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Tara E. Dwyer

Member

[email protected]

+1.202.585.3504

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Tara enjoys working with managed care organizations, pharmaceutical services providers such as PBMs, and integrated delivery systems, and companies that invest in them, on matters relating to compliance with federal health care program regulations, federal and state fraud, waste and abuse laws and plan benefits.

She works closely with Medicare Advantage Organizations (MAOs) and Medicare Part D Plan Sponsors, including Employer Group Waiver Plans (EGWPs), and first tier and downstream entities to address regulatory and compliance matters that arise as a result of participating in Medicare Parts C and D.  Tara often advises clients on matters relating to plan bids, medical loss ratio reporting, drug pricing in both Medicare Part B and Part D and direct and indirect remuneration (DIR) reporting.  She regularly counsels clients regarding risk adjustment systems and practices needed to support them. Tara also actively engages with CMS on behalf of clients on many matters.

She also works closely with discount medical and pharmacy plan operators (DMPOs) on matters relating to compliance with state laws and provider contracting.

Tara uses her substantive day-to-day compliance experience to assist clients in litigation matters and transactions. 

Tara has extensive experience preparing and negotiating complex services agreements for and between MAOs, providers, PBMs, pharmacies, wholesalers, manufacturers, and DMPOs.     

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In ‘Third Edition: Q2 2024’ of the Mintz IRA Update, we cover updates to the Medicare Drug Price Negotiation Program being considered by CMS, developments in litigation challenging the program, the consequences and costs of redesigning the Part D program, opposition to the use of march-in rights to lower drug prices, and the growing use of state prescription drug affordability boards.

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On July 9, 2024, the Federal Trade Commission (FTC) Office of Policy Planning released an Interim Staff Report titled Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies. The Interim Staff Report reflects the FTC’s work since it began its 6(b) study of PBMs in June 2022.  Mintz’s Health and Antitrust teams actively monitor federal and state regulatory and legislative developments in the PBM space, including those from the FTC. In this Special Edition of the PBM Policy and Legislative Update, the Mintz Health team partnered with our Antitrust colleagues to analyze the Interim Staff Report including Commissioner Melissa Holyoak’s dissenting statement.  We also highlight upcoming Congressional testimony by CEOs of the three largest PBMs, as well as media reports of a forthcoming FTC action related to PBM insulin rebate practices.

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In the Proposed Medicare Advantage and Part D Rules for 2025, the Centers for Medicare & Medicaid Services (CMS) proposed significant changes to how Medicare Advantage organizations (MAOs) are allowed to contract with and compensate entities that provide agent/broker and enrollment services.  The proposed rules were heavily disfavored by entities that provide such services, but were not widely commented on by MAOs or Part D sponsors (PDP Sponsors), which are the entities to which the rules actually apply.

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As part of its 2025 Medicare Advantage and Part D Final Rule (the Final Rule), the Centers for Medicare & Medicaid Services (CMS) finalized a number of regulatory changes relating to how Medicare Advantage (MA) plans offer supplemental benefits and how they communicate such benefits to plan members. As previewed in the Proposed 2025 Rules, the Final Rule outlines CMS’s intentions to (i) more closely monitor the supplemental benefits that a Medicare Advantage organization (MAO) offers and categorizes as "Special Supplemental Benefits" for the Chronically Ill (SSBCI) and (ii) require MA plans to send annual notices to MA plan enrollees regarding their available supplemental benefits.

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Mintz is pleased to present its quarterly publication, PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from October through December 2023 that affects the PBM industry and will specifically highlight (i) federal legislative and enforcement updates, (ii) state legislative updates and litigation, (iii) other industry news, and (iv) Inflation Reduction Act (IRA) updates.

 

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As part of its 2025 Medicare Advantage and Part D Final Rule (the Final Rule), the Centers for Medicare & Medicaid Services (CMS) made a number of enrollment changes impacting dual eligible special needs plans (DSNPs). The goal of these changes is to promote integration of Medicaid and Medicare services for full benefit dually eligible (FBDE) individuals. While stakeholders support the overall goal of better integration, the new policies are complex and may discourage Medicare Advantage Organizations (MAOs) from participating in Medicaid managed care programs in certain regions. They also highlight how a federal DSNP regulation that is tied to how a state contracts with entities that offer Medicaid benefits can result in different impacts in different states.

