Category: Health

Monkeypox Outbreak Declared a Public Health Emergency

On August 4, 2022, the Biden administration declared the monkeypox outbreak a public health emergency. This comes at a time where the number of cases in the United States are rapidly rising and with cases found in almost every state. This declaration primarily affects testing and vaccination. The government’s focus on vaccination has primarily been on health care workers treating monkeypox patients and men who have sex with men. The declaration follows the World Health Organization’s (WHO) declaration last month of monkeypox as a public health emergency of international concern.

The information affecting the workplace is still somewhat limited. The U.S. Centers for Disease Control and Prevention (CDC) recommends that people with monkeypox remain isolated at home or in another location for the duration of the illness, which typically can last two to four weeks.

It is still not known if monkeypox can be spread through respiratory secretions. Accordingly, a well-fitting mask and frequent handwashing are likely important preventive measures.

Monkeypox can spread to anyone through close, personal, often skin-to-skin contact, including:

  • via direct contact with monkeypox rash, scabs, or body fluids from a person with monkeypox;

  • by touching objects, fabrics (clothing, bedding, or towels), and surfaces that have been used by someone with monkeypox; and

  • possibly through contact with respiratory secretions.

Employers may wish to educate their employees about monkeypox, including that employees with concerns should consult their physicians or health department, and may wish to inquire about testing and vaccination. Employers may also wish to consider how they will handle absences of up to one month, if remote work is not a possibility and/or when remote work is a possibility. Knowledge is often a way to avoid panic in the workplace and both the CDC and WHO have excellent fact sheets on their websites. State health agencies are likely to have them as well.

It may also be worthwhile to consider how to protect employees who are required to handle linens used by other people, people who are frequently in close contact with others for extended periods, or who come into close physical contact with others. For example, in its monkeypox congregate settings guidelines, the CDC recommends that personal protective equipment (PPE) be worn when cleaning the area where an individual with monkeypox has spent time.

The CDC also stated in its monkeypox congregate settings guidelines that “[e]mployers must comply with [the Occupational Safety and Health Administration’s] standards on Bloodborne Pathogens…, PPE…, Respiratory Protection…, and other requirements, including those established by state plans, whenever these requirements apply.”

Public health officials are emphasizing the fact that anyone can get monkeypox. The current outbreak is most prevalent among men having sex with other men, but can spread to anyone. Employers may want to stay attuned to any harassment or discrimination in the workplace resulting from misinformation about the disease.

Ogletree Deakins will continue to monitor and report on developments with respect to monkeypox.

Article By Katherine Dudley Helms of Ogletree, Deakins, Nash, Smoak & Stewart, P.C.

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

© 2022, Ogletree, Deakins, Nash, Smoak & Stewart, P.C., All Rights Reserved.

What Employers Need to Know in a Post-Dobbs Landscape

On June 24, 2022, in Dobbs v. Jackson Women’s Health Organization, the United States Supreme Court overturned both Roe v. Wade and Planned Parenthood v. Casey and held the access to abortion is not a right protected by the United States Constitution. This article analyzes several employment law issues employers may face following the Dobbs decision.

Federal Law

The Pregnancy Discrimination Act (PDA) prohibits employment discrimination “on the basis of pregnancy, childbirth, or related medical conditions.” In construing the PDA’s reference to “childbirth”, federal courts around the country have held the PDA prevents employers from taking adverse employment actions (including firing, demotion, or preventing the opportunity for advancement) because of an employee’s decision to have an abortion as well as an employee’s contemplation of an abortion. The PDA also prohibits adverse employment actions based upon an employee’s decision not to have an abortion. So, for example, an employer would violate the PDA if it pressured an employee to have, or not to have, an abortion in order to keep her job or be considered for a promotion.

State Law

Several states have implemented “trigger laws,” which impose restrictions or categorical bans on abortion following Dobbs. In addition, states such as Texas have enacted laws that allow individuals to file civil actions against entities that “knowingly engage in conduct that aids or abets the performance or inducement of an abortion, including paying for or reimbursing the cost of an abortion through insurance or otherwise.” Relying on that law, Texas legislators have already threatened at least two high profile employers for implementing policies which reimburse travel costs for abortion care unavailable in an employee’s home state. Although the Texas statute is currently being challenged in court, its text provides for statutory damages “in an amount of not less than $10,000” for “each abortion . . . induced.”

Although the issue has not been litigated yet, courts will likely have to decide how the PDA’s protections interact with a state’s anti-abortion laws.

