NLRB Issues Complaint for Athlete Misclassification against NCAA, Pac-12, and USC

On May 18, 2023, the National Labor Relations Board’s (the Board) regional director in Region 31 issued a complaint against the National Collegiate Athletic Association (NCAA), the Pac-12 Conference, and the University of Southern California (USC), alleging they violated the National Labor Relations Act (the Act) by misclassifying college football and basketball players as “non-employee student-athletes.” The original charge was issued back in February 2022 and alleged all three entities were in violation of the Act as “joint employers” of these athletes.

While this issue is not necessarily new to higher education, the Board’s decision to issue a complaint—and issue that complaint against all three entities—is new ground, as it departs from a 2015 precedent and paves the way for student-athletes to unionize at potentially both private and now public institutions. Under the Act, the Board has authority over private-sector workers, while state labor boards have jurisdiction over employees at state institutions. However, because the students at issue in Thursday’s complaint would be considered employees of the private NCAA and Pac-12 as well as USC, all three entities would be subject to potential liability as “joint employers.” What this means for public institutions is that there is a real and likely potential that the “joint employer” doctrine will allow for an end run around the Act’s coverage exemption for public-sector entities. As such, all student-athletes could potentially seek to collectively bargain at the NCAA level.

Finding merit to the charge and issuing this complaint is a logical result of General Counsel (GC) Memorandum GC 21-08 issued by the Board’s GC Jennifer Abruzzo in late September 2021. At that time, we issued an alert detailing the GC’s desire to expand the definition of “employee” in order to bring scholarship collegiate athletes under the Act. In February 2022, we issued another alert detailing how USC was likely to be the test case for that endeavor.

Alleging the violation of Section 7 of the Act, Thursday’s complaint arises from charges filed by the National College Players Association, a nonprofit advocacy association founded by former UCLA football player Ramogi Huma. The charge and complaint asserted that USC, the Pac-12, and NCAA misclassified student-athletes in order to deny them their rights under the Act, including the right to speak about compensation and working conditions. In addition to the alleged misclassification issue, the complaint alleges that USC illegally obstructed athletes’ organizing by “maintaining unlawful rules and policies in its handbook, including restricting communications with third parties, in the media, etc.”

Colleges and universities may be tempted to minimize this issue by thinking that the shift to seeing student-athletes as employees would affect them only in the event their athletes attempt to form a union. That is not the case. While a Board determination that student-athletes are employees could lead to a renewed effort by college athletes to organize, the GC has already cautioned (and made good on that warning) that the Board will seek to issue unfair labor practice charges against colleges and universities that misclassify student-athletes as “non-employees” or engage in other violations of the Act. For example, the GC has previously made clear that protections afforded by the Act apply to concerted activity such as expressions of support for social justice issues and other advocacy. As such, higher education institutions would be wise to tread lightly into these waters when they arise, because where employee status exists, concerted efforts of those employees to speak their minds or speak out on certain issues will be viewed as protected under the Act.

The hearing on the Board’s complaint is set for November 7, 2023.

© Steptoe & Johnson PLLC. All Rights Reserved.

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Marijuana in the Manufacturing Workplace

The requirement to maintain a safe workplace often clashes with state and local laws that protect the rights of individuals who use marijuana while off-duty, creating unique challenges for manufacturing employers.

Manufacturing employers still may prohibit the use of marijuana at work, as well as marijuana impairment at work. But marijuana drug testing is complicated and controversial because of the legal protections for off-duty marijuana use in some states and cities, the legal protections for medical marijuana users in many jurisdictions, and because there are no drug tests that can detect current marijuana impairment or very recent use of marijuana.

Federal Law

Manufacturers no longer should defend “zero tolerance” marijuana drug testing policies. Previously, employers could argue that marijuana still is illegal under federal law or that the employer is a federal contractor that must comply with the federal Drug-Free Workplace Act. The federal government has not enforced the law that makes marijuana illegal for some time, and it has permitted states to create and enforce their own laws with respect to medical and recreational marijuana.

Some courts have recognized that the federal government is allowing state governments to regulate marijuana and, therefore, courts are enforcing state marijuana laws despite marijuana’s illegal status at the federal level. Courts also have rejected arguments that federal contractors “must follow federal law” because the federal Drug-Free Workplace Act does not require drug testing and does not permit employers to regulate off-duty conduct.

State Laws

At present, 39 states and the District of Columbia have medical marijuana laws, while 22 states and the District of Columbia have recreational marijuana laws (Maryland’s law will take effect in July and others will be enacted in the coming months). Many of these laws provide employment protections to applicants and employees. The variations in the laws make it difficult for multi-state manufacturers to have consistent marijuana policies in all locations.

