She is a wife and a mom of two children. She is sweet and she is strong, and life has dealt her some pretty tough hands. There is little she hasn’t been able to handle.
The spouse and the best friend of a United States Marine, and a woman who was raised in a “hereditary cancer” family, adversity is not a stranger to her.
For years, she has waited at home, while her husband has been at war, fearing the phone may ring, cared for a child with Chiara Malformation which caused the little girl to develop a large syrinx in her spinal cord and undergo treatment of brain surgery, as well as worry about herself and her family who are affected by Lynch syndrome, and its strong predisposition to an extremely high risk of a litany of cancers.
She is a patient of TriCare, the military’s health insurance program which was charged with the responsibility of making certain she and her family are kept well while her husband was deployed with his Infantry Division of the United States Marines Corp. While he was performing his mission overseas, and she was taking care of her mission at home, TriCare failed with their mission and has lead Cynthia on an long journey to obtain a lifesaving genetic test, to determine if she is predisposed to cancer.
Lynch syndrome is generational in Cynthia’s family. Her father, grandmother and many family members are diagnosed. Her father passed away, from Lynch syndrome (LS) colorectal cancer, in 1987 at the age of 31, when she was young. Those with LS, face an up to 82% lifetime risk of developing colorectal cancer. His mother fought several different cancers before succumbing to pancreatic cancer at the age of 59. Persons with LS often contract several primary cancers during their lifetime. Currently, her cousin has recently experienced a multitude of Lynch syndrome cancers. The son of that cousin, passed away from a brain tumor at the age of seventeen.
Living with Lynch syndrome in a family such as Cynthia’s can be a frightening situation to live with, however in Cynthia’s family, hope exists. Someone had already been diagnosed with LS through genetic testing, and many of her family members have as well and are now receiving annual preventative care in which growths, polyps, tumors and cancers are found early, and removed and treated before becoming life threatening. Cynthia’s test is not expensive and will spare her the burden of having to undergo regularly screenings which are costly and may be unnecessary, so she not have the genetic mutation.
Cynthia’s biggest fear had always been contracting a Lynch syndrome cancer and leaving her children and husband behind. All she needs is a simple genetic test, to test for the mutation which was common within her family. And the organization charged with providing her with this care, is Tricare which for some reason, has chosen on several occasions not to allow her the test despite meeting all the basic criteria for the basic standard of care to have it administered.
Last year, following assessment of family history, her physician prescribed the test for her. They didn’t expect the staggering blow of denial from Tricare, stating there was lack of medical need. The prescription of the physician complied with the standard of medical care and the family history was strongly established. A mutation of a mismatch repair gene, within the family, had already been detected. Tricare was most likely wrong in the decision they made, Cynthia thought for Tricare stated in their own online webpage the following coverage of services:
“Tricare Covered Services: Genetic Testing: “…testing is covered when medically proven and appropriate, and when the results of the test will influence he medical management of the patient. Routine genetic testing is not covered.” That covered services still reads upon the webpage.
However, there was also a very serious contradiction which had been published in an antiquated regulation from 1983 was furnished to Cynthia, reading, “Tests for most genetic conditions fall under Tricare Policy Manual, Chapter 1, Section 2.1, which states: “If the drug or device cannot be lawfully marketed without the approval or clearance of the U.S. Food and Drug Administration (FDA) and approval or clearance for marketing has not been given at the time the drug or device is furnished to the patient…”
The two paragraphs were contradictory with one another, as almost all genetic tests are not FDA approved. Someone at Tricare had found a way to deny genetic testing to military members and military dependents. By the insertion of this paragraph, there was one certainty for the families with hereditary cancers. Nobody with a genetic condition would be granted a test by TriCare.
The rub is the specific genetic test Cynthia needs to protect her from the devastation of contracting cancer is considered to be a laboratory developed test (LDT), which doesn’t require FDA approval. In fact, genetic testing has been prescribed to patients since 1993 and Tricare, until January 2013, had been following the basic standard of care and providing the tests as equally as they have been providing the PAP test, and a number of tests for other disorders…all which are considered LDTs.
