Category: Regulatory

4 Frequently Asked Questions About MSO Investigations and 3 Defense Strategies

In the last decade, Management Services Organizations, or MSOs, became popular service providers and investment tools for the medical and health care field. Unfortunately, the way some MSOs are structured, they can violate several important laws against healthcare fraud, like the Stark Law or the Anti-Kickback Statute.

Because this is such a novel issue in the medical field, lots of healthcare providers have questions about it. Some want to know how they can defend themselves if they get accused of wrongdoing for their activity with an MSO.

Dr. Nick Oberheiden is an MSO investigation lawyer at Oberheiden P.C. Here are some questions that he frequently gets asked and a few defense strategies that can help.

FAQs About MSO Investigations

1. What are MSOs?

An MSO is a company that provides administrative services to medical professionals. They can help healthcare providers with their:

  • Human resources
  • Operations
  • Coding and billing services
  • Office space management
  • Compliance
  • Contract management

Healthcare companies can either contract with an MSO to provide these services or can outright sell the administrative wing of their practice to an MSO so they can focus on the medical side of their business.

2. Why are MSOs Problematic?

MSO arrangements can become legally problematic when they act as an investment tool for medical professionals. Physicians could buy an ownership stake in an MSO that provided services to, say, a pharmacy. Those physicians could then begin referring patients to that same pharmacy.

In theory, that referral is going to a company – the pharmacy – that neither the physician nor his or her immediate family members have a financial interest in. In reality, though, the distinction gets blurred if the MSO – and therefore the physician – makes money off the referral. This can arguably amount to a kickback, which is unlawful.

3. Is Law Enforcement Actually Looking Into MSOs?

Yes, the justice department or the U.S. Department of Justice (DOJ) has recently begun investigating MSOs that appears to be a medium for illegal kickbacks from one healthcare provider to a referring physician.

Together with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), the DOJ has taken the position that MSOs that are only indirectly recouping physicians for referrals is enough to violate anti-kickback laws. In one case, the agencies are pursuing False Claims Act (31 U.S.C. § 3729) violations in addition to violations of the Stark Law (42 U.S.C. § 1395nn) and the Anti-Kickback Statute (42 U.S.C. § 1320a-7b).

However, not all MSOs have come under the scrutiny of federal law enforcement. The DOJ has not declared a blanket rule that all MSOs are unlawful. Instead, it is only targeting those that show the signs of potential healthcare fraud.

4. What are the Potential Penalties for Investing in the Wrong MSO?

At this stage, it is hard to tell. MSOs are still a new development, and we are only seeing the very first charges getting filed against physicians who invest in the “wrong” MSOs. Courts have not yet ruled whether MSOs can facilitate a kickback or amount to a false claim.

If courts do go along with the DOJ’s interpretation of the law, then physicians can face steep penalties for sending business to another healthcare facility that contracts with an MSO that they own or invest in.

The Anti-Kickback Statute is a criminal law that carries up to five years in prison for a conviction, as well as fines of up to $25,000 and program exclusion. The Stark Law is a civil law that, while it does not carry criminal sanctions or jail time, does impose:

  • Denial of payments provided
  • Disgorgement of ill-gotten gains
  • Civil penalties of up to $15,000 for each violation
  • Treble damages
  • Program exclusion

Defense Strategies for Investigations into Your MSO

If you do have an ownership stake in an MSO and are concerned about a potential investigation, or if you are interested in investing in one of these new companies and want to do it right, there are several things that you can do. While every case is unique, here are three defense strategies and compliance procedures that MSO investigation attorney Dr. Nick Oberheiden often recommends considering.

1. Look for Signs That an MSO is Problematic

Not all MSOs are attracting the attention of federal law enforcement. Instead, it is the ones that do not comply with the requirements of anti-kickback statutes and illegal referrals.

Some signs that an MSO is lacking in that department include:

  • A lack of a compliance officer in the company
  • No training regarding important laws like HIPAA, the Stark Law, or the Anti-Kickback Statute
  • The MSO is paid on a percentage basis, rather than through a flat fee (payments should be at fair market value rates)
  • The MSO charges unreasonably high service fees
  • There are incentives for investing physicians to refer clients to the company

All of these are strong signs that the MSO is at risk of civil or even criminal action for healthcare fraud and illegal referrals. Unfortunately, many of these signs also give an investing physician the power to increase his or her return on the investment – a feature that makes the investment seem especially lucrative.

