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ScoliScore

The ScoliScore Test is the first and only genetic test proven to give physicians and parents insight into the possible progression of Adolescent Idiopathic Scoliosis (AIS), thereby reducing the uncertainty of AIS progression, and allowing for a more personalized treatment plan.

Product Documents

Product Description

The ScoliScore Test is the first and only genetic test proven to give physicians and parents insight into the possible progression of Adolescent Idiopathic Scoliosis (AIS), thereby reducing the uncertainty of AIS progression, and allowing for a more personalized treatment plan.

The ScoliScore Test analyzes 53 genetic markers correlated with spinal curve progression in AIS patients and has a 99% negative predictive value (NPV) in determining the risk of progression in a manner that is superior to all current clinical predictors. The test was developed in collaboration with over 110 clinicians worldwide and was designed through the analysis of over 10,000 patient samples. After this extensive development, the ScoliScore test was validated in three multi-center independent clinical trials.

  • The ScoliScore Test assigns a numerical value (between 1 and 200) to the likelihood of curve progression based on a child’s DNA and current Cobb angle.
  • The ScoliScore Test is a highly accurate prognostic test for AIS curve progression.
    • 99% Negative Predictive Value (NPV) for the likelihood of AIS spinal curvature NOT progressing to >40º Cobb angle.
    • 95% probability in the High Risk category (ScoliScore of 181-200) for the likelihood that the AIS spinal curvature WILL progress >40º Cobb angle.
  • The ScoliScore Test is performed by collecting a saliva sample during a physician’s office visit. The sample is then sent to Transgenomic for analysis.
  • Within four weeks of the laboratory receiving the sample, the ScoliScore Test result report will be sent to the ordering physician’s office.
  • The ScoliScore Test assigns a numerical value (between 1 and 200) to the likelihood of curve progression based on the child’s DNA and current Cobb angle.
  • The physician can then use this information, combined with other clinical factors, to determine a personalized treatment plan.
  • Is performed by a state-of-the-art laboratory regulated under and by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

The ScoliScore Test is appropriate for:

Indications
  • Adolescent Idiopathic Scoliosis
  • Between the ages of 9 years – skeletal maturity
  • Self reported Caucasian males and females (North American, South American, European, Eastern European, Middle Eastern)
  • Mild Curve (10° – 25° Cobb angle)

 

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Genetics Influence Progression

The existing methods of assessing curve progression are based on reported observational criteria alone, and may result in inefficient patient care. Recent studies51 have shown a strong genetic link to Adolescent Idiopathic Scoliosis (AIS) progression and have paved the way for science based, personalized patient care decisions.

lc_study3

Current Prognostic Standards

The diagnosis of Adolescent Idiopathic Scoliosis (AIS) is straightforward given that most mild curves are visible or can be detected with a forward bending test, a scoliometer, or a radiograph. Due to a lack of useful prognostic tools, the standard treatment pathway following diagnosis with a mild curve is currently driven by the uncertainty of progression leading to months and perhaps years of office visits and radiographic series to assess further curve progression.

Following initial diagnosis of AIS, patients today are often forced to “watch and wait”, and are subjected to observational x-rays every 4 – 6 months to determine curve progression. If the curve progresses to at least 25°, bracing to try to arrest curve progression is eventually prescribed to 7 – 10% of initially diagnosed patients,2 despite the success rate of bracing being largely unknown.16

Out of approximately 4,000,000 children in the US in the indicated age group,17 each year 100,000 present to physicians with a mild AIS curve ≥10°. Approximately 1,000 – 4,000 will eventually experience curve progression necessitating an instrumented fusion procedure.1-3 This means that approximately 96,000-99,000 of these newly diagnosed patients will not progress to a curve requiring instrumented fusion (Figure 3). As a result of this inability to predict which patients will require surgical intervention and which patients will not, a large majority of patients undergo medical and radiographic monitoring that may not be required.

schoolscreeningObservational Inefficiency

Adolescent Idiopathic Scoliosis (AIS) diagnosis is estimated to result in more than 600,000 physician visits annually.1

In one study of 26,947 children screened for AIS, 1,222 patients were identified to have the disease of which only 584 had curves greater than 10º. Only 77 of these patients (13%) progressed to a curve of greater than 21º.2 Yet all patients identified to have the disease were monitored and radiographed identically.

