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Ellen L. Janos

Member

EJanos@mintz.com

+1.617.348.1662

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Ellen utilizes her in-depth knowledge of health care regulation to assist clients with government audits and investigations, M&A and financing transactions, and corporate compliance activities. She also provides strategic advice to traditional health care providers, investors, and start-ups on telehealth initiatives as well as the traditional practice of medicine across multiple states. Ellen often comments on developments in telehealth, HIPAA, and the corporate practice of medicine. As an assistant attorney general for the Commonwealth of Massachusetts, Ellen represented state agencies responsible for health care reimbursement, licensing, and Medicaid fraud prosecutions. She has successfully argued two cases before the US Supreme Court.

Ellen specializes in providing regulatory and strategic advice to health care providers and payors of all types, including hospitals, managed care organizations, long-term care facilities, pharmacies, pharmaceutical and device manufacturers, telemedicine providers, and urgent care and retail health clinics. She also represents companies doing business with, and investing in, health care providers. One of Ellen’s provider clients was quoted saying, “I can bring her any issue or question and she is able to quickly provide insights and answers that are practical and business-oriented. She is a true health care expert.”

Ellen's practice focuses on Medicare, Medicaid, and third-party payor audits and investigations, the development of corporate compliance programs, and hospital/physician relationships, including compliance with the state and federal anti-kickback laws and the Stark Law. In addition, she advises clients on how to deploy telemedicine and internet based health initiatives, electronic health records, and how to address HIPAA privacy and security matters.

Before joining Mintz, Ellen was an assistant attorney general for the Commonwealth of Massachusetts, representing state agencies responsible for health care reimbursement, licensing, and Medicaid fraud prosecutions.

Ellen served as a member of the advisory committee that worked with the Massachusetts Health IT Council on the development and implementation of the statewide HIT strategic plan and health information exchange.

She has written about and speaks frequently on state and federal telehealth laws, the corporate practice of medicine, compliance programs, board governance matters, HIPAA privacy and data security, technology and health care, and hospital/physician relationships. Ellen has successfully argued two cases before the US Supreme Court.

Ellen utilizes her in-depth knowledge of health care regulation to assist clients with government audits and investigations, M&A and financing transactions, and corporate compliance activities. She also provides strategic advice to traditional health care providers, investors, and start-ups on telehealth initiatives as well as the traditional practice of medicine across multiple states. Ellen often comments on developments in telehealth, HIPAA, and the corporate practice of medicine. As an assistant attorney general for the Commonwealth of Massachusetts, Ellen represented state agencies responsible for health care reimbursement, licensing, and Medicaid fraud prosecutions. She has successfully argued two cases before the US Supreme Court.

Experience

  • Regularly advise hospital clients on medical staff peer review laws and internal peer review proceedings
  • Advise telemedicine start-ups on state corporate practice of medicine, prescription and telehealth laws
  • Represented a long term care provider in an internal investigation involving drug diversion by facility nurses.
  • Represent Urgent Care Centers of New England d/b/a CareWell Urgent Care, a venture-backed company that develops, operates, or manages urgent care centers, in connection with the Company's roll-out of urgent care centers and joint venture models.
  • Advised a multi-state operator of skilled nursing facilities in several acquisitions, including health care regulatory compliance and Medicaid provider enrollment.
  • Provided state and federal health care regulatory advice to American Well, a pioneer in telehealth technology.
  • Represent a behavioral health management company, that specializes in drug and alcohol treatment, on a range of health care regulatory issues.
  • Researched and analyzed state pharmacy laws relating to licensing, patient choice, mail order pharmacies, autorefill programs, and refills by mail and labeling for a nonprofit organization that provides reproductive health care.
  • Represent a large health system in establishing a national telehealth program in compliance with state corporate practice of medicine and professional entity laws.
  • Advised a long term care facility on the state and federal notice and reporting obligations following a data breach.
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viewpoints

Telehealth Update: Assessing PHE Flexibilities, Pending Legislation Entering Fall 2022

