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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

Tackling Drug Prices: CMS and PhRMA Propose Steps to Promote Value-Based Purchasing

March 15, 2016 | Blog | By Theresa Carnegie, Lauren Moldawer

Last week, the Centers for Medicare & Medicaid Services (CMS) and the Pharmaceutical Research and Manufacturers of America (PhRMA) released proposals to address recent criticism over rising drug prices.
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CMS Releases 2017 Advance Notice and Draft Call Letter

February 29, 2016 | Blog | By Bridgette Keller, Lauren Moldawer

Last week, the Centers for Medicare & Medicaid Services (CMS) released its 2017 Advance Rate Notice and draft Call Letter (“2017 Draft Call Letter”) for the Medicare Advantage (“MA”) and Part D programs. With the final 2017 Call Letter to be released April 4, 2015, CMS is providing interested stakeholders until this Friday, March 4th to provide comments.
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Last week, Mintz Levin and ML Strategies released a joint Alert analyzing key provisions of the Covered Outpatient Drug final rule (“Final AMP Rule”) and their impact on manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies. 
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Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

February 10, 2016 | Advisory | By Theresa Carnegie, Lauren Moldawer

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”).
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Gun Control: HIPAA Final Rule Targets Background Checks and Mental Health Reporting

January 7, 2016 | Blog | By Lauren Moldawer, Daria Niewenhous

President Obama has announced plans to tighten gun control regulations, including applying the background check requirement to dealers at gun shows and on websites. Federal law already requires that those “engaged in the business” of selling guns must have a Federal Firearms License (FFL) and conduct background checks at the time of every purchase.
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The Pharmacy Industry - 2015 Year In Review

December 8, 2015 | Blog | By Theresa Carnegie, Lauren Moldawer

With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. 
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On Monday November 2, 2015, ML Strategies released another edition of its Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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The Proposed 340B Guidance:  Who is the Biggest Loser?

October 8, 2015 | Blog | By Lauren Moldawer

We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program.
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Earlier this week, ML Strategies posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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Final Drug Shortage Reporting Rules Will Go Into Effect September 2015

July 9, 2015 | Blog | By Joanne Hawana , Lauren Moldawer

Earlier this week, FDA issued its final rule implementing statutory requirements for drug manufacturers to report the permanent discontinuation or temporary interruption in the manufacturing of certain drugs and biological products to FDA.
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podcasts

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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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