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 […]

Sunshine in Your Pocket: CMS Releases Mobile Apps for Tracking and Reviewing OPEN PAYMENTS Data

Industry and physicians preparing to comply with federal sunshine provisions have a new resource available. To facilitate tracking and reviewing OPEN PAYMENTS Data, CMS has released two mobile applications (apps): one for physicians and one for applicable manufacturers and applicable GPOs. Use of the apps is optional and both are available […]

OIG Blesses Tiered Rebate Arrangement

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently determined that a proposed tiered rebate program would not constitute grounds for sanctions under the federal health care program anti-kickback statute (42 U.S.C. § 1320a-7b(b)(7)), or the civil monetary penalty provision of the Social Security Act […]

FDA Continues Enforcement Against Internet Marketing of Unapproved and Misbranded Drugs

EvaPharmacy recently received a Warning Letter from the United States Food and Drug Administration (“FDA”), Office of Drug Security, Integrity and Recalls regarding products available for sale to consumers in the United States on its websites.  The FDA requested that EvaPharmacy take prompt action and notify the FDA within ten […]