Category: Health Care Law

Poor Oversight: Healthcare Company & Owner to Pay $1 Million for Care Plan Oversight Service Billing Fraud

The United States announced that Chicago-based healthcare company Apollo Health Inc. (Apollo), and its owner, Brian J. Weinstein, will pay $1 million to resolve False Claims Act allegations. The claims state that Apollo, under the direction of Weinstein, submitted bills to Medicare for services that were never performed. The case was brought by two whistleblowers who will be rewarded for their efforts.

From December 2014 through March 2017, Apollo allegedly submitted Medicare claims for care plan oversight services (CPO) that did not occur. CPOs detail a physician’s duties to supervise a patient receiving complex medical care. Weinstein allegedly directed Apollo to submit 12,592 CPO service claims for over two dozen providers employed by Apollo, despite Weinstein’s knowledge that no services had been rendered to Medicare patients, and no CPO services were documented in medical records.
Medicare fraud undermines the trust and integrity of the healthcare system, resulting in significant financial burdens on taxpayers. When individuals or organizations engage in fraudulent activities, such as billing for services not rendered or submitting false claims, they siphon funds from Medicare’s intended beneficiaries. Medicare fraud diminishes the resources available for legitimate healthcare services for truly ill Medicare beneficiaries.
The settlement resolves claims brought by two whistleblowers, also known as relators, under the qui tam provisions of the False Claims Act. Javar Jones and Louis Curet, the relators in the case, will receive 20% of the settlement amount for bringing the fraudulent activity to the United States’ attention. Whistleblowers who report fraud against the government via a qui tam lawsuit can earn a 15-25% share of the government’s recovery.

© 2024 by Tycko & Zavareei LLP
For more news on Whistleblower Settlements, visit the Criminal Law / Business Crimes section.

A Guide for All Medicare Whistleblowers

Becoming a whistleblower and notifying federal authorities of Medicare fraud is a big public service and can even lead to a lucrative whistleblower award. Furthermore, the chief concern for interested whistleblowers is whether they could get reprimanded at their job for blowing the whistle on healthcare fraud or even fired, but any form of whistleblower retaliation is unlawful under the Whistleblower Protection Enhancement Act.

If you think that you have uncovered evidence of Medicare fraud and want to learn more about what could happen next, here are four things to know.

  1. There are Lots of Known Ways to Defraud Medicare

Medicare is an $800 billion federal program, but estimates are that tens of billions, if not nearly $100 billion of that is lost to fraud every year – and that estimate is widely regarded as a conservative one.

A lot of this type of health care fraud can be categorized into one of the following types of schemes, many of them having to do with fraudulent billing tactics:

  • Phantom billing, where medical goods or services are billed against Medicare even though they were never provided or the purported patient does not exist
  • Double billing for the same goods or services
  • Providing medically unnecessary healthcare
  • Buying prescription drugs with Medicare drug plan money and then reselling them
  • Upcoding, or providing a healthcare service to a patient, but then billing Medicare for a similar but more expensive one
  • Unbundling, or billing for each service independently even though they are normally charged in a discounted package because they are often performed together
  • Paying or taking financial kickbacks for referring patients to a certain healthcare provider, or to a provider that the referring party has a financial stake in

However, these are just the types of Medicare fraud that have been discovered. There are likely other ways of defrauding the program that have yet to be detected. Therefore, even if the evidence that you have uncovered does not fit squarely into one of these types of Medicare fraud does not necessarily mean that it is not a problem.

  1. What Happens After Deciding the Blow the Whistle on Medicare Fraud

Most people are not completely familiar with how other civil or criminal cases move forward in the justice system. Because whistleblower cases are different and even more nuanced and complex, even fewer people understand the process – and those that presume that they are just like other cases find themselves misinformed.

Whistleblower cases are nearly unique in that they have three parties to them:

  1. The whistleblower
  2. The government
  3. The defendant

After you have found evidence of Medicare fraud and abuse, decided to report suspected fraud and become a whistleblower, and hired a law firm well versed in federal laws to represent you, you will continue to gather evidence to support your allegations. This is a sensitive endeavor, as most whistleblowers only have access to the incriminating evidence through their employment, and their employer may be actively trying to cover up the fraudulent activity.

Being represented by an experienced whistleblower lawyer is essential for this stage of the process. They will have gone through it before and will see how to gather evidence to support your case without exposing yourself to the risk of being detected for reporting fraud.

Once you have a strong case, the next step is to present it to the law enforcement agency that would have jurisdiction over your case. Typically you would present information to the Health and Human Services Office or Office of the Inspector General (OIG) hotline. For Medicare fraud, reports are often made to the Centers for Medicare and Medicaid Services, or CMS. The goal is typically to persuade agents there to intervene in your case, conduct the investigation that you started, and prosecute the fraudsters.

If the agency declines to intervene, you can still pursue the case on the government’s behalf.

  1. You Can Receive a Financial Award

One of the main incentives for whistleblowers is the award that they can receive for bringing the evidence to the attention of federal law enforcement. That award can be substantial.

Because Medicare is a federal program, most claims of Medicare fraud advance under the False Claims Act (31 U.S.C. §§ 3729 et seq.). This federal law provides an avenue for whistleblowers who have evidence of fraud against the government.

