Category: Health

A COVID Surge in China Results in Renewed Restrictions for Travel to the United States

Effective January 5 (at 12:01am, Eastern Standard Time), all passengers inbound from China, Hong Kong and Macau, or who were in the country in the 10 days prior to their departure to the United States, must show a negative PCR or monitored antigen test in order to board flights to the United States. In addition, the same requirement will apply for those passengers who were physically present in China within the 10 days prior to flying through South Korea’s Incheon International Airport, Toronto Pearson International, and Vancouver International.

Background:

Amid concerns over lack of transparency around COVID case data and loosening of COVID-related restrictions, China is facing their largest coronavirus outbreak since the start of the pandemic. The large surge of cases could potentially infect upwards of 800 million people over the next few months. Such a spike in infections over a very short period increases the chances of a new variant emerging, and with the risk of new mutations come the risks of heightened transmission and death rates.

In response, several countries including the United States, Japan, Italy, India, South Korea and Taiwan are implementing measures for travelers to both limit the spread of infection and to improve early detection of new variants. As of January 5, 2023, in order to enter the United States either directly or indirectly from China, Hong Kong and Macau, all passengers over the age of 2, regardless of nationality or vaccination status, must show evidence of a negative PCR or antigen test taken within two days at the departure gate. The only exception will be for those who have recently tested positive. Those who have had COVID-19 in the 90 days prior to their travel to the United States may present documentation of recovery from COVID-19 in lieu of a negative test result.

In addition to the steps taken to specifically protect against those who test positive while traveling from China to the United States, the CDC is also expanding its Traveler Genomic Surveillance program (TGS) to additional airports. TGS, run by the Travelers’ Health Branch at the Center for Disease Control, tests international travelers to detect new variants entering the country and to fill in gaps in global surveillance. During the early days of the Omicron surge, TGS detected two Omicron subvariants weeks before they were reported elsewhere. As part of the program, arriving international travelers volunteer to participate and anonymously provide nasal swabs that are then sent for testing to allow for detection of multiple variants as well as viral characterization to help provide information on a variant’s transmissibility, virulence, and response to current treatments or vaccines.

As the case counts and variants evolve and increase, so, too, must the guidelines around international travel and efforts to control the spread. Before making any international travel plans, make sure to double-check the guidelines in place for each intended destination, prepare for delays and disruption, and continually monitor reliable news sources for updates.

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Copyright © 2023, Hunton Andrews Kurth LLP.
For more Coronavirus Legal News, click here to visit the National Law Review.

Office of Science and Technology Policy Requests Public Input on Biotechnology Regulation

  • The Office of Science and Technology Policy (OSTP) issued a request for information (RFI) today in which it invites public comment on the Coordinated Framework for the Regulation of Biotechnology (the “Coordinated Framework”).
  • The Coordinated Framework, which is a Federal regulatory policy for ensuring the safety of biotechnology products, was first issued in 1986, updated in 1992— to affirm that federal regulation should focus on characteristics of the product and the environment into which it being introduced, and not on the process by which it is produced—and then updated again in 2017 to clarify the roles of EPA, FDA, and USDA. And, in September of this year, Executive Order 14081 directed the three agencies to clarify and streamline regulations to support the safe of use of biotechnology products.
  • Accordingly, the RFI requests comment on seven questions related to the Coordinated Framework. The questions include a request for comment on identification of any regulatory gaps, inefficiencies, or uncertainties; data or information to improve any identified issues; and new or emerging biotechnology products that the agencies should be prepared to address. Comments to the RFI are due by February 3, 2023. Also, on January 12, 2023, OTSP will host a virtual event in which it will listen to public feedback on the RFI.

Article By Food and Drug Law at Keller and Heckman

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

© 2022 Keller and Heckman LLP

Warning Sign? A New Round of FDA Warning Letters Over CBD Consumer Confusion May Signal a Shift in Government Enforcement

FDA warning letters are nothing new in the cannabis industry. In fact, we here at Budding Trends have covered this topic a number of times (here, here, and here). Not resigned to playing the hits, however, the FDA issued a new set of warning letters on November 21 that may signal a shift in enforcement posture away from solely targeting companies that market CBD as a potential medical treatment and towards including companies that market their products in ways that could cause consumer confusion. This is a “Warning Sign” that might cause the cannabis industry “A Rush of Blood to the Head,” much like Coldplay’s multi-platinum album that recently celebrated its 20-year anniversary. So, turn back the “Clocks,” book your flight to “Amsterdam,” and indulge us if you will — just not too much.

