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 representing a Fortune 250 kidney care company and providers of radiology services. She also has experience in health care enforcement defense, supporting clients undergoing federal and state agency investigations. She regularly advises on health care regulatory topics, including telehealth, scope of practice, and the corporate practice of medicine. Additionally, she advises clients in the pharmaceutical and medical device industries on FDA regulatory and compliance matters.
Jean is a 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 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 earned a Master of Public Health through her law school’s joint-degree program.
viewpoints
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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New York Joins Other States with Health Care Transaction Review Laws
May 11, 2023 | Blog | By Jean D. Mancheno, Cody Keetch, Pamela Polevoy
On May 3, 2023, New York joined Connecticut, Delaware, Massachusetts, Nevada, New Jersey, Oregon, Rhode Island, Washington, and California in enacting legislation that increases oversight over certain health care transactions. Governor Kathy Hochul signed the Fiscal Year 2024 New York State Executive Budget (FY 24 Executive Budget) into law which enacted the final version of Article 45-A of the New York Public Health Law (PHL) titled “Disclosure of Material Transactions.” The law takes effect on August 1, 2023.
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Moving Towards MOCRA Implementation: FDA Announces Industry “Listening Session”
April 28, 2023 | Blog | By Joanne Hawana, Jean D. Mancheno
Since the late December 2022 seismic shift in the legal landscape for cosmetic companies – when Congress passed and President Biden signed the Modernization of Cosmetics Regulation Act, or MOCRA, into law (see our prior post here) – the Food and Drug Administration (FDA) has been relatively subdued in providing guidance to the affected industries regarding questions around “what happens next.” The most significant public announcements made by FDA since the law was passed are arguably that: (1) the voluntary cosmetic establishment registration program would be shuttered in favor of the yet-to-be-explained mandatory registration and listing system for cosmetic facilities; and (2) cosmetic manufacturers that want to report adverse events to the agency now should do so via the existing MedWatch program, which is currently used for drugs, biologics, and medical devices.
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The End of the Federal COVID-19 Public Health Emergency is Near: What to Expect as HHS Transitions beyond the Emergency Phase
April 27, 2023 | Blog | By Jean D. Mancheno, Sophia Temis
With less than two weeks left until the end of the federal COVID-19 Public Health Emergency (PHE), which is set to expire on May 11, 2023, the Department of Health and Human Services (HHS) is preparing to transition certain COVID-19 flexibilities. On February 9, 2023, HHS released a COVID-19 PHE Transition Roadmap, which provides guidance on what to expect beyond the emergency phase of the COVID-19 pandemic. While many of the relaxed rules and regulations that helped facilitate an efficient and timely response during the PHE have been permanently signed into law, others, some of which are discussed below, will soon expire.
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New York Proposes Regulatory Review and Approval of Material Health Care Entity Transactions
March 1, 2023 | Blog | By Jean D. Mancheno, Pamela Polevoy, Lara Compton
On February 1, 2023, New York Governor Kathy Hochul announced the Fiscal Year 2024 New York State Executive Budget (the Executive Budget). One component of the Executive Budget’s Health and Mental Hygiene Article VII Legislation is a proposal to require certain “health care entities” to obtain approval from the New York State Department of Health (DOH) prior to consummating a material transaction.
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Mintz Health Law: What We Are Grateful For
January 11, 2023 | Podcast | By Bridgette Keller
Bridgette Keller speaks with the Mintz Health Law team about what they are grateful for as they look back on a year of client service, mentorship, and working together as a team.
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Cosmetic Regulatory Reform Finally Becomes Law
January 3, 2023 | Blog | By Joanne Hawana, Jean D. Mancheno
As the 2022 calendar year ended, the Consolidated Appropriations Act, 2023 was signed into law by President Biden. The massive piece of legislation included the Modernization of Cosmetics Regulation Act of 2022 (MOCRA), comprising a long-awaited update to the nation’s cosmetic laws. MOCRA amends Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C Act). As noted by one of the bill’s co-sponsors, Senator Dianne Feinstein, after its passage, it finally brings the federal government’s “oversight tools” for cosmetics and personal care products “into the 21st century.”
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New Year, New Laws: Changes to New York Health Care Provider Staffing Laws Taking Effect in January 2023
November 30, 2022 | Blog | By Cody Keetch, Jean D. Mancheno
In this post, we summarize the reforms under Article 28 of the New York Public Health Law and changes to general hospital and nursing home staffing laws and discuss what these changes mean for both.
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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, 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.
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- Member, American Health Law Association
- Member, New York State Bar Association
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