Category: Health

EPA’s Spring 2022 Unified Agenda Includes Proposed and Final TSCA and TRI Rules

The U.S. Environmental Protection Agency’s (EPA) spring 2022 Unified Agenda, published on June 21, 2022, includes the following rulemakings under the Toxic Substances Control Act (TSCA) or the Toxics Release Inventory (TRI).

Proposed Rule Stage

  • Tiered Data Reporting to Inform Prioritization, Risk Evaluation, and Risk Management under TSCA (2070-AK62): EPA is developing a rulemaking under TSCA Sections 8(a) and (d) to establish reporting requirements based upon a chemical’s status in the Risk Evaluation/Risk Management (RE/RM) Lifecycle and update the reporting requirements under the 40 C.F.R. Part 711 Chemical Data Reporting (CDR) regulation. Specifically, EPA is seeking occupational, environmental, and consumer exposure information. EPA is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. According to the Unified Agenda item, EPA needs this information to inform prioritization, risk evaluation, and risk management of chemical substances under TSCA Section 6. EPA intends to issue a notice of proposed rulemaking (NPRM) in May 2023 and a final rule in September 2024. More information on EPA’s July 27, 2021, webinar on development of the proposed rule is available in our July 29, 2021, memorandum.
  • Revisions to the TSCA Fees Rule (2070-AK64): In January 2021, EPA proposed updates and adjustments to the 2018 TSCA fees rule. EPA proposed modifications to the TSCA fees and fee categories for fiscal years (FY) 2022, 2023, and 2024 and explained the methodology by which the proposed TSCA fees were determined. EPA proposed to add three new fee categories: A Bona Fide Intent to Manufacture or Import Notice, a Notice of Commencement of Manufacture or Import, and an additional fee associated with test orders. In addition, EPA proposed exemptions for entities subject to certain fee-triggering activities, including an exemption for research and development (R&D) activities; an exemption for entities manufacturing less than 2,500 pounds of a chemical subject to an EPA-initiated risk evaluation fee; an exemption for manufacturers of chemical substances produced as a non-isolated intermediate; and exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, produced as a byproduct, or produced or imported as an impurity. EPA updated its cost estimates for administering TSCA, relevant information management activities, and individual fee calculation methodologies. EPA proposed a volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario where a consortium is not formed and is proposing to require export-only manufacturers to pay fees for EPA-initiated risk evaluations. EPA also proposed various changes to the timing of certain activities required throughout the fee payment process. In light of public comments, EPA states that it has decided to issue a supplemental NPRM in October 2022 and seek additional public comment on changes to the January 2021 proposal. More information on the proposed rule is available in our December 30, 2020, memorandum.
  • New Chemicals Procedural Regulations to Reflect the 2016 Amendments to TSCA (2070-AK65): On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) was signed into law, amending TSCA and impacting how EPA reviews and makes determinations on new chemical notices under TSCA Section 5. EPA states that as a result of these increased responsibilities, it has become more challenging to complete reviews within 90 days. This rulemaking seeks to revise the new chemicals procedural regulations in 40 C.F.R. Part 720 to improve the efficiency of EPA’s review process and to align its processes and procedures with the new statutory requirements. This rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and improve EPA’s processes to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review. EPA intends to publish an NPRM in February 2023.
  • Confidential Business Information (CBI) Claims under TSCA (2070-AK68): EPA is considering proposing new and amended rules concerning the assertion and maintenance of claims of CBI under TSCA. Amendments to TSCA in 2016 included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. EPA states that it is considering procedures for submitting and supporting such claims in TSCA submissions, including substantiation requirements, exemptions, electronic reporting enhancements, and maintenance or withdrawal of confidentiality claims. EPA is also considering whether the proposed rule should also elaborate on EPA’s procedures for reviewing and communicating with TSCA submitters about confidentiality claims. EPA expects the proposed rule to include new provisions, as well as revisions to existing rules on asserting confidentiality claims to conform to the 2016 amendments to TSCA. As reported in our May 17 and May 18, 2022, memoranda, EPA issued a proposed rule on May 12, 2022. EPA intends to issue a final rule in May 2023.
  • Chemical-Specific Rulemakings under TSCA Section 6(a): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following risk evaluations for the following chemicals carried out under the authority of TSCA Section 6, EPA initiated rulemakings to address unreasonable risks of injury to health identified in the final risk evaluations:
    • Methylene Chloride (2070-AK70): EPA’s risk evaluation for methylene chloride, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0437, with additional information in docket EPA-HQ-OPPT-2016-0742. EPA intends to issue an NPRM in February 2023 and a final rule in August 2024. More information on EPA’s draft revision to its risk determination for methylene chloride will be available in a forthcoming memorandum;
    • 1-Bromopropane (2070-AK73): EPA’s risk evaluation for 1-bromopropane, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0235, with additional information in docket EPA-HQ-OPPT-2016-0741. EPA intends to publish an NPRM in May 2023 and a final rule in August 2024;
    • Carbon Tetrachloride (2070-AK82): EPA’s risk evaluation, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0499, with additional information in docket EPA-HQ-OPPT-2016-0733. EPA intends to publish an NPRM in April 2023 and a final rule in August 2024;
    • Trichloroethylene (TCE) (2070-AK83): EPA’s risk evaluation for TCE, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0500, with additional information in docket EPA-HQ-OPPT-2016-0737. EPA intends to publish an NPRM in March 2023 and a final rule in August 2024. More information on EPA’s draft revision to its risk determination for TCE will be available in a forthcoming memorandum;
    • Perchloroethylene (PCE) (2070-AK84): EPA’s risk evaluation for PCE, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0502, with additional information in docket EPA-HQ-OPPT-2016-0732. EPA intends to publish an NPRM in February 2023 and a final rule in August 2024. More information on EPA’s draft revision to its risk determination for PCE will be available in a forthcoming memorandum;
    • N-Methylpyrrolidone (NMP) (2070-AK85): EPA’s risk evaluation for NMP, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0236, with additional information in docket EPA-HQ-OPPT-2016-0743. EPA intends to publish an NPRM in May 2023 and a final rule in August 2024. More information on EPA’s draft revision to its risk determination for NMP will be available in a forthcoming memorandum; and
    • Asbestos (Part 1: Chrysotile Asbestos) (2070-AK86): EPA’s risk evaluation for chrysotile asbestos, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0501, with additional information in docket EPA-HQ-OPPT-2016-0736. More information on EPA’s proposed rule to prohibit ongoing uses of chrysotile asbestos is available in our April 7, 2022, memorandum. EPA intends to publish a final rule in November 2023.
