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

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...

Publication/Podcast

More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries

The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to...

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...

News

39 Verrill Attorneys Named 2019 Super Lawyers and Rising Stars

Verrill Attorney Karen Frink Wolf Again Named One of New England’s Top 100 Attorneys and Top 50 Women Attorneys (December 11, 2019) – The 2019 edition of New England Super Lawyers and Rising Stars...

Matter

Conflicts of Interest

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

Publication/Podcast

CMS Cracking Down on Health Care Fraud and Abuse

To increase provider and supplier transparency and accountability, the Centers for Medicare & Medicaid Services (CMS) recently issued a final rule (Final Rule) with comment period that allows CMS greater ability to prevent fraud...

Publication/Podcast

Keep Medicare Enrollment Information Correct and Current or Suffer Consequences

While most providers understand the need to bill Medicare correctly, many often fail to recognize the potentially disastrous results of not keeping Medicare informed of your correct and up-to-date practice information . A recent...

News

Verrill Welcomes Health Care Attorney Sarah V. Ferranti

Sarah V. Ferranti
Publication/Podcast

Avoid Rejection: Make Sure Your Medicare Cost Report is Properly Completed

As the calendar year draws to a close, hospitals with a 9/30 fiscal year end are working intensely on completing their FY 2019 Medicare cost reports. This seemed like a good time to remind...

News

Michael K. Fee to Lead Verrill’s Health Care and Life Sciences Defense Practice

(January 22, 2020) – Verrill is pleased to welcome Michael K. Fee to the firm’s Boston office as a Partner in its nationally recognized Health Care & Life Sciences Group and as the leader...