Subcommittee on Oversight and Investigations Holds “Medicare Program Integrity: Screening Out Errors, Fraud and Abuse” Hearing

On June 25, 2014, the U.S. House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing, “Medicare Program Integrity: Screening Out Errors, Fraud, and Abuse.” During the hearing, subcommittee members heard testimony from administration officials from the Centers for Medicare and Medicaid Services (“CMS”), the Office of Inspector […]

Health System Agrees to Pay $800,000 following Improper Disclosure of Medical Records

This week, Parkview Health System, Inc. (“Parkview”) agreed to pay $800,000 and enter into a Corrective Action Plan to settle allegations that Parkview violated the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  In 2008, Parkview took custody of between 5,000 and 8,000 medical records of patients for a retiring physician in order […]

CMS Releases New Open Payments FAQs

The Centers for Medicare & Medicaid Services (CMS) released this week 28 new frequently asked questions (FAQs) related to reporting payments and transfers of value provided by applicable manufacturers and group purchasing organizations (GPOs) to physicians and teaching hospitals in connection with the federal Sunshine law.  The FAQs generally relate […]

HHS Issues Reports on HIPAA Breaches and HIPAA Compliance

Last week, the U.S. Department of Health and Human Services (“HHS”) released two reports to Congress, pursuant to its obligations under the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”): a report on Breaches of Unsecured Protected Health Information for 2011 – 2012 (the “Breach Report”) and a […]

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.