Every year, 60,000 women in the U.S. are diagnosed with ductal carcinoma in situ (DCIS), considered the earliest non-invasive form of breast cancer. Many women with DCIS receive radiation therapy (RT) after surgery—but not all of them need it.
Genomic tests like DCISionRT help personalize care by providing biological insights that help patients and their doctors understand whether radiation therapy is likely to benefit them. With this information, women can make more informed decisions and potentially avoid unnecessary treatment and side effects.
Medicare currently covers this test. Medicare recognizes DCISionRT as an Advanced Diagnostic Laboratory Test (ADLT), and it is covered nationally. Thousands of women on Medicare have already benefited from the test, leading to more personalized and effective treatment choices.
But that could change. A contractor to Medicare (called MolDX) has proposed a new policy that would eliminate coverage for DCISionRT and all other similar genomic tests for DCIS. This draft policy (called an LCD) says these tests are “not reasonable and necessary” — even though Medicare already covers them.
Why this matters to patients:
- Women could lose access to a test that helps them avoid unnecessary radiation.
- Patients would have fewer tools for making informed decisions.
- Doctors would lose a valuable source of information for tailoring care.
- Women would have less choice in making their own treatment decisions!
What you can do: Medicare is accepting public comments on this proposed policy until August 31, 2025. Your story and your voice can make a difference.
How to Comment:
- Send an email to: MolDX.Policy@palmettogba.com
- Subject line: Comment on DL40142
- In your message, share why genomic tests like DCISionRT matter to you or someone you love. Tell Medicare why patients deserve a choice and access to personalized testing.
To ensure your voice is heard, we recommend that you copy/paste the following list of other relevant Medicare Contractors in CC:
- policydraft@noridian.com
- policycomments@wpsic.com
- cmd.inquiry@cgsadmin.com
- Please also BCC: clinicaldataupdates@preludedx.com
Comments are due by August 31, 2025.
And please considering signing the patient-driven petition on Change.org found here! Sign Petition
This advocacy effort is being conducted in partnership with patient advocates, breast cancer clinicians and researchers.