Category: Health

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.

Confronting Cognitive Abilities in Well-Rounded Estate Planning

Ask anyone how they would define “trusts and estates law” and the odds are the answer will uniformly focus on the act of making the plan as to who will receive a person’s assets when he or she dies.

What happens, however, when the person who makes the so-called plan loses the cognitive ability not only to plan, but further, to carry on with the tasks of ordinary daily living. When that happens, the person we expect to be planning may be taking actions that unbeknownst to him or her are, in fact, jeopardizing the financial well-being of the estate in question and the ultimate inheritance that he or she intends for his or her loved ones to receive upon his or her death.

A recent decision from the Supreme Court, Suffolk County (Acting Justice Chris Ann Kelley), In the Matter of the Application of T.K., 2024 N.Y. Slip Op. 50045 (Suffolk Cnty. Sup. Ct. 2024), illustrates what can happen when the person whom we expect to make the estate plan is no longer competent to protect the very assets contemplated for disposition under that plan.

In T.K., a petition was filed by T.K. (son of K.K.) seeking the appointment of a guardian for his father’s personal needs and property management under Article 81 of the New York Mental Hygiene Law. The basis for the petition was that T.K.’s father was suffering from “severe delusions,” which put his well-being at risk of imminent harm, and which could cause “catastrophic financial loss.”

K.K., the alleged incapacitated person (“AIP”) was an 80-year-old retired advertising executive. He resided with his wife of more than 50 years. T.K. testified that his father had deteriorated mentally over the past 10 years, including more regular consumption of alcohol in large quantities. Of most concern, the AIP had a 15-year business relationship with “Hugh Austin” (“Mr. Austin”), who lived two miles away from the AIP.

T.K. testified that his father had given Mr. Austin approximately $2,500,000 as part of a so-called investment in Mr. Austin’s businesses, which the AIP believed would result in an “imminent return” to the tune of millions of dollars—the AIP never received any money back from Mr. Austin.

Mr. Austin (and his son), meanwhile, was indicted for fraud crimes against 20 victims in excess of $10 million. Yet, the AIP insisted that Mr. Austin “has done nothing wrong.” While Mr. Austin was under house arrest, the AIP continued to meet with him.

The Court Evaluator reported that the AIP had become a “willing participant” in the exploitation perpetrated by Mr. Austin, luring the father into investments coupled with promises of major returns. The evidence also showed that the AIP’s funds were used to pay Mr. Austin’s personal expenses, including trips to Las Vegas. Cash App payments, and various other non-“business-related” charges.

The Court ultimately found that there was a substantial likelihood that the AIP would continue to engage in self-harming activities as a result of years of being psychologically victimized by Mr. Austin. Such victimization caused psychological stress to the AIP, which manifested itself in the forms of “substantial weight loss, excessive consumption of alcohol and diminished abilities to concentrate and communicate.”

In view of the foregoing, the Court appointed a property management guardian to prevent the AIP from self-harm “by reason of his functional limitations and lack of understanding and appreciation of them.”

Many of us have lived the experience of having a parent, or grandparent, lose cognitive functioning to the point where it is inconceivable that such a person could be in any position to properly plan for the disposition of his or her assets.

The T.K. decision presents another reminder as to why a critical element of estate planning is not just the plan to dispose of one’s assets, but also, defining how to implement that plan when the individual himself or herself is no longer able to carry out the directives of that very plan, and to ensure that a plan is in place to address the situation where the individual lacks the necessary capacity to continue to make decisions with respect to his or her own personal affairs.

These are difficult discussions to have, particularly amidst a culture that walks on eggshells when topics such as death and divorce enter the fray. But to ignore these discussions within our own families, and separately, with our trusts and estates counsel, is a mistake; they are elemental to proper estate planning, not to mention the acceptance of reality.

© 2024 Blank Rome LLP
For more news on Estate Planning, visit the NLR Estates & Trusts section.

Minimizing National Labor Relations Act Liability for Employers with Non-Unionized Workforces

This post continues our consideration of comments submitted in response to proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA).

Under current law, if a plan provides any mental health or substance use disorder (MH/SUD) benefits in any classification of benefits, benefits for that condition or use disorder must be provided in every classification in which medical/surgical (M/S) benefits are provided. Classifications for this purpose include inpatient, in-network; inpatient, out-of-network; outpatient, in-network; outpatient, out-of-network; emergency care; and prescription drugs. The proposed regulations modify this standard by providing that a plan does not provide benefits for MH/SUD benefits in every classification in which M/S benefits are provided unless the plan provides meaningful benefits for treatment for the condition or disorder in each such classification “as determined in comparison to the benefits provided for medical/surgical conditions in the classification.”