X-Ray Exposure

Studies show that average radiation doses from spinal x-rays of the lumbar region are about 30 times higher than two conventional chest x-rays.3

The U.S. Food and Drug Administration (FDA) has issued public warnings to scoliosis patients about the cancer risk associated with frequent X-ray examinations and emphasized the importance of keeping radiation doses to the breast as low as possible. 52

The National Cancer Institute (NCI) further emphasized that the risk of breast cancer depends on dose of radiation and age at exposure, with the highest risk occurring during puberty. No dose of radiation should be considered completely safe, and attempts should be made to keep radiation doses as low as possible.53

Lonstein and Carlson

For the past 25 years, Lonstein and Carlson’s4 study of 727 patients has been the basis for physicians’ estimates of probability of curve progression. While the study was in many ways forward thinking;

  • Its outcome only predicted progression of 5º – 10º.
  • The accompanying progression factor formula and nomogram were only valid for curves between 20º -29°.
  • The predictive value for a patient with a curve of less than 20° was invalid.

Lonstein-Carlson 1984 Study

Today’s management of the Adolescent Idiopathic Scoliosis (AIS) patient is quite similar to what it has been for the past 25 years. Since Lonstein and Carlson published their criteria for predicting curve progression in 1984, no other research built on their original work has ever been published in a peer reviewed journal. Surgeons however, have taken what Lonstein and Carlson proposed and liberally applied these criteria, expanding the interpretation of the data beyond the 20 – 29° Cobb angle and beyond just 5 – 10° of progression, to encompass lesser curve magnitudes and subsequent progression much greater than 10°.

Though Lonstein-Carlson criteria for progression of an AIS curve represented interesting observations with respect to understanding the disease of AIS at the time, its use as a prognostic tool has the same reported limits today as it did in 1984. Because the criteria are based solely on observational parameters that have already occurred (age, Risser sign, Cobb angle), the criteria have less predictive value.

The progression factor equation and resulting graph were reported to be valid only for curves of 20 – 29° and could be used to estimate further risk of progression of 5 – 10°. This very narrow predictive capability does not approach the curve magnitude generally accepted as a reasonable point at which instrumented correction would be considered.

Given these extensive limitations, use of Lonstein-Carlson criteria to predict curve progression is just slightly better than the random chance of assessing progression by flipping a coin.

 

Familial Characteristics of AIS

For over forty years, physicians have suspected a genetic link to Adolescent Idiopathic Scoliosis (AIS). Recent breakthroughs in genetic research have confirmed that AIS is a complex, multifactorial genetic disorder having a strong pattern of inheritance. This further supports that current prognostic practices alone cannot accurately predict the likelihood of progression of AIS curves.

Below is an example of an actual pedigree chart going back five generations and demonstrating the relatedness of people with AIS.

 

 

Strong Genetic Linkage

Though the familial aspect of AIS was suggested in 1968 by Wynne-Davies,6 and later supported by Riseborough,8 and Cowell et. al.,7 the mode of heritability of AIS was not well understood until recently. Early genetic research could not accurately detect whether AIS was passed on to offspring via a dominant gene, or through a multi-factorial (multi-gene) pathway. It was Cowell et. al. who noted that the literature contained little information about male-to-male transmission of the disease suggesting an X chromosome dominant inheritance pattern.

Multi-Factorial Expression

In 200010 and 2005,18 Miller hypothesized that variability in phenotypes (observed characteristics) of patients with AIS, was more likely to be evidence of a multi-factorial genetically expressed disease, meaning multiple genes across multiple chromosomes played a role in the genetic expression of the disease. However, there was no strong evidence for that hypothesis.

In 2006, Ogilvie et. al.11 interviewed 145 people with AIS and found that 100 were from families known to have members affected by AIS. Individuals from the 100 families as well as the 45 "sporadic" cases were searched against a proprietary database, GenDB, containing 18 million names of ancestors and 3 million descendants from the original founders of the Salt Lake Valley in Utah. This was done to identify genealogical links between families.

  • Of the 145 individuals, 127 (97%) were related to at least one other scoliosis family.
  • In this study, the kinship coefficient compared 1,000 control sets of 100 individuals to the 131 known to have AIS, demonstrating a high degree of relatedness of the individuals with AIS compared to the controls.

