Category: Health

School Law Update: CDC Adjusts Direction on Exposure Quarantine Requirements for Employees

CDC Adjusts Direction on Exposure Quarantine Requirements for Employees

On August 11, 2022, the CDC updated its COVID-19 guidance as the risk of severe illness, hospitalization, and death from COVID exposure has significantly declined. More specific guidance for school districts was issued by the CDC, which can be found here.

In addition, the Department of Public Instruction has published guidance entitled “COVID-19 Infection Control and Mitigation Measures for Wisconsin Schools 2022/2023,” which can be found here.

While we published a Legal Update on the recent CDC guidance changes last week, that Update primarily focused on the private sector. This Update is primarily focused on the impact the new CDC guidance will have on school districts and identifies some of the key changes.

The more significant mask guidance has been reduced. Guidance now indicates that if COVID-19 is at a high Community Level, universal indoor masking in schools is recommended. The CDC also recommends masking in health care settings such as the school nurse’s office. The updated CDC guidance makes significant changes to quarantine and isolation protocols. Asymptomatic (exposed) children and staff, regardless of where the exposure occurred or vaccination status, no longer need to quarantine. Students or staff who self-identify as close contacts may continue to attend school/work if they remain asymptomatic.

Students or staff who come to school with symptoms or develop symptoms while at school should be asked to wear a well-fitting mask or respirator while in the building and be sent home. If testing is unavailable at school, students and staff should also be encouraged to get tested. Symptomatic people who cannot wear a mask should be separated from others as much as possible; children should be supervised by a designated caregiver who is wearing a well-fitting mask or respirator until they leave school grounds but masking with a high quality mask is suggested for 10 days from exposure.

If the school provides COVID-19 testing, a symptomatic student or staff member may remain in school if they are tested immediately onsite, and that test is negative. Best practice would include wearing a mask, if possible, until symptoms are fully resolved. If the student is “too ill” to be in school (fever, severe cough, vomiting, diarrhea, etc.), they should be sent home regardless of COVID-19 test results. If the symptomatic student or staff cannot be tested immediately, they should be sent home and encouraged to use an at-home-test-kit or be referred to a testing site.

Students and staff who test positive for COVID-19 should isolate for at least 5 days. If they are asymptomatic, they may end isolation after Day 5 (return Day 6). If they had symptoms, they may return to school/work after Day 5 if:

  • they are fever-free for 24 hours (without the use of fever-reducing medication)

  • their symptoms are improving

If the individual still has a fever or other symptoms have not improved, they should continue to isolate until the symptoms improve. Once isolation has ended, people should wear a well-fitting mask or respirator around others through Day 10. Testing is not required to determine the end of isolation or mask use following COVID-19 infection.

Article By James R. Macy, Ryan P. Heiden, and Anthony S. Wachewicz III of von Briesen & Roper, s.c.

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

©2022 von Briesen & Roper, s.c

EPA Updates Safer Chemical Ingredients List, Adding 22 Chemicals and Changing the Status of One Chemical

The U.S. Environmental Protection Agency (EPA) announced on August 11, 2022, that it updated the Safer Chemical Ingredients List (SCIL), “a living list of chemicals by functional-use class that EPA’s Safer Choice program has evaluated and determined meet the Safer Choice Standard.” EPA added 22 chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages manufacturers to submit their safer chemicals for review and listing on the SCIL. In support of the Biden Administration’s goals, the addition of chemicals to the SCIL “incentivizes further innovation in safer chemistry, which can promote environmental justice, bolster resilience to the impacts of climate change, and improve water quality.” According to EPA, chemicals on the SCIL “are among the safest for their functional use.”