On July 19, 2010, the FDA wrote a letter to manufacturers of genetic testing stating they wished to develop a policy regarding FDA approval for genetic testing. It didn’t ever occur, and to date, that goal of the FDA hasn’t been accomplished. They have continued with their basic loosely allowed LDT testing.
At that time, as well, President Obama began pressing Tricare to increase their fees to lower the cost of governmental health care services. It was shortly thereafter the pay codes for genetic testing were quietly changed, with little or no notification.
In 2012, the American Medical Association revised codes to make it easier to define, with more specificity, each genetic test. After this was completed, Tricare began to realize the many laboratory developed tests (LDTs) which existed and immediately and quietly began disallowing the majority of the tests in January of 2013, including the genetic test to diagnose Lynch syndrome.
On 10/1/2013, Tricare published the following: “Diagnostic genetic testing: Diagnostic genetic testing is covered only to confirm a clinical diagnosis that is already suspected based on a patient’s symptoms. Services should be billed using the appropriate Evaluation and Management codes. Refer to the TRICARE Policy Manual, Chapter 6, and Section 3.1. For antepartum services, refer to the TRICARE Policy Manual, Chapter 4, Section 18.2 at http://manuals.tricare.osd.mil.”
Interestingly enough, the codes in existence for Lynch syndrome read, “Do Not Pay.” Every code Cynthia tried to utilize came back indicating “Do Not Pay,” clearly indicating Tricare intended not to test any person who was at risk for Lynch syndrome.
On this same date, the document stipulated genetic testing would be one of the few lab tests which required advance authorization. “Labs (except for genetic testing, which requires authorization.)” Obviously, under current regulations, they could have tested for Lynch syndrome with advance authorization, however determined to deny the authorization.
This document was not listed upon the website, which indicated coverage for Tricare insurance.
In the meantime, tests were still prescribed for military members and dependents, however, the billing from the laboratories was not paid by TriCare, in contradiction of their statements. As of late, those billings been forwarded back to the military members to be paid, placing the burden of payment upon military families.
Tricare referred her to a genetic counselor, who advised she should be genetically tested. Then oddly enough, despite the test had been placed on the “Do Not Pay List,” Cynthia was required by Tricare to file an appeal and document her medical need, presumably so they could document her family history and official denial.
Cynthia complied. Both she and her physician emphasized the medical need and inserted a copy of her sister’s positive test results to substantiate the need, and how it fell into a basic standard of care necessity.
Despite this, she received another denial, this time with a different reason. Tricare cited it was an unproven test by the FDA citing the antiquated 1983 regulation.
Cynthia is not alone. Another military dependent, the wife of a soldier was actually tested, in accordance with Tri-Care coverage and Tricare left them holding the bill. In another situation, lifesaving testing for an individual with leukemia was denied. Tests to diagnose cystic fibrosis, which could open the door for children to receive intervention and potentially lifesaving treatment to prolong life have been denied the families of our service members. The list goes on and on…
It has been reported Tricare is considering starting a “pilot program” for genetic testing, despite the fact genetic testing for Lynch syndrome has been undergoing for the past fifteen years. To halt it and restart the process of “pilot programs,” is unacceptable. Though assurances have been made Tricare’s actions would not jeopardize lives, lives have already been jeopardized and will continue, as Lynch syndrome cancers can metastasize in two to three years.
“I don’t understand it,” Cynthia stated. “We have always been there for our country. And when we need them they aren’t there for us. I proved to Tricare, beyond any doubt, that these tests are essential to the medical management of my care. My life depends upon them. Tricare denying these tests is horrific.”
It is deplorable when two agencies of the United States Government cannot speak to one another and do what is right for our soldiers, veterans and their families and leave them vulnerable for over a year, without the necessary lifesaving tests they need to survive.
Cynthia’s husband has had our backs for years. It is time we showed our support and stand by him and his family during this terrible time of need. We urge our partner organizations to join us.
Call your Congressional and Senator today and ask them what has gone so terribly wrong that even the children and wives of those who risking their lives for our country, cannot get access to the basic care, which is afforded to everyday Americans.