When comparing these data to the control data, kinship coefficients were calculated. A kinship coefficient is defined as the probability that one allele, selected randomly from each of two individuals is inherited from a common ancestor. For example, siblings are expected to share approximately half of their genetic material yielding a kinship coefficient of 0.25. Secondary relatives such as first cousins have a kinship coefficient of 0.125 or half of siblings.

 

The mean kinship coefficients for the randomly selected controls and the 131 individuals with AIS are shown demonstrating that individuals with scoliosis are far more connected to each other than individuals without scoliosis.

Further research of the pedigrees showed 50% of the patients were connected to individuals with AIS whose ancestors all resided in England in the mid-1500's. The connections between previously unrelated pedigrees and the significantly higher kinship coefficient in the AIS cohort suggest it is highly likely that there is a major AIS gene for susceptibility to the disease. Additional research by Ogilvie et. al. suggested there are at least two different regions of linkage for AIS in these families.

 

 

Clinical Test Development

The ScoliScore Test was developed in collaboration with over 110 clinicians worldwide, and designed through the analysis of over 9,500 ethnic and racially diverse patient samples.

  • Test design and algorithm was validated in a large patient data set.
  • Identifying 28 progression and 25 protection associated markers (p-value of 2.34 x 10-165).
  • Clinical Trials confirmed highly predictive performance on multiple intended use patient populations.8

Clinical Validation

Further studies were performed to validate the Negative Predictive Value (NPV) of the ScoliScore Test using a different set of samples and three different clinical trials,19 on intended use populations.

Clinical Trial #1 – School Screening Population – Large Majority with Mild Curves
Sample Size = 277 Caucasian female patients as presenting for school screening for AIS and having at least a 10° curve.
  85% Mild curve  
  12% Intermediate curve  
  3% Severe curve  
Results: Negative Predictive Value of 100% (Confidence Interval, 99-100%)

 

Clinical Trial #2 – Intent to Treat Population – Spinal Deformity Practice
Sample Size = 257 Caucasian female patients with at least a 10° curve as presenting at a spinal deformity surgeon's office following referral from a pediatrician.
  68% Mild curve  
  21% Intermediate curve  
  11% Severe curve  
Results: Negative Predictive Value of 99% (Confidence Interval, 99-100%)

 

Clinical Trial #3 – Intent to Treat Population – Spinal Deformity Practice
Sample Size = 163 Caucasian male patients with at least a 10° curve as presenting at a spinal deformity surgeon's office following referral from a pediatrician.
  78% Mild curve  
  11% Intermediate curve  
  1% Severe curve  

 

 

Accurately Predicting the Likelihood of Progression

Using a scale of 1 – 200, the risk of progression increases with increasing test score. Given the tightness of the confidence intervals at the extremes, intervals of group risk were identified as follows:13

  • In indicated patient with a score in the Low Risk range of 1 – 50 has a >99% probability that she or he will not experience progression to a severe curve.
  • In clinical trial, 75% of the patients tested fell into the Low Risk category, while 24% were in the Intermediate Risk group.
  • In an indicated patient with a score in the High Risk range of 181-200, the patient has a >95% probability of progressing to a severe curve (>40º Cobb angle).
    • 1% fell into the High Risk group.

 Click to View larger: Risk of Progression Chart

Demonstrated Accuracy

The ScoliScore Test demonstrates a Negative Predictive Value of 99% (Confidence Intervals 97.7% – 100%).

  • Negative Predictive Value is the probability that a patient diagnosed with a non-progressive curve, will in fact not progress.
  • Compared to other published studies assessing progression of Adolescent Idiopathic Scoliosis (AIS), the ScoliScore Test is the only clinically validated, highly predictive and accurate tool to assess the likelihood of AIS curve progression.

demo_accuracy

Empowering Informed Decisions

The ScoliScore Test is the first, clinically validated and highly accurate prognostic test, developed to predict the likelihood of curve progression, thereby empowering informed patient care decisions when combined with existing radiographic and clinical information.

The ScoliScore Test :

  • Is performed on DNA extracted from saliva, making sample collection simple and pain-free.
  • Provides test results in weeks versus years of conventional observation.
  • Is performed by a state-of-the-art laboratory regulated under and certified by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
  • Calculates a progression score of 1 – 200 using marker weighting factors and a logistic regression algorithm.