EPA also changed the status for one chemical on the SCIL and will remove the chemical from the list in one year “because of a growing understanding of the potential health and environmental effects.” According to EPA, the chemical was originally listed on the SCIL based on data from a closely related substance that EPA marked with a grey square earlier this year. EPA’s process for removing a chemical from the SCIL is first to mark the chemical with a grey square on the SCIL web page to provide notice to chemical and product manufacturers that the chemical may no longer be acceptable for use in Safer Choice-certified products. A grey square notation on the SCIL means that the chemical may not be allowed for use in products that are candidates for the Safer Choice label, and any current Safer Choice-certified products that contain this chemical must be reformulated unless relevant health and safety data are provided to justify continuing to list the chemical on the SCIL. EPA states that the data required are determined on a case-by-case basis. In general, data useful for making such a determination provide evidence of low concern for human health and environmental impacts. Unless information provided to EPA adequately justifies continued listing, EPA then removes the chemical from the SCIL 12 months after the grey square designation.

According to EPA, after this update is made, there will be 1,055 chemicals listed on the SCIL. EPA is committed to updating the SCIL with safer chemicals on a regular basis. EPA states that the SCIL is a resource that can help many different stakeholders:

  • Product manufacturers use the SCIL to help make high-functioning products that contain safer ingredients;
  • Chemical manufacturers use the SCIL to promote the safer chemicals they manufacture;
  • Retailers use the SCIL to help shape their sustainability programs; and
  • Environmental and health advocates use the SCIL to support their work with industry to encourage the use of the safest possible chemistry.

EPA’s Safer Choice program certifies products containing ingredients that have met the program’s rigorous human health and environmental safety criteria. The Safer Choice program allows companies to use its label on products that meet the Safer Choice Standard. The EPA website contains a complete list of Safer Choice-certified products.

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

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

©2022 Bergeson & Campbell, P.C.

Biden Administration Seeks to Clarify Patient Privacy Protections Post-Dobbs, Though Questions Remain

On July 8, two weeks following the Supreme Court’s ruling in Dobbs v. Jackson that invalidated the constitutional right to abortion, President Biden signed Executive Order 14076 (E.O.). The E.O. directed federal agencies to take various actions to protect access to reproductive health care services,[1] including directing the Secretary of the U.S. Department of Health and Human Services (HHS) to “consider actions” to strengthen the protection of sensitive healthcare information, including data on reproductive healthcare services like abortion, by issuing new guidance under the Health Insurance and Accountability Act of 1996 (HIPAA).[2]

The directive bolstered efforts already underway by the Biden Administration. A week before the E.O. was signed, HHS Secretary Xavier Becerra directed the HHS Office for Civil Rights (OCR) to take steps to ensure privacy protections for patients who receive, and providers who furnish, reproductive health care services, including abortions.[3] The following day, OCR issued two guidance documents to carry out this order, which are described below.

Although the guidance issued by OCR clarifies the privacy protections as they exist under current law post-Dobbs, it does not offer patients or providers new or strengthened privacy rights. Indeed, the guidance illustrates the limitations of HIPAA regarding protection of health information of individuals related to abortion services.

A.  HHS Actions to Safeguard PHI Post-Dobbs

Following Secretary Becerra’s press announcement, OCR issued two new guidance documents outlining (1) when the HIPAA Privacy Rule may prevent the unconsented disclosure of reproductive health-related information; and (2) best practices for consumers to protect sensitive health information collected by personal cell phones, tablets, and apps.

(1) HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care

In the “Guidance to Protect Patient Privacy in Wake of Supreme Court Decision on Roe,”[4] OCR addresses three existing exceptions in the HIPAA Privacy Rule to the disclosure of PHI without an individual’s authorization and provides examples of how those exceptions may be applied post-Dobbs.

The three exceptions discussed in the OCR guidance are the exceptions for disclosures required by law,[5]  for purposes of law enforcement,[6] or to avert a serious threat to health or safety.[7]

While the OCR guidance reiterates that the Privacy Rule permits, “but does not require” disclosure of PHI in each of these exceptions,[8] this offers limited protection that relies on the choice of providers whether to disclose or not disclose the information. Although these exceptions are highlighted as “protections,” they expressly permit the disclosure of protected health information. Further, while true that the HIPAA Privacy Rule itself may not compel disclosure (but merely permits disclosure), the guidance fails to mention that in many situations in which these exceptions apply, the provider will have other legal authority (such as state law) mandating the disclosure and thus, a refusal to disclose the PHI may be unlawful based on a law other than HIPAA.

