Legislation That Mendates to Collect National Data on Legal Actions Agains Healthcare Provider

• January 01, 2022

• Lisa A. Lucido , Hall Render Killian Heath & Lyman PC
• Benjamin C. Fee , Hall Return Killian Heath & Lyman PC
• Lisl Dunlop , Axinn Veltrop & Harkrider LLP
• Jody Rudman , Husch Blackwell LLP
• Shalyn Smith McKitt , Balch & Bingham LLP
• Nathan A. Kottkamp , Williams Mullen
• Tiffany Buckley-Norwood , Trinity Health
• Michael Herald , Guardian Healthcare
• Sarah Swank , Nixon Peabody LLP
• Purvi Maniar , Norton Rose Fulbright US LLP
• Tiana Korley , University of Michigan Office of the General Counsel
• Robin Locke Nagele , Post & Schell PC

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1. Full Disclosure—Surprise Billing and Hospital Price Transparency in 2022

Lisa A. Lucido and Benjamin C. Fee, Hall Render Killian Heath & Lyman PC

+Mind to Episode 1

In an endeavor to promote greater transparency for consumers in wellness care, Congress, the Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), and several states have implemented laws and regulations related to cost transparency and surprise billing.

Surprise Billing. After years of debating a federal solution to end surprise medical bills, on Dec 22, 2020, Congress passed the No Surprises Act (Act). At a high level, the Act prohibits remainder billing for: (1) emergency services provided by an out-of-network provider; (2) not-emergency services provided by an out-of-network provider at an in-network facility; and (3) air ambulance services. The requirements under the Act were effective January 1, 2022.

HHS, the Department of Labor, the Department of Treasury, and the Office of Personnel Direction (collectively, Departments) issued ii interim final rules (IFRs) on July 13, 2022 and September 30, 2021, respectively, to implement certain provisions of the Act. The commencement round of rulemaking addressed: (ane) the scope of the surprise billing prohibition; (two) the process by which patient cost-sharing and the provider out-of-network rate is calculated; (iii) the detect and consent process in cases where patients can waive their residue-billing protections under the Act; and (iv) a complaint process for any potential violations. The 2d IFR addressed (in relevant part): (1) the independent dispute resolution process; (ii) the expert faith approximate requirements for uninsured/self-pay patients; and (3) the patient-provider dispute resolution process.

Looking to the Time to come—Implementation, Enforcement, Future Rulemaking, and Legal Challenges. Implementation of the Act requires substantial changes in how providers, facilities, and health plans operate. Internal workflows, technology, and communication processes with patients will need to exist revamped to comply with the requirements nether the Act. While HHS has deferred enforcement of some of the Deed's requirements including: (1) the requirement for providers/facilities to provide a adept organized religion estimate for insured patients; and (ii) the requirement the practiced faith estimate include expected charges from co-providers and co-facilities, it is not known whether HHS will exercise its enforcement discretion elsewhere. Additionally, several other key provisions of the Act are still subject to future rulemaking, including: (1) implementation of plan and issuer drug cost reporting; and (ii) implementation of the good faith judge process and advanced explanation of benefits (EOB) for insured individuals. Only fourth dimension will tell whether HHS will answer to stakeholder concerns through further rulemaking, sub-regulatory guidance, or additional enforcement delays. On Dec nine, 2021, the American Hospital Clan and the American Medical Clan forth with ii wellness systems and two medico groups filed a lawsuit challenging a function of the September 30 IFR that establishes a presumption in favor of the median in-network rate during disputes betwixt providers and health insurers. Providers should closely monitor the challenge and its impact on the Departments' regulations as the litigation moves frontward.

Hospital Price Transparency Enforcement Ramps-Upwards. The federal regulation requiring hospitals to publicly disclose the prices they accuse for items and services, including negotiated reimbursement rates with third-party payers, was effective Jan 1, 2021. The dominion survived multiple legal challenges and the change in administrations following the 2022 presidential election. In fact, the Biden administration has just reinforced the federal government'south delivery to ensuring consumers accept access to health intendance pricing information.

Every bit evidence of that commitment, CMS audited hospital compliance with the toll transparency rule throughout 2021. Those audits resulted in hundreds of hospitals receiving warning letters for noncompliance, ordinarily with a 90-solar day menstruum to resolve the cited deficiencies. Although there were no public reports of CMS penalizing a hospital for noncompliance as of this writing, such occurrences appear inevitable given the assistants'due south commitment to enforcement.

CMS too finalized increases in the fiscal penalties for noncompliance. The original rule capped the financial punishment at $300 per day per hospital, a relatively insignificant corporeality that likely contributed to hospital noncompliance. Every bit a upshot, CMS raised the fiscal penalties to $10 per day per bed for near hospitals. Hospitals with 30 beds or fewer are still subject to a minimum penalty of $300 per day and hospitals over 550 beds a maximum punishment of $five,500 per mean solar day. The change increases the potential penalties for a twelvemonth of noncompliance for hospitals over 550 beds from $109,500 to a maximum of $ii,007,500. The increased penalties use to noncompliance get-go January 1, 2022.

Good Faith Estimates. Along with the increased enforcement of the hospital price transparency rules, HHS finalized rulemaking implementing a provision in the Human activity that requires providers to communicate a "skilful faith estimate" (GFE) of expected charges to uninsured (including self-pay) patients upon their asking and at the time of scheduling the health care item or service. That requirement begins January 1, 2022. Hereafter rulemaking will implement a similar requirement for providers to provide payers a GFE of expected charges for insured patients. These new requirements merely reaffirm the ongoing commitment from the federal government to price transparency in health care.

two. Provider 1000&A Faces New Antitrust Headwinds

Lisl Dunlop, Axinn Veltrop & Harkrider LLP

+Listen to Episode two

The alter in assistants has brought a more than ambitious approach to antitrust enforcement with a sharp focus on the health care industry. In July 2021, President Biden issued a sweeping Executive Order on Promoting Contest in the American Economy reasserting the assistants's policy to vigorously enforce the antitrust laws through a whole-of-regime arroyo. ^ane The Biden Executive Order pointed out that past wellness care mergers had led to a situation where the ten largest health care systems now control a quarter of the market, and hospital consolidation has left many geographic areas, especially rural communities, without good options for convenient and affordable health care. The Biden Executive Order exhorted the Federal Trade Commission (FTC) and Section of Justice (DOJ) Antitrust Sectionalisation to stride up their enforcement activities to address these problems.

While the antitrust agencies accept had a successful program of enforcement against health care mergers throughout the Trump administration and earlier Democratic administrations—including bringing several successful court challenges—the Biden Executive Order, too as recent agency statements and actions, bespeak a major shift in the way that the agencies (in particular the FTC) will approach provider mergers going into 2022 and beyond.