The ScoliScore Test is appropriate for:

Indications
  • Adolescent Idiopathic Scoliosis (AIS)
  • Between the ages of 9 years – skeletal maturity
  • Self reported Caucasian males and females (North American, South American, European, Eastern European, Middle Eastern)
  • Mild Curve (10° – 25° Cobb angle)

 

4 weeks

Expert Opinion: ScoliScore Patient Management Algorithm

The introduction of the ScoliScore Adolescent Idiopathic Scoliosis (AIS) Prognostic Test has changed the way many clinicians manage low-risk patients (ScoliScore 1-50). Prior to having an accurate prognostic test, most clinicians monitored all patients alike which required many office visits and x-rays to monitor progression. The majority of children with Scoliosis have a low-risk of progression to spinal curvature that requires surgery, so it is proposed that many children do not need identical levels of observation and frequency of x-rays. The AIS patients having a ScoliScore of 1-50 are considered to have a >99% chance (NPV) of NOT progressing to a Cobb angle of >40º. The accuracy of the ScoliScore test is thought to provide clinicians and parents with confidence that they do not have to monitor the low-risk patients as closely as higher-risk patients.

The views below are reflective of Scoliosis experts that included:

Baron Lonner, MD
Clinical Professor of Orthopaedic Surgery
NYU Hospital for Joint Diseases

Suken Shah, MD
Division Chief, Spine and Scoliosis Center
Clinical Fellowship Director
Department of Orthopaedics
Nemours/Alfred I duPont Hospital for Children

Jonathan Grauer, MD
Associated Professor, Department of Othopaedics and Rehabilitation, Yale University School of Medicine
Co-Director, Yale New Haven Hospital Spine Center

Patient Maturity

ScoliScore Result

Premenarchal
PHV, PGA
Risser 0
Sanders 2, 3, 4
Postmenarchal<1yr
Risser 1, 2
Sanders 5
Postmenarchal>1yr
Risser 3, 4
Sanders 6
High Risk

(181-200)

4-6 months
X-ray: Yes
6 months
X-ray: Yes
12 months
X-ray: Yes
Intermediate Risk

(51-180)

6 months

X-ray: Yes

6-12 months

X-ray: Optional
(Dependent on the ScoliScore)

12-18 months

X-ray: Optional
(Unless last visit to document at maturity)

Low Risk

(1-50)

9-12 months
X-ray: Optional

(Clinical exam)

12 months

X-ray: Optional (Clinical exam)

At maturity

X-ray: Yes
(to document at maturity)

PHV = Peak Height Velocity
PGA = Peak Growth Age
Sanders JO, “Predicting scoliosis progression from skeletal maturity: a simplified classification during
adolescence,” J Bone Joint Surg Am, 2008.

This panel was constructed from a consensus of expert opinion as a recommended algorithm for clinical follow up and need for X-ray in the clinical management of a patient with mild adolescent idiopathic scoliosis based on the patient’s skeletal maturity (and further growth potential) and the ScoliScore  result. This is an expert opinion and has not been scientifically validated.

The care of the patient with mild AIS can be specifically tailored to maximize the efficiency of care and limit exposure to X-rays.

Indications for ScoliScore

  • Mild AIS (Cobb angle 10-25°)
  • Age 9-13 years
  • Self-reported caucasian males and females (North American, South American, European, Eastern European, Middle Eastern)

 

 

ScoliScore Case Study

This is an actual case study reported by Keith Mankin, MD, Pediatric Orthopedic Surgeon from Raleigh, NC.

 

 

 

 

 

 

 

 
10-year old female diagnoses with Adolescent Idiopathic Scoliosis (AIS)
 

Clinical Presentation

Patient History

  • Age: 10-year-old

  • Gender: Premenarchal female

  • Heigh & Weight: 5'1'' and 98lbs.

  • Risser:1

  • Cobb angle: 17°

  • ScoliScore: 18

  • Lonstein-Carlson clinical rating: moderate risk

  • Lifestyle: Active, soccer and dancing

  • Family history of scoliosis caused the patient and parents to be anxious.

  • The family awaits decisions.

