Method and system for rapid and secure approval and release of implantable products

A method for assuring compliance with respect to the current and/or revised and/or updated National Coverage Determination implantation indication criteria for implantable medical devices such as pacemakers and defibrillators, as issued by the Center for Medicare Service, comprising

• inputting demographic data for a patient into a computerized system or processor for enrolling and tracking each subscribed institution and each implanting operator or provider to enroll the patient with regard to possible implantation of an implantable medical device;
• quantifying each National Coverage Determination implantation indication into preset source document baskets, each of which entirely satisfies one of the National Coverage Determination implantation indication criteria;
• uploading source data documents and storing said documents in each basket for review and compliance approval prior to said possible implantation;
• independently reviewing and evaluating source documents in said baskets and determining whether each source document meets corresponding implantation indication criteria as determined by the National Coverage Determination;
• approving or disproving a proposed implantation as meeting all of said implantation indication criteria and submitting said approval for secure release of an implantable medical device for the patient;
• and
• generating a secure code for release of said implantable medical device for the approved implantation procedure.

A system for assuring compliance with respect to the National Coverage Determination implantation indication criteria for implantable medical devices such as pacemakers and defibrillators as issued by the Center for Medicare and Medicaid Services, comprising

• a computerized system or processor for enrolling and tracking each subscribed institution and each implanting operator or provider;
• a source of demographic data to be inputted to enroll each patient proposed for an implantation;
• means for quantifying each National Coverage Determination implantation indication criteria into preset source document baskets, each of which entirely satisfies one of the National Coverage Determination implantation indication criteria;
• means for uploading said source data to the computerized system or processor to store said documents into said baskets for review and compliance approval prior to said implantation;
• means to independently review and evaluate said baskets and determine whether the source documents meet the National Coverage Determination implantation indication criteria;
• means for a reviewer to approve or disprove said implantation as meeting all of the implantation indication criteria and to submit said approval for secure release of an implantable medical device for the patient;
• and
• means to generate as secure code for release of said implantable medical device for the approved implantation procedure.

A method for ensuring compliance with guidelines and/or appropriate use criteria as set by national and/or international societies and also in compliance with their geographic governmental regulatory agency or agencies regarding the appropriate implantation of implantable medical devices, which comprises:

• uploading source documentation through a computerized system to a third party evaluation;
• comparing said source documentation with criteria established by national and/or international societies and their geographic governmental regulatory bodies in order to determine whether or not there has been compliance;
• and
• issuing approval documentation if there has been compliance.

A system for ensuring compliance with National Coverage Determination implantation indication criteria regarding the implantation of implantable medical devices, which comprises:

• means to upload source documentation through a computerized system to a third party evaluation;
• means to compare said source documentation with criteria established by the National Coverage Determination Registry to determine whether or not there has been compliance;
• and
• means to issue approval documentation if there has been compliance.