The records have been reviewed. The member is an adult male with a birth date of 03/10/1960. He has a diagnosis of prostate cancer. His treating provider, Samuel Torres, MD, recommended the Oncotype DX Prostate Cancer Assay, which was performed on 12/30/2015.
The carrier has denied coverage of Oncotype DX Prostate Cancer Assay as experimental and/or investigational and not medically necessary. A letter from the carrier to the provider, dated 06/22/2016, states in part:
“Claim number 201602083184074 (Genomic Health Inc.) was denied as services that are experimental/investigational are not a covered benefit. According to Humana's medical coverage policy, while the Oncotype DX assay may eventually have a role in making treatment decisions about
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Boyter was proposed a variety of options regarding how best to treat his cancer. His biopsy and PSA level indicated that he had low risk of disease. These characteristics are helpful, but often are not reflective of the extent of the tumor within the prostate. Thus, a physician cannot fully determine whether a patient has low risk prostate cancer that can be managed with active surveillance (AS), a clinically acceptable course of conservative management for men with low risk cancers, or whether he has aggressive prostate cancer and would benefit from surgery or radiation therapy without the results of an Oncotype DX Prostate Cancer Assay, he and his physician did not have a complete understanding of the biology of his …show more content…
The biopsy revealed Gleason score 6 adenocarcinoma in 3 cores. The clinical stage was T1c. An OncotypeDx Prostate test was ordered on the biopsy specimens; this was performed on 12/30/2015. The Health Plan considers the testing experimental/investigational and has denied coverage. Medical necessity of the testing is under review.
The Oncotype DX Prostate Cancer Assay is a real time polymerase chain reaction (RT-PCR) assay designed for analysis of prostate core needle biopsies. The assay measures the expression of 17 genes to calculate a Genomic Prostate Score (GPS). A lower GPS score has a more favorable biology and less aggressive disease. This test may be utilized to counsel men regarding the best course of therapy (active surveillance vs. treatment) in newly diagnosed low or low-intermediate prostate cancer.
Two recent studies have suggested that Oncotype Dx can predict adverse pathology and unfavorable outcomes after radical prostatectomy. In both of these studies, multiple authors are either employed by the manufacturer of the test or have a financial interest. These studies are recently published and need continued validation prior to widespread clinical use. The medical literature is still insufficient to conclude that the use of this test for decision making after prostate biopsy yields improved
“Claim number 201603086651381 (Biodesix, Inc.) was denied as services that are experimental/investigational are not a covered benefit. Total billed charges of $3,480.00 may be billed to Mr. Charles Henderson at the non-network
Second is age- and race-specific PSA reference ranges. Age- and race-specific PSA reference ranges compare the PSA test results among men in the same group. Third is Percent-free PSA (fPSA) is the percentage of the total PSA that is unbound. Evidence suggests that fPSA is lower in men who have prostate cancer compared with men who do not. Fourth are the complexed PSA (cPSA) test measures the amount of bound PSA circulating in the blood. Fifth is the PSA density (PSAD) which is a test sometimes used by doctors in patients who have a large prostate gland. To determine PSAD, the PSA value (ng/mL) is divided by the volume (size in cubic centimeters) of the prostate. The size of the prostate gland is determined by Tran’s rectal ultrasound (TRUS), a procedure that uses sound waves to create a picture of the prostate. ( (Diagnosis))
“Ms. Gelch had the Oncotype DX Colon Cancer Assay performed to assist in determining an appropriate, individualized, post-surgical treatment decision, as recommended and ordered by her physician, Dr. Stephen Grabelsky. HUMANA ONE POS has denied this Oncotype DX claim based on a presumption this test was experimental/investigative.”
The carrier has denied coverage of Olipaub (Lynparza) as experimental and/or investigational and not medically necessary. There is a letter from the carrier to the member dated 04/12/2016, which states in part:
There are multiple methods for screening for Prostate Cancer; the most common is Digital Rectal Examination. During a digital rectal exam a doctor inserts a glove, lubricated finger into the rectum to feel for any irregular or abnormal firm area in the prostate gland.
Acid Phosphatase is an enzyme found in seminal fluid. It comes from the prostate gland (Johnson 2009). Typically, the more Prostatic Acid Phosphatase found in a sample of semen is a sign of prostate cancer. This is important because the Acid Phosphatase Color Test was once used to determine of a male had prostate cancer. It was later replaced by Prostate Specific Antigen, aka PSA. Forensic scientists still use this test to identify semen, however. In 1938, Gutman and Gutman reported increased levels of acid phosphatase in patients with metastatic prostate cancer (Taira, Merrick, Wallner, and Dattoli, “Reviving the Acid Phosphatase Test for Prostate Cancer”). It was later replaced by the Prostate Specific Antigen in 1971 (Taira, Merrick, Wallner, and Dattoli, “Reviving the Acid Phosphatase Test
The most accurate way to detect cancer cells inside the prostate gland is the surgical removal and histopathological examination of the entire gland. As this approach is clinically inapplicable to each patient with suspicious findings, Transrectal ultrasound (TRUS) guided prostatic biopsy is considered the standard diagnostic procedure for the detection of prostate cancer for patients with a high suspicion for prostate cancer 1.