Importantly, the False Claims Act offers quite generous whistleblower awards, even when compared to other whistleblower statutes. The amount that you receive depends on several factors, the most important of which is whether the government intervened in your case or not. If it did, you can receive between 15 and 25 percent of the proceeds of the case. If it did not and you prosecuted the case on behalf of the government, you can recover up to 30 percent of the case’s proceeds.

Other factors include:

  • Whether there are other whistleblowers who played a role in the case
  • How important the evidence was that you brought to the table
  • Whether you played a part in the Medicare fraud
  1. Your Job is Protected 

Because workplace retaliation is such a foreseeable outcome of becoming a whistleblower, and because the federal government relies so heavily on whistleblowers, it should come as no surprise that the False Claims Act and other whistleblower statutes provide legal protections in the workplace for those who engage in lawful whistleblower activities.

For Medicare fraud whistleblowers, the False Claims Act’s anti-retaliation provision, 31 U.S.C. § 3730(h), is particularly strong. Not only does it protect you from retaliatory conduct that falls short of termination, like workplace harassment and threats to fire you, it also entitles you to significant remedies if your employer breaks the law and commits an act of reprisal.

Oberheiden P.C. © 2024
For more news on Medicare fraud whistleblowers, visit the NLR Criminal Law / Business Crimes section.

The 80/20 Rule is Here: CMS Finalizes HCBS Care Worker Payment Requirements

In May 2023, the Centers for Medicare and Medicaid Services (“CMS”) proposed a series of rule changes intended to help promote the availability of home and community-based services (“HCBS”) for Medicaid beneficiaries. Chief among these proposals was a new rule that would require HCBS agencies to spend at least 80% of their Medicaid payments for homemaker, home health aide, and personal care services on direct care worker compensation (the “80/20 Rule”). Intended to help stabilize the HCBS workforce, the proposal faced immediate backlash from HCBS providers and Medicaid agencies, who expressed concern that the 80/20 rule would harm HCBS providers by mandating specific allocations to worker compensation and bogging down providers and Medicaid agencies with burdensome reporting requirements.

After reviewing thousands of comments, CMS released an advance copy of the final rule this week. Defying stakeholder anticipation that the 80/20 Rule would be relaxed, or updated to provide more flexibility for providers, CMS finalized the 80/20 Rule largely as originally proposed, including the following key requirements:

  • HCBS providers must spend at least 80% of Medicaid payments on direct care worker compensation;
  • HCBS providers will have six years (increased from four) from the effective date of the final rule to demonstrate compliance with the 80/20 Rule;
  • States must begin collecting and tracking data on direct care worker compensation within four years of the effective date of the final rule; and
  • States are permitted to establish different standards for smaller HCBS providers and to establish hardship exemptions – in both cases based on objective and transparent criteria.

Under the broad mandate of the 80/20 Rule, there are a number of key definitions that HCBS providers must consider as they evaluate these new requirements:

Direct Care Workers

Because the 80/20 Rule was adopted largely to stabilize the HCBS workforce, a key component is whose compensation qualifies for inclusion. CMS’s proposed definition encompassed almost any person with a role in providing direct care to patients (e.g., RNs, LPNs, individuals practicing under their supervision, home health aides, etc.). Under the final 80/20 Rule, CMS clarified that “direct care workers” also include those whose role is specifically tied to clinical supervision (e.g., nurse supervisors).

Compensation

Compensation of direct care workers means:“[s]alary, wages, and other remunerations as defined by the Fair Labor Standards Act and implementing regulations; [b]enefits (such as health and dental benefits, life and disability insurance, paid leave, retirement, and tuition reimbursement); and [t]he employer share of payroll taxes for direct care workers delivering services authorized under section 1915(c) of the Act.” CMS clarified that “compensation” also includes:

  1. Overtime pay;
  2. All forms of paid leave (e.g., sick leave, holidays, and vacations);
  3. Different types of retirement plans and employer contributions; and
  4. All types of benefits: CMS intentionally used the phrase “such as” to indicate the list of benefits was non-exhaustive, and indicated technical guidance to states on this subject is forthcoming.

Excluded Costs

CMS expressed concern that HCBS providers would include training costs for direct care workers as “compensation,” and that calculating compensation in this way could result in negative outcomes, such as diminished training opportunities. To address these concerns, CMS created the concept of “excluded costs,” which are excluded from the percentage calculations under the 80/20 Rule. See § 441.302(k)(1)(iii) (“costs that are not included in the calculation of the percentage of Medicaid payments to providers that are spent on compensation for direct care workers.”). Excluded costs are limited to:

  1. Costs of required direct care worker training;
  2. Direct care worker travel costs (mileage, public transportation subsidy, etc.); and
  3. Personal protective equipment costs.

Medicaid Payments

CMS largely adopted its expansive view of what qualifies as a “Medicaid Payment” for purposes of 80/20 Rule calculations. CMS clarified that the 80/20 Rule encompasses both standard and supplemental payments and applies regardless of whether HBCS services are delivered through fee-for-service or managed care delivery systems. CMS also declined to create a formal carve-out for value-based care or pay-for-performance arrangements, despite recognizing their value.

