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Lauren M. Moldawer

Associate

[email protected]

+1.202.434.7486

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Lauren's practice focuses on advising pharmacies, PBMs, managed care organizations and other payors on a variety of transactional, regulatory, and fraud and abuse matters.

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, and payment issues.

Lauren also focuses much of her practice on counseling clients on various matters relating to federal and state regulatory issues, including compliance with the anti-kickback statute, corporate practice of medicine and fee-splitting prohibitions, telemedicine, and prescribing and licensing requirements. She has advised entities on compliance with the 340B Drug Pricing Program requirements. She also assists in representing clients in connection with mergers and acquisitions, provider contracts, network development programs, and general contracting.

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. During law school, Lauren was a member of the George Washington Journal of Energy & Environmental Law and competed in the Van Vleck Moot Court Competition.

Education

  • George Washington University (JD, with honors)
  • Georgetown University (BS, cum laude)

Recent Insights

News & Press

Viewpoints

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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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Biden Administration’s Drug Pricing Plan Calls for Bold Action by Congress

September 10, 2021 | Blog | By Joanne Hawana, Theresa Carnegie, Lauren Moldawer

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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Health Plan Transparency Rule: Comment Period Ends This Week

January 29, 2020 | Blog | By Lauren Moldawer

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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CMS Finalizes Medicare Advantage and Part D Drug Pricing Rule

May 28, 2019 | Blog | By Bridgette Keller, Daryl Berke, Lauren Moldawer

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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News & Press

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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.