Employer Handbook Policies and Procedures

The Dobbs decision may also impact workplace morale and productivity. Accordingly, employers should consider reviewing their handbooks as well as policies and procedures, with human resources and managers to ensure requisite familiarity with the employer’s social media policy, dress code, code of conduct, and how the employer handles confidential health information. Employers should be prepared for increased public expression from the workforce—including social media posts, discussions with other employees and third parties, and wearing clothing or other accessories reflecting strong opinions. Human resources should also be prepared for an increase in leave requests and employee resignations.

Travel Benefits for Employees Seeking Reproductive Care

In the wake of Dobbs, many businesses in states where access to abortion will be prohibited or highly restricted are considering—or have already implemented—benefit or employee expense plan amendments that would cover travel and lodging for out-of-state abortions. Ultimately, the legal and regulatory future for such plans remains unclear; especially in states where abortion laws are the most restrictive and contain “aiding and abetting” liability.

At a high level, employers seeking to enact such benefit or expense plans may find some comfort in a statement contained in Justice Kavanaugh’s concurrence in Dobbs. Specifically, Justice Kavanaugh wrote:

  • Some of the other abortion related legal questions raised by today’s decision are not especially difficult as a constitutional matter. 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.

Thus, it appears that outright travel bans or similar prohibitive restrictions would face significant legal challenges, and could be declared void.

At this early stage in the post-Roe era, there appear to be several ‘paths’ emerging for employers seeking to provide travel benefits. Each comes with its own set of potential issues and considerations that employers, in conjunction with their counsel and benefit providers, should evaluate carefully. Below is a brief discussion of some of the travel-reimbursement plans employers have begun to implement or consider in the wake of Dobbs:

  1. Travel and lodging benefits under existing group health plans.
    • Assuming the plans are self-funded and subject to ERISA, they must also comply with other applicable rules such as HIPAA and the ACA.
    • Such benefits may not be available under non-ERISA plans in states restricting abortion access.
    • Generally would be limited to individuals enrolled in the employer’s plan.
  2. Travel and lodging benefits under Health Reimbursement Arrangements (HRA’s).
    • An HRA is a type of health savings account offering tax-free reimbursement up to a fixed amount each year.
    • HRA’s are generally subject to ERISA and cannot reimburse above the very minimal IRS limits (Section 213), such as mileage (.18 cents) and lodging ($50/per day).
    • Should be integrated with other coverage or qualify as an “Excepted Benefit HRA” or else it may violate certain ACA rules that prohibit lifetime annual dollar limits for certain benefits.
  3. Employee Assistance Programs (EAP’s).
    • EAP’s are voluntary benefit programs some employers use to allow employees access to certain types of care without accruing co-pays, deductibles, or out of pocket costs. Historically, EAP’s have been predominately used for mental health benefits such as therapy or substance abuse counseling.
    • In certain circumstances, EAP’s are exempt from the ACA. To be an “excepted benefit,” the EAP:
      • Cannot provide significant benefits in the nature of medical care or treatment;
      • Cannot be coordinated with benefits under another group health plan;
      • Cannot charge a premium for participation; and
      • Cannot require cost sharing for offered services.
    • The first of the above requirements (significant benefits of a medical nature) is highly subjective and may create risk for employers because it is difficult to determine whether a benefit is “significant.” Accordingly, it may be difficult to locate a third-party vendor or provider that would administer travel and lodging benefits through an EAP.
  4. Travel and lodging benefits to employees as taxable reimbursements.
    • Taxable reimbursements—up to a certain amount annually—for travel to obtain abortion or other medical care not available in the employee’s place of residence.
    • Some employers are requiring only receipts for lodging, but are not requesting substantiation of the employee’s abortion procedure. Some argue this might insulate an employer from liability in states with statutes prohibiting “aiding or abetting” an abortion, on the grounds that the employer does not know what the employee is using the benefit for. Ultimately, whether that is true remains largely untested and unclear.
    • Likely more costly for the employer, because the benefit is broader in scope. In addition, employers may run the risk that a payroll reimbursement of this kind could qualify as setting up a “new medical plan,” thereby raising compliance and other related issues.