What Comes Next?

HCBS providers and state Medicaid agencies have six years to sort out their compliance with the 80/20 Rule (though data tracking and reporting begins after year three). On the provider side, this means carefully evaluating the business and economic impacts of compliance with the 80/20 Rule and monitoring CMS and state-level guidance on implementation as it develops over time. For multi-state providers, this process becomes even more complicated, as there is a high likelihood that states will choose to implement the 80/20 Rule in different, and potentially contradictory, ways.

Providers also need to work with the state agencies to address the adequacy of HCBS rates generally. CMS recognized the important role that the underlying rates play in HCBS sustainability but declined to mandate specific payment rates or methodologies. As a result, positive momentum on the rates themselves must come from state initiatives.

© Polsinelli PC, Polsinelli LLP in California
For more news on Healthcare Provider Regulations, visit the NLR Health Law & Managed Care section.

Curb Your Pollution: EPA Issues Final Rule to Reduce Toxic Air Pollution

EPA Issues Final Rule to Reduce Toxic Air Pollution from the Synthetic Organic Chemical Manufacturing Industry and the Polymers and Resins Industries

On April 9, 2024, the U.S. Environmental Protection Agency (EPA) announced its final rule that is touted to provide critical health protections to hundreds of thousands of people living near chemical plants. The final rule, signed March 28, 2024, will reduce emissions of hazardous air pollutants, including the toxic chemicals chloroprene and ethylene oxide (EtO). The rule implements sections 111 and 112 of the Clean Air Act.

When fully implemented, the final rule will reduce more than 6,200 tons a year of over 100 air toxics – including EtO and chloroprene – from covered equipment and processes at plants in Texas and Louisiana, along with plants in other parts of the country including Delaware, New Jersey, and the Ohio River Valley.

As part of the final rule, the EPA is also issuing new emissions limits for dioxins and furans. This will reduce more than 23,000 tons of smog-forming volatile organic compounds (VOCs) each year.

EPA’s final rule will also require plants to conduct fenceline monitoring if any of the equipment or processes covered by the rule use, produce, store, or emit EtO, chloroprene, benzene, 1,3- butadiene, ethylene dichloride or vinyl chloride. Fenceline monitoring is used to measure levels of pollution in the air around the perimeter of a facility. The fenceline monitoring provisions of the rule require owners and operators to ensure that levels of these six pollutants remain below a specified “action level.” Fenceline monitoring provides owners and operators the flexibility to determine what measures to take to remain below the action level, while ensuring that they are effectively controlling toxic air pollution.

The final rule will significantly reduce emissions of air toxins, especially those that are potentially harmful for surrounding communities. According to the EPA, these emission reductions will yield significant reductions in lifetime cancer risk attributable to these air pollutants, in addition to other health benefits.

©2024 Norris McLaughlin P.A., All Rights Reserved
For more on Air Pollution, visit the NLR Environmental, Energy & Resources section.

The Hidden Dangers: Long-Term Effects of Mild Traumatic Brain Injury

Traumatic brain injuries can have life-changing impacts on a person’s life, and understandably so because they result from injuries to the brain either through a massive blow to the head or injury by a penetrative object into the brain matter.

However, not all types of traumatic brain injuries have quite dramatic symptoms, and a mild TBI (traumatic brain injury) is one such injury. They result from a relatively minor blow to the head or a jerking of the head, causing injuries to the brain tissue.

While most mild TBIs resolve in a few weeks, some can affect the victim’s life in the long term.

Symptoms of a Mild TBI

If you have suffered a blow to the head in an accident, you need to pay attention to your symptoms, as it can help you identify signs of a mild TBI, also known as a concussion. Symptoms like passing out briefly, headache, memory loss, confusion, loss of balance, sensitivity to light and noise, problems keeping balance, tingling in your fingers, etc., are indicative of a concussion.

However, other injuries can present similar symptoms, so it is best to have a doctor make that determination. Also, it is important to note that concussions can go undetected for days because they tend to have delayed symptoms.

Unfortunately, taking too much time before seeking medical attention for a mild TBI can introduce treatment gaps, which can result in complications when seeking compensation for the long-term effects of a concussion. A timely hospital visit helps create a link between an accident and symptoms that could show days after the accident. Which is why personal injury lawyers always insist on seeking medical attention even when you feel okay.

Long-Term Effects of a Mild TBI

While most effects of a concussion will be gone after 90 days of suffering an accident, and this is for cases of severe injuries, there are situations where the effects of an injury can last years or a lifetime. Common long-term effects of a mild TBI on a person’s life include:

LONG-TERM MEMORY LOSS

Memory loss is pretty common after a concussion. However, it involves losing a recollection of the few minutes before and after an injury.

In some cases, the affected person can start remembering things once forgotten. However, in severe cases, memory loss can impact a person’s life in the long term.

DEPRESSION

Many people will develop symptoms of depression after a concussion, usually as a result of chemical changes resulting from the brain injury. While most symptoms will disappear as the brain recovers, some people may have to live with the symptoms for an extended period.

In some cases, symptoms of depression won’t show until some time after other symptoms are gone.