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On April 23, 2024, the Centers for Medicare & Medicaid Services (CMS) published final rules setting forth Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024--Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program…et alThese sweeping final rules finalized many changes that were introduced in the Proposed 2025 Rules and other changes that were proposed in the Proposed 2024 Rules. The rules will implement changes related to many areas, including, for example, Star Ratings, marketing and communications standards and requirements, agent/broker compensation, health equity, dual eligible special needs plans (D-SNPs), Part D formularies, utilization management, and the Medicare Advantage and Part D application process.

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On February 15, 2024, the Centers for Medicare and Medicaid Services (CMS) released the Medicare Prescription Payment Plan Draft Part Two Guidance (Part Two Guidance) as part of the Inflation Reduction Act’s (IRA) efforts to tackle high prescription drug costs. The Medicare Prescription Payment Part Plan (the Program), which was previously referred to as the “OOP Smoothing Program”, was established as part of the IRA and requires Part D plans (PDPs) to offer their members an option to pay for out-of-pocket (OOP) prescription drug costs in monthly capped payments, as opposed to all at once, at a pharmacy. Meaning, for members who opt-in to the Program, they will pay $0 at the pharmacy and the PDP must pay the pharmacy the full cost-sharing amount of the drug and then bill the member the amount of the cost-sharing over the remainder of the calendar year. 

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In this edition of the Mintz IRA Update, we cover the status of the negotiations underway between CMS and manufacturers pursuant to the Medicare Drug Price Negotiation Program and current legal challenges to the program, other drug pricing–related IRA initiatives, the IRA’s small biotech exemption, implications associated with removing the average manufacturer price cap on Medicaid rebates, and the Biden administration’s proposed draft guidance on patent “march-in” rights.

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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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Member Tara Dwyer spoke to Bloomberg Law and discussed potential roadblocks delaying Medicare's plans for negotiating lower drug prices.

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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 Member Tara Dwyer was quoted in Law360 examining the release of a Health and Human Services rule which prompted backlash and predictions of litigation.

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Mintz Member Tara Dwyer was quoted in a Bloomberg Government article on the passage of the bipartisan infrastructure package and reconciliation bill, which would be paid for in part by delaying a controversial rebate rule – a rule which pharmacy benefit managers and insurers are in stiff opposition to.
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Mintz Member and Chair of the firm’s Employee Benefits & Executive Compensation Practice Alden J. Bianchi and Member Tara E. Dwyer co-authored an article published by Bloomberg Tax & Accounting’s Compensation Planning Journal examining the U.S. Supreme Court’s recent decision in Rutledge v. Pharmaceutical Care Management Association, holding that the Employee Retirement Income Security Act of 1974 (ERISA) does not preempt an Arkansas statute that regulates reimbursement levels paid by Pharmacy Benefit Managers (PBMs) to local pharmacies, and its impact on employer-sponsored group health plans.
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In an article published by Bloomberg Law, Mintz Member Tara E. Dwyer was quoted on the Trump administration’s proposed final rule, which is currently under review by the Office of Management and Budget, that would end legal shields for drug rebates.
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In the latest guide, Mintz garnered rankings as a top national firm in eight practice areas, and 32 firm attorneys were individually recognized.
This feature article discusses a potentially significant change proposed to Medicare Advantage audits by the Centers for Medicare & Medicaid Services (CMS). Health Law Member Tara Dwyer is among the industry sources quoted in the story providing commentary.
Mintz is pleased to announce that eight attorneys have been named Washington, D.C. Super Lawyers for 2018 and three others have been named Washington, D.C. Rising Stars. The annual publication identifies lawyers who have attained a high degree of peer recognition and professional achievement.
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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.
Eight Mintz attorneys have been named Washington, D.C. Super Lawyers for 2017 and four have been named Washington, D.C. Rising Stars. The list will be published in a special advertising supplement in The Washington Post Magazine and in a stand-alone magazine, Washington D.C. Super Lawyers Magazine.
Seven Mintz attorneys have been named Washington, D.C. Super Lawyers for 2015 and five have been named Washington, D.C. Rising Stars. The list will be published in a special advertising supplement in Washington Post Magazine and in a stand-alone Washington D.C. Super Lawyers Magazine.
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Recognition & Awards

  • Best Lawyers in America: Health Care (2024)

  • Chambers USA: District of Columbia – Healthcare (2024)

  • Included on the Washington DC Super Lawyers Rising Stars: Health Care list (2016 - 2021)

  • The Legal 500 United States for Healthcare: Service Providers (2019-2020, 2024)

  • Order of the Coif

  • ABA-BNA Award for Excellence in the Study of Health Law

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