The Centers for Medicare and Medicaid Services (CMS) released guidance back in December regarding the implementation of the Federal Sunshine Law and the proposed timing. Since then, the timeline for formal introduction of the law has been revised by CMS, delaying how soon those manufacturers must begin to collect data for their reports. Rather than requiring the collections to begin on January 1st, CMS will not require them to begin until the issuance of the law’s final ruling.
This law will require manufacturers of drugs, biologics, devices and medical supplies covered under Medicare, Medicaid and the Children’s Health Insurance Program to report payments and other transfers of value made to physicians Read more…
When confronted with an impending storm such as the forecasted Hurricane Irene, many companies find themselves vulnerable and unprepared for loss. This is particularly true in these difficult economic times when there is a greater dependency on a single source location for production capacity, inventory storage, third-party data centers, etc. Additionally, many mid-size companies have not implemented, or even created, a comprehensive business continuity plan to rely on in such instances.
With Hurricane Irene gathering strength and making its way up the East Coast, now is a good time to review your facility’s emergency plan and ensure that copies are accessible off site. Here are other steps to take Read more…
Effective 9/1/10, there are changes to the Federal Drug Law pending in Russia that will have a material effect on the approval and management of clinical trials that are being conducted there. The changes are related to the regulatory approval process being transferred from the Federal Service on Surveillance in Healthcare and Social Development to the Ministry of Health and Social Development. The majority of this criteria is related to investigator sites, mainly to contracts with investigators, investigator experience, patient consents and insurance amounts. Unfortunately, the current version of the law is full of inconsistencies and requires further clarification. Many CROs are still evaluating how these changes will affect studies (specifically on start-up operations) and continue to report any new developments. The relationship between the Insurer, Insured (sponsor) and the Patient (test subject) will be defined in these new proposed regulations which are still pending approval by the Government of the Russian Federation. At this time no such “regulations” have been approved and this continues to be closely monitored.
The Centers for Medicare and Medicaid Services (CMS) released guidance back in December regarding the implementation of the Federal Sunshine Law and the proposed timing. Since then, the timeline for formal introduction of the law has been revised by CMS, delaying how soon those manufacturers must begin to collect data for their reports. Rather than requiring the collections to begin on January 1st, CMS will not require them to begin until the issuance of the law’s final ruling.
