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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 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 truestaff 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 non-profit integrated health delivery system, in its affiliation with The Evangelical Lutheran Good Samaritan Society (the “Society”), a non-profit 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

Summer 2022: Key Trends in Pharmacy Enforcement Actions

August 29, 2022 | Blog | By Lauren Moldawer, Grady Campion, Pat Ouellette

Pharmacies have long been a focus of enforcement actions brought by the Department of Justice (DOJ) and Department of Health and Human Services Office of Inspector General (OIG). This summer has been no exception, with the DOJ and OIG bringing a number of fraud cases against pharmacies and pharmacists. We also saw enforcement against pharmacies for allegedly falsifying prior authorization information and providing more insulin than the pharmacy billed to payors. This blog summarizes some of these and other key pharmacy enforcement trends this summer.
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Disclosing known or suspected fraud to regulators can have its benefits.  As reported in a previous post, the Department of Justice (DOJ) issued policy guidance in 2019 on providing credit in False Claims Act (FCA) settlements to corporations for “disclosure, cooperation, and remediation” (the Policy Guidance).  Since then, the industry has been watching to see how  DOJ implements this Policy Guidance. 

Two settlements announced earlier this month seem to demonstrate that DOJ is applying the Policy Guidance in resolving FCA cases.  Although the facts of these two settlements differ significantly, they highlight the benefits of self-disclosure, cooperation with the government in its investigation, and proactive efforts to remediate non-compliance.
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Continuing our series discussing the CY 2023 Medicare Advantage and Part D Final Rule (Final Rule), this post focuses on the D-SNP related provisions under the Final Rule.  As we discussed, the Centers for Medicare & Medicaid Services (CMS) proposed significant modifications to its regulations governing Dual Eligible Special Needs Plans (D-SNPs).  CMS finalized the majority of its proposals with limited modifications.  This blog summarizes some of the key D-SNP provisions, focusing on the modifications from the proposed rule and CMS’ commentary that provides insight into CMS’ priorities and focus areas.  Please refer to our prior post on D-SNPs for a more in-depth overview of the proposals.
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The Centers for Medicare & Medicaid Services (CMS) released its Final Rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (Final Rule) late last week.  We summarized the major provisions of CY 2023 Proposed Rule in a blog series in January, noting that the proposals sought to increase consumer protections and reduce health disparities, with a strong emphasis on policies impacting individuals who are dually eligible for Medicare and Medicaid. This is the first blog post in our series on the Final Rule in which we discuss policy changes to the maximum out-of-pocket (MOOP) rules requiring that all cost-sharing, including cost sharing paid by secondary payors, be included in the calculations for MOOP.
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At the end of March 2022, the Centers for Medicare & Medicaid Services (CMS) released guidance to drug manufacturers and states on reporting Medicaid Best Price under value based purchasing (VBP) arrangements (Medicaid Best Price Guidance or Guidance).  This Guidance follows CMS’ final rule issued on December 31, 2020 (Final Rule) responding to criticism that Medicaid Best Price requirements are hindering the use of VBP arrangements.  The Final Rule and Guidance will go into effect on July 1, 2022, allowing manufacturers to report multiple best prices for VBP arrangements so long as the manufacturer offers the VBP arrangement to state Medicaid programs. This blog post will begin with a “101” on the Medicaid Best Price Policy, and then delve into an overview of the Final Rule, including the surrounding criticism from stakeholders; summarize the Medicaid Best Price Guidance; and discuss the potential impact of this change on states and manufacturers
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Health Law Diagnosed — Transactions Part 2: The Role of 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

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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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Removing Barriers to Second Chances

January 24, 2022 | Article

Mintz initiated many pro bono projects to combat systemic racism after the murder of George Floyd, including organizing Massachusetts Criminal Offender Record Information sealing clinics with the Lawyers Clearinghouse and conducting research for a Boston-based nonprofit into how housing authorities around the country evaluate applicants with open criminal charges.
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As we noted, Centers for Medicare & Medicaid Services (“CMS”) recently proposed its Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rules (“Proposed Rule”) that would increase consumer protections and reduce health care disparities in Medicare Advantage (“MA”) and Part D. In the Proposed Rule, CMS proposes major modifications to its regulations governing Dual Eligible Special Needs Plans (“D-SNPs”), which are MA products specifically for individuals who are dually eligible for Medicare and Medicaid. These changes are informed by the success of CMS’ Financial Alignment Demonstration and Medicare-Medicaid Plans (“MMPs”). In fact, under the Proposed Rule, CMS is proposing that many key characteristics of MMPs be incorporated into D-SNPs. CMS is also proposing to update the definitions of Fully Integrated Dual Eligible Special Needs Plans (“FIDE SNPs”) and Highly Integrated Dual Eligible Special Needs Plans (“HIDE SNPs”) to incorporate successful characteristics of MMPs and to better clarify and differentiate these terms.
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At the end of September, the Departments of Health and Human Services (HHS), Labor, and Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), released Part II of its regulations implementing the No Surprise Act (the “Act”). The “Requirements Related to Surprise Billing; Part II” interim final rule (IFR) sets forth the Federal independent dispute resolution (IDR) process to determine the out-of-network payment rates. Major provider associations have released statements criticizing the IDR process and methodology for determining payment.
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News & Press

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The Cigna Health Group signed a deal selling its Medicare businesses to Health Care Service Corporation (HCSC) for $3.7 billion. A Mintz team led by Tara Dwyer and Lauren Moldawer acted as regulatory counsel to The Cigna Group on the sale. In the deal, which is expected to close in the first quarter of 2025, HCSC will acquire Cigna’s Medicare lines including Medicare Advantage, Medicare supplement, and Medicare drug plans, as well as CareAllies, a unit that works with physician groups and other healthcare providers.
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Mintz proudly announced the election of 13 attorneys to Members and the addition of a record-setting 22 new lateral Members in 2023, with 11 Partners in the newly opened Toronto office. This diverse group strengthens Mintz’s core areas, spanning Commercial and IP Litigation, Life Sciences, Tech, Private Equity, and Energy & Sustainability. The elevated Members and new lateral additions bring invaluable expertise to help clients navigate complex legal landscapes.
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Theresa Carnegie, Lauren Moldawer, and Hassan Shaikh co-authored an article published by Law360 on the Inflation Reduction Act's Medicare drug pricing negotiation program.
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Mintz is pleased to announce that 120 firm attorneys have been recognized as leaders by Best Lawyers® in the 2024 edition of The Best Lawyers in America©.
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Mintz is advising a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their acquisition of Curo Health Services, one of the nation’s leading hospice providers. The definitive agreement was announced on April 23, 2018. The deal is valued at approximately $1.4 billion.
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Mintz is advising a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their acquisition of Kindred Healthcare, Inc. The definitive agreement totals approximately $4.1 billion in cash including the assumption or repayment of net debt.
Lauren Moldawer, a Mintz Health Law Associate based in Washington, DC, authored this AHLA article providing a comprehensive look at the operations and particulars of Medicaid programs across the United States.
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Recognition & Awards

  • Best Lawyers in America: Ones to Watch - Health Care Law (2024)

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