  • Procedures for Chemical Risk Evaluation under TSCA (2070-AK90): As required under TSCA Section 6(b)(4), EPA published a final rule on July 20, 2017, that established a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. The final rule established the steps of a risk evaluation process, including: scope, hazard assessment, exposure assessment, risk characterization, and risk determination. EPA states that it is now considering revisions to that final rule and will solicit public comment through an NPRM. EPA intends to publish the NPRM in September 2022. More information on EPA’s 2017 rule is available in our June 26, 2017, memorandum.
  • Asbestos; Reporting and Recordkeeping Requirements under TSCA (2070-AK99): This rulemaking, under the authority of TSCA Section 8(a), would require certain persons that manufactured (including imported) or processed asbestos and asbestos-containing articles (including as an impurity) to report certain exposure-related information, including quantities of asbestos and asbestos-containing articles manufactured (including imported) or processed, types of asbestos used, and employee data. Reported information would be used by EPA and other federal agencies in considering the regulation of asbestos. EPA notes that this rulemaking is the result of a settlement agreement stemming from litigation pursuant to TSCA Section 21. See Asbestos Disease Awareness Organization v. EPA, No. 19-CV-00871; State of California et al. v. EPA, No. 19-CV-03807. More information on EPA’s proposed reporting and recordkeeping requirements is available in our May 6, 2022, memorandum. EPA intends to publish a final rule in November 2022.
  • Other Chemical Substances Undergoing TSCA Section 6 Risk Evaluation; Significant New Use Rule (SNUR) for Certain Non-Ongoing Uses (2070-AL05): EPA is developing TSCA Section 5(a)(2) SNURs on conditions of use identified as not currently ongoing in the final scope documents for the high-priority substances undergoing TSCA Section 6 risk evaluations. EPA states that it will use the SNURs to require notice to EPA before chemical substances and mixtures are used in new ways that might create concerns. Persons subject to a SNUR who intend to manufacture (including import) or process the chemical substance for the significant new use must notify EPA at least 90 days prior to initiating activities via a significant new use notice (SNUN). EPA intends to publish an NPRM in December 2022 and a final rule in May 2024.
  • The Unified Agenda includes the following chemical-specific SNURs for certain non-ongoing uses:
    • Phthalates; SNUR for Certain Non-Ongoing Uses (2070-AL06): EPA intends to publish an NPRM in November 2022 and a final rule in May 2024;
    • Flame Retardants; SNUR for Certain Non-Ongoing Uses (2070-AL07): EPA intends to publish an NPRM in December 2022 and a final rule in November 2023; and
    • Certain Solvents; SNUR for Certain Non-Ongoing Uses (2070-AL08): EPA intends to publish an NPRM in December 2022 and a final rule in May 2024.
  • Inactive Inventory Per- and Polyfluoroalkyl Substances (PFAS) SNUR (2070-AL10): EPA is developing a SNUR under TSCA Section 5(a)(2) for certain uses of Inactive Inventory PFAS. Persons subject to the Inactive Inventory PFAS SNUR would be required to notify EPA at least 90 days before commencing manufacture or processing for any use that EPA has determined is a significant new use. The required notifications would initiate EPA’s evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use would be unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination. EPA intends to publish an NPRM in September 2022 and a final rule in June 2023.
  • TRI; Response to Petition to Add Diisononyl Phthalate (DINP) to the TRI List of Toxic Chemicals (2025-AA17): According to EPA, this action arises from a petition received by EPA to add DINP to the list of toxic chemicals reportable under Section 313 of the Emergency Planning and Community Right to Know Act (EPCRA). In response to the petition, EPA initiated a rulemaking on September 5, 2000, proposing to add DINP to the TRI list. On June 14, 2005, EPA issued a notice of data availability seeking comments on EPA’s revised hazard assessment for DINP in further support of EPA’s proposal to add DINP to the TRI list. EPA states that the addition of DINP to the TRI list would make it subject to all the reporting requirements under the Toxic Chemical Release Reporting Rule. EPA intends to publish a supplemental NPRM in July 2022 and a final rule in May 2023;
  • Changes to Reporting Requirements for PFAS; Community Right-to-Know Toxic Chemical Release Reporting (2070-AK97): EPA is developing a proposal to add PFAS subject to reporting under EPCRA Section 313 and Section 6607 of the Pollution Prevention Act (PPA) to the list of Lower Thresholds for Chemicals of Special Concern (Chemicals of Special Concern). EPA states that the addition of the PFAS to the Chemicals of Special Concern list will eliminate the use of the de minimis exemption, eliminate the option to use Form A, and limit the use of range reporting. In addition, EPA is proposing to eliminate the use of the de minimis exemption under the Supplier Notification Requirements for facilities that manufacture or process all chemicals included on the Chemicals of Special Concern list. According to EPA, Chemicals of Special Concern may be found in products below de minimis levels; this is especially true for PFAS that are used at low concentrations in many products. Because of the widespread use of PFAS and their (or their degradants) persistence in the environment, however, even concentrations below de minimis levels can contribute significantly to environmental loading. The elimination of the de minimis exemption for supplier notification purposes will help facilities to identify potential sources of PFAS and other Chemicals of Special Concern. EPA believes that the elimination of the de minimis exemption under the Supplier Notification Requirements for PFAS and other Chemicals of Special Concern will result in a more complete picture of the releases and waste management quantities for these chemicals. EPA intends to publish an NPRM in September 2022 and a final rule in November 2023.
  • Addition of Certain PFAS to the TRI (2070-AL03): EPA is developing a rulemaking to add certain PFAS to the list of chemicals reportable under EPCRA Section 313. EPA states that the addition of these PFAS is in direct response to a statutory mandate under Section 7321(d) of the National Defense Authorization Act for Fiscal Year 2020 (NDAA). Under Section 7321(d), EPA was required to evaluate whether certain specific PFAS meet the EPCRA Section 313 listing criteria by December 2021 and is required to add any PFAS that EPA determines meet the listing criteria by December 2023. EPA intends to publish an NPRM in February 2023 and a final rule in November 2023.
  • Community Right-to-Know; Adopting 2022 North American Industry Classification System (NAICS) Codes for TRI Reporting (2070-AL09): EPA is developing a proposed rule to incorporate the revised 2022 North American Industry Classification System (NAICS) codes for TRI reporting purposes. According to EPA, the Office of Management and Budget (OMB) updates the NAICS codes every five years. OMB approved the 2022 NAICS codes on December 21, 2021 (86 Fed. Reg. 72277), with an effective date of January 1, 2022. EPA currently uses 2017 NAICS codes, and with this proposed rule would implement the 2022 codes for TRI Reporting Year 2022. Facilities reporting to the TRI would be required to use 2022 NAICS codes on reports that are due to EPA by July 1, 2023. This rule also proposed to update the C.F.R. to clarify the scope of facilities required to report to the TRI. According to EPA, the actual data required by a TRI form would not change as a result of this rulemaking, nor would the rule affect the universe of TRI reporting facilities that are required to submit reports to EPA under EPCRA Section 313. EPA intended to publish an NPRM in June 2022 and a final rule in November 2022.

