Category: Administrative & Regulatory

DOL Issues Additional FFCRA Guidance as Schools Reopen

On Aug. 27, 2020, the U.S. Department of Labor (DOL) issued three new Frequently Asked Questions (FAQ) related to the reopening of schools in various formats and employee paid leave eligibility under the Families First Coronavirus Response Act (FFCRA).

The FFCRA requires employers with fewer than 500 employees to provide up to 80 hours of paid leave to employees for certain reasons related to the 2019 novel coronavirus (COVID-19) pandemic under the Emergency Paid Sick Leave Act (PSLA) and expands the Family and Medical Leave Act (FMLA) to provide employees up to 12 weeks of emergency job-protected leave to care for a child as a result of school or child care closings due to a public health emergency. The recent FAQ address caregiver leave associated with the closure of schools, which, if eligible, entitles employees to two-thirds’ pay up to $200 per day ($10,000 in aggregate).

NEW FAQ ADDRESSING SCHOOL CLOSURES

The following is an overview of DOL’s three newly issued FAQ regarding school closures:

A child attends a school operating on an alternate day basis

The DOL confirmed in FAQ #98 that an employee will be eligible for paid leave on an intermittent basis to accommodate a hybrid school schedule whereby children attend school both in-person and remotely. For purposes of the FFCRA and its implementing regulations, the school is effectively closed on days that a child cannot attend in person and leave is available on remote-learning days. The DOL cautions in its guidance that even under these circumstances, leave is only available if no other suitable person is available to care for the child.

A parent chooses remote learning when in-person instruction is available

FAQ #99 makes clear that FFCRA leave is not available to take care of a child whose school is otherwise open for in-person attendance. As a result, if a child needs care because the employee chose a virtual or remote school option, the employee is ineligible for leave. The DOL notes, however, that if the child is home due to a quarantine order or has been advised by a health care provider to self-isolate or self-quarantine, an employee may be eligible to take paid leave to care for the child.

School begins with remote learning, but shifts to in-person instruction if conditions change

FAQ #100 clarifies that leave eligibility will change as schools adopt different teaching models. Using the example of a school that starts virtually with the hope of returning to in-person teaching in the future, the DOL explains that an employee will be eligible for leave during the remote learning period for so long as the school remains closed, but eligibility will end when the school converts to in-person instruction.

ADDITIONAL FFCRA RESOURCES

Consider reviewing the following resources to learn more about the FFCRA:

Copyright © 2020 Godfrey & Kahn S.C.

ARTICLE BY Margaret R. Kurlinski and Christine McLaughlin of Godfrey & Kahn S.C. 

For more on DOL guidance, see the National Law Review Labor and Employment Legal and Regulatory Law News section.

Register for the 51st Annual PLI Estate Planning Institute

Live Webcast: Sept 14 – 15, 2020, 9 a.m. EDT

Click here to register.

The Tax Cuts and Jobs Act of 2017 (the “2017 Act”), which was enacted on December 22, 2017, included significant changes to the federal transfer tax regime and related income tax provisions.  More recently, the financial and societal impact of the COVID-19 pandemic of 2020 continues to reverberate and create uncertainty in the future.

This program will review the transfer tax and related income tax developments with the 2017 Act as a starting point, and will discuss how such developments impact estate, trust and income tax planning, and the administration of decedents’ estates.  Moreover, the program will review other recent developments regarding estate, trust and transfer tax and income tax planning.  Further, the COVID-19 crisis and the related estate, trust and income tax legislation and rulings promulgated in response to such crisis will be discussed.

What You Will Learn

  • Advising clients in a time of unprecedented uncertainty
  • An update on recent developments in all areas of estate, trust and transfer tax planning including legislation and rulings issued as a result of the COVID-19 crisis
  • A review of the interaction between the federal transfer tax regime and state transfer tax regimes
  • A review of the transfer tax and related income tax provisions of the 2017 Act
  • Income tax planning for estates and trusts
  • Administering estates and trusts during and after the COVID-19 pandemic
  • A review of the SECURE Act of 2019
  • A review of international estate planning and tax changes
  • FATCA and its progeny
  • A discussion of trust planning and divorce
  • Ethical considerations for attorneys
  • Elder law and special needs planning considerations
  • A review of tax issues for art collectors
  • An update on charitable donation planning
  • A review of electronic Wills and modern-day estate planning
  • Asset protection planning in a pandemic world

…and much more!

Special Features

  • Full hour of ethics credit

Who Should Attend

Attorneys and other professionals advising on estate planning and/or transfer tax planning, including accountants, financial planners and anyone else whose practice requires a solid understanding of estate planning.

Program Level: Overview

Prerequisites: Attendees should have a basic understanding of trusts and estates terminology and a foundational background in tax

Intended Audience: Attorneys, accountants, financial planners, and other professionals who specialize in estate planning, life insurance products and/or transfer tax planning

Advanced Preparation: None

See other upcoming events from PLI here.

Surprise! President Trump Nominates Democrat and Republican to FERC

On July 27, 2020, President Trump nominated two candidates to the Federal Energy Regulatory Commission (FERC), securing a Republican majority on the Commission through June 2021 while also ensuring a continued quorum.

