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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
The OIG Issues New FAQs on Financial Assistance Policies and Marketing to Patients
July 18, 2024 | Blog | By Rachel Yount, Madison Castle
On July 8, 2024, the Office of Inspector General (OIG) updated its General Questions on Fraud and Abuse Authorities (FAQs) related to the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Prohibition of Civil Monetary Penalties Law (CMPL) with clarifications regarding waiving patients’ cost-sharing amounts pursuant to health care providers’ financial assistance policies. The new FAQs (FAQs #13-16) reiterate the OIG’s longstanding position that hospitals and other health care providers may provide financial assistance to Medicare and Medicaid beneficiaries on the basis of financial need. Of note, the OIG also provides some guidance on the distinction between marketing and advertising to patients as opposed to making patients aware about the availability of financial assistance, and this guidance may be useful in a variety of contexts beyond cost-sharing waivers.
Mintz IRA Update — Learning From Experience: Medicare Drug Price Negotiation Program Updates
July 15, 2024 | Blog | By Stephnie John, Samantha Hawkins, Madison Castle
Mintz IRA Update — The Growing Use of State Prescription Drug Affordability Boards
July 15, 2024 | Blog | By Madison Castle
Mintz IRA Update — Third Edition: Q2 2024
July 15, 2024 | Blog | By Rachel A. Alexander, Theresa Carnegie, Madison Castle, Mitchell Clough, Tara E. Dwyer, David Gilboa, Xavier Hardy, Samantha Hawkins, Stephnie John, Bridgette Keller, Lauren Moldawer, Abdie Santiago, Hassan Shaikh
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.
The Uncertain Landscape of Medicare Agent/Broker Compensation Rules
July 11, 2024 | Blog | By Tara E. Dwyer, Xavier Hardy, Madison Castle
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.
Court Split Creates Uncertainty Around Enforcement of the No Surprises Act
June 20, 2024 | Blog | By Cassandra Paolillo, Madison Castle
A recent court split about whether awards granted through arbitration under the No Surprises Act (NSA) are enforceable through litigation has created uncertainty around an already complicated process. A Texas judge recently held that the NSA does not grant parties a right to bring suit to enforce arbitration awards, while last year a New Jersey court granted enforcement of a similar award. The resulting split raises questions about the enforceability and utility of the NSA and its Independent Dispute Resolution (IDR) process.
National Academies of Science, Engineering, and Medicine Issues Report on Inclusion of Pregnant and Lactating Persons in Clinical Research
May 8, 2024 | Blog | By Madison Castle, Kate Stewart
Last month, the National Academies of Science, Engineering, and Medicine (“NASEM”) issued a report discussing the inclusion of pregnant and lactating people in clinical research and the health impacts of inadequate data from research involving this subpopulation. Titled “Advancing Clinical Research with Pregnant and Lactating Persons: Overcoming Real and Perceived Liability Risks,” the report came as a response to Congress calling upon NASEM to examine the real and perceived prevalence of legal liability resulting from including these research subjects in clinical trials. Overall, the report concluded that legal liability for including pregnant and lactating persons in research is very limited, but that perceptions of potential liability and a lack of explicit guidance for including this population safely have created real barriers to their inclusion. In response, the report provides recommended actions for Congress, the Food and Drug Administration (“FDA”), the National Institutes of Health (“NIH”), and the Office of Human Research Protections (“OHRP”) to take to enhance the inclusion of this population in clinical trials, thereby enhancing data around the safety and efficacy of approved drug products for pregnant and lactating persons. Study sponsors and institutions conducting research should continue to monitor developments in this area, including guidance from FDA.
PBM Policy and Legislative Update — Winter 2024
May 2, 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
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.
Unpacking CMS’s 2025 DSNP Changes: Considerations for Medicare Advantage Organizations
May 1, 2024 | Blog | By Tara E. Dwyer, Lauren Moldawer, Madison Castle
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.
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.
News & Press
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)