The term “meaningful benefits” is nowhere defined. The regulators nevertheless “recognize that the proposal to require meaningful benefits [ ] is related to scope of services.” “Scope of services” for this purpose generally refers to the types of treatments and treatment settings that are covered by a group health plan or health insurance issuer. The preamble to the proposed regulation invites comments on how the meaningful benefits requirement “would interact with the approach related to scope of services adopted under the 2013 final regulations.” The preamble of the 2013 final regulations addressed an issue characterized as ‘‘scope of services’’ or ‘‘continuum of care’’ but otherwise failed to provide any substance. Two examples from the proposed regulations do, however, give us a sense of what the regulators have in mind.

  • A plan that generally covers treatment for autism spectrum disorder (ASD), a mental health condition, and covers outpatient, out-of-network developmental evaluations for ASD but excludes all other benefits for outpatient treatment for ASD, including applied behavior analysis (ABA) therapy, when provided on an out-of-network basis. (ABA therapy is one of the primary treatments for ASD in children.) The plan generally covers the full range of outpatient treatments and treatment settings for M/S conditions and procedures when provided on an out-of-network basis. The plan in this example violates the applicable parity standards.
  • In another example, a plan generally covers diagnosis and treatment for eating disorders, a mental health condition, but specifically excludes coverage for nutrition counseling to treat eating disorders, including in the outpatient, in-network classification. Nutrition counseling is one of the primary treatments for eating disorders. The plan generally provides benefits for the primary treatments for medical conditions and surgical procedures in the outpatient, in-network classification. The exclusion of coverage for nutrition counseling for eating disorders results in the plan failing to provide meaningful benefits for the treatment of eating disorders in the outpatient, in-network classification, as determined in comparison to the benefits provided for M/S conditions in the classification. Therefore, the plan violates the proposed rules.

Notably, the newly proposed meaningful benefits requirement is separate from, and in addition to, the newly prescribed nonquantitative treatment limitation (NQTL) testing standards. These latter standards include a “no more restrictive” requirement, a “design and application” requirement and an “outcomes data and network composition” requirement. A handful of comments nevertheless urge the regulators to add scope of services to its non-exhaustive list of NQTLs. As a result, a plan’s scope of services would be subject to comprehensive NQTL testing. Or, put another way, they would be fed back into the NQTL testing loop. Using the first of the examples above, this would require that ABA therapy to be first compared to the treatment limitations imposed on some M/S benefits in each classification. But what benefits, exactly? The problem is that a plan’s scope of services – what types of treatments a plan will pay for and in what settings – is a high-level plan design feature and not an NQTL.

While reasonable minds can and do differ on much of the substance of the proposed regulations, we doubt that anyone would claim that they streamline or simplify compliance. Compliance with these rules is already complicated and expensive; if the final rule looks anything like the proposed regulations, compliance will only get more complicated and more expensive. The proposed meaningful benefits requirement is intended to prevent plans, as a matter of plan design, from satisfying the parity rules by offering nominal or insubstantial MH/SUD benefits when compared to similar M/S benefits in each classification. Treating a plan’s scope of services as itself a separate NQTL does not advance this goal.

© 2024 McDermott Will & Emery
by: Alden J. Bianchi of McDermott Will & Emery 

For more news on Health Care Law, visit the NLR Health Law and Managed Care section.

WHO Publishes Guidance for Ethics and Governance of AI for Healthcare Sector

The World Health Organization (WHO) recently published “Ethics and Governance of Artificial Intelligence for Health: Guidance on large multi-modal models” (LMMs), which is designed to provide “guidance to assist Member States in mapping the benefits and challenges associated with the use of for health and in developing policies and practices for appropriate development, provision and use. The guidance includes recommendations for governance within companies, by governments, and through international collaboration, aligned with the guiding principles. The principles and recommendations, which account for the unique ways in which humans can use generative AI for health, are the basis of this guidance.”

The guidance focused on one type of generative AI, large multi-modal models (LMMs), “which can accept one or more type of data input and generate diverse outputs that are not limited to the type of data fed into the algorithm.” According to the report, LMMs have “been adopted faster than any consumer application in history.” The report outlines the benefits and risks of LLMs, particularly the risk of using LLMs in the healthcare sector.

The report proposes solutions to address the risks of using LMMs in health care during development, provision, and deployment of LMMs and ethics and governance of LLMs, “what can be done, and by who.”

