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Pat G. Ouellette

(he/him)

Associate

[email protected]

+1.617.348.4759

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Pat is an attorney who focuses his practice on representing health care organizations and is a Certified Information Privacy Professional–US (CIPP–US). He advises clients on a broad spectrum of health care regulatory, clinical trial, data privacy, PBM, health care technology, and transactional matters. He has experience drafting and negotiating health care services agreements and with technology transactions as well as counseling clients on state licensure rules, compliance with fraud and abuse laws, privacy and data protection issues, and the Interoperability and Information Blocking Rules under the 21st Century Cures Act.

Prior to joining Mintz, Pat was corporate counsel for a Massachusetts-based company that provides products and services to individuals with renal disease. In that role, he provided counsel on a broad range of regulatory and compliance matters and drafted and negotiated acute care and other health services agreements. Earlier, he was an assistant general counsel for information technology with the Massachusetts Executive Office of Health and Human Services, where he negotiated technology transaction agreements and assisted with privacy issues. He also previously worked as an attorney with a Massachusetts-based consulting company focused on health care cost containment.

Pat earned his JD with a concentration in Health & Biomedical Law, with distinction. In law school, he served as chief content editor of Suffolk Law’s Journal of Health & Biomedical Law.

While attending law school, Pat worked in the development office of a teaching hospital affiliated with a preeminent medical school. He also served as a legal intern in the hospital’s Office of the General Counsel and as a certified student attorney with the Massachusetts Executive Office of Health and Human Services.

Before law school, Pat worked as sports writer and an editor for B2B health care and technology publications.

Pat is an editor of and contributor to the firm's Health Care Viewpoints.

viewpoints

As illustrated by a recent Office for Civil Rights (OCR) settlement with a dental practice, health care entities continue to struggle with how to respond to negative online reviews while maintaining compliance with the HIPAA Privacy Rule. Given the significant reputational harm that negative reviews on Yelp and other social media and public platforms (Platforms) can create, providers may be tempted to respond to such negative comments with patient specifics in an attempt to mitigate harm to their businesses.
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The Pandemic Response Accountability Committee (PRAC) Health Care Subgroup recently published an expansive report that highlighted the sheer volume of expanded access to and use of telehealth services in certain federal health care programs during the first year of the COVID-19 pandemic. The report also focused on program integrity risks related to this expanded use and included recommended safeguards for future oversight of telehealth services.
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MintzRx Newsletter — Your Prescription for the Pharmaceutical Supply Chain

October 3, 2022 | Article | By Theresa Carnegie, Tara E. Dwyer, Xavier Hardy, Stephnie John, Bridgette Keller, Lauren Moldawer, Pat Ouellette, Hassan Shaikh

MintzRx is a regular newsletter providing you with everything you need to know to stay abreast of the legal, regulatory, and industry developments across the pharmaceutical supply chain.
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The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has been busy over the past month announcing new enforcement actions and settlement agreements related to violations of the Privacy Rule implemented under the Health Insurance Portability and Accountability Act (HIPAA).  OCR’s latest actions offer a reminder for HIPAA Covered Entities that Privacy Rule enforcement activity can come in a variety of types and sizes.
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Summer 2022: Key Trends in Pharmacy Enforcement Actions

August 29, 2022 | Blog | By Lauren Moldawer, Grady Campion, Pat Ouellette

Pharmacies have long been a focus of enforcement actions brought by the Department of Justice (DOJ) and Department of Health and Human Services Office of Inspector General (OIG). This summer has been no exception, with the DOJ and OIG bringing a number of fraud cases against pharmacies and pharmacists. We also saw enforcement against pharmacies for allegedly falsifying prior authorization information and providing more insulin than the pharmacy billed to payors. This blog summarizes some of these and other key pharmacy enforcement trends this summer.
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Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA)  have recently occurred.  As a result, the clinical laboratory industry is hopeful that Medicare cuts scheduled to resume in 2023 and other aspects of PAMA’s price reporting requirements will be reformed. This blogpost provides an analysis of the ACLA lawsuit and newly introduced legislation that amends PAMA.  
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OIG Approves Manufacturer’s Offer of Free Genetic Testing

April 14, 2022 | Blog | By Karen Lovitch, Theresa Carnegie, Pat Ouellette

The Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a pharmaceutical manufacturer would not result in the imposition of sanctions under the federal Anti-Kickback Statute (AKS) and the beneficiary inducements civil monetary penalty provision (Beneficiary Inducements CMP).  This Advisory Opinion is the first to address this type of arrangement and thus provides useful insight for the health care and life sciences industries.
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The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) released a Request for Information (RFI) to obtain industry feedback and inform potential future rulemaking regarding information security practices and civil money penalties (CMPs) under the Health Information Technology for Economic and Clinical Health (HITECH) Act and the HIPAA Security Rule. OCR is seeking input on how HIPAA covered entities and business associates are operationalizing “recognized security practices” as defined by Public Law 116-321. It is also requesting commentary on the methodologies used to disperse CMPs to individuals harmed by violations of certain privacy or security provisions of the HITECH Act or the Social Security Act, which we will cover in a separate post.
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The United States Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) leadership announced during last week’s HIMSS 2022 Conference that the agencies will be focusing on information blocking enforcement for the remainder of 2022. This blog post discusses the importance of closing the enforcement gap and the development of disincentives for health care providers. 
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News & Press

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Mintz is pleased to announce that 32 attorneys have been named Massachusetts Super Lawyers and 27 attorneys have been named Massachusetts Rising Stars for 2023.
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Mintz Associate Patrick Ouellette co-authored an article published by the American Health Law Association titled "Medicare Advantage and Medicare Part D 2022 Final Rule". 
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Mintz Associate Patrick Ouellette co-authored an article published by Compliance Today titled "'Low-Hanging Fruit' and Other Recent HIPAA Compliance Items".
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Mintz Associate Patrick Ouellette co-authored an article published by The Health Lawyer titled "Analyzing the First Eliminating Kickbacks in Recovery Act (EKRA) Enforcement Action and Its Application to Federal and State False Claims Statutes".
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Mintz Associate Patrick Ouellette authored an article published by Health Law Weekly titled "Comparing and Contrasting AKS and EKRA Safe Harbors: Clinical Lab Impact". 
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Mintz Associate Patrick Ouellette authored an article published by The Self-Insurer titled "The Practical Impact of Ariana M. v. Humana Health Plan of Tex., Inc. on ERISA Denials of Benefits". 
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Mintz Associate Patrick Ouellette authored an article published by Journal of Health & Biomedical Law titled "Class Arguing False Advertising of Health Supplement Meets Sixth Circuit's Moderate Rule 23 Standards".
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Events & Speaking

Recognition & Awards

  • Massachusetts Super Lawyers Rising Stars: Health Care (2023)

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Involvement

  • Member, International Association of Privacy Professionals
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