Clinical Features in Diagnosing AIS

10-year-old Caucasian premenarchal female was referred to me by her Pediatrician with a scoliometer measurement of 15°. The patient is active and is an avid soccer player and dancer. The patient and family arrive to office anxious as there is a family history of scoliosis with a first cousin having a curve significant enough to warrant bracing. Child expressed concern about having to wear a brace and not being able to play sports.

Patient Visit 1

Physical exam:

  • Her examination was remarkable for curvature in the thoracic spine with apex pointing right. There was mild rotation of the upper trunk and a rib prominence was accentuated on Stygnara forward bend test.
  • Minimal compensation curve in the lumbar spine.
  • Minimal decompensation of the trunk to the right by ~1/2 centimeter.
  • No bony tenderness.
  • Her inspirations were symmetric with no evidence of chest wall deformity.
  • Leg lengths were equal.
  • Neurological examination was intact including deep tendon and abdominal reflexes.
  • ScoliScore offered and accepted by the patient and family.
  • A single view shielded posteroanterior radiograph was performed of her entire spine.

Patient Visit 2

Discussion on clinical, radiographic and ScoliScore findings:

  • Thoracic curvature measuring 17° Cobb angle with apex at the eighth Thoracic level.
  • Mild to moderate rotation as measured by pedicle obliquity.
  • A small lumbar  curve measured 10° with partial compensation for the thoracic curve.
  • There were no obvious congenital malformations.
  • Lliac wings determined a Risser socre1.
  • Her age, Risser score and the nature and magnitude of her curve, this person was determined to be a moderate risk for progression by the Lonstein-Carlson standard. The typical clinical course would mandate follow-up at three months for repeat x-rays, followed by repeat radiographic studies every 4-6 months until skeletal maturity.
  • The patient's ScoliScore was 18, comfortable in the low range. The risk of this patient progressing to spinal curvature of a >40° Cobb angle is <1%. This result allowed me to modify the treatment plan.
  • We discussed the low risk of progression which relieved the family of much of their anxiety.

Patient Visit 3

Patient monitoring – 6 months post 1st visit

  • This was one of my first patients I used ScoliScore on, although I currently have over 150, so I did my first follow up exam in 6-months.
  • The repeat radiograph indicated the Cobb angle remained at 17° with no change in trunk balance.
  • This provided me with the confidence to schedule her next visit in one year.
  • She was also told that she could continue to participate in all the activities she enjoyed and that the risk of having to be braced was extremely remote.

Patient Visit 4

Patient monitoring – 1 year

  • Patient had been menarchal for about 9-months.
  • Her clinical exam had not changed and no radiograph was obtained.
  • Her next visit was scheduled for one year later. 

Patient Visit 5

Patient monitoring – 1 year

The patient reported no complaints in her follow-up appointment. She had very minimal curvature with no trunk imbalance on clinical exam. No x-rays were taken.

The patient and family reported significantly decreased anxiety about her spine, since they were confident that the curvature will not progress. She had remained active in both sports and dance. Radiation exposure was minimized reducing this patient's risk of developing breast cancer in the future.

ScoliScore's Value

"The above report illustrates a typical ScoliScore case. In this case, the patient would have needed far more visits and radiographs to determine the benign nature of her deformity based on the descriptive standard that has historically been used. The estimated cost savings is significant, including not only the office visit and the radiograph, but also time away from work and school for multiple visits. Her radiation dose was decreased by at least half and maybe more, since the patient was most likely not yet skeletally mature at the time of most recent visit. There is as yet no quantification of the psychological effect of the low score, but by this patient's report it is significant. She reports markedly less anxiety and worry about the current state of her spine as well of the risk of future problems. Her family also report improved concern and anxiety." Keith Mankin, MD

Confidence in Patient Care

Confidence in Patient Care

The ScoliScore Test, when combined with existing radiographic and clinical information, enables physicians to focus valuable clinical resources and provide individualized patient care with confidence, which may help to reduce the anxiety associated with an Adolescent Idiopathic Scoliosis (AIS) diagnosis.

Focused Monitoring

With the additional information provided by the ScoliScore Test, physicians may choose to eliminate additional office visits for patients with a test result demonstrating a Low Risk of progression.

