CMS Releases New Information About State Medicaid Drug Utilization Review Practices

On July 30, 2013, the Centers for Medicare & Medicaid Services (“CMS”) posted state annual Medicaid DUR reports for fiscal year 2012.  States are required to complete annual Medicaid drug utilization review (“DUR”) surveys outlining prescribing habits, and describing cost savings generated from state Medicaid DUR programs and their Medicaid program’s […]

Pharmacist’s Snooping Leads to $1.8 Million Verdict in Indiana

On July 26, 2013, an Indiana jury awarded Abigail Hinchy $1.8 million for damages suffered as a result of a Walgreen Co. pharmacist, Audra Peterson,  impermissibly accessing and exposing her confidential medical records.  The Marion County Superior Court jury found that Peterson acted as a Walgreen employee when infringing upon Hinchy’s privacy […]

Additional Transparency for Clinical Trials Announced by Industry Groups

On July 24, 2013, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) announced joint endorsement of the “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.”  These principles applicable to biopharmaceutical companies take effect January 1, […]

HRSA Finalizes 340B Drug Discount Program Orphan Drug Rule – 340B Discounts Available to New Covered Entities for Non-Orphan Indications

On June 22, 2013, the Health Resources and Services Administration (“HRSA”) released its final rule on the exclusion of orphan drugs for certain covered entities under the 340B Drug Discount Program.  The advance copy is currently available for viewing at the Office of the Federal Register Public Inspection Desk, and […]

CMS Publishes FAQs for OPEN PAYMENTS Mobile Apps for Physicians & Industry

As we noted last week, CMS released two mobile apps for tracking reportable payments: one for physicians and one for applicable manufacturers and applicable GPOs. Both are available for download now for iOS (Apple™) and Android™ mobile phones.  New FAQs from CMS provide additional visibility into how CMS envisions physicians and industry using these […]

LITIGATION ROUND-UP

Settlements The U.S. Department of Justice (DOJ) announced on July 18, 2013 that pharmaceutical manufacturer Mallinckrodt LLC agreed to pay $3.5 million to settle a civil False Claims Act suit. The complaint alleged that Mallinckrodt paid illegal kickbacks to health care professionals in the form of speaker honoraria, clinical trials funding, and honoraria […]

U.S. House of Representatives Vote to Delay Employer and Individual Mandates

On July 17, 2013, the U. S. House of Representatives (the “House”) voted on two key provisions of the Affordable Care Act (“ACA”): the employer and individual mandates. The House voted 264-161 on H.R. 2667, the Authority for Mandate Delay Act, to delay the employer mandate for a year.  Additionally, the House voted […]