2. Tighten Up the Compliance

If you are invested in an MSO and suddenly see proof that it was too good to be true, you are not powerless. You are a partial owner, after all. You can push the company to tighten up its compliance with anti-kickback laws. In the best cases, this can successfully protect you and avoid scrutiny from law enforcement. Even if it does not, though, it can reduce the restitution that you can be made to pay, and the efforts to fix the MSO can be used to show your good intentions.

3. Stress the Distance Between an MSO’s Ownership and Its Clients

At this point, we still have not seen whether law enforcement’s interpretation of the law will get adopted by a court. Until we know for sure that an indirect payment is enough for anti-kickback liability, a strong defense should be that the MSO’s ownership was too far removed from the MSO’s clients to amount to a violation of the law.

As Dr. Nick Oberheiden, an MSO investigation attorney at Oberheiden P.C., says, “The law is still very much in flux at this point. Kickbacks are generally seen to be direct payments for referrals, and the whole point of the MSO investment opportunity was to avoid that exact setup.”

Article By Dr. Nick Oberheiden of Oberheiden P.C.

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

Oberheiden P.C. © 2022

Metaverse Casinos: A Regulatory Wild West

A New World of Gaming

The metaverse is an immersive online universe on the blockchain where users interact with a multitude of digital worlds and with each other. As in the real world, the metaverse offers a wide variety of activities and entertainment options. The metaverse has become a haven for gaming. Users can explore casino “districts,” offering slots, poker, roulette, blackjack and more, go to shows and nightclubs, and even purchase real estate, including an entire casino. Some platforms within the metaverse are more developed than others, with their own parcels of land, decentralized governmental structures and native tokens. As this space continues to expand into various aspects of daily life, participants in the metaverse ecosystem, and in particular, gaming operators, should proceed with caution as the line between fantasy and reality continues to blur.

The metaverse provides an alternative virtual reality for those who visit, seemingly outside of the legal and regulatory structure of the real world. Now, due to the development of digital assets1 including cryptocurrencies and non-fungible tokens (“NFTs”), visitors can add real-world economic value to some in-game activities. Players can buy, sell, or gamble items in the metaverse for digital assets that can convert to fiat currency, further blurring the lines between a virtual game experience and reality. What seems to some like a game will increasingly have real-world economic consequences for users, and the businesses with which they engage in the metaverse, resulting in more regulatory scrutiny and legal disputes.

Metaverse Gaming vs. Traditional Online Gaming

It is helpful to distinguish metaverse gaming from traditional online gaming. Gaming in the metaverse and online gaming both allow users to play casino games with their friends and social network virtually without the burdens and restrictions of physical travel. Unlike traditional online casinos, the metaverse attempts to replicate the full casino experience, allowing users to explore a digital representation of a casino using a unique avatar and virtual reality technology. Through advancements in technology, users can control their avatar’s behavior in a similar manner to controlling their own conduct in the real world. Essentially, avatars are digital representation of users – they physically walk around and engage with other avatars, including making observations of other avatars’ tells and contributing to an authentic casino experience, all from the comfort of home.

Metaverse casinos generally do not accept traditional fiat currency. A metaverse casino requires a participant to convert their fiat into one of the crypto currencies accepted in the metaverse and deposit funds using a crypto wallet. Users exchange the NFTs and cryptocurrency that they win in the metaverse for fiat currency in the real world, however.

The use of crypto in metaverse gaming has some clear benefits. In addition to providing an immersive interaction compared to fiat-based online gambling platforms, metaverse casinos offer higher levels of security, transparency, and privacy for users. For example, the history of the entire transaction history is accessible on a blockchain. Although the transaction is visible on a blockchain, users may remain anonymous without having to disclose certain personal information, thereby protecting privacy. Deposits and withdrawals are processed virtually instantaneously because there is no third party verifying the transaction.

Regulatory Considerations for Metaverse Gaming

Casino and sports gaming is one of the most heavily regulated industries in the United States. The regulation is primarily at the state level. Some mistakenly believe the metaverse is insulated from real life legal restrictions. To the contrary, any gaming and wagering activity, which constitutes a game of chance involving the risk of something of value and a prize,2 that is being offered to U.S. citizens in the metaverse (on an unregulated basis) is likely to draw the attention of regulators.

