CIS Compliance Blog

By: | On: August 20, 2014 | In: CIS Compliance Blog | Government Programs
CMS issued a warning again today to manufacturers that they will be deleting NDCs from the Medicaid Drug Rebate Program on September 30, 2014 that are not electronically listed with the Food and Drug Administration (FDA). CMS notified the Technical Contacts for manufacturers earlier this year that this “clean...
Rapidly Changing Environment. No one can argue that the US health care system is changing at an epic pace.  Not surprisingly, these changes also impact contracts between pharmaceutical manufacturers and their various trading partners.  The evolving environment around contracts requires that a manufacturer must be willing to do more...
Thou Shalt Have Written Policies and Procedures The PDMA states, “…a manufacturer or authorized distributor of record that distributes drug samples shall establish, maintain, and adhere to written policies and procedures describing its administrative systems…” Written procedures provide the foundation for a sampling program and must include Standard Operating...
A Sample Accountability Program should address many aspects of business: compliance risks, business risks, compliance and ethics considerations and business goals. Interestingly, over the past few years, CIS has seen an increase in medical device manufacturers turning to the policies and procedures used by the pharmaceutical industry as a...
Thou Shalt Make the Program Sustainable After the Program has been implemented, it is imperative that it be maintained and capable of adapting to an ever-changing environment. Program management can be a resource-intensive proposition, but as new legislation passes on the state level, existing regulations are revised, and the...
Thou Shalt Use Data Intelligently Once data is collected effectively and in a compliant manner, and the Program meets all of the compliance requirements, manufacturers are able to leverage the data for other uses. Using the data intelligently allows a manufacturer to realize the most value from the Program....
The drama around Obamacare continues.  If you haven’t heard, two federal appeals panels disagreed on July 22 on the legality of Obamacare subsidies that gave billions of dollars to help 4.7 million people buy insurance on HealthCare.gov.   Of course there are 36 states that decided not to pursue creating...
Thou Shalt Ensure Vendor Compliance Since transparency reporting touches many different business units, compliance to federal and state requirements is especially challenging when managing third-party resources. Often activities managed by third parties such as promotional speaker programs, advisory boards, clinical research and contract sales organizations are impacted by the...
Thou Shalt Enforce Disciplinary and Corrective Actions Aligning the compliance program to OIG Guidelines and meeting the federal and state regulations brings us to Disciplinary and Corrective Actions. Establishing policies and procedures to govern activities sets the foundation for the reporting solution, but having consequences and a plan for...
By: | On: August 5, 2014 | In: CIS Compliance Blog | Clinical R&D
FDA issued a draft revision of the Guidance around Informed Consent on July 15, 2014.  The basics of the new draft document entitled “Informed Consent Information Sheet” remain unchanged from the previous version; the Guidance discusses individual provisions of informed consent regulations pertaining to FDA regulated clinical research (...