Additionally, employer travel-and-lodging benefits of this type present innumerable other questions and issues. Such questions should include:

  1. Is the employer’s benefit plan subject to ERISA?
    • ERISA is the federal law applicable to qualifying employee benefits plans, including employer-sponsored group health plans. Plans subject to ERISA must also comply with HIPAA, the ACA, and other applicable rules and regulations. So-called self-funded employer plans are subject to ERISA.
    • With some exceptions, ERISA preempts or blocks the implementation of state laws that ”relate to” the ERISA plan.
    • However, ERISA does not:
      • Preempt a state law that regulates insurance companies operating in the state; or
      • Preempt state criminal laws of general applicability.
    • If a plan is self-insured and subject to ERISA it may not be required to comply with state laws related to abortion services based on ERISA preemption.
    • However, the impact of new and untested civil and/or criminal penalties remains unclear.
  2. What procedures does the plan cover?
    • In this environment—especially in states with the most restrictive abortion laws—employers should have a firm understanding of what specific type of abortion procedures the plan covers.
  3. Specific or “general” travel stipends?
    • As noted above, some companies are choosing to provide travel/lodging stipends and benefits to access abortion care in jurisdictions where the procedure is lawful.
    • Some employers are making this travel stipend more general—i.e., not requiring the stipend be used for abortion, or otherwise naming abortion in the benefit program. As an example, a policy that provides a stiped for an employee to “travel to receive medical care that is unavailable within 100 miles of the employee’s place of residence.”
    • Note that out-of-plan reimbursements to employees are likely taxable as wages. Some employees may choose to gross up such stipends to compensate.
  4. What about privacy concerns?
    • Employers should think carefully about how to provide any benefits or stipends while protecting employee privacy, not violating HIPAA, and—where applicable—not running afoul of so-called ‘aiding and abetting’ legislation.
    • To that end, as noted above, some companies are requiring only that employees provide travel receipts—not documentation of the underlying procedure—to qualify for the benefit, reimbursement, or stipend.
    • Of course, without any verification, there is always the potential for abuse—or otherwise using the program for something well beyond its core intent, such as travel, elective plastic surgery, etc. However, some employers may evaluate the risk of abuse as worth the potential lessening of privacy and other concerns.

Protected Activity

Employers must also be aware that certain speech in the workplace—including speech about abortion—may be legally protected. Although the First Amendment generally does not extend to private companies, the National Labor Relations Act (NLRA) prohibits retaliation against employees who discuss the terms and conditions of employment, commonly referred to as “protected concerted activity.” Thus, employees (1) discussing or advocating for an employer to provide benefits to women seeking reproductive and abortion-related healthcare services, (2) advocating for the employer to take a certain public stance on the issue, or (3) protesting the employer’s public position on the issue, may constitute protected activity under the NLRA.

Contacts and Next Steps

Employment law issues will continue to arise and evolve in the coming months following the Dobbs decision. The EEOC, DOL, and HHS may provide further guidance on how Dobbs impacts employment laws such as the Family and Medical Leave Act (FMLA), Americans with Disabilities Act (ADA), and PDA. Employers should consult with legal counsel concerning these developments.

Article By Denise E. Giraudo, Stephen E. Fox, Jonathan E. Clark, and Dan Syed of Sheppard, Mullin, Richter & Hampton LLP

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

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.

PFAS Health Advisories Under Legal Attack…Again

On June 15, 2022, the EPA issued Health Advisories (HAs) for five specific PFAS, including PFOA and PFOS. On July 29, 2022, the American Chemistry Council filed a petition in the Court of Appeals for the District of Columbia challenging the validity of the EPA’s PFOA and PFOS HAs. The group alleges that the EPA did not follow proper procedure in setting the HAs and that the EPA’s determinations were scientifically flawed. The petition follows closely on the heels of a similar challenge to the EPA’s HA for GenX PFAS. Industries that will be impacted by upcoming EPA PFAS regulations will closely follow the petition as it makes its way through court, as it may provide predictive indicators of arguments that will unfold as the EPA’s PFAS regulations increase.

PFAS Health Advisories

In October 2021, the EPA released its PFAS Roadmap, which stated explicit goals and deadlines for over twenty action items specific to PFAS. As part of the Roadmap, the EPA pledged to re-assess the existing Health Advisories (HAs) for PFOA and PFOS, as well as establish HAs for PFBS and GenX chemicals. In June 2022, the EPA fulfilled its promise on all fronts when it set HAs for PFOA (interim), PFOS (interim), PFBS (final) and GenX (final). While not enforceable levels for PFAS in drinking water, the EPA’s PFAS Health Advisories are nevertheless incredibly significant for a variety of reasons, including influence on future federal and state drinking water limits, as well as potential impacts on future PFAS litigation.

