Michelle focuses her practice on life sciences and health care transactions and health care compliance matters.
She advises pharmacies, PBMs, plans, and other stakeholders on a variety of drug supply chain issues. Michelle has experience drafting and negotiating PBM services agreements, rebate contracts, pharmacy services agreements, clinical trial agreements, and pharmaceutical support services contracts.
Michelle counsels clients on HIPAA compliance issues and represents clients before regulators in HIPAA compliance matters.
Prior to joining Mintz, Michelle was an associate in the Government Contracts group and subsequently the Health Care Regulatory group of another large law firm, where she advised clients on a variety of regulatory and compliance issues. Michelle drafted, reviewed, and negotiated contracts relating to specialty pharmacy services and distribution arrangements, 340B program participation, pharmaceutical support services, and related matters. She also worked on health care transactions, drafted organizational policies and procedures, and prepared communications to the Food and Drug Administration.
While in law school, Michelle was a legal intern with the Department of Homeland Security, first in Immigration and Customs Enforcement and later in the Transportation Security Administration.
Before pursuing her legal career, Michelle held project management positions for companies in Oregon and Maine.
Education
- George Mason University (JD, magna cum laude)
- University of Maine (BA, summa cum laude)
Involvement
- Member, American Health Lawyers Association
- Member, American Bar Association
- Member, Military Spouse J.D. Network
Recent Insights
Viewpoints
HIPAA 2021 – What Can We Expect?
December 28, 2020 |Blog
HHS Keeps On Sprinting with Proposed Modifications to the HIPAA Privacy Rule
December 14, 2020 |Blog
Viewpoints
Providers May Contact Recovered COVID-19 Patients About Blood and Plasma Donation, According to OCR Guidance
June 17, 2020 | Blog | By Michelle Caton
Late last week, the Department of Health and Human Services’ Office for Civil Rights (OCR) issued guidance aimed at “making sure misconceptions about HIPAA do not get in the way of a promising COVID-19 response,” according to OCR Director Roger Severino. That “promising response” relates to emerging evidence that plasma from recovered patients (often referred to as “convalescent plasma”) may contain antibodies to SARS-CoV-2, the virus that causes COVID-19. Those antibodies could be useful in treating individuals who are sick with COVID-19. The OCR’s guidance addresses how health care providers may contact, in a HIPAA-compliant manner, recovered COVID-19 patients to provide them with information about donating blood and plasma to potentially help other COVID-19 patients.
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Massive House Bill Proposes Mandatory Coverage of COVID-19 Vaccines and Therapies
May 18, 2020 | Blog | By Theresa Carnegie, Michelle Caton
As the COVID-19 public health crisis continues, it is sometimes easy to forget what issues were at the forefront of our national conversation before the pandemic. It was mere months ago when Congress appeared to be edging closer to a deal on legislation addressing drug pricing. While the focus on drug pricing issues may have shifted of late, the American public’s access to drugs—and, more recently, vaccines—remains a critical public health issue, perhaps now more than ever. As Congress works feverishly to pass legislation to mitigate the effects of the COVID-19 crisis, it remains to be seen what will come of the various drug pricing proposals that were being debated earlier this session. For now, it looks like any legislative action to enhance patients’ access to drug therapies will likely come through a coronavirus-related stimulus bill, such as the one introduced by the House of Representatives last week.
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In Case You Missed It: COVID-19 Webinars to Keep You Informed
April 24, 2020 | Blog | By Michelle Caton
The ongoing COVID-19 pandemic has introduced uncertainty and unique challenges in nearly every aspect of life. During this unprecedented time, Mintz is working to keep our clients and community informed and empowered to navigate this new world. To that end, we’ve created a number of webinars on a variety of COVID-19-related topics of interest to health care industry stakeholders. In case you missed them, here’s a highlights reel of what we’ve covered so far – just click on the links below to access the webinar recordings.
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Clinical Trial Results Will See Daylight After HHS Final Rule Is Set Aside
March 5, 2020 | Blog | By Michelle Caton
Some clinical trial sponsors and principal investigators will be digging through their archives soon as a result of a recent ruling in the case of Seife v. U.S. Department of Health and Human Services, case number 1:18-cv-11462 (S.D.N.Y. 2018). In Seife, the plaintiffs – an investigative journalist and a former Associate Commissioner at the Food and Drug Administration (FDA) – challenged a Department of Health and Human Services (HHS) final rule that implemented clinical trial reporting requirements mandated by the Food and Drug Administration Amendments Act (FDAAA).
