After Delays, Reimbursement Approvals Seen for Diagnostic Tests

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 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 into 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.⁵

ConfirmMDx. 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 reocgnizing 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 ConfirmMDx, 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.⁶

Prolaris. 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

Decipher. GenomeDx describes Decipher as a “unique genomic test intended for men who have had prostate surgery and are considered by guidelines to be at high-risk for their cancer returning.” It is designed for men with specific risk factors for cancer recurrence, including positive surgical margins, stage T3 disease (seminal vesicle invasion, extraprostatic extension, and bladder neck invasion), or rising PSA after an initial drop-off.³

Breast Cancer Test Receives LCD

On October 15, 2014, BioTheranostics announced that it had received a positive local coverage determination from Palmetto GBA for its Breast Cancer Index, or BCI, test, a gene expression test that assesses risk during the following periods:

• In the first 5 years after diagnosis

• Late recurrence beyond 5 years after diagnosis

• Overall 10-year risk.

In a statement, BioTheranostics said that the draft Medicare language calls for covering BCI to predict risk of late (5—10 years) distant recurrence in women with early stage, estrogen receptor-positive breast cancer who are considering extended therapy but are concerned about continuing anti-hormonal therapy because of documented toxicity or possible significant patient-specific side effects.

“We are pleased that we have attained such a significant milestone within the first eight months of full commercialization of the Breast Cancer Index—the only molecular test covered by Medicare that accurately assesses a patient’s individualized risk of breast cancer recurrence after 5 years and is validated to identify which patients will benefit from extended hormone therapy,” Nicolas Barthelemy, who recently joined BioTheranostics as president and CEO, said in a statement. “This critical information will allow many women to avoid unnecessary treatment and potential side effects that can adversely affect their health and quality of life.”⁸ EBOReferences

1. MDxHealth’s ConfirmMDx for prostate cancer test qualifies for Medicare coverage effective November 3, 2014 [press release]. Irvine, CA, and Herstal, Belgium: MDx Health; September 23, 2014. http://mdxhealth.com/news-and-events/press-releases-and-events?detail=1857455.

2. Myriad receives draft Medicare coverage for Prolaris [press release]. Salt Lake City, UT: Globe Newswire; October 16, 2014. http://investor.myriad.com/releasedetail. cfm?releaseid=876733.

3. Centers for Medicare & Medicaid Services publishes draft coverage decision to reimburse Decipher test for intermediate and high-risk cancer [press release]. San Diego, CA: Genome Dx; October 16, 2014. http://genomedx.com/press-releases/centers-medicare-medicaidservices-publishes-draft-coverage-decision-reimburse-decipher-test-intermediate-high-risk-

4. Myriad announces inclusion of Prolarid in NCCN guidelines [press release]. Salt Lake City, UT: Globe Newswire; October 27, 2014. http://www.myriad.com/investor/press-releasedetail/?newsItemId=878212.

5. Caffrey MK. When science outpaces payers: reimbursement in molecular diagnostics. Am J Manag Care. 2014;20(SP7):SP234-SP236.

6. Caffrey MK. A test to prevent repeat prostate cancer biopsies? perhaps, if the bar of “clinical utility” can be met. Am J Manag Care. 2014;(SP2):SP30-SP31.

7. Studies see value of Prolaris cancer diagnostic test, but will CMS pay for it? Am J Manag Care. 2014;20(SP11):(SP323-SP327)

8. BioTheranostics gets Medicare coverage for Breast Cancer Index test [press release]. New York: GenomeWeb; October 15, 2014. http://www.genomeweb.com/clinical-genomics/biotheranostics-gets-medicare-coverage-breastcancer-index-test