COGNITIVE IMPAIRMENT

In most cases, the effect of a mild TBI on a person’s thinking and cognitive abilities resolves in a few months at most.

But there is no guarantee that your cognitive abilities will return to your pre-injury levels, especially with relatively severe concussions or injuries that went undetected for a long time.

Treatment and Support for Mild TBI

You may not need hospitalization after a TBI. Often, doctors focus on treating the symptoms and may prescribe cognitive and behavioral therapy to address the psychological and injury effects on a person’s mental well-being.

If the injuries resulted from an accident and another person’s negligence was to blame, you could consider talking to a personal injury lawyer to help recover damages.

Buckfire & Buckfire, P.C. 2024
For more news on Traumatic Injuries, visit the NLR Personal Injury section.

Incorporating AI to Address Mental Health Challenges in K-12 Students

The National Institute of Mental Health reported that 16.32% of youth (aged 12-17) in the District of Columbia (DC) experience at least one major depressive episode (MDE).
Although the prevalence of youth with MDE in DC is lower compared to some states, such as Oregon (where it reached 21.13%), it is important to address mental health challenges in youth early, as untreated mental health challenges can persist into adulthood. Further, the number of youths with MDE climbs nationally each year, including last year when it rose by almost 2% to approximately 300,000 youth.

It is important to note that there are programs specifically designed to help and treat youth that have experienced trauma and are living with mental health challenges. In DC, several mental health services and professional counseling services are available to residents. Most importantly, there is a broad reaching school-based mental health program that aims to provide a behavioral health expert in every school building. Additionally, on the DC government’s website, there is a list of mental health services programs available, which can be found here.

In conjunction with the mental health programs, early identification of students at risk for suicide, self-harm, and behavioral issues can help states, including DC, ensure access to mental health care and support for these young individuals. In response to the widespread youth mental health crisis, K-12 schools are employing the use of artificial intelligence (AI)-based tools to identify students at risk for suicide and self-harm. Through AI-based suicide risk monitoring, natural language processing, sentiment analysis, predictive models, early intervention, and surveillance and evaluation, AI is playing a crucial role in addressing the mental challenges faced by youth.

AI systems, developed by companies like Bark, Gaggle, and GoGuardian, aim to monitor students’ digital footprint through various data inputs, such as online interactions and behavioral patterns, for signs of distress or risk. These programs identify students who may be at risk for self-harm or suicide and alert the school and parents accordingly.

Proposals for using AI models to enhance mental health surveillance in school settings by implementing chat boxes to interact with students are being introduced. The chat box conversation logs serve as the source of raw data for the machine learning. According to Using AI for Mental Health Analysis and Prediction in School Surveys, existing survey results evaluated by health experts can be used to create a test dataset to validate the machine learning models. Supervised learning can then be deployed to classify specific behaviors and mental health patterns. However, there are concerns about how these programs work and what safeguards the companies have in place to protect youths’ data from being sold to other platforms. Additionally, there are concerns about whether these companies are complying with relevant laws (e.g., the Family Educational Rights and Privacy Act [FERPA]).

The University of Michigan identified AI technologies, such as natural language processing (NLP) and sentiment analysis, that can analyze user interactions, such as posts and comments, to identify signs of distress, anxiety, or depression. For example, Breathhh is an AI-powered Chrome extension designed to automatically deliver mental health exercises based on an individual’s web activity and online behaviors. By monitoring and analyzing the user’s interactions, the application can determine appropriate moments to present stress-relieving practices and strategies. Applications, like Breathhh, are just one example of personalized interventions designed by monitoring user interaction.

When using AI to address mental health concerns among K-12 students, policy implications must be carefully considered.

First, developers must obtain informed consent from students, parents, guardians, and all stakeholders before deploying such AI models. The use of AI models is always a topic of concern for policymakers because of the privacy concerns that come with it. To safely deploy AI models, there needs to be privacy protection policies in place to safeguard sensitive information from being improperly used. There is no comprehensive legislation that addresses those concerns either nationally or locally.
Second, developers also need to consider and factor in any bias engrained in their algorithm through data testing and regular monitoring of data output before it reaches the user. AI has the ability to detect early signs of mental health challenges. However, without such proper safeguards in place, we risk failing to protect students from being disproportionately impacted. When collected data reflects biases, it can lead to unfair treatment of certain groups. For youth, this can result in feelings of marginalization and adversely affect their mental health.
Effective policy considerations should encourage the use of AI models that will provide interpretable results, and policymakers need to understand how these decisions are made. Policies should outline how schools will respond to alerts generated by the system. A standard of care needs to be universally recognized, whether it be through policy or the companies’ internal safeguards. This standard of care should outline guidelines that address situations in which AI data output conflicts with human judgment.

Responsible AI implementation can enhance student well-being, but it requires careful evaluation to ensure students’ data is protected from potential harm. Moving forward, school leaders, policymakers, and technology developers need to consider the benefits and risks of AI-based mental health monitoring programs. Balancing the intended benefits while mitigating potential harms is crucial for student well-being.

© 2024 ArentFox Schiff LLP
by: David P. Grosso, Starshine S. Chun of ArentFox Schiff LLP

For more news on Artificial Intelligence and Mental Health, visit the NLR Communications, Media & Internet section.