Investigations with Broader Scope. FTC Chair Khan's October 2022 memo to staff on the Committee's priorities identified the need to employ a broader frame of reference to assess the effects of transactions on competition. In dissimilarity to the traditional approach of analyzing provider transactions primarily in terms of their bear on on prices paid by commercial insurers, Khan has directed staff to consider a wider range of effects, such as impacts on workers and modest businesses and effects on marginalized communities. Providers with deals before the Commission are already seeing a significantly wider range of questions from the FTC around the possible effects of the deal on medical professionals and other staff, including the existence of non-compete agreements and other aspects of contest relating to employment. The socioeconomic impacts of transactions also are likely to become an area of involvement; although transactions tin can atomic number 82 to increased investment in health intendance avails in marginalized communities, demonstrating such procompetitive touch on can be challenging.

New Guidelines and Changing Approaches. Consistent with the Biden Executive Club and the FTC's new "holistic" approach, both antitrust agencies have announced a review of the current horizontal merger guidelines, suggesting that the electric current version (introduced in 2010) may be "overly permissive." The FTC has already taken a more dramatic pace in repealing vertical merger guidelines that were introduced but last twelvemonth, with the Autonomous Commissioners expressing doubts as to the basis for arguments that vertical integration tin can have procompetitive furnishings. Information technology is also likely that the 25-year-old joint agency Statements of Antitrust Enforcement Policy in Health Care—which extend far beyond mergers—also will be reconsidered. The underlying presumption for these developments is that the existing bureau guidelines under which health care transactions have been judged in the past have contributed to the current "rampant consolidation and dominance" and demand to exist inverse. Until new guidance bug, however, in that location will be more dubiousness about how the agencies will approach wellness care deals.

More Investigations of Consummated Transactions. The Biden Executive Club encouraged the FTC and DOJ to "challenge prior bad mergers that by Administrations did non previously challenge." ⁱⁱ In addition, ostensibly due to workload constraints, the FTC has taken the approach of sending merging parties a letter later the expiration of the Hart-Scott-Rodino (HSR) premerger notification waiting catamenia indicating that the investigation is ongoing and that they consummate their deal at their own risk. While post-consummation challenges were non unknown before at present, they have been relatively rare, specially when a transaction had been through the HSR review process. Organizations that have previously completed significant transactions should anticipate new and ongoing inquiries from the FTC, which may lead to enforcement action.

Increased Attention to Non-Hospital Provider Mergers. Early in 2021, the FTC initiated a report of the impacts of non-hospital provider mergers—including combinations of physician groups, hospital acquisitions of physician practices, and mergers of non-infirmary outpatient facilities—examining both price furnishings and not-price factors, such as health care outcomes. While the FTC has in the past investigated and challenged physician group mergers, such equally Sanford Health's acquisition of Mid-Dakota Clinic in 2017, parties are likely to run across more investigations of transactions involving providers and potentially more than enforcement activeness, including challenges to consummated deals, as the results of the FTC's written report become available.

iii. Pandemic-Related Enforcement and Oversight

Jody Rudman, Husch Blackwell LLP

+Heed to Episode 3

The COVID-19 pandemic ushered in an unprecedented array of measures to provide relief, aid, and monetary protections for Americans, businesses, and health care systems and providers, among others. The Coronavirus, Aid, Relief, and Economic Security Deed (CARES Act), signed into constabulary on March 27, 2020, served equally the initial major relief package. The CARES Act alone made available $2.2 trillion in relief funds through a number of programs. ³ These include the Paycheck Protection Program (PPP) and Provider Relief Fund. ⁴

With any funding mechanism of such a substantial size, mail-hoc enforcement is inevitable. Indeed, DOJ chop-chop proclaimed its intention to investigate misconduct associated with CARES Human action and COVID-19. ⁵ Hotlines were established for reporting fraud and U.Due south. Attorneys' Offices were encouraged to maintain prosecution resources defended to COVID-19-related fraud cases. ⁶ While the rollout of the CARES Act and other pandemic relief programs was extremely quick, many investigations, audits, and enforcement activities—particularly with regard to the Provider Relief Fund—will likely accept years.

Early enforcement efforts of misused CARES Act funds are already well nether style. Less than a year after the pandemic began, DOJ appear scores of criminal fraud cases, at least 11 civil fraud deportment to enjoin fraudulent coronavirus-related schemes, and more than than 50 PPP cases involving over $225 million in intended loss. ⁷ Loan applicants who lied on their applications about their businesses or who claimed entitlement to funds non borne out by actual fact have already been the target of investigation and prosecution. Similarly, federal prosecutors and investigating agencies have uncovered and pursued the misuse of PPP funds for luxury purchases, the payment of personal debt, stock market investments, and the like. ^eight These types of enforcement efforts are ongoing and can be expected to proceed steadily for some time.

More circuitous investigations and more than complicated fraud schemes or Fake Claims Act cases will likely follow audits nether the CARES Act's Provider Relief Fund. Recipients of CARES Act funding have found themselves navigating through complex and changing terms and conditions of participation in the program. The outset tranche of funding just arrived in providers' banking concern accounts, with an after-the-fact attestation or presumed attestation of entitlement to the funds if they were not returned. Guidance governing entitlement and reporting has shifted over time. Recipients are bound to spend the funds inside the boundaries of the program, but that guidance has been similarly uneven. The program itself entails mandatory reporting, self-auditing, audits by HHS, and hook-backs of funds improvidently granted or improperly spent. This is a recipe ripe for years of enforcement efforts.

Enforcement activity may come from any number of sources, some established within the CARES Human activity itself, and others that already exist in the law. These include the Office of Inspector Full general for Pandemic Recovery, which exists within the Section of the Treasury and oversees the PPP, amidst other programs; and the Pandemic Response Accountability Committee, which consists of 20 Inspectors General of various Departments and is tasked with conducting, coordinating, and supporting them in their oversight of CARES Human action funds. Enforcement mechanisms also include the existing federal False Claims Human activity ⁹ and a number of criminal laws that are used to prosecute and punish fraud schemes.

Contemporaneous documentation will be fundamental as the audits and investigations unfold. Keeping guidance documents, even as they shifted, that diameter upon conclusion making will prove a helpful tool for proving good faith. Internal audits, including responsiveness to employee or whistleblower concerns, should help mitigate hereafter problems. Targets of enforcement activities would be wise to have a response program and to maintain important communications. Such efforts may help minimize the chance of a negative mail-hoc audit for providers.