  • In clinical use, the ScoliScore Test showed that 75% of patients tested demonstrated Low Risk of progression to a surgical curve.
  • In clinical trials17 of the ScoliScore Test, the negative predictive value was 99% (C.I. 98.9% – 99.9%)

Indications
  • Adolescent Idiopathic Scoliosis
  • Between the ages of 9 years – skeletal maturity
  • Self reported Caucasian males and females (North American, South American, European, Eastern European, Middle Eastern)
  • Mild Curve (10° – 25° Cobb angle)

 

 

Reduced X-Ray Exposure

With the additional information provided by the ScoliScore Test, physicians may choose to reduce the amount of unnecessary x-rays their patients are exposed to.

  • One pivotal study in the Journal of the National Cancer Institute showed that multiple diagnostic x-rays during childhood and adolescence increases the risk of breast cancer among women with scoliosis.18,19
  • Children with scoliosis received an average of 29 spinal x-rays over a period of 9 years.
  • The U.S. Food and Drug Administration (FDA) has issued public warnings to scoliosis patients about the cancer risk associated with frequent X-ray examinations and emphasized the importance of keeping radiation doses to the breast as low as possible. 52
  • The National Cancer Institute (NCI) further emphasized that the risk of breast cancer depends on dose of radiation and age at exposure, with the highest risk occurring during puberty. No dose of radiation should be considered completely safe, and attempts should be made to keep radiation doses as low as possible.53

The ScoliScore Test is designed to empower clinically actionable decisions by utilizing validated genetic markers which assess the likelihood of curve progression. When combined with existing radiographic and clinical information, the ScoliScore Test enables physicians and families to make personalized patient care decisions.

 

Order a complimentary AIS specimen collection kit.

Statement on Billing Policies

Transgenomic believes health care costs are shared obligations between a patient and the service provider.

Patients actively participate in their own health care by selecting health plans, physicians, pharmacies, etc. As part of that participation, patients agree to pay a percentage of the services and products they use. These payments are contractually obligated and take the form of co-payments and deductibles.

Transgenomic believes no individual or entity should interfere with established contracts between a patient and a third party insurance payer.

An individual chooses the health care coverage and services they need by purchasing health care coverage from a third party insurance provider. When a third party insurance plan defers an individual’s health care costs in exchange for payment (a monthly premium) a contract has been created.

Many states have specific laws barring the interference by outside parties in a contract. For example:

Section 18-13-119 of the Colorado Criminal Code indicates that waiving or reducing of co-payment or deductibles (interference with contractual obligations entered into between the insured and the insurer) is a class 1 petty offense.

Florida Statute § 483.035 and Florida Administrative Code 59A-7.037 indicates no owner, director, administrator, physician, surgeon, consultant, employee, organization, agency, representative, or person either directly or indirectly shall pay or receive any commission, bonus, kickback, rebate or gratuity or engage in any split fee arrangement in any form whatsoever for the referral of a patient.

Massachusetts G.L.c. 111D, § 8(4) indicates a clinical laboratory shall not: (4) offer or give a commission, rebate, or other fee, directly or indirectly to any person as consideration for the referral of a specimen derived from a human body to a clinical laboratory for examination by such laboratory.

In Texas, the State Attorney General has indicated “the payment of benefits under an assignment does not relieve the covered person of contractual responsibility for the payment of deductibles and co-payments. A physician or other health care provider may not waive co-payments or deductibles by acceptance of an assignment.”

Additionally, third party insurance plans have specific language regarding the obligations of the insured:

From Cigna’s Patient’s Bill of Rights: (You have the responsibility to) “Pay all co-pays, deductibles and coinsurance for which you are responsible at the time service is rendered or when they are due.” http://www.cigna.com/member-rights

Transgenomic believes participating with both government and private payers will result in the lowest overall costs to the health care system.

Contracting and accepting both private and Government patients ensures the largest possible number of patients receive needed health care services.

Transgenomic believes no action it takes should jeopardize the patient-physician-provider relationship.

