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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

In November 2019, the Department of Health, along with the Department of Treasury and Department of Labor (“Departments”) released a proposed rule requiring group health plans and health insurance issuers in the individual and group markets to disclose cost-sharing information to enrollees (“Proposed Rule”). Earlier this month, the Departments extended the deadline for comments on Proposed Rule to January 29, 2020. To date and with one day remaining in the comment period, the Departments have already received over 20,000 comments on the Proposed Rule.
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Earlier this month, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued its 2019 “Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: Top Unimplemented Recommendations.” The OIG releases a version of this report each year outlining its top 25 unimplemented recommendations to reduce fraud, waste, and abuse (“FWA”) among HHS programs. This blog post focuses on those recommendations specific to Medicare Part C and Part D for 2019.
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Earlier this month, CMS issued a final rule aimed at lowering drug prices and reducing out-of-pocket expenses in Medicare Advantage and Medicare Part D. This rule is the Administration’s latest effort to address prescription drug prices and builds off the Administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs and arrive on the heels of CMS publishing a rule requiring the disclosure of drug prices in TV ads. Below we’ve provided a brief overview of the major provisions in the final rule, noting changes from the proposed rule that was issued in November 2018.
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Earlier this week, Alex Azar, Secretary of the Department of Health and Human Services (“HHS”), delivered keynote remarks at AHLA’s 2019 Institute on Medicare and Medicaid Payment Issues. 

Framing his remarks around two key initiatives of the Administration, regulatory reform and affordable healthcare, Secretary Azar promised a bold and swift approach to regulatory reform over the coming years. 

Secretary Azar discussed HHS’ initiative known as the “Regulatory Sprint to Coordinated Care,” which we’ve previously discussed on the blog. The agency is undergoing a “comprehensive reexamination of rules that may be impeding coordinated care.”  As a “sprint,” he noted the goal is to issue rulemaking to alleviate impediments “as soon as possible.”
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As of January 30, 2019, CMS lifted its temporary provider enrollment moratoria for home health agencies in Florida, Illinois, Michigan and Texas. The Enrollment Moratorium had prevented new home health agencies in these states from enrolling in Medicare and Medicaid.
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The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule that would require pharmaceutical manufacturers to disclose the list price of their pharmaceutical products in direct-to-consumer (“DTC”) television ads (the “Proposed Rule”).
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Last week, the Department of Health and Human Services – Office of Inspector General (“OIG”) released a portfolio report identifying multiple vulnerabilities in the Medicare Hospice Program (the “Hospice Portfolio Report”), including concerns around billing, federal oversight, and quality of care. The OIG made 16 recommendations to CMS to strengthen the hospice program; CMS only concurred with 6 of the recommendations.
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States may be starting to take aim at prescription automatic refill programs. Automatic refill programs have been proven to increase patient adherence, especially among patients with chronic conditions. However, regulators argue that automatic refill programs result in waste to the system, stockpiling, and federal program payment for unneeded prescriptions.
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Medicare Part D plan sponsors and pharmacies are often confused by the program's any willing pharmacy (AWP) requirements while allowing any pharmacy willing to accept the terms and conditions to participate in the sponsor’s network (AWP Requirements).
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Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of October 23, 2017. The preview discusses the Alexander-Murray stabilization package introduced by Senators Lamar Alexander (R-TN) and Patty Murray (D-WA).
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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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Podcast Viewpoint Image

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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Podcast Viewpoint Image
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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