January 2012—Exclusive Report

| January 18, 2012

by Robin L. Blackstone, MD, FACS, FASMBS

Robin L. Blackstone, MD, FACS, FASMBS
Dr. Blackstone is President of the American Society for Metabolic and Bariatric Surgery and Medical Director, Scottsdale Healthcare Bariatric Center, Scottsdale, Arizona.

ASMBS Mission Statement
The American Society for Metabolic and Bariatric Surgery was founded in 1983 to establish educational and support programs for surgeons and integrated health professionals. Our mission is to improve the care and treatment of people with obesity and related disease; to advance the science and understanding of metabolic surgery; to advocate for health care policy that ensures patient access to high-quality prevention and treatment of obesity. For more information, visit www. ASMBS.org. If you are interested in becoming a member or have questions about ASMBS, please contact Georgeann Mallory, the ASMBS Executive Director, via phone: (352)-331-4900 or e-mail: info@asmbs.org.

The American Society for Metabolic and Bariatric Surgery Terminates Contract with Surgical Review Corporation to administer the ASMBS Bariatric Center of Excellence Program.
The American Society for Metabolic and Bariatric Surgery (ASMBS) Executive Council notified ASMBS members on December 29, 2011 that ASMBS had terminated our contract with the Surgical Review Corporation (SRC) for the administration of our ASMBS Bariatric Centers of Excellence Program. This will be effective on March 31, 2012.

The decision to terminate the contractual relationship between ASMBS and SRC was based on serious breaches in the contract between ASMBS and the SRC by SRC including:

•    Despite multiple attempts to work in a collegial fashion by ASMBS leadership over years, including a new contract, the working relationship with SRC leadership remains difficult and combative.
•    Lack of transparency surrounding the use of data and lack of disclosure of financial information makes it difficult for ASMBS leadership to ensure credibility and security of the ASMBS quality program, especially in light of recent public filing of the SRC 2010 tax return, which shows unpaid payroll taxes due in excess of $576,909.
•    Certain SRC executive leadership and board members are in a position to personally benefit from service at SRC in contradiction to their charter.
•    Failure to notify ASMBS of data releases within 30 days as required by contract.
•    Use of data collected in Bariatric Outcomes Longitudinal Database (BOLD) provided to industry without appropriate oversight by the ASMBS.
•    Unwillingness of SRC to accept the leadership of ASMBS in providing guidance and oversight for the evolution of the current program.
•    Desire of the ASMBS membership to see a unified accreditation program with the American College of Surgeons (ACS) and opposition by SRC to that process.

An injunction against any action taken by SRC against the ASMBS and our programs has been filed in federal court due to the serious nature of the allegations against SRC. Not all the reasons for this action can be discussed in this forum, but be assured the unanimous decision made by the Executive Council carefully considered all factors.

Over the last few weeks we have spoken with many of our members and with program coordinators and surgeons about the upcoming transition. The Executive Council appreciates the overwhelming support and consensus for the direction we have taken in securing the future of our program.

Outside of the issues of the breach of contract and resulting termination, the Society had embarked on a careful and thorough process to examine and renew the current accreditation program. The following is an outline of that process:

•    Survey of ASMBS Membership indicates that over 71 percent favor creation of one accreditation standard with ACS (March/April 2010)
•    Creation in February of 2011 of the ASMBS Quality and Standards Committee (QS) with Chairs of Core Committees of ASMBS and representatives from the American College of Surgeons (ACS) and the Michigan Bariatric Surgery Collaborative (MBSC) and Surgical Review Corporation (SRC).
•    Extensive analysis of accreditation criteria, verification process, data from both databases, and database evaluations by the committee
•    Creation of a white paper outlining a pathway to proposed changes (widely commented on—September 2011)
•    The ASMBS Executive Council and ACS Board of Regents endorse merging the two programs under one standard (Sept/Oct 2011) with details to be worked out over time.
•    Posting of background and initial proposals for change in accreditation from the current criteria to composite outcomes based accreditation and continuous quality improvement posted December 19, 2011 at reports.asmbs.org.

Planned next steps:

•    Focus meeting of people representing all three organizations (ASMBS, ACS, and MBSC) to review the following four areas: 1) Database, 2) accreditation standards, 3) credentialing, and 4) verification through site visits (both for data and for structure and process) January 2012.
•    Final draft of the new accreditation standards available for payor comment February 1, 2012.
•    Planned discussions with Centers for Medicaire and Medicaid Services (CMS), Blue Cross Blue Shield (BCBS) Association and others for their input on the proposed standards and for advice regarding an implementation process for new accreditation standards (February, 2012)
•    Posting March 1, 2012 for public comment the final draft of new accreditation standards
•    All programs currently in the separate ASMSB and ACS programs will continue to qualify under the current (2006) standards until the new standards are recognized and fully implemented

The ASMBS was following the process outlined above regarding the review of the program in a carefully defined manner when the SRC financial situation and data security issues came to light and had to be addressed urgently. Moving forward, the following statements apply:

•    All programs recognized by the current ASMBS BSCOE process administered by SRC will remain accredited when ASMBS transitions the program on April 1, 2012. They will remain in their current accreditation cycle.
•    The ASMBS is focused on establishing a unified accreditation standard within bariatric surgery and is working closely with the ACS to move directly forward with that goal.
•    When the final new accreditation standards have been completed, your individual program will have ample time to implement the new requirements.
Lynne Thompson, RN, formerly with the SRC, has accepted a position with ASMBS as the Clinical Program Director. She will be facilitating the transition of programs and is available to answer questions that apply to your specific center. You can email Lynne at quality@asmbs.org. Lynne and the ASMBS Transition team put together the following list of questions and answers for your information.

Frequently Asked Questions regarding Data Submission

Q:    Should we continue entering patients into the BOLD database?
A: You should continue to enter patients into BOLD through March 30, 2012.

Q:    What will I do with my data on March 31, 2012?
A: A new database will be available into which you may enter your data. No data will be lost and there will be no interruption in reporting. This is a priority for the transition team and more information will be available about this in the next few weeks.

Q:    Will there be training provided on the new data registry and how to enter data?
A: Yes. Extensive training on the database will be available beginning in March 2012. We anticipate this training will be done via webinar and teleconference. Additional training will be offered on understanding data definitions and data entry at the annual ASMBS meeting in June. We expect the new database to be easier to use and more functional in terms of reporting.

Q:    How do we know that the new data registry will provide value to our program and/or surgeon?
A: The ASMBS is committed to ensuring that the primary focus for the future data registry will be to deliver value from the entered data to the program participants so that it can be used to improve outcomes and patient safety. All programs will receive their composite outcomes measure and risk-adjusted serious complication data at the National Bariatric Quality Forum in June 2012 at the annual ASMBS meeting.

Q:    How can we ensure that our third-party electronic medical records (EMR) vendor and their products remain in compliance?
A: ASMBS has spoken with one large vendor already and will be arranging a meeting for mid-February 2012 where we can speak with all of the vendors to help them understand the direction and plan for the database.

Q:    Do we continue to collect data through our third party vendor?
A: Programs with a vendor will continue to collect their data within the third-party product, but will no longer transmit to BOLD after March 30, 2012.

Q:    Will the vendors have time to prepare and support our program through their product?
A: The vendors will have adequate time to understand the new database definitions and will be able to bridge to the new database before it comes up live and participants are required to use it. ASMBS will also provide extensive training and certification of your data-entry staff prior to implementation of the new data registry. We will work this out with you on a case-by-case basis.

Q:    We see Medicare patients. How does this change affect our compliance with requirement 10 of the BSCOE program and the requirement to enter data into a registry?
A: Programs are required in the National Coverage Determination (NCD) to collect their own data. The NCD was issued before there were any national registries. All data for 2012 will be collected and reported and there will not be any gaps.

Q:    Are we going to need to hire a full-time nurse for data entry?
A: No. Each program will decide who is most appropriate to enter their data into the new data registry. These data-entry personnel will be thoroughly trained and certified in March 2012.

Q:    When will training in the new data registry take place?
A: Training will take place using teleconferences and webinars starting in late February 2012. The first live training sessions will be held during the annual meeting of the ASMBS in San Diego, California, June 2012. It is strongly encouraged that you plan to attend the BSCOE course that will be given at the annual meeting if at all possible. Other training courses will be organized over the summer so that everyone can get complete training and certification in the registry.

Frequently Asked Questions regarding Fees

Q:    Our facility has paid the annual fee and the fee for a site inspection to SRC. We have a site inspection scheduled. How do the changes affect us?
A: If your site inspection is scheduled prior to March 1, 2012, you should proceed with the site inspection. The Bariatric Surgery Review Committee (BSRC) is committed to completing your cycle of accreditation prior to the transition on March 31, 2012. The ASMBS will not charge fees beyond those that have already been paid, even if they have been paid to SRC, and your program does not need to worry about it further. If for some reason SRC is not able to complete these site visits, the ASMBS will ensure that they occur in a timely fashion and will work with you one on one to accomplish your recertification site visit or qualifying site visit.

Q:    Our facility has paid the annual fee and the fee for site inspection to SRC. We do not have a site inspection scheduled yet. How do the changes affect us?
A: Please be sure to indicate this on the survey referenced in the sidebar “Register Your Program for the Transition.” You will be contacted regarding scheduling your site inspection. Site inspections will take place on schedule. The ASMBS will not charge additional fees if they have already been paid.

Q:    Our facility has paid the annual fee, but has not paid the site inspection fee to SRC. Should we pay the inspection fee and move forward with scheduling our site inspection?
A: Do nothing regarding this for the moment. Please be sure to indicate this on the survey referenced in the sidebar “Register Your Program for the Transition.” Further instructions regarding payments of fees for your site inspection will be forthcoming in the next few weeks.

