No Doubt About It: Sunshine Reporting Will Draw Interest

Since the introduction of the Sunshine Act legislation several years ago, one question has been whether transparency will impact relationships between pharmaceutical and medical device manufacturers and health care providers and entities.  Others have wondered whether patients, enforcement authorities and the public at large will be interested in the reported data.  While these […]

CBO Estimates Employer Mandate and Related ACA Delays To Cost $12 Billion

On July 30, 2013, the Congressional Budget Office (“CBO”) and the Joint Committee on Taxation (“JCT”) raised their estimate of the 10-year net cost of the health insurance coverage provisions under the Affordable Care Act (“ACA”) by $12 billion to $1,375 billion.  At the request of Congressman Paul Ryan, Chairman of […]

Grassley Letter to Walgreens Expresses Interest in 340B Contract Pharmacy Arrangments

On July 31, 2013, Senator Chuck Grassley (R-IA), Ranking Member of the Senate Judiciary Committee, sent a letter to Walgreens, Inc., requesting additional information about the pharmacy chain’s participation as a contract pharmacy in the 340B Drug Discount Program.  While the letter does not allege any wrongdoing by Walgreens, it […]

TIME IS UP! Sunshine Data Tracking Starts Today

The day long awaited by the health care industry has finally arrived.  Today is the day that pharmaceutical, biotechnology and medical device manufacturers and group purchasing organizations (GPOs) must begin tracking payments and other transfers of value provided to “covered recipients” in accordance with Section 6002 of the Affordable Care Act (commonly […]

HHS Requests Information Regarding the Affordable Care Act’s Nondiscrimination Requirements

On August 1, 2013, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) published a Request for Information (“RFI”) regarding the nondiscrimination provisions set forth in Section 1557 of the Affordable Care Act (“ACA”). This Section prohibits discrimination on the basis of race, […]

Wyeth’s $491 Million Fraud Settlement

The U.S. Department of Justice (DOJ) announced on July 30, 2013 that it had reached a settlement with Wyeth Pharmaceuticals to resolve criminal and civil liability related to the unlawful marketing of its prescription drug Rapamune for uses not approved by the U.S. Food and Drug Administration (FDA) that caused false claims to be submitted […]

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 […]