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Public Policy and Advocacy

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October 2011 - ISASS Letter to AMA CPT Editorial Panel Regarding Coding Changes for Presacral Fusion Procedure

I am writing to voice our society's support for graduation of the pre-sacral interbody fusion procedure from a Category III Code to a Category I Code. Upon review of the available data, ISASS has concluded that the current literature on this technique (over 40 peer-reviewed publications) warrants a Category I code, similar to the other established fusion procedures (ALIF, PLIF, TLIF, direct lateral).

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October 2011 - ISASS Statement to Orthopedics This Week Regarding Variations in Fusion Surger Outcome Data

A recent article on “clinical guidelines and payer policies on fusion for the treatment chronic low back pain” raises concerns and also illustrates the lack of rigor and transparency in creating guidelines and performing health technology assessments. In reviewing three systematic reviews of general guidelines and five guidelines with recommendations on fusion, there was consistency in the general guidelines with respect to recommendations for diagnosis, but inconsistency regarding recommendations for treatment.

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September 25, 2011 - ISASS Seeks Members' Participation on New Coding & Reimbursement Task Force

"In order to advocate properly for spine surgeons, ISASS seeks members who have an interest in coding, valuation and reimbursement issues, and who might lend their expertise to our nascent efforts through participation in a newly formed Coding & Reimbursement Task Force."

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August 2011 - ISASS Comments to BCBS Medical Avisory Panel Regarding Cervical Disk Arthroplasty Policy

"In response to the MAP’s initial conclusion that “artificial intervertebral disc arthroplasty for the treatment of patients with cervical degenerative disc disease does not meet the TEC criteria,” we wanted to make sure that your assessment is inclusive of the latest data, including the most recent long-term outcomes data from Medtronic (5 year follow-up post-surgery) and Synthes (4 year follow-up post- surgery)."

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July 15, 2011 - Advocacy Alert - Dr. Jean-Charles LeHuec Responds to First Coast Service Operations, Inc.'s Draft LCD number DL32074 - “Lumbar Spinal Fusion for Instability and Degenerative Disc Conditions”

"I am writing on behalf of the International Society for the Advancement of Spine Surgery (ISASS) in regards to the above-mentioned Draft Local Coverage Determination. ISASS is an international, scientific and educational society organized to discuss and assess existing strategies and innovative ideas in the clinical and basic sciences related to spine surgery to enhance patient care...."

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July 15, 2011 - ISASS Policy Statement on Lumbar Fusion Surgery

International Society for the Advancement of Spine Surgery (ISASS) Policy Statement on Lumbar Spinal Fusion Surgery, including:

  • Introduction
  • Scope
  • Definitions
  • Conditions for which Lumbar Fusion is Medically indicated
  • Conditions for which Lumbar Fusion is Indicated on a Case-by-Case Basis
  • Conditions for which Lumbar Fusion is Not Medically Appropriate
  • Scientific Background
  • Conclusion
  • References

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April 2011 - ISASS Statement Regarding Changes to FDA 501(K) Device Approval Process

In January 2011, the FDA announced proposed changes to the 510(k) premarket regulatory pathway process by which most medical devices are approved for use. ISASS is generally supportive of FDA’s recommendations, including a streamlined approval process for classifying low-risk products, greater training for FDA examiners, increased use of guidance documents and consensus standards, and a greater transparency into all FDA processes. The FDA must make every effort to assure that American patients have timely access to important new technologies and next-generation products without compromising their safety.

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ISASS Members on 10 Spine Surgeons Advocates List

Becker's Orthopedic, Spine and Pain Management has published a list of "10 spine surgeons who are dedicated to spine advocacy efforts through national societies, regional programs or through practice organizations."

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January 26, 2011 - Advocacy Alert: BCBS-NC Changes Lumbar Fusion Policy

On January 20th, SAS President Tom Errico and leaders from eight other professional spine societies met with the medical leadership of Blue Cross & Blue Shield of North Carolina (BCBS-NC) to discuss the spine community's concerns with a newly published BCBS-NC policy on lumbar fusions.

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January 10, 2011 - Journalists Using Sensationalistic Stories to Bias Public Opinion about Spinal Fusion Surgery

The International Society for the Advancement of Spine Surgery (ISASS)
Lumbar Fusion Evidence & Policy Review Task Force

The Bloomberg business news web site recently published an article asserting that fusion is an unnecessary and unfounded procedure.The article is unscientific and based on incomplete information. The International Society for the Advancement of Spine Surgery (ISASS) would like to take this opportunity educate the business community about the medical benefits of lumbar fusion surgery.

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December 16, 2010 - Advocacy Alert: House Passes by Voice Vote 30 Day "Doc Fix"

SAS/ISASS would like to alert you to the US House of Representatives passage of the Physician Payment and Therapy Relief Act of 2010 related to Medicare and Tricare payments...