Despite the popularity of metaverse gaming, the top U.S. operators have largely stayed on the sidelines while offshore and smaller companies dominate the space. This is unsurprising for three reasons:

  1. The fact that metaverse gaming lacks a dedicated regulatory framework and online gaming is legal in only a handful of states;

  2. As we wrote previously, the reluctance of regulated gaming companies operating in the U.S. to pursue the legal use of cryptocurrency given its volatility, lack of acceptance, and regulatory and/or legislative hurdles; and

  3. General legal uncertainty.

An operator that wishes to offer a gaming platform to U.S. citizens in the metaverse would need to do so with the express permission and under the oversight of each state’s gaming commission whose residents they serve. This may also require new legislation and regulatory schemes. For example, Wyoming, an early adopter of cryptocurrency, passed legislation in 2021 that allows sportsbooks to accept “digital, crypto and virtual currencies.”3 Generally, however, regulators and legislators are not known for their speed in adopting new and emerging technologies and the industry as a whole is still working toward more immediate and attainable goals, such as expanding legal online gaming. Currently, fewer than 10 states offer online casinos and/or poker.

There is significant regulatory and legal uncertainty surrounding metaverse casinos. For example, which oversight bodies have authority to regulate metaverse casinos? Can users face consequences in the real world for the actions of their avatar in metaverse casinos? How are players protected from unlawful conduct in metaverse casinos? Can operators be held responsible for that misconduct? State gaming regulators would have jurisdiction over gaming activity being offered to their residents in the metaverse alongside other regulators including the SEC, the U.S. Commodity Futures Trading Commission, and the Financial Crimes Enforcement Network, given the use of cryptocurrency and NFTs.4 At this early stage, there are more questions than answers. The history of the real-world gaming industry suggests it is highly probable that metaverse casinos will be subject to direct regulation.

New Legal Parameters Around Metaverse Gaming Are Expected

The competitive nature of the U.S. gaming market, the vast lobbying power of licensed gaming operators, and the substantial fees for licensure indicate that it is not a matter of if, but when regulators will intervene in metaverse gaming. While the concept of metaverse casinos is exciting and creates the opportunity for significant growth in the gaming industry, like many innovations, it brings additional challenges and risks for operators.

In fact, earlier this year securities regulators in Texas and Arizona demanded that a metaverse casino developer cease its funding for the development of its metaverse casino (and expansion of its metaverse casinos to all other relevant metaverses) through NFTs for failing to register the NFTs as securities and on the grounds that it was conducting an illegal fraudulent securities scheme.5

About a month later, securities regulators in Texas, Wisconsin, Kentucky, New Jersey, and Alabama filed an action against another metaverse casino due to its alleged ties to Russia and a fraudulent investment scheme it was running in violation of securities laws.6 The Texas State Securities Board stated its concerns about scammers being able to hide their identities (also referred to as “going dark”), as they alleged occurred here, in metaverse casinos.

In addition, just a few months ago, 28 members of Congress urged the Department of Justice to work with the industry, and other stakeholders to prosecute offshore sports betting companies operating illegally in the U.S.7 Similarly, absent a known regulatory scheme, even “successful” operation of a metaverse casino at present does not foreclose adverse action or shutdowns in the future due to increasing regulatory scrutiny.

While it is unclear how, if, and to what extent, existing regulations apply to metaverse gaming, the actions referenced above demonstrate that some state regulators are taking the position that the same rules that apply to investments in the real world also apply to investments in the metaverse. The risk is not limited to the virtual world, but also exposes investors to the potential loss of real money. The above matters also highlight the broad range of risks government authorities could be motivated to address, from international policy implications to financial fraud scams.

Pioneering the Metaverse

Although there are significant barriers to operating gaming platforms in the metaverse, forward-thinking gaming companies have wisely been preparing to enter this new world when it is safe to do so. If the metaverse becomes as integrated into daily life as it is expected to be, those pioneers will reap the rewards. We recommend gaming operators in the metaverse proceed with caution and retain highly qualified counsel to help them navigate the developing regulatory landscape.

For more internet and cybersecurity legal news, click here to visit the National Law Review

Copyright ©2022 Nelson Mullins Riley & Scarborough LLP

FOOTNOTES

  1. Regulators in the United States including the Securities and Exchange Commission (“SEC”) use the term “digital asset” to refer to “an asset that is issued and transferred using distributed ledger or blockchain technology.” Statement on Digital Asset Securities Issuance and Trading, Division of Corporation Finance, Division of Investment Management, and Division of Trading and Markets, SEC (Nov. 16, 2018), available here. As the SEC has noted, digital assets include, but are not limited to, virtual currencies, coins, and tokens. Id. A digital asset may in certain instances be deemed a security under the federal securities laws. While not defined in the securities laws, the SEC often refers to digital assets that are securities as a “digital asset securities.” Id.