In the ever-changing world of AI, this is one report that is timely and provides steps and solutions to follow to tackle the risk of using LMMs.

Copyright © 2024 Robinson & Cole LLP. All rights reserved.
For more news on AI in Healthcare, visit the NLR Health Law & Managed Care section.

2024: The Year of the Telehealth Cliff

What does December 31, 2024, mean to you? New Year’s Eve? Post-2024 election? Too far away to know?

Our answer: December 31, 2024, is when we will go over a “telehealth cliff” if Congress fails to act before that date, directly impacting care and access for Medicare beneficiaries. What is this telehealth cliff? Let’s back up a bit.

TELEHEALTH COVERAGE POLICIES

Current statute (1834(m) of the Social Security Act) lays out payment and coverage policies for Medicare telehealth services. As written, the provisions significantly limit Medicare providers’—and therefore patients’—ability to utilize telehealth services. Some examples:

  • If the patient is in their home when the telehealth service is being provided, telehealth is generally not eligible for reimbursement.
  • Providers cannot bill for telehealth services provided via audio-only communication.
  • There is a narrow list of providers who are eligible to seek reimbursement for telehealth services.

COVID-19-RELATED TELEHEALTH FLEXIBILITIES

When the COVID-19 pandemic hit in 2020, a public health emergency (PHE) was declared. Congress passed several laws, and the administration acted through its own authorities to provide flexibilities around these Medicare telehealth restrictions. In general, nearly all statutory limitations on telehealth were lifted during the PHE. As we all know, utilization of telehealth skyrocketed.

The PHE ended last year, and through subsequent congressional efforts and regulatory actions by the Centers for Medicare and Medicaid Services (CMS), many flexibilities were extended beyond the end of the PHE, through December 31, 2024. Congress and CMS continue to grapple with how to support the provision of Medicare telehealth services for the future.

CMS has taken steps through the annual payment rule, the Medicare Physician Fee Schedule (MPFS), to align many of the payment and coverage policies for which it has regulatory authority with congressional deadlines. CMS has also restructured its telehealth list, giving more clarity to stakeholders and Congress as to which pandemic-era telehealth services could continue if an extension is passed. But CMS can’t address the statutory limitations on its own. Congress must legislate. CMS highlighted this in the final calendar year (CY) 2024 MPFS rule released on November 2, 2023, noting that “while the CAA, 2023, does extend certain COVID-19 PHE flexibilities, including allowing the beneficiary’s home to serve as an originating site, such flexibilities are only extended through the end of CY 2024.”

THE TELEHEALTH CLIFF

This brings us to the telehealth cliff. CMS generally releases the annual MPFS proposed rule in July, with the final rule coming on or around November 1. If history is any indication, Congress is not likely to act on the extensions much before the current December 31 deadline. This sets up the potential for a high level of uncertainty headed into 2025.

If we go over, this telehealth cliff would directly impact care and access for Medicare beneficiaries. The effects could be felt acutely in rural and underserved areas, where patients have been able to access, via telehealth, medical services that may have been out of reach for them in the past. The telehealth cliff would also impact how providers interact with their patients, and their collective ability to continue to utilize telehealth in a way that has benefited patients and providers alike. It could also influence how health plans choose to cover these services in the private marketplace beyond 2024. Such a dramatic change would impact business decisions for many providers and practices heading into 2025. And, at a time when provider shortages are still a significant issue, it would eliminate an option that has allowed many providers, practices and facilities to extend scarce resources for patient care.

TAKE ACTION

Stakeholders should be raising these concerns to Congress now. There are many ways to engage, including reaching out directly to key Members of Congress, looking for opportunities to testify or submit written testimony for relevant congressional hearings, and participating in organized events where Members of Congress will be present. This cliff can be avoided, but not without a concentrated effort and a lot of noise.

© 2024 McDermott Will & Emery
For more on Telehealth, visit the NLR Communications, Media & Internet section.

OSHA and NLRB Set Forth MOU to Strengthen Protections for the Health and Safety of Workers: A 2024 Outlook

On October 31, 2023, the National Labor Relations Board (NLRB) and Occupational Safety and Health Administration (OSHA) entered into a Memorandum of Understanding (MOU) to strengthen their interagency partnership. The purpose of this partnership is to establish a process for information sharing, referrals, training, and outreach between the agencies. Additionally, the agencies wish to address certain anti-retaliation and whistleblowing issues through this collaboration.