What It Means for Employers

Due to the recent trend in some states to protect off-duty use of marijuana, and even prohibiting pre-employment marijuana testing, many manufacturers are discontinuing pre-employment marijuana testing, especially in states where marijuana is legal. Applicants often are surprised to learn that a positive marijuana drug test will lead to withdrawal of the job offer. If the positive marijuana drug test result is due to medical use (and there are no general off-duty protections in the state), manufacturers must be familiar with the applicable law.

Some states prohibit discrimination against medical marijuana users, while other states may allow an employer to take an adverse employment action if the job is considered “safety-sensitive,” i.e., a job with dangerous duties, as defined by applicable state law.

In certain other states where discrimination is prohibited and the manufacturing employer has safety concerns, the employer should engage in the “individualized assessment” and “direct threat analysis” required under state laws that mirror the federal Americans With Disabilities Act. This process includes discussions with the applicant and the applicant’s physician to assess the safety risk.

Reasonable suspicion marijuana testing is permissible in most states because impairment at work never is permitted. In states where off-duty marijuana use is protected, manufacturers should rely on the impaired behaviors when taking disciplinary action, rather than rely solely on the positive marijuana drug test result (assuming that testing for marijuana is permitted). This is because marijuana stays in the human body for a long time, so the positive drug test result is not conclusive proof that the employee was impaired at work. Manufacturers also should make sure that supervisors and managers are trained to observe and document reasonable suspicion determinations properly, as these documented observations will be key evidence in a potential lawsuit.

To make matters even more complicated, CBD (cannabidiol), “low THC,” and hemp products are being marketed and sold everywhere since Congress legalized hemp (having no more than 0.3 percent THC, the psychoactive component of marijuana) in 2018. Separate from marijuana laws, the use of “low THC” or CBD products is allowed in a number of states, usually for medical purposes, which means that manufacturing employers should tread carefully when an applicant or employee claims to use CBD products for medical reasons. While many CBD and hemp products are marketed as having little or no THC, these statements may not be true, because the U.S. Food and Drug Administration does not yet regulate them. These products may cause positive drug test results for marijuana. There has been an increase in lawsuits where former employees claim that their positive marijuana drug test results allegedly were caused by CBD products.

While it appears that marijuana eventually will be legalized at the federal level, manufacturers must ensure they are complying with all applicable laws. Manufacturing employers should:

  • Review drug and alcohol policies for compliance with applicable drug testing and marijuana laws;
  • Remove marijuana from the drug testing panel in locations where testing for marijuana is prohibited and locations where off-duty use is protected and consider removing it in other locations where it may be an obstacle in the hiring process;
  • Train Human Resources employees and other managers to engage in the interactive process with employees who use medical marijuana (or medical CBD products); and
  • Train supervisors to make appropriate and timely “reasonable suspicion” determinations.

Jackson Lewis P.C. © 2023

For more cannabis legal news, click here to visit the National Law Review.

CMS Takes Steps to Lower SNF Medicare Payment Error Rates

With the Medicare Comprehensive Error Rate Testing program projected error rate for skilled nursing facilities (SNFs) showing a significant increase in 2022 (15.1%, up from 7.9% in 2021), the Centers for Medicare and Medicaid Services (CMS) has instructed each of its Medicare Administrative Contractors (MACs) that review SNF Medicare claims to initiate a five-claim probe and educate medical review for each SNF in the MAC’s jurisdiction.

CMS surmises that the source of the increase in improper payments may lie with the change from resource utilization group (RUG) IV to the patient driven payment model (PDPM) and has noted that the primary root cause of SNF errors is missing documentation.

MACs are instructed to implement the five-claim probe on a rolling basis beginning with the top 20% of SNFs that show the highest risk. If any improper payments are identified, the MAC will adjust (or deny) the claim(s) and offer either widespread education or 1:1 individualized education depending on the error rate. 1:1 education will include claim specific information and allow the SNF to review the claim decision, ask questions and receive feedback.

Beginning June 5, 2023, SNFs nation-wide should be on the lookout for a prepayment probe and educate record request from the MAC and be prepared to respond within 45 days.

Copyright © 2023, Sheppard Mullin Richter & Hampton LLP.

For more Healthcare Legal News, click here to visit the National Law Review.

