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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

Viewpoint
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.

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.
Viewpoint General

Secretary Azar Addresses Drug Pricing and Care Coordination in AHLA Keynote

March 22, 2019 | Blog | By Lauren Moldawer, Sarah Beth Kuyers

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.”
Viewpoint General
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.
Viewpoint General

Trump Administration Proposes Requiring Disclosure of Drug Prices in TV Ads

October 17, 2018 | Blog | By Lauren Moldawer, Theresa Carnegie

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”).
Viewpoint
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.

The Hazards of Prescription Auto-Refill Programs

June 6, 2018 | Blog | By Lauren Moldawer

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.
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).
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).

ML Strategies Explores the Evolution of “Repeal and Replace”

September 28, 2017 | Blog | By Lauren Moldawer

Last week, ML Strategies released an Advisory providing a comprehensive review of the Republican’s efforts this past year to repeal and replace the Affordable Care Act.  

News & Press

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.
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.