4. Health Intendance Workforce Employment Police Issues to Lookout man in 2022

Shalyn Smith McKitt, Balch & Bingham LLP

+Heed to Episode 4

Nosotros thought 2022 was unprecedented, only health intendance employers were faced with new challenges in employment law as the world adjusted to COVID-19 in 2021. And 2022 won't be any different. The introduction of vaccines in 2022 led to workforce dilemmas and the shift to the new "normal" called for regulation of the manufacture regarding the safety and welfare of health intendance employees. In 2022, 4 issues for wellness intendance employers to spotter are discussed below.

Vaccine Mandates. Every bit 2022 came to a close, the issue of requiring employees to be vaccinated became even more than contentious than before. Equally a result, wellness intendance employers volition near likely find themselves torn between implementing vaccination policies and foregoing them in 2022. In September 2021, President Biden ordered vaccination mandates for the federal workforce, federal contractors, and private sector businesses with more than 100 employees. The administration likewise appear that information technology would require COVID-nineteen vaccinations for health intendance workers in hospitals and other facilities and settings that participate in Medicare and Medicaid. This order came shortly after litigation in multiple states where hospital employees refused to follow infirmary policy requiring COVID-xix vaccination. Nether an interim concluding rule issued in Nov 2021, CMS required health care providers to establish policies to ensure all eligible staff go vaccinated past January four, 2022. However, federal courts in Missouri and Louisiana granted preliminary injunctions blocking the administration from enforcing the vaccination requirement for wellness care workers nationwide after finding u.s.a. challeging the IFR were likely to succeed on their merits that CMS exceeded its statutory potency. The 5th Circuit later narrowed the scope of the injunction then that the administration is at present enjoined from enforcing the mandate in 24 states. Every bit of this writing, the administration had asked the Supreme Court to allow the vaccination mandate for health intendance workers to go into effect in those states while appeals continue in the two challenges. In 2022, wellness care employers will take to monitor how these challenges play out in courtroom or decide to motility forward with vaccination requirements on their ain.

COVID-19 Exposure Liability. 2022 marked the beginning of lawsuits from family members of health care workers who contracted COVID-19 when at work. Cases in New Jersey and Illinois demonstrate just how unexpected these lawsuits were, and likely will be in the coming year. Substantially, near workforce members are usually prohibited from bringing arrange against their employers for contracting a disease at work under workers' bounty laws. Merely, when a family unit member is exposed due to an employer's negligent direction of the affliction in the workplace, the employer is exposed to liability. Employers will need to ensure they follow government guidelines and manage the spread of COVID-19 to avoid these lawsuits.

Staffing Shortages. In 2022, the wellness care workforce shortage will probably keep its spiral, and wellness intendance providers will exist faced with more than challenges than ever earlier. It is currently estimated that by 2030 there will be a global shortfall of more than than 10 meg nurses, for instance. Enquiry shows that COVID-19 has impacted the health care workforce both physically and mentally. Employees are not but more susceptible to contracting COVID-xix, but they are also prone to increased stress and mental health problems. Health care providers accept to take time in 2022 to focus on retaining and growing their workforces before information technology is too late. Organizations like the World Health System and the American Infirmary Association have published widely on this topic and tin be bully resource for wellness care employers.

Whistleblower Cases on the Rising. States are reacting to the rise of whistleblower claims related to COVID-19, and 2022 will likely bespeak a new era for these claims for health intendance providers. Generally, under federal law and most state laws, employers cannot retaliate against an employee who reports a practise that threatens public health and rubber. Notwithstanding, in 2022 and 2022 these complaints skyrocketed due to employees with concerns regarding the availability of personal protective equipment (PPE), the implementation of facemask policies, or lack of COVID-19-related training. Cases in California, Texas, and Illinois included employees who raised these kinds of concerns and were ultimately terminated. New York has already started to react to this miracle past updating its labor laws in 2020, but other states are sure to follow.

5. Beware, Ransomware: Considerations When Arrangement Access Exceeds the Value of the (Digital) Assets

Nathan A. Kottkamp, Williams Mullen

+Heed to Episode v

Ransomware is a electric current darling of cybercriminals for a broad array of industries, and for good reason: the return on investment from extortion can exist extraordinary. The wellness care industry is particularly vulnerable considering the value and importance of having access to information are separate from, and often greater than, the inherent value of the data itself.

Every bit a full general matter, cybercrime is pervasive considering nearly all important information in today'south globe is digital. Call up the famous quote from Willie Sutton on why he robbed banks: "Because that's where the money is." Today, the value of so many things is in bits and bytes. And, unfortunately, cybercriminals accept learned that breaking into "secure" systems is actually not overly hard.

Once the criminals compromise a system, the adjacent question is what to practise. The most obvious options include (1) stealing and selling data, (2) using the data to establish financial fraud schemes, and (3) holding the entity hostage. Since the offset two options often require considerable follow-up work and exit more than detailed cyber footprints, the returns on "investment" brand them less attractive for many cybercriminals. By contrast, holding an entity hostage with an encryption programme is comparatively simple, and the payout (where the assault actually yields a ransom) is nearly immediate. Furthermore, the rising of cryptocurrency has made the receipt of ransom funds substantially easier and swifter than traditional methods of exchanging and/or laundering large amounts of money and/or trying to sell health information on the "night web." Finally, with respect to calibration, the effort to breach security may not differ all that much based on the entity's size. Every bit a result, cybercriminals have an incentive to get large.

Every bit frustrating as it may exist, at this point in the evolution of our digital lives, the risk of ransomware should not be considered a surprise for whatsoever entity. Therefore, all entities should have a response programme, with at least 3 core components:

• Preventive: keep educating employees virtually the fundamental ways in which digital systems get compromised, particularly how the vast majority of compromises involve basic gullibility and human being mistake.
• Operational: past maintaining a robust system of backups, redundancies, and information segmentation, entities can substantially reduce the bear on on their systems.
• Strategic: to pay or not to pay, that is the question. If the entity anticipates a willingness to pay, it should consider such variables as its payout limit, how information technology will assemble the funds, and whether anyone in the organization has cryptocurrency feel. If the entity plans not to pay, information technology should consider its strategies and alternatives to operating without the original data, what kind of messaging it will provide to patients and business partners while its systems are compromised, and its public image management if the ransomware assail blows upwardly in the traditional or social media.

Beyond the to a higher place, all entities should have robust cyberinsurance to help mitigate the costs of managing an assault. ^x

It would be helpful if there were straightforward and consistent guidance on what to do in response to an set on. Unfortunately, recommendations and actual experiences vary. Remarkably, fifty-fifty the Federal Bureau of Investigation (FBI) does not take a potent position; instead, it offers only that "The FBI does non encourage paying a ransom to criminal actors." ¹¹ Furthermore, it is probable (only not entirely clear) that paying a ransom is de facto illegal under certain electric current laws. There besides are various proposed laws floating around country legislatures that would directly and expressly address the legality of such payments. Of course, punishing the victims of an attack may not reduce the number of attacks or the number of payments. Reporting matters to law enforcement is sensible, but information technology may non help a current victim. Finally, despite the encouraging news that DOJ was able to recover a meaning portion of the Colonial Pipeline ransom, information technology is unlikely that law enforcement would devote similar recoupment efforts to small medical practices or facilities. As a outcome, health care entities may be left with little practical guidance and few supports in the event of an attack.