No More Surprise Medical Bills: Providers Score More Victories in First Year of No Surprises Act Arbitrations, But Claims Backlog Otherwise Complicates Implementation

In the year following the implementation of the arbitration process established under the federal No Surprises Act (NSA), more than 330,000 disputes have been submitted for resolution. This figure far outpaces the predictions of the US Departments of Health and Human Services (HHS), Labor, and the Treasury (the Departments), and complicates the implementation of the NSA.

*This is the eighth article in a series analyzing the No Surprises Act and its implementation. To view the entire series, click here.

As background, Congress passed the NSA in 2020, effective in 2022, to curb so-called “surprise” medical bills — balance bills received by patients in situations where they have no control over who is involved in their care. Frequently, patients incur these bills when they obtain emergency care from out-of-network facilities or non-emergency services at in-network facilities where at least one member of the care team is out-of-network. In these situations, the NSA forbids out-of-network providers from balance billing the patients to collect the difference between billed charges and what the patient’s health insurance actually paid. Instead, to protect patients and ensure that reasonable payments are made to providers, the NSA establishes an alternative dispute resolution process, allowing eligible parties to submit disputed claims to independent dispute resolution entities (IDREs) to determine appropriate out-of-network payment rates.

Dispute resolution was intended to be streamlined and efficient, but IDREs have been inundated with submissions in the year since the NSA became effective. The volume of claims has created a significant backlog, hindering providers’ ability to obtain timely and appropriate reimbursement for the services they rendered. In an effort to promote transparency, the Departments recently issued a “status update” on the arbitration process. The report revealed several key findings regarding the volume, eligibility, and outcomes of claims submitted under the NSA to date.

Key Findings of the Status Update Report

First, the report provided insight into the overall numbers of claims that have been filed since the NSA became effective. Since the federal claims submission portal first went live in April 2022, disputing parties have initiated more than 330,000 arbitration submissions. This figure is nearly 14 times greater than the Departments’ initial estimates. The sheer volume of claims has drastically slowed the adjudication of claims submitted under the NSA.

Second, the report states that IDREs have rendered determinations in favor of one party or the other in only a small fraction of cases, with approximately 42,000 disputes decided as of March 31, 2023. Of these, initiating parties (typically health care providers) have prevailed approximately 71% of the time.

Third, to date, IDREs have closed more cases than they have decided. Overall, more than 100,000 claims,  – more than four times the amount anticipated by the Departments, have been closed. There are various reasons for this. Some claims were closed following successful negotiations between the parties. Others were closed due to one or both parties failing to submit the required fees mandated under the NSA. A large number — nearly 40,000 — were closed for eligibility reasons. Non-initiating parties have challenged the eligibility of more than a third of claims submitted for arbitration, balking at approximately 120,000 disputes. Non-initiating parties frequently object that claims are not eligible for arbitration under the NSA for multiple reasons, including lack of timely negotiation or arbitration submission, or because the disputed claims involve insurance programs outside the scope of the NSA.

In addition to the objections lodged by non-initiating parties, the IDREs have an independent duty to confirm that all claims submitted for arbitration are eligible under the NSA. These determinations require IDREs to engage in what can be a complex and time-consuming analysis of each claim, frequently requiring the submission of additional information from the parties. The report finds that these eligibility determinations represent the primary cause for the delays in processing arbitration submissions.

Finally, in an effort to help resolve delays, the status update includes that the Departments have begun to require initiating parties to submit additional information to assist IDREs in evaluating the eligibility of claims. The Departments have also modified the arbitration portal to require the input of additional information to enable non-initiating parties to identify disputed claims. These are among the “ongoing technical and operational improvements” the report states the Departments have been making over the last year.

Looking Ahead: Additional Legislation and Ongoing Court Challenges

The report highlights a series of problems that have hampered the implementation of the NSA, including larger-than-expected dispute volume, complex eligibility determinations, and technical issues. Collectively, these problems have left many parties awaiting arbitration awards and payment.

Meanwhile, the legal challenges to the Departments’ implementing regulations under the NSA continue, and HHS Secretary Xavier Bacerra recently testified before Congress regarding the implementation of the NSA. These developments have fueled speculation that Congress may step in and pass additional legislation to streamline the arbitration process. While these events play out, providers should continue to submit timely open negotiation notices and IDR initiation forms to preserve their rights under the NSA.

A copy of CMS’s report can be found here.

© 2023 ArentFox Schiff LLP

For more Healthcare Legal News, click here to visit the National Law Review.

Upstream and Affiliate Guaranties in NAV Loans

Guaranties are a common feature in fund finance transactions. Particularly in NAV loans, upstream and affiliate (or “sideways”) guaranties are used. Below we discuss some of the context for the use of these types of guaranties, as well as some of the issues that lenders should consider in relying on them.

