Monday, July 6, 2026

Palmetto MolDx Shows Up in National News (DCIS)

Palmetto MolDx and its pending decision on DCIS test coverage has made national news on NBC.  The news includes a detailed article as well as video stories. This article quotes Linkd-In, quotes an NBC video, and abstracts points from a long NBC article.


See an article on Linked In by Dan Forche, CEO at PreludeDX.  Prelude makes the "DCISionRT' test to help make decisions about RT (radiotherapy) in DCIS patients.

He links to a firewalled NBC article by Gretchen Morgenstern. Headlining:

"Millions of women may lose Medicare coverage for a breast cancer test hailed by doctors. A private company advising the agency that oversees Medicare has recommended against reimbursing for the biomarker tests, sparking a backlash from cancer specialists."

See the firewalled article here:

And there's a five minute video version:

https://www.nbcnews.com/video/millions-may-lose-medicare-coverage-for-breast-cancer-test-hailed-by-doctors-265914437537

Or at YouTube:

The  5-minute video transcript is here: 

Think about the next five years of your life. Hopefully, they do not include surgery, radiation, and five years of hormone blockers. But for Leanne Looney, that became the reality after she was diagnosed with early-stage breast cancer in 2024.

“I was 48 at the time, and I guess I didn’t really understand the treatment plan,” Looney said. “Once I did, I became more and more concerned about what that meant.”

To treat her type of cancer, ductal carcinoma in situ, or DCIS, Looney was given two options. She could have a mastectomy, with a lengthy recovery, or she could have a less invasive surgery followed by several weeks of intensive radiation.

“What scared me the most about getting radiation was that I felt the side effects, and the possible chance of getting another cancer from radiation, were greater than the actual benefit of getting the radiation,” she said.

Like many patients, Looney looked online for support. There, women shared their experiences of taking a biomarker test before choosing a treatment path. The test assesses the risk that the cancer will progress and whether radiation therapy is actually necessary. Looney pressed her doctors to order it.

“The results came in, and my score was the lowest possible score,” she said. “So they were recommending six weeks of radiation therapy when it would have zero effect on my recurrence rate.”

With that information, she made a life-changing choice: she opted out of radiation after her lumpectomy.

But for some 35 million women across the country on Medicare, coverage for that crucial test is uncertain. Medicare contracts with outside companies to help make coverage decisions for new treatments. In this case, a subsidiary of Blue Cross Blue Shield of South Carolina formed a committee of doctors to review the test. Just one year after Looney’s diagnosis, the committee recommended that Medicare no longer pay for it. This particular contractor’s decision affects about half the country.

“My reaction is, I’m shocked,” said Dr. Patrick Borgen, chairman of the Department of Surgery at Maimonides Medical Center in New York.

Borgen is among the physicians concerned that a committee with no cancer specialists, and made up of employees from major health insurers, overrode experts in the field. Critics say the decision appeared to be driven more by money than by medicine.

“You have 60,000 women a year, 40,000 or 50,000 of whom would fit the criteria for breast conservation,” Borgen said. “A course of radiation is $20,000 to $30,000 per patient. And so these are really big numbers.”

The fewer benefits an insurer agrees to cover, the more it can protect its profits.

During the review process, Dr. Borgen spoke at another meeting in favor of the biomarker test. He said that about 60 percent of women with DCIS today do not need radiation and do not benefit from it. Radiation is also very expensive.

Still, the contracted company recommended that Medicare not cover the test, which costs about $5,000.

The review was led by a pathologist, Dr. Gabriel B. Wilner, who argued that the data supporting the test were “sufficiently flawed,” even though the test has been the subject of several published, peer-reviewed studies.

“Our goal is to write policy, the best possible policy we can, that considers the most accurate evidence that’s available,” Wilner said.

He announced in May that he was leaving the company and declined to comment to NBC News, saying the determination is not final.

The company did not respond to NBC News’ question about whether its parent company, Blue Cross Blue Shield of South Carolina, had any influence over the decision. The Centers for Medicare & Medicaid Services told NBC News that the committee is reviewing public feedback on its decision from last summer, adding that it would not “speculate on the outcome.”

But if the decision stands, it could leave tens of thousands of women diagnosed with DCIS each year without a clear path for treatment. These decisions can have far-reaching implications, because private insurers often follow Medicare’s coverage determinations and decline to reimburse for treatments that Medicare does not cover.

Fortunately for Leanne Looney, who received the biomarker test, she is now cancer-free two years later. She never received radiation, avoiding what she describes as a massive sacrifice for what turned out to be a tiny tumor.

“I really encourage anybody out there who is going through something like this to advocate for yourself and find out what’s available,” she said.

Yasmin Vossoughian, NBC News. [end transcript of video]

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I can't display the firewalled news article but Chat GPT highlights the parts that circled directly onto the Medicare MAC topic.