Since 1975, the NLRB and OSHA have engaged in cooperative efforts during investigations. According to NLRB General Counsel Jennifer Abruzzo and OSHA Assistant Secretary Doug Parker, the MOU seeks to strengthen this interoffice coordination in an effort to provide greater protection for workers to speak out on unsafe working conditions without fear of punishment or termination.

Exchange of Information

According to the MOU, the NLRB and OSHA “may share, either upon request or upon the respective agency’s own initiative, any information or data that supports each agency’s enforcement mandates, whether obtained during an investigation or through any other sources.” This information may include complaint referrals and information in complaint or investigative files. The MOU notes that this information will be shared only if it is relevant or necessary to the recipient agency’s enforcement responsibilities and ensures that the sharing of information is compatible with the purposes of the agency that is collecting the records.

For example, if OSHA learns during an investigation that there are potential victims of unfair labor practices who have not filed a complaint with the NLRB, OSHA will explain the employees’ rights and provide them with the NLRB’s phone number and web address. Additionally, if an employee files with OSHA an untimely complaint of retaliation, OSHA may then advise the employee to file a complaint with the NLRB, because the NLRB has a six-month time limit for filing such complaints whereas OSHA’s time limit is only 30 days. As a result, employers may be facing both agencies during an investigation.

Coordinated Investigations and Enforcement

The NLRB and OSHA will determine whether to conduct coordinated investigations and inspections in order to facilitate appropriate enforcement actions. If coordinated investigations occur and there are overlapping statutory violations, each agency may take relevant enforcement actions. In practice, employers should assume that if either agency is conducting an investigation into alleged retaliation, that agency will consider involving the other.

Takeaways for Employers

Heading into 2024, employers can expect to see more interagency coordination between the NLRB and OSHA during investigations. While the two agencies remain separate, there is a clear entanglement of enforcement action as the NLRB seeks to increase federal agency collaboration. As such, employers may presume that information collected by one agency will be provided to the other. As the agencies seek to increase worker protection across the board, employers will want to ensure that their management personnel are trained and up-to-date on the anti-retaliation and whistleblowing provisions of the Occupational Safety and Health Act and the National Labor Relations Act.

© 2023 Jones Walker LLP
For more news on the Partnership between OSHA and NLRB, visit the NLR Labor & Employment section.

5 Trends to Watch: 2024 Artificial Intelligence

  1. Banner Year for Artificial Intelligence (AI) in Health – With AI-designed drugs entering clinical trials, growing adoption of generative AI tools in medical practices, increasing FDA approvals for AI-enabled devices, and new FDA guidance on AI usage, 2023 was a banner year for advancements in AI for medtech, healthtech, and techbio—even with the industry-wide layoffs that also hit digital and AI teams. The coming year should see continued innovation and investment in AI in areas from drug design to new devices to clinical decision support to documentation and revenue cycle management (RCM) to surgical augmented reality (AR) and more, together with the arrival of more new U.S. government guidance on and best practices for use of this fast-evolving technology.
  2. Congress and AI Regulation – Congress continues to grapple with the proper regulatory structure for AI. At a minimum, expect Congress in 2024 to continue funding AI research and the development of standards required under the Biden Administration’s October 2023 Executive Order. Congress will also debate legislation relating to the use of AI in elections, intelligence operations, military weapons systems, surveillance and reconnaissance, logistics, cybersecurity, health care, and education.
  3. New State and City Laws Governing AI’s Use in HR Decisions – Look for additional state and city laws to be enacted governing an employer’s use of AI in hiring and performance software, similar to New York City’s Local Law 144, known as the Automated Employment Decisions Tools law. More than 200 AI-related laws have been introduced in state legislatures across the country, as states move forward with their own regulation while debate over federal law continues. GT expects 2024 to bring continued guidance from the EEOC and other federal agencies, mandating notice to employees regarding the use of AI in HR-function software as well as restricting its use absent human oversight.
  4. Data Privacy Rules Collide with Use of AI – Application of existing laws to AI, both within the United States and internationally, will be a key issue as companies apply transparency, consent, automated decision making, and risk assessment requirements in existing privacy laws to AI personal information processing. U.S. states will continue to propose new privacy legislation in 2024, with new implementing regulations for previously passed laws also expected. Additionally, there’s a growing trend towards the adoption of “privacy by design” principles in AI development, ensuring privacy considerations are integrated into algorithms and platforms from the ground up. These evolving legal landscapes are not only shaping AI development but also compelling organizations to reevaluate their data strategies, balancing innovation with the imperative to protect individual privacy rights, all while trying to “future proof” AI personal information processing from privacy regulatory changes.
  5. Continued Rise in AI-Related Copyright & Patent Filings, Litigation – Expect the Patent and Copyright Offices to develop and publish guidance on issues at the intersection of AI and IP, including patent eligibility and inventorship for AI-related innovations, the scope of protection for works produced using AI, and the treatment of copyrighted works in AI training, as mandated in the Biden Administration Executive Order. IP holders are likely to become more sophisticated in how they integrate AI into their innovation and authorship workflows. And expect to see a surge in litigation around AI-generated IP, particularly given the ongoing denial of IP protection for AI-generated content and the lack of precedent in this space in general.
©2023 Greenberg Traurig, LLP. All rights reserved.
For more on AI in 2024, visit the NLR Artificial Intelligence section.