  2. The issue of what is a “thing of value” within the meaning of state anti-gambling law has been the subject of recent litigation. See, e.g., Kater v. Churchill Downs, Inc., 886 F.3d 784 (9th Cir. 2018) (virtual chips in online game held to be a “thing of value” for purposes of Washington’s illegal gambling law); Coffee v. Google, LLC, No. 20-CV-03901-BLF, 2022 WL 94986, at *13 (N.D. Cal. Jan. 10, 2022) (“loot box” prizes limited to use in in-app game not “things of value” under California illegal gambling law).

  3. Pat Evans, Cryptocurrency In Legal Sports Betting: What’s Next?, (June 9, 2022), available here.

  4. We will discuss the potential role of these Federal regulators in future articles.

  5. Dorothy N. Giobbe, et. al, Texas and Alabama Securities Regulators File Enforcement Actions Against Online Casino Developer Selling NFTs to Operate Casinos in a Metaverse, (April 29, 2022), available here.

  6. Five States File Enforcement Actions to Stop Russian Scammers Perpetrating Metaverse Investment Fraud, (May 11, 2022), available here.

  7. Chris Altruda, Congressional Group Calls on DOJ to Help Fight Illegal Offshore Sportsbooks, (Jun. 30, 2022), available here.

 

DOT Proposes New Guidance For Medical Examiners To Address CBD Use By Commercial Motor Vehicle Drivers

The U.S. Department of Transportation, Federal Motor Carrier Safety Administration (FMCSA) published a proposed draft Medical Examiner’s Handbook (MEH), including updates to the Medical Advisory Criteria, in the Federal Register on August 16, 2022.  The FMCSA’s regulations provide the basic driver physical qualification standards for commercial motor vehicle (CMV) drivers, in 49 CFR 391.41 through 391.49. DOT Medical Examiners currently make physical qualification determinations on a case-by-case basis and may consider guidance to assist with making those determinations.

FMCSA stated that the goal of the updated MEH and related Medical Advisory Criteria is to provide information about regulatory requirements and guidance for Medical Examiners to consider when making physical qualification determinations in conjunction with established best medical practices. The revised Medical Advisory Criteria, in addition to being included in the MEH, would also be published in Appendix A to 49 CFR part 391. The final version of the criteria would be identical in both publications. FMCSA is proposing to update both the MEH and Medical Advisory Criteria and seeks public comment on these documents until September 30, 2022.  The draft MEH may be viewed here.

Use of CBD with 0.3% THC or Less Is Not Automatically Disqualifying

Under FMCSA regulation 49 CFR 391.41(b)(12)(i), CMV drivers are not permitted to be physically qualified when using Schedule I drugs under any circumstances. The federal Controlled Substances Act lists marijuana, including marijuana extracts containing greater than 0.3% delta-9-tetrahydrocannabinol (THC), as Schedule I drugs and substances. A driver who uses marijuana cannot be physically qualified even if marijuana is legal in the State where the driver resides for recreational or medical use.

However, under current federal law cannabidiol (CBD) products containing less than 0.3% THC are not considered Schedule I substances; therefore, their use by a CMV driver is not grounds to automatically preclude physical qualification of the driver under §391.41(b)(12)(i).

FMCSA emphasized that the U.S. Food and Drug Administration (FDA) does not currently determine or certify the levels of THC in products that contain CBD, so there is no federal oversight to ensure that the labels on CBD products that claim to contain less than 0.3% of THC are accurate. Therefore, drivers who use these products are doing so at their own risk.

FMCSA now proposes that each driver should be evaluated on a case-by-case basis and encourages Medical Examiners to take a comprehensive approach to medical certification and to consider any additional relevant health information or evaluations that may objectively support the medical certification decision. Medical Examiners may request that drivers obtain and provide the results of a non-DOT drug test during the medical certification process, if it is deemed to be helpful in determining whether a driver is using a prohibited substance, such as a CBD product that contains more than 0.3% THC.

This guidance does not impact FMCSA’s drug and alcohol testing regulations.  Use of a CBD product does not excuse a positive marijuana drug test result.

Use of Suboxone and Similar Drugs Is Not Automatically Disqualifying

FMCSA received a large number of inquiries related to Suboxone (a Schedule III drug under federal law, meaning that it has a lower potential for abuse than Schedule I and II drugs).  Treatment with Suboxone and other drugs that contain buprenorphine and naloxone, as well as methadone, are not identified in the FMCSA regulations as precluding medical certification for operating a CMV. FMCSA relies on the Medical Examiner to evaluate and determine whether a driver treated with Suboxone singularly or in combination with other medications should be issued a medical certificate. The Medical Examiner should obtain the opinion of the prescribing licensed medical practitioner who is familiar with the driver’s health history as to whether treatment with Suboxone will or will not adversely affect the driver’s ability to safely operate a CMV. The final medical certification determination, however, rests with the Medical Examiner who is familiar with the duties, responsibilities, and physical and mental demands of CMV driving and non-driving tasks.