Congress legalized the production of hemp and hemp-derived products under the 2018 Farm Bill. But federal legalization did not exempt the hemp industry from federal regulation. Indeed, the FDA and FTC retain overlapping enforcement authority over CBD marketing, with the FDA having primary authority over labeling. Far more than “A Whisper,” the FDA and FTC have not been shy about issuing warning letters to hemp companies that fail to follow the FDA’s labeling requirements and guidance.

Since its first set of warning letters to CBD companies in April 2019, the FDA has focused its enforcement activity on companies that market their CBD products as treatment and cures for a variety of diseases and illnesses. But the FDA’s most recent warning letters took a different tack, focusing on potential health risks from long-term CBD use, consumer confusion leading to unintentional or overconsumption of CBD, and CBD products that could be seen as marketed to children.

The basis of the FDA’s five new warning letters was that CBD is neither an authorized food additive nor generally recognized as safe. The FDA noted it had “not found adequate information showing how much CBD can be consumed, and for how long, before causing harm,” and claimed that “scientific studies show” potential harm to the “male reproductive system” and “liver” from long-term CBD use. In the FDA’s words, “[p]eople should be aware of the potential risks associated with the use of CBD products.”

The products highlighted in the warning letters included gummies, fruit snacks, lollipops, cookies, teas, and other beverages. The FDA said these products were targeted because consumers may confuse them for traditional foods or beverages, “which may result in unintentional consumption of overconsumption of CBD.” Further, the FDA noted that gummies, candies, and cookies are especially concerning because they may appeal to children. Likewise, the FDA cited tea, coffee, sparkling water, beverage “shots,” and honey as products similar to traditional food that may confuse consumers into over-consuming CBD.

Keeping its focus on unintended consumption or unintended overconsumption, the FDA also chastised one company for failing to specifically list CBD as an ingredient on the label of its hemp-infused tea. This is particularly important to note for hemp companies, many of which have sought to avoid listing “CBD” on the product labels for full spectrum hemp extracts in an effort to avoid the FDA and FTC’s seemingly CBD-focused enforcement actions.

Given this new enforcement posture, CBD companies may consider avoiding marketing attempts that seek to link CBD products too closely with traditional foods and beverages. This may include limiting references to the similarity of CBD products to traditional ones. And CBD companies should continue to avoid product labels and marketing campaigns that would be enticing to children, especially for CBD products that are in a form children might be likely to consume (such as gummies and candies).

It remains to be seen where the FDA will draw the line between appropriate marketing and marketing that goes too far towards confusing consumers, but, aside from a falsetto Chris Martin, “nobody said it was easy.” Until then, watch this space and remember to follow the marketing dos and don’ts we provided in one of our previous blog posts.

Article By J. Hunter Robinson and Josh Kleppin of Bradley Arant Boult Cummings LLP

© 2022 Bradley Arant Boult Cummings LLP

CMS Issues Calendar Year 2023 Home Health Final Rule

On November 4, 2022, the Centers for Medicare & Medicaid Services (CMS) published the calendar year 2023 Home Health Prospective Payment System Rate final rule, which updates Medicare payment policies and rates for home health agencies.  Some of the key changes implemented by the final rule are summarized below.

  • Home Health Payment Rates. Instead of imposing a significant rate cut, as was included in the proposed rule released earlier this year, CMS has increased calendar year 2023 Medicare payments to home health agencies by 0.7 percent or $125 million in comparison to calendar year 2022.

 

  • Patient-Driven Groupings Model and Behavioral Changes. A -3.925 percent permanent adjustment to the 30-day payment rate has been implemented for calendar year 2023. The purpose of this adjustment is to ensure that aggregate expenditures under the new patient-driven groupings model payment system are equal to what they would have been under the old payment system. Additional permanent adjustments are expected to be proposed in future rulemaking.

 

  • Permanent Cap on Wage Index Decreases. The rule finalizes a permanent 5 percent cap on negative wage index changes for home health agencies.

 

  • Recalibration of Patient-Driven Groupings Model Case-Mix Weights. CMS has finalized the recalibration of the case-mix weights, including the functional levels and co-morbidity adjustment subgroups and the low utilization payment adjustment thresholds, using calendar year 2021 data in an effort to more accurately pay for the types of patients home health agencies are serving.

 

  • Telehealth. CMS plans to begin collecting data on the use of telecommunications technology under the home health benefit on a voluntary basis beginning on January 1, 2023, and on a mandatory basis beginning on July 1, 2023. Further program instruction for reporting this information on home health claims is expected to be issued in January of 2023.