Final Rule Stage

  • Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (PMN) (2070-AJ94): In 2016, EPA proposed changes to the existing regulations governing significant new uses of chemical substances under TSCA (40 C.F.R. Part 721, specifically “Protection in the Workplace” (40 C.F.R. Section 721.63) and “Hazard Communication Program” (40 C.F.R. Section 721.72)) to align these regulations with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS) (29 C.F.R. Section 1910.1200), which are proposed to be cross referenced, and with changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. EPA also proposed changes to the significant new uses of chemical substance regulations based on issues that have been identified by EPA and issues raised by public commenters for SNURs previously proposed and issued under these regulations. Additionally, EPA proposed a minor change to reporting requirements for PMNs and other TSCA Section 5 notices. EPA states that it expects these changes to have minimal impacts on the costs and burdens of complying, while updating the significant new use reporting requirements to assist in addressing any potential effects to human health and the environment. EPA is reviewing the comments received and is planning to issue a final rule. EPA intends to issue a final rule in October 2022. More information on the proposed rule is available in our July 29, 2016, memorandum.
  • Reporting and Recordkeeping for PFAS under TSCA Section 8(a)(7) (2070-AK67): EPA published a proposed rule on June 28, 2021, addressing reporting and recordkeeping requirements for PFAS under TSCA Section 8(a)(7). In accordance with obligations under TSCA Section 8(a), as amended by NDAA Section 7351, persons that manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011, would be subject to the reporting and recordkeeping requirements. In addition to fulfilling statutory obligations under TSCA, EPA states that it expects that the proposed rule would enable it to characterize better the sources and quantities of manufactured PFAS in the United States. EPA intends to publish a final rule in December 2022. More information on EPA’s proposed rule is available in our June 11, 2021, memorandum.
  • TRI; Response to Petition from the Toxics Use Reduction Institute (TURI) to Add 25 Chemicals (2070-AK26): The Toxics Use Reduction Institute (TURI) submitted a petition under EPCRA Section 313(e)(1) to add 25 chemicals to the EPCRA Section 313 list of toxic chemicals subject to reporting under the TRI. Three of the 25 chemicals were added to the EPCRA Section 313 list through actions unrelated to the petition. EPA states that it evaluated the remaining 22 chemicals to determine if they met the listing criteria of EPCRA Section 313(d)(2). EPA proposed the addition of 12 of the 22 chemicals that were determined to meet the EPCRA Section 313(d)(2) criteria and for which reports were expected to be filed. EPA is reviewing the comments received and is planning to issue a final rule. EPA intends to issue a final rule in November 2022.
  • Parent Company Definition for TRI Reporting (2070-AK42): In 2021, EPA proposed to codify the definition of “parent company” for purposes of reporting to the TRI. Although the existing regulation requires facilities reporting to the TRI to identify their parent company in annual reporting forms, no codified definition of this data element exists. Among the facilities reporting to the TRI are those with complicated corporate ownership structures. As such, effort is required each year by reporting facilities and EPA to clarify how the parent company data element should be represented on the form. According to EPA, a codified definition of parent company would allow EPA to address various corporate ownership scenarios explicitly and reduce the reporting burden caused by regulatory uncertainty. EPA states that the proposed rule would clarify existing regulations to reporting facilities and add a foreign parent company data element, if applicable, while improving EPA’s data quality. EPA is reviewing the comments received and is determining next steps. EPA intends to publish a final rule in October 2022.
  • NDAA Mandated Addition of Certain PFAS to the TRI for Reporting Year 2022 (2070-AL04): According to EPA, NDAA Section 7321 provides a framework for PFAS to be added automatically to the TRI list on January 1 of the year following certain EPA actions. In December 2021, EPA announced the statutory addition of the PFAS chemicals covered by the NDAA to the list of chemical substances subject to reporting for the TRI. This regulatory action amends the EPCRA regulations in 40 C.F.R. Part 372 to reflect this statutory addition. EPA intended to publish a final rule in June 2022.