Article By Kathryn J. Russo of Jackson Lewis P.C.

For more biotech, food, and drug legal news, click here to visit the National Law Review.

Jackson Lewis P.C. © 2022

All Federal Research Agencies to Update Public Access Policies

On 25 August 2022, the Office of Science and Technology Policy (OSTP) released a guidance memorandum instructing federal agencies with research and development expenditures to update their public access policies. Notably, OSTP is retracting prior guidance that gave discretion to agencies to allow a 12-month embargo on the free and public release of peer-reviewed publications, so that federal funded research results will be timely and equitably available at no cost. The memo also directs affected agencies to develop policies that:

  1. Ensure public access to scientific data, even if not associated with peer-reviewed publications;
  2. Ensure scientific and research integrity in the agency’s public access by requiring publication of the metadata, including the unique digital persistent identifier; and
  3. Coordinate with OSTP to ensure equitable delivery of federally funded research results and data.

KEY COMPONENTS OF GUIDANCE:

Updating Public Access Policies

Federal agencies will need to develop new, or update existing, public access plans, and submit them to OSTP and the Office of Management and Budget (OMB). Deadlines for submission are within 180 days for federal agencies with more than US$100 million in annual research and development expenditures, and within 360 days for those with less than US$100 million in expenditures.

Agencies will need to ensure that any peer-reviewed scholarly publication is free and available by default in agency-designated repositories without any embargo or delay following publication. Similarly, OSTP expects the access polices to address publication of any other federally funded scientific data, even if not associated with peer-reviewed scholarly publications. As a concession, federal agencies are being asked to allow researchers to include the “reasonable publication costs and costs associated with submission, curation, management of data, and special handling instructions as allowable expenses in all research budgets.1”

Ensuring Scientific Integrity

To strengthen trust in governmentally funded research, the new or updated policies must transparently communicate information designed to promote OSTP’s research integrity goals. Accordingly, agencies are instructed to collect and make appropriate metadata available in their public access repositories, including (i) all author and co-author names, affiliations, and source of funding, referencing their digital persistent identifiers, as appropriate; (ii) date of publication; and (iii) a unique digital persistent identifier for research output. Agencies should submit to OSTP and OMB (by 31 December 2024) a second update to their policies specifying the approaches taken to implement this transparency, and publish such policy updates by 31 December 2026, with an effective date no later than one year after publication of the updated plan.

IMPLICATIONS FOR THE NATIONAL INSTITUTES OF HEALTH (NIH), OTHER FEDERAL AGENCIES, AND THEIR GRANTEES

The NIH is expected to update its Public Access Policy, potentially along with its Data Management and Sharing Policy to conform with the new OSTP guidance. Universities, academic medical centers, research institutes, and federally funded investigators should monitor agency publications of draft and revised policies in order to update their processes to ensure continued compliance.

In doing so, affected stakeholders may want to consider and comment to relevant federal agencies on the following issues in their respective public access policy development:

  • Federal agency security practices to prevent foreign misappropriation of research data;
  • Implications for research misconduct investigations and research integrity;
  • Any intellectual property considerations without a 12-month embargo, especially to the extent this captures scientific data not yet published in a peer-review journal; and
  • Costs allowable research budgets to support these data management and submission expectations.

1 Office of Science and Technology Policy, Memorandum for the Heads of Executive Departments and Agencies: Ensuring Free, Immediate, and Equitable Access to Federally Funded Research at p. 5 (25 August 2022) available at https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf

Article By Cindy L. Ortega Ramos and Rebecca M. Schaefer of K&L Gates

For more administrative and regulatory legal news, click here to visit the National Law Review.

Copyright 2022 K & L Gates

FDA Publishes 2022 Retail Food Program Standards

  • On August 24, 2022, FDA announced that it had published the 2022 edition of its Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards). The standards are intended to provide information on the key elements of an effective retail food regulatory program for local, tribal, state, and territorial regulatory agencies.
  • The Retail Program Standards provide recommendations for creating and managing retail food regulatory programs. Recommendations include how to provide effective inspections, reinforce proper sanitation, implement foodborne illness prevention strategies, and identify areas for improvement.
  • This year’s edition of the Retail Program Standards considers comments that were made during the Conference for Food Protection 2020 Biennial meeting, including reformatted curriculum forms and alternative sampling methods. A list of jurisdictions currently enrolled in the Retail Program Standards is available here. 