 

  • Home Infusion Therapy Benefit. The Consumer Price Index for all urban consumers for June 2022 is 9.1 percent and the corresponding productivity adjustment is a reduction of 0.4 percent. Therefore, the final home infusion therapy payment rate update for calendar year 2023 is an increase of 8.7 percent. The standardization factor, the final geographic adjustment factors, national home infusion therapy payment rates, and locality-adjusted home infusion therapy payment rates will be posted on CMS’ Home Infusion Therapy Services webpage once the rates are finalized.

 

  • Finalization of All-Payer Policy for the Home Health Quality Reporting Program. CMS has ended the temporary suspension of Outcome and Assessment Information Set (OASIS) data collection on non-Medicare/non-Medicaid home health agency patients. Beginning in calendar year 2027, home health agencies will be required to submit all-payer OASIS data, with two quarters of data required for program year 2027. A phase-in period will occur from January 1, 2025 through June 30, 2025, and during that time the failure to submit the data will not result in a penalty.

 

  • Health Equity Request for Information. The comments received from stakeholders providing feedback on health equity measure development for the Home Health Quality Reporting Program and the potential future application of health equity in the Home Health Value-Based Purchasing Expanded Model’s scoring and payment methodologies are summarized in the final rule.

 

  • Baseline Years in the Expanded Home Health Value-Based Purchasing (HHVBP) Model. For the Expanded Home Health Value-Based Purchasing Expanded Model, CMS is: updating definitions, changing the home health agency baseline calendar year (from 2019 to 2022 for existing home health agencies with a Medicare certification date prior to January 1, 2019, and from 2021 to 2022 for home health agencies with a Medicare certification date prior to January 1, 2022); and changing the model baseline calendar year from 2019 to 2022 starting in 2023.

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Copyright © 2022 Robinson & Cole LLP. All rights reserved.

FDA Issues Warning Letters to 7 Dietary Supplement Companies for Drug Claims

  • On November 17, 2022, FDA posted warning letters to 7 companies for selling different dietary supplements with claims that caused the products to be “drugs” in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Under the FD&C Act, products intended to diagnose, cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements.

  • The claims were found on the 7 companies’ websites, social media pages, and/or Amazon or Walmart storefronts, and included a variety of statements regarding the products’ claimed abilities to cure, treat, mitigate, or prevent cardiovascular disease (or related conditions, such as atherosclerosis, stroke, or heart failure).  Six of the companies at issue sell a product(s) containing one or more dietary ingredients identified as Vitamin B3, red yeast rice, pine bark extract, EPA and DHA omega-3 fatty acids, magnesium, zinc, bergamot, Hawthorn berry, Hawthorn extract, Coleus forskohlii, hops, taurine, garlic powder, amino sulfonic acid, Co-Q-10, and/or octacosanol.  The seventh company does not list a dietary ingredient but identifies its product as a “glycocalyx regenerating product” and notes various “pathologies associated with impaired endothelial glycocalyx.”  As noted in the warning letters, FDA has not evaluated whether the unapproved products are effective for their intended use, the proper dosage, potential interaction with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.  Further, in addition to characterizing the products as unapproved “new drugs,” FDA’s letters note misbranding charges based on the impossibility of writing adequate directions for a layperson to use the products safely for the intended purpose of treating one more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.

  • FDA requested that the companies respond to the warning letters within 15 working days and describe how they will address the issues, or provide reasoning and substantiation as to why they believe the products are not in violation of the law.  Failure to adequately address could result in legal action, such as product seizure and/or injunction.

For more Biotech, Food and Drug Law news, click here to visit the National Law Review

© 2022 Keller and Heckman LLP

Colorado Legalizes Therapeutic Psychedelics – Now What?

Ten years after Coloradans voted for their state to be one of the first to legalize recreational cannabis, Colorado is again making history as the second state in the country to legalize therapeutic psychedelics for adults.

Colorado voters narrowly approved Proposition 122 with nearly 53% of the votes (as of the morning of November 14th 97% of the votes have been counted). Their vote thus enacted the Natural Medicine Health Act of 2022 (NMHA) which legalizes supervised or facilitated therapeutic sessions for adults twenty-one years and older using certain psychedelic plants and fungi. Click here for our initial takeaways and a high-level summary of key provisions of the NMHA.

Now that therapeutic psychedelics are legal in Colorado, what should be expected next? Below are key dates and next steps as Colorado navigates implementation of the NMHA.