In the context to a higher place, response strategies have become even more than complicated past questionable reliability of the criminals to exercise as they say. Specifically, there is a pregnant chance that the criminals will take a victim'due south money but so non actually return/release the ransomed data. Another risk is that paying a ransom in the get-go place may increase the likelihood of existence a repeat victim based on the presumption that payment once signals willingness to pay again. For what it is worth, game theory probably has a lot to say most ransomware for both the bad actors and the victims. Specifically, if too many criminals fail to restore encrypted information, then victims will be much less probable to pay. If victims uniformly refuse to pay, so ransomware may be worthless. Of class, with so many actors, the range of responses is all simply certain to keep ransomware around for a while.

While the word above primarily focuses on money and logistics, it is important non to lose sight of why wellness intendance entities (and those with which they contract) are particularly vulnerable: lives depend on data. Significantly, a case that is currently working through the courts expressly poses the question well-nigh causation betwixt a ransomware assail and a baby'due south expiry. Specifically, according to the lawsuit, a multi-day ransomware assail on Springhill Medical Centre compromised a wide array of the infirmary'south systems, including its fetal monitors, which led to the failure to detect complications with one of the hospital'south meaning patients and which then was a fabric cause of the baby's death nine months after birth. ¹² Regardless of the outcome of this item example, there will undoubtedly be subsequent lawsuits, presumably with much tighter facts and easier causation arguments.

Finally, as if the to a higher place issues with ransomware were not enough for providers, the Office for Civil Rights (OCR) has taken the position that all ransomware incidents must be considered under the Health Insurance Portability and Accountability Deed (HIPAA) Breach Notification Rule. ¹³ Significantly, considering there are no bright line standards in the Breach Risk Cess requirements, ¹⁴ entities may be forced to make the difficult choice of providing expensive and potentially image-damaging notice about an event that actually may not have compromised patient data in the first place or, in the culling, risk a significant enforcement penalty if the OCR learns nearly the incident and so disagrees with the entity's alienation risk cess conclusions.

Unfortunately, the risks of ransomware are not express to organizations. The stakes are growing at the personal level every bit "connected" devices and the "internet of things" put more and more health information in net-accessible form. Imagine a person with a connected pacemaker who receives an email saying: "I've hacked your middle, at present pay upwardly in bitcoin," or consider a diabetic individual who gets a text along these lines: "Do y'all know what your blood saccharide is correct now? I do. To unlock your monitor, ship $100 to [anonymous account]." With these types of situations, game theory, in one case over again, comes into play, where the scope, amount of ransom, and ease of payment may enable criminals to make a fortune from a big-scale attack with relatively pocket-size ransoms that are very likely to exist paid considering the risks of non-payment are potentially fatal. It is for these circumstances, that anyone developing a health care app or a continued device should comprise robust security features at the absolute beginning of the design process (i.east., "security by design"). Similarly, providers, insurers, or others who recommend or reimburse for the use of continued devices should exist mindful of the security features built into the systems, lest they find themselves indirectly liable for individual device attacks.

Every bit long every bit information is digital, information technology will be vulnerable. And, it is foolish to assume that the cybersecurity manufacture will really stay ahead of cybercriminals. Of course, this does non hateful ignoring technical features to minimize the take chances of a successful attack or structural/operational features to reduce the bear upon of a successful attack. But reliance on these measures is not plenty; workforce education is also essential.

Until cybercriminals motility on to a new favorite method of attack, entities should presume that a ransomware attack could happen at any moment. As a result, it is essential to have a logistical program for either restoring the entity'south relevant information or operating without such data, and information technology is as important to have a strategy regarding whether to pay. With whatsoever luck, a victim entity will simply take to bargain with the significant challenges of implementing its plan rather than the even greater challenge of figuring out its programme and rolling information technology out at the same fourth dimension. #forewarnedisforearmed

6. The Health Care Workforce Thought (Inclusion, Diversity, Disinterestedness & Accessibility)

Tiffany Buckley-Norwood, Trinity Health

+Heed to Episode half-dozen

Diversity and inclusion in the health care workplace carries several benefits, such as higher employee morale, better recruitment and memory, more artistic problem solving through varied perspectives, and improve treat the customs. ^xv The post-obit are three areas to watch.

Defining Multifariousness. Every bit wellness intendance employers continue to create and implement diverseness initiatives, it is important to define diversity. That definition may continue to change in 2022, just as it has in the by. Early civil rights laws, such every bit the Equal Pay Act of 1963, Title VII of the Ceremonious Rights Act of 1964, and the Historic period Bigotry in Employment Human action (1967), in addition to early on Presidential Executive Orders, reverberate that the conversation about diversity began with overt characteristics, such as race, gender, religion, and national origin. Adjacent the diversity discussion continued to expand to protections for medical condition such every bit disability, pregnancy, and genetic data. This is seen in the passage of the Pregnancy Discrimination Act (1978), Americans with Disabilities Act of 1990, Family Medical Go out Deed (1993), and Genetic Information Nondiscrimination Act (2008). Then, the variety conversation expanded again to include more discussions around equity, accessibility, and sexual orientation. This is seen in the passage of the Lilly Ledbetter Fair Pay Human action (2009), the accessibility and breast milk expression provisions of the Affordable Care Deed (2010), and changes to existing laws to include gender identity and sexual orientation as forms of sex discrimination. ¹⁶ It is besides seen in the passage of numerous country laws related to pay disinterestedness and paid family and medical exit. The definition of diversity will likely proceed to expand into 2022 to involve more than lifestyle topics. During the pandemic, employees spent more fourth dimension with their families and working from abode, which has prompted them to reevaluate how work impacts their life.

As the definition of diversity continues to expand, employers will need to be able to conspicuously articulate what "diversity" means for their system. A starting foundation should be state and federal civil rights laws to avoid creating unlawful policies. Simply the culture of a health intendance workplace should too dictate other specifics of the multifariousness definition for the organization.

