Jean focuses her practice on health care transactional, regulatory, and enforcement defense matters. She represents a variety of clients across the health care industry, including hospitals, physician organizations, health care systems, and long-term and urgent care providers.
Jean’s health care industry transactions experience includes mergers and acquisitions, divestitures, joint ventures, and due diligence for health care providers and investors across the United States. Her recent transactional experience includes representing a Fortune 250 kidney care company, providers of radiology services, a private equity funded cardiology platform, and a national veterinary practice. She also has experience in health care enforcement defense, including supporting clients undergoing federal and state agency investigations, preparing self-disclosures to federal and state agencies, and conducting internal compliance investigations. She regularly advises on various health care regulatory topics, including telehealth, scope of practice, and the corporate practice of medicine. Additionally, she advises clients in the cosmetics, medical device, and pharmaceutical industries on FDA regulatory and compliance matters.
Jean maintains an active pro bono practice at Mintz. Recently, Jean succeeded on an appeal before an administrative law judge and secured social security benefits for her client. Jean is also Senior Fellow for the Gitenstein Institute of Health Law and Policy at the Maurice A. Deane School of Law at Hofstra University. She frequently speaks at Hofstra University events focused on building a career in health law and mentors law students interested in pursuing the field.
Prior to joining Mintz, Jean was an associate at a Long Island, New York-based boutique law firm that serves the health care industry, where she counseled clients on a broad range of health care compliance and health care litigation matters. During law school, Jean focused her professional and academic experiences on health law. She held legal internships at a national pediatric urgent care practice, a major nonprofit health care system in New York, and the Health Care Bureau of the New York State Attorney General’s Office. Upon law school graduation, she received the Excellence in Health Law Award and concurrently earned a Master of Public Health through her law school’s joint-degree program.
viewpoints
New York City's Health Care Price Transparency Law Takes Effect
February 29, 2024 | Blog | By Jean D. Mancheno, Cody Keetch
In summer of 2023, New York City Mayor Eric Adams signed Intro. 844-A (Local Law 844-A) and amended the New York City Charter. Local Law 844-A directs Mayor Adams to establish an Office of Healthcare Accountability that will serve to increase health care price transparency in New York City. Though health care price transparency laws have been enacted at the state level across the nation, New York City has become the first municipality in the nation to implement a price transparency law. Indeed, New York City Councilmember Julie Menin, who sponsored Local Law 844-A, emphasized “the positive impact of price transparency measures in other states, and it’s time for New York City to curb excessive health care prices” alongside other states during the bill’s signing ceremony. The law took effect on February 18, 2024.
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Safeguarding Reproductive Rights
February 23, 2024 | Article
Lawyers for Good Government, in partnership with the American College of Obstetricians and Gynecologists, initiated a vital project known as The Policy Resource Hub in 2022.
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Health Law Diagnosed — Mintz Health Law Team: Reflecting on What We Are Grateful For
February 5, 2024 | Podcast | By Bridgette Keller
As the Mintz Health Law team welcomes the beginning of 2024, many of its members take a moment to reflect on the exciting growth of the Health Law Practice, opportunities to partner with clients on complex legal issues, and the celebration of numerous milestones.
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Looking Back and Moving Forward: MoCRA Regulatory Developments Ring in the New Year
January 2, 2024 | Blog | By Madison Castle, Joanne Hawana, Jean D. Mancheno
A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation efforts steadily increased throughout the calendar year, as the December 29, 2023 compliance date for most MoCRA provisions approached, FDA’s release of information and deployment of new systems for the industry came to a climax. Several recent MoCRA-related developments will influence how cosmetic industry stakeholders, consumers, and even the FDA will approach and navigate the law’s requirements over the next year. In this blog post, we will discuss each of these developments and forecast the law’s future as we move into 2024.
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New York State Prepares to Regulate Hospital Cybersecurity Programs
November 28, 2023 | Blog | By Sophia Temis, Cody Keetch, Jean D. Mancheno
On November 13, 2023, Governor Kathy Hochul announced plans to regulate cybersecurity for New York general hospitals regulated under Article 28 of the Public Health Law. As proposed, the regulations will provide an additional level of security for hospitals, which have been increasingly targeted for cybersecurity scams and breaches. The proposed regulations would be additive to those requirements of the federal Health Insurance Portability and Accountability Act (HIPAA), which already includes a variety of requirements meant to safeguard Protected Health Information (PHI). Accompanying the proposed regulations, a $500 million dollar fund has been appropriated under Governor Hochul’s FY24 budget to assist hospitals in complying with the proposed cybersecurity regulations. The funds will be made available through a Health Care Technology Capital program, which will be established by the New York State Department of Health (DOH).
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FDA Delays Enforcement of MoCRA Facility Registration and Cosmetic Product Listing Requirements
November 13, 2023 | Blog | By Madison Castle, Jean D. Mancheno
Since the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law, cosmetics companies have spent the past year preparing to comply with its provisions. This includes the facility registration and cosmetic product listing requirements that have were mandated by Congress in the new law. Under MoCRA, the statutory deadline for meeting these foundational requirements is set at December 29, 2023 (one year after MoCRA’s enactment). However, on November 8, 2023, the Food and Drug Administration (FDA) issued Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (Compliance Guidance) and announced that enforcement of facility registration and cosmetic product listing requirements will be delayed six months.