  • The Colorado Department of Regulatory Agencies (DORA) must establish the Natural Medicine Advisory Board (Board) and appoint initial members to the Board by January 31, 2023. The Board must have 15 members who will be appointed by the Governor with the consent of the Colorado Senate. The primary role of the Board is to advise DORA as to implementation of the NMHA program.
  • By September 30, 2023, and annually thereafter, the Board must make recommendations to DORA on certain areas related to natural medicine, such as recommendations related to product safety, herm reduction, and cultural responsibility, training programs, educational and experiential qualifications for facilitators, regulatory considerations for each type of natural medicine and the rules to be promulgated by DORA.
  •  DORA has until January 1, 2024 to adopt rules and establish the qualifications, education and training requirements that facilitators must meet prior to providing natural medicine services to participants.
  • By September 30, 2024, DORA must adopt rules to implement the NMHA program and begin accepting applications for licensure of facilitators, healing centers, entities to test natural medicines, and any categories of licensure as determined by DORA.
  • Once applications are accepted, DORA must make decisions on licensure applications within 60 days of receiving an application.
  • From the launch of the NMHA program until June 1, 2026, “natural medicines” are limited to psilocybin and psilocyn. After June 1, 2026, upon recommendation by the Board, DORA may add one of more of the following to types of natural medicines that can be provided under the NMHA program: dimethyltryptamine, Ibogaine, and Mescaline (excluding peyote).

A notable takeaway and something to watch for in the forthcoming rules is a focus on social equity. Seemingly applying lessons learned from the rollout of the state’s cannabis program, the NMHA expressly requires DORA to prioritize equity and inclusivity as it establishes rules to implement the NMHA program. Specifically, DORA is required to adopt rules which: (i) establish procedures, policies and programs to ensure the NMHA program is equitable and inclusive; (ii) promote the licensing of and provision of natural medicine services to (a) persons from communities that have been disproportionally harmed by high rates of controlled substances (including cannabis); (b) persons who face barriers to access to health care; (c) persons who have traditional or indigenous history with natural medicines; and (d) persons who are veterans by, offering, at a minimum reduced fees for licensure and training, incentivizing the provision of natural medicine services at a reduced cost to low income individuals, and incentivizing geographic and cultural diversity in licensing and the provision of and availability of natural medicine services.

In addition, DORA is prohibited from imposing unreasonable financial or logistical barriers that would prevent individuals with lower income from applying for a license and individuals are limited to having a financial interest in five healing centers. Currently, the definition of “individuals” does not include corporations. However, DORA could establish a rule which includes corporations in this limitation and would arguably level the playing field in this budding market.

We will continue to monitor developments and closely follow the rulemaking process as Colorado designs and implements this historical new program.

Article By Lauren P. Carboni of Foley & Lardner LLP

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

© 2022 Foley & Lardner LLP

Comparison of Three Federal Fraud and Abuse Laws

In the post-COVID era, health care fraud and abuse issues will be aggressively and swiftly enforced by the government. The legal framework and regulations in the health care space can be intimidating. Below is a comparison of three of the big federal fraud and abuse laws that the government actively enforces; but they are not an exclusive list.  The summary below is a primer on the three main federal fraud and abuse laws and is intended to increase your basic understanding of these laws.

False Claims Act (FCA)

PROHIBITIONS:

  • Prohibits the submission of false or fraudulent claims, false statements material to a false claim, and conspiracy to commit violation
  • Prohibits concealing or avoiding obligation to repay money to government (failure to return overpayments)
  • Claims that violate AKS or Stark can also be considered false claims
  • Common false claims include lack of medical necessity; quality of care; billing/coding issues; off-labeled marketing; retention of overpayments

EXCEPTIONS:

  • n/a

PENALTIES:

  • Treble damages and as of May 9, 2022 per claim penalties between $12,537 and $25,076
  • Regulated by the DOJ

Physician Self-Referral (Stark)

PROHIBITIONS:

  • Prohibits referrals of designated health services by a physician (or an immediate family member) if the physician has a financial relationship with the entity performing the designated health service
  • Regulates financial relationships with physicians (and physician’s immediate family members) only

EXCEPTIONS:

  • The arrangement must completely satisfy an exception or it violates the Stark law

PENALTIES:

  • No criminal enforcement; CMP enforcement for knowing violations: per violation penalties– 3x claims and/or per circumvention scheme penalties; Nonpayment of claims arising from prohibited arrangement; Recoupment of amounts received; Exclusion from federal health programs; FCA liability
  • Regulated by CMS

Anti-Kickback Statute (AKS)

PROHIBITIONS:

  • Prohibits offers of, solicitation of, or payment or receipt of remuneration intended to induce referrals for health care services covered by a government program
  • Covers provision of anything of value to a person who refers, orders/purchases or recommends

EXCEPTIONS:

  • Voluntary safe harbors exist, but arrangements are not required to fit within a safe harbors

PENALTIES:

  • Applies to either party involved in an arrangement that violates AKS; Criminal penalties $100,000 /violation, up to 10 years imprisonment); Civil penalties (CMP3x unlawful remuneration and $100,000/violation); Exclusion from federal health programs; FCA liability
  • Regulated by the OIG

Providers should also be aware of other enforcement statutes such as the Eliminating Kickbacks in Recovery (“EKRA”), the Civil Monetary Penalties Act (“CMP”), and the Travel Act, to name a few, in addition to being well versed in the relevant state health care fraud and abuse frameworks.

