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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

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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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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It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9, 2021. The Plan makes it clear that the Biden Administration supports aggressive action to address rising drug prices, including controversial actions such as allowing HHS to negotiate the cost of Medicare Part B and D drugs. The Plan also outlines a set of administrative actions that HHS and its operating agencies can take, without the need for intervention by Congress. A notable gap in the Plan, however, is the Administration’s potential approach to manufacturer rebates and the Rebate Rule.
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On Friday, July 9th, President Biden released an Executive Order “to promote competition in the American economy” and to “to reduce the trend of corporate consolidation” (the “Order”). As part of this Order, the Biden Administration specifically targets competition in the pharmaceutical industry and sets forth policies to combat the high cost of prescription drugs. As the Administration’s first major policy initiative on drug pricing, this Order may serve as a preview of the Administration’s drug pricing reform agenda. For additional information about the Executive Order, please see our Antitrust colleagues' alert on the Order's initiatives specifically earmarked for the Federal Trade Commission and the Department of Justice’s Antitrust Division.
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Late last week, the Departments of Health and Human Services (HHS), Labor, and Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), released the “Requirements Related to Surprise Billing; Part I” interim final rule (IFR). The IFR implements key provisions of the No Surprise Act, which is intended to protect people from surprise bills and significant out-of-network cost-sharing for emergency services, services provided by out-of-network providers during an in-network facility visit, and air ambulance services.

The provisions of the IFR apply to group health plans, health insurance issuers offering group or individual health insurance coverage, and carriers in the FEHB Program (collectively, health plans), as well as certain health care facilities. The majority of the requirements in the IRF will be effective January 1, 2022. Below, we outline the major provisions of the IFR.
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Earlier this week, a committee of the National Academies sponsored by the CDC and NIH released its Draft Framework for Equitable Allocation of COVID-19 Vaccine. This Draft Framework builds on the successes and challenges of past vaccine allocation frameworks, as well as current frameworks for allocating scarce COVID-19 resources. This blog reviews these past frameworks that laid the foundation for the committee to develop its decision-making framework.
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As a continuation of our series on the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program (the “Proposed Rule”) released by the Centers for Medicare & Medicaid Services (“CMS”) earlier this month, this blog focuses on CMS’s codification of its recent guidance on supplemental benefits, including guidance on Special Supplemental Benefits for the Chronically Ill (“SSBCI”). It also discusses CMS’s proposed changes to the medical loss ratio (“MLR”) to account for changes in supplemental benefits.
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In CMS’s recently released proposed rule (the Medicare and Medicaid Programs: Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program and Programs of All-Inclusive Care for the Elderly) (the “Proposed Rule”) and supplemental HPMS memos, CMS is proposing several significant changes to its star rating system and to its methodology for reviewing plan past performance. This blog post highlights the key details of the proposed changes to the star rating system and past performance methodology and their potential impact on Medicare Advantage and Part D plans.
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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 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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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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