Trump nominated Allison Clements, the Democrats’ top pick, alongside Republican Mark C. Christie. Clements currently serves as founder and president of Goodgrid, LLC, an energy policy and strategy consulting firm. She previously worked for over a decade at the Natural Resources Defense Council, and spent two years as director of the clean energy markets program at the Energy Foundation. Christie currently serves as chairman of the Virginia State Corporation Commission, having served for 16 years on the Virginia board that oversees utilities.

FERC is a five-member agency that should have no more than three members of any one party. For much of the past year it has been operating with three Republicans and one Democrat. FERC’s newest commissioner, James Danly, was confirmed in March despite requests from Democrats to pair his nomination with Clements. Clements would fill the seat left vacant by Commissioner Cheryl LaFleur in August 2019. If confirmed, Christie will take the seat of Republican Commissioner Bernard McNamee, whose tenure expired in June but who plans to stay on until his replacement is seated.

Republican Chairman Chatterjee has announced that he will remain on the Commission until the end of his term, which expires June 2021, although the next President will determine if he continues to serve as chairman. Trump’s appointment of Christie, paired with Chairman Chatterjee’s intention to fulfill his term, could secure a Republican-held Commission for the first months of a Biden presidency in the event the Democratic nominee is successful in November.

©2020 Pierce Atwood LLP. All rights reserved.

FTC Proposes New Rule Codifying “Made in USA” Policy

On July 16, 2020 the FTC published a notice of proposed rulemaking in which it announced its intention to codify its long-time enforcement policy regarding products labeled as “Made in the USA” (MUSA); these claims are currently enforced through the FTC’s general authority to prevent unfair and deceptive practices.

The proposed rule does not change the substantive criteria on which such claims will be evaluated and rather is primarily intended to (1) strengthen the FTC’s enforcement mechanism by making it easier for the FTC to assess civil penalties against those making unlawful MUSA claims and (2) give marketers more regulatory certainty. Under the proposed rule, a MUSA claim may, as before, only be made where (1) the final processing or assembly occurs in the USA, (2) all significant processing that goes in the product occurs in the USA, and (3) all or virtually all of the ingredients or components of the product are made and sourced in the U.S. While the proposed rule would apply to a broad range of product labels, it would also apply to MUSA claims found outside of the product label such as mail order catalogs and mail order promotional materials defined to include “any materials, used in the direct sale or direct offering for sale of any product or service, that are disseminated in print or by electronic means, and that solicit the purchase of such product or service by mail, telephone, electronic mail, or some other method without examining the actual product purchased.”  The proposed rule would not apply to qualified MUSA claims.

Comments to the proposed rule are due by September 14, 2020.

© 2020 Keller and Heckman LLP

For more on labeling regulation, see the National Law Review Administrative & Regulatory law section.

June 2020 New Jersey State Regulatory Developments

Here are the most recent health care related regulatory developments as published in the New Jersey Register in June 2020:

  • On June 1, 2020, at 52 N.J.R. 1150(a), the Department of Health Commissioner issued a notice of rule waiver/modification/suspension pursuant to Executive Order No. 103 (2020) related to the qualifications an administrator of an assisted living residence or comprehensive personal care home.  This waiver was issued to ensure that a sufficient number of qualified administrators are available to staff New Jersey’s assisted living facilities and comprehensive personal care homes so that the facilities can effectively address the increasing number of both staff and residents being diagnosed with or suspected of having COVID-19.  Section 8:36-3.2 has been temporarily amended to permit individuals whose Assisted Living Administration certification had become inactive within the past three years (April 1, 2017-April 1, 2020) to restore their licenses provided that they have not been disqualified, is not under an investigation by the ALA panel or other state licensing authority, does not have a suspended, revoked or restricted certification and no failed a criminal background check.  If these bars have been cleared, then the applicant must complete a 10 hour Temporary Living Administrator Program sponsored by Longtree & Associates, LLC; successfully pass a criminal background check pursuant to N.J.A.C. 8:43I-4; and pay the current Assisted Living Administrator certification fee.

This temporary rule waiver/modification, as well as any provisional certifications issued thereunder, will expire 45 days after the end of the Public Health Emergency declared by Governor Philip D. Murphy in Executive Order No. 103 (2020). After the provisional certifications issued under this subsection have expired, individuals whose Assisted Living Administrator certifications have expired will no longer be permitted to function as certified assisted living administrators. Individuals wishing to obtain full certification as an assisted living administrator will be required to successfully complete all the requirements for restoration of such certifications set forth in this section (excluding the new subsection).

  • On June 1, 2020, at 52 N.J.R. 1151(a), the Department of Health Commissioner issued a notice of rule wavier modification/suspension pursuant to Executive Order No. 103 (2020) related to the time period within which a certified medication aide candidate must sit for the medication aide exam after completing his or her medication aide training course. Pursuant to this rule waiver/modification, if a candidate’s deadline to sit for the standardized examination falls between March 1, 2020 and May 31, 2020, then the candidate shall have an additional six (6) months from the original deadline to sit for the examination. For example, if a candidate was required to sit for the examination by March 1, 2020, the deadline will be extended to August 31, 2020. The remaining provisions set forth in N.J.A.C. 8:36-9.2 shall remain in effect.