Article By Courtney G. Tito of Nelson Mullins

For more criminal law and business crimes legal news, click here to visit the National Law Review.

Copyright ©2022 Nelson Mullins Riley & Scarborough LLP

Five States Put Abortion Questions on the Ballot; Health Care and Other Employers Should Stay Tuned

In the wake of the landmark decision in Dobbs v. Jackson Women’s Health Organization, we have been closely monitoring legal developments across the country. In addition to well publicized “trigger laws” that were effectuated as a result of the U.S. Supreme Court’s order, states have taken up a variety of legislative actions in response to the ruling, which placed authority for the regulation of abortion with the states.

On Election Day, five states will have voters consider various proposals in light of Dobbs and its directive that abortion law belongs with the people. Here is a run-down of abortion-related ballot initiatives that will be put to a popular vote on November 8, 2022.

A Constitutional Amendment for California

On the ballot in California is Proposition 1: Constitutional Right to Reproductive Freedom, which would amend the state Constitution at Article I, Section 1.1, to provide that the state cannot “deny or interfere with an individual’s reproductive freedom in their most intimate decisions, which includes their fundamental right to choose to have an abortion and their fundamental right to choose or refuse contraceptives.” Any amendment to the California Constitution requires a simple majority of voters. If the amendment is passed, changes take effect the fifth day after the Secretary of State files the statement of the vote for the election.

Should Proposition 1 pass, it would add express protection for reproductive freedom, including decisions about abortion and contraception, to the state constitution, under its existing guaranteed right to privacy. If the proposition does not pass, it will not affect the status quo of reproductive rights in California: while current protections for abortion and other reproductive medical care would not be constitutionally guaranteed, they would remain in place under state law.

California currently has strong protections for the right to abortion, generally only prohibiting abortion at viability. Since the Dobbs decision earlier this year, California has promoted access to abortion, including launching abortion.ca.gov, a website dedicated towards providing information on reproductive health care services to people both inside and outside of California. Recently, in late September, Governor Gavin Newsom signed a package of 12 bills of abortion protections, aimed towards improving access to abortion and protecting patients and clinicians who undergo or provide them.

With the backdrop of an already-strong California legal reproductive health network, consistent polling indicates the ballot measure is expected to pass by a wide margin. Passage of the proposition will likely signal and establish the state as a refuge for individuals from more restrictive states seeking abortions.

Michigan May Modify its Constitution, Too

Michigan will also turn to its voters to decide whether its state constitution should be amended to include protections for abortion. The Michigan proposal, referred to as “Proposal 3 of 2022 – ‘Reproductive Freedom for All’ Petition,” seeks to protect the right to an abortion with a constitutional amendment that declares a right to reproductive freedom. The petition sets forth proposed language for a new section of the Michigan Constitution, stating, in part, that “[e]very individual has a fundamental right to reproductive freedom, which entails the right to make and effectuate decisions about all matters relating to pregnancy, including but not limited to prenatal care, childbirth, postpartum care, contraception, sterilization, abortion care, miscarriage management, and infertility care.”

Proposal 3 would take effect 45 days following the ballot initiative if approved by the majority of voters. It would (1) establish new individual rights to reproductive freedom, to broadly include the right to make and carry out all decisions relating to pregnancy; (2) permit state regulation of abortion in limited circumstances; (3) forbid discrimination in enforcement of reproductive rights; (4) prohibit adverse action by the state with respect to “potential, perceived, or alleged pregnancy outcomes;” and (5) invalidate state laws that conflict with the Constitution as amended by Proposal 3.

If Proposal 3 is not passed and the state constitution remains as is, the future of the right to an abortion in Michigan will be unclear. Michigan has a pre-Roe ban that, if enforced, would prohibit abortion in nearly all situations and make abortions in non-life saving circumstances potentially prosecuted as manslaughter. However, a Michigan Court of Claims judge granted a permanent injunction in Governor Gretchen Whitmer’s suit to block local prosecutors from enforcing the ban. The ban is subject to an ongoing lawsuit.

Given the uncertainty of the ballot initiative’s outcome, Michigan employers should closely monitor the results of the November 8, 2022 vote.

Vermont’s Vote

In Vermont, abortion remains legal after Dobbs under state law. However, on November 8, 2022, voters will have the opportunity to further protect abortion rights through a ballot initiative. This initiative, referred to as Proposal 5, asks registered Vermont voters whether they are in favor of amending the state’s constitution to add the following language: “That an individual’s right to personal reproductive autonomy is central to the liberty and dignity to determine one’s own life course and shall not be denied or infringed unless justified by a compelling State interest achieved by the least restrictive means.” Passage would guarantee the right to access and obtain an abortion as well as other reproductive care, and prohibit government infringement of reproductive rights absent a compelling state interest, which would need to be achieved through the least restrictive means.

Should Proposal 5 pass, the resulting constitutional amendment is not expected to significantly alter the legal landscape of abortion in Vermont, which currently has strong protection for the right to abortion. If approved, the amendment will become part of Vermont’s constitution on November 22, 2022.

In Contrast, Kentucky Seeks to Constitutionally Exclude Abortion Rights

Kentuckians will cast their votes deciding whether to amend the state’s constitution to explicitly provide that the state constitution offers no protection for a right to abortion. The proposal further clarifies that there is no constitutional right to use public funds for abortion. “Constitutional Amendment 2” poses the following question to voters: “Are you in favor of amending the Constitution of Kentucky by creating a new Section of the Constitution to be numbered Section 26A to state as follows: ‘To protect human life, nothing in this Constitution shall be construed to secure or protect a right to abortion or require the funding of abortion?’”

If the majority of votes are affirmative, a new section will be added to Kentucky’s constitution. This does not constitute an outright abortion ban, but rather prohibits courts from finding an implicit right to an abortion within the state’s constitution. Kentucky laws restricting abortion, including those triggered by Dobbs, are among the most restrictive in the nation. Approval of Constitutional Amendment 2 would not alter these laws or their existing narrow exceptions, which permit the procedure only when necessary to preserve the health or life of the mother.

An advisory from the Kentucky Attorney General provides further color on the ramifications of the amendment, noting that Amendment 2 does not ban abortion, but rather ensures that elected officials of Kentucky’s General Assembly, and not courts, would regulate abortion. The Advisory also explains that implementation of Amendment 2 would not amend other provisions in the state’s constitution.

Montana’s Ballot – NOT a Proposed Constitutional Amendment

Abortion is currently legal in Montana, as a 1999 Supreme Court ruling held that the state constitution protects abortion under its right-of-privacy provision. However, in 2021, a number of restrictive abortion laws were enacted, including a law that prohibits abortions after 20 weeks. These laws are under legal challenge by abortion providers and are temporarily enjoined pending litigation.

Meanwhile, on the ballot for November 8 is a referendum on LR-131, also known as the Born Alive Infant Protection Act. The Act proposes a new statute that would classify any infant born alive as “a legal person” and require the provision of “medically appropriate and reasonable care” to such person. This would include all infants born alive from an induced labor, C-section, or attempted abortion. The Act also includes a provision mandating providers, employees, and volunteers to report a failure to comply to law enforcement, and sets forth criminal penalties. Violation of this law would be a felony with a maximum sentence of 20 years in prison or a fine of up to $50,000. The proposed law is aimed at health care workers, and does not impose liability on parents or other parties.

Health care providers have raised concerns that the broad language of the bill could lead to unintended consequences, particularly for OB/GYN practitioners. Health care providers would be required to take “medically appropriate and reasonable care” to keep any infant alive, but these terms are not defined in the bill. Health care workers that could be held liable include doctors, nurses, and “any individual who may be asked to participate in any way in a health care service of procedure.”

If approved by the Montana electorate, the law would take effect on January 1, 2023. Hospitals and other health care providers would need to reexamine their operating procedures to comply with the bill, should it pass, including compliance with the mandatory reporting requirement.

Keeping Up With The Changes

We continue to track litigation, legislative developments, and the entirety of the post-Dobbs legal landscape as it continues to shift. Our 50-state survey and other resources provide employers, health care providers, life sciences stakeholders, and others impacted by these rapidly changing circumstances with in-depth analysis and monthly updates. Election Day results will be another element of this evolving story.

Article By Susan Gross Sholinsky, Amy K. Dow, and Catherine Kang of Epstein Becker & Green, P.C.

