Legislation

At long last, the U.S. Food and Drug Administration (FDA) has announced updates to mammography regulations to notify women and their referring providers about a woman’s breast density. States will have until Sept 10, 2024 to comply and once the rule goes into effect one of the two (not dense or dense) federal density notification statements will be required in all patient letters. More HERE.

As mentioned, a U.S. federal bill for expanded breast imaging coverage, the Find It Early Act, has been introduced. While that legislation progresses on the federal level, 10 individual states have also introduced 2023 bills for expanded breast imaging insurance coverage. This is the beginning of most state legislative sessions, and more bills may be introduced.

The individual bills vary in scope of proposed coverage; please click on the link for actual bill content. Please note, a bill is often amended as it moves through the legislative process and bill language may not reflect the final language if signed into law.

Delaware          HB60
Hawaii               SB273
Missouri            HB575
                            HB147
Mississippi       SB2219
Nebraska          LB145
New Mexico     HB27
New Jersey       A4550
Pennsylvania*  SB1225
Virginia              SB1368
Washington     SB5396

*Pennsylvania’s bill carried over from the 2022 session

Federal legislation that would require insurers to cover no cost-sharing additional breast imaging for women with dense breasts or at higher risk for breast cancer, the “Find It Early Act”, was announced on Capitol Hill. This legislation should help address insurance barriers which contribute to the lack of health equity.

DB-i’s JoAnn Pushkin joined Reps. Rosa DeLauro and Brian Fitzpatrick and journalist Katie Couric to speak at the press conference. Creative credit goes to Dr. Wendie Berg for her suggestion that the DB-i tagline “Find it Early” be considered as the bill’s name.

While a bill number/link is pending, below is an excerpt from the bill:

COVERAGE WITH NO COST-SHARING FOR ADDITIONAL BREAST SCREENINGS FOR CERTAIN INDIVIDUALS AT GREATER RISK FOR BREAST CANCER

• (A) With respect to an individual who is at increased risk of breast cancer (as determined in accordance with the most recent applicable American College of Radiology Appropriateness Criteria or the most recent applicable guidelines of the National Comprehensive Cancer Network) or with heterogeneously or extremely dense breast tissue (as defined by the Breast Imaging Reporting and Data System established by the American College of Radiology), screening and diagnostic imaging (with no limitation applied on frequency) for the detection of breast cancer, including 2D or 3D mammograms, breast ultrasounds, breast magnetic resonance imaging, or other technologies (as determined in accordance with such applicable criteria or guidelines); and
• (B) with respect to an individual who is not described in subparagraph (A) and who is determined by a health care provider (in accordance with such most recent applicable criteria or guidelines) to require screening or diagnostic breast imaging by reason of factors, including age, race, ethnicity, or personