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LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Arianne Callender
Agencies' recent responses to Senate call for action on physician-owned distributors offer few details on policies. Stakeholders must await CMS rulemaking and OIG study for possible answers.
Presentation | Speech
Stephen Mahinka
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Phoebe Mounts, M. Elizabeth Bierman, Michele Buenafe
On July 27, the Food and Drug Administration (FDA) issued a draft guidance titled "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device."[1] Once ... more
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
M. Elizabeth Bierman, Michele Buenafe
On July 19, the Food and Drug Administration (FDA) issued a new draft guidance document, titled Mobile Medical Applications , describing FDA's position on the regulation of mobile applications, i.e., software applications inten... more
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Life Sciences and Healthcare Practice
On June 23, the U.S. Supreme Court issued a 6–3 decision in Sorrell v. IMS Health Inc., declaring a Vermont law designed to prevent data mining unconstitutional. The Vermont Prescription Confidentiality Law at issue restr... more
Presentation | Speech
Donna Lee Yesner
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Arianne Callender, Howard Young
In a strong signal that physician-owned distributors (PODs) may be in the line of enforcement fire, on June 9, five senators, representing the Committees on Finance, Aging, and Judiciary (Committees), signed joint letters to the... more
Outside Publication | Article
Kathleen McDermott, Arianne Callender
Outside Publication | Article
Heather Deixler, W. Reece Hirsch
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
FDA & Healthcare, Life Sciences, and Employee Benefits Practices
On May 31, the U.S. Department of Health and Human Services (HHS) released a notice of proposed rulemaking (Proposed Rule) creating a new requirement that covered entities produce an "access report" informing individuals of all ... more
LawFlash/Client Alert | FDA and Healthcare LawFlash
Howard Young, Daniele Capasso, Albert Shay
Recently, in United States v. Borrasi ,[1] the Seventh Circuit aligned with the Third, Fifth, Ninth, and Tenth Circuits in determining that the Anti-Kickback Statute (AKS)more
Presentation | Speech
Howard Young
LawFlash/Client Alert | FDA and Healthcare LawFlash
Lee Rosebush, Kathleen McDermott, Michele Buenafe
The State of Vermont regulates expenditures and gifts to healthcare professionals and entities by manufacturers of prescribed products (medical device, pharmaceutical, and biological products entities). Such entities with repor... more
LawFlash/Client Alert | FDA and Healthcare LawFlash
Kathleen McDermott, Arianne Callender
The U.S. Department of Health and Human Services (HHS) Office of Inspector General's (OIG's) Health Care Fraud Prevention and Enforcement Action Team (HEAT) has garnered headlines for its coordinated Medicare fraud criminal swee... more
Presentation | Speech
Stephen Mahinka
Presentation | Webinar
Kathleen McDermott
Morgan Lewis partner Katie McDermott participated in AHLA's hosted webinar on "Medicare ACOs: Details From the Fraud and Abuse Perspective" on May 24, 2011. The much-anticipated proposed regulations regarding the Medicare Shared ... more
LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen Sanzo, Phoebe Mounts, Lee Rosebush, Stephen Mahinka
On May 10, the Food and Drug Administration (FDA) issued a Federal Register notice requesting comments relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitt... more
LawFlash/Client Alert | FDA and Healthcare LawFlash
Phoebe Mounts, Jacqueline Berman
The Food and Drug Administration (FDA) has issued a proposed rule which, if finalized, will expand the scope and consequences of clinical investigator disqualifications. [1] Under the propose... more
Presentation | Speech
Robin Silva
Presentation | Speech
Stephen Mahinka, Richard Aldridge
LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Andrew Ruskin
With the passage of the Patient Protection and Affordable Care Act (the Healthcare Reform Law) three months ago, pharmaceutical manufacturers are continuing to assess how the changes to their price-reporting responsibilities are... more
LawFlash/Client Alert | Tax LawFlash
Gary Wilcox
On May 21, 2010, the U.S. Department of the Treasury (Treasury) issued Notice 2010-45 (the Guidance), [1] which outlines the procedures for obtaining a valuable new 50% tax credit or equival... more
Presentation | Speech
Stephen Mahinka, Joyce Cowan
Presentation | Webinar
John McAleese, III, J.J. Broderick
LawFlash/Client Alert | Washington Government Relations and Public Policy LawFlash
Scott Memmott, Howard Young
With the passage of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care Education Reconciliation Act of 2010 (the Healthcare Reform Law), Congress for the first time has mandated that a broad ra... more