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

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

EPA’s Contaminant List Includes All PFAS

We previously reported on the EPA’s announcement for its Draft Fifth Contaminant Candidate List (CCL 5), which contemplated listing all PFAS as an entire class on the Contaminant List. On October 28, 2022, the EPA issued its prepublication version of the final CCL 5 rule. The EPA’s contaminant list final version is the first step in the Safe Drinking Water Act regulatory process, which will allow the EPA to begin its assessment into any of the over 12,000 PFAS as to whether they should be included in a drinking water enforceable limit. Such a move would build upon the EPA’s current progress towards regulating PFOA and PFOS with an enforceable drinking water limit, and open the door to significant future enforcement action and litigation.

EPA’s Contaminant List and PFAS

On October 28, 2022, the EPA announced its Final Fifth Contaminant Candidate List (CCL 5). The CCL is a list of contaminants that are currently not subject to any proposed or promulgated national primary drinking water regulations, but are known or anticipated to occur in public water systems. Contaminants listed on the CCL may require future regulation under the Safe Drinking Water Act (SDWA). On the CCL 5 are 66 individual chemicals, but notably PFAS as an entire class are also listed on the CCL 5. Simply because PFAS are listed on the CCL 5 does not guarantee that regulation will occur; however, it does open doors to research that are not otherwise available without the listing on the CCL.

The EPA’s contaminant list rule is not the only step the agency has taken with respect to PFAS and drinking water, but developing the CCL is the first step under the Safe Drinking Water Act (SDWA) in potentially regulating drinking water contaminants. SDWA requires EPA to publish a list of currently unregulated contaminants that are known or anticipated to occur in public water systems and that may require regulation. EPA must publish a CCL every five years. The CCL does not create or impose regulatory burden on public water systems or state, local, or Tribal governments. EPA has completed four rounds of CCLs since 1996. The last cycle of CCL, CCL 4, was published in November 2016. EPA began the development of the CCL 5 in 2018 by asking the public to nominate chemicals, microbes, or other materials for consideration for the CCL 5.

Impact On Businesses and Litigation

Many companies assume that any regulation under the Safe Drinking Water Act will not impact them, as virtually no industries, aside from water utilities, have any direct impact on drinking water. However, this belief provides a false sense of security that must immediately be dispelled. There are three specific ways that drinking water limits for PFAS will trigger scrutiny on environmental practices of businesses: (1) elffluent discharges into water sources; (2) waste sent to landfills that may leach into drinking water sources; and (3) properties abutting or in the vicinity of water sources.

Direct industry effluent discharges into water sources (which may not be drinking water sources, but may feed into drinking water sources) will be the low-hanging fruit target for local environmental agencies at the state level. Companies must ensure that they have all permitting in order, and it is advisable that the permitting specifically encompasses PFAS. Failing to do so will cause issues down the line when local environmental regulatory bodies look to determine, even retroactively, who PFAS water polluters are or were, as those agencies seek to hold businesses responsible for the costs associated with cleaning up PFAS in drinking water.

Companies that send their industrial waste to landfills are also well advised to do a full compliance check. While many companies do not use PFAS directly in their own manufacturing processes, do the parts or other raw materials used in the manufacturing process have PFAS contamination issues? If so, a company could unknowingly send PFAS-laden industrial waste products to landfills, and so these are questions that companies must get answers to. Over time, it is possible that the PFAS may leach out of the landfill and find their way into local water sources. Environmental regulatory agencies will look to these sites, the owners of the sites, and potentially companies sending waste to the sites as responsible parties for PFAS contamination in waterways.

Finally, even businesses having nothing to do with PFAS or manufacturing from which PFAS could be a contaminant need to follow news regarding PFAS regulations. For example, has the property on which your business sits ever had fires that have required a local fire department to extinguish flames using foam (historically, a PFAS containing product)? What did the owner of the site prior to you use the site for? Were there possible PFAS contamination issues stemming from that prior business? Did your due diligence reports and tests when purchasing the property take PFAS into consideration? If PFAS were a contaminant on the land on which your business now operates, local environmental agencies will pursue cleanup costs from any such business regardless of knowledge or intent, and regardless of whether the PFAS issues were the result of a prior company on the site. These investigations and remediations can be extremely expensive and disruptive to businesses.

Should the EPA broaden its regulations for PFAS in drinking water to include more than PFOA and PFOS, this will trigger considerable enforcement action at the state level to identify responsible parties and ensure that the parties pay for remediation costs. Historically, this has also led to civil litigation, as companies identified as responsible parties litigate the percent allocation that they are responsible for the alleged pollution, and look to bring in additional companies to reduce allocation shares for remediation costs.

Conclusion

Future regulatory steps for certain PFAS under the Safe Drinking Water Act will require states to act (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. 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.

