Reduce Your Target Footprint                                                                             May 2011

 

With dramatic increases in the use of social media, your customers may now have higher expectations for timely access to all your product and service information.  Your proprietary and sensitive information is always under increased scrutiny from regulatory agencies to integrity offices at your customer's organizations. Sensitive information is any information that may lead to legal peril if it is abused or misused.

 

Pharmaceutical and medical device companies are increasingly faced with greater pressures in areas currently under immense regulatory enforcement initiatives that may inadvertently bring increased risks to you and your field sales teams solicited to share your sensitive information such as labeling and reimbursement.

For example, hospital new product forms given to physicians and sales people to complete before they purchase your product often contain fields requesting full accompanying product literature and documentation.  Such requests may easily compromise manufacturer, distributor, and/or supplier compliance. These forms may include request(s) for: product specifications, accompanying literature, competitive information, labeling, clinical support literature, certificates of product training, quality control documentation, instructions for use, contracts, manufacture agreements, consent forms, reimbursement information, coding, pricing, product credentialing, facility credentialing, sales rep credentialing, and stakeholder disclosures.

 

(See Example Here: New Medical Device Request Form )

 

Importantly, these forms nearly always state they are to be signed by physicians yet, are often filled out by sales people for the convenience of the physician.  How can a rep possibly sign for a physician?  How can a physician confidently sign a response they did not create?

 

With broad enforcement power such as Permissive Exclusion where vendor management personnel unknowing of wrongful practices may be personally excluded from Medicare without due process, vendors absolutely must implement effective measures and reduce their enforcement target footprint.

 

The new web-based subscription; YourDocs.net, can provide the perfect tool to easily and inexpensively streamline your compliant response to every day customer information requests. YourDocs allows vendors complete control over the way they share, what they share and under what terms they share sensitive product information.  Recipients are held solely accountable for how they use it, thus, greatly reducing the acquisition of the vendor as a target of accountability.

 

YourDocs subscription based web service is the unique tool your company can implement today for providing medical content and product information to end users.

- YourDocs Team

 

The Lessor Known

Certificates of Medical Necessity

 

  • (April 19th, 2011) A different type of Certificate of Medical Necessity (CMN) is much less known in the general health care compliance environment: certifications in the FDA context.  The FDA uses consent decrees to address regulatory violations, especially of good manufacturing practices. Enforcement is increasingly extending beyond the sales and marketing of pharmaceuticals and medical devices, and into their regulatory and manufacturing functions. In an era of increased vigilance and enforcement activity by the FDA, it is not only corporations that face tough consequences, but also health care providers as they struggle to comply with restrictions on regulated products and to address the challenges and decisions sometimes placed on them as to whether to continue using such products.   (Read More) 
 

Continued Emphasis On Individual Accountability

 

(April 8th, 2011) The OIG worries that some large healthcare enterprises and other providers view themselves as so critical to the healthcare delivery system that they are "Too Big to Fire."  Their answer to this mentality is to force a change on leadership in companies who are not motivated by compliance enforcement by holding individuals accountable for corporate noncompliance on a strict liability basis. They believe that attributing responsibility to individuals at the highest corporate levels will have a strong deterrent effect and thus enhance compliance with healthcare laws.  

 

American Health Lawyers Association, April 08, 2011 Vol. IX Issue 14

 

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