September 1, 2022 | Blog | By Ellen Janos, Cassandra Paolillo

Many of the flexibilities upon which telehealth providers have come to rely in recent years are tied to the federal Public Health Emergency related to the COVID-19 pandemic (PHE). As we move into Fall 2022, we review the current state of the PHE flexibilities around Medicare reimbursement and prescription of controlled substances, examine pending legislation that, if passed, would bring greater certainty to patients and providers, and discuss what we know about the status of a possible PHE extension.
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ML Strategies Outlook: Federal Action Post-Dobbs Decision

July 25, 2022 | Blog | By Pamela Mejia, Ellen Janos, Kaitlyn Sprague

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Potential Pitfalls of Telehealth Prescribing

May 31, 2022 | Blog | By Lara Compton, Ellen Janos, Cassandra Paolillo

As we’ve previously covered, while Congress has acted to extend certain COVID-era telehealth flexibilities (mostly related to Medicare coverage) beyond the Public Health Emergency (PHE), the future of prescribing controlled substances via telehealth is uncertain.  Although the American Telemedicine Association and other industry groups continue to advocate for changes to allow telehealth providers to prescribe controlled substances in certain circumstances, without further action by Congress or the Drug Enforcement Administration (DEA), telehealth providers who prescribe controlled substances will need to conduct an in-person examination of the patient once the PHE ends. 
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Last week saw a lot of great news in the world of telehealth. On March 15, President Biden signed into law H.R. 2471, the “Consolidated Appropriations Act, 2022”, which extends many of the Medicare telehealth flexibilities put in place during the COVID-19 pandemic for a period following the end of the Public Health Emergency (“PHE”). The same day, the OIG issued a report highlighting the positive impact telehealth had on increasing access for beneficiaries during the first year of the pandemic. Then, during a press conference on March 18, HHS Secretary Xavier Becerra said that HHS will seek to sustain and expand access to telehealth services after the public health emergency ends. While these developments signal the continued expansion of telehealth, there is still some uncertainty surrounding coverage, reimbursement and licensure flexibilities that have allowed telehealth to flourish for the past two years.
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Telehealth Update: New Bill Could Provide Much Needed Certainty to Providers and Patients

February 10, 2022 | Blog | By Ellen Janos, Cassandra Paolillo

On Monday, February 7, 2022, U.S. Senators Catherine Cortez Masto, D-Nevada, and Todd Young, R-Indiana, introduced the Telehealth Extension and Evaluation Act, which if passed, would extend several of the telehealth waivers for two years after the end of the federal public health emergency (PHE). See our previous coverage of telehealth during the COVID-19 pandemic. The PHE was most recently renewed for an additional 90 days on January 16, 2022. Since January 2020, providers who pivoted to telehealth in order to deliver care to their patients during the pandemic have had to closely monitor the status of the PHE, which the Secretary of HHS is only authorized to extend for 90 days at a time. Passage of the proposed legislation would provide some much-needed certainty and would give providers time to transition back to in-person care where necessary. It would also further the growth and expansion of telehealth services and continued integration into our health care delivery system.
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Webinar Recording: Telehealth Regulation & Enforcement: 2021 Year in Review & 2022 Outlook

December 7, 2021 | Webinar | By Alexander Hecht, Ellen Janos, Karen Lovitch, Kate Stewart

Over the past year, the demand for health care via telehealth has continued to skyrocket as a result of the COVID-19 pandemic and the public’s increased comfort with obtaining health care goods and services virtually. Join Ellen Janos, Karen Lovitch, Kate Stewart and Alex Hecht as they demystify the current status of laws and regulations, untangle the web of legislation before Congress related to the expansion of telehealth services, discuss recent enforcement activity, and look ahead to trends we see on the horizon.  
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Last week, CMS announced its final Physician Fee Schedule Payment Policies (the “Final Rule”), which will become effective January 1, 2022. The Final Rule included several updates to Medicare coverage of telehealth services, including a number of COVID-19 related changes that will be extended or be made permanent. As previously covered, while temporary orders allowing expanded use of telehealth have increased access to care across the country during the public health emergency (“PHE”), the regulatory environment for telehealth has always been somewhat unsettled. The changes in the Final Rule described below signal a move towards increased access to telehealth for Medicare beneficiaries as regulators acknowledge the potential benefits of these alternate methods of delivering care.
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Health Law Diagnosed — Telehealth Transformation: Where We Are and Where We’re Headed