The Evolving New York City Workplace: Two Important Updates Effective November 1st

Two important measures impacting New York City employers will be effective on November 1, 2022. The first measure is Mayor Adams’ lifting of the COVID-19 vaccine requirement for private employers, which was implemented by his predecessor Mayor de Blasio shortly before he left office. The second measure is New York City’s new “pay transparency” law, which continues the city’s aggressive efforts to eradicate pay disparity and requires employers to immediately review and update their hiring practices.

Vaccine Mandate Lifted

The New York City COVID-19 vaccine mandate, which became effective on December 27, 2021, mandated all New York City private employers to require that all in-person employees be vaccinated against COVID-19, subject only to approved religious and medical exemptions. Effective November 1, 2022, this vaccine mandate will be lifted.

Going forward, New York City employers retain the right to implement their own vaccination policies. New York City employers may lift the requirement and allow employees who are not vaccinated to return to work on site. Alternately, employers may continue to require the COVID-19 vaccine for in-person staff, in which case such employer mandatory vaccination policies must still provide for medical or religious exemptions consistent with applicable laws.

Pay Transparency

Following a recent national trend, New York City continues to aggressively regulate pay equity by amending the New York City Human Rights Law (“NYCHRL”) to implement “pay transparency” requirements. The law also contains an anti-retaliation provision. The New York City pay transparency law applies to employers with four or more employees (or one or more domestic workers) and employment agencies of any size. The new law does not apply to temporary help firms seeking applicants to join their pool of available workers.

Going forward, covered entities must include the minimum and maximum annual base salary or hourly range of compensation that the employer believes in good faith to be accurate at the time in any advertisement for a job, promotion or transfer opportunity that can or will be performed, in whole or part, in New York City.  While the statutory language is sparse, and regulations have not yet been issued, according to a Fact Sheet published by the New York City Commission on Human Rights (“Commission”) (https://f.datasrvr.com/fr1/622/87383/Salary-Transparency-Factsheet.pdf?cbcachex=897118), an “advertisement” is defined broadly as a written description of an available job, promotion or transfer opportunity that is publicized to a pool of potential applicants, regardless of the medium, and includes postings on internal bulletin boards, internet advertisements, printed flyers at job fairs and newspaper advertisements. The requirement applies when advertising for full-time or part-time employees, interns, domestic workers or independent contractors. The law does not prohibit employers from hiring without using an advertisement or require employers to create an advertisement in order to hire.

According to the Fact Sheet, employers must include both a minimum and maximum salary, and the salary range cannot be open-ended. However, note that “salary” does not include other forms of compensation or benefits offered, including overtime, commissions, tips, bonuses or stock. For example, “$15 per hour and up” or “maximum $50,000 per year” would not be consistent with the new New York City requirements. Further, an advertisement that solely provides that a salary will be commensurate “with experience” also would appear to be inconsistent with the new law.

The Commission investigates complaints of discrimination, as well as the new salary transparency protections. Employers and employment agencies who are found to have violated the NYCHRL may have to pay monetary damages to affected employees, amend advertisements and postings, create or update policies, conduct training, provide notices of rights to employees or applicants and engage in other forms of affirmative relief. According to the Fact Sheet, the Commission will not assess a civil penalty for the first complaint alleging violation of the salary transparency provision, provided that the employer shows that it has fixed the violation within 30 days.

Notably, New York State lawmakers have also passed a similar pay transparency bill, which is currently pending Governor Hochul’s signature and would go into effect 270 days after it is signed into law. The New York State bill, if it is enacted in its current form, will be potentially broader in its application, such as requiring provision of a job description for the position, if one exists.

It is also important to note that prior recent measures adopted by New York State and/or New York City to ensure non-discriminatory hiring practices and equal employment opportunities include regulations prohibiting employers from asking candidates about their prior salary history, pay equity provisions requiring equal pay for the same or substantially similar work, and stringent limitations on criminal history inquiries.

Takeaways

New York City continues to be at the forefront of enacting employment legislation to protect the rights of employees and applicants. It is critical for New York City employers to be vigilant to ensure compliance with the ever-changing legal requirements, including those relating to COVID-19, and to implement appropriate policies and practices.

With regard to the new pay transparency law, it is important for employers to promptly assess their pay practices, ensure that pay ranges are appropriate and equitable, consider documenting the applicable factors that were considered in reaching the salary decision, review job descriptions and ensure that advertising complies with the new requirements (including online recruitment sites).

For more Labor and Employment Law news, click here to visit the National Law Review.

© Copyright 2022 Sills Cummis & Gross P.C.