Upstream Guaranties

It is not uncommon in NAV loan transactions for the borrower to hold the underwritten assets for the financing (i.e., the fund’s portfolio of investments) through one or more controlled subsidiary holding vehicles (each, a “HoldCo”). Lenders may take a pledge of the management and economic interests in the HoldCos (rather than the underlying investments). In order to get as close to the underlying investments as possible (without taking a pledge), lenders may require that a HoldCo issue a guaranty directly to the lenders (or the administrative agent, on behalf of the lenders), guaranteeing the borrower’s obligations under the NAV loan facility. This “upstream” guaranty provides the lenders a direct claim against the HoldCo for amounts due under the loan, mitigating some of the risk of structural subordination to potential creditors (expected or unexpected) at the level of the HoldCo.[1]

Affiliate Guaranties

It is also common in NAV loan facilities for the borrower’s portfolio of investments to be held by multiple subsidiaries and/or affiliates of the borrower. Each such subsidiary or affiliate may be designated as a guarantor for repayment of the loan. As a result, such entities end up guaranteeing the obligations of their affiliates. The purpose of these affiliate guaranties is the same as the upstream guaranties discussed above – namely, to provide the lenders with a more direct enforcement claim in a default scenario.

Use of Such Guaranties

Motivations for the use of such upstream and affiliate guaranties may include:

a lender’s desire to underwrite a broader portfolio of investments, mitigating concentration risk to the portfolio of a single holding entity;
a lender’s desire to ensure that it is not subordinate to creditors that may arise at the level of the entity that directly owns the investment; or
a borrower’s desire to obtain a higher loan-to-value ratio than the lenders would otherwise provide based on the investments alone.
While upstream and affiliate guaranties can help to address these issues, they may raise nuanced legal issues that should be discussed with counsel in light of the relevant facts and circumstances.

Enforceability Considerations

Guaranties constitute the assumption of the liabilities of another entity and are contingent claims against the guarantor. Under certain insolvency laws, guaranties may be subject to challenge, and payments under guaranties may be subject to avoidance. Upstream or affiliate guaranties may be subject to heightened scrutiny and challenge in a bankruptcy or distress scenario. Below are a few potential issues lenders should bear in mind with respect to upstream and affiliate guaranties.

1. Constructively Fraudulent Transfer Avoidance. Under Bankruptcy Code section 548 and certain state laws, (a) transfers of property (including grants of security interests or liens), or (b) obligations assumed (such as incurring a loan or guaranty obligation) may be avoided as constructively fraudulent if BOTH of the following requirements are satisfied:[2]

  • (i) the transferor/guarantor does not receive reasonably equivalent value; AND
  • (ii) the transferor/guarantor is insolvent or undercapitalized or rendered insolvent, undercapitalized or unable to pay its debts because of the transfer or the assumed liability.

A guaranty by a parent of the obligations of a wholly owned and solvent subsidiary, a so-called downstream guaranty, is generally regarded as providing the parent with reasonably equivalent value through an enhancement of the value of its equity ownership of the subsidiary.

Upstream and affiliate guaranties require more scrutiny than guaranties by a borrower parent to determine whether any potential enforceability issues are present.

a. Reasonably Equivalent Value. The determination of value is not formulaic or mechanical, but rather generally determined by the substance of the transaction. Value or benefits from a transfer may be direct (e.g., receipt of loan proceeds) or indirect. But if indirect, they must be “fairly concrete.”

In each of the above scenarios, we are assuming that the upstream or affiliate guarantor would not use the proceeds of any loans and, consequently, would not be added to the loan facility as a borrower. However, other indirect but tangible benefits or value to the guarantor should be identified, e.g., favorable loan terms or amendments, use of the NAV facility proceeds that may indirectly but materially benefit the guarantor, maintenance of the entire fund group of entities that benefits the guarantor, etc.

b. Financial Condition of Guarantor. The financial condition of the transferor/guarantor is evaluated at the time of the incurrence of the guaranty. The evaluation is made from the debtor/guarantor – in what condition was the guarantor left after giving effect to the transfer or assumption of the obligation. Diligence regarding a guarantor’s financial condition may demonstrate that such guarantor is sufficiently creditworthy to undertake the guaranty and remain solvent and able to conduct its respective businesses. Representations from the guarantor may be sought to confirm its financial condition.

c. Potential Mitigants. In addition to performing diligence with respect to the above points, lenders and their counsel will often include contractual provisions to mitigate the possibility that a guaranty may be found to constitute a fraudulent transfer. Savings clauses, limited recourse guaranties, and net worth guaranties are all tools that can be used to address the issues noted above. The scope and appropriateness of such provisions is beyond the scope of this article and should be discussed with external deal and restructuring counsel.