The Affordable Care Act of 2010 states, “A group health plan, or a health insurance issuer offering group or individual health insurance coverage, must not rescind coverage except in the case of fraud or an intentional misrepresentation of a material fact.”

http://healthreform.gov/newsroom/new_patients_bill_of_rights.html

The Insurance Lobby states, “In most states, it is illegal to routinely waive co-pays and deductibles for patients. Health care providers who do this may be charged with the crime of health insurance fraud because they are claiming the wrong amount for services when they make insurance claims. Example: If a patient has a 10 percent co-pay, the insurance company pays $90 on a $100 bill. But if the health care provider waives the co-pay, the patient’s bill is only $90 total, not $100.”

http://www.abramslaw.com/CM/Articles/Automatic-Waiver-of-Copays.asp

Transgenomic believes in providing comprehensive patient services.

No testing begins without the patient’s permission. Transgenomic is an in-network provider with many major insurance carriers to keep the patient’s out-of-pocket expenses as low as possible.

Benefits Investigation – Once we receive a test order, a Patient Services Associate contacts the patient’s insurance carrier to determine insurance benefits. We then contact the patient to explain their benefits and provide an estimate of out-of-pocket expenses.

Insurance Pre-authorization – We work with the patient, their insurance company, and physician to have testing pre-approved. This keeps the patient’s out-of-pocket expenses as low as possible.

Appeals – If the patient’s insurance company rejects the claim, we work with the physician and patient to appeal the decision.

Flexible Payment Plans – Patients may choose one of our flexible payment plans to help manage their out-of-pocket expenses. These are offered with no interest or financing fees. We do not require credit cards up front.

Patients receive consistent discounts across our entire catalogue of tests and not just for certain specialty tests.

Transgenomic believes in business practices that put patients first.

Transgenomic, Inc. ©2012 Transgenomic, Inc. All rights reserved.  Document No. 602216-00 02/12

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referencelinks

Clicking on any of the links will take you to a Web site to which this Privacy Policy does not apply. You are solely responsible for your interactions with such Web sites.

The National Scoliosis Foundation (NSF)
The National Scoliosis Foundation (NSF) is a patient-led nonprofit organization dedicated since 1976 to helping children, parents, adults, and health-care providers to understand the complexities of spinal deformities such as scoliosis

American Academy of Orthopaedic Surgeons
This site hosts an excellent informational section for the public. Visit the Patient Information section and double click on "Patient/Public Education" for various orthopedic topics. Refine your search by clicking on the small icon of the spine. This will take you to a list of fact sheets, brochures, and booklets about the spine. You can also use this web site to locate a surgeon.

Scoliosis Research Society
Refer to the section on patient information. Along with the meeting and membership information for society participants, there is an extensive glossary of spine terms. View the "Library" section for information on clinical assessment, imaging, and the causes and treatment of congenital and neuromuscular scoliosis, idiopathic scoliosis, adolescent idiopathic scoliosis, and kyphosis.

American Association of Neurological Surgeons and Congress of Neurosurgeons
Founded in 1931 as the Harvey Cushing Society, the American Association of Neurological Surgeons (AANS) is a scientific and educational association with over 6,500 members worldwide. The AANS is dedicated to advancing the specialty of neurological surgery in order to provide the highest quality of neurosurgical care to the public. All Active members of the AANS are board certified by the American Board of Neurosurgery, the Royal College of Physicians and Surgeons of Canada, or the Mexican Council of Neurological Surgery, A.C. Neurosurgery is the medical specialty concerned with the prevention, diagnosis, treatment and rehabilitation of disorders that affect the spinal column, spinal cord, brain, nervous system and peripheral nerves.

North American Spine Society
NASS is a multidisciplinary medical organization that advances quality spine care through education, research and advocacy.


References

1. Screening for idiopathic scoliosis in adolescents: update of the evidence for the U.S. Preventitive Services Task force. 2003.

2. Aebi M. The adult scoliosis. Eur Spine J 2005;14:925-48.

3. Andersen MO, Thomsen K, Kyvik KO. Adolescent idiopathic scoliosis in twins: a population-based survey. Spine 2007;32:927-30.

4. Asher MA, Burton DC. Adolescent idiopathic scoliosis: natural history and long term treatment effects. Scoliosis 2006;1:2.

5. Bradford DS, Tay BK, Hu SS. Adult scoliosis: surgical indications, operative management, complications, and outcomes. Spine 1999;24:2617-29.

6. Braun JT, Akyuz E. Prediction of curve progression in a goat scoliosis model. J Spinal Disord Tech 2005;18:272-6.

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