    Article By Food and Drug Law Practice Group at Keller and Heckman LLP

For more food and drug law legal news, click here to visit the National Law Review.

© 2022 Keller and Heckman LLP

Cal/OSHA COVID-19 Regulations Will Likely Continue in 2023

The current Cal/OSHA COVID-19 Emergency Temporary Standard (ETS) expires at the end of 2022. But Cal/OSHA is not done with COVID-19 regulations. There is a Non-Emergency Regulation in process. The Standards Board recently published its proposed non-emergency regulation and announced a public hearing for September 15, 2022.

Though the proposal is a non-emergency regulation, the proposed text states the requirements would only remain in effect for two years, except for certain recordkeeping requirements.

Here are other highlights of the proposed regulation:

  • Directs employers to include COVID-19 procedures in their written Injury and Illness Prevention Program (IIPP) or as a separate document.

  • As part of an employer’s COVID-19 procedures, an employer must provide training to employees regarding COVID-19

  • Employers must have effective methods and procedures for responding to COVID-19 cases in the workplace such as exclusion and quarantine requirements.

  • Employers will still have certain notice requirements regarding positive cases in the workplace.

  • Face covering requirements shall still follow California Department of Public Health requirements

One notable omission from the proposed regulation is exclusion pay, which was a very contentious requirement under the ETS.

Article By Sean Paisan of Jackson Lewis P.C.

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

Jackson Lewis P.C. © 2022

MLB To Allow CBD Sponsorships

Recently, Major League Baseball (MLB) informed teams that cannabidiol (CBD) sponsorships were no longer off limits and that they were free to pursue sponsorships in the CBD category under certain conditions. CBD companies will also no longer be prohibited from airing commercials during MLB game telecasts.

According to MLB’s Chief Revenue Officer Noah Garden, to be permitted, CBD sponsorships must promote products that are certified as not containing psychoactive levels of THC, the main active ingredient of cannabis. Any CBD product with concentrations of THC above 0.3% would not be permitted, as it is classified as marijuana, which is a Schedule I illicit substance. All CBD sponsorships will also require signoff by the MLB Commissioner’s Office.

MLB is the first of the four major US sports leagues to permit CBD sponsorships. Previously, only UFC and NASCAR had opened up the CBD sponsorship category for sale. And while MLB has opened the door to certain CBD sponsorships, for now, neither MLB nor any of the other major US sports leagues permit sponsorships in the broader cannabis category.

This change follows the new MLB collective bargaining agreement freeing up MLB teams to sell advertising positions on team jerseys and player batting helmets beginning with the 2023 season. MLB has confirmed that these lucrative jersey and batting helmet positions will not be off-limits to CBD companies. Garden noted specifically that “[MLB is] open-minded to doing a patch deal [in the CBD category], depending on the brand and what that brand represents. It has to [be] a brand that represents sports.”

Time will tell if MLB, its teams, and its fans embrace CBD sponsorships, but with cannabis industry valuations exceeding $13 billion in 2021, the rule change opens the door to a potentially lucrative sponsorship category.

Article By Richard L. Brand, Shahiedah Shabazz, and Zak Welsh of ArentFox Schiff LLP

For more entertainment and sports legal news, click here to visit the National Law Review.

© 2022 ArentFox Schiff LLP

Federal Reserve Doubles Down on Oversight of Crypto Activities for Banks

The Federal Reserve Board (the “FRB”) issued Supervision and Regulation Letter 22-6 (“SR 22-6”), providing guidance for FRB-supervised banking organizations (referred to collectively herein as “FRB banks”) seeking to engage in activities related to cryptocurrency and other digital assets.  The letter states that prior to engaging in crypto-asset-related activities, such FRB banks must ensure that their activities are “legally permissible” and determine whether any regulatory filings are required.  SR 22-6 further states that FRB banks should notify the FRB prior to engaging in crypto-asset-related activities.  Any FRB bank that is already engaged in crypto-asset-related activities should notify the FRB promptly regarding the engagement in such activities, if it has not already done so.  The FRB also encourages state member banks to contact state regulators before engaging in any crypto-asset-related activity.

These requirements send a clear message to FRB banks and in fact to all banks that their crypto-asset related activities are considered to be risky and not to be entered into lightly.

Indeed, the FRB noted that crypto-asset-related activities may pose risks related to safety and soundness, consumer protection, and financial stability, and thus a FRB bank should have in place adequate systems, risk management, and controls to conduct such activities in a safe and sound manner and consistent with all applicable laws.