Importance of Negotiating Assignment and Subletting Provisions in Health Care Leases

In our ongoing series of blog posts, we examine key negotiating points for tenants in triple net health care leases. We also offer suggestions for certain lease provisions that will protect tenants from overreaching and unfair expenses, overly burdensome obligations, and ambiguous terms with respect to the rights and responsibilities of the parties. These suggestions are intended to result in efficient lease negotiations and favorable lease terms from a tenant’s perspective. In our first two blog posts, we considered the importance of negotiating initial terms and renewal terms and operating expense provisions. This latest blog post in our series focuses on negotiating assignment and subletting provisions.

It is imperative for a commercial tenant, particularly a private equity-owned health care tenant, to include provisions in a lease which allow the tenant the flexibility to assign and sublease the commercial space without the necessity of having to obtain the landlord’s consent and/or to meet burdensome landlord conditions.

Most leases prohibit transfers by assignment and subletting or require landlord’s prior written consent subject to meeting certain burdensome conditions. In addition, landlords often include a “change of control” provision which provides that sale of a controlling interest is deemed a transfer requiring landlord consent. A health care tenant looking for flexibility for reorganization or internal transfer subject to private equity control will want to push back on change of control provisions and will want to ensure that their lease allows for certain permitted transfers that do not require landlord consent. Carving out “permitted transfers” customarily includes transfers to: (i) an affiliate of the named tenant under the lease (meaning, any entity, directly or indirectly, which controls, is controlled by or is under common control with tenant); (ii) a successor entity created by merger, consolidation or reorganization of tenant; or (iii) an entity which shall purchase all or substantially all of the assets or a controlling interest in the stock or membership of tenant. If the tenant is a management services organization (MSO), the lease should also include explicit landlord permission for a sublease between the MSO and the provider that will occupy the leased premises.

Landlords may accept the concept of permitted transfers but often seek to impose certain conditions to allowing such transfers. Certain conditions on permitted transfers are reasonable, such as requirements for advance notice, that the proposed permitted transferee assume all obligations under the lease, that the permitted transferee operate only for the permitted use set forth in the lease, and that a copy of the transfer document be provided to landlord. However, other conditions, such as requiring a net worth test for the assignee or financial reporting requirements, can be burdensome and serve to undermine the concept of permitted transfers without landlord consent. We advise our clients in these instances to push back or limit these conditions as much as possible.

Other common assignment and subletting provisions should expressly not apply to permitted transfers. These include recapture provisions which allow a landlord to terminate the lease and recapture the space, excess profit provisions which provide that any excess profits realized as the result of a transfer will be shared between landlord and tenant, and administrative fees and reimbursements to landlord which are often charged to tenants in connection with an assignment or subletting request. Restrictions on transfers should not apply to guarantor entities. Often with private equity, the guarantor is the parent entity and cannot be restricted by a landlord as to transfer, restructuring or reorganization at the top of its organization.

In the case of transfers that do not fall within the definition of “permitted transfers” and require landlord consent, a tenant will want to include language that landlord will not unreasonably withhold, condition, or delay such consent. Other tenant protections should also be considered, including a cap on administrative and review fees reimbursable by tenant to landlord, a reasonably short time period for landlord to approve or disapprove a request (i.e., 30 days) or be deemed to have approved, a reasonably short time period for landlord to exercise recapture rights or be deemed to have approved, and a provision that excess profits will be shared equally rather than all belonging to landlord.

Negotiation of assignment and subletting terms is critical for tenants, particularly with respect to private equity-owned health care tenants. The goal for tenants in negotiating these points is to provide flexibility for addressing future financial and operational needs. As with other highly negotiated lease terms, we recommend addressing assignment and subletting provisions in detail in advance in the letter of intent. This makes expectations of the parties clear, saves time and money by avoiding protracted negotiations, and results in an overall efficient lease negotiation process.

In our next post, we will cover the importance of negotiating maintenance and repair terms and will offer suggestions for limiting a tenant’s exposure.

©2024 Epstein Becker & Green, P.C. All rights reserved.
For more news on Health Care Leases, visit the NLR Health Law & Managed Care section.

The Antitrust Investigator Will See You Now: What Healthcare And Pharma Should Expect In A World Of Enhanced Antitrust Scrutiny

Highlights

  • Healthcare entities should expect heightened government scrutiny of mergers, acquisitions, and business behaviors that could be construed as restricting competition in healthcare and pharma
  • The FTC, DOJ, and HHS have advanced a “whole-of-government approach,” including data sharing, cooperative enforcement, and enhanced antitrust training
  • Businesses should take note of practices that are likely to trigger investigatory and enforcement actions

According to media reports, the Department of Justice (DOJ) has opened an antitrust investigation into UnitedHealth Group, which is the owner of the United States’ largest health insurer, UnitedHealthcare. The focus of the inquiry appears to be the relationship between the UnitedHealthcare insurance plan and one of its health services divisions, Optum, and the potential impact on rivals and consumers.

While tech giants have grabbed most of the headlines when it comes to enhanced antitrust scrutiny, this new matter is the DOJ’s second antitrust investigation into UnitedHealth Group in recent years, giving teeth to the administration’s claim that it has an aggressive antitrust policy in the healthcare sector.