10 Market Predictions for 2024 from a Healthcare Lawyer

As a healthcare lawyer, 2023 was a pretty unusual year with the sudden entrance of a number of new players into the healthcare marketplace and a rapid retrenchment of others. With innovation showing no signs of slowing down in the year ahead, healthcare providers should consider how to adapt to improve the patient experience, increase their bottom line, and remain competitive in an evolving industry. Here are 10 personal observations of the past year that may help you plan for the year ahead.

  1. Health tech will continue to boom. Without a doubt, in my practice, health tech exploded, and understandably. In the face of tight margins, healthcare technology may offer the promise of immediate returns (think revenue cycle). But it is also important to understand the context. Health tech offers the promise of quick implementation relative to construction of clinical space, and it can be accomplished without additional clinical staff or regulatory oversight, potentially resulting in a prompt return on investment. Advancing technologies and AI will enable real-time, data driven surgical algorithms and patient-specific instruments to improve outcomes in a variety of specialties.
  2. Value-based care is here to stay. Everyone is interested in value-based care. In the past, value-based care was simply aspirational. Now, there are significant attempts to implement it on a sustained basis. It is not a coincidence that there has also been significant turnover in healthcare leadership in the past few years, and that has likely led to more receptivity.
  3. Expansion of value-based care models. There has been considerable activity around advanced primary care and single-condition chronic disease management. We are now starting to see broader efforts to manage care up and down the continuum of care, involving multi-specialty care and the gamut of care locations. Increased pressure to lower costs will result in increased volumes in lower cost, ambulatory settings.
  4. Regulatory scrutiny will continue to increase. For most, this is a given. In 2023, we saw increased scrutiny up and down the continuum, whether related to pharmaceutical costs, regulation of pharmacy benefit managers, healthcare transaction laws, or innovations in thinking around healthcare from the Federal Trade Commission. With the impending election, it is likely healthcare will receive considerable attention and scrutiny.
  5. Private equity (“PE”) will resume the march – with discipline. In my practice, PE entities rethought their growth strategies to focus on how to bring acquisitions to profitability quickly, from a “growth at all costs” mind set. Now there appears to be an increasing focus on operations and an emphasis on making realistic assumptions to underly growth. This has led to a more realistic pricing discipline and investment in management teams with operational experience.
  6. Partnerships. There is an increasing trend towards partnerships between PE entities and health systems. Health systems are under considerable financial stress, and while they do not universally welcome PE with open arms, some systems do appear open to targeted partnerships. By the same token, PE entities are beginning to realize that they require clinical assets that are most readily available at health systems. This will continue in 2024.
  7. The rise of independent physician groups. There is increasing activity among freestanding physician groups. Some doctors are leery of PE because they believe it is solely focused on profits. Similarly, many physicians are reluctant to be employed by health systems because they believe they will simply become a referral source. While we are not likely to see a return to 2002, where many PE and health system physician deals were unwound, we will see increasing growth by independent physician groups.
  8. Continued consolidation. The trend towards consolidation in healthcare is nowhere near ending. To assume risk (the ultimate goal of value-based care), providers require scale, both vertically and horizontally. While segments of healthcare slowed in 2023, a resumption of growth is inevitable.
  9. Increased insolvencies. Most healthcare providers have very high fixed costs and low margins. Small swings in accounts receivable collections, wages, and managed care payments can have a large impact on entities that are just squeezing by.
  10. New entrants. Last year saw several new entrants to the healthcare marketplace nationally. Who in 2023 would have thought Best Buy would enter the healthcare marketplace? There is still plenty of room for new models of care, which we will see in 2024.

2024 promises to be an interesting year in the healthcare industry.

© 2023 Blank Rome LLP
For more news on 2024 Healthcare Industry Laws, visit the NLR Health Law & Managed Care section.