SR 22-6 is similar to guidance previously issued by the OCC and FDIC; in all cases, the agencies require banks to notify regulators before engaging in any kind of digital asset activity, including custody activities. The three agencies also released a joint statement last November in which they pledged to provide greater guidance on the issue in 2022.  Further, in an August 17, 2022 speech, FRB Governor Bowman stated that the FRB staff is working to articulate supervisory expectations for banks on a variety of digital asset-related activities, including:

  • custody of crypto-assets
  • facilitation of customer purchases and sales of crypto-assets
  • loans collateralized by crypto-assets, and
  • issuance and distribution of stablecoins by banking organizations

Interestingly, SR 22-6 comes a few days after a group of Democratic senators sent a letter to the OCC requesting that the OCC withdraw its interpretive letters permitting national banks to engage in cryptocurrency activities and a day after Senator Toomey sent a letter to the FDIC questioning whether it is deterring banks from offering cryptocurrency services.

Although past guidance already required banks to notify regulators of crypto activity, this guidance likely could discourage additional banks from entering into crypto-related activities in the future or from adding additional crypto services. In the end, it could have the unfortunate effect of making it more difficult for cryptocurrency companies to obtain banking services.

Article By Grant F. Butler, Jeremy M. McLaughlin, Anthony R.G. Nolan, and Judith E. Rinearson of K&L Gates

For more finance and banking legal news, click here to visit the National Law Review.

Copyright 2022 K & L Gates

CERCLA PFAS Designation Major Step Forward

On January 10, 2022, the EPA submitted a plan for a PFAS Superfund designation to the White House Office of Management and Budget (OMB) when it indicated an intent to designate two legacy PFAS – PFOA and PFOS – as “hazardous substances” under the Comprehensive Environmental Response, Compensation & Liability Act (CERCLA, also known as the Superfund law). The EPA previously stated its intent to make the proposed designation by March 2022 when it introduced its PFAS Roadmap in October 2021. Under the Roadmap, the EPA planned to issue its proposed CERCLA designation in the spring of 2022. On Friday, a CERCLA PFAS designation took a significant step forward when the OMB approved the EPA’s plan for PFOA and PFOS designation. This step opens the door for the EPA to put forth its proposed designation of PFOA and PFOS under CERCLA and engage in the required public comment period.

Any PFAS designation will have enormous financial impacts on companies with any sort of legacy or current PFOA and PFOS pollution concerns. Corporations, insurers, investment firms, and private equity alike must pay attention to this change in law when considering risk issues.

Opposition to CERCLA Designation

Since the EPA’s submission of its intent to designate PFOA and PFOS as hazardous substance to the OMB, the EPA has been met with industry pushback on the proposal. Three industries met with the OMB earlier in 2022 to explain the enormity of regulatory and cleanup costs that the industries would face with a CERCLA designation of PFOA and PFOS – water utilities, waste management companies, and the International Liquid Terminals Association. These industries in particular are concerned about bearing the burden of enormous cleanup costs for pollution that third parties are responsible for. Industries are urging the OMB and EPA to consider other ways to achieve regulatory and remediation goals aside from a CERCLA designation.

During an April 5, 2022 meeting of the Environmental Council of the States (ECOS), several states also expressed concerns regarding the impact that a CERCLA designation for PFAS types would have in their states and on their constituent companies. The state environmental leaders discussed with EPA representatives how the EPA would view companies in their states that fall into categories such as waste management and water utilities, who are already facing uphill battles in disposing of waste or sludge that contains PFAS.

Realizing that the EPA is likely set on its path to designate at least two PFAS as “hazardous substances”, though, industries are asking the EPA to consider PFAS CERCLA exemptions for certain industries, which would exempt certain industry types from liability under CERCLA. Industries are also pushing the EPA, OMB and the U.S. Chamber of Commerce to conduct a robust risk analysis to fully vet the impact that the designation will have on companies financially. The EPA is statutorily required to conduct a risk analysis as part of its CERCLA designation process, so it is likely that the EPA’s delay in issuing a proposed hazardous substance designation until it feels that adequate time has passed for its designation to survive the likely legal challenges that will likely follow the designation.

CERCLA PFAS Designation: Impact On Businesses

Once a substance is classified as a “hazardous substance” under CERCLA, the EPA can force parties that it deems to be polluters to either cleanup the polluted site or reimburse the EPA for the full remediation of the contaminated site. Without a PFAS Superfund designation, the EPA can merely attribute blame to parties that it feels contributed to the pollution, but it has no authority to force the parties to remediate or pay costs. The designation also triggers considerable reporting requirements for companies. Currently, those reporting requirements with respect to PFAS do not exist, but they would apply to industries well beyond just PFAS manufacturers.