The levels set by the EPA’s PFAS Health Advisories were as follows:

PFOA

.004 ppt

PFOS

.02 ppt

GenX

10 ppt

PFBS

2,000 ppt

Legal Challenge To PFAS Health Advisories

On July 13, 2022, The Chemours Company filed a petition challenging the validity of the EPA’s GenX HA. On July 29, 2022, the American Chemistry Council (ACC) followed suit and petitioned to have the EPA’s HAs for PFOA and PFOS vacated. In the petition, the ACC argues that the EPA circumvented procedural requirements in the Safe Drinking Water Act by setting interim HAs for PFOA and PFOS and that the EPA is improperly attempting to create enforcement standards for drinking water that are unattainable. While the HAs themselves are not enforceable, the ACC argues that the HAs are relied upon by states when they set their own drinking water standards and signal an EPA intent to set unachievably low levels of enforceable PFAS standards at the federal level. The ACC points to recent findings by the Science Advisory Board (SAB) that criticized the EPA’s reliance on the same studies and scientific articles upon which the HAs were based.

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 Roadmap 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

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

©2022 CMBG3 Law, LLC. All rights reserved.

Erasing the Stigma—Michael Kasdan [PODCAST]

Men often hide their mental health struggles deeming it not manly for them to acknowledge weakness. Michael Kasdan was there at one point in his career, but he’s long since learned better. Today, Michael is an active member of the Good Men Project, sharing his personal struggles with depression with others in the legal profession and beyond. Now, he shares his story and perspective on the state of men’s mental health with Mark Yacano in this episode of Erasing the Stigma.

Michael Kasdan is a partner in Wiggin & Dana’s Intellectual Property Group. He focuses on all areas of intellectual property law, providing his clients with full- service IP expertise that ranges from patent, trademark, copyright and trade secret litigation to IP-related transactions – including licensing and monetization – to helping companies to protect and reap maximum value from their own innovations and brands.

Michael was listed as one of the world’s-leading IP Strategists in the 2103 and 2017 – 2021 editions of IAM Strategy 300 – The World’s Leading IP Strategists and has regularly been listed in Super Lawyers. Clients describe him as creative, energetic, and easy to work with and seek his insight into the business, technology, and legal facets of their IP issues.

Michael writes and speaks extensively. His articles have appeared in Intellectual Asset Management (IAM) Magazine, LEXIS, Thomson/Reuters, Practical Law Company, IP Law360, Bloomberg/BNA, Managing IP Magazine, The National Law Review, and elsewhere. Michael is the sole author of Practical Law Company’s Practice Note on Patent Law and the Lexis Practice Advisor on Patent Licensing and is a co-author of Practical Law Company’s Practice Notes on Global Patent Litigation and Licensing and on Tracking and Privacy.

A member of the firm’s Inclusion, Diversity and Equity Committee, Michael has been the keynote speaker at conferences addressing topics such as diversity and mentorship. He is also a passionate advocate for mental health and wellness in the legal profession and the world at large and serves on the Communications Committee of The Institute for Well-Being in Law.

Michael serves as on the Board and as Director of Communications and Development of the nonprofit MyChild’sCancer and on the Board of the SouthNextFestival. He was formerly Chairman of the Board of the nonprofit CityScience, which focuses on improving STEM education in cities. He is also the Director of Special Projects and Sr. Sports Editor for The Good Men Project.

Michael received his J.D. magna cum laude from New York University School of Law. He was a member of the NYU Law Review and the Order of the Coif, was Fish & Neave Fellow for the Engelberg Center on Innovation Law and Policy, and served as President of the Intellectual Property and Entertainment Law Society. After law school, he clerked for the Honorable Judge Roderick R. McKelvie in the U.S. District Court for the District of Delaware. Michael received a B.S.E. in electrical engineering magna cum laude from the University of Pennsylvania, with a minor in mathematics. He was a member of Eta Kappa Nu, Tau Beta Pi, and the Penn Parliamentary Debate Team.

©2022 Major, Lindsey & Africa, an Allegis Group

CareDx v. Natera – The Broad Road to Patent Ineligibility

In CareDx v Natera, Appeal No. 2022-1027, (Fed. Cir., July 18, 2022), a three judge panel of Judges Lourie, Bryson and Hughes, affirmed the district court’s finding that the claims of U. S. patent nos. 8703652, 9845497 and 10329607 are invalid for failing to survive the Alice/Mayo test for patent eligibility. I subtitled this post using Mathew 7:13-14: “Enter through the narrow gate. For wide is the gate and broad is the road, that leads to destruction.” The appeal to the Federal Circuit, which I wrote about on October 15, 2021, never got on the narrow road that leads to viable diagnostic claims. It may not have been possible to overcome the obstacles that blocked the road, but CareDx managed to hit them all, and ended up with three invalid patents on natural phenomena.