Unconscious Bias and Microaggressions. Just as the definition of diversity has expanded, the definition of inequality has as well. In 2022 and 2021, the terms "unconscious bias" and "microaggressions" became more prominent in the national dialogue around diversity and inclusion. Specific to the health care manufacture, there was a focus on health care inequalities (peculiarly related to the pandemic), potential causes for those inequalities, and laws that could be enacted to remediate those causes. For example, on June one, 2021, Michigan's Department of Licensing and Regulatory Affairs (LARA) adopted new administrative rules mandating implicit bias training as part of the knowledge and skills necessary for obtaining and maintaining a health care license in Michigan. ¹⁷ More states may make unconscious bias training mandatory for health intendance workers. Additionally, more health care employers may voluntarily decide to include an unconscious bias segment in their grooming. In doing so, yet, information technology is important to be aware of whatever laws or regulations that dictate or restrict the content of that training. For example, at present-revoked federal Executive Society 13950 prohibited federal contractors from using sure types of diversity and unconscious bias training.

Use of Statistics in Diversity Initiatives. Under the federal Executive Society 11246, the Rehabilitation Human activity, and Vietnam Era Veterans Act, many health intendance employers who are federal contractors are already required to utilize statistics to create diversity goals as part of a formal affirmative activity plan. But other employers are starting to see the benefit of using statistics to be more efficient in creating and tracking their strategic variety initiatives. While such statistics can exist a do good, at that place are sure pitfalls that should exist avoided. For example, public pronouncements that involve statistics should exist carefully worded to minimize claims of intentional discrimination or disparate bear on discrimination, in violation of country and federal civil rights laws. Likewise, while information technology is permissible to create goals based on multifariousness analytics, creating quotas may atomic number 82 to claims of bigotry. Thus, it is important to have an employment attorney familiar with the pitfalls of such statistical analysis review any strategic plan based on diversity analytics for appropriate wording.

In determination, the conversation around what constitutes multifariousness and how to attain it will proceed to evolve in 2022. It is important to remain upwards to date on the laws regulating this area to avert pitfalls.

vii. Securing the Supply Chain for Wellness Intendance Providers

Michael Herald, Guardian Healthcare, and Sarah Swank, Nixon Peabody LLP

+Listen to Episode 7

In the early on days of the pandemic, many health care providers, their workers, and patients experienced kickoff-hand the impact of supply chain disruption. Supplies such equally masks, gloves, and gowns used to proceed workers rubber were in limited supply. In some parts of the state, supply chain issues left surging hospitals without enough PPE or ventilators to care for those infected with COVID-19.

Today, challenges with the supply chain persist. While the global market place has slowly reopened and manufacturing has resumed, nosotros are still competing for scarce resources with other countries. The U.s.a. as well 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 of import role in carrying goods out of ports for commitment. Disquisitional medical supplies and equipment remain in brusque supply, potentially jeopardizing patient care or worker safety.

FDA Guidance and Waivers. During the initial weeks of the pandemic, the Food and Drug Assistants (FDA) in conjunction with the Centers for Disease Control and Prevention (CDC) provided guidance regarding alternatives to PPE such as cloth masks and actions to accept when medical supplies were low. In October 2021, the FDA published a notice announcing the procedure for making COVID-xix guidance bachelor to the public, including periodic publication of consolidated notices describing all COVID-19-related guidance issued during a relevant catamenia. ¹⁸ The FDA said the new process will help the agency to more than apace disseminate and implement recommendations and policies related to COVID-nineteen. Before in the twelvemonth, the FDA published updated information on exercising enforcement discretion for importing sure medical devices during the pandemic. Providers should look to prior guidance on single apply and infection control processes with concerns of medical supply shortages.

OSHA Enforcement. Procuring PPE like N95 respirators has always been important for health intendance providers. The Occupational Safety and Health Administration's (OSHA's) respiratory protection plan standard requires employers to provide appropriate protection for employees from a known hazard, like COVID-19, in the workplace. ¹⁹ OSHA and many state agencies are updating guidance for employers equally the pandemic continues. Providers must ensure they secure acceptable supplies of PPE for wellness care workers to avert fines and penalties from OSHA or land agencies.

Defense Production Deed. During the initial phase of the pandemic, it quickly became credible that the national stockpile did non contain sufficient supplies to back up the increased demand across the country every bit individual health care providers experienced shortfalls in their own inventory. Somewhen, the Federal Emergency Direction Agency (FEMA) and HHS moved to increase supply and domestic production of medical supplies and equipment under the Defense force Production Act. FEMA and Customs and Edge Protection also continue to piece of work to preclude domestic brokers, distributors, and others from diverting critical medical resources overseas.

Office of States. Individual health intendance providers and states were also competing for the same limited resources. Land governors prepared executive orders to accost supply shortages specially in surge areas. For example, in New York, a ventilator shortage during the initial surges of the pandemic prompted the governor to issue an executive order allowing supplies, equipment, and staff to be redistributed across the land to hard hit areas, besides equally acknowledging that ventilators intended for one patient were now beingness used for two patients.

Supply Chain Fraud. The supply shortage likewise opened the door to fraudulent action. On Apr ii, 2020, DOJ released an alert regarding enforcement by the FBI and DOJ against those hoarding scarce medical supplies like PPE and hand sanitizer and then selling them at excessive prices. ²⁰ Other health care providers experienced fraud when they ordered and paid for critical supplies that never arrived. The FBI issued releases to wait out for suspicious activity related to fraudulent sales, including warning signs such as unusual payment terms, last-minute excuses for delays in shipment, and terminal-minute changes in payment terms.

Crisis Standard of Intendance. COVID-19 pandemic surges have impacted wellness care arrangement capacity including space, staff, and supplies. A crisis standard of care describes the plan for managing patient services and allocating scarce resources. A crisis standard is defined as a substantial change in usual health care operations and the level of care it is possible to deliver during a pervasive or catastrophic disaster. Reviewing and planning for a crisis standard of care prior to a surge helps ensure health intendance providers accept disquisitional guidance in place before facing a demand to ration or allocate scarce resources.

It Is Not Over. As the pandemic continues, the idea of a well-managed supply chain is being redefined. Supply chain models used to reward those who kept a express supply of what they needed on hand with shut review of expiration dates to eliminate waste material. Every bit we look to 2022 and beyond, the global pandemic may take a lasting impact on how the medical supply chain affects the delivery of wellness care.

