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Lauren M. Moldawer

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[email protected]

+1.202.434.7486

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Lauren's practice focuses on advising clients through complex health care transactions and regulatory matters. She has served as health care counsel on numerous private equity and strategic transactions, including mergers and acquisitions, joint ventures, affiliations, and investments involving pharmacies, PBMs, physician practices, long-term care facilities, third-party payors, value-based contracting entities, nurse staffing companies, and health care technology firms.

Lauren’s deal work is complimented by her regulatory practice, which primarily focuses on advising pharmacies, PBMs, managed care organizations and other clients in the payor space. Drawing from her experience working for the Federal Coordinated Health Care Office (the “Duals Office”) within the Centers for Medicare & Medicaid Services (CMS), she is able to provide practical advice to clients on regulatory and compliance issues relating to Medicare Advantage, Medicare Part D, and Medicaid. She has advised clients on Medicare Advantage and Medicare Part D applications, audit appeals, contract negotiations, Medicaid managed care RFPs, and payment issues.

Lauren’s regulatory practice also focuses on compliance with the anti-kickback statute, corporate practice of medicine and fee-splitting prohibitions, telemedicine, and prescribing and licensing requirements (including change of ownership requirements).

Prior to her tenure with CMS, she was a research consultant with a health care consulting company in the Washington, DC area, working primarily with state Medicaid agencies and Medicaid managed care plans.

Experience

  • Counseled private equity sponsors on health care acquisitions, including fraud and abuse issues, licensure, change of ownership, and payor matters.
  • Served as health care regulatory counsel to several banks and lenders in debt financing transactions, including advising on the impact of corporate practice of medicine and other health care regulatory matters on the credit agreement and accompanying deal documents.
  • Provided health care regulatory counsel to Cornell Capital in its acquisitions of Trustaff and CardioSolution, as well as the acquisitions of various nurse staffing companies by Ingenovis Health.
  • Advised national pharmacy chain in multiple specialty pharmacy and long-term care pharmacy acquisitions.
  • Advised venture capital and private equity firms on Series C and minority investments in various health care technology firms and value-based contracting entities.
  • Represented Sanford Health, a nonprofit integrated health delivery system, in its affiliation with The Evangelical Lutheran Good Samaritan Society, a nonprofit long-term care provider. Our representation primarily focused on assisting Sanford in navigating the change of ownership filings for the Society’s licenses and Medicare and Medicaid filings.
  • Conducted the due diligence and provided state and federal regulatory research and analysis in connection with TPG’s acquisition of Convey Health Solutions, a specialized health care technology company that provides health plan administration, supplemental benefits administration, and consulting services to health plans.
  • Advised a global health care company on a variety of issues in connection with its acquisition of several health plans and provider groups, including health care regulatory due diligence, health care regulatory advice regarding transaction structure and strategy, and preparation of regulatory notices and other filings.
  • Served as regulatory counsel to a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their $4.1 billion acquisition of Kindred Healthcare, Inc. (NYSE: KND). The transaction was recognized by The Deal as the 2018 Private Equity Deal of the Year.
  • Advised a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their $1.4 billion acquisition of Curo Health Services.
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viewpoints

Will Republicans Embrace CMMI’s Authority?

November 18, 2016 | Blog | By Lauren Moldawer

The Affordable Care Act (ACA) and the Medicare and CHIP Reauthorization Act (MACRA) provided the Centers for Medicare & Medicaid Services (CMS) and the newly created Center for Medicare and Medicaid Innovation (CMMI) tremendous authority.  With Republicans set to take control of both the White House and Congress, the future of that authority is very much in question.
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2017 MA and Part D Audit Protocols and Data Requests are Open for Comment

November 14, 2016 | Blog | By Lauren Moldawer, Tara E. Dwyer

CMS issued its Audit Protocols and Data Requests for Medicare Advantage and Part D plans on November 4, 2016 (the “Protocols”). The Protocols have been updated based on the over 500 comments CMS received in response to the draft released in June.
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Last week, CMS released a Fact Sheet announcing that it is further delaying enforcement of the Medicare Part D Prescriber Enrollment Requirements, with full enforcement to begin on January 1, 2019.
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CMS releases Final Rule Overhauling Long-Term Care Facility Requirements

October 10, 2016 | Blog | By Lauren Moldawer, Cassandra Paolillo

The Centers for Medicare & Medicaid Services (CMS) recently released its final rule overhauling long-term care (LTC) facility participation requirements for Medicare and Medicaid (“Final Rule”).
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2018 Notice of Benefits and Payment: Proposed Updates to the HHS Risk Adjustment Model

September 8, 2016 | Blog | By Lauren Moldawer, Tara E. Dwyer

Last week, the Centers for Medicare & Medicaid Services (“CMS”) released its 2018 Notice of Benefit and Payment setting out payment parameters for the Health Insurance Marketplace for upcoming years.
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Last week, the OIG issued a favorable opinion to a hospice provider seeking to make supplemental payments to skilled nursing facilities. Under the proposed arrangement, the hospice provider would make a supplemental payment to the nursing facility for dual-eligible individuals electing the hospice benefit that would be in addition to and separate from what the managed care organization (“MCO”) pays the nursing facility.
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Earlier this month, the Court of Appeals for the D.C. Circuit issued its decision in Central United Life Insurance Co., v. Burwell, striking down a Department of Health and Human Services (HHS) rule prohibiting the sale and marketing of “fixed indemnity” plans to consumers who did not otherwise have minimum essential coverage.
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Thus far, 2016 has been a relatively quiet year for the 340B program at the federal level. Neither Congress nor the Health Resource and Service Administration (HRSA) has shown an appetite to take on the issues plaguing the program.
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Continuing our blog series on CMS’s massive proposed rule for the implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), we dedicate this post to examining the Advance Payment Model (APM) provisions of the proposed rule.
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FDA Differentiates Biosimilar Labeling from Generic Drug Labeling

April 4, 2016 | Blog | By Joanne Hawana , Lauren Moldawer

In another highly anticipated regulatory move, FDA has released draft guidance on “Labeling for Biosimilar Products.” Made public on March 31st, the draft guidance sets forth FDA’s recommendations on the labeling of biosimilar products that are approved via the abbreviated licensure pathway created in 2010 by the BPCIA.
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podcasts

Podcast Viewpoint Image

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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Health Law Diagnosed: Transactions Part 2: Health Regulatory Diligence and How to Prepare for a Sell-Side Transaction

March 24, 2022 | Podcast | By Tara E. Dwyer, Xavier Hardy, Bridgette Keller, Lauren Moldawer, Cassandra Paolillo, Kate Stewart

Health regulatory diligence has the ability to make or break a deal. Listen to hear about our team’s firsthand experience in the importance of conducting health regulatory diligence and best practices in preparing for a sell-side transaction.

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Health Law Diagnosed — Transactions Part 1: Regulatory Trends in Recent Health Care Transactions

March 3, 2022 | Podcast | By Xavier Hardy, Bridgette Keller, Lauren Moldawer, Cassandra Paolillo, Kate Stewart

2021 was a busy year for Mintz ’s Health Law team, as they helped clients navigate complex health care transactions.
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Recognition & Awards

  • Best Lawyers in America: Ones to Watch – Health Care Law (2024, 2025)

  • Legal 500 United States: Healthcare – Service Providers (2025)

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