Q:    My facility (or surgeon) just received an annual invoice from SRC, should we pay it?
A: Do nothing regarding this for the moment. Further instructions regarding payments of fees will be coming out in the next few weeks.

Q:    Our fees are due today. Who should we pay, SRC or ASMBS?
A: Do nothing for the moment. Information about fees that are due will be forthcoming in the next few weeks. The ASMBS will continue your accreditation at your current status during this period of transition. ANY threats to withdraw accreditation due to non-payment should NOT be considered a concern during this time.

Q:    We have dual designation with ASMBS and the ACS. We have paid our annual fee to SRC and are waiting for scheduling of our site inspection. We are due for renewal with ACS, but have not paid the fees yet. Should we request a refund from SRC and pay ASMBS?
A: Do not pay for an additional accreditation at this time. The ASMBS will recognize fees paid to SRC as having been paid to ASMBS if paid before January 1, 2012. Any issues between ASMBS and SRC in regards to fees will be handled by the two organizations.

Frequently Asked Questions regarding Site Inspections

Q:    In the ASMBS e-mail distributed to the membership on December 29, 2011, the ASMBS Executive Council stated: “ASMBS will not recognize, promote or encourage any accreditation by any non-ASMBS recognized designation. Any future SRC-related accreditation will not represent ASMBS.” Does this mean that if we are in the middle of the site inspection or review process with SRC that our designation will not be recognized by ASMBS?
A: The current program is an ASMBS BSCOE program. SRC is the vendor used to administer it. ASMBS has a contract with SRC for SRC to administer the BSCOE program through March 30, 2012. BSCOE designation is granted when a program meets the accreditation requirements as reviewed by the Bariatric Surgery Review Committee (BSRC) chaired by Dr. David Provost who is an ASMBS Executive Council member. All current ASMBS BSCOE programs, whether fully approved or provisional, will be grandfathered into the new ASMBS Quality Improvement (QI) program.

Q:    Our program has a site inspection scheduled in January or February 2012. Should we cancel it and wait for the new program to be implemented?
A: Not necessarily. You may proceed with your site inspection. SRC is administering the ASMBS BSCOE program through March 2012 and ASMBS will recognize any site inspections done in January and February of 2012. If you are uncomfortable proceeding with your site inspection by SRC, please contact Lynne Thompson at quality@asmbs.org and she will reschedule your site inspection after the transition.

Q:    My program has had a site inspection but the review cycle is not complete. How does the change affect us?
A: ASMBS has a contract with SRC to administer the BSCOE program through March 30, 2012. All decisions related to designation are made by the BSRC, chaired by Dr. David Provost, MD, a member of the ASMBS Executive Council. The ASMBS is keeping the BSRC intact through March 30, 2012 in order to ensure that all programs get processed and complete the review cycle by the transition date. At that time the BSRC will transfer responsibility directly within the new program structure under Dr. Provosts’ direction to provide continuity.

Q:     Are the requirements for BSCOE designation changing?
A: At the present time the requirements have not changed. All programs will come through the transition with the current requirements. HOWEVER, it is important that you go to the ASMBS website at reports.asmbs.org and read the proposed program changes to become familiar with the new quality program under consideration. It is anticipated that there will be changes to the program as outlined in the five documents on the ASMBS website, but final decisions have not been made and your input is important. Once the transition has occurred, a process will be put in place to get wide input from payors and others prior to any final program changes.

Q:    Does the same apply to free-standing centers?
A: Yes.

Q:    What designation will Medicare and the other payors recognize?
A: The BSCOE program has always belonged to the ASMBS and designation has always come from ASMBS and the ACS. Therefore, there is no change at the present time.

Q:    Our program is on probation (or has been denied) due to deficiencies found on site inspection? We are working on correcting those deficiencies. How will we be impacted by the transition?
A: You will transition with the same status as you have in the current SRC administered program. Deficiencies should be corrected and the program re-inspected as required by the process. If you are on probation or have been denied, please indicate this on the survey (see sidebar “Register Your Program for the Transition.”) and we will be in touch with you.

Q:    What is the relationship between the ASMBS and the ACS?
A: The ASMBS members voted in a large majority that they wished to see the two quality programs in bariatric surgery have a closer working relationship. Approval to pursue a process that would result in the fusion of the two programs was approved by both the Executive Council of the ASMBS in September 2011 as well as the Board of Regents in October of 2011. We had planned a transition over a three-year period but are now planning to transition April 1, 2012. The ASMBS leadership has been working with the leadership of the ACS to provide one standard in quality for bariatric surgery. We expect that the two programs will come together and offer one program, with one standardized data registry as of April 1, 2012. A formal announcement about this will be made in the upcoming weeks.

ASMBS greatly values member feedback and would like to know the membership’s concerns and questions as we move forward. It is important that you take a moment to complete the survey and register your program for the transition. This will enable the ASMBS staff to make sure your needs are met. http://asmbs.org/?p=4807

Category: ASMBS News and Update

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