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FDA Issues Drug Shortage Report Identifying Root Causes and Potential Solutions
November 7, 2019 | Blog | By Michelle Caton, Elizabeth Conti
Despite congressional attention, Food and Drug Administration (FDA) action, public and private sector efforts, and ongoing media coverage, drug shortages remain a significant public health crisis in the United States. In response to that crisis (and at Congress’s urging), the FDA formed the interagency Drug Shortages Task Force (Task Force) to study the issue. FDA has now released the report resulting from the Task Force’s activities: “Drug Shortages: Root Causes and Potential Solutions.” The report, issued on October 29, 2019, concludes that drug shortages are primarily the consequence of economic factors driven by private and public business practices. Those practices, according to the report, disrupt the supply chain availability of marketed pharmaceuticals. The report offers recommendations to provide a framework for stakeholders to address the underlying economic factors leading to drug shortages.
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HHS Proposes Sweeping Changes to AKS and Stark Law, Part 1: Value-Based Arrangements
October 15, 2019 | Blog | By Theresa Carnegie, Rachel Yount, Michelle Caton
As we reported last week, the Department of Health & Human Services (HHS) recently issued two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that, if finalized, would implement sweeping changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). The proposed rules seek to reduce barriers to value-based contracting in several ways, including: (1) creating new safe harbors to the AKS; (2) adding new exceptions to the Stark Law; and (3) retooling existing AKS safe harbors, along with the Civil Monetary Penalties rules regarding beneficiary inducements. Below are key takeaways from both the OIG’s and the CMS’s proposed rules as they relate to the new value-based arrangements safe harbors and Stark Law exceptions.
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Senate Finance Committee Passes Drug Pricing Bill
July 30, 2019 | Blog | By Theresa Carnegie, Ellyn Sternfield, Michelle Caton
Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), Chairman and Ranking Member (respectively) of the Senate Finance Committee, have fired the latest shot in Congress’s ongoing battle against high drug prices. Last week, the Senators introduced their much-anticipated proposal to lower drug prices: a chairman’s mark called the Prescription Drug Pricing Reduction Act (PDPRA) of 2019.
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Heritage Pharmaceuticals Admits to Generic Drug Price Fixing Scheme
June 13, 2019 | Blog | By Michelle Caton, Farrah Short
In the latest development in the Department of Justice (DOJ) Antitrust Division’s ongoing investigation into the generic pharmaceutical industry, Heritage Pharmaceuticals, Inc. has entered into a deferred prosecution agreement (DPA) with DOJ. The terms of the DPA require Heritage to pay a $225,000 criminal penalty and provide full cooperation with the ongoing investigation. The one-count felony charge, filed in the Eastern District of Pennsylvania on May 30, alleges that Heritage violated Section 1 of the Sherman Act by conspiring with multiple unnamed parties to divide up the domestic market and fix prices for glyburide, a diabetes medication, from April 2014 through December 2015. According to DOJ, the DPA provides that the United States will not prosecute Heritage for three years.
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Maryland’s Prescription Drug Affordability Board Bill Set to Take Effect
May 28, 2019 | Blog | By Michelle Caton
In the ongoing public dialogue about prescription drug affordability, Maryland seems poised to lead the way for states considering a new way to rein in drug spending: drug affordability boards.
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Five Takeaways from the Senate Finance Committee’s Hearing on Drug Pricing
March 4, 2019 | Blog | By Michelle Caton
On February 26, 2019, the Senate Finance Committee heard testimony from top executives representing seven high-profile drug manufacturers. This hearing was the second to examine drug pricing in America. The Committee’s questions to executives from Pfizer, Merck & Co., Johnson & Johnson, AbbVie, Bristol-Myers Squibb, Sanofi, and AstraZeneca were aimed at identifying why already-high drug prices continue to climb and what can be done to stop the trend. The hearing comes during a period of increasing pressure on pharmaceutical manufacturers and others in the drug supply chain to improve patient access to drugs, increase transparency in drug pricing, and stop the trend of significant price increases. This type of high profile hearing just confirms that these pressures will continue, and as a number of proposals to address drug prices work their way through Congress and multiple federal agencies, the discussion around drug pricing reforms will undoubtedly continue. Following on ML Strategies’ coverage of the Senate hearing, below are a handful of key takeaways from the hearing.
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