The claims were directed to a method for detecting transplant rejection or organ failure by isolating and genotyping a sample from the subject who received the donation, quantifying the cfDNA, and diagnosing the transplant status for an increase in donor cfDNA over time. An increase indicates possible transplant failure.

Judge Lourie summarized the claims, some of which are more than a page long, this way:

“Here, as in Ariosa, the claims boil down to collecting a bodily sample, analyzing the cfDNA  using conventional techniques, including PCR, identifying naturally occurring DNA from the donor organ, and then using the natural correlation between heightened cfDNA levels and transplant health, to identify a potential rejection, none of which was inventive. The claims here are equally as ineligible as those in Ariosa.”

Let’s take a quick look at how CareDx got onto the broad road. CareRx hoped to avoid Ariosa by arguing that it was doing more than just measuring a biomarker correlated to an existing phenomenon. Problem 1 is that CareDx did not discover the correlation; it just improved on it (or did it?). Louie writes:

“CareDx argues that the patents’ claims are directed not to natural phenomena, but to improved laboratory techniques. CareDx contends that the ‘claimed advance’ is an ‘improved, human-designed method for measuring increases in donor cfDNA in a recipient’s body to identify organ rejection.’ … In particular, CareDx identifies the use of digital PCR, NGS, and selective amplification to more accurately measure the donor SNPs of cfDNA transplant recipients. However, CareDx does not actually claim any improvements in laboratory techniques … Furthermore the specification admits that the laboratory techniques disclosed in the claims require only conventional techniques and off-the-shelf technology.”

In fact, CareDx had at least one claim in the ‘497 patent that recites that the assay detects the donor-specific circulating cfDNA from the organ transplant when the donor-specific circulating cfDNA [makes] up at least 0.3% of the total circulating cfDNA in the biological sample. I presume that this claim limitation was put into the claim so that “improvement”  could be argued, but the limitation is not mentioned in the opinion.

Let’s look at a few other things CareDx encountered on its broad road to legal destruction. The panel looked at every step of the method in isolation. In other words, once CareDx argued “improvement” it was forced to admit that the specification disclosed that all those analytical techniques, such as PCR, NGS and “selective amplification”, would be considered as conventional in the art. CareDx might have relied on some of the decisions finding patent eligibility where physical equipment was necessarily involved, such as XL LLC v. Trans Ova Genetics or Illumina v Ariosa.

The finding of conventionality of individual steps permitted the court and the panel to effectively rule that the method was directed to a natural product, since the devices used to carry it out were given no weight. Therefore, the patents failed to pass Step 1 of Mayo/Alice. Could it have been argued, if that was the case, that the equipment used to carry out the method was arranged in a novel sequence? (Also, is someone going to argue that PCR involves replicating small amounts of DNA to afford useful amounts? – This is accomplished by the hand of man.)

These are minor thoughts, CareDX should left the word “diagnostic” out of the claims and the specification. This is certainly no more of a diagnostic test than the Mayo range-finding step was. It is presently clear that in the life sciences, recognition of the utility of a naturally occurring correlation is not enough to avoid patent ineligibility. Of course, and this is cold comfort to CareDx, would it have helped to get this method into the safe harbor of methods of medical treatment? In other words, the first step could recite the actual transplantation step and/or the final step of the process could recite some sort of medical intervention. Narrower claims might have returned CareDx to the narrow path of patent life.

Article By Warren Woessner of Schwegman, Lundberg & Woessner, P.A.

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

© 2022 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.

Update to EEOC’s Position on Mandatory COVID Testing

On July 12, 2022, the Equal Employment Opportunity Commission (“EEOC”) updated its guidance regarding COVID-19 workplace viral screening testing. 

The EEOC’s original position on COVID-19 workplace viral screening testing was that it always met the Americans with Disabilities Act (“ADA”) standard for conducting medical examinations.

However, on July 12, 2022, the EEOC explained that going forward, “employers will need to assess whether current pandemic circumstances and individual workplace circumstances justify viral screening testing of employees to prevent workplace transmission of COVID-19.”

The EEOC’s FAQ A.6 now provides that an employer, as a mandatory screening measure, may administer a COVID-19 viral test “if the employer can show it is job-related and consistent with business necessity.”

Fortunately, the EEOC has provided eight factors for businesses to consider in determining whether the new “business necessity” standard is met:

  • the level of community transmission;
  • the vaccination status of employees;
  • the accuracy and speed of processing for different types of COVID-19 viral tests;
  • the degree to which breakthrough infections are possible for employees who are “up to date” on vaccinations;
  • the ease of transmissibility of the current variant(s);
  • the possible severity of illness from the current variant(s);
  • what types of contacts employees may have with others in the workplace or elsewhere that they are required to work (e.g., working with medically vulnerable individuals); and,
  • the potential impact on operations if an employee enters the workplace with COVID-19.