April 9, 2021 | Podcast | By Ellen Janos, Cassandra Paolillo

The ability to provide health care from a remote location has been around for many years, but with the arrival of COVID-19, hospitals, physicians, and other health care providers have had to rapidly rethink their traditional models of health care delivery.
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Telehealth Update: States Move to Permanently Expand Access to Telehealth

March 30, 2021 | Blog | By Cassandra Paolillo, Ellen Janos

Over the past year the telehealth landscape has been a patchwork of temporary waivers and regulations, expanding access during the COVID-19 pandemic but leaving providers and patients uncertain about whether the positive coverage and reimbursement changes and relaxation of pre-pandemic restrictions would continue in the future. In recent weeks, we have seen a number of state actions making permanent changes to expand access to telehealth. These changes suggest a positive trend towards making telehealth an integral part of the care delivery system, although the complicated regulatory frameworks still present challenges to providers seeking to treat patients via telehealth.
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Since the beginning of the pandemic, telehealth providers have seen a dramatic increase in demand for their services along with a number of temporary regulatory measures aimed at expanding telehealth access to more patient populations. In this post, we outline some important developments that will bring greater certainty to telehealth providers and suggest that expanded access to telehealth is here to stay.
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News & Press

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35 Mintz attorneys have been named Massachusetts Super Lawyers and 25 Mintz attorneys have been named Massachusetts Rising Stars for 2022.
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Firm provides pro bono legal counsel to global health nonprofit on groundbreaking initiative to slow the spread of COVID-19 in the Commonwealth of Massachusetts.
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This feature article discusses how artificial intelligence solutions could be used to help answer beneficiary questions, review claims. Ellen Janos, a Member and experienced health care regulatory attorney, provides commentary within the piece.
This feature story discusses the rise in use of mobile therapy apps as suicide rates increase. The regulatory concerns and issues associated with these apps are highlighted within the piece and Health Law Member Ellen Janos is quoted providing commentary.
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Mintz partner and Massachusetts lawyer Julie Korostoff is one of 49 attorneys recognized as “Leaders in Their Fields” by the 2018 Chambers USA: America's Leading Lawyers for Business guide. Chambers named Korostoff a “Recognized Practitioner” in Technology.
This feature article discusses a Medicare proposal to expand patient access to medical records. The piece notes that while the proposal could help to streamline the use of electronic health records, it could prove to be burdensome to health care providers.
This feature story notes concerns in regards to the potential hacking of all the data being collected by makers of personal health care devices. Mintz Health Law Member Ellen Janos is among the industry sources providing commentary within the piece.
Health Law Member Ellen Janos provides commentary in this feature article discussing the recommendations of a recent Government Accountability Office report noting the need for increased data security oversight by the Centers for Medicare & Medicaid Services.
Mintz Member and health care attorney Ellen Janos is quoted in this article, which notes that Medicare plans will make sharing patient records easier. Ellen is among those sources quoted discussing the potential impact of the plan which would give patients more control over their medical data.
Ellen Janos, a Member in Mintz’s health law practice, quoted in Bloomberg BNA regarding the upcoming information blocking ruling and whether or not it will curb the blocking of the exchange of health data.
Ellen Janos is a Member in the Health Law Practice at Mintz. The government issued a draft of the Trusted Exchange Framework, released on January 5th, encouraging health-data networks to link up and provide access to each other.
Member Ellen Janos is a health law and health care enforcement defense attorney. She authored a column for Law360 column on the topic of digital health. Ellen points out some questions to consider when assessing a digital health service or product.
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Best Lawyers named 85 Mintz attorneys to its 2018 list of The Best Lawyers in America. In addition, Mintz attorneys Matthew J. Gardella and Samuel M. Tony Starr were named “Lawyer of the Year” in their respective practice areas.
Fifty-three Mintz attorneys have been named Massachusetts Super Lawyers for 2016 and thirty-one have been named Massachusetts Rising Stars. The findings will be published in the November 2016 issue of Boston Magazine and in a stand-alone magazine, New England Super Lawyers. 
Best Lawyers named 73 Mintz attorneys to its 2017 list of The Best Lawyers in America. Mintz attorneys selected for inclusion in this year’s list span 44 practice areas. 
Firm’s National Healthcare Practice, NY Corporate/M&A and Litigation: General Commercial Among Newest Rankings
The 2015 Chambers USA: America's Leading Lawyers for Business guide names 52 Mintz, Cohn, Ferris, Glovsky and Popeo, P.C.  attorneys as “Leaders in Their Fields.”
Julie Korostoff, Co-chair of Mintz’s IT Transactions & Outsourcing Practice, and Mintz partner Ellen Janos are participating in a panel on “Operating a Successful Telemedicine Program” at the 2015 American Telemedicine Association Annual International Meeting & Trade Show.
Mintz partner Julie Korostoff is giving a presentation on "IT Contracting for Telemedicine” and participating with Mintz Partner Ellen Janos in a panel on legal and contract issues facing telemedicine programs at the 2014 American Telemedicine Association Annual International Meeting & Trade Show.
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Events & Speaking

