Resources
Events

11th Annual mHealth & Telehealth World Summit

July 31, 2019

Boston, Massachusetts 

On Wednesday, July 31, health care and life sciences attorney Jim Roosevelt will be presenting with Laura Koman, an associate at Jones Day in the session "Address the Legal and Regulatory Barriers to Expand Telehealth Capabilities." The session will provide strategies to navigate regulatory issues and optimize your services to elevate your programs to new clinical and financial heights.

For the agenda, visit the event page here.

Firm Highlights

Matter

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.

Publication/Podcast

Massachusetts Final Budget: MassHealth Gains Greater Authority to Negotiate Supplemental Rebates with Pharmaceutical Companies

On July 31, 2019, Governor Charlie Baker signed a $43.3 billion fiscal year 2020 budget (“ General Appropriations Act ”).  Originating from the Conference Committee’s budget, the General Appropriations Act accounts for any vetoes...

Matter

Research Non-Compliance Investigations

Assisted various hospital systems and research institutes with the investigation of alleged non-compliance with applicable U.S. Department of Health and Human Services (HHS) and U.S. Department of Food and Drug Administration (FDA) regulations in...

Publication/Podcast

U.S. Supreme Court Sides with Hospitals in Allina DSH Part C Days Decision

On June 3, 2019, the U.S. Supreme Court (“Court”) issued a 7-1 decision in  Azar v. Allina Health Services , favoring hospitals that had sued the U.S. Department of Health and Human Services (“HHS&rdquo...

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

OIG Proposes Revisions to Anti-Kickback Safe Harbor Regulations Affecting Prescription Drug Rebates

Recently, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a  proposed rule  (“Proposed Rule”) in the  Federal Register  to amend the federal anti-kickback statute safe harbor regulations...

Publication/Podcast

Summer is Here, But Will Your Medicare Outpatient Claims Get Paid?

CMS’  Exact Match  Requirement for Addresses Your hospital may have some corrective work to do over the next few weeks if you want to avoid delays in receiving payment for your Medicare claims for...

Publication/Podcast

Massachusetts Budget Update: Commonwealth Now Waiting on Governor Baker

On July 22, 2019, the Massachusetts House of Representatives (“House”) and Senate Conference Committee (“Conference Committee”) released the Commonwealth’s $43.1 billion fiscal year 2020 budget bill (“ H. 4000 ”). It passed the House...

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.