CIS Compliance Blog

Corporate decision-making about whether a company should become an “inverted domestic corporation” to avoid some US taxes has recently become national news and a hot topic of political discussion. A prominent example of the agony that such decision-making can create for corporate leadership is apparent in the recent airing...
Thou Shalt Require Accountability The PDMA states, “persons required to create or maintain reports, lists or other records under PDMA…shall retain them…for at least 3 years.” Individual employees are responsible for maintaining their own records and retaining them for three years to comply with the PDMA. However, the District...
Thou Shalt Provide Training A Sample Accountability program is never successful if no one knows about it. Corporate training on sample accountability should minimally include an overview of the federal and state laws, a review of the legal responsibilities, the consequences for noncompliance, and most importantly the administrative requirements....
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...
Thou Shalt Require Employee Compliance The PDMA states, “A manufacturer or authorized distributor of record that has reason to believe that any person has falsified drug sample requests, receipts or records shall conduct a full and complete investigation, and shall notify the FDA…” Any Sample Accountability program is only...
Thou Shalt Have Documentation 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 for…distributing drug samples…including the methodology for reconciliation of requests and receipts…the methodology for their independent sample distribution...
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...