The downstream effects of a PFOA and PFOS designation would be massive. Companies that utilized PFOA and PFOS in their industrial or manufacturing processes and sent the PFOA/PFOS waste to landfills or otherwise discharged the chemicals into the environment will be at immediate risk for enforcement action by the EPA given the EPA’s stated intent to hold all PFAS polluters of any kind accountable. Waste management companies should be especially concerned given the large swaths of land that are utilized for landfills and the likely PFAS pollution that can be found in most landfills due to the chemicals’ prevalence in consumer goods. These site owners may be the first targeted when the PFOA/PFOS designation is made, which will lead to lawsuits filed against any company that sent waste to the landfills for contribution to the cost of cleanup that the waste management company or its insured will bear.

Also of concern to companies are the re-opener possibilities that a CERCLA designation would result in. Sites that are or were previously designated as Superfund sites will be subject to additional review for PFOA/PFOS concerns. Sites found to have PFOA/PFOS pollution can be re-opened by the EPA for investigation and remediation cost attribution to parties that the EPA finds to be responsible parties for the pollution. Whether through direct enforcement action, re-opener remediation actions, or lawsuits for contribution, the costs for site cleanup could amount to tens of millions of dollars, of course depending on the scope of pollution.

Conclusion

Now more than ever, the EPA is clearly on a path to regulate PFAS contamination in the country’s water, land and air. The EPA has also for the first time publicly stated when they expect such regulations to be enacted. These regulations will require states to act, as well (and some states may still enact stronger regulations than the EPA). Both the federal and the state level regulations will impact businesses and industries of many kinds, even if their contribution to drinking water contamination issues may seem on the surface to be de minimus. In states that already have PFAS drinking water standards enacted, businesses and property owners have already seen local environmental agencies scrutinize possible sources of PFAS pollution much more closely than ever before, which has resulted in unexpected costs. Beyond drinking water, though, the EPA PFAS plan shows the EPA’s desire to take regulatory action well beyond just drinking water, and companies absolutely must begin preparing now for regulatory actions that will have significant financial impacts down the road.

Article By John Gardella of CMBG3 Law

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©2022 CMBG3 Law, LLC. All rights reserved.

GAO Publishes Report on Technologies for PFAS Assessment, Detection, and Treatment

The U.S. Government Accountability Office (GAO) published a report on July 28, 2022, entitled Persistent Chemicals: Technologies for PFAS Assessment, Detection, and Treatment. GAO was asked to conduct a technology assessment on per- and polyfluoroalkyl substances (PFAS) assessment, detection, and treatment. The report examines the technologies for more efficient assessments of the adverse health effects of PFAS and alternative substances; the benefits and challenges of current and emerging technologies for PFAS detection and treatment; and policy options that could help enhance benefits and mitigate challenges associated with these technologies. GAO assessed relevant technologies; surveyed PFAS subject matter experts; interviewed stakeholder groups, including government, non-governmental organizations (NGO), industry, and academia; and reviewed key reports. GAO identified three challenges associated with PFAS assessment, detection, and treatment technologies:

  • PFAS chemical structures are diverse and difficult to analyze for health risks, and machine learning requires extensive training data that may not be available;
  • Researchers lack analytical standards for many PFAS, limiting the development of effective detection methods; and
  • The effectiveness and availability of disposal and destruction options for PFAS are uncertain because of a lack of data, monitoring, and guidance.

GAO developed the following three policy options that could help mitigate these challenges:

  • Promote research: Policymakers could support development of technologies and methods to more efficiently research PFAS health risks. This policy option could help address the challenge of limited information on the large number and diversity of PFAS, as well as a lack of standardized data sets for machine learning;
  • Expand method development: Policymakers could collaborate to improve access to standard reference samples of PFAS and increase the pace of method and reference sample development for PFAS detection. This policy option could help address the challenges of a lack of validated methods in media other than water, lack of analytical standards, and cost, which all affect researchers’ ability to develop new detection technologies; and
  • Support full-scale treatment: Policymakers could encourage the development and evaluation of full-scale technologies and methods to dispose of or destroy PFAS. This policy option could help address the challenges of cost and efficiency of disposal and destruction technologies and a lack of guidance from regulators.

GAO notes that these policy options involve possible actions by policymakers, which may include Congress, federal agencies, state and local governments, academia, and industry.

Article By Lynn L. Bergeson and Carla N. Hutton of Bergeson & Campbell, P.C.

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©2022 Bergeson & Campbell, P.C.