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Madison M. Castle

Associate

[email protected]

+1.202.434.7309

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Madison focuses her practice on health care regulatory, transactional, privacy, and compliance matters. She represents clients across the health care sector, including providers, physician organizations, PBMs, pharmacies, and health care systems. 

While earning her JD, Madison served as an extern at the Center for Scientific Responsibility and Justice, which is part of the American Association for the Advancement of Science. In that role, she conducted legal research for amicus briefs concerning topics at the intersection of science and civil rights, including race, sex, and disability discrimination in STEM education and employment. She also interned with the National Health Law Program (NHeLP), where she researched state Medicaid program requirements, the Affordable Care Act and related case law. During her time at NHeLP she also prepared a legal memorandum analyzing nonprofit hospitals' charity care spending. In addition, while working as a law clerk for Health Law Advocates, Madison conducted research on and assisted with cases involving Medicaid coverage.

In law school, Madison earned a JD with a concentration in Health Law. She also served as a student attorney at GW Law’s Health Rights Law Clinic and an Administrative Law teaching assistant.

viewpoints

PBM Policy and Legislative Update — Winter 2024

April 9, 2024 | Blog | By Theresa Carnegie, Tara E. Dwyer, Rachel A. Alexander, Bridgette Keller, Madison Castle, David Gilboa, Xavier Hardy, Abdie Santiago, Hassan Shaikh, Sophia Temis

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CMS Releases Part Two of Guidance for the Inflation Reduction Act’s Medicare Prescription Payment Plan

February 27, 2024 | Blog | By Tara E. Dwyer, Lauren Moldawer, Madison Castle

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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Mintz IRA Update — Removal of AMP-Cap on Medicaid Rebates Causes Insulin Price Decrease

February 21, 2024 | Blog | By Bridgette Keller, Madison Castle, Abdie Santiago

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Mintz IRA Update — Second Edition: Q1 2024

February 21, 2024 | Blog | By Rachel A. Alexander, Theresa Carnegie, Tara E. Dwyer, Madison Castle, Mitchell Clough, Xavier Hardy, Stephnie John, Bridgette Keller, Abdie Santiago, Hassan Shaikh

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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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OCR Releases Long Awaited Final Rule Regarding the Conscience Protections for Religious and Moral Objections in Health Care

January 29, 2024 | Blog | By Madison Castle, Kathryn Edgerton, Maya Lytje, Matthew Tikhonovsky, Rachel Wang

On January 11, 2024, the Office of Civil Rights (OCR) issued its highly anticipated Final Rule regarding conscience protections. The Final Rule clarifies the religious beliefs and moral convictions protections practitioners and entities may assert in their health care practices. The Final Rule, entitled Safeguarding the Rights of Conscience as Protected by Federal Statutes, becomes effective March 11, 2024.
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Health Care Privacy and Security in 2024: Six Critical Topics to Watch

January 25, 2024 | Blog | By Dianne Bourque, Madison Castle, Lara Compton, Ellen Janos, Pat Ouellette, Cassandra Paolillo

As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages of federal agency movement to align the regulatory environment with modern health care delivery, cutting-edge technologies, and innovative data-sharing techniques. Some of this work has been done in the form of federal agency guidance in which health care organizations will be looking for additional updates and there are also a handful of pending U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) proposals that call for substantial changes to the HIPAA Privacy Rule.
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Looking Back and Moving Forward: MoCRA Regulatory Developments Ring in the New Year

January 2, 2024 | Blog | By Madison Castle, Joanne Hawana, Jean D. Mancheno

A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation efforts steadily increased throughout the calendar year, as the December 29, 2023 compliance date for most MoCRA provisions approached, FDA’s release of information and deployment of new systems for the industry came to a climax. Several recent MoCRA-related developments will influence how cosmetic industry stakeholders, consumers, and even the FDA will approach and navigate the law’s requirements over the next year. In this blog post, we will discuss each of these developments and forecast the law’s future as we move into 2024.
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Since the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law, cosmetics companies have spent the past year preparing to comply with its provisions. This includes the facility registration and cosmetic product listing requirements that have were mandated by Congress in the new law. Under MoCRA, the statutory deadline for meeting these foundational requirements is set at December 29, 2023 (one year after MoCRA’s enactment). However, on November 8, 2023, the Food and Drug Administration (FDA) issued Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (Compliance Guidance) and announced that enforcement of facility registration and cosmetic product listing requirements will be delayed six months.
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Publications

  • Co-author, “California Health Programs Must Take Steps to Implement Non-Binary Gender Markers,” National Health Law Program (July 2022)
  • Co-author: "HIPAA happenings: 2023 year in review." Compliance Today (March 2024)
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