Skip to main content

Jeannie Mancheno

(she/her/hers)

Associate

[email protected]

+1.212.692.6847

Share:

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

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.
Read more
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.
Read more
Health Care Viewpoints Thumbnail
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).
Read more
Health Care Viewpoints Thumbnail
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.
Read more
Health Care Viewpoints Thumbnail
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.
Read more
Health Care Viewpoints Thumbnail
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).
Read more
Health Care Viewpoints Thumbnail
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.
Read more
Health Care Viewpoints Thumbnail
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.
Read more
Health Care Viewpoints Thumbnail
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.
Read more
Health Care Viewpoints Thumbnail
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.
Read more
Read less

News & Press

News Thumbnail
Mintz Member Joanne Hawana and Associate Jean Krebs were interviewed by CosmeticDesign about legal reform in the U.S. Food and Drug Administration.
News Thumbnail
Mintz Associate Jean Krebs co-authored an article published by Outpatient Surgery Magazine titled "Avoiding Pandemic Predicaments".
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".
News Thumbnail
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".
Read less

Publications

*Reprinted with permission from the New York State Bar Association © 2023.

Read less

Involvement

  • 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
Read less

Jeannie Mancheno

(she/her/hers)

Associate

New York