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.

© 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.

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.

©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.

©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.

Buying, Selling, and Investing in Telehealth Companies: Navigating Structural and Compliance Issues

A multi-part series highlighting the unique health regulatory aspects of Telemedicine mergers and acquisitions, and financing transactions

Investors in the telehealth space and buyers and sellers of telehealth companies need to account for a set of health regulatory considerations that are unique to deals in this sector. As all parties to potential telehealth transactions analyze their long term role in the telehealth marketplace, two of the central issues to any transaction are compliance and structure – both in terms of structuring the telehealth transaction itself and due diligence issues that arise related to a target’s structure.

The COVID-19 pandemic, combined with strained health care staffing and provider availability, have accelerated the growth of the telehealth, and start-ups and traditional health systems alike are competing for access to patient populations in the telehealth space. However, as we adjust to life with COVID-19 as the norm, the expiration of the federal Public Health Emergency (PHE) looms, and the national economy contracts, we expect that the remainder of 2022 and into 2023 will see consolidation as the telehealth market begins to saturate and the long-term viability of certain platforms are tested. Telehealth companies, health systems, pharma companies and investors are all in potential positions to take advantage of this consolidation in a ripening M&A sector (while startups in the telehealth space continue to seek venture and institutional capital).

This is the first post in a series highlighting the unique health regulatory aspects of telehealth transactions. Future installments of this series are expected to cover licensure and regulatory approvals, compliance / clinical delivery models, and future market developments.

Telehealth Transaction Structure Considerations

The structure of any given telehealth transaction will largely depend on the business of the telehealth organization at play, but also will depend on the acquirer / investor. Regardless of whether a party is buying, selling or investing in a telehealth company, structuring the transaction appropriately will be important for all parties involved. While a standard stock purchase, asset purchase or merger may make sense for many of these transactions, we have also seen a proliferation of, affiliation arrangements, joint ventures (JV), alliances and partnerships.  These varieties of affiliation transactions can be a good choice for health systems that are not necessarily looking to manage or develop an existing platform, but instead are looking to leverage their patient populations and resources to partner with an existing technology platform. An affiliation or JV is more popular for telehealth companies operating purely as a technology platform (with no core business involving clinical services being provided). For parties in the traditional healthcare provider sector that provide clinical services, an affiliation or JV, which is easier to unwind or terminate than a traditional M&A transaction, can allow the parties to “test the waters” in a new, combined business venture. The affiliation or JV can take a variety of forms, including technology licensing agreements; the creation of a new entity to house the telehealth mission, which then has contractual arrangements with the both the JV parties; and exclusivity arrangements relating to use of the technology and access to patient populations.

While an affiliation or JV offers flexibility, can minimize the need for a large upfront investment, and can be an attractive alternative to a more permanent purchase or sale, there can be increased regulatory risk. Entrepreneurs, investors, and providers considering any such arrangement should bear in mind that in the wake of the COVID-19 pandemic and proliferation of telehealth, the Office of Inspector General of the Department of Health and Human Services (HHS-OIG) has expressed a heightened interest in investigating so called “telefraud” and recently issued a special fraud alert regarding suspect arrangements, discussed in this prior post. Further, the OIG’s guidance on contractual joint ventures that would run afoul of the federal Anti-Kickback Statute (AKS) should be front of mind and parties should strive to structure any affiliation or JV in a manner that meets or approximates an AKS safe harbor.

Target Telehealth Company Structure Compliance

Where telehealth companies are providing clinical services, and are not purely technology platforms, structuring and transaction diligence should focus on whether the target is operating in compliance with corporate practice of medicine (CPOM) laws. The CPOM doctrine is intended to maintain the independence of physician decision-making and reduce a “profits over people” mentality, and prevent physician employment by a lay-owned corporation unless an exception applies. Most states that have adopted CPOM impose similar restrictions on other types of clinical professionals, such as nurses, physical therapists, social workers, and psychologists. Telehealth companies often attempt to utilize a so-called “friendly PC” structure to comply with CPOM, whereby an investor-owned management services organization (“MSO”) affiliates with a physician-owned professional corporation (or other type of professional entity) (a “PC”) through a series of contractual agreements that foster a close working relationship between the MSO, PC, and PC owner and whereby the MSO provides management services, and sometimes start-up financing. The overall arrangement is intended to allow the MSO to handle the management side of the PC’s operations without impeding the professional judgment of the PC or the medical practice of its physicians and the PC owner.

