Saturday, June 26, 2021

Very Brief Blog: Reducing Hereditary Cancer Act Introduced by Congr. Wasserman-Schultz

One of the major quirks of Medicare policy is that the agency feels it can pay for hereditary cancer risk testing only if a patient has already been diagnosed with cancer.   For example, a woman who is a Medicare beneficiary with three close relatives with breast cancer does not qualify for BRCA testing, but a woman with three close relatives with breast cancer can be tested after SHE personally develops breast cancer.   

This is unique to Medicare; woman in commercial health plans would qualify for BRCA testing based on USPSTF and HHS guidelines for implementing required preventive services.

  • On June 23, 2021, legislation to correct this was introduced into Congress by Representative Wasserman-Schultz of Florida.   It's bill HR 4110 in the current 117th Congress.   Read it here.  
    • Note: I've posted the link; the legislation text wasn't visible online yet as of June 26.
  • Press release, dateline June 23, at Wasserman-Schultz website here.
  • See discussion at the website of FORCE, Facing Our Risk of Cancer Empowered - here.  
  • The Medicare benefit would be linked to major clinical guidelines, such as NCCN.


There are two arguments in play more generally in this area.   

One argument today is that persons with high familial risk should have testing (as per USTPF for example) for management of their risk, their schedule of colonoscopy or mammography, etc.   This management should be able to commence before a personal history of cancer.

A different argument, and it's separate, is when, whom, what to test after a diagnosis of cancer.  There have been multiple large studies (here) that after a diagnosis or breast or colon cancer, the risk of finding actionable genetics is just not much different with or without a high family history of cancer.  Therefore, the argument goes, it would be more rationale to predicate this testing on the patient's personal history of cancer, even if a family history is not present in the available data.   


And yet another twist in the field is that in some cancers, like colorectal cancer, testing of the cancer may include mismatch repair genes (MMR genes) which cause microsatellite instability (MSI) which is medically necessary testing for some types of treatment selection.   

The MMR/MSI findings may be of germline or somatic origin, but are used to guide present therapy choices, so hereditary risk is not invoked as "the" reason for testing the same hereditary risk genes.   Another way of reaching the same point is to argue that germline testing (including hereditary oncogenes) is necessary to properly interpret the results and actions following comprehensive genomic profiling (CGP) of the tumor tissue.


Readers may have notice that a woman who is 64 with three breast cancer relatives is covered for BRCA testing now, per national preventive benefits under the ACA and USPSTF, and should get it now, because she won't be covered when she turns 65 next year and flips into Medicare coverage.


I've summarized what I think I understand, below.  


A:  Medicare covers genetic risk screening for patients with a personal history of cancer AND a family risk history.

B:  USPSTF/ACA covers women without breast cancer but with a high risk family history, for BRCA testing (here). This applies to commercial insurance under the ACA but doesn't apply to Medicare.

C:  FORCE bill, newly proposed, provides CMS hereditary gene coverage based on preventive guidelines, e.g. NCCN.

D:  Some currently argue that patients with cancer, but with or without a family history on the record, all have enough genetic risk to justify genetic testing.  Data for genetic findings "in guidelines" and "outside" guidelines justify this.   In fact, it's become dated to refer to this testing as "outside guidelines" in that at least one major guideline already now includes women with breast cancer with or without family history (here, here).

E:  Some argue for population-wide screening of certain risk genes, e.g. BRCA, regardless of family history or personal cancer history.

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