In another example of increased antitrust scrutiny, the Federal Trade Commission (FTC) recently announced a new initiative in partnership with the DOJ and Department of Health and Human Services (HHS) to address what they consider to be the effects of anticompetitive behavior in the healthcare and pharmaceutical spaces. According to the government, these new efforts are aimed at lowering consumer costs and will include “partnering on new initiatives which include a joint Request for Information to seek input on how private-equity and other corporations’ control of health care is impacting Americans.”

Although interagency cooperation is the focus of the recent push to ramp up antitrust investigations and enforcement, each agency will still spearheaded their own regulatory activity.

Federal Trade Commission

FTC Chair Lina Khan has made it clear that her agency will devote more resources to enforcement in the healthcare industry, and emphasized that “safeguarding fair competition and rooting out unlawful business practices in health care markets is a top priority for the FTC.” In furtherance of these priorities, the commission has recently taken the following actions:

  • Orange Book Policy: The FTC challenged more than 100 patents held by pharmaceutical companies that they claim are inaccurately or improperly listed in the FDA’s Orange Book. The commission also released a policy statement explaining its renewed focus on Orange Book infractions.
  • Proposed Non-compete Rule: The FTC presented a new rule that would place a ban on non-compete clauses in employee contracts.

U.S. Department of Justice

Jonathan Kanter, Assistant Attorney General of the DOJ’s Antitrust Division, highlighted the division’s emphasis on the healthcare space when he said, “we are committed to weeding out anticompetitive practices and market consolidation that hinder Americans’ access to quality care at affordable rates, or deprive health care workers of fair wages and opportunity.” The following are just a few examples of how the DOJ has implemented this renewed focus:

  • Criminal Penalties: Recently, the DOJ’s Antitrust Division successfully secured a deferred prosecution agreement against Teva Pharmaceuticals, obtaining the largest monetary penalty ever (over $200 million) against a purely domestic producer that was allegedly operating an antitrust cartel.
  • Blocked Mergers: The Antitrust Division filed a suit to stop Aon plc’s $30 billion proposal to acquire Willis Towers Watson, two of the three largest brokers of health insurance and retirement benefits consulting. The companies later ceased their pursuit of the merger.

U.S. Department of Health and Human Services

HHS Secretary Xavier Becerra made his agency’s priorities clear when he recently stated that “the Biden-Harris Administration remains laser-focused on increasing access to high-quality, affordable health care for all Americans, like by making hearing aids available for sale over the counter and lowering prescription drug costs through the Inflation Reduction Act.” The department’s initiatives have included:

  • Ownership Transparency: For the first time, HHS, via the Centers for Medicare & Medicaid Services, made ownership data available on federal qualified health centers and rural health clinics on data.cms.gov. HHS hopes the release of this data will help catalyze enforcement actions by identifying common ownership.
  • Medicare Advantage Marketing: HHS also announced new efforts to crack down on what it considers “predatory marketing” that seeks to steer patients towards Medicare Advantage plans that “may not best meet their needs.”

Takeaways

In light of the government’s renewed focus on increased competition, expanded enforcement actions, access to quality care, more affordable services and products, and transparency of ownership in the healthcare and pharmaceutical industries, legal and compliance departments should consider being proactive about conducting thorough reviews of current practices. This is particularly true for mergers and acquisitions, competitive strategies, and pricing decisions, which are the business activities most likely to conflict with these recently energized regulatory bodies. Even healthcare providers with stellar compliance programs should expect to receive more frequent and targeted requests for information from enforcement authorities about their business partners, payors, and marketing practices.

© 2024 BARNES & THORNBURG LLP
For more news on Antitrust Enforcement in the Healthcare Sector, visit the NLR Health Law & Managed Care section.

Concussions and Their Impact: Recognizing the Signs and Seeking Help

A concussion is a mild form of traumatic brain injury and is usually caused by blunt force to the head. In some cases, it can result from a back-and-forth jerking of the head, resulting in the brain matter being dashed against the skull wall. It’s a pretty common injury in children, individuals engaged in contact sports, and Michigan car accidents.

Most concussions are not life-threatening. However, some cases can develop complications that could significantly impact a victim’s life. So, the first step in getting timely treatment is understanding its symptoms and what you ought to do after suffering an injury.

Signs and Symptoms of a Concussion

Symptoms and signs of a concussion fall into three categories: physical, cognitive, and psychological or emotional.

PHYSICAL SYMPTOMS

Where a significant blow to the head causes a concussion, the victim could pass out for a few seconds. However, this is not always the case, so you cannot use passing out as the litmus test for concussions. Often, patients exhibit symptoms like headaches, nausea and vomiting, blurred vision, dizziness, loss of balance, slurred speech, fatigue, ringing ears, tingling in the hands, loss of taste or smell, etc.

COGNITIVE SYMPTOMS

With a concussion being a brain injury, it is unsurprising that it may cause problems with brain function. In some patients, a concussion will cause problems with concentration, confusion, forgetfulness, feeling slowed down in your thinking, and trouble finding words.