2. Preference Challenge. Under Bankruptcy Code section 547, a transfer made by a debtor to a creditor, on account of an antecedent debt, that is made while the debtor was insolvent and within 90 days before the bankruptcy case has been commenced may be subject to avoidance as a preferential transfer. Certain defenses may apply to a potential preferential transfer, including the simultaneous exchange of “new value” by the creditor. However, note that any pre-bankruptcy transfers of value, like payments under a guaranty, may be subject to scrutiny and potential challenge by the guarantor/debtor or a bankruptcy trustee.

Guaranties can be an important element in structuring NAV loan transactions to achieve the terms desired by the parties and to provide necessary protections for the lenders, but consideration needs to be given to the legal issues, such as the ones mentioned here, that their inclusion can present.

[1] Lenders will typically also require the HoldCo to pledge its accounts to which proceeds of the underlying investments are paid, allowing lenders to foreclose on such cash at the HoldCo level, without the need for such cash to first be distributed up to the borrower.

[2] Note that the precise language of certain state fraudulent transfer laws may differ, but conceptually, most state statutes require a showing of (i) insufficient or unreasonably small consideration in exchange for the transfer or liability incurred, and (ii) the transferor/debtor being insolvent at the time of the transfer, or becoming insolvent or subject to financial distress as a result of the transfer.

© Copyright 2023 Cadwalader, Wickersham & Taft LLP

Secure Software Regulations and Self-Attestation Required for Federal Contractors

US Policy and Regulatory Alert

Government contractors providing software across the federal government’s supply chain will be required later this year to comply with a new Secure Software Design Framework (SSDF). The SSDF requires software vendors to attest to new security controls in the design of code used by the federal government.

Cybersecurity Compromises of Government Software on the Rise

In the aftermath of the cybersecurity compromises of significant enterprise software systems embedded in government supply chains, the federal government has increasingly prioritized reducing the vulnerability of software used within agency networks. Recognizing that most of the enterprise software that is used by the federal government is provided by a wide range of private sector contractors, the White House has been moving to impose a range of new software security regulations on both prime and subcontractors. One priority area is an effort to require government contractors to ensure that software used by federal agencies incorporates security by design. As a result, federal contractors supplying software to the government now face a new set of requirements to supply secure software code. That is, to provide software that is developed with security in mind so that flaws and vulnerabilities can be mitigated before the government buys and deploys the software.

The SSDF as A Government Response

In response, the White House issued Executive Order 14028, “Executive Order on Improving the Nation’s Cybersecurity” (EO 14028), on 12 May 2021. EO 14028 requires the National Institute of Standards and Technology (NIST) to develop standards, tools, and best practices to enhance the security of the software supply chain. NIST subsequently promulgated the SSDF in special publication NIST SP 800-218. EO 14028 also mandates that the director of the Office of Management and Budget (OMB) take appropriate steps to ensure that federal agencies comply with NIST guidance and standards regarding the SSDF. This resulted in OMB Memorandum M-22-18, “Enhancing the Security of the Software Supply Chain through Secure Software Development Practices” (M-22-18). The OMB memo provides that a federal agency may use software subject to M-22-18’s requirements only if the producer of that software has first attested to compliance with federal government-specified secure software development practices drawn from the SSDF. Meaning, if the producer of the software cannot attest to meeting the NIST requirements, it will not be able to supply software to the federal government. There are some exceptions and processes for software to gradually enter into compliance under various milestones for improvements, all of which are highly technical and subjective.

In accordance with these regulations, the Cybersecurity and Infrastructure Security Agency (CISA) of the Department of Homeland Security issued a draft form for collecting the relevant attestations and associated information. CISA released the draft form on 27 April 2023 and is accepting comments until 26 June 2023.1

SSDF Implementation Deadline and Requirements for Government Suppliers

CISA initially set a deadline of 11 June 2023 for critical software and 13 September 2023 for non-critical software to comply with SSDF. Press reports indicate that these deadlines will be extended due to both the complexity of the SSDF requirements and the fact that the comment period remains open until 26 June  2023. However, CISA has not yet confirmed an extension of the deadline.

Attestation and Compliance with the SSDF

Based on what we know now, the attestation form generally requires software producers to confirm that:

  • The software was developed and built in secure environments.
  • The software producer has made a good-faith effort to maintain trusted source code supply chains.
  • The software producer maintains provenance data for internal and third-party code incorporated into the software.
  • The software producer employed automated tools or comparable processes that check for security vulnerabilities.

