Shire Corporate Integrity Agreement: New Payment Disclosure Requirements
We recently wrote about Shire’s $56.5 million settlement to resolve False Claims Act allegations involving the company’s ADHD…
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Physician Payments Sunshine Act: CMS Extends Data Correction to October 31,…
The Centers for Medicare and Medicaid Services (CMS) made a number of announcements related to their Open Payments…
Can Silicon Valley and FDA Work Together?
Silicon Valley has been interested in the healthcare industry for many years. Genetic testing startup 23andMe’s battle with the…
Drug and Device Companies Critical Of FDA’s Guidance Development
Recently, the Combination Products Coalition ("CPC") wrote a letter to Leslie Kux, FDA's Assistant Commissioner for…
Minimally Invasive Surgery: Educating Surgeons Though Proctorships
The benefits of minimally invasive surgery (MIS), surgery done through one or more tiny incisions rather than one large opening,…
ICD-10: HHS Officially Delays Compliance Deadline to October 1, 2015; CMS…
In August, the Department of Health and Human Services (HHS) issued a final rule which delayed the transition to ICD-10 until …
Hospital Compare: Controversy Surrounds What to Report
Our continued coverage of the CMS Open Payments website includes transparency-related issues regarding the Physical…
RICO: Offering Co-Pay Coupons Does Not Constitute A Racketeering…
Pharmaceutical manufacturer co-payment coupons have come under a lot of scrutiny recently. HHS-OIG recently warned these coupons…
Clinical Trial Transparency: Starting Jan. 1, 2015, European Medicines…
On October 2, 2014, the European Medicines Agency (EMA) unanimously voted to publish the clinical reports “that underpin…
Secretary Burwell Addresses Open Payments: The Data Wasn’t Perfect, But…
The Secretary of the Department of Health and Human Services, Sylvia Burwell, yesterday held a press conference on…