8. Behavioral Health Transactions Outlook for 2022

Purvi Maniar, Norton Rose Fulbright Us LLP

+Listen to Episode 8

A Pandemic Inside a Pandemic. Already one of the almost active sectors in health care mergers and acquisitions for a number of years, behavioral health was propelled to the forefront by the challenge to our commonage mental health and wellbeing posed by COVID-19. During the pandemic, about four in ten adults nationwide have reported symptoms of anxiety or depressive disorder—a four-fold increment from pre-pandemic levels. ²¹ While rates of childhood mental health concerns and suicide accept been rising steadily since 2010, the pandemic also intensified this crisis. Following dramatic increases beyond the state in emergency department visits for pediatric mental health emergencies, including suicide attempts, the American Academy of Pediatrics, the American Academy of Child and Boyish Psychiatry, and the Children's Hospital Clan recently jointly declared a National State of Emergency in Children's Mental Health, issuing a call to action to policy makers. ²²

Increased Market Activity. The increase in demand led to several significant behavioral health transactions in 2021. For example, Lyra Health, which provides comprehensive mental wellness services through employee assistance programs, raised $200 meg in its latest funding round (bringing its valuation to over $2 billion) in order to accelerate delivery of mental health benefits for companies with employees effectually the world. ²³ In June 2021, global investment giant, KKR announced the launch of Geode Wellness, which intends to build a new platform to offer in-person and virtual outpatient mental health beyond the The states. Overall, by the second quarter of 2021, at that place were already 119 behavioral health transactions, on rails to more than double the 179 transactions completed in all of 2020.

Regulatory Advances. On the regulatory side, the federal Consolidated Appropriations Deed, 2022 (CAA) amended the federal Mental Health Parity and Addiction Equity Human activity, including new reporting and oversight requirements focused on strengthening mental health parity requirements applicative to group health plans. The CAA every bit well as the American Rescue Plan Human activity of 2022 connected and expanded telehealth funding and reimbursement due to the COVID-19 public wellness emergency. ²⁴ These funding and reimbursement expansions, too as regulatory flexibility implemented in 2022 related to doc state licensure, prescribing controlled substances, and HIPAA compliance related to the provision of telehealth (including telebehavioral health) services, are express to the elapsing of the public wellness emergency at the time of this writing. Yet, they accept helped prove the effectiveness of health care services via telemedicine, especially in behavioral health. Given the national shortage in behavioral wellness providers, too every bit the fact that, because a concrete test is normally not required, behavioral health services can generally be provided remotely much more often than full general telemedicine services, central stakeholder groups are pushing to make these changes permanent. In light of the growing pediatric mental health crisis, several bills take been introduced in Congress that are intended to ameliorate students' access to mental health services and provide funding for suicide sensation and prevention. ²⁵ The outlook for additional helpful legislative changes is bright given the wide bipartisan support for improving behavioral health in the country.

Current Market and Consolidation. Despite the increase in behavioral wellness transactions, the behavioral health market remains highly fragmented. Aside from a handful of established players, well-nigh behavioral health providers are small or solo practices or operators of 1 to ii facilities. The behavioral health market is now more ripe for consolidation than e'er before driven by the wider awareness and increased prevalence of mental wellness and substance utilise disorders during the pandemic, awareness of the significant comeback in outcomes and overall cost savings that can exist accomplished through better integration of behavioral health care with physical health care in primary intendance, inpatient settings and emergency room visits, increasing progress towards overall parity of reimbursement for behavioral health services, and the relaxation of regulations related to telebehavioral wellness.

Consolidation of health practices and facilities by individual disinterestedness and traditional health care players (such as large nonprofit behavioral wellness providers and hospitals and health systems) will permit consistent implementation of best practices and professional direction beyond this sector. This consolidation will likewise advance the movement towards amend integration of behavioral health with traditional health care, including collaborations and joint ventures between behavioral health providers and hospitals and health systems. Further, the increased market place power brought almost through the consolidation, combined with increasing awareness and demand volition likely atomic number 82 to higher reimbursement rates. Although the behavioral health provider shortage will remain a challenge in the almost term, these market forces volition attract more than talent to the profession in the longer term to aid bridge the gap.

Heightened Scrutiny. While by and large good news, the expansion of reimbursement will like bring greater regulatory scrutiny and enforcement. Smaller behavioral health facilities and providers, many of which were largely dependent on self-pay, often flew below the radar, but large, private equity-backed players and other deep-pocketed consolidators that receive significant governmental and commercial reimbursement will become attractive targets for federal enforcement of the Imitation Claims Human action (FCA). Since 2013, at least 25 private equity-backed health care companies have paid settlements in excess of $570 million for allegedly violations of the FCA. Behavioral health companies may exist at greater risk for enforcement (compared to other wellness intendance services companies) given the availability of legislative tools specific to behavioral health, such every bit EKRA, the Eliminating Kickbacks in Recovery Act of 2018. However, larger players in behavioral wellness, which have both the resources and incentives to invest in appropriate pre-conquering diligence and maintain audio compliance programs and practices post-acquisition, have the opportunity to raise the bar for quality across the behavioral health industry equally a whole.

Silverish Linings. These recent market and regulatory advances in behavioral health correspond pregnant overall progress towards closing the gap in an area of health care that has been historically misunderstood and neglected. Improving behavioral health through greater access and closer integration with physical health intendance represents a significant opportunity to improve health care outcomes, patient satisfaction and achieving efficiencies that volition improve the bottom line. Much like the overall acceleration in telemedicine trends that resulted from the pandemic, the progress nosotros have recently seen in behavioral wellness, including increased admission to telebehavioral health and early attention to pediatric mental health, and will continue to run across in 2022 and beyond represent some of the silver linings of a tumultuous period for health care in the Usa.

ix. Towards A Common Definition for Value-Based Arrangements

Tiana Korley, University of Michigan Office of the General Counsel

+Listen to Episode 9

A survey of the general public revealed that amid the pocket-sized number of respondents who had heard of the phrase "value-based care," there were widespread differences in their understanding of the phrase's meaning. ²⁶ Many wellness care industry stakeholders likely detect this result unsurprising. Providers traditionally have used the phrase in so many ways that it has lost some meaning.

At the end of 2020, the HHS Office of Inspector Full general (OIG) and CMS released companion terminal rules that provided a construct of "value-based care" by which we can sympathise what regulators and enforcement agencies believe this phrase ways. With the creation of new safety harbors under the Anti-Kickback Statute (AKS) and new exceptions under the Stark Police force designed to facilitate value-based arrangements, CMS and OIG accept established a mutual prototype under which providers and regulators can operate. ²⁷

Health intendance manufacture stakeholders have entirely new terminology, such as "value-based enterprises," "target patient populations," and "patient engagement tools and supports." It is fair to say that with the deregulatory companion rules came numerous regulatory terms for industry stakeholders to understand and utilize.

There has been some criticism from the provider customs that the new regulatory flexibility did not go far enough. Some providers were unhappy that the safe harbor for care coordination arrangements includes a contribution requirement. Others wanted higher thresholds for the patient appointment tools and supports prophylactic harbor to allow for even more expansive efforts to address social determinants of wellness. Furthermore, OIG declined to establish safe harbors in some areas, such as for wide waivers of cost-sharing obligations. Providers volition have to proceed to rely upon the informational opinion process.

