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View Public Comments for Screening for Colorectal Cancer-Blood-Based Biomarker Tests (CAG-00454N)

Cossman, Jeffrey

I am a physician, a pathologist, and have dedicated my 45-year career, including 12 years at NIH, to bringing forward new technologies to diagnose and better treat cancer. I am writing today to strongly urge the Centers for Medicare and Medicaid Services (CMS) to immediately enable coverage of a proven colon cancer screening test that will prevent tens of thousands of deaths.

In April 2016 FDA approved (PMA) a DNA blood test for colorectal cancer. Regrettably, that was four long years ago, yet CMS still has not initiated the National Coverage Decision (NCD) process to enable Medicare coverage of this blood test. This bottleneck at CMS prevents the test from reaching the public. During this four-year delay, 200,000 in the USA have died of colorectal cancer and ¾ of those deaths, or 175,000, were Americans who were not screened for colorectal cancer. By improving the screening rate just 10% would save over 8000 American lives each year (American Cancer Society). That is one life saved every hour of every day. The blood test will do this and studies of nearly 10,000 patients prove it. Why are we waiting? Why do we need to see people die unnecessarily when we have the technology in our hands to save these precious lives?

The data is overwhelming that people will accept this blood test even if they have refused all other forms of screening. In study after study nearly 100% of those who have previously refused all screening readily take the blood test and, if positive, many go on to the gold standard, colonoscopy. That means potentially saving thousands of lives by finding cancer early, long before it has spread. Every day that CMS waits to cover the blood test means more deaths that could have been prevented. It is a shameful travesty and a national embarrassment that an agency dedicated to preserving the public health has dragged this out while Americans suffer.

The blood test is designed to be run in CMS approved (CLIA) laboratories throughout the USA. CMS has already established both a Common Procedural Technology (CPT) code and a payment level of $192 but another HHS office has blocked the life-saving test from Americans and refuses to engage in coverage review. Why? Is it due to bureaucracy, incompetence, conflict of interest or is it something else? There is no moral explanation. We cannot wait while thousands die.

This cancer test is only the beginning. Years of research and development have fueled the pace of technological advancement enabled in HHS programs at the NIH and Human Genome Project. This progress has been harnessed to better treat cancers through improved screening, recurrence and response monitoring. How can another HHS office prevent Americans from receiving the benefits of our nation’s research? The floodgate must be opened to let proven technology reach the public. It is imperative that HHS agencies are aligned to enable the use of new, approved, safe and effective, technologies to quickly become covered services. Within the decade, many new liquid biopsy methods for blood-based cancer monitoring will change the outcomes but only if appropriately covered. CMS should not use blocking of coverage to discourage scientific development of promising new technologies that save lives and healthcare dollars.

Specifically, in the case of colorectal cancer, the US spends $18 billion on care each year. Over 75% ($14B) of those dollars are spent on patients who are non-compliant to current screening practices. At highest risk are the underserved, especially rural populations and inner-city African Americans. A recent study showed that fewer than 15% of these underserved minorities would accept the simplest and cheapest colorectal cancer screening test, FIT, a stool test, but an astonishing 93% accepted and received the blood test. The blood test eliminates cultural barriers and becomes the choice of the underserved and we know it leads to far greater screening in the populations at greatest risk. It has been clearly concluded that increased screening will save lives (American Cancer Society), increase cost savings to Medicare (Chin, CMS, 2015) and do so in a more efficient manner ((D’Andrea, Harvard, 2019).

Who among us doesn’t want to save lives from horrible metastatic colorectal cancer and at the same time save millions of health care dollars? It is time, today, to open the door and cover this life saving test. “How wonderful it is that no one has to wait but can start right now to change the world!” (Anne Frank) Do not wait one minute longer.