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Connecticut Law Imposes New Requirements on Pharmaceutical Manufacturers, Defined to Include Device and Cosmetic Manufacturers, that Employ “Pharmaceutical Sales Representatives”
November 9, 2023 | Blog | By Joanne Hawana, Jean D. Mancheno
Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs pharmaceutical sales representatives (PSRs) is required to register with the Connecticut Department of Consumer Protection (Department) as a so-called “pharmaceutical marketing firm” (PMF). As discussed in our previous blog post, there are few jurisdictions in the United States that require registration or licensure of PSRs, and up until now, these obligations were placed on PSRs at the individual level. However, this new Connecticut law deviates from the typical regulatory scheme. In this post, we will provide an overview of the affirmative obligations that the Act imposes on PMs, PMFs, and PSRs and compare them to the laws, regulations, and ordinances of other United States jurisdictions.
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New York’s Office of the Medicaid Inspector General Creates Abbreviated Self-Disclosure Process
September 13, 2023 | Blog | By Jean D. Mancheno
On August 21, 2023, the New York State Office of the Medicaid Inspector General (OMIG) issued updated guidance regarding its Self-Disclosure Program (Updated Guidance). In the final days of 2022, New York’s Department of Social Services adopted revised regulations that set forth the requirements for participation in OMIG’s Self-Disclosure Program, as well as regulations regarding Medicaid fraud, waste, and abuse prevention, and Medicaid compliance programs. Since the enactment of these regulations, OMIG has promulgated several guidance documents, including in January 2023, when it first published guidance (Original Guidance) regarding the Self-Disclosure Program. In the Updated Guidance, which replaced the Original Guidance, OMIG announced its new Abbreviated Self-Disclosure Process (ASDP).
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FDA Publishes Draft Guidance on Cosmetic Product Facility Registration and Cosmetic Product Listing
August 9, 2023 | Blog | By Benjamin Zegarelli, Jean D. Mancheno
On August 7, 2023, the Food and Drug Administration (FDA) published Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (the Draft Guidance), which provides much-needed clarifications to the registration and listing requirements that will soon apply to cosmetics companies under the Modernization of Cosmetics Regulation Act (MoCRA), for review and public comment. MoCRA was signed into law in December 2022 (see our prior post here) and added significant new provisions on cosmetic products to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under Section 607 of the amended FD&C Act, facilities that manufacture or process a cosmetic product for distribution in the United States must register with FDA and submit a cosmetic product listing, and the Draft Guidance answers basic and essential questions about who must register and list, what information must be included, and how to submit information to FDA. This post summarizes key takeaways from the Draft Guidance and discusses its implications as the December 29, 2023 initial registration and listing deadline approaches.
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New York and Connecticut Increase Regulation Over Hospital and Health System Facility Fees
July 20, 2023 | Blog | By Jean D. Mancheno, Sophia Temis
Since the federal No Surprises Act took effect in January 2022, many pieces of legislation have been, and continue to be, geared toward promoting price transparency in health care. One such example is seen in the momentum of state legislative activity surrounding the billing of facility fees. These fees are typically charged to cover the overhead costs associated with the operation of a health care facility, such as payment of staff, maintenance of the facilities, and administrative costs. Patients, however, are often unaware that such costs will be factored into their medical bills. In response, New York and Connecticut, among other states, have recently enacted and expanded laws regulating facility fee billing.
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News & Press
MoCRA- Industry Must Prepare For Mandatory Adverse Event Reporting And Safety Substantiation Now: Expert
January 11, 2023
Mintz Member Joanne Hawana and Associate Jean Krebs were interviewed by CosmeticDesign about legal reform in the U.S. Food and Drug Administration.
Avoiding Pandemic Predicaments
May 1, 2021
Mintz Associate Jean Krebs co-authored an article published by Outpatient Surgery Magazine titled "Avoiding Pandemic Predicaments".
Racial Disparities in Payment Source of Opioid Use Disorder Treatment among Non-Incarcerated Justice-Involved Adults in the United States
February 1, 2020
Mintz Associate Jean Krebs co-authored an article published by the Journal of Mental Health Policy and Economics titled "Racial Disparities in Payment Source of Opioid Use Disorder Treatment among Non-Incarcerated Justice-Involved Adults in the United States".
Mintz Associated Jean Krebs authored an article published by Hofstra Law Review titled "Any Man Can Be A Father, But Should A Dead Man Be A Dad?: An Approach To The Formal Legalization Of Posthumous Sperm Retrieval And Posthumous Reproduction In The United States".
Publications
- Co-author, The Grocer Will Fill Your Order Now: Modernizing Online Food Shopping Becomes a Priority for Federal Agencies, Update Magazine (Fall 2023).
- Co-author, An Examination of State Trends in Facility Fee Legislation as New York’s Public Health Law § 2830 Takes Effect, New York State Bar Association’s Health Law Journal (September 2023)*
- Co-author, An Overview of the Office of Medicaid Inspector General’s Proposed Medicaid Fraud, Waste, and Abuse Prevention Regulations, New York State Bar Association’s Health Law Journal (January 2023)*
- Co-author, Avoiding Pandemic Predicaments, Outpatient Surgery Magazine (May 2021)
- Co-author, Racial Disparities in Payment Source of Opioid Use Disorder Treatment among Non-Incarcerated Justice-Involved Adults in the United States, Journal of Mental Health Policy and Economics (March 2020)
- Author, Any Man Can Be a Father, but Should a Dead Man Be a Dad?: An Approach to the Formal Legalization of Posthumous Sperm Retrieval and Posthumous Reproduction in the United States, Hofstra Law Review (Fall 2018)
*Reprinted with permission from the New York State Bar Association © 2023.
Read lessInvolvement
- Member, American Health Law Association
- Member, New York State Bar Association
- Member, New York State Bar Association Health Law Section Membership Committee
- Member, Food & Drug Law Institute’s New to FDA Law and Regulation Committee
Recent Insights
New York City's Health Care Price Transparency Law Takes Effect
February 29, 2024| Blog|
Safeguarding Reproductive Rights
February 23, 2024| Article|