EMOTIONAL SYMPTOMS

A concussion can, in some patients, cause emotional problems, resulting in a deviation from a person’s normal behavior. For example, patients may become easily irritable, report feeling foggy or “out of it,” experience immense sadness, and have anxiety.

When to See a Doctor

In most cases, symptoms of a concussion will start to show immediately after an accident, in which case seeing a doctor makes absolute sense. However, concussions are among the few types of injuries that tend to have delayed onset. In some cases, it can take up to 72 hours or even more for the first signs of a concussion to show.

If you are in an accident where you have suffered a blow to the head or are violently shaken, it is always a good idea to see a doctor. You may not have to call 911 if your symptoms are not as severe, but it is best to see a doctor on the same day or within 72 hours of an accident at most.

Timely medical interventions help in several ways. It helps stop the deterioration of an injury, shortens recovery time, and provides the documentation necessary for filing a personal injury claim if you intend to seek compensation.

What to Do To Recover Damages

Once your health is taken care of, focus on evidence gathering, starting with scene documentation in pictures and video. If there were any witnesses to the incident, talk to them, record their statements, and get their contacts so you can easily trace them if you need help with your case. If it is a car accident, you will need to get the other driver’s insurance and vehicle registration details.

Besides evidence, you need to prepare for the legal battle. It doesn’t always have to go all the way to court, but you will still need to work with a personal injury lawyer to get the best chances at recovering fair compensation.

Personal injury lawyers bring knowledge, investigation and evidence-gathering skills, negotiation skills, and respect, which altogether help you in mitigating mistakes and increasing your chances of getting a fair outcome.

Buckfire & Buckfire, P.C. 2024
For more news on How to Handle a Concussion, visit the NLR Health Law & Managed Care section.

In Alabama, Pre-Embryos are “Extrauterine Children” Under the State’s Wrongful Death Statute

Background

On February 16, 2024, the Alabama Supreme Court issued an opinion in the consolidated cases LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine et al., SC-2022-0579, in which the Court reversed a trial court’s dismissal of the plaintiffs’ civil wrongful-death claims and allowed the plaintiffs to move forward with a cause of action under the Alabama Wrongful Death of a Minor Act (the “Act”).[1] In so holding, the Alabama Supreme Court found that fertilized pre-embryos stored outside of the human body are “extrauterine children” and thus are included in the definition of “minor children” for purposes of the Act.

Originally passed in 1872, when in-vitro fertilization (“IVF”) would have been considered science fiction, the Act allows the parents or legal representatives of a “minor child” to sue defendants in civil court for monetary damages for “any wrongful act, omission, or negligence” that caused the minor child’s death.[2] However, the Act does not define “child” or “minor child”. Instead, the Court relied on prior cases that interpreted the term “minor child” to include an “unborn child . . . regardless of the child’s viability or stage of development”.[3] The Court then extended that meaning to include pre-embryos, reasoning that “extrauterine children” must be children based on the Court’s interpretation of the dictionary definition of the meaning of the word “child”. As a result, the Court has created a pathway for plaintiffs to sue IVF providers under civil law for the wrongful death of a minor child for having terminated pre-embryos in Alabama. This type of decision has been a goal for those in the fetal personhood movement.[4]

Scope of the Alabama Supreme Court Decision

This decision is rightfully garnering attention from the IVF provider community and the wider public because it may be the first time a court has conferred even limited “personhood” rights to a pre-embryo that has never entered a human body. Historically, pre-embryos have been treated as property and have been the subject of disputes in the family law context across the country.[5] While some state abortion bans prohibit termination from the point of fertilization, such bans tend to govern only the activity that occurs within a uterus or at least within the human body.[6] Instead, re-classifying pre-embryos as human children in all contexts could make IVF treatment using pre-embryos impossible. For example, common practices such as cryogenic freezing of pre-embryos for long-term storage or disposal of stored pre-embryos for medical research purposes could be considered child endangerment or even homicide.

However, the Alabama Supreme Court’s decision is limited to the interpretation of what constitutes a “minor child” under the Act. The majority did not interpret the meaning of what constitutes a human being or a child under any other Alabama law. Thus, for the moment, the immediate impact of this decision is on the application of a particular statute – the Alabama Wrongful Death of a Minor Act – in a particular context – the alleged negligent termination of pre-embryos by a rogue patient in a fertility clinic.

Further, the Court did not resolve the defendant clinics’ claims that the plaintiffs waived the possibility of raising wrongful death claims by signing contracts with the defendant clinics that contained provisions governing the destruction of pre-embryos that had remained frozen for longer than five years, donation of pre-embryos to medical research, or discarding “abnormal embryos” created through IVF. Instead, the Court acknowledged the need for further briefing on whether the plaintiffs had indeed contractually waived wrongful death claims or were otherwise equitably estopped from bringing them against the defendant clinics.

In the near term, the defendant clinics could ask the Alabama Supreme Court to reconsider its decision, or the defendant clinics could petition the United States Supreme Court for certiorari. In the long term, the defendant clinics and other IVF providers could petition the Alabama legislature for an amendment to the Act that would define “minor child” in a manner that would exclude pre-embryos created and stored outside of the human body.

