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Legislation that advocates believe would significantly reduce prostate cancer misdiagnoses is making its way through Congress and has the support of major urologic organizations and prostate cancer interest groups.

The bill, HR 2577, the Prostate Cancer Misdiagnoses Elimination Act of 2017, sponsored by Rep. Larry Bucshon, MD (R-IN), a cardiac surgeon, has been cleared by the House Energy & Commerce Committee following a July hearing, but still has a long way to go before it becomes law.

The point of the legislation is to authorize the Centers for Medicare & Medicaid Services (CMS) to pay up to $200 to laboratories for DNA testing so a patient’s needle biopsy tissue can be compared with cells from inside the cheek taken with a cotton swab to make certain both came from the same person.

That, according to Dr. Bucshon and advocates, would dramatically reduce, if not eliminate, cases where provenance complications, including specimen mix-ups, result in erroneous prostate cancer diagnoses.

Deepak A. Kapoor, MD, chairman and CEO, Integrated Medical Professionals, Melville, NY, told the Energy and Commerce Committee that a 2015 study found that misdiagnoses based on needle biopsies occurred in 2.5% of cases and would largely be eliminated if the backup DNA test became standard practice (J Urol 2015; 193:1170-7). The study concluded that at least 1.28% of those patients were actually cancer free.

Bill endorsed by LUGPA, AUA

Dr. Kapoor is health policy chair at LUGPA, which along with the AUA, the Men’s Health Network, the Prostate Health Education Network, and several other related groups has endorsed Dr. Bucshon’s bill.

Read: Urologists' resolutions for 2018

“Recently, the clinical literature has revealed a troubling persistence of specimen complications where a relatively high number of biopsies had been switched or contaminated with tissue from another patient,” Dr. Kapoor testified. “To improve diagnostic accuracy and eliminate medical mistakes, our practice changed our treatment protocol to require a DNA test for all positive biopsies to ensure that the right patient receives the right treatment—or no treatment at all.”

He said the service is performed by an outside lab and not billed by his practice, so there is no financial incentive for doctors to order the test. Moreover, he cited an April 2016 Milliman, Inc. study, “Prostate Cancer Treatment Utilization and Cost Analysis,” that estimated Medicare would save at least $539 million over 10 years by eliminating these errors.

That would result by avoiding unnecessary treatment for the 1.28% of newly diagnosed patients who do not actually have cancer and eliminating over-treatment of the 0.19% of newly diagnosed patients that are misdirected to active therapy when they should really be monitored through active surveillance.

However, Medicare does not currently approve payments for the DNA Specimen Provenance Assignment (DSPA) test because it does not specifically diagnose or treat disease.

“This interpretation of the Medicare statute is harmful to patients, wasteful of Medicare resources, and is in direct conflict with Medicare’s own acknowledgement that ‘DSPA testing is very useful as a tool for avoiding error and misidentification of a patient with cancer,’ ” Dr. Kapoor said.

The bill’s primary sponsor, Dr. Bucshon, in an email told Urology Times that as a physician in Congress he is “working to ensure that the federal health care policies, rules, regulations, etc… don’t unnecessarily stand in the way of physicians being able to provide the best care possible for their patients.” But, he said, Medicare’s current policy regarding payment for DSPA testing does exactly that.

His bill, he said, “would help eliminate these medical errors by requiring Medicare coverage for DSPA testing for positive biopsies of prostate cancer and give patients reassurance in the accuracy of their positive prostate biopsy results, prevent unnecessary invasive medical procedures, and save taxpayer money.”

Dr. Bucshon said that under the bill, the lab performing the test would bill CMS as any lab would normally do for any other test, and that eliminating misdiagnosis “will save on average over $10,000 per procedure, resulting in a net decrease in Medicare spending.”

While there have been suggestions that getting a second diagnosis, which Medicare does pay for, would cost less than the $200 per DSPA test, Dr. Bucshon said, “The bill is aimed at the specific problem of misdiagnosing prostate cancer through additional lab testing to ensure results are accurate and not contaminated. Questions on next steps and second opinions are medical in basis and should be directed at specialists that are well versed in urology, such as the American Urological Association.”

Also see: Urologists, lawmakers share experience, expertise at AACU event

The AUA, in a letter in July that was cosigned by the Men’s Health Network and the Prostate Health Education Network, urging Congress to approve Dr. Bucshon’s bill, said, “To deprive Medicare beneficiaries of access to an important test which eliminated medical errors is contrary to the best interests of patients.”

What’s the outlook for the legislation?

Said Dr. Bucshon, “The bill passed unanimously through the Energy and Commerce Committee and we are working with the committee to find the best path forward. We are also working to find bipartisan support for a companion bill in the Senate.”

Most likely, if the bill is to move forward, that will happen in the second session of Congress, which begins in January.

Urology Times