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

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

©2022 Bergeson & Campbell, P.C.

EEOC Sanctions Employer for GINA Violations Relating to Collection of Employees’ Family Members’ COVID Test Results

On July 6, 2022, the Equal Employment Opportunity Commission (EEOC) announced it has entered into a conciliation agreement with a Florida-based medical practice for violations of the Genetic Information Non-Discrimination Act (GINA) arising out of the practice’s collection of employees’ family members’ COVID-19 testing results.

In a press release announcing the agreement, the EEOC stated that, following an investigation, it found that the medical practice – Brandon Dermatology – violated GINA by requesting the test results of employees’ family members and that “[s]uch conduct violates the GINA, which prohibits employers from requesting, requiring or purchasing genetic information about applicants or employees and their family members, except in very narrow circumstances which do not apply in this matter.”  GINA defines “genetic information” to include “the manifestation of a disease or disorder in an employee’s family members.”

While the press release includes limited details on the matter, the EEOC noted that “[i]n addition to compensating affected employees through restoration of leave time or back pay, as well as compensatory damages, the conciliation agreement resolving the charge requires Brandon Dermatology to review its COVID-19 policies; conduct training on EEO laws as they pertain to COVID-19; and post a notice.”

In its technical assistance guidance relating to COVID-19, the EEOC states that GINA “prohibits employers from asking employees medical questions about family members” including asking an employee who is physically coming into the workplace whether they have family members who have COVID-19 or symptoms associated with COVID-19.  However, the guidance goes on to state that “GINA . . . does not prohibit an employer from asking employees whether they have had contact with anyone diagnosed with COVID-19 or who may have symptoms associated with the disease.”  It also notes that “from a public health perspective, only asking about an employee’s contact with family members would unnecessarily limit the information obtained about an employee’s potential exposure to COVID-19.”

Article By Evandro C Gigante and Laura M. Fant of Proskauer Rose LLP

For more labor and employment legal news, click here to visit the National Law Review.

© 2022 Proskauer Rose LLP.

Looking into Our (Slightly Hazy) Crystal Ball: What Will the Mississippi Cannabis Market Look Like?

When you do what we do, you get a lot of calls and a lot of questions. Many of the calls and questions are not fruitful. Quite honestly, some of the calls are from folks whose interest in and experience with cannabis is, we suspect, on a purely personal and leisurely level. In the words of Hyman Roth, this is the business we’ve chosen.

But one legitimate question we’re often asked is what we think the cannabis market will look like in Mississippi. And, more specifically, whether Mississippi’s new medical cannabis regime will be similar to the one in Oklahoma.

It’s a loaded question, and one we suspect many questioners don’t fully appreciate. On the one hand, Oklahoma’s medical cannabis program has been compared to the Wild West. At last count, there were more medical cannabis dispensaries than liquor stores or supermarkets in the state. Many have concluded that this is a bad thing and/or that the program is a failure. Others have deemed the program a triumph of capitalism, a survival-of-the-fittest trial where only the “best” will survive.

As is often the case, we think the answer is probably somewhere in the middle.

On the one hand, the obvious and primary similarity between the programs is the absence of an expressed cap on the number of licenses available. While most states limit the number of licenses available, neither Oklahoma nor Mississippi does so. Many believe this feature will lead to Mississippi following the lead of Oklahoma in terms of the proliferation of dispensaries throughout the Magnolia State.

On the other hand, there are a number of differences between the two states and their statutes that indicate to us that Mississippi’s regime will differ in several important ways – ways we are seeing play out now. First, while the license fee for a dispensary in Oklahoma is $2,500, the fee in Mississippi is $25,000, 10 times the amount. And that amount is owed annually and is in addition to the initial $15,000 application fee. As a practical matter, and for better or worse, this feature alone should significantly cull the number of dispensaries because it provides a substantial barrier to entry into the industry.

Second, there may be significantly fewer locations available to open a dispensary in Mississippi than one would expect due to several geographic-limiting features of the law. Initially, localities have until May 3 to opt out of the medical cannabis regime, and several cities have already done so. Also, dispensaries cannot be located within 1,000 feet of any church, school, or daycare facility. For those unfamiliar with Mississippi, it may be tough to find anywhere in the state that isn’t within 1,000 feet of a church. Even more, the law forbids one dispensary from being within 1,500 feet from another dispensary, and dispensaries are only permissible in commercially zoned areas.

Third, the cannabis industry examining the Mississippi market will have the benefit of having lived through the Oklahoma experience. This is likely to minimize the “goldrush” mentality seen in Oklahoma’s early days. Instead, look for larger players to let the dust settle and come in looking to acquire operators who proved successful breaking out of the initial melee.

Conclusion

It seems possible that, at least in the early years, the Mississippi medical cannabis regime may more closely resemble Oklahoma than a state like Florida with strict limitations on the number of licenses. But our prediction is that certain aspects of Mississippi law and culture will lead to less of a free-for-all at the outset, hopefully leading to a more efficient and more orderly transition to a rational cannabis market in Mississippi.

