HRSA Stands By Its Interpretation of 340B Drug Discount Program Orphan Drug Availability, Despite Court Decision Vacating Regulation

The U.S. Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) published today a statement responding to the recent court decision vacating the 340B Drug Discount Program Orphan Drug Rule.  As we previously reported, the D.C. District Court permanently enjoined HRSA from implementing its July 23, 2013 […]

CMS Sunshine Reporting Underway; Additional Resources Available

As previously announced, Phase 2 Sunshine reporting to the Centers for Medicare & Medicaid Services (CMS) of payments and transfers of value provided by pharmaceutical, biotechnology and medical device manufacturers to physicians and teaching hospitals in the Open Payments system is currently underway and available until June 30th.  CMS has released the following three video […]

FDA Releases Two Social Media Guidance Documents

The U.S. Food and Drug Administration (FDA) released today two highly anticipated draft guidance documents: Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices; and Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.

Resource Launch – “Cloud Computing in Healthcare: HIPAA and State Law Challenges”

We are pleased to announce that a new resource has been added to our blog. On May 20, 2014, Cooley sponsored “Cloud Computing in Healthcare: HIPAA and State Law Challenges,” a presentation led by Cooley attorneys Matt Karlyn, Phil Mitchell, and Leah Roffman. The presentation began with a discussion of […]

HHS Attorney Advises to Expect More Aggressive HIPAA Enforcement

Jerome Meites, a chief regional civil rights counsel for the U.S. Department of Health and Human Services (“HHS”), provided important insight into upcoming HIPAA enforcement at the recent American Bar Association conference in Chicago .  Since June 2013, over $10 million has been paid by entities to settle alleged HIPAA violations.  Mr. Meites predicted that, […]

AMA Tackles Conflicts of Interest with Industry

Interactions between health care professionals and industry representatives was a key topic at the American Medical Association (AMA) House of Delegates (HOD) meeting this week. As reported in BNA today (subscription required), the AMA HOD supported a resolution on June 9th that seeks greater consistency among conflicts of interest policies […]

The Deadline for Submitting Comments Regarding the Self-Referral Disclosure Protocol Is Fast Approaching

On May 2, 2014, the Centers for Medicare and Medicaid Services (“CMS”)  published a request for comments relating to the Self-Referral Disclosure Protocol (“SRDP”). The SRDP is a voluntary self-disclosure instrument that allows providers of services and suppliers to disclose actual or potential violations of Section 1877 of the Social […]