Article AI summary, with emphasis on the MAC/CAC story

The NBC/Morgenstern story uses the patient experience of Leanne Looney, a woman diagnosed with DCIS in 2024, to illustrate a much larger Medicare coverage battle. Looney was facing lumpectomy plus weeks of radiation, but after receiving a DCIS biomarker test showing the lowest possible risk score, she chose to forgo radiation. The article’s policy point is that Medicare coverage for this kind of test is now uncertain, even though clinicians interviewed by NBC describe it as important for avoiding both undertreatment and overtreatment.

The central Medicare dispute is not about whether DCIS is real cancer, but whether molecular/proteomic biomarker tests add enough proven value beyond traditional clinical-pathologic tools to justify Medicare coverage. The draft LCD says these tests are currently noncovered by the contractor, while leaving open the possibility of future coverage if stronger evidence shows that a test improves risk stratification over existing tools such as nomograms and risk scores.

[That is my MAC-document footwork from the CMS proposed LCD, not a quote from NBC/Morgenstern. (Centers for Medicare & Medicaid Services)]

The MAC chronology matters. In July 2024, MolDX convened a multi-jurisdictional CAC on DCIS biomarker testing, with breast surgeons and radiation oncologists serving as subject-matter experts; the 2025 proposed LCD itself acknowledges that CAC as part of the evidence-development process. (Centers for Medicare & Medicaid Services) In July 2025, the proposed noncoverage LCD was posted, with a public comment period from July 17 to August 31, 2025, and CMS still lists the final notice and final effective date as “N/A,” meaning the policy remains proposed rather than final. (Centers for Medicare & Medicaid Services)

There was then an August 27, 2025 open meeting, conducted by WPS and moderated by Dr. Denise Nachodsky, but strictly speaking it was an open meeting on the proposed LCD, not another CAC. The WPS transcript states that the meeting’s purpose was to receive public comments on the proposed LCDs, and that the MACs were mainly there to listen rather than debate speakers in real time. (WPSGHA)

That open meeting is where the MAC-human-interest story becomes especially interesting. 

Dr. Patrick Borgen, chair of surgery at Maimonides and former chief breast surgeon at Memorial Sloan Kettering, argued that DCIS has been misunderstood for decades as an obligate precursor to invasive cancer, and that modern treatment should “match the treatment to the disease.” He emphasized that the old MSKCC nomogram was the best available tool in 2002, but that clinicians now need to look at tumor biology, not just age, margins, size, and grade. (WPSGHA)

Borgen also argued that the test changed physician recommendations in almost 40% of cases in a 2,007-patient, 63-center study: some women initially not recommended for radiation were shifted toward radiation, while many women initially told they needed radiation were shifted away from it. That is from the WPS transcript, not NBC/Morgenstern. (WPSGHA)

The Morgenstern/NBC article adds the sharper criticism of the MAC interaction. Borgen reportedly said he was alarmed by his open-meeting interview because the physicians’ questions were unsophisticated and showed deep unfamiliarity with DCIS: “They’re certainly good people, but their fundamental understanding of the concepts was lacking,” Borgen said, characterizing the questions as “medical-school level.” He added: “I was astounded at how broken that system is and how much oversight they have with virtually no insight.”

That quote is the key journalistic payload. In the official WPS transcript, the MAC moderator is courteous and even appreciative, telling Borgen that his presentation helped people “at the MAC level” who may not be in his specialty. (WPSGHA) But in the NBC/Morgenstern account, Borgen interprets the same process more darkly: the people with practical power over coverage did not appear to him to understand the disease area at a specialist level.

The insurer angle is also central to why NBC framed the story as a hidden conflict. Palmetto GBA, which administers MolDX, describes itself as a Celerian Group company within the BlueCross BlueShield of South Carolina family of companies. (Palmetto GBA) That does not prove that BlueCross influenced the draft LCD, but it explains why patients and physicians may be uneasy when a Medicare contractor tied to a major insurer family plays a gatekeeping role over a test that could reduce or redirect expensive radiation therapy.

The practical bottom line is that this is not merely a dispute over one DCIS test. It is a vivid example of how MACs, MolDX, CACs, draft LCDs, and open meetings can determine access to diagnostics for millions of Medicare patients. NBC/Morgenstern tells the story through a patient and a skeptical breast surgeon. The MAC records tell the same story in bureaucratic terms: a proposed noncoverage LCD, a 2024 CAC, a 2025 public-comment process, and an unresolved final decision.


Readers have easy access to the Linked In post by the CEO Forche; here's a Chat GPT summary.

In a LinkedIn post, PreludeDx President and CEO Forche thanked NBC News for bringing national attention to the Medicare coverage dispute over DCIS biomarker testing. He argued that DCISionRT has, for nearly a decade, helped tens of thousands of women with DCIS avoid unnecessary radiation while identifying higher-risk patients who may benefit from treatment. He criticized MolDX’s proposed LCD DL40142, issued through Palmetto GBA, which he says would end Medicare coverage for DCIS biomarker testing in 28 states despite 10 published studies and support from breast cancer specialists, including MolDX’s own CAC experts. 

Forche writes that PreludeDx is engaging with Palmetto, MolDX, CMS, clinicians, and patient advocates to reverse the proposed policy and preserve access to evidence-based, individualized treatment planning.