N.J.A.C. 8:36-9.2(c) requires a certified medication aide candidate to sit for the Department of Health approved standardized examination within six (6) months of successfully completing an approved medication administration training course. The standardized examinations are administered by PSI Testing Centers. In an effort to protect the community from the spread of COVID-19, PSI Testing Centers are closed and no longer administering standardized examinations. As a result, medication aide candidates that successfully completed the approved training course are not able to sit for the standardized examination within the specified time frame. Accordingly, an extension of the time period that certified medication aide candidates have to sit for the exam is warranted so that the candidates do not have to unnecessarily retake the training course to qualify for the exam and gain certification after the public health emergency concludes.

  • On June 1, 2020, at 52 N.J.R. 1151(b) the Department of Health Commissioner issued a notice of rule wavier modification/suspension pursuant to Executive Order No. 103 (2020) regarding nurse aid competency.  N.J.A.C. 8:39-43.1 sets forth certain criteria for an individual to qualify to work as a Certified Nurse Aide (CNA) in a licensed long-term care facility in New Jersey. In order to increase the number of direct care staff available to work at long-term care facilities, the Department is modifying the requirements of N.J.A.C. 8:39-43.1. Pursuant to this rule waiver/modification, Personal Care Assistants (PCA) and Certified Medical Assistants (CMA) are temporarily permitted to function in the role of a CNA in licensed long-term care facilities within New Jersey so long as the PCA or CMA meet the following conditions: (1) the CMA or PCA must complete the Temporary Nurse Aide training course at  http://educate.ahcancal.org/products/temporary-nurse-aide  prior to functioning as a CNA; (2) the facility shall provide staff a basic orientation addressing fire safety, infection control, and abuse prevention prior to allowing them to perform any duties in the facility; and (3) the facility shall maintain relevant supervision requirements for CMAs and PCAs functioning as CNAs. The remaining provisions set forth in N.J.A.C. 8:39-43.1 shall remain in effect.

Long- term care facilities that take action under the terms of this waiver/modification must also provide a written report to the Department regarding the facility’s implementation. This waiver is effective only during the period of Public Health Emergency declared by Governor Philip D. Murphy in Executive Order Nos. 103 and 119. Within 45 days after the Public Health Emergency has ended, PCAs and CMAs will no longer be permitted to function in the role of a CNA and anyone wishing to act as a CNA will be required to satisfy the competency requirements set forth in N.J.A.C. 8:39-43.1. Long- term care facilities will also be required to resume operating in accordance with all licensure standards within 45 days after the Public Health Emergency has ended.

  • On June 1, 2020 at 52 NJ.R. 1154(a) the Department of Health Commissioner issued a notice of rule wavier modification/suspension pursuant to Executive Order No. 103 (2020) related to recertification of EMTs whose certifications have expired. Pursuant to this rule waiver and modification, individuals whose EMT certification expired within the past five years (April 1, 2015 to April 1, 2020) are eligible for “COVID-19 EMT re-entry” so long as: (1) the applicant is not currently under investigation by any State EMT licensing authority; (2) the applicant does not have a proposed or final enforcement action pending or entered against him or her by any State EMT licensing authority; (3) the applicant is not excluded from acting as an EMT pursuant to a settlement reached with any State EMT licensing authority; (4) the applicant has not been cited for impersonating an EMT and/or Paramedic; (5) the applicant does not have a criminal history or pending criminal charges referenced in N.J.A.C. 8:40A-10.2; and (6) the applicant successfully completed all continuing education audits conducted by the Department while certified as an EMT. If an applicant does not fall into one of these disqualification categories, the applicant may proceed with the “COVID-19 EMT re-entry” process that is outlined in the regulations.  Upon successful completion of these requirements, the Department will issue the applicant a 6-month provisional EMT certification. To obtain full certification as an EMT, the applicant must successfully complete a New Jersey approved refresher program and achieve a passing score on the National Registry EMT-Basic Certification Examination, as set forth in N.J.A.C. 8:40A-7.6, by the end of the provisional period.  Individuals issued provisional certifications under this waiver shall only provide services as an EMT in a limited capacity as specified in the regulations.
  • On June 1, 2020, at 52 N.J.R. 1156(a) the Department of Health Commissioner issued a notice of rule wavier modification/suspension of N.J.A.C. 8:41A-4.3, which set forth the requirements necessary for individuals to restore their paramedic certifications from inactive status to active status, pursuant to Executive Order No. 103 (2020).  Pursuant to this rule waiver and modification, individuals whose EMT-Paramedic certification was placed into inactive status within the past five years (April 15, 2015 to April 15, 2020) are eligible for the “COVID-19 EMT-Paramedic Re-Entry” so long as: (1) the applicant is not currently under investigation by any State EMT-Paramedic licensing authority; (2) the applicant does not have a proposed or final enforcement action pending or entered against him or her by any State EMT-Paramedic licensing authority; (3) the applicant is not excluded from acting as an EMT-Paramedic pursuant to a settlement reached with any State EMT-Paramedic licensing authority; (4) the applicant has not been cited for impersonating an EMT and/or EMT-Paramedic; (5) the applicant does not have a criminal history or pending criminal charges referenced in N.J.A.C. 8:41A-5.2; and (6) the applicant successfully completed all continuing education audits conducted by the Department’s Office of Emergency Medical Services (OEMS) while certified as an EMT-Paramedic and/or EMT. If an applicant does not fall into one of these disqualifying categories, then the applicant may proceed with the “COVID-19 EMT-Paramedic Re-Entry” process.  In a 2 person crew of a Mobile Intensive Care Unit, only 1 of the 2 people may possess a 6 month provisional/modified status.
  • On June 15, 2020 at 52 N.J.R. 1240(a), the Office of the Governor issued Executive Order 145 (2020) allowing elective surgeries and invasive procedures to resume on May 26, 2020.
  • On June 15, 2020 at 52 N.J.R. 1251(a), the Department of Health Commissioner issued a notice of rule wavier modification/suspension of N.J.A.C. 8:43G-31.11 regarding the maintenance of respiratory care equipment in hospitals, pursuant to Executive Order No. 103 (2020).  The waiver is effective during the period of the Public Health Emergency declared in Executive Order No. 103 and expires forty-five (45) days after the Public Health Emergency has ended.

