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Hot Topics in Healthcare Law


 
Cindy Reisz

A Conversation with AHLA President-Elect Designate Cindy Reisz

Will the Affordable Care Act stand or fall in the face of the latest court challenges? How does the move to a value-based system impact providers and contracting? What does the 21st Century Cures Act mean for data sharing? How do self-referral regulations come into play in light of consolidations and partnerships across the continuum of care? What about liability in the face of ongoing cybersecurity threats?

The highly regulated nature of the healthcare industry certainly serves as job security for America's health lawyers as they help clients navigate reams of rules that carry significant legal consequences from hefty fines and possible exclusion from the Medicare program to potential criminal penalties. Cindy Reisz, president-elect-designate of the American Health Lawyers Association (AHLA), recently shared thoughts with Medical News on hot topics keeping attorneys busy on behalf of their industry clients.

In addition to her more than three decades of transactional and operational experience in advising healthcare clients, Reisz has served on the AHLA Board of Directors since 2013 and has taken on leadership roles with the national organization for more than two decades. Over the course of the next two years, leading up to her installation as AHLA president in July 2021, Reisz has been tasked with helping chart AHLA's financial, educational and strategic planning course.


Payment Models

"The shift from fee-for-service to a value-based payment model is something that is of critical importance to all healthcare providers," Reisz stated. "No matter what happens to the Affordable Care Act, the value-based structure is going to continue and get more sophisticated with the use of health technology."

What started with federal payers has now reached the commercial market, she noted, so that the shift in reimbursement, contracting and benchmarking has substantially reached all payers. "It requires the ability to take data and analyze that data and essentially prove you have provided value to the patients, to their employers and to the payer, and therefore you deserved to be compensated," she pointed out.

"We have to be familiar with the models and the regulations adopted by CMS [Centers for Medicare & Medicaid Services]," Reisz said of the onus on healthcare attorneys. "We have to be prepared to advise our clients how to interact and work with each other," she added, noting provider organizations are more interdependent than ever with the shift from episodic care to keeping populations healthy.

The Bundled Payments for Care Improvement Advanced (BPCIA) program is an example of an advanced payment model developed by CMS that includes both risk and reward. "There is a lot of contracting that goes with that model between the entity that is a Convener and the entities that are Episode Initiators or NPRA Sharing Partners," said Reisz. "It's a particularly complicated model."

While fostering price transparency for patients and a more coordinated approach across the episode of care, bundled payments also present reimbursement risks for participants who fall short of CMS cost targets. Starting in 2020, a recently announced change to the BPCIA model is that the program can be applied to all Medicare ACO beneficiaries as part of the Medicare Shared Savings Program.

Each tweak to the program and each new specialty bundle comes with its own set of regulatory requirements and issues to be considered. "CMS keeps putting out new models ... so there is always a new model to learn and advise our clients on regarding their participation," Reisz noted.


Consolidation

"Among hospitals and health systems, I think there will continue to be consolidation there as challenges to reimbursement continue," said Reisz. She added that for many smaller hospitals and rural facilities, there often simply isn't a viable way forward without the critical mass that comes from being part of a larger system. Reisz pointed out deploying artificial intelligence and other new technologies, investing in updated equipment, and recruiting and retaining providers all take significant capital.

"On the vertical side, you see more and more insurers buying practices and hospitals and health plans joining together," she said. "That means we, as lawyers, have to navigate those transactions and alliances with them."

In addition to concerns over creating market monopolies, these vertical integrations have opened up interesting new challenges pertaining to federal and state laws regulating financial relationships and referrals between physicians and other providers. "Almost every state has its own version of the Stark Law and Anti-Kickback Statute, so it's a fairly complicated analysis of how to put those transactions together," said Reisz.


Data Protection

"Privacy and security is another area that is continuing to increase in focus," said Reisz. "Patient data must be protected."

She noted the risk of a data breach for providers is significant both in terms of reputational harm and possible penalties. On the other side, there is great potential for improved quality and efficiency. "When you use cloud-based products, they are vulnerable at times to attack, but it's a balancing act," she pointed out of the risk/reward profile.

Citing the use of de-identified, aggregated data, Reisz said, "I think the more artificial intelligence allows companies to provide information to our providers, the more the healthcare industry can advance the quality of healthcare and improve patients' health. The more information you have, the more you can tailor that information to your specific patient."

Healthcare lawyers are called on not only to help industry clients assess and address legal exposure after a breach has occurred but also to create compliance plans to help prevent a cyberattack on the front end and mitigate damage should a breach occur.


Opioid Enforcement Actions

"We have noted the rise in the number of DOJ [Department of Justice] enforcement actions," said Reisz of crackdowns on everything from pill mills and overprescribing to liability questions for manufacturers and distributors.

"The trend appears to indicate plaintiffs' attorneys are seeking to hold pharmaceutical companies responsible for their marketing practices," she continued. Reisz was quick to add, however, that it was important to see how some of these high-profile cases play out in court before making a definitive assessment on trends.


Behavioral Health

Reisz noted recent legislative activity at the federal level should result in increased reimbursement for providers of mental health and substance use disorder (SUD) services and new options for Medicaid beneficiaries to access behavioral health services.

"As of 2016, the Mental Health Parity and Addiction Equity Act applies to Medicaid and the Children's Health Insurance Program [CHIP] and requires managed care organizations, alternative benefit plans and CHIP to provide access to mental health and SUD benefits that comply with parity standards," she explained, adding those same parity protections were also extended to long-term care services.

Reisz continued, "The SUPPORT for Patients and Communities Act provides some flexibility to the IMD [Institution for Mental Diseases] exclusion, which traditionally prohibited states from using federal Medicaid funding to provide mental health and SUD services to Medicaid beneficiaries aged 21-64 in residential treatment facilities with more than 16 beds." She noted that from fiscal years 2019-2023, states might be able to use federal Medical funds to cover services in certain IMD facilities, within specified limits.


AHLA

While touching on just a few of the healthcare issues garnering recent attention, Reisz said AHLA offers resources on these topics and many others, as well. "We strive to be an essential resource to our members and the community," she added of the mission for the national organization of approximately 14,000 healthcare professionals. AHLA's "mission is to enable its members to serve their clients more effectively; to produce the highest quality non-partisan educational programs, products and services concerning health law issues; and to serve as a public resource on selected healthcare legal issues," Reisz concluded.

For more information on AHLA's education and event offerings, publications and other resources, go online to healthlawyers.org.

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Cindy Reisz

 
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Tags:
AHLA, American Health Lawyers Association, Behavioral Health Parity, Bundled Payments, Cindy Reisz, Health Law Hot Topics, Healthcare Consolidation, Healthcare M&A, Opioid Enforcement Actions, Physician Contracting & Compensation
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