Two of the exceptions discussed in the guidance – the required by law exception and the law enforcement exception – both only apply in the first place when valid legal authority is requiring disclosure. In these situations, the fact that HIPAA does not compel disclosure is of no relevance. Certainly, when there is not valid legal authority requiring disclosure of PHI, then HIPAA prohibits disclosure, as noted as in the OCR guidance.  However, in states with restrictive abortion laws, the state legal authorities are likely to be designed to require disclosure – which HIPAA does not prevent.

For instance, if a health care provider receives a valid subpoena from a Texas court that is ordering the disclosure of PHI as part of a case against an individual suspected of aiding and abetting an abortion, in violation of Texas’ S.B. 8, then that provider could be held in contempt of court for failing to comply with the subpoena, despite the fact that HIPAA does not compel disclosure.[9] For more examples on when a covered entity may be required to disclose PHI, please see EBG’s prior blog: The Pendulum Swings Both Ways: State Responses to Protect Reproductive Health Data, Post-Roe.[10]

Notably, the OCR guidance does provide a new interpretation of the application of the exception for disclosures to avert a serious threat to health or safety. Under this exception, covered entities may disclose PHI, consistent with applicable law and standards of ethical conduct, if the covered entity, in good faith, believes the use or disclosure is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public. OCR states that it would be inconsistent with professional standards of ethical conduct to make such a disclosure of PHI to law enforcement or others regarding an individual’s interest, intent, or prior experience with reproductive health care. Thus, in the guidance, OCR takes the position that if a patient in a state where abortion is prohibited informs a health care provider of the patient’s intent to seek an abortion that would be legal in another state, this would not fall into the exception for disclosures to avert a serious threat to health or safety.  Covered entities should be aware of OCR’s position and understand that presumably OCR would view any such disclosure as a HIPAA violation.

(2) Protecting the Privacy and Security of Individuals’ Health Information When Using Personal Cell Phones or Tablets

OCR also issued guidance on how individuals can best protect their PHI on their own personal devices. HIPAA does not generally protect the privacy or security of health information when it is accessed through or stored on personal cell phones or tablets. Rather, HIPAA only applies when PHI is created, received, maintained, or transmitted by covered entities and business associates. As a result, it is not unlawful under HIPAA for information collected by devices or apps – including data pertaining to reproductive healthcare – to be disclosed without consumer’s knowledge.[11]

In an effort to clarify HIPAA’s limitation to protect such information, OCR issued guidance to protect consumer sensitive information stored in personal devices and apps.[12] This includes step-by-step guidance on how to control data collection on their location, and how to securely dispose old devices.[13]

Further, some states have taken steps to fill the legal gaps to varying degrees of success. For example, California’s Confidentiality of Medical Information Act (“CMIA”) extends to “any business that offers software or hardware to consumers, including a mobile application or other related device that is designed to maintain medical information.”[14] As applied, a direct-to-consumer period tracker app provided by a technology company, for example, would fall under the CMIA’s data privacy protections, but not under HIPAA. Regardless, gaps remain as the CMIA does not protect against a Texas prosecutor subpoenaing information from the direct-to-consumer app. Conversely, Connecticut’s new reproductive health privacy law,[15] does prevent a Connecticut covered entity from disclosing reproductive health information based on a subpoena, but Connecticut’s law does not apply to non-covered entities, such as a period tracker app. Therefore, even the U.S.’s most protective state privacy laws do not fill in all of the privacy gaps.

Alongside OCR’s guidance, the Federal Trade Commission (FTC) published a blog post warning companies with access to confidential consumer information to consider FTC’s enforcement powers under Section 5 of the FTC Act, as well as the Safeguards Rule, the Health Breach Notification Rule, and the Children’s Online Privacy Protection Rule.[16] Consistent with OCR’s guidance, the FTC’s blog post reiterates the Biden Administration’s goal of protecting reproductive health data post-Dobbs, but does not go so far as to create new privacy protections relative to current law.