Software producers that must comply with SSDF should move quickly and begin reviewing their approach to software security. The SSDF requirements are complex and likely will take time to review, implement, and document. In particular, many of the requirements call for subjective analysis rather than objective evaluation against a set of quantifiable criteria, as is usually the case with such regulations. The SSDF also includes numerous ambiguities. For example, the SSDF requires versioning changes in software to have certain impacts in the security assessment, although the term “versioning” does not have a standard definition in the software sector.

Next Steps and Ricks of Noncompliance

Critically, the attestations on the new form carry risk under the civil False Claims Act for government contractors and subcontractors. Given the fact that many of the attestations require subjective analysis, contractors must take exceptional care in completing the attestation form. Contractors should carefully document their assessment that the software they produce is compliant. In particular, contractors and other interested parties should use this opportunity to share feedback and insights with CISA through the public comment process.

K&L Gates lawyers in our National Security Practice are closely tracking the implementation of these new requirements.

1 88 Fed. Reg. 25,670.

Copyright 2023 K & L Gates

Automating Entertainment: Writers Demand that Studios Not Use AI

When the Writers Guild of America (WGA) came with their list of demands in the strike that has already grinded production on many shows to a halt, chief among them was that the studios agree not to use artificial intelligence to write scripts. Specifically, the Guild had two asks: First, they said that “literary material,” including screenplays and outlines, must be generated by a person and not an AI; Second, they insisted that “source material” not be AI-generated.

The Alliance of Motion Picture and Television Producers (AMPTP), which represents the studios, rejected this proposal. They countered that they would be open to holding annual meetings to discuss advancements in technology. Alarm bells sounded as the WGA saw an existential threat to their survival and that Hollywood was already planning for it.

Writers are often paid at a far lower rate to adapt “source material” such as a comic book or a novel into a screenplay than they are paid to generate original literary material. By using AI tools to generate an outline or first draft of an original story and then enlisting a human to “adapt” it into screenplay, production studios potentially stand to save significantly.

Many industries have embraced the workflow of an AI-generated “first draft” that the human then punches up. And the WGA has said that its writers’ using AI as a tool is acceptable: There would essentially be a robot in the writers’ room with writers supplementing their craft with AI-generated copy, but without AI wholly usurping their jobs.

Everyone appears in agreement that AI could never write the next season of White Lotus or Succession, but lower brow shows could easily be AI aped. Law and Order, for instance, is an often cited example. Not just because it’s formulaic but because AIs are trained on massive data sets of copyrighted content and there are 20 seasons of Law and Order for the AI to ingest. And as AI technology gets more advanced who knows what it could do? Chat GPT was initially released last November and as of writing we’re on GPT-4, a far more powerful version of a platform that is advancing exponentially.

The studios’ push for the expanded use of AI is not without its own risks. The Copyright Office has equivocated somewhat in its determination that AI-generated art is not protectable. In a recent Statement of Policy, the Office said that copyright will only protect aspects of the work that were judged to have been made by the authoring human, resulting in partial protections of AI-generated works. So, the better the AI gets—the more it contributes to cutting out the human writer—the weaker the copyright protection for the studios/networks.

Whether or not AI works infringe the copyrights on the original works is an issue that is currently being litigated in a pair of lawsuits against Stability AI, the startup that created Stable Diffusion (an AI tool with the impressive ability to turn text into images in what some have dubbed the most massive art heist in history). Some have questioned whether the humans who wrote the original episodes would get compensated, and the answer is maybe not. In most cases the scripts were likely works for hire, owned by the studios.

If the studios own the underlying scripts, what happens to the original content if the studios take copyrighted content and put it through a machine that turns out uncopyrightable content? Can you DMCA or sue someone who copies that? As of this writing, there are no clear answers to these questions.

There are legal questions and deeper philosophical questions about making art. As the AI improves and humans become more cyborgian, does the art become indistinguishable? Prolific users of Twitter say they think their thoughts in 280 characters. Perhaps our readers can relate to thinking of their time in 6 minute increments, or .1’s of an hour. Further, perhaps our readers can relate to their industry being threatened by automation. According to a recent report from Goldman Sachs, generative artificial intelligence is putting 44% of legal jobs at risk.

© Copyright 2023 Squire Patton Boggs (US) LLP

For more Employment Legal News, click here to visit the National Law Review.