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December 16, 2010 - Advocacy Alert: Dr. Thomas Errico Responds to WSJ Article

SAS/ISASS would like to alert you to a recent article in the Wall Street Journal covering Congressman Darrell Issa's (incoming chairman of the House's chief investigative committee) goal of "cutting the overuse of expensive medical procedures.... ...data came in a report suggesting that expensive cardiovascular and orthopedic implants are overused by doctors, sometimes after aggressive promotion by device makers."

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December 16, 2010 - Advocacy Alert: SAS/ISASS Efforts Highlighted in Orthopedics This Week

SAS/ISASS thought you would be interested in two recent articles in Orthopedics This Week (OTW) advocating support for spine surgeons and patients. OTW is providing non-subscribers of the SAS with a “community pass” which allows the members unlimited access to ALL articles. The pass is renewable and allows members to download full PDFs of articles.

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December 15, 2010 - Advocacy Alert: BCBS/NC Lumbar Fusion Response

The American Association of Neurological Surgeons (AANS), the American Association of Orthopaedic Surgeons (AAOS), the Congress of Neurological Surgeons (CNS), the AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves, the International Society for the Advancement of Spine Surgery (ISASS), the North American Spine Society (NASS), the North Carolina Neurosurgical Society (NCNS), the Pediatric Orthopaedic Society of North America (POSNA) and the Scoliosis Research Society (SRS) would like to thank BlueCross and BlueShield of North Carolina (BCBS of NC) for the opportunity to provide comments on the draft Corporate Medical Policy pertaining to Lumbar Spine Fusion Surgery, with a policy effect date of January 1, 2011.

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December 2, 2010 - SAS Will Engage Payers on Spine Surgery-Related Procedures

SAS President Dr. Thomas Errico, MD has posted an update on The SAS response to the BCBS/NC insurance policy changes. The SAS community has vigorously responded to our original alert on this issue. However, limiting communication to email and phone discussions has not been the most efficient method for us - as a community - to collaborate on this topic. Looking forward, we have established a new online forum to facilitate additional community participation.

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November 17, 2010 - Alert: Changes to Spine Fusion Insurance Reimbursement Policy

The SAS is alerting our membership regarding recent changes to a US insurance reimbursement policy covering spine fusion procedures. The revised policy may affect all SAS members, including international members, in the future. As past SAS President Chun-Kun Park, MD, PhD said:

“Such changes are likely to have an impact on the reimbursement policy quite a bit even in the other countries, because as you know, 'bad news travels fast' in the recent information society with advanced telecommunications. So, it can lead to a grave international issue.”

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November 15, 2010 - North Carolina-based SAS members

We wanted to bring your attention to an issue that may adversely impact patient access to necessary spine fusion procedures. We have learned that North Carolina BC/BS has issued a new, more restrictive policy for lumbar fusion procedures, effective January 2011.

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October 9, 2009

SAS Position Statements will be reviewed every five years, or at the request of one of our members if compelling new data becomes available.

SAS Advocacy in Action

Georgia Surgeon Rallies Colleagues in Support of Cervical Disc Arthroplasty

US-based SAS Members and their patients often face significant obstacles in obtaining insurance carrier coverage for lumbar and cervical disc arthroplasty. Given that disc arthroplasty products have only been on the US market for less than 7 years, many insurers often cite their proposed use as “experimental or investigational,” which leaves little opportunity for appeal of such decisions.

However, many of our members won’t take no for an answer, knowing that disc arthroplasty is a superior technology for many patients who would otherwise settle for a fusion procedure. 

One such member is Jim Lindley, from Savannah, Georgia. Dr. Lindley, frustrated by the continuous denials from Blue Cross/Blue Shield of Georgia (a WellPoint company) is enlisting his Georgia surgical colleagues in an attempt to change the payer’s current policy.

Dr. Lindley sent a letter to all Georgia surgeons who participated in an IDE trial for, or have been trained by manufacturers in the use of, any of the three FDA-approved artificial cervical discs, asking that they sign an affidavit as evidence of their support for BC/BS coverage of cervical disc arthroplasty. 

Dr. Lindley has been in contact with WellPoint, and will provide his affidavits, and other supportive material including SAS’ Position Statement on Cervical Total Disc Arthroplasty, to their medical director prior to a February 25th coverage determination hearing.

To date, Dr. Lindley has received 50 signed affidavits - a response rate of over 60 percent, and is hopeful that his efforts will lead to a positive outcome with WellPoint.

SAS needs your help – If you are interested in signing on to Dr. Lindley’s affidavit, which will be shared with WellPoint in late February, please contact Dr. Lindley at jlindley9@comcast.net, or simply fax your signed affidavit to 912-356-9634.

Click Here (PDF - 10/9/2009) to view a copy of the letter and the affidavit that Dr. Lindley sent to his Georgia colleagues.

Click Here (HTML) to view a copy of the SAS’ Position Statement on Cervical Total Disc Arthroplasty, approved by the SAS Board in October 2009.

If you have a similar advocacy story, and would like to share it with your SAS colleagues, please contact David Porter at david@ISASS.org.  We are eager to know what the SAS membership is doing to fight for patient access to these life-changing technologies.

 

 

 

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