B.  Despite the Biden Administration’s Guidance, Questions Remain Regarding the Future of Reproductive Health Privacy Protections Post-Dobbs

Through E.O. 14076, Secretary Becerra’s press conference, OCR’s guidance, and the FTC’s blog, the Biden Administration is signaling that it intends to use the full force of its authorities – including those vested by HIPAA – to protect patient privacy in the wake of Roe.

However, it remains unclear how this messaging will translate to affirmative executive actions, and how successful such executive actions would be. How far is the executive branch willing to push reproductive rights? Would more aggressive executive actions be upheld by a Supreme Court that just struck down decades of precedent permitting access to abortion? Will the Biden Administration’s executive actions persist if the administration changes in the next Presidential election?

Attorneys at Epstein Becker & Green are well-positioned to assist covered entities, business associates, and other companies holding sensitive reproductive health data understand how to navigate HIPAA’s exemptions and interactions with emerging guidance, regulations, and statutes at both the state and Federal levels.

Ada Peters, a 2022 Summer Associate (not admitted to the practice of law) in the firm’s Washington, DC office and Jack Ferdman, a 2022 Summer Associate (not admitted to the practice of law) in the firm’s Boston office, contributed to the preparation of this post. 

[1] 87 Fed. Reg. 42053 (Jul. 8, 2022), https://bit.ly/3b4N4rp.

[2] Id.

[3] HHS, Remarks by Secretary Xavier Becerra at the Press Conference in Response to President Biden’s Directive following Overturning of Roe v. Wade (June 28, 2022), https://bit.ly/3zzGYsf.

[4] HHS, Guidance to Protect Patient Privacy in Wake of Supreme Court Decision on Roe (June 29, 2022),  https://bit.ly/3PE2rWK.

[5] 45 CFR 164.512(a)(1)

[6] 45 CFR 164.512(f)(1)

[7] 45 CFR 164.512(j)

[8] Id.

[9] See Texas S.B. 8; e.g., Fed. R. Civ. Pro. R.37 (outlining available sanctions associated with the failure to make disclosures or to cooperate in discovery in Federal courts), https://bit.ly/3BjX4I2.

[10] EBG Health Law Advisor, The Pendulum Swings Both Ways: State Responses to Protect Reproductive Health Data, Post-Roe (June 17, 2022), https://bit.ly/3oPDegl.

[11] A 2019 Kaiser Family Foundation survey concluded that almost one third of female respondents used a smartphone app to monitor their menstrual cycles and other reproductive health data. Kaiser Family Foundation, Health Apps and Information Survey (Sept. 2019), https://bit.ly/3PC9Gyt.

[12] HHS, Protecting the Privacy and Security of Your Health Information When Using Your Personal Cell Phone1 or Tablet (last visited Jul. 26, 2022), https://bit.ly/3S2MNWs.

[13] Id.

[14] Cal. Civ. Code § 56.10, Effective Jan. 1, 2022, https://bit.ly/3J5iDxM.

[15] 2022 Conn. Legis. Serv. P.A. 22-19 § 2 (S.B. 5414), Effective July 1, 2022, https://bit.ly/3zwn95c.

[16] FTC, Location, Health, and Other Sensitive Information: FTC Committed To Fully Enforcing the Law Against Illegal Use and Sharing of Highly Sensitive Data (July 11, 2022), https://bit.ly/3BjrzNV.

Article By Alaap B. Shah, Allen R. Killworth, Marylana Saadeh Helou, and Devon Minnick of Epstein Becker & Green, P.C.

For more privacy-related legal news, click here to visit the National Law Review.

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

Do You Have a College Student? Important Healthcare, Financial, and Educational Documents That They (and You) Need

August is upon us and you may soon be sending children off to college. If your child is age 18 or older, you and your child will need to take some simple steps so that, in the event of an emergency, you will be able to make health care and financial decisions for your child and have access to your child’s medical information and financial accounts. The same is true if you are to have access to your child’s educational records.

