When Personalized Medicine Becomes Less Personal

Imagine hearing the words: "You have Stage 0 breast cancer."

Within days, you're faced with decisions that may affect your body, your future, and your quality of life. Should you have radiation? Can it safely be avoided? Is your risk of recurrence low or high?

These aren't easy questions—and they deserve thoughtful, individualized answers.

That's why recent news surrounding Medicare coverage for genomic testing in ductal carcinoma in situ (DCIS), also known as Stage 0 breast cancer, deserves our attention.

A proposed Medicare coverage change could limit access to certain genomic tests that help estimate an individual's risk of recurrence and whether radiation therapy is likely to provide meaningful benefit. While the proposal directly affects Medicare beneficiaries in jurisdictions covered by the MolDX program, coverage decisions like these often extend far beyond Medicare. Private insurers frequently look to Medicare policies when determining what they will cover, meaning the ripple effects could impact patients of all ages.

First, What Is DCIS?

Ductal Carcinoma In Situ (DCIS) is often referred to as Stage 0 breast cancer, but that label doesn't capture the complexity of the diagnosis.

DCIS develops when abnormal cells are found inside the milk ducts of the breast. Unlike invasive breast cancer, these cells have not broken through the duct wall or spread into the surrounding breast tissue. Because the abnormal cells remain confined to the ducts, DCIS is considered non-invasive.

Today, DCIS accounts for approximately one in every five new breast cancer diagnoses in the United States, largely because routine mammograms are able to detect these early changes before they become invasive.

While DCIS is highly treatable and carries an excellent prognosis, it is not one disease. Some DCIS lesions are unlikely to ever progress or return after surgery, while others have a higher risk of recurring or developing into invasive breast cancer over time.

That is what makes treatment decisions so challenging.

There is no universal "right" answer for every patient.

Treatment recommendations may include lumpectomy alone, lumpectomy followed by radiation therapy, hormone therapy for some hormone receptor-positive tumors, or mastectomy in select situations. These recommendations are based on many factors, including the size and grade of the DCIS, surgical margins, hormone-receptor status, age, family history, personal preferences and values, and in some cases genomic or biomarker testing.

The goal is to understand the biology of the tumor well enough to recommend the treatment that is most appropriate for that person.

What Is Genomic (Biomarker) Testing?

This is where many patients become confused. Genomic testing does not tell you whether you have cancer. It also does not replace your pathology report.

Instead, these tests analyze the biology of the tumor itself to better understand how that specific DCIS may behave. In certain cases, these tests can provide additional information about the likelihood of recurrence and whether radiation therapy is likely to provide meaningful benefit after breast-conserving surgery.

The current Medicare Local Coverage Determination itself acknowledges that traditional clinical and pathologic features do not always reliably predict recurrence risk and that validated biomarkers may provide additional prognostic information to help distinguish patients who may benefit from more treatment from those who may benefit from less.

This is the very definition of precision medicine.

Information Empowers Patients.

At SurvivingBreastCancer.org, we believe that informed patients make better decisions not because they choose one treatment over another, but because they understand why a treatment is being recommended for them.

Genomic testing is not a replacement for conversations with your surgeon, radiation oncologist, or medical oncologist. It is another piece of information, another data point, another tool that can help patients and physicians weigh risks, benefits, and personal preferences together.

Access to information should never depend on a person's financial resources.

If a validated test can help someone better understand their individual risk and make a more informed treatment decision, patients deserve the opportunity to discuss that option with their care team.

Why This Matters Beyond Medicare

Many people assume Medicare policy affects only older adults. Unfortunately, that's often not the case. Medicare coverage decisions frequently influence private insurance policies, employer-sponsored plans, and future payer decisions. While there is no guarantee private insurers will mirror this proposal, history suggests they often consider Medicare coverage when developing their own policies. That means today's Medicare decision could shape tomorrow's access for women diagnosed with DCIS across the country.

What Can We Do?

One of the questions I kept asking myself while researching this issue was:

"What can we actually do?" The good news is that patients and advocates do have a voice.

Here are a few meaningful ways to get involved:

• Learn about the proposed policy from reliable sources before sharing information.

• Contact your members of Congress and let them know that access to evidence-based, personalized cancer care matters to you.

• If public comment opportunities are open during Medicare contractor review periods, submit your perspective as a patient, caregiver, clinician, or advocate.

• Share your story. Real patient experiences help policymakers understand that these decisions affect people, not just policies.

• Talk with your healthcare team. If you've benefited from genomic testing, ask whether they're participating in professional advocacy efforts through their medical societies.

Our Commitment

At SurvivingBreastCancer.org, we don't advocate for one company or one test.

We advocate for those impacted by breast cancer. We advocate for access to high-quality information. And we advocate for a future where treatment decisions are driven by science, evidence, and the unique circumstances of each individual, not simply by whether a diagnostic tool happens to be covered.

Because every person diagnosed with breast cancer deserves the opportunity to make informed decisions with their healthcare team.

Learn More

If you're newly diagnosed with DCIS and want to better understand your options, we invite you to listen to our Breast Cancer Conversations episode: DCIS Isn't 'Nothing': Stage 0 Breast Cancer and the Decisions No One Explains.

In this conversation, we explore why DCIS treatment is often more nuanced than people realize, what genomic testing can and cannot tell us, and why personalized decision-making matters.