Blunt Rejection of Attorney Fees in Stipulated Dismissal

The US Court of Appeals for the Federal Circuit affirmed the rejection of attorney fees, finding that neither inequitable conduct nor a conflict of interest rendered the case exceptional given the limited factual record following a stipulated dismissal in a patent case. United Cannabis Corp. v. Pure Hemp Collective Inc., Case No. 22-1363 (Fed. Cir. May 8, 2023) (Lourie, Cunningham, Stark, JJ.).

United Cannabis Corporation (UCANN) sued Pure Hemp for patent infringement. After the litigation was stayed pending bankruptcy proceedings, the parties stipulated to the dismissal. Pure Hemp then sought attorney fees based on alleged inequitable conduct by UCANN during prosecution of the asserted patent due to nondisclosure of a prior art reference used in the patent’s specification and based on a purported conflict of interest by UCANN’s litigation counsel. The district court denied Pure Hemp’s request, finding that the case was not exceptional. Pure Hemp appealed.

Pure Hemp argued that the district court erred by (1) failing to find Pure Hemp to be the prevailing party in the litigation, (2) not concluding that the undisputed facts established inequitable conduct and (3) not recognizing that UCANN’s attorneys had a conflict of interest.

The Federal Circuit found that although the district court erred in not finding Pure Hemp to be the prevailing party, this was a harmless error. The Court explained that by fending off UCANN’s lawsuit with a stipulation dismissing UCANN’s claims with prejudice, Pure Hemp is a prevailing party under § 285. However, the Court concluded that this error was harmless because the district court ultimately concluded that this case was unexceptional.

The Federal Circuit found Pure Hemp’s arguments on inequitable conduct without merit. The Court explained that it had no findings to review because Pure Hemp voluntarily dismissed its inequitable conduct counterclaim and did not seek any post-dismissal inequitable conduct proceedings. Although Pure Hemp argued that it could prevail based on the undisputed facts in the record, the Court disagreed. It explained that even the limited record demonstrated at least a genuine dispute as to both the materiality and intent prongs of inequitable conduct and, therefore, the district court properly determined that Pure Hemp did not demonstrate that this case was exceptional.

The Federal Circuit also rejected Pure Hemp’s argument that copying and pasting portions from the prior art in the patent’s specification (but not disclosing the same prior art references) was inequitable conduct. The Court explained that unlike the nonbinding cases Pure Hemp relied on, the district court here did not find that the copied prior art was material, and the record gave no reason to disbelieve the explanation provided by UCANN’s prosecution counsel. The Court was also unpersuaded by Pure Hemp’s arguments to support inequitable conduct, explaining that the Court was not free to make its own findings on intent to deceive and materiality and, further, the district court was not required to provide its reasoning for its decision in attorney fee cases.

As to Pure Hemp’s argument that the case was exceptional because UCANN’s attorneys suffered from a conflict of interest, the Federal Circuit found that this argument was waived and, in any event, lacked merit because Pure Hemp presented no evidence to support the alleged conflict.

Finally, having sua sponte raised the issue of whether this was a frivolous appeal. The Federal Circuit determined that although it was “not pleased with how Pure Hemp has argued this appeal,” the appeal was nonetheless not frivolous because [Pure Hemp] properly argued that it was the prevailing party.

© 2023 McDermott Will & Emery
For more Intellectual Property Legal News, click here to visit the National Law Review.

The End of the COVID Public Health Emergency and Its Effect on Employee Benefit Plans

The COVID-19 public health emergency ends on May 11, 2023. The emergency resulted in two big changes to welfare plans: the relaxation of certain notification and timing requirements, and the requirement for plans to cover COVID testing and vaccination at no cost to plan participants. While the public health emergency ends May 11, 2023, plans have a grace period until July 11 to take certain actions and come into compliance with the normal rules.

Plan Sponsor Requirements

Before the grace period ends, plan sponsors will generally need to follow the rules that existed before COVID. Among the most important of these rules are the requirements for plan sponsors to:

  • Timely provide all notices, including those for HIPAA and COBRA.
  • Review COVID-related coverage under their employee assistance programs (EAPs) to determine if such coverage would be considered “significant medical care,” which can result in additional reporting and compliance obligations.
  • Review telehealth options to ensure they are properly integrated and provided by an entity that can comply with the post-COVID requirements. Telehealth rules were substantially relaxed during COVID. With telehealth now expected and utilized by more participants, getting telehealth right is more crucial than before.

Plan Sponsor Decisions

With the end of the public health emergency, plan sponsors must also make several important decisions with respect to their employee benefit plans:

  • Whether testing will continue free of charge or will be subject to cost sharing.
  • Whether non-preventative care vaccines for COVID will continue to be free of charge.
  • Whether costs for certain COVID-related services will continue to be posted.