CPOM Compliance Considerations and Diligence for Telehealth Companies

A sophisticated buyer will want to confirm that the target’s friendly PC structure is not only formally established, but is also operationalized properly and in a manner that minimizes fraud and abuse risk. If CPOM compliance gaps are identified in diligence this may, at worst, tank the deal and, at best, cause unexpected delays in the transaction timeline, as restructuring may be required or advisable. The buyer may also request additional deal concessions, such as a purchase price reduction and special indemnification coverage (with potentially a higher liability limit and an escrow as security). Accordingly, a telehealth company anticipating a sale or fund raise would be well served to engage in a self-audit to identify any CPOM compliance issues and undertake necessary corrective actions prior to the commencement of a transaction process.

Below are nine key questions with respect to CPOM compliance and related fraud and abuse issues that a buyer/investor in a telehealth transaction should examine carefully (and that the target should be prepared to answer):

  1. Does target have a PC that is properly incorporated or foreign qualified in all states where clinical services are provided (based on the location of the patient)?
  2. Does the PC owner (and any directors and officers of the PC, to the extent different from the PC owner) have a medical license in all states where the PC conducts business (to the extent in-state licensure is required)? To the extent the PC has multiple physician owners and directors/officers, are all such individuals licensed as required under applicable state law?
  3. Does the PC(s) have its own federal employer identification number, bank account (including double lockbox arrangement if enrolled in federal healthcare programs), and Medicare/Medicaid enrollments?
  4. Does the PC owner exercise meaningful oversight and control over the governance and clinical activities of the PC? Does the PC owner have background and expertise relevant to the business (e.g., a cardiologist would not have appropriate experience to be the PC owner of a PC that provides telemental health services)?
  5. Are the physicians and other professionals providing clinical services for the business employed or contracted through a PC (rather than the MSO)? Employment or independent contractor agreements should be reviewed, as well as W-2s, and payroll accounts.
  6. Is the PC properly contracted with customers (to the extent services are provided on a B2B basis) and payors?
  7. Do the contractual agreements between the MSO and PC respect the independent clinical judgment of the PC owner and PC physicians and otherwise comply with state CPOM laws.
  8. Do the financial arrangements between the MSO, PC, and PC owner comply with AKS, the federal Stark Law, and corollary state laws and fee-splitting prohibitions, to the extent applicable?
  9. Is the PC owner or any other physician performing clinical services for the PC an equity holder in the MSO? If so, are these equity interests tied to volume/value of referrals to the PC or MSO (i.e., if the MSO provides ancillary services such as lab or prescription drugs) or could equity interests be construed as an improper incentive to generate healthcare business (e.g., warrants that can only be exercised upon attainment of certain volume)?

Telehealth companies considering a sale or financing transaction, and potential buyers and investors, would be well served to spend time on the front end of a potential transaction assessing the above issues to determine potential risk areas that could impact deal terms or necessitate any friendly PC structuring.

© 2022 Foley & Lardner LLP

Feds Announce More Aggressive Enforcement of Poor Performing Nursing Homes

In February of 2022, during his State of the Union Address, President Biden announced an action plan to improve the safety and quality of care in the nation’s nursing homes.[i] On October 21, 2022, Centers for Medicare and Medicaid Services (CMS) announced new requirements to help with oversight of facilities selected to the Special Focus Facilities (SFF) Program.[ii]

The SFF Program was created to help and oversee the poorest performing nursing homes in the country and improve nursing homes that have a history of noncompliance.  The goal is to improve safety and quality of care. The facilities selected for the SFF Program must be inspected no less than once every six months and if severe enforcement is needed, it is at the discretion of the state surveyors. The main objective for the SFF Program is for facilities to show exponential improvement, graduate from the program, and then maintain compliance and better quality of care and safety.

The new CMS requirements, outlined below, are aimed at facilities that continuously fail to improve and remain in the SFF Program for a prolonged period of time. Health and Human Services Secretary Xavier Becerra stated, “Let us be clear: we are cracking down on enforcement of our nation’s poorest-performing nursing homes. As President Biden directed, we are increasing scrutiny and taking aggressive action to ensure everyone living in nursing homes gets the high-quality care they deserve. We are demanding better because our seniors deserve better.”

CMS announced the following revisions to the SFF Program:

  • Effective immediately, CMS will use escalating penalties for violations for deficiencies cited at the same level in subsequent surveys. This can include possible discretionary termination from Medicare and/or Medicaid funding for facilities that are cited with immediate jeopardy deficiencies on any two surveys while participating the in the SFF Program.
  • CMS will consider facilities’ efforts to improve when considering discretionary termination from Medicare and/or Medicaid programs.
  • CMS will impose more severe escalating enforcement remedies for SFF Program facilities for noncompliance and no effort to improve performance.
  • Increased requirements that nursing homes in the SFF Program must meet to graduate from the SFF Program.
  • For three years after graduation from the SFF Program, CMS will ensure nursing homes consistently maintain compliance with safety requirements by continuing to closely monitor these facilities.
  • CMS is offering more support resources to facilities selected for the SFF Program.

