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Case Law, Regulations Don’t Support Individual’s Biospecimen Ownership

June 7, 2017 Media Mentions

Kate Gallin Heffernan, a Partner in Verrill Dana's Health Care Group and Chair of the firm's Academic and Clinical Research Group, was quoted extensively in a July 7 Bloomberg BNA article entitled "Case Law, Regulations Don't Support Individual's Biospeciman Ownership." The article discusses whether or not an individual has any property rights to biological materials taken from their body. Kate points out that "...there is not much support in existing case law for individuals retaining rights in materials that are voluntarily donated for research or otherwise abandoned in the course of medical practice per normal hospital policies and practices."

Firm Highlights

Publication/Podcast

340B Providers Get Partial Relief from New Dispute Resolution Regulation

1. 340B ADR Process Established At long last, more than ten years after Congress directed it to do so, HHS has finalized an alternative dispute resolution (“ADR”) process for both providers and pharmaceutical manufacturers...

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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...

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Hospital Price Transparency Rule: Full Steam Ahead

Neither COVID-19 nor continued legal challenges appear likely to derail the Centers for Medicare & Medicaid Services ( CMS) Hospital Price Transparency Rule from going into effect on January 1, 2021. Hospitals therefore should...

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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...

News

65 Verrill Attorneys Recognized by Best Lawyers® 2022, Including Eight Named Lawyers of the Year

(August 31, 2021) – 65 Verrill attorneys were recognized as "Best Lawyers" by Best Lawyers® 2022 , including 8 attorneys named “Lawyer of the Year,” a distinguished recognition for only a single lawyer in...

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...

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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...

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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...

Publication/Podcast

“If I've told you once, I've told you eight times…” HHS OIG Issues Another Audit Report on Hospitals’ Failure to Report Credits for Explanted Cardiac Devices and Lays the Groundwork Collection of Overpayments

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