Moderator
Panelist
Mar
10
2021

Healthcare Law & Compliance Institute

International Performance Management Institute

Virtual Event

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Moderator
Dec
1
2020

Telehealth: What's Next?

Women Business Leaders of the U.S. Health Care Industry Foundation (WBL) Event

Online Event

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Speaker
May
13
2019

Regulatory and Business Strategies for MedTech and Telehealth

Effective Business Planning: Additional Regulatory and Policy Challenges

Wiley Rein LLP, 1776 K Street, NW

Speaker
Panelist
Dec
13
2018

HFMA Annual Compliance Update

Compliance Roles and Responsibilities in Relation to Disruptive Technology

Offices of Deloitte & Touche, 200 Berkley Street, Boston, MA

Panelist
Jun
13
2018

American Well’s Client Forum 2018

American Well

Boston, MA

Speaker
Panelist
Jun
22
2016

The Promise of Telemedicine

Massachusetts Hospital Association

Boston, MA

Panelist
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Ellen utilizes her in-depth knowledge of health care regulation to assist clients with government audits and investigations, M&A and financing transactions, and corporate compliance activities. She also provides strategic advice to traditional health care providers, investors, and start-ups on telehealth initiatives as well as the traditional practice of medicine across multiple states. Ellen often comments on developments in telehealth, HIPAA, and the corporate practice of medicine. As an assistant attorney general for the Commonwealth of Massachusetts, Ellen represented state agencies responsible for health care reimbursement, licensing, and Medicaid fraud prosecutions. She has successfully argued two cases before the US Supreme Court.

Recognition & Awards

  • Best Lawyers in America: Boston Health Care Law Lawyer of the Year (2014)
  • Best Lawyers in America: Health Care Law (2008 – 2023)
  • Chambers USA: Massachusetts – Healthcare (2008 – 2020); (Band 1) - Healthcare (2021 – 2022)
  • Recognized by The Legal 500 United States for Healthcare: Service Providers (2014 – 2015)
  • Included on the Massachusetts Super Lawyers: Health Care list (2004 – 2018, 2021-2022)
  • Heroes of the Field Award 2010, Massachusetts Medical Law Report
  • Martindale-Hubbell AV Preeminent
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Ellen utilizes her in-depth knowledge of health care regulation to assist clients with government audits and investigations, M&A and financing transactions, and corporate compliance activities. She also provides strategic advice to traditional health care providers, investors, and start-ups on telehealth initiatives as well as the traditional practice of medicine across multiple states. Ellen often comments on developments in telehealth, HIPAA, and the corporate practice of medicine. As an assistant attorney general for the Commonwealth of Massachusetts, Ellen represented state agencies responsible for health care reimbursement, licensing, and Medicaid fraud prosecutions. She has successfully argued two cases before the US Supreme Court.

Involvement

  • Member, Board of Trustees of the North End Waterfront Health
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Ellen L. Janos

Member

Boston