Though the terminal rules did non provide exhaustive relief, the breadth that providers now have to compensate physicians differently under the Stark Constabulary, and to partner with physicians and other health care organizations under new AKS condom harbors is unprecedented. Many health care leaders have been request for flexibility to partner in new ways around caring for patients. Such innovation can event in lower wellness care costs for all involved—federal health intendance programs (and thus taxpayers) every bit well as beneficiaries.

Organizations that brand strategic utilise of this flexibility may be able to motility more expeditiously out of fee-for-service and into risk-based models of care. CMS recently appear that it hopes to drive accountable intendance in a more meaningful way such that all Medicare beneficiaries with Parts A and B will be in a care human relationship with accountability for quality and total cost of care by 2030. ²⁸ This has heightened the urgency for providers to move towards more efficient, cost-effective models of health care delivery.

Innovative leaders will leverage this regulatory flexibility to intendance for patients in new ways. Hospitals tin now partner with each other to have care of patients with a particular medical diagnosis and more easily provide in-kind exchanges of remuneration, such as staff. Every bit participants in value-based enterprises, hospitals can assure patients tin can admission remote patient monitoring tools and other modalities to amend their health in alternate intendance settings. Hospitals tin can compensate physicians involved in such care coordination arrangements in a more than flexible fashion. This is a big win for hospitals attempting to partner with physicians—and each other—in innovative ways.

Looking to the Future. In 2022, nosotros may run into further clarity regarding how OIG and CMS interpret the new regulations. The ambiguity and newness of value-based arrangements will eventually be a target for whistleblowers. It will be interesting to meet whether skilful religion participation in value-based enterprises negates bad intent in causes of action involving the AKS. We likewise may run into the commencement advisory opinions that provide additional insight every bit to how OIG applies the regulations to specific arrangements.

The Medicare Trust Fund faces insolvency in 2026. ²⁹ With recent pronouncements from CMS every bit to the agency's vision for federal health care programs, the question is whether in 2022 and across, hospitals and other health care providers successfully leverage new flexibilities to take ameliorate intendance of patients at a lower cost and improve health care quality for the communities that they serve.

x. COVID Is a Catalyst for APP Expansion

Robin Locke Nagele, Post & Schell PC

+Listen to Episode 10

In the coming yr, we expect that Advance Do Professionals (APPs) will proceed to encounter pregnant opportunity for expansion equally to their scope of their services and their level of independence in the clinical and the business cease of providing services. COVID has taught that "the assumption that a task is automatically safer when it is performed by the highest trained practitioners" is faulty and "actually risks a more hazardous intendance environs" by placing onerous responsibility on the medico, instead of using skilled non-physicians to salve some of that brunt. ^thirty During COVID, APPs, facilitated by the COVID waivers, take demonstrated their value in ensuring access and continuity of care. ³¹ However, they also face considerable uncertainty nigh their status equally the waivers elapse.

Historical Barriers to Practice Autonomy. APPs, including Md Assistants (PAs), Certified Registered Nurse Practitioners (CRNPs), Certified Nurse Midwives (CNMs), and Certified Nurse Specialists (CNSs), accept long advocated for greater autonomy in the provision of health care services. Strides have been made in many states, but restrictions remain. Equally of the beginning of the pandemic, only 22 states provided "Full Practice Authority" to NPs—allowing them to diagnose and treat patients and prescribe medications without a supervising or collaborating doc. ³² Beyond the licensure restrictions, APPs are challenged by restrictive insurance and reimbursement policies, CMS regulations, and institutional and organizational policies related to credentialing equally providers. The price of mandated collaborative or supervisory services is unregulated and can be cost-prohibitive. ³³

Bear on of COVID. During COVID, the federal emergency declaration and state waivers of licensure, practice, and telehealth restrictions radically shifted the practice landscape for APPs. APPs have been able to practise across country lines, across their usual scope of do limitations, and via telehealth. ³⁴ The impacts on APP practices included an increased power to do independently and without delays resulting from the demand for physician nautical chart review, blessing of orders, and the ability to follow patients through home wellness and direct intendance. And the dramatic increase in the use of telehealth has enabled APPs to treat patients in wide variety of practise settings. ³⁵ The pandemic response has provided evidence that some of the restrictive rules surrounding APP practice are unnecessary and can even impede the delivery of quality wellness care. ³⁶

At the federal level, CMS has begun to relax some of the more onerous requirements for APPs. Effective January 1, 2020, CMS removed its ain supervision requirements for PAs, and instead at present merely requires that they come across applicative state law licensure and scope of do requirements. ³⁷ Effective January 1, 2021, CMS now allows a wide range of APPs—PAs, NPs, CNSs, CNMs, and CRNAs—to review and verify (sign/date) documentation in the medical record without have to re-document notes already in the tape, for purposes of Office B Billing. ³⁸

The Post-Pandemic Hereafter. Notwithstanding these important gains, APPs face up an uncertain future in the immediate term. Many states have completely lifted their emergency waiver provisions, suddenly returning APPs to the licensure and telescopic of practice restrictions that existed pre-COVID. ³⁹ Some forwards-looking states—including Colorado, New Hampshire, and Virginia—have replaced the emergency waivers with permanent legislative practice expansions—particularly in the area of telehealth. ^xl For example, New Hampshire passed permanent telehealth legislation that, amidst other things, expanded the list of providers able to provide telehealth to include PAs and APRNs, among others. ⁴¹

APPs still face pregnant barriers to achieving the level of independent exercise that they seek. Country-specific barriers to owning their own practices, to practicing without supervision or collaboration, to performing services that are within their training but non permitted scope of practice continue to exist and volition require legislative initiatives to effectuate change. Just there are signs that APPs are increasingly being recognized and deployed in appropriate settings equally good quality, cost-effective alternatives to physicians. ⁴² And many in the industry hope that the data and knowledge generated during the pandemic regarding the valuable skillsets that APPs tin can offer in a wide range of practise settings will provide powerful arguments for continuing their march towards greater independence and self-conclusion.

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Lisa Lucido is an attorney with Hall Render where she concentrates her practice in the areas of regulatory compliance, reimbursement, billing, and payment practices. Lisa provides counsel to a wide diverseness of health care entities in developing strategies and policies to ensure compliance with the Medicare and Medicaid programs, including the evaluation of provider-based issues, conditions of payment, disclosure, and compliance matters. Additionally, Lisa advises providers in the negotiation and administration of managed care contracts and works closely with clients to address regulatory and compliance issues related to participation in Medicare Advantage.

Ben Fee is an chaser with Hall Render where he practices exclusively in the area of health law advising health systems and hospitals on a variety of regulatory, compliance, and corporate transactional matters. He regularly advises clients on reimbursement and financial strategies; regime reimbursement and payment matters; corporate structure and reorganization; the 340B drug discount program; and corporate compliance bug.

