After months of delay, the Medicare Administrative Contractor (MAC), with jurisdiction over most molecular diagnostic tests used to treat cancer, made a series of decisions this fall that will allow Medicare reimbursement for several well-known tests, including 3 used in the treatment of prostate cancer.
On September 23, 2014, Palmetto GBA’s MolDx program issued a draft local coverage determination (LCD) for the ConfirmMDx test, made by MDxHealth, which is designed to avoid repeat biopsies.1
On October 16, 2014, Palmetto GBA issued an LCD for Myriad’s Prolaris test and for Decipher Prostate Cancer Classifer, made by GenomeDx Biosciences, for different indications.2,3
Myriad’s Prolaris test received draft language for reimbursement for approximately 50% of prostate cancer patients defined as low and very low risk, while the Decipher test received draft reimbursement language for using the test with men who have undergone radical prostatectomy. Per Medicare rules, the draft LCD is subject to a minimum 45-day public comment period; once comments are considered, the final language goes into effect after a minimum notification period of 45 days.
Ten days after Medicare’s reimbursement announcement, Myriad announced that Prolaris had been included in the prostate treatment guideline of the National Comprehensive Cancer Center (NCCN), regardless of risk category. In its statement, Myriad said NCCN guidelines are considered the “gold standard” in cancer treatment.4
Palmetto GBA’s action on reimbursement for molecular diagnostic tests for prostate cancer drew plenty of attention across the industry, given this year’s disputes with CMS on reimbursement issues. In recent years, CMS generally, and Palmetto GBA, specifically, have been under scrutiny over the MolDx program, which was developed to handle reimbursement questions involving this emerging industry. MolDx increasingly required testing companies to build evidence that demonstrated “clinical utility,” a standard that means a test makes a difference in physicians’ treatment decisions.
But what should be required became a matter of disagreement. On April 18, 2014, the California Clinical Laboratory Association sued the HHS, of which CMS is a part, over what the plaintiffs claimed was an unlawful transfer of CMS’ authority to set reimbursement policy and, especially, to allow diagnostic companies to appeal an unfavorable LCD.5ConfirmMDx
. Last year, during a presentation at Oral Oncolytics in Philadelphia, Pennsylvania, MDxHealth officials said ConfirmMDx still uses an intial biopsy as the “gold standard,” while recognizing the standard 12-core method might miss cancerous tissue. ConfirmMDx seeks to confirm the presence of an epigenetic “halo” that exists around a tumor, which might be present even though the cells look normal under a microscope.
The test relies upon DNA methylation, a biochemical process that can alter gene expression as cells divide and result in the silencing of tumor suppressors. When DNA methylation goes awry, unfolding either too quickly or too slowly, cancer can result. This process does not happen all at once; thus, DNA methylation can be used as a readout for a pre-cancerous or cancerous state.
If a patient has a negative biopsy but a positive result with Confirm- MDx, the doctor can either treat as if the patient had a positive pathology result, or limit additional cores to the area of known “hot spots,” reducing costs, discomfort, and side effects. Thus, the ConfirmMDx test can not only limit costs but also improve quality of life.6Prolaris
. The Prolaris test, which came on the market in 2010 and costs $3400, is a 46-gene test designed to gauge the aggressiveness of prostate cancer in individual patients, based on the expression of cell cycle regulator genes. Unlike the prostate-specific antigen (PSA), which offers a snapshot of the cancer on a given day, Prolaris’ supporters say it offers a window into the future, assigning a score that increases along with the risk of progression.7