Benign prostate hyperplasia (BPH) and prostate cancer share a few similarities, elevated prostate-specific antigen (PSA). Along with enlargement of prostate gland that causes urinary symptoms such as, frequent urination, hesitancy, dribbling, and frequent nighttime urination. However, they are quite different which is why more tests need to be done to confirm one or the other condition. These two diseases are also similar in the fact that they both cause an enlargement of the prostate. However with BPH the central portion of the prostate is enlarged and with prostate cancer more commonly the lateral lobes or side of the prostate are enlarged, but can affect any were on the prostate. Both can even be detected by a digital rectal exam however
The paper Prostate Cancer Screening is written as an analysis of the controversy on the use of screening for prostate cancer. The paper itself is written between doctors Elie Mulhem, Nikolaus Fulbright, and Norah Duncan. The analysis, while likely directed to those in the medical field, is tailored to be easily understood by laypeople. While the paper itself is a somewhat brief, surface level analysis of the situation, it does support the notion that prostate cancer screening through methods like prostate-specific antigen (PSA) testing and digital-rectal examinations (DRE) have questionable effectiveness. The intention of the paper appears to persuade doctors and the public to the viewpoint that prostate
Today, prostate cancer is usually detected through screening, and there are two methods for early detection. The prostate-specific antigen test (PSA) is used, but there are
In the case for PSA screening, PCa is the leading internal malignancy in US men and the second leading cause of cancer death in American men. Early detection of prostate cancers offers the best chance of cure. The PSA blood test is the best chance of cure. Currently, the PSA blood test is the best currently available way to detect PCa and it is easy, safe and inexpensive. PSA test results is a piece of information, it is what doctors do with the information that becomes the issue. However, the great majority of PSA detected tumors have the histologic characteristics of clinically important cancers. Also, PSA detection has found tumors early advancing the diagnosis by Seeral years (5-13) and prostate cancer mortality rates in U.S have decreased by 4% (patho book) since 1992, which is 5 years after initiation of prostate screenings. The dilemma is over treating the clinically unimportant disease versus under
Each year approximately 233,000 men will be diagnosed with prostate cancer (Eggener, Cifu, & Nabhan, 2015). In 2015, prostate cancer was the second most common cancer related cause of death among United States men (Eggener, et. al., 2015). While the majority of prostate cancers are slow growing with a 5-year survival rate of approximately 98%, statistics show that when prostate cancer is identified as metastatic, the 5-year survival rate dramatically drops down to 20-25% (Eggener, et. al., 2015). According to these numbers alone, it appears screening for prostate cancer would be a well-accepted practice. However, current methods of screening for this cancer are controversial and has lead organizations like the U.S Preventative Service Task Force (USPSTF) and the American Cancer Society (ACS) to different guidelines for screening.
Although PSA Screening tests can facilitate to detect prostate cancer in its early stage, there is controversy and concern about patient being unnecessarily treated and over-diagnosed. The reliability of prostate specific antigen (PSA) testing is very poor. PSA values could be false positive caused by conditions such as benign prostatic hyperplasia, ejaculation, perineal trauma and PSA value cannot be used to rule out prostate cancer. PSA-screening misses a considerable number of patients with PCa (false-negatives) and wrongly suspects or false-positives (Hayat, Nordin and Berglund, 2013). Sensitivity of the test is determined with the percentage of people tested with the disease that had positive results equals the number of patients that were true positive. The cut-off range for an abnormal PSA screening is 4.0 ng/mL. The American Cancer Society estimated that, the sensitivity of a PSA levels cutoff of 4.0 ng/mL, was twenty one percent for detecting any prostate cancer and fifty one percent for detecting high-grade cancers (Gleason ≥8). Validity of the test can be determined by the ability of its screening to accurately identify, if the patient has the disease or not. With PSA screening alone, one cannot validate if the patient has prostate cancer and other diagnostic tests such as digital rectal exam
Cancer biology can be defined as the ‘study of irregularities and incontrollable growth of individual cells, tissue or organ in any organisms’ thus prostate cancer as one form. In addition to this I also feel there are other disciplines seeing within this research, such as structural biology (shape and organization of biological macromolecules) and endocrinology (glands and hormones), relevant when discussing PSA testing. The discipline of cell biology (e.g. study of cell life) and
Hypothesis/Objective: Prostate molecular markers have been first discovered using the cancer genome of individuals other than African American decent. Due to the lack of screening in a large cohort of AA PCa the prevalence of these markers in AA PCa is not known. Given the fundamental differences in the ancestral history of the genome of AA and EA the prevalence of these molecular markers may be markedly different. Conventional systematic sampling approaches may not reveal the true prevalence in AA PCa. Therefore, we propose to undertake an innovative approach using whole-mount radical prostatectomy to understand the racial disparity.