Lisl Dunlop is a Partner at Axinn Veltrop & Harkrider LLP. Lisl has more than than 25 years of experience guiding leading U.Due south. and multinational companies through the antitrust-related aspects of mergers and acquisitions, joint ventures, and other combinations. For her health intendance clients, Lisl provides antitrust and strategic communication in evaluating value-based payment initiatives, the establishment and operation of ACOs and independent physician networks, fiscal and clinical integration bug, and other transactions and collaborations.

Jody L. Rudman is a Partner at Husch Blackwell LLP in the Austin, TX office. Jody is a litigator with well over two decades' experience in jury trials, bench trials, contested hearings and oral arguments in federal and state courtrooms. Jody focuses primarily on government investigations, both civil and criminal, in the health intendance infinite. A former Assistant United states of america Chaser for the Northern District of Texas, she handles all aspects of government investigations, trials, sentencings, and appeals.  Her work is largely white collar criminal and Simulated Claims Act matters, representing clients during investigations, negotiations, and litigation. She is a frequent speaker and published author in health care matters, antitrust matters, and litigation issues.

Shalyn Smith McKitt is a Litigation Associate at Balch & Bingham LLP in the Birmingham, Alabama function. She earned her BA from Stillman College and her JD and MA in Health Studies from the University of Alabama. Shalyn started her practice as a litigator in the Ohio Attorney General's Office Health and Human Services section where she represented the Section of Developmental Disabilities, the Department of Mental Wellness and Habit Services, the Department of Medicaid, and the Chemic Dependency Professionals Lath. She then joined the Dallas office for the U.Due south. Department of Health and Human Services Function of the General Counsel as Assistant Regional Counsel. In that location she primarily represented CMS and OCR in matters relating to Medicare and Medicaid billing and overpayments, facility compliance, HIPAA, and Ceremonious Rights. Shalyn then served as Senior Legal Counsel at SS&C Health, a Healthcare Technology company. There she drafted and negotiated multi-meg dollar contracts for health and pharmacy solutions and was essential in analyzing company HIPAA compliance. She then came to Balch where she works on a variety of litigation matters including those related to health care providers and suppliers, health systems, and HIPAA compliance.

Nathan A. Kottkamp is a Partner in the Healthcare Department of Williams Mullen, in Richmond, Virginia. Nathan'southward practice focuses on a broad array of operational and regulatory issues, including HIPAA, licensure/accreditation/professional lath matters, and ethics. Nathan is too the Founder of National Healthcare Decisions Day (world wide web.nhdd.org), in which AHLA has been a participant since its inception in 2008.

Tiffany Buckley-Norwood is the Vice Chair of Publishing for AHLA's Labor and Employment Practise Group. Equally of November 1, 2021, she is also an Acquaintance Counsel, Employment for Trinity Wellness. Prior to that, she was the Healthcare Industry Grouping Co-Lead and a Main at Jackson Lewis PC. Any statements in this article are Tiffany's opinion and practice not necessarily represent the views of Trinity Health.

Michael Herald is the Chief Administrative Officeholder & General Counsel at Guardian Healthcare. He is responsible for managing the legal diplomacy and leading the human resources, It, shared services, and loss prevention teams for the post-acute care enterprise. In addition, Michael serves equally an adjunct faculty member for Penn State University'southward Nursing Domicile Administrator preparation plan, a member of the Board of Visitors for the Health Care Assistants and Management Program at Glace Stone University, and is a fellow member of the Lath of Directors at Global Links.

Sarah Swank is a health care attorney in Nixon Peabody LLP's Washington, DC office, with more than 20 years of experience as senior in-business firm counsel for two of the largest national health intendance systems and equally a thought leader and counselor in two nationally recognized, tiptop-rated law firms. Sarah supports clients navigating a complex and irresolute regulatory mural to promote innovation and thoughtful growth by providing strategic and applied advice on CMMI programs, ACOs, telehealth, AI, wellness equity, and clinical enquiry and where they intersection with operations, compliance, the Stark Law, Anti-Kickback Statute, HIPAA, OCR civil rights, and other health care regulatory issues. She is a nationally recognized speaker and author, a Vice Chair on the Publications Lath of ABA Health Section and the Vice Chair of Education for AHLA's In-House Counsel Practice Grouping.

Purvi Maniar is a member of Norton Rose Fulbright'due south wellness care transactions squad and is a partner based in the firm's St. Louis and New York offices. She is a wellness care business organisation lawyer who focuses on bringing together hospitals, health systems, medical group practices, behavioral health organizations, private disinterestedness clients, and emerging wellness care companies in mergers, acquisitions, articulation ventures, and other strategic business arrangements. Purvi focuses on both domestic and international health intendance transactions and helped lead the expansion of the global law firm'due south loftier caliber domestic health system practise to include international health intendance transactions. Purvi is passionate about improving access to and quality of behavioral health. She represents private disinterestedness companies and prominent nonprofit behavioral health providers in connection with their mergers, acquisitions, strategic partnerships, and clinically integrated networks. She also advises hospitals in connection with restructuring their inpatient behavioral health programs, as well as tele-behavioral health providers and other clients focused on the behavioral wellness space. She is the Chair of AHLA's Behavioral Health Practice Group.

Tiana Korley is an Associate General Counsel for the Academy of Michigan Office of the Vice President and General Counsel.  In this role, she provides advice on regulatory compliance matters, including interpretation and guidance related to the fraud and abuse laws. Tiana too provides guidance on delivery arrangement reform efforts, including alternative payment models. Prior to joining the Academy of Michigan, Tiana worked in several other capacities in the health care arena, including as a health care consultant, congressional staffer, and equally a senior staffer for the Centers for Medicare and Medicaid Services.

Robin Locke Nagele is Co-Chair of the Health Care Exercise Group of Mail & Schell in Philadelphia. She has a national health care litigation and consulting practise in which she counsels and represents hospitals, health systems, and other health care provider entities in complex medical staff matters, including peer review proceedings, summary suspensions, corrective action, fair hearing processes, and associated litigation.  She as well counsels and represents federally listed Patient Prophylactic Organizations (PSOs) and Participating Providers with regard to legal compliance and privilege protection under the federal Patient Safety Quality Improvement Act, and litigates PSQIA privilege disputes. She is a former Chair of AHLA'due south Medical Staff, Credentialing, and Peer Review Exercise Group, and has written and spoken extensively on medical staff issues.

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Source: https://www.americanhealthlaw.org/content-library/connections-magazine/article/d4c53b68-6b75-4a9f-a56c-5ed7122fc3b0/top-ten-issues-in-health-law