Pursuant to this temporary rule waiver/modification, hospitals shall perform a mechanical and electrical function test on a ventilator released from State storage or from the federal stockpile prior to placing it into service and using it for the first time. The ventilator mechanical and electrical equipment function test shall consist of the following: performance of standard preoperational checks as recommended by the manufacturer; performance of a power-on self-test; and running the ventilator for a minimum of 15 minutes. Upon successful completion of the test, the hospital shall affix a sticker indicating the date that the ventilator passed the test. Hospitals shall create and maintain records showing that each State storage or federal stockpile ventilator placed into service met these requirements prior to being placed into service.

Hospitals that take action under the terms of this waiver must also provide a written report to the Department detailing the number of ventilators placed into service and any adverse outcomes attributable to these actions.  Upon the expiration of this temporary rule waiver/modification, hospitals will be required to resume operating in accordance with all licensure standards and perform the required equipment checks and maintenance. The remaining provisions set forth in N.J.A.C. 8:43G-31.11 shall remain in effect.

  • On June 15, 2020, at 52 N.J.R. 1251(b) the Department of Health Commissioner issued a notice of rule wavier modification/suspension of N.J.A.C. 10:161B-11.10, which would permit individuals receiving opioid treatment services to receive medication that they can take at home, pursuant to Executive Order No. 103 (2020).  In order to ensure the clients of OTPs have access to needed medications, the Department is waiving the requirements of N.J.A.C. 10:161B-11.10 and permitting facilities to provide medication to clients at locations other than the location listed on their OTP facility license, in accordance with the guidance issued by the Drug Enforcement Agency (DEA078) on April 7, 2020. The intent of the guidance is to provide OTPs greater flexibility in the delivery of take-home doses of methadone to their patients. OTPs must still adhere to certain standards. Specifically, before using the unregistered off-site location, the OTP must first contact its State Opioid Treatment Authority (SOTA) and receive the SOTA’s approval to use the offsite location. Additionally, the OTP must receive approval from the local DEA field office. Once the SOTA approves the location, it should contact the local DEA field office. If the SOTA does not contact the DEA field office, the OTP must contact the field office itself. The facility must submit the approvals received from the SOTA and the DEA field office to the Department. Each day, the facility may only transport those take-home methadone doses to the off-site location that the facility reasonably anticipates will be delivered to clients that day. The facility cannot transport a reserve of methadone to the off-site location. Any methadone not delivered to clients at the off-site location must be returned to the facility’s DEA-registered location the same day. No methadone may be stored at the off-site location when a facility staff member is not present

All OTPs that take action under the terms of N.J.A.C. 10:161B-11.10 shall provide a written report to the Department detailing the extent to which the facility implemented the terms of this waiver/modification and any adverse outcomes attributable to such implementation. OTPs may operate under the terms of this waiver/modification as necessary until the conclusion of the public health emergency declared by Governor Philip D. Murphy in Executive Order Nos. 103. Upon the conclusion of the public health emergency, OTP facilities will be required to resume determining eligibility for take-home medication under the criteria set forth in N.J.A.C. 10:161B-11.10(a).