Medical Information. Once your child reaches age 18, your child is deemed to be an adult by law and you no longer have a legal right to make health care decisions on behalf of your child or to access your child’s health care information. As a result, if you have an adult child, your child must execute certain legal documents naming you as his or her health care agent and permitting you to access his or her medical information:

  1. Your child must execute a “Health Care Proxy” naming you as his or her agent for health care decisions. In this document, your child authorizes you to make health care decisions on your child’s behalf if he or she becomes unable to make or communicate such decisions him or herself. The child may also share his or her own wishes regarding medical treatment.
  2. Your child must also sign a “HIPAA Authorization Form.” The Health Insurance Portability & Accountability Act of 1996 (generally known as “HIPAA”) protects the privacy of an individual’s medical information, and health care providers may require written consent from a patient to share information with family members, including parents of an adult child. Your child’s college or university may also have policies in place preventing it from sharing medical information without the student’s consent. This form will serve as written permission authorizing those providing health care services to your child to share medical information with you as your child’s health care agent.
  3. In addition, you should be in contact with the health services department of your child’s college or university. The institution may provide its own form for authorizing the release of medical information that can be kept on record with the institution’s health services department.

Financial Accounts. If you are to have the ability to act on behalf of your adult child with respect to financial matters, your child also needs to execute a “Durable Power of Attorney” naming you as your child’s agent with respect to the child’s assets and finances. If your child is attending college away from home, is studying abroad, or undergoes a medical emergency, it may be useful for you to access your child’s accounts on his or her behalf. This allows you to pay bills for a child out of their accounts, make deposits and open or close accounts. In addition, a durable power of attorney allows you to handle other financial tasks for the child, like filing tax returns or renewing a lease.

Educational Records. Finally, the Family Educational Rights and Privacy Act (FERPA) protects the educational records of a child who has turned 18 or is enrolled at a postsecondary institution from access by his or her parents. If the child’s parents claim the child as a dependent on their tax returns, the parents may still access the child’s education records without the child’s consent. However, institutions may be reluctant to allow access to education records for any child over the age of 18 without a “FERPA Waiver” signed by the child, regardless of their status as a dependent. If you would like to have access to your child’s educational records, you should contact the institution to request a FERPA Waiver form.

Article By John H. Ramsey and Kerry L. Spindler of Goulston & Storrs

For more public education and services legal news, click here to visit the National Law Review.

2022 Goulston & Storrs PC.

Medicare CERT Audits and How to Prepare for Them

CERT audits are an unfortunate part of doing business for healthcare providers who accept Medicare. Failing the audit can mean the provider has to pay back overcharges and be subjected to increased scrutiny in the future. 

The best way to be prepared for a CERT audit is to have a compliance strategy in place and to follow it to the letter. Retaining a healthcare lawyer to craft that strategy is essential if you want to make sure that it is all-encompassing and effective. It can also help to hire independent counsel to conduct an internal review to ensure the compliance plan is doing its job.

When providers are notified of a CERT audit, hiring a Medicare lawyer is usually a good idea. Providers can fail the audit automatically if they do not comply with the document demands.

What is a CERT Audit?

The Comprehensive Error Rate Testing (CERT) program is an audit process developed by the Centers for Medicare and Medicaid Services (CMS). It is administered by private companies, called CERT Contractors, which work with the CMS. Current information about those companies is on the CMS website.

The CERT audit compares a sampling of bills for Medicare fee-for-service (FFS) payments, which were sent by the healthcare provider to its Medicare Administrative Contractor (MAC), against medical records for the patient. The audit looks at whether there is sufficient documentation to back up the claim against Medicare, whether the procedure was medically necessary, whether it was correctly coded, and whether the care was eligible for reimbursement through the Medicare program.

Every year, the CERT program audits enough of these FFS payments – generally around 50,000 per year – to create a statistically significant snapshot of inaccuracies in the Medicare program.

The results from those audits are reported to CMS. After appropriately weighing the results, CMS publishes the estimated improper payments or payment errors from the entire Medicare program in its annual report. In 2021, the CMS estimated that, based on data from the CERT audits, 6.26 percent of Medicare funding was incorrectly paid out, totaling $25.03 billion.