Impact on IVF in Alabama

Though the Alabama Supreme Court confined its holding to Alabama’s Wrongful Death of a Minor Statute, the limited nature of the ruling is causing confusion and uncertainty around what is and what is not allowed under Alabama law. For example, some fertility providers in the state have announced that they will pause IVF treatments to evaluate the impact of the Court’s decision.[7]

The majority justices were careful not to extend this interpretation of the meaning of a “child” to the state’s criminal code or other portions of Alabama law. Some future action would be required to apply this ruling beyond Alabama’s wrongful death statute, such as future litigation. Alabama’s criminal homicide and assault laws, at least, apply only to “unborn children in utero”.[8] Nevertheless, IVF clinics and providers in Alabama may not wish to serve as test cases for a possible expansion of the Alabama Supreme Court’s logic in the present case to laws such as Alabama’s child abuse and neglect laws, where the term “child” is similarly underdefined.[9] Alabama already has used Alabama’s child abuse and neglect laws to prosecute pregnant women for alleged harms to “unborn” children under a theory of child endangerment.[10] Moreover, aggravated child abuse – which includes abuse on more than one occasion or abuse that causes “serious physical injury” – is a felony in Alabama.[11]

At present, the most significant difference between allowing a plaintiff in Alabama to sue an IVF provider for the destruction of pre-embryos as property based on a theory of negligence versus allowing a plaintiff to sue for the wrongful death of a human child is the availability of punitive damages – plaintiffs cannot recover punitive damages from a claim of negligence in Alabama.[12] Moreover, there are no caps on punitive damages in wrongful death cases in Alabama[13] and thus, awards for damages can be exponentially higher in a wrongful death case.

At the very least, IVF providers in Alabama who wish to continue to offer the full range of IVF services in Alabama should evaluate whether they have in place appropriate controls to ensure pre-embryos are safely and securely stored and should also review insurance policies to ensure adequate coverage, given the possibility of expanding liability. Cautious providers in Alabama may choose to limit services, such as limiting the number of retrievals, so that no more than one pre-embryo is created at a time or eliminate storage options for multiple pre-embryos such as cryogenic freezing or only freezing eggs with the possibility of crossing state lines when it is time for the creation of the embryo. Unfortunately for patients in need of assisted reproductive therapies, the chilling effect of the Alabama Supreme Court’s decision in this case may mean some providers in Alabama may stop providing IVF services altogether. It will be interesting to see how other states respond in light of this new decision from the Alabama Supreme Court.

ENDNOTES

[1] Ala. Code § 6-5-391 (“When the death of a minor child is caused by the wrongful act, omission, or negligence of any person, persons, or corporation, or the servants or agents of either, the father, or the mother as specified in Section 6-5-390, or, if the father and mother are both dead or if they decline to commence the action, or fail to do so, within six months from the death of the minor, the personal representative of the minor may commence an action.”).

[2] Id.

[3] Citing Mack v. Carmack, 79 So. 3d 597 (Ala. 2011).

[4] See, e.g., Bloomberg Law, Alabama Embryo Ruling Gives Boost to Fetal Personhood Movement (Feb. 21, 2024)

[5] See, e.g., Davis v. Davis, 842 S.W.2d 588, 594 (Tenn. 1992), on reh’g in part, No. 34, 1992 WL 341632 (Tenn. Nov. 23, 1992) (“One of the fundamental issues the inquiry poses is whether the preembryos in this case should be considered “persons” or “property” in the contemplation of the law. The Court of Appeals held, correctly, that they cannot be considered “persons” under Tennessee law[.]”

[6] See, e.g., Idaho Code § 18-604(1) (““Abortion” means the use of any means to intentionally terminate the clinically diagnosable pregnancy of a woman with knowledge that the termination by those means will, with reasonable likelihood, cause the death of the unborn child”) and Idaho Code § 18-604(11) (““Pregnant” and “pregnancy.” Each term shall mean the reproductive condition of having a developing fetus in the body and commences with fertilization.”).

[7] Associated Press, Alabama hospital puts pause on IVF in wake of ruling saying frozen embryos are children (Feb. 21, 2024).

[8] Ala. Code § 13A-6-1 (emphasis added).

[9] See Ala. Code § 26-14-1 (defining “child” as “[a] person under the age of 18 years.”)

[10] Hicks v. State, 153 So. 3d 53, 58 (Ala. 2014). Note also that the Alabama Supreme Court in the present case cited to Hicks – which held that the term “child” included an “unborn” child – in support of extending the definition of “unborn child” to include an “extrauterine child”.

[11] Ala. Code § 26-15-3.1.

[12] Lafarge N. Am., Inc. v. Nord, 86 So. 3d 326, 335 (Ala. 2011) (“Punitive damages cannot be awarded on a negligence claim[.]”)

[13] Ala. Code § 6-11-21(j); see also Springhill Hosps., Inc. v. Patricia Bilbrey W., No. SC-2022-0719 (Ala. Aug. 4, 2023).

©2024 Epstein Becker & Green, P.C. All rights reserved.

by: Erin Sutton , Lynn Shapiro Snyder , Amy K. Dow , Susan Gross Sholinsky of Epstein Becker & Green, P.C.

For more news on the Alabama Supreme Court’s IVF Decision, visit the NLR Litigation / Trial Practice section.