic, the progress we have recently seen in behavioral health, including increased access to telebehavioral health and early attention to pediatric mental health, and will continue to see in 2022 and beyond, represent some of the silver linings of a tumultuous period for healthcare in the U.S."
Moving Toward a Common Definition for Value-Based Arrangements
"In 2022, we may see further clarity regarding how OIG (DHHS' Office of Inspector General) and CMS interpret the new regulations," said Tiana Korley, University of Michigan Office of the General Counsel. "The ambiguity and newness of value-based arrangements will eventually be a target for whistleblowers. It'll be interesting to see whether good faith participation in value-based enterprises negates bad intent in causes of action involving the AKS (Anti-Kickback Statute). We also may see the first advisory opinions that provide additional insight as to how OIG applies the regulations to specific arrangements."
COVID is a Catalyst for APP Expansion
Expect Advance Practice Professionals (APPs) to continue significant opportunity for expansion concerning their scope of services and level of independence in the clinical and business end of providing services, said Robin Locke Nagele of Post & Schell PC.
"During COVID, APPs, facilitated by the COVID waivers, have demonstrated their value in ensuring access and continuity of care," said Nagele. "However, they also face considerable uncertainty about their status as the waivers expire."