  • On June 15, 2020, at 52 N.J.R. 1253(a) the Department of Human Services Commissioner issued a notice of rule waiver modification/suspension of certain rules at N.J.A.C. 10:51-1.25(j)(3), N.J.A.C.10:167A-1.27(j)(4) and N.J.A.C. 10:167C-1.25(j)(3), which require signatures by Medicaid/NJ FamilyCare, Pharmaceutical Assistance to the Aged and Disabled (PAAD) and Senior Gold beneficiaries at the time a prescription is dispensed or delivered. During the public health emergency, beneficiaries of these programs will no longer be required to provide signatures at the time a prescription is dispensed or delivered. The pharmacist must document in the patient’s profile the date the beneficiary received the prescription.
  • On June 15, 2020, at 52 N.J.R. 1287(a), the Department of Health Commissioner issued a public notice announcing the cancellation of the call for certificate of need (CN) applications for new home health agencies in accordance with the provisions of N.J.A.C. 8:42 and N.J.S.A. 26:2H-1 et seq. In accordance with N.J.A.C. 8:33-4.1(a), the next scheduled call for new home agencies will be July 1, 2022. The Department will continue to monitor the utilization and availability of home health services and, should the need arise, issue a future call for these services prior to July 1, 2022.
  • On June 15, 2020, at 52 N.J.R. 1287(b), the Department of Health Commissioner issued a public notice of postponement of  the certificate of need call for applications for home health care services in accordance with the provisions of N.J.A.C. 8:33 and N.J.S.A. 26:2H-1 et seq., scheduled for July 1, 2019, is hereby postponed.  The Department is in the process of gathering and evaluating data to determine whether there is currently a need for home health care services. Accordingly, it is necessary to delay the call for home health care services to allow the Department sufficient time to complete its evaluation of need, and to provide potential applicants and affected parties sufficient time to respond appropriately to a certificate of need call notice in the event the Department determines that a call is appropriate. If the Department proceeds with the call, then a call for home health care services will be published in an upcoming publication of the New Jersey Register, providing the necessary time for both potential applicants and interested parties to respond to the call notice. In the alternative, if the determination is made to cancel the call, then the Department will publish a cancellation notice in the New Jersey Register.
  • On June 15, 2020, at 52 N.J.R. 1247(a), the Department of Law and Public Safety, Division of Consumer Affairs, New Jersey Board of Nursing published a notice of administrative correction to the text of N.J.A.C. 13:37-7.2, pertaining to the education requirements for certification. Effective April 20, 2020, the Board deleted then-existing N.J.A.C. 13:37-7.2(b) and recodified then-existing subsections (c) and (d) as (b) and (c). (See 51 N.J.R. 922(a); 52 N.J.R. 896(a).) As part of the April 20, 2020 rulemaking, the Board inadvertently did not update the cross-reference at subsection (c) to account for the recodifications in this section. The Board is correcting that oversight to change the cross-reference at now-codified subsection (c) to refer to the “requirements of (a) and (b) above.”
© 2020 Giordano, Halleran & Ciesla, P.C. All Rights Reserved

EPA OIG Report States Further Efforts Needed to Uphold Scientific Integrity Policy at EPA

On May 20, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled Further Efforts Needed to Uphold Scientific Integrity Policy at EPA.  OIG conducted an Agency-wide survey to determine whether EPA’s Scientific Integrity Policy is being implemented as intended to ensure scientific integrity throughout EPA.  OIG received 4,320 responses (a 23.5 percent response rate), showing that 3,987 respondents were aware of or had some familiarity with the Scientific Integrity Policy.  According to OIG, among those respondents with a basis to judge, the majority (56 percent; 1,025 of 1,842) were satisfied with the overall implementation of the Policy.  OIG states that the survey also revealed some concerns with specific aspects of scientific integrity at EPA, including dissatisfaction with EPA’s culture of scientific integrity (59 percent; 1,425 of 2,402) and the release of scientific information to the public (57 percent; 1,049 of 1,842).  OIG recommends that EPA’s deputy administrator lead an effort to examine the causes associated with the scientific integrity concerns identified in the survey and communicate the results to EPA employees, including planned actions to address the causes.  OIG also made 11 recommendations to the EPA science advisor, including developing procedures for addressing and resolving allegations of scientific integrity violations, communicating the outcomes of reports of scientific integrity violations, and improving the release of scientific information to the public.  OIG states that EPA agreed with its recommendations and provided acceptable corrective actions.  According to OIG, EPA has completed two recommendations, and the others are resolved with corrective actions pending.

©2020 Bergeson & Campbell, P.C.

Sweeping Executive Order on Deregulation Seeks to Spur Post-Pandemic Economy

President Trump signed an Executive Order (Order) this week to alter or eliminate regulations that the Administration maintains hamper economic recovery as the nation emerges from the COVID-19 pandemic.

The Regulatory Relief to Support Economic Recovery Order calls on agencies across the federal government to use emergency authorities provided under the Administrative Procedures Act to swiftly rescind, modify, waive or provide exemptions from regulations and other requirements that inhibit job creation and economic growth.  It further calls on agencies to consider permanently rescinding or modifying any regulations that were temporarily halted in response to COVID-19. The Order notes that it does not change agencies’ statutory obligations.

The Order also directs enforcement discretion by agencies for businesses that make good-faith attempts to follow agency guidance and regulations during the pandemic.  It establishes the following “principles of fairness” that are to be followed in enforcement and adjudication:

  • The Government should bear the burden of proving an alleged violation of law; the subject of enforcement should not bear the burden of proving compliance.
  • Administrative enforcement should be prompt and fair.
  • Administrative adjudicators should be independent of enforcement staff.
  • Consistent with any executive branch confidentiality interests, the Government should provide favorable relevant evidence in possession of the agency to the subject of an administrative enforcement action.
  • All rules of evidence and procedure should be public, clear, and effective.
  • Penalties should be proportionate, transparent, and imposed in adherence to consistent standards and only as authorized by law.
  • Administrative enforcement should be free of improper Government coercion.
  • Liability should be imposed only for violations of statutes or duly issued regulations, after notice and an opportunity to respond.
  • Administrative enforcement should be free of unfair surprise.
  • Agencies must be accountable for their administrative enforcement decisions.

Finally, the Order instructs agencies to provide pre-enforcement rulings, permitting businesses to ask an agency for a determination on whether some proposed conduct in the business’s response to COVID-19 is allowable.

IMPLICATIONS AND OUTLOOK

The Order is consistent with the longstanding stated desire by the Administration to reduce regulatory burdens.  It has the potential to alter the regulatory landscape across a wide array of industries. The Order could impact virtually any regulation from the numerous government agencies that promulgate rules, including financial regulations, environmental protections, and agricultural production and distribution guidelines, among many others.

In addition to ordering the rescission or modification of current regulations, the White House is calling on agencies to speed up the rulemaking process, including moving proposed rulemakings to interim final rules with immediate effect. This will likely draw resistance and possibly litigation from organizations that have already opposed the Administration’s approach on regulatory reforms.

The Order’s provisions on pre-enforcement rulings supersedes the provisions contained in Section 6 of Executive Order 13892, which establishes principles for using guidance in civil administrative enforcement, in an effort to provide faster compliance feedback to companies looking to reopen so they can proceed with the confidence that doing so will not trigger violations of the governing laws or regulations.

The “principles of fairness” detailed above seek to provide another level of legal cover for regulated entities. However, the extent to which the Order would provide protection for businesses against pandemic-related liability would be limited.  This has been a particularly challenging issue among lawmakers as the next legislative response package is developed.  While Senate Majority Leader Mitch McConnell (R-KY) has stated that liability protections for business must be included in the next relief bill, House Speaker Nancy Pelosi (D-CA) opposes such provisions.

Although it remains to be seen how agencies will respond to the Order, it is likely that they will look to the businesses and industries they regulate to assist them in identifying regulations that should be rescinded or modified.

© 2020 Van Ness Feldman LLP

For more on government regulations, see the National Law Review Administrative and Regulatory law section.

Best Practices for Commercial Property Owners/ Operators: Phase One of Reopening the Economy

The Federal Coronavirus Task Force issued a three-stage plan last week to reopen the economy, where authorities in each state – not the federal government – will decide when it is safe to reopen shops, schools, restaurants, movie theaters, sporting arenas and other facilities that were closed to minimize community spread of the deadly virus. Once phase one is adopted in certain states, businesses that reopen will need to be prepared to take certain precautions to meet their common law duty to provide and maintain reasonably safe premises.

Phase One

The first stage of the plan will affect certain segments of society and businesses differently. For example, schools and organized youth activities that are currently closed, such as day care, should remain closed. The guidance also says that bars should remain closed. However, larger venues such as movie theaters, churches, ballparks and arenas may open and operate but under strict distancing protocols. If possible, employers should follow recommendations from the federal guidance to have workers return to their jobs in phases.

Also, under phase one vulnerable individuals such as older people and those with underlying health conditions should continue to shelter in place. Individuals who do go out should avoid socializing in groups of more than 10 people in places that don’t provide for appropriate physical distancing. Trade shows and receptions, for example, are the types of events that should be avoided. Unnecessary travel also should be avoided.

Assuming the infection rate continues to drop, then the second phase will see schools, day care centers and bars reopening; crowds of up to 50 permitted; and vacation travel resuming. The final stage would permit the elderly and immunologically compromised to participate in social settings. There is no timeline prescribed, however, for any of these phases.

Precautionary Basics

Once businesses are reopened during phase one, there are several common sense and intuitive safety practices that business owners/operators must absolutely ensure are in place to meet their common law duty to provide a reasonably safe environment for those present on their premises.

The guidelines issued by the CDC are the core protocols that form the baseline for minimal safety precautions: persistent hand washing, use of masks/gloves and strict social distancing.

Additional Measures

Given the highly infectious nature of the virus, the fact that it is capable of being transmitted by asymptomatic people who are nonetheless infected, and the apparent viability of transmission through recirculated air or via HVAC systems without negative pressure (per a recent report from China about transmission from one restaurant customer to several others via the air circulation system), there is nothing that reasonably can be adopted that will effectively and readily ensure that a business is completely free of someone who is infected and capable of spreading the virus.

As such, additional measures are advisable beyond the CDC protocols, such as robust cleaning/hygienic regimens/complimentary wipes and hand sanitizer for common areas, buttons and handles; and the necessary protections for employees who interact with the public (e.g., shielding and protective gear for checkout clerks at the supermarket or lobby desk/check-in personnel in hotels and office buildings). In addition, it would not be unreasonable or unduly intrusive to check the temperatures (via no-touch infrared devices) of those entering the premises. In the absence of available portable, instant and unobtrusive virus testing methods, temperature readings are the most practical and reasonable precautionary measure beyond the CDC baseline deterrents.

Conscientious and infallible implementation of maintenance, housekeeping and hygiene protocols for the commercial, hospitality, retail and restaurant industries also will be critical to mitigate potential liability claims for negligently failing to provide an environment reasonably safe from the spread of coronavirus.

Advisability of Warnings

Aside from conspicuously publicizing – via posted signage or announcements – the CDC guidelines relating to persistent hand washing, use of masks/gloves and strict social distancing, the need to warn of the potential for – or a history of – infections generally is not considered to be necessary or essential unless there is an imminent threat of a specific foreseeable harm.

Unless there is a specific condition leading to a cluster of infections within a particular property (unlikely given the ubiquity of the disease and community spread, but the reporting would be to the CDC or local health authorities in such an instance), or an isolated circumstance that can be identified to be the source of likely infections to others who proximately were exposed, there is no need or obligation under existing law or regulatory guidelines to report generally that someone who tested positive for the virus may have been on a particular property.

Moreover, unless the business is an employer who administers a self-funded health plan (who are thus charged with the duty to maintain “protected health information”), businesses that are not health providers are not subject to HIPAA; as such, concerns about HIPAA violations are misplaced to the extent that the identity of someone who is infected is somehow disclosed or otherwise required to be disseminated by a business not otherwise charged with the duty to maintain “protected health information.”

A Coordinated Approach

While the CDC’s guidelines are important, they are not exclusive. Businesses planning to reopen also should consider regulations and guidelines from a number of other sources, including OSHA and state and local departments of public health.

© 2020 Wilson Elser

For more on reopening the economy, see the National Law Review Coronavirus News section.

CMS Waives Certain Penalties Classes of the Stark Law

On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) announced it will waive certain penalties classes of violations of the Physician Self-Referral Law, known as the Stark Law. The affected penalties are those listed under Section 1877(g) of the Social Security Act (42 U.S.C. 1877). These blanket waivers are effective retroactively to March 1, 2020.

The Stark Law is a strict liability statute generally prohibiting a physician from making referrals of Medicare- and Medicaid-designated health services to an entity with which the physician or an immediate family member has a financial relationship. Typically, if such a relationship exists between a physician and an entity, then the arrangement must satisfy an express Stark Law exception for the physician to bill for the referred services.

The blanket waivers temporarily allow payments and referrals between physicians and covered entities if the relationship falls into one of the express categories during the COVID-19 pandemic, even if such an arrangement would otherwise not meet a Stark Law exception. The blanket waivers apply to payments and referrals between an entity covered under the Stark Law and (1) a physician, (2) the physician’s organization defined under 42 C.F.R. 411.354(c) or (3) the physician’s immediate family member.

The blanket waivers must relate to one of the explicitly defined COVID-19 purposes and meet the following conditions:

  1. The providers are acting in good faith to provide care in response to the COVID-19 pandemic.
  2. The financial relationship or referral is protected by one of CMS’s 18 permitted relationships (discussed below).
  3. The government does not determine that the financial relationship creates fraud and abuse concerns.

Defined COVID-19 Purposes

To apply, the blanket waivers must be related to COVID-19 purposes. Such purposes include:

  • “Diagnosis or medically necessary treatment of COVID-19 for any patient or individual, whether or not the patient or individual is diagnosed with a confirmed case of COVID-19;
  • Securing the services of physicians and other health care practitioners and professionals to furnish medically necessary patient care services, including services not related to the diagnosis and treatment of COVID-19, in response to the COVID-19 outbreak in the United States;
  • Ensuring the ability of health care providers to address patient and community needs due to the COVID-19 outbreak in the United States;
  • Expanding the capacity of health care providers to address patient and community needs due to the COVID-19 outbreak in the United States;
  • Shifting the diagnosis and care of patients to appropriate alternative settings due to the COVID-19 outbreak in the United States; or
  • Addressing medical practice or business interruption due to the COVID-19 outbreak in the United States in order to maintain the availability of medical care and related services for patients and the community.”

Those wishing to use the blanket waivers need not provide advance notice to or receive approval from CMS. Those who rely on a blanket waiver, however, must retain records relating to its use, and the records must be available for the U.S. Department of Health and Human Services to review upon request.

The Blanket Waivers

The blanket waivers do not suspend the entire Stark Law. Rather, they apply only to 18 expressly enumerated relationships. These relationships can be divided into two classes: those that address payments and those that address referrals.

Allowed Payments

  1. Personally Performed Services: Remuneration paid by an entity to a physician above or below the fair market value (FMV) for the physician’s personally performed services to the entity is permitted.
  2. Office Space and Equipment Rental Payments: Remuneration paid by an entity to a physician or by a physician to an entity below FMV for rental of office space or equipment is permitted by the waivers. Rental payments exceeding FMV are not covered.
  3. Purchase of Items or Services: Remuneration paid by an entity to a physician or by a physician to an entity below FMV for the purchased items or services, including use of the entity’s premises, is permitted by the purchase waivers. The purpose of these waivers is to permit parties to rapidly source critical items or services without overpaying for the service.
  4. Additional Incidental Benefits to Medical Staff: Remuneration from a hospital to a physician in the form of medical staff incidental benefits that exceed the $36-per-item limit set forth in 42 CFR § 411.357(m)(5) is protected. This waiver permits a hospital to offer a range of benefits to its medical staff members to facilitate participation in the health care workforce, such as childcare services or clean clothing for the physician while at the hospital.
  5. Nonmonetary Compensation: Remuneration from an entity to a physician in the form of nonmonetary compensation that exceeds the $423 annual limit set forth in 42 CFR § 411.357(k)(1) is permitted. Similar to the medical staff benefit waiver, this waiver allows an entity to provide additional services that would otherwise exceed the limits established by the regulations to facilitate participation in the health care workforce during the COVID-19 pandemic. Currently, it is unclear how this waiver will be assessed when the blanket waiver period ends because the public emergency declaration caused by the COVID-19 pandemic is terminated. More guidance from CMS on the application of this waiver may be issued.
  6. Low-Interest or Interest-Free Loans: Remuneration among individuals and entities in the healthcare industry in the form of a loan, with an interest rate below FMV or on terms that are unavailable from another independent lender, is allowed. Essentially, CMS is attempting to increase cash liquidity within the health care industry to mitigate potential cash flow problems among health care workers and providers during the COVID-19 pandemic.