The vast majority of those incorrect payments, 64.1 percent, were marked as incorrect because they had insufficient documentation to support the Medicare claim. Another 13.6 percent were flagged as medically unnecessary. 10.6 percent was labeled as incorrectly paid out due to improper coding. 4.8 percent had no supporting documentation, at all. 6.9 percent was flagged as incorrectly paid for some other reason.

The CERT Audit Process

Healthcare providers who accept Medicare will receive a notice from a CERT Contractor. The notice informs the provider that it is being CERT audited and requests medical records from a random sampling of Medicare claims made by the provider to its MAC.

It is important to note that, at this point, there is no suspicion of wrongdoing. CERT audits examine Medicare claims at random.

Healthcare providers have 75 days to provide these medical records. Failing to provide the requested records is treated as an audit failure. In 2021, nearly 5 percent of failed CERT audits happened because no documentation was provided to support a Medicare claim.

Once the CERT Contractor has the documents, its team of reviewers – which consists of doctors, nurses, and certified medical coders – compares the Medicare claim against the patient’s medical records and looks for errors. According to the CMS, there are five major error categories:

  • No documentation

  • Insufficient documentation

  • Medical necessity

  • Incorrect coding

  • Other

Errors found during the CERT audit are reported to the healthcare provider’s MAC. The MAC can then make adjustments to the payments it sent to the provider.

Potential Repercussions from Errors Found in a CERT Audit

CERT audits that uncover errors in a healthcare provider’s Medicare billings lead to recoupments of overpayments, future scrutiny, and potentially even an investigation for Medicare fraud.

When the CERT audit results are brought to the MAC’s attention, the MAC will adjust the payments that it made to the provider. If the claims led to an overpayment, the MAC will demand that money back.

But Medicare Administrative Contractors (MACs) can go further than just demanding restitution for overpayments. They can also require prepayment reviews of all of the provider’s future Medicare claims, and can even suspend the provider from the program, entirely.

Worse still, CERT audits that uncover indications of Medicare fraud may be reported to a law enforcement agency for further review. This can lead to a criminal investigation and potentially even criminal charges.

Appealing a CERT Audit’s Results

With penalties so significant, healthcare providers should seriously consider hiring a lawyer to appeal the results of a CERT audit.

Appeals are first made to the MAC, requesting a redetermination of the audit results. The request for redetermination has to be made within 120 days of receiving notice of the audit results. However, if the provider wants to stop the MAC from recouping an overpayment in the meantime, it has to lodge the request within 30 days.

Providers can appeal the results of the redetermination, as well. They can request a reconsideration by a Qualified Independent Contractor within 180 of the redetermination, or within 60 days to stop the MAC’s recoupment process.

Providers who are still dissatisfied can appeal the case to an administrative law judge, then to the Medicare Appeals Council, and finally to a federal district court for review.

How to Handle a CERT Audit

The best way to handle and to prepare for a CERT audit is to hire Medicare audit attorneys to guide you through the process. It would also help to start internal audits within the company.

For providers who have been notified that they are under an audit, getting a lawyer on board immediately is essential. An experienced healthcare attorney can conduct a thorough internal investigation of the claims being audited. This can uncover potential problems before the audit points them out, giving the healthcare provider the time it needs to prepare its next steps.

Providers who are not currently being audited can still benefit from an attorney’s guidance. Whether by drafting a compliance plan that will prepare the provider for an inevitable CERT audit or by conducting an internal investigation to see how well a current compliance plan is performing, a lawyer can make sure that the provider is ready for an audit at a moment’s notice.

Taking these preventative steps soon is important. CMS put the CERT audit program on halt for the coronavirus pandemic, but that temporary hold was rescinded on August 11, 2020. While the CMS has reduced the sample sizes that will be used for its 2021 and 2022 reports, it will likely go back to the original numbers after that. Healthcare providers should prepare for this increased regulatory oversight appropriately.

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

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

Oberheiden P.C. © 2022

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.