Experience

European Union GDPR—Institution

Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies.

Conflicts of Interest

Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.

Multi-Site Global Research

Developed and negotiated site and coordinating center agreements in connection with a multi-site, international, National Institutes of Health (NIH)-funded study, and advised on regulatory issues related to the conduct of the study and subsequent government review of NIH funding activities.

Common Rule

Guided multiple clients through the implementation of the revised HHS regulations (the "Common Rule"), including reviewing and revising policies and procedures, and assisting with institutional approaches to implementation.

FDA Advertising/Promotion

Presented to senior executives and other management of a start-up pharmaceutical company on complying with the FDA advertising and promotion requirements pre- and post-launch.

On-Site Counsel

Served as on-site, long-term legal counsel for various clients, including pharmaceutical and device companies during times of staffing shortage at the clients.

Informed Consent Form Templates

Developed 23 different types of global research informed consent templates for a major pharmaceutical company along with detailed negotiation guidelines for compliance with applicable laws and best practices.

European Union GDPR—Pharmaceutical Company

Advised pharmaceutical company on all aspects of compliance with the GDPR, including gap analysis, policy and procedure development, and vendor and other third party contract revisions.

Government Enforcement

Obtained a jury verdict in federal court for a qui tam whistleblower against a medical device company that had retaliated against our client for filing a qui tam lawsuit under the False Claims Act, which resulted in the federal Medicare and California Medicaid programs recovering in excess of $25 million.

Medicaid Appeal

Developed and prosecuted coordinated Medicaid appeals and litigation on behalf of a group of hospitals that resulted in a landmark settlement of approximately $95 million with the State.

Health Information Exchange

Worked on behalf of a client to effect statutory changes to a state law that would allow for the creation of one of the nation's first state-wide health information exchanges.

Health System Affiliation

Acted as corporate counsel to a large health system during a major affiliation, negotiating deal documents and advising on structural and various legal issues, which ultimately lead to the creation of the second largest non-profit health system in New England.

Payor-Provider Joint Venture

Worked with an insurance company and a network of primary care practices to create a joint venture, providing patients with access to high-quality, personalized health care in a community setting.

Sale of Teaching/Community Hospital

Assisted with the sale of a 500-bed teaching and community hospital to the teaching hospital of a major university, making this hospital system one of the largest in the country.

Appellate Tax Board Decision Appeal

Represented a trade association, on behalf of a health insurer, before the state Supreme Judicial Court in a successful appeal of an Appellate Tax Board decision.

Sale of Nursing College

Worked with a hospital in the sale of its nursing college to a nearby university, including negotiation of a management agreement to allow the university to operate the college pending regulatory approvals.

Acquisition of Urgent Care Centers

Represented a private equity group in acquiring the stock of two entities which owned 13 urgent care centers.

Corporate Governance

Assisted a tax-exempt health care organization to draft new bylaws following extensive discussions with board committees and the full board to assure that both the mission and governance structure of the organization were fully captured in the new bylaws.

Firm Highlights

News

Verrill Welcomes Health Care Attorney Alicia Siani

(February 2, 2021) – Verrill is pleased to welcome health care attorney Alicia Siani to the firm’s Boston, Massachusetts office. Siani represents clients in a wide range of regulatory issues, including HIPAA privacy matters...

Matter

European Union GDPR—Institution

Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies...

News

Verrill Ranked in American Bar Association’s Health Law Top 10 in the Northeast

(January 19, 2021) – Verrill was recently ranked third in the American Bar Association (ABA) Health Law Section's Eighth Annual Top 10 Recognition for the Northeast Region. This is the sixth consecutive year that...

Publication/Podcast

HHS Confirms Providers’ Right to 340B Discount Pricing for Contract Pharmacies

As a holiday gift to providers, the U.S. Department of Health and Human Services (HHS) General Counsel recently issued a strongly worded Advisory Opinion indicating that federal law requires drug manufacturers to deliver covered...

Publication/Podcast

Massachusetts Health Care Bill Makes Several Significant Changes

While you were celebrating the New Year, Governor Baker signed Chapter 260 of the Acts of 2020, an “Act promoting a resilient health care system that puts patients first,” the result of the Legislature’s...

Publication/Podcast

Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition.

Health care attorney Paul Shaw co-authored Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition with Robert Griffith, published by the American Health Law Association (AHLA). Paul and Robert provide legal...

Matter

Multi-Site Global Research

Developed and negotiated site and coordinating center agreements in connection with a multi-site, international, National Institutes of Health (NIH)-funded study, and advised on regulatory issues related to the conduct of the study and subsequent...

Matter

Conflicts of Interest

Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.

News

Verrill Welcomes Jeffrey A. Smagula, Experienced Health Care and Life Sciences Attorney, Former Health Plan Compliance Executive

(May 12, 2021) – Verrill is pleased to welcome Jeffrey A. Smagula to the firm’s Boston office as Counsel in its nationally recognized Health Care & Life Sciences Group. Jeff Smagula brings to Verrill...

Publication/Podcast

The Regulatory Sprint is Over - What’s at the Finish Line Under the New Stark and AKS Final Rules?

The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare...

Contact Verrill at (855) 307 0700