BSRC Update BSCOE Program Requirements
Novemeber 10, 2006

The Bariatric Surgery Review Committee (BSRC) met in October and made the following decisions affecting the Bariatric Surgery Centers of Excellence® (BSCOE) program requirements. All decisions are effective immediately unless otherwise noted.

BSCOE requirements are re-evaluated and clarified by the BSRC on a regular basis to eliminate confusion, solidify requirements and strengthen the quality of the program.

Requirement Two: Applicant Fast-tracking Process Added
Fast-tracking of applications will be permitted in situations where a fully approved BSCOE surgeon has relocated to a non-BSCOE hospital. A non-BSCOE hospital may apply with a BSCOE surgeon for Full Approval if it performs 63 cases (approximately half of the 125 required annual volume) within the prior six-month period. Applicants must successfully complete a site inspection and meet all other requirements. Full Approval may be granted if circumstances indicate that the 125 minimum is probable by the end of one year. An automatic review will be performed at one year (from the start date of the six-month period stated on the application) from the date Full Approval is granted. The hospital is still required to submit an application for Provisional Status.

Candidates for the fast-track application processing should contact SRC.

Requirement Two: Averaging Annual Case Volumes Considered
For applicants who have experienced a recent decline in case volume due to insurance reimbursement issues or natural disasters preventing them from reaching their annual case volume requirement, the BSRC will consider volumes from both the 12 month application period and its preceding two years. For hospital applicants, Full Approval may be granted at the discretion of the BSRC if the average is equal to or greater than 125. For surgeon applicants, Full Approval may be granted at the discretion of the BSRC if the average is equal to or greater than 50. The specific situation of each applicant will be considered including an explanation of the reason for the decline in volumes. Only the cases of surgeons still operating at the applicant hospital will be considered in determining the average case volume for hospital applicants.

A feature has been added to the online BSCOE application to facilitate the averaging of volumes and will be available within the next few weeks. Please see the note at the end of this memo regarding an updated version of the BSCOE application software.

Requirement Six: Covering Surgeons Requirement Deadline Approaching
The continuing medical education (CME) requirements for non-bariatric covering surgeons go into effect for all Full Approval applicants and renewing BSCOEs on January 1, 2007. As of that date, new applicants for Full Approval and current BSCOE centers applying for renewal must show that non-bariatric covering surgeons are board certified, have at least eight hours of Category 1 CME in bariatric surgery, and have assisted on at least five non-stapling gastric procedures and/or 10 gastric stapling and/or anastomotic procedures, depending on the covering arrangement within the previous three years.

Requirement Seven: Minimum Clinical Pathways Specified
Effective June 1, 2007, the following specific clinical pathways will be required (i.e., approved and implemented at the time of the site inspection):

1) Anesthesia including monitoring and airway management.
2) Perioperative care including monitoring and airway management.
3) DVT management.
4) Instructions for the management of warning signs such as tachycardia, fever, and hemorrhage.

In addition, at least 10 of the following additional clinical pathways must be approved and implemented at the time of the site inspection:

• Indications
• Contraindications
• Initial patient instruction
• Patient evaluation
• Laboratory studies
• Imaging studies
• Patient education/consent
• Admission workup and evaluation
• Preoperative and postoperative dietary regimen
• Wound care management
• Pain management

Nurses, physician assistants, residents, applicant surgeons and other applicable staff must be aware of these protocols and follow them.

Requirement Eight: Status Criteria for Bariatric Coordinators Established
Applicant centers performing more than 150 bariatric surgeries annually are required to have a full-time bariatric coordinator. Centers performing 150 surgeries or less per year may employ a part-time bariatric coordinator. This ruling is effective June 1, 2007 for renewing BSCOE centers and for new applicants whose site inspections occur on or after that date.

The BSRC is in the process developing a definition of the functions of the bariatric coordinator including their educational and licensing requirements and will release them in the near future.

Requirement Ten: Outsourcing Patient Follow-Up Recognized
Outsourcing patient follow-up to third parties is acceptable provided that the outsourcing agent can be site inspected and the surgeon and/or hospital maintains adequate communications with the outsourcing agent to track patient outcomes on an ongoing basis. Follow-up performed by the patient's primary care physician is also acceptable provided the surgeon or hospital maintains adequate communications with the primary care physician to track outcomes.

Updated BSCOE Application to be Released Soon
In December, Surgical Review Corporation plans to release a revised version of the online BSCOE application which incorporates recent changes made by the BSRC. A separate memorandum detailing the changes and the steps to update the applications will be forthcoming in the next few weeks.