Allowed Referrals

  1. Referrals by Physician-Owner of a Hospital: Referrals by a physician-owner of a hospital that temporarily expands its facility capacity above the number of operating rooms, procedure rooms and beds for which the hospital was licensed on March 23, 2010 without prior application and approval of the expansion of facility capacity will temporarily not be prohibited by the Stark Law. (In the case of a hospital that did not have a provider agreement in effect as of March 23, 2010, but did have a provider agreement in effect on December 31, 2010, the effective date of such provider agreement applies.)
  2. Referrals by Physician-Owner of Ambulatory Surgical Centers that Temporarily Convert to Hospitals: Referrals by a physician-owner of a hospital that converted from a physician-owned ambulatory surgical center to a hospital on or after March 1, 2020 are permitted provided that:
  • The hospital does not satisfy one or more of the requirements of Section 1877(i)(1)(A) through (E) of the Act.
  • The hospital enrolled in Medicare as a hospital during the period of the public health emergency described in Section II.A of this blanket waiver document.
  • The hospital meets the Medicare conditions of participation and other requirements not waived by CMS during the period of the public health emergency described in section II.A of this blanket waiver document.
  • The hospital’s Medicare enrollment is not inconsistent with the Emergency Preparedness or Pandemic Plan of the state in which it is located.
  1. Referrals by Owners to a Home Health Agency: Referrals are now permitted by a physician of a Medicare beneficiary for the provision of designated health services to a home health agency (1) that does not qualify as a rural provider under 42 CFR 411.356(c)(1) and (2) in which the physician (or an immediate family member of the physician) has an ownership or investment interest.
  2. Referrals for Services at Locations Other than the Health Care Facility: Referrals are now permitted by a physician in a group practice for medically necessary designated health services furnished by the group practice in a location that does not qualify as a “same building” or “centralized building” for purposes of 42 CFR 411.355(b)(2). Also, referrals by a physician in a group practice for medically necessary designated health services furnished by the group practice to a patient in his or her private home, an assisted living facility, or independent living facility where the referring physician’s principal medical practice does not consist of treating patients in their private homes will not violate the Stark Law.
  3. Referrals to Immediate Family Members in Rural Areas: Referrals are now permitted by a physician to an entity with which the physician’s immediate family member has a financial relationship if the patient who is referred resides in a rural area.
  4. Relaxing Compensation Arrangement Written Requirements: Stark Law compensation arrangement exceptions frequently require the arrangement to be in writing. However, referrals are now permitted by a physician to an entity that the physician (or an immediate family member of the physician) has a compensation arrangement that does not satisfy the writing requirements of an applicable exception but satisfies all other requirements of the applicable exception, unless that requirement is waived under one or more of the blanket waivers above.

CMS encourages providers to contact CMS with questions regarding the applicability of the blanket waivers. Providers should send any requests to 1877CallCenter@cms.hhs.gov and include the words “Request for 1877(g) Waiver” in the subject line. All requests should include the following minimum information:

  • the name and address of requesting entity
  • the name, phone number and email address of the person designated to represent the entity
  • the CMS Certification Number (CCN) or Taxpayer Identification Number (TIN) of the requesting entity; and
  • the nature of the request.

The contours and applications of these blanket waivers are complex and often require a nuanced understanding of how they are couched into the existing regulatory framework addressing the provision of health care services under the Social Security Act, the Stark Law, and a number of other statutes and regulations.

© 2020 Much Shelist, P.C.

For more on healthcare blanket waivers amidst COVID-19, see the National Law Review Coronavirus News section.

DOT Issues Notice of Enforcement Discretion Regarding the Transportation of Hand Sanitizers to Address COVID-19

On April 2, 2020, the U.S. Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a Notice of Enforcement Discretion (Notice) that provides temporary relief from certain aspects of the DOT Hazardous Materials Regulations (HMR) that normally apply to the transportation of ethyl alcohol or isopropyl alcohol-based hand sanitizers. [1]

Due to the Coronavirus Disease 2019 (COVID-19) public health emergency, demand for hand sanitizer has reached unprecedented levels. Many of these sanitizers are classified as Class 3 flammable liquids due to the alcohol content, which would trigger certain marking, labeling, packaging, documentation, and other compliance obligations for shippers (and carriers) under the DOT HMR. Although the DOT HMR already provide some regulatory relief for certain ethyl alcohol products in 49 CFR 173.150(g), this does not cover isopropyl alcohol products and it does not cover ethyl alcohol products in larger containers. To facilitate the availability of these products, PHMSA is providing temporary relief from certain HMR requirements.

The Notice indicates that the relief applies to companies producing hand sanitizer under a recently issued Food and Drug Administration (FDA) Guidance document and to those who subsequently transport the hand sanitizer. [2]

Importantly, it applies only to highway shipments (by private, common, or contract carriers by motor vehicle) and not shipments by air, vessel, or rail.

If parties follow the procedures for preparing hand sanitizer for shipment set forth in the Notice (as compared to all of the requirements specified in the HMR), PHMSA will not take enforcement action for violations of the HMR. The Notice provides separate procedures for shipping small quantities (< 1 gallon/container or 8 gallons/package) and for larger quantities (> 8 gallons to 119 gallons/package) of hand sanitizer.

© 2020 Keller and Heckman LLP

For more on manufacture & transportation of emergency medical supplies for the COVID-19 pandemic, see the National Law Review Coronavirus News section.