Article By Whitt Steineker and Slates C. Veazey of Bradley Arant Boult Cummings LLP

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

© 2022 Bradley Arant Boult Cummings LLP

Abortion-Related Travel Benefits Post-Dobbs

Immediately following the Supreme Court decision in Dobbs v. Jackson returning the power to regulate abortion to the states, a number of large employers announced that they would offer out-of-state travel benefits for employees living in states where abortion-related medical care is unavailable. Employers considering offering abortion-related travel benefits have several key considerations to keep in mind. The law currently allows health plans to provide reimbursement for travel primarily for and essential to medical care. Although this area of the law is evolving, employers with self-funded medical plans may amend their existing medical plans to provide abortion-related travel benefits while those with fully insured medical plans may face more obstacles in providing such benefits.

In Dobbs v. Jackson, an abortion clinic challenged a Mississippi law that would ban abortion after 15 weeks of pregnancy, with limited exceptions. In establishing the constitutional right to abortion in Roe v. Wade, the Supreme Court restricted states in their ability to limit or ban abortions before viability of the fetus, or 24 weeks from the time of conception. In upholding the Mississippi law, the Supreme Court overturned Roe and held that the protection or regulation of abortion is a decision for each state.

Alabama, Arkansas, Kentucky, Missouri, Oklahoma and South Dakota have already banned or made abortion illegal pursuant to trigger laws which went into effect as of the Supreme Court decision on June 24, 2022.  Also, a number of additional states are expected to soon have similar legislation in effect, either by virtue of expected legislative action or trigger laws with slightly delayed effective dates.  In response, a number of employers have announced that they will reimburse all or a portion of abortion-related travel expenses for employees in states where abortions are banned or otherwise not available.

Under Section 213(d) of the Internal Revenue Code, the definition of “medical care” includes transportation that is both “primarily for and essential to” the medical care sought by an individual. These types of travel benefits have historically been utilized in connection with certain specialized medical treatments, such as organ transplants.  However, Section 213(d) is not limited to particular types of procedures, and thus forms the framework for providing abortion-related travel benefits through existing medical plans.

Although Code Section 213(d) applies to both self-insured and insured medical plans, the substantive coverage provisions of insured medical plans will generally be governed by the state insurance code of the state in which the insurance policy is issued.  Coverage for abortion services or any related travel benefits may not be permitted under the insurance code of the state in which the policy is issued, or an insurer may not offer a travel benefit for such services even if permitted to do so.  Self-insured plans, by contrast, provide employers more flexibility in plan design, including control, consistent with existing federal requirements, over the types and levels of benefits covered under the plan. As noted above, existing plans may already cover travel-related benefits for certain types of medical procedures.

Employers with high-deductible health plans tied to health savings accounts (HSAs) will need to consider the impact of adding abortion-related travel benefits to such plans.  Travel-related benefits of any type would not appear to be eligible for first dollar coverage, and thus may be of minimal benefit to participants enrolled in high-deductible health plans.

Employers with fully insured medical plans that do not cover abortion-related travel benefits may be able to offer a medical travel reimbursement program through an integrated health reimbursement arrangement (HRA).  An integrated HRA is an employer-funded group health plan from which employees enrolled in the employer’s traditional group medical insurance plan are reimbursed for qualifying expenses not paid by the traditional plan.

Another potential option for employers with fully insured medical plans may be to offer a stipend entirely outside of any established group health plan. Such reimbursement programs may result in taxable compensation for employees who receive such reimbursements. Also, employers would need to be sensitive to privacy and confidentiality considerations of such a policy, which should generally be minimized if offered in accordance with the existing protections of HIPAA through a medical plan and under which claims are processed by an insurer or third-party administrator rather than by the employer itself.

Additionally, some state laws may attempt to criminalize or otherwise sanction so-called aiding and abetting actions related to the procurement of abortion services in another state.  This is an untested area of the law, and it is unclear whether any actions brought under such statutes would be legally viable.  In this regard, Justice Kavanaugh stated as follows in his concurring opinion in Dobbs:  “For example, may a State bar a resident of that State from traveling to another State to obtain an abortion? In my view, the answer is no based on the constitutional right to interstate travel.” (Kavanaugh Concurring Opinion, page 10.)  This is an area that will require continual monitoring by employers who offer abortion-related travel benefits.

Article By Thomas G. Hancuch, Philip L. Mowery, and Amal Rafiq of Vedder Price

For more labor and employment legal news, click here to visit the National Law Review.

© 2022 Vedder Price

Update: In Opioid Liability Ruling for Doctors, SCOTUS Deals Blow to DOJ

On June 27, 2022, the United States Supreme Court ruled that doctors who act in subjective good faith in prescribing controlled substances to their patients cannot be convicted under the Controlled Substance Act (“CSA”).  The Court’s decision will have broad implications for physicians and patients alike.  Practitioners who sincerely and honestly believe – even if mistakenly – that their prescriptions are within the usual course of professional practice will be shielded from criminal liability.

The ruling stemmed from the convictions of Dr. Xiulu Ruan and Dr. Shakeel Kahn for unlawfully prescribing opioid painkillers.  At their trials, the district courts rejected any consideration of good faith and instructed the members of the jury that the doctors could be convicted if they prescribed opioids outside the recognized standards of medical practice. The Tenth and Eleventh Circuits affirmed the instructions.  Drs. Ruan and Kahn were sentenced to 21 and 25 years in prison, respectively.

The Court vacated the decisions of the courts of appeals and sent the cases back for further review.

The question before the court concerned the state of mind that the Government must prove to convict a doctor of violating the CSA.  Justice Breyer framed the issue: “To prove that a doctor’s dispensation of drugs via prescription falls within the statute’s prohibition and outside the authorization exception, is it sufficient for the Government to prove that a prescription was in fact not authorized, or must the Government prove that the doctor knew or intended that the prescription was unauthorized?”

The doctors urged the Court to adopt a subjective good-faith standard that would protect practitioners from criminal prosecution if they sincerely and honestly believed their prescriptions were within the usual course of professional practice.  The Government argued for an objective, good-faith standard based on the hypothetical “reasonable” doctor.  The Court took it one step further.

Justice Breyer delivered the opinion of the Court.  He said that for purposes of a criminal conviction under the CSA, “the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.”  To hold otherwise “would turn a defendant’s criminal liability on the mental state of a hypothetical ‘reasonable’ doctor” and “reduce culpability on the all-important element of the crime to negligence,” he explained.  The Court has “long been reluctant to infer that a negligence standard was intended in criminal statutes,” wrote Justice Breyer.

Justice Samuel Alito wrote a concurring opinion, which Justice Clarence Thomas joined and Justice Amy Coney Barrett joined in part.  Although Justice Alito would vacate the judgments below and remand for further proceedings, he would hold that the “except as authorized” clause of the CSA creates an affirmative defense that defendant doctors must prove by a preponderance of the evidence.

The Court’s decision will protect patient access to prescriptions written in good faith.  However, for the government, the Court’s decision means prosecutors face an uphill battle in charging, much less convicting, physicians under the CSA.  Indeed, the Court’s decision may have a chilling effect on the recent surge in DOJ prosecutions of medical practitioners and pain clinics.

Article By Lindsay K. Gerdes and Madeline R. Pinto of Dinsmore & Shohl LLP

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

© 2022 Dinsmore & Shohl LLP. All rights reserved.

Preparing Corporate Messaging in the Wake of Dobbs

The United States Supreme Court (“SCOTUS”), in Dobbs v. Jackson Women’s Health Organization, has held that there is no constitutional right to abortion, overruling Roe v. Wade and Casey v. Planned Parenthood.

Employers, who increasingly are finding themselves on the front lines of many societal issues, will need to decide quickly whether and how they might address the Dobbs decision, as public reaction has been and is likely to remain strong. Board members, employees, and shareholders may advocate for corporations to take a visible stand on the issue of abortion and reproductive rights. And employees may want to speak up themselves (possibly via employer social media accounts).

It is important to remember that company communication decisions and actions regarding the Dobbs ruling, as well as other political and social issues, can have practical and legal implications.

The first question is whether your company will comment on Dobbs. If you decide to comment, there are many factors to consider. Your message is an important starting point. Who is your intended audience? Will your employees consider it an opportunity to join in the conversation? What will you say? Even if your message is internal, keep in mind that it may not stay that way, given the nature of social media. And before you think, “I’ll just stay out of it,” remember that some will view silence or neutrality as a statement in and of itself. If you choose not to speak, are you prepared to deal with any potential reaction from customers, employees, or shareholders?

Internally, employees may have questions about health benefits or other terms and conditions of employment because of Dobbs. It will be important to arm all key stakeholders, including leadership, corporate communications, and human resources, with tools to consistently manage these communications and responses.

Whether it’s internal or external communications, expect feedback! How that feedback is handled is as important as the initial communication (or lack thereof).

Certain industries, like healthcare and insurance, may also feel compelled to make an affirmative statement if the Dobbs decision has a direct impact on services and/or products. In those cases, the need to consider all implications is even more pressing.

In thinking through these decisions, employers should also consider who may need to approve any messaging. The board of directors, senior executives, legal, and marketing and communications teams are among the key stakeholders who may need to be consulted. And don’t forget that your public-facing employees may bear the brunt of your response. Are they prepared?

Employers should also keep in mind various laws that may govern their reaction, including those they might otherwise not consider. For example, the National Labor Relations Act protects employees’ rights to collectively discuss terms and conditions of employment at work and off duty – and that applies to employers with and without a unionized workforce. The current Biden-appointed General Counsel of the National Labor Relations Board has taken an expanded view of topics that are connected to the workplace. Moreover, some states, including California and New York, have enacted off-duty conduct laws that prohibit employers from disciplining employees for lawful conduct outside of work, which may include political advocacy. There may also be anti-discrimination laws and potential civil and criminal liability associated with your statements, depending on their wording.

Reactions to the Dobbs decision may vary. Some reaction may be comparable to what we’ve seen with respect to other recent political and/or social justice movements, such as Black Lives Matter and #MeToo; others may react differently, or not at all. In these rapidly changing times, companies — particularly publicly traded and consumer-facing ones — need to be make informed decisions. Clear, consistent messaging is key to establishing confident and consistent responses to potential concerns by employees and other stakeholders.

Article By M. Carter DeLorme, Frank C. Morris, JR, Susan Gross Sholinsky, Jennifer Barna, and Erin E. Schaefer of Epstein Becker & Green, P.C.

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

©2022 Epstein Becker & Green, P.C. All rights reserved.

U.S. Supreme Court Overturns Roe and Casey: What This Decision Means for Employers

As many expected based on the draft opinion that was leaked months ago, the U.S. Supreme Court has held the U.S. Constitution does not protect the right to obtain an abortion. Dobbs v. Jackson Women’s Health Organization, No. 19-1392 (June 24, 2022).

Dobbs overturns nearly 50 years of precedent from the Court’s decision in Roe v. Wade and Planned Parenthood Pennsylvania v. Casey on the issue.

The impact of Dobbs will vary, as states are now at liberty to enforce and create abortion legislation without restrictions arising out of constitutional protections.

What does this mean for employers?

As pressure mounts on this issue, some employers may be considering what, if anything, they can or should do. Many states have enacted legislation that restricts individual abortion rights and potentially third parties who assist individuals who seek abortions. To the extent any state laws were not enforced because of the Court’s holding in Roe or Casey, states can move forward now to implement and enforce those laws.

Laws often referred to as “trigger laws,” those that are in place but unenforceable due to overriding federal restrictions, become enforceable once those federal restrictions are lifted. As a result of Dobbs, abortion-related “trigger laws” previously unenforceable can take effect, creating new standards for individuals and others that will redefine the national abortion law landscape.

Some existing state laws and trigger laws may affect employers and put employers at risk of violating state law if they implement policies to assist employees seeking an abortion or even continue to cover abortions under group health plans. For example, a state law may create liability for anyone who “aids or abets” a person who obtains an abortion. Employers also must be cognizant of how they apply their leave policies, who may seek accommodations based on a sincerely held religious belief, and whether certain provisions of the Pregnancy Discrimination Act apply to women who are seeking or who have had an abortion.

In addition, the Court’s ruling may affect employee benefit plans. Many employers are considering additional benefits for their employees, and their covered dependents, such as travel reimbursement for seeking an abortion outside of the local jurisdiction due to state law restrictions. There are many legal issues to consider in connection with the coverage of abortion-related services under employee benefit plans. (For additional guidance on the issue, see our article, Group Health Plan Considerations in the Face of (Potentially) Changing Abortion Laws.) Depending on how the state laws are enacted, there also may be issues with relying on ERISA preemption provisions to avoid these obligations.

Corporate management and directors should plan for changes and be aware of policies and fiduciary responsibilities. This can include preparing for public and employee reactions (for and against), legislative and law enforcement threats, social media posts, and other employee demonstrations. Pressure from a variety of groups to take a corporate public opinion also may occur.

Whether changes to leave policies, employee benefits, travel reimbursement, or handling accommodation requests, employers considering policies or benefit offerings in response to Dobbs must carefully review and consider federal and state laws, including state abortion-related legislation to evaluate the risk of potential liability.

Article By Patricia Anderson Pryor, Joy Napier-Joyce, Melissa Ostrower, and Tasos C. Paindiris of Jackson Lewis P.C.

For more labor and employment legal news, click here to visit the National Law Review.
Jackson Lewis P.C. © 2022

CMS Reduces COVID-19 Vaccine Mandate Surveys and Rescinds Surveyor Vaccination Requirements

In two recent memoranda, the Centers for Medicare and Medicaid Services (CMS) made changes to previously issued survey guidance related to COVID-19 vaccination issues.

In QSO-22-17-ALL, CMS modified the frequency by which State Agencies and Accreditation Organizations will survey for compliance with the federal staff vaccine mandate applicable to health care providers and suppliers (discussed in a prior post).  Noting that 95% of providers and suppliers surveyed have been found in substantial compliance with the rule, CMS is eliminating the previous requirement that State Agencies and Accreditation Organizations survey for compliance with the vaccine mandate during every survey.  Review of compliance with vaccine mandate is still required, however, during initial surveys, recertification surveys, and in response to specific complaint allegations that allege non-compliance with the staff vaccination requirement.  This means that a State Agency or Accreditation Organization is not required to review compliance with the staff vaccination requirement during, for example, a validation survey or a complaint survey unrelated to compliance with the staff vaccination requirement.  A State Agency or Accreditation Organization may still choose to expand any survey to include review of vaccine mandate compliance; however, the new guidance should result in a reduction in survey frequency of this issue for providers and suppliers.

In QSO-22-18-ALL, CMS rescinded, in its entirety, the previously issued QSO-22-10-ALL memorandum, which had mandated that surveyors of State Agencies and Accreditation Organizations be vaccinated for COVID-19.  However, CMS noted that the State Agencies and Accreditation Organizations were responsible for compliance and prohibited providers and suppliers from asking surveyors for proof of vaccination.  While CMS is now encouraging vaccination of surveyors performing federal oversight surveys, the mandate for vaccination is no longer in effect.

Article By Allen R. Killworth of Epstein Becker & Green, P.C.

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

©2022 Epstein Becker & Green, P.C. All rights reserved.

Governor Rolls Back California COVID-19 Executive Orders & Cal/OSHA Releases Draft Permanent COVID-19 Standard

On June 17, 2022, Governor Newsom issued an executive order terminating certain provisions of prior executive orders related to Cal/OSHA’s COVID-19 Emergency Temporary Standards (ETS). Some of the terminated orders were no longer necessary due to changes in the ETS. For example, previously the Governor had issued an executive order stating exclusion periods could not be longer than California Department of Public Health (CDPH) guidelines or local ordinances. However, since the ETS now defers to CDPH guidance on isolation and quarantine, the Governor has rescinded his prior executive order on this issue. Moreover, Cal/OSHA has issued guidance for employers on COVID-19 Isolation and Quarantine that aligns with CDPH requirements.

The current version of the ETS remains in effect until the end of 2022. However, Cal/OSHA won’t be done with COVID-19 regulations in 2023. The agency is currently working on a permanent COVID-19 Standard. Recently, the draft of the proposed regulation was released.

The draft regulation carries over many of the employer obligations from the current ETS. The following are some of the proposed requirements:

  • COVID-19 procedures, either included in their Injury and Illness Prevention Program (IIPP) or a separate document.
  • Exclusion and prevention requirements for positive employees and close contacts.
  • Employers would continue to be required to provide testing to employees who have a close contact in the workplace.
  • Employers would continue to have notice requirements for COVID-19 exposure.
  • Employers would continue to have to provide face coverings to employees.
  • Employers would continue to have reporting and recordkeeping requirements for COVID-19 cases and outbreaks in the workplace.

Currently, no public hearing has been set for the proposed permanent COVID-19 Standard, so it is uncertain how soon the regulations may be implemented.

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

Health Care Providers on Alert: Two Hospitals Penalized for Continuous Noncompliance with the Hospital Price Transparency Rule

We previously discussed the requirements of the Hospital Price Transparency Rule (“Rule”) on health care providers and health plans, as well as CMS’s proposal to increase penalties for a hospital’s failure to comply with the Rule.  About a year and a half after the Rule became effective, CMS has now imposed its first set of civil monetary penalties (“CMPs”) on Northside Hospital Atlanta and Northside Hospital Cherokee, which have been fined $883,180 and $214,320, respectively.

The Rule requires, in part, hospitals to make public a machine-readable file containing a list of all standard charges for all items and services, such as, e.g., supplies, room and board, and use of the facility, among other items.  See 45 C.F.R. § 180.40(a); id. at § 180.20.  The Rule also requires hospitals to display shoppable services in a consumer-friendly manner.  See id. at § 180.60(d)(2); id. at § 180.60(b).  The goal of these specific requirements, in addition to those set forth in the remainder of the Rule, is to provide consumers with sufficient information about the charges for certain items and services by requiring health care providers and health plans to be publicly transparent about such charges.

Based on CMS’s CMP letters, dated June 7, 2022, Northside Hospital Atlanta and Northside Hospital Cherokee were non-compliant with the aforementioned specific requirements of the Rule.  The chronology of events is important to understand how CMS ended up issuing its CMP letters.

Northside Hospital Atlanta

For Northside Hospital Atlanta:

  • CMS documented the hospital’s non-compliance since March 24, 2021.
  • CMS issued a Warning Letter, dated April 19, 2021, to the hospital and provided it the opportunity to respond and to provide supporting documentation to CMS.
  • Northside Hospital Atlanta did not respond.
  • On September 2, 2021, CMS reviewed the hospital’s website and determined that the non-compliance persisted.
  • On September 30, 2021, CMS issued a Request for Corrective Action Plan (CAP) to the hospital, stating that it was non-compliant with the aforementioned specific requirements of the Rule.
  • On November 15, 2021, in response to the Request for CAP, the hospital stated that patients could request specific price estimate quotes by calling or emailing Northside Hospital Atlanta, which CMS determined was insufficient in response to its Request for CAP and to comply with the Rule.
  • On December 20, 2021, CMS requested a revised CAP from the hospital.
  • Northside Hospital Atlanta did not respond.
  • On January 11, 2022, CMS conducted a technical assistance call with the hospital, during which the hospital confirmed that it was non-compliant with the Rule and explained that it had intentionally removed all previously posted pricing files.
  • On January 24, 2022, CMS, again, requested a revised CAP from the hospital.
  • Northside Hospital Atlanta did not respond.

Based on the foregoing, CMS imposed an $883,180 CMP on Northside Hospital Atlanta, calculated as follows, pursuant to 45 C.F.R. § 180.90:

  • $36,300
    • $300 per day of non-compliance times 121 days.
    • 121 days represents the number of calendar days during 2021 that Northside Hospital Atlanta was non-compliant with the Rule (September 2, 2021 through December 31, 2021), pursuant to 45 C.F.R. § 180.90(2)(i).

 plus

  • $846,880
    • $10 per bed per day times 536 beds times 158 days.
    • 158 days represents the number of calendar days during 2022 that Northside Hospital Atlanta was non-compliant with the Rule (January 1, 2022 through the date of CMS’s CMP letter, June 7, 2022), pursuant to 45 C.F.R. § 180.90(2)(ii).

Northside Hospital Atlanta has until 60 calendar days from the date of CMS’s CMP letter to pay.  Until the hospital notifies CMS that all non-compliance has been corrected, CMPs will continue to accrue.

Northside Hospital Cherokee

For similar reasons as Northside Hospital Atlanta, Northside Hospital Cherokee was fined $214,320.  CMS noted that Northside Hospital Cherokee was non-compliant since April 16, 2021, and notified the hospital by Warning Letter, dated May 18, 2021.  CMS reviewed the hospital’s website on September 9, 2021, and issued a Request for CAP on October 27, 2021—to which the hospital did not respond.  Similar to Northside Hospital Atlanta, CMS held a technical assistance call on January 11, 2022, during which Northside Hospital Cherokee notified CMS that it had intentionally removed all previously posted pricing files.  CMS requested a Request for CAP on January 24, 2022—to which the hospital did not respond.

Similar to Northside Hospital Atlanta, Northside Hospital Cherokee was penalized $214,320, calculated as follows:

  • $34,200
    • $300 per day of non-compliance times 114 days.
    • 114 days represents the number of calendar days during 2021 that Northside Hospital Cherokee was non-compliant with the Rule (September 9, 2021 through December 31, 2021), pursuant to 45 C.F.R. § 180.90(2)(i).

plus

  • $180,120
    • $10 per bed per day times 114 beds times 158 days.
    • 158 days represents the number of calendar days during 2022 that Northside Hospital Cherokee was non-compliant with the Rule (January 1, 2022 through the date of CMS’s CMP letter, June 7, 2022), pursuant to 45 C.F.R. § 180.90(2)(ii).

Similar to Northside Hospital Atlanta, CMS noted that Northside Hospital Cherokee continues to be non-compliant and, thus, CMPs will continue to accrue.

Takeaways

These fines reflect CMS’s willingness to take material enforcement action where the Rule’s regulatory requirements are largely ignored and CMS’s subsequent efforts to obtain compliance are rejected.  Non-compliance carries heavy fines that are calculated, in part, by the number of days of non-compliance and by bed count.  Health care providers should take notice and ensure that they are compliant or, at least, making efforts towards compliance with the Rule’s requirements.  Critically, CMS will not accept a refusal to comply, as reflected in CMS’s responses to Northside Hospital Atlanta’s and Northside Hospital Cherokee’s refusals to submit CAPs.  As noted in CMS’s CMP letters to these providers, CMS is scanning websites and subsequently notifying providers that appear to be non-compliant with the Rule—which are ignored at the provider’s peril.

Article By Edward S. Kornreich and Matthew J. Westbrook of Proskauer Rose LLP

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

© 2022 Proskauer Rose LLP.