As they are mostly based on what costs the plan sponsor or plan will cover going forward, these plan sponsor decisions are largely business-related. In the absence of a choice by the plan sponsor, the insurance provider will likely make a default choice. The important legal consideration is that the plan documents and employee communications should be consistent and accurately reflect the plan sponsor’s decisions.

Participant Requirements

In addition to the changes for plan sponsors, the end of the public health emergency will result in the reinstatement of a number of rules applicable to participants. Participants will need to:

Follow the HIPAA Special Enrollment timing rules.

Elect COBRA within the 60-day window for elections.

Make all COBRA payments timely.

Timely notify the plan of disabilities and qualifying events under COBRA.

Follow the timing limitations of their plans and insurance policies regarding filing claims, appeals, and external reviews.

Next Steps

First, plan sponsors should decide what COVID-related coverage will remain fully paid by the plan, if any. Some insurance companies are already starting to communicate with participants, and maintaining a consistent message will avoid unnecessary problems.

Second, plan sponsors should review their EAP and telehealth coverages for compliance with the rules that will soon be in effect. To the extent necessary, plan sponsors should update the documentation for their plans.

Finally, plan sponsors should consider a voluntary reminder communication to participants. Many rules have been relaxed over the last two years or so, and participants may be confused regarding the rules. A reminder may save stress for participants and those administering the plan, and will also serve to document the plan sponsor’s intention to properly follow the terms of the plan.

© 2023 Varnum LLP

For more healthcare legal news, click here to visit the National Law Review.

Software as a Medical Device: Challenges Facing the Industry

SaMD Blog Series: Introduction

Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations that utilize software and medical devices. We will be addressing various considerations including technology, data, intellectual property, licensing, and contracting.

The intersection of software, technology and health care and the proliferation of software as a medical device in the health care arena has become common place and has spurred significant innovations. The term Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” In other words, SaMD need not be part of a physical device to achieve its intended purpose. For instance, SaMD could be an application on a mobile phone and not be connected to a physical medical device.

With the proliferation of SaMD also comes the need for those building and using it to firmly grasp legal and regulatory considerations to ensure successful use and commercialization. Over the next several weeks, we will be addressing some of more common issues faced by digital health companies, investors, innovators, and clinicians when developing, utilizing, or commercializing SaMD. The Food and Drug Administration (FDA) has already cleared a significant amount of SaMD, including more than 500 algorithms employing artificial intelligence (AI). Some notable examples include FDA-cleared SaMD such as wearable technology for remote patient monitoring; doctor prescribed video game treatment for children with ADHD; fully immersive virtual reality tools for both physical therapy and mental wellness; and end to end software that generates 3D printed models to better plan surgery and reduce operation time. With this rapid innovation comes a host of legal and regulatory considerations which will be discussed over the course of this SaMD Blog Series.

General Intellectual Property (IP) Considerations for SaMD

This edition will discuss the sophisticated IP strategies that can be used to protect innovations for the three categories of software for biomedical applications: SaMD, software in a medical device, and software used in the manufacture or maintenance of a medical device, including clinical trial collaboration and sponsored research agreements, filing patent applications, and pursuing other forms of protection, such as trade secrets.

Licensing and Contracting with Third Parties for SaMD

This edition will unpack engaging with third parties practically and comprehensively, whether in the context of (i) developing new SaMD or (ii) refining or testing existing SaMD. Data and IP can be effectively either owned or licensed, provided such licenses protect the future interests of the licensee. Such ownership and licensing are particularly important in the AI and machine learning space, which is one area of focus for this edition.

FDA Considerations for SaMD

This edition will explore how FDA is regulating SaMD, which will include a discussion of what constitutes a regulated device, legislative actions to spur innovation, and how FDA is approaching regulation of specific categories of SaMD such as clinical decision support software, general wellness applications, and other mobile medical devices. It will also examine the different regulatory pathways for SaMD and FDA’s current focus on Cybersecurity issues for software.

Health Care Regulatory and Reimbursement Considerations for SAMD

This edition will discuss the intersection of remote monitoring services and SaMD, prescription digital therapeutics and how they intersect with SaMD, licensure and distributor considerations associated with commercializing SaMD, and the growing trend to seek out device specific codes for SaMD.

Our hope is that this series will be a starting point for digital health companies, investors, innovators, and clinicians as each approaches development and use of SaMD as part of their business and clinical offerings.

© 2023 Foley & Lardner LLP

For more information on Healthcare, click here to visit the National Law Review.

 

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