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Jeannie Mancheno

(she/her/hers)

Associate

[email protected]

+1.212.692.6847

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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

The New York State Office of Medicaid Inspector General (OMIG) published proposed regulations in the July 13, 2022 issue of the New York State Register.  The proposed regulations would repeal the current Part 521 - Provider Compliance Programs of Title 18 of the New York Codes, Rules and Regulations (NYCRR) in its entirety and establish new requirements for providers to detect and prevent fraud, waste and abuse in the Medicaid Program under a new Part 521: Fraud, Waste, and Abuse Prevention (Part 521). This blogpost highlights certain provisions from the first of Part 521’s three subparts, Subpart 521-1, that are relevant to New York Medicaid providers as they structure and update their compliance programs.
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Bridgette Keller speaks with Kerlann Flowers, Legal Director and Senior Attorney for Hofstra University School of Law’s Medical-Legal Partnership (MLP), and Mintz Associate Jean Krebs about the MLP’s work and how collaboration between medical providers and lawyers can improve outcomes.
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White House Issues Telehealth Guidance on Substance Use Disorder Services

July 11, 2022 | Blog | By Lara Compton, Cody Keetch, Jean D. Mancheno

On June 22, 2022, the White House Office of National Drug Control Policy (ONDCP) issued guidance advocating for Congress and federal agencies to make permanent certain telehealth access measures for people struggling with substance use disorders (SUD). The guidance, titled Telehealth and Substance Use Disorder Services in the Era of Covid-19: Review and Recommendations (Guidance), made four recommendations geared at increasing telehealth access, utilization, and equity among individuals who have experienced an SUD. This blogpost with provide an analysis of the four recommendations and their implications. 
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On May 11, 2022, New York Governor Kathy Hochul announced the creation of the Department of Financial Services’ Pharmacy Benefits Bureau. Governor Hochul noted that the Pharmacy Benefits Bureau is the first of its kind in the country. The Pharmacy Benefits Bureau will be tasked with implementing and overseeing new licensing and reporting requirements impacting Pharmacy Benefit Managers (PBMs) in New York. This blog post provides an analysis of the intended purpose of the Pharmacy Benefits Bureau and an overview of the new PBM guidance from the Department of Financial Services.
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On April 27, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services issued Advisory Opinion No. 22-08 (AO 22-08), which addresses an existing arrangement of a federally qualified health center (FQHC) (hereafter, Requestor) that loans limited-use smartphones to enable existing patients’ access to Requestor’s telehealth platform (the Arrangement).  The Arrangement’s purpose is described as increasing access to telehealth services and combating isolation by allowing patients to talk and text with others, including during the COVID-19 public health emergency (PHE).
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Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services (HHS) is authorized to distribute funds from its Provider Relief Fund (PRF) to certain providers. These providers can then use the funds to support COVID-19 prevention, preparedness, and response, or to alleviate loss of patient care revenue.  However, HRSA requires that providers receiving PRF funds comply with certain requirements, including post-payment reporting requirements.  HRSA is now notifying providers that failed to comply with the reporting requirements that they must return the PRF funds they received. 
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On March 18, 2022, President Biden signed the Dr. Lorna Breen Health Care Provider Protection Act (Act) into law. The Act is named for Dr. Lorna Breen, who served as the Medical Director of New York-Presbyterian Allen Hospital. Dr. Breen died by suicide in April 2020, as the COVID-19 pandemic was taking hold of the nation and, in particular, New York City. Since Dr. Breen’s passing, her family has established the Dr. Lorna Breen Heroes’ Foundation (Heroes’ Foundation). The Heroes' Foundation’s mission is to reduce burnout, safeguard the well-being of health care providers (HCPs), and reduce the stigma surrounding HCPs seeking help or treatment. The Act is a crucial step in achieving this mission.
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New York To Require Licensure of Pharmacy Benefit Managers

February 25, 2022 | Blog | By Cody Keetch, Jean D. Mancheno

In an effort to counteract rising prescription drug costs and health insurance premiums, New York Governor Hochul signed S3762/A1396 (the Act) on December 31, 2021.  This legislation specifies the registration, licensure, and reporting requirements of pharmacy benefit managers (PBMs) operating in New York. The Superintendent of the Department of Financial Services (Superintendent) will oversee the implementation of this legislation and the ongoing registration and licensure of PBMs in New York. Notably, this legislation establishes a duty of accountability and transparency that PBMs owe in the performance of pharmacy benefit management services.
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In this episode of the Health Law Diagnosed podcast, members of the Mintz Health Law team discuss their health law–focused 2022 New Year’s resolutions and how they’re helping clients and colleagues navigate the continued challenges and opportunities of the current era.
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On January 1, 2022, S.B. 763 took effect in Oregon, requiring pharmaceutical sales representatives (“PSR”) to obtain a license prior to marketing or promoting pharmaceutical products to health care providers. Oregon is not the first jurisdiction to enact such a law, but it is one of few jurisdictions in the United States to require licensure or registration of PSRs. This post discusses S.B. 763 and similar laws, regulations, and ordinances that are in effect in Nevada, Illinois, and Washington, D.C. below.
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News & Press

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Mintz Member Joanne Hawana and Associate Jean Krebs were interviewed by CosmeticDesign about legal reform in the U.S. Food and Drug Administration.
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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".
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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".
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Publications

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

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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
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Jeannie Mancheno

(she/her/hers)

Associate

New York