Additionally, the Biden administration released a fact sheet with the steps they are taking to in improve the quality of nursing homes. [iii] Some of the steps mentioned include more resources to support union jobs in nursing home care, establishing minimum staffing requirements, incentivizing quality performance through Medicare and Medicaid funding, and enhanced efforts to prevent fraud and abuse.


  1. https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/28/…
  2. https://www.cms.gov/files/document/qso-23-01-nh.pdf
  3. https://www.whitehouse.gov/briefing-room/statements-releases/2022/10/21/…

Article By Thomas W. Hess, Kelly A. Leahy, Sydney N. Pahren, and Bryan L. Cockroft of Dinsmore & Shohl LLP

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

© 2022 Dinsmore & Shohl LLP. All rights reserved.

Fair Market Value Defensibility Analysis: Why is It Different from a Fair Market Value Opinion?

Fair market value is a pinnacle issue for compliance under the Stark Law and Anti-Kickback Statute. Compensation arrangements that are required to be representative of fair market value under Stark/AKS include employment, independent contractor, medical directorships, exclusive service arrangements, call coverage, quality reviews, medical staff officer stipends, etc.

Many consulting firms provide fair market value opinions relying extensively on the application of benchmark data. Based upon CMS’s statements in the Stark Law Final Rules, although application of benchmark data is a resource that can be utilized, fair market value can and should include the application of market/service area issues (i.e., deficiency of specialty) or physician-specific issues (i.e., expertise, productivity).

Commercial reasonableness is a separate concept from fair market value under Stark/AKS. Commercial reasonableness also entails whether the application of benchmark/market factors are defensible.

When analyzing the defensibility of compensation arrangements, it is important to view fair market value and commercial reasonableness as if advocating the facts and circumstances of the proposed compensation arrangement before a governmental entity (i.e., CMS, OIG, DOJ). When an attorney is rendering a fair market value defensibility analysis, not only will the analysis be protected under the attorney-client privilege, but the analysis will also include references and attachments to all of the applicable documentation and relevant information in case the compensation arrangement is ever required to be defended.

Copyright ©2022 Nelson Mullins Riley & Scarborough LLP

FDA Updates Regulatory Definition of “Healthy” for the First Time Since 1994

The U.S. Food and Drug Administration (FDA) has issued a proposed rule (“Proposed Rule”)[1] that updates the definition of the “healthy” nutrient content claim under 21 C.F.R. § 101.65(d) for the first time since its issuance in 1994. The Proposed Rule, published on September 29, 2022, notes that “nutrition science has evolved since the 1990s” and that the proposed changes are intended to make the regulation “consistent with current nutrition science and Federal dietary guidance.”[2]

FDA is accepting comments until December 28, 2022.  Stakeholders should note that the proposed amendments may require companies to remove “healthy” claims from current labels and may make new products eligible to bear “healthy” claims. The comment period affords impacted companies the opportunity to provide FDA with input that could modify the current Proposed Rule. K&L Gates’ FDA team can assist clients with submitting comments and with assessing the impact of the Proposed Rule.

Highlights of the Proposed Rule

The changes in the Proposed Rule align with the FDA’s 2016 changes to the nutrition labeling regulation at 21 C.F.R. § 101.9,[3] primarily by refocusing the attention from limiting fat to limiting sugar intake.  The proposal also addresses several areas to make the regulation more consistent with current nutrition guidelines; for example, the Proposed Regulation would permit water, avocados, nuts, and seeds to bear the “healthy” claim, whereas products such as highly sweetened cereals would not be eligible for the claim.[4] 

Under the existing regulation,[5] a “healthy” food must meet certain criteria, including limits on total fat, saturated fat, cholesterol, and sodium, and minimum amounts (at least 10 percent of the Daily Value) of favorable nutrients (e.g., vitamin A, vitamin C, calcium, iron, protein, and dietary fiber).[6] In contrast, while continuing to place limits on the presence of certain nutrients (e.g., added sugar, sodium, saturated fat), the Proposed Rule’s updated “healthy” criteria take a very different approach to promoting the consumption of certain foods, consistent with the 2020-2025 Dietary Guidelines for Americans, through the new concept of “food group equivalents.” Specifically, to meet the proposed “healthy” claim criteria, a food would need to contain minimum amounts of one or more of the following food groups or subgroups: fruit, vegetables, grains, dairy, and protein foods. FDA’s proposed table of “food group equivalents” is reproduced below:

FDA Proposed Rule – Food Group Equivalents

Food Group Food Group Equivalent

Examples
Vegetable 1/2 cup equivalent vegetable 1/2 cup cooked green beans; 1 cup raw spinach
Fruit 1/2 cup equivalent fruit 1/2 cup strawberries; 1/2 cup 100% orange juice; 1/4 cup raisins
Grains No less than 3/4 oz. equivalent whole grain 1 slide of bread; 1/2 cup cooked brown rice
Dairy 3/4 cup equivalent dairy 6 oz. fat free yogurt; 1 1/8 oz. nonfat cheese
Protein foods 1 1/2 equivalent game meat, 1 oz. equivalent seafood, 1 oz. equivalent egg, 1 oz. equivalent beans, peas, or soy products, or 1 oz. equivalent nuts and seeds 1 1/2 oz. venison; 1 oz. tuna; 1 large egg; 1/4 cup black beans; 1/2 oz. walnuts

In a change from the current “healthy” regulation, the Proposed Rule distinguishes between undesirable fat (i.e., saturated fat) and desirable fats (i.e., monounsaturated and polyunsaturated fats) in the diet. In this regard, the Proposed Rule reflects the impact of the 2015 citizen petition submitted by KIND LLC (Docket No. FDA-2015-P-4564[7]), a manufacturer of sweetened nut snack bars, which requested that FDA accommodate “healthy” claims for products containing monounsaturated and polyunsaturated fats but that are not “low fat” as defined under 21 C.F.R. § 101.62(b)(2).  KIND filed its petition after receiving a warning letter from FDA in 2015, requesting that they remove the “healthy” claim from products due to disqualifying levels of fat from nut ingredients (e.g., almonds, peanuts).  In a press release issued with submission of its petition, KIND highlighted that the current “healthy” regulation permits products like fat-free chocolate pudding, sweetened cereals, and toaster pastries to qualify as “healthy,” whereas foods like almonds, avocados, and salmon were ineligible due to their fat content.[8] In response to KIND’s petition, FDA had been exercising enforcement discretion since September 2016 for certain products not low in fat but that contain predominantly mono and polyunsaturated fats.[9]

Under the Proposed Rule, FDA has eliminated total fat and cholesterol from consideration for “healthy” claims.  Also, while a food product must adhere to limits for added sugars, saturated fat, and sodium, limits on unfavorable nutrients are no longer keyed to compliance with other nutrient content claim regulations (e.g., meeting the definition of “low saturated fat” under 21 C.F.R. § 101.62(c)(2)). The Proposed Rule expresses disqualifying levels for unfavorable nutrients as percentages of daily values under 21 C.F.R. § 101.9.

FDA summarizes the criteria for “healthy” claims by product type below.  Unlike the current regulation, the Proposed Rule would specifically allow all raw whole fruits and vegetables to qualify for the “healthy” claim because of their positive contribution to an overall healthy diet, as well as to allow water to bear the “healthy” claim:

FDA Proposed Rule – Eligible Products for “Healthy” Nutrient Content Claim

Product Criteria for bearing “healthy” claim
Raw, whole fruits and vegetables No additional criteria; all raw, whole fruits and vegetables may bear the claim.
Individual food products At least 1 food group equivalent per RACC from 1 food group, and Nutrients to limit.
Mixed products At least 1/2 food group equivalent each from at least 2 different food groups, and Nutrients to limit.
Main dish as defined at 21 CFR 101.13(m) At least 1 food group equivalent each from at least 2 different food groups, and Nutrients to limit.
Meal as defined at 21 CFR 101.13(l) At least 1 food group equivalent each from at least 3 different food groups, and Nutrients to limit.
Water Plain water and plain, carbonated water may bear the claim.

This proposed rule is likely the first of many that will bring FDA’s nutrient content claim regulations in line with its 2016 revisions to the nutrition labeling regulation.  The comment period for the Proposed Rule closes on December 28, 2022; comments can be submitted at https://www.federalregister.gov/documents/2022/09/29/2022-20975/food-labeling-nutrient-content-claims-definition-of-term-healthy#open-comment.

For more Food and Drug Legal News, click here to visit the National Law Review.

Copyright 2022 K & L Gates.


FOOTNOTES

[1] 87 Fed. Reg. 59168 (Sept. 29, 2022), https://www.federalregister.gov/d/2022-20975.

[2] Id. at 59174.

[3] For more information, see FDA, Changes to the Nutrition Facts Labelhttps://www.fda.gov/food/food-labeling-nutrition/changes-nutrition-facts-label.

[4] Id.

[5] 21 C.F.R. 101.65(d).

[6] 87 FR 59168, at pg. 59172, https://www.federalregister.gov/d/2022-20975/p-57.

[7] The petition is available at https://s3.amazonaws.com/kind-docs/citizen-petition.pdf.

[8] See KIND, Seven Years After KIND’s Citizen Petition, FDA Proposes New Definition of “Healthy, Press Release,  https://www.kindsnacks.com/media-center/press-releases/KIND+Citizen+Petition+FDA+proposes+new+definition+of+healthy.html

[9] FDA, Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Productshttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-use-term-healthy-labeling-human-food-products