It is important for business owners to appropriately conduct and document the above analysis.

The EEOC’s COVID-19 guidance concerning COVID-19 workplace viral testing may further evolve, so it will be important for business owners to periodically review the EEOC’s current FAQs.

Article By William A. Oden, III of Ward and Smith, P.A.

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

© 2022 Ward and Smith, P.A.. All Rights Reserved.

PFAS GenX Health Advisories Challenged In Court

On June 15, 2022, the EPA issued Health Advisories (HAs) for five specific PFAS, including GenX PFAS chemicals. The PFAS GenX health advisories set levels at 10ppt for this chemical group. On July 13, 2022, The Chemours Co. filed a petition in the Third Circuit challenging the validity of the EPA’s GenX HA. The company alleges that the EPA acted outside of its bounds of authority, as well as arbitrarily and capriciously, among other arguments. Other industries that will be impacted by upcoming EPA PFAS regulations will closely follow the lawsuit as it makes its way through court, as it may provide predictive indicators of arguments that will unfold as the EPA’s PFAS regulations increase.

PFAS GenX Health Advisories

In October 2021, the EPA released its PFAS Roadmap, which stated explicit goals and deadlines for over twenty action items specific to PFAS. As part of the Roadmap, the EPA pledged to re-assess the existing Health Advisories (HAs) for PFOA and PFOS, as well as establish HAs for PFBS and GenX chemicals. In June 2022, the EPA fulfilled its promise on all fronts when it set HAs for PFOA (interim), PFOS (interim), PFBS (final) and GenX (final). While not enforceable levels for PFAS in drinking water, the EPA’s PFAS Health Advisories are nevertheless incredibly significant for a variety of reasons, including influence on future federal and state drinking water limits, as well as potential impacts on future PFAS litigation.

The levels set by the EPA’s PFAS Health Advisories were as follows:

PFOA .004 ppt
PFOS .02 ppt
GenX 10 ppt
PFBS 2,000 ppt

Chemours Challenge To GenX Health Advisories

Chemours is challenging the EPA’s PFAS GenX Health Advisories primarily on the grounds that the HAs are “arbitrary and capricious.” The company alleges that the HAs are arbitrary and capricious because (1) they incorporated toxicity assumptions that deviate from the EPA’s own standard methods; and (2) “EPA incorporated grossly incorrect and overstated exposure assumptions―in essence, EPA used the wrong chemical when making its exposure assumptions, thereby resulting in a significantly less tolerant health advisory for [GenX] than is warranted by the data. In addition, Chemours argues that the EPA failed to go through the necessary public comment period before issuing its final GenX HA, and that in creating the GenX HA, the EPA exceeded its authority under the Safe Drinking Water Act.

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 Roadmap 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

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

©2022 CMBG3 Law, LLC. All rights reserved.

OSHA Proposes More Changes to Recordkeeping Rules

Employers across numerous industries may soon face additional recordkeeping and reporting obligations based on a new rule proposed by the Occupational Safety and Health Administration.

In March 2022, OSHA proposed amendment of its injury and illness tracking rule, which requires certain employers to file illness and injury data with the agency each year.  The tracking rule was first implemented in 2016, and required reporting of fatalities, hospitalizations, and other serious injuries for all covered employers with 250 or more employees, and for employers with 20-249 employees in certain “high hazard industries.” The rule required most covered employers to submit their Form 300A  “Summary of Work-Related Injuries and Illnesses” annually.  It also required certain employer establishments with 250 or more employees to submit their complete Form 300 Logs of Work-Related Injury and Illnesses, and their Form 301 Injury and Illness Incident reports annually.  Finally, the rule called for creation of a public database of employer illness/injury data, including business names and illness/injury locations.

The rule generated immediate objections from the business community based on privacy concerns.  Both the Form 300 Logs and the Form 301s Incident Reports contain personal employee information related to their health status.  Employers worried that if OSHA required broad disclosure of these documents and created a public database based on their content, it would jeopardize employee privacy. Even though OSHA claimed it would not make personal identifying information available, employers were not confident the agency could prevent inadvertent disclosure. Also, employers saw myriad ways in which the information could be used against them that have nothing to do with worker safety.

In response to this criticism and after a change in the presidential administration, OSHA rolled back the tracking rule in 2019. The 2019 Rule rescinded the requirement for employers of 250 or more employees to electronically submit Form 300s and Form 301s, but continued to require them to submit Form 300A summaries each year.  Because the summaries did not contain personal information, the modified rule alleviated employee privacy worries.

Now, OSHA is poised to revive the original tracking rule, but expand the application of the most onerous requirements to smaller establishments.  On March 30, 2022, OSHA published its proposed rule in the Federal Register.  If the final rule mirrors the proposed rule, it would largely restore the 2016 rule, but apply the Form 300 and 301 reporting requirements to covered establishments with 100 or more employees instead of 250 employees. Those employers covered by the new 100+ rule are limited to the industries in Appendix B of the proposed rule.  The list is lengthy and includes many farming, manufacturing and packaging industry employers, healthcare employers as well as grocery, department and furniture stores.

OSHA received public comment on the proposed rule through June 30, 2022.  OSHA received 83 comments from a mix of private and public entities, citizens, and industry groups.  OSHA will review the comments and employers should expect the agency to issue a Final Rule by the end of the calendar year, which would become effective 30 days after publication.

If OSHA enacts its proposed rule, covered employers will face significant additional burdens.  Employers must ensure that their Form 300 and 301 Forms are maintained accurately and filed in time to comply with the rule.  They can expect that OSHA will scrutinize these forms and potentially use them for inspection purposes or to develop industry-specific enforcement programs.  Moreover, OSHA may impose redaction burdens on employers and force them to remove personal identifying information from the forms before submission, which can be an administrative burden with potentially significant privacy implications if not followed carefully.  Finally, with additional data publicly available, employers should expect enhanced media and interest group activity based on their injury and illness data.  Even if personal information is not disclosed, interest groups and labor organizations will certainly seize on the available data to criticize employers or push for regulations, without consideration of the fact that employer fault cannot be determined from the data alone.

Employers should take steps now to prepare for the proposed rule and continue to ensure their safety and health programs minimize employee illness/injury risk.  The new rule would greatly increase potential legislative and public relations risks associated with poor safety and health outcomes, and effective illness/injury prevention programs can help employers avoid such scrutiny before the enhanced disclosure requirements take effect.

Article By Susan F. Wiltsie and Reilly C. Moore of Hunton Andrews Kurth. Scott W. Burton also contributed to this article.

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Copyright © 2022, Hunton Andrews Kurth LLP. All Rights Reserved.

U.S. Supreme Court Agrees with HHS Payment Methodology for Disproportionate Share Hospitals

The fight about how Medicare compensates disproportionate share hospitals (“DSH”) is one of the longest-running reimbursement disputes of recent years, and it has generated copious work for judges around the country.  In a 5-4 decision, the U.S. Supreme Court settled one piece of the conflict:  the counting of “Medicare-entitled” patients in the Medicare fraction of the “disproportionate-patient percentage.”  Becerra v. Empire Health Found., 597 U.S. ___ (2022) (slip op.).  The Supreme Court concluded that the proper calculation, under the statute, counts “individuals ‘entitled to [Medicare] benefits[,]’ . . . regardless of whether they are receiving Medicare payments” for certain services.  Id. (slip op., at 18) (emphasis added).

DSH payments are made to hospitals with a large low-income patient mix.  “The mark-up reflects that low-income individuals are often more expensive to treat than higher income ones, even for the same medical conditions.”  Id. (slip op., at 3).  The federal government thus gives hospitals a financial boost for treating a “disproportionate share” of the indigent population.

The DHS payment depends on a hospital’s “disproportionate-patient percentage,” which is basically the sum of two fractions: the Medicare fraction, which reflects what portion of the Medicare patients were low-income; and the Medicaid fraction, which reflects what portion of the non-Medicare patients were on Medicaid.  Historically, HHS calculated the Medicare fraction by including only patients actually receiving certain Medicare benefits for their care.  In 2004, however, HHS changed course and issued a new rule.  It counted, in the Medicare fraction, all patients who were eligible for Medicare benefits generally (essentially, over 65 or disabled), even if particular benefits were not actually being paid.  For most providers, that change resulted in a pay cut.

The new rule sparked several lawsuits.  Hospitals challenged HHS’s policy based on the authorizing statutory language.  These hospitals essentially argued in favor of the old methodology.  Appeals led to a circuit split, with the Sixth and D.C. Circuits agreeing with HHS, and the Ninth Circuit ruling that HHS had misread the statute.

The Supreme Court has now resolved the issue.  The majority opinion, authored by Justice Kagan, sided with HHS.  The majority concluded that, based on the statutory language, “individuals ‘entitled to [Medicare] benefits’ are all those qualifying for the program, regardless of whether they are receiving Medicare payments for part or all of a hospital stay.”  Id. (slip op., at 18).  The majority also explained that if “entitlement to benefits” bore the meaning suggested by the hospital, “Medicare beneficiaries would lose important rights and protections . . . [and a] patient could lose his ability to enroll in other Medicare programs whenever he lacked a right to [certain] payments for hospital care.”  Id. (slip op., at 11).

Justice Kavanaugh dissented, joined by Chief Justice Roberts and Justices Gorsuch and Alito.  The dissent argued that those lacking certain Medicare coverage should be excluded from HHS’s formula, based on “the most fundamental principle of statutory interpretation: Read the statute.”  Id. (Kavanaugh, J., dissenting) (slip op., at 2).  According to the dissent, the majority’s ruling will also restrict hospitals’ ability to provide care to underprivileged communities.  “HHS’s misreading of the statute has significant real-world effects: It financially harms hospitals that serve low-income patients, thereby hamstringing those hospitals’ ability to provide needed care to low-income communities.”  Id. (slip op., at 4).

There was one point of agreement among the majority and dissenting justices: the complexity of the statutory language for DSH payments.  Echoing the thoughts often held by healthcare advisors, Justice Kagan found the statutory formula to be “a mouthful” and “a lot to digest.”  Id. (majority opinion) (slip op., at 4).  And in his dissent, Justice Kavanaugh called the statute “mind-numbingly complex,” and resorted to an interpretation that he found “straightforward and commonsensical”: that patients cannot be “simultaneously entitled and disentitled” to Medicare benefits.  Id. (Kavanaugh, J., dissenting) (slip op., at 1, 3).

Article By Jeffrey DeBeer and Keith Bradley of Squire Patton Boggs (US) LLP

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© Copyright 2022 Squire Patton Boggs (US) LLP

Federal District Court Says Pre-Shift COVID Screening Time Not Compensable

In the first reported decision we’ve seen addressing the issue head on, a federal district court in California dismissed a putative collective action claim under the Fair Labor Standards Act (FLSA) seeking payment for time spent in pre-shift COVID screening.

Prior to clocking in each day, the plaintiff—a non-exempt truck driver whose job duties included loading and transporting automobile parts from a central distribution center to stores throughout southern California—was required to submit to COVID-related health screening conducted on his employer’s premises.  During the screening process, a company employee asked the plaintiff a series of questions and took the plaintiff’s temperature.  The total time spent in the screening process often exceeded five minutes, which included waiting time.

The plaintiff filed a collective action claim, contending that the time spent by him and other employees participating in the daily screening was compensable under the FLSA.

Starting with the premise that time spent in pre-shift activities is only compensable under the FLSA if it is “integral and indispensable” to the employee’s “principal activities or activities which [the] employee is employed to perform,” the district court granted the employer’s motion to dismiss the FLSA claims, noting:

A pre-shift COVID screening is not the “principal activity or activities which [the] employee is employed to perform.”  29 U.S.C. § 254(a)(1).  O’Reilly did not hire the employees to undergo health screenings, but instead to load and transport products to stores….  [T]he pre-shift COVID screenings were not “integral and indispensable” to the employees’ duties because the screening was not an intrinsic element of the loading and transporting of products to the stores.  The screenings were not indispensable to the employees’ duties because O’Reilly could eliminate them completely without hindering the employees’ ability to perform their duties….  A pre-shift COVID temperature check and short questions regarding exposure do not share the required nexus with Plaintiff’s duties of retrieving automotive parts and delivering them to auto part stores to make the screening a compensable activity that is integral and indispensable to those activities.

Notably, the court referenced—and then distinguished—the U.S. Department of Labor’s COVID-19 and the Fair Labor Standards Act Questions and Answers, which were issued during the height of the pandemic and which many employers felt were ambiguous on the issue of which COVID-related activities were and weren’t considered “hours worked” under the FLSA:

Unlike the nurse in the DOL example whose principal job duty is to keep patients healthy and has direct patient contact, Plaintiff’s principal activities consisted of manual labor and transportation of auto parts to stores.

We examined those agency Q&As—and the broader issues around compensability of time spent in vaccination, testing, and screening activities—in an earlier blog.

The decision is Pipich v. O’Reilly Auto Enterprises, LLC (S.D. Cal. Mar. 15, 2022).

Article By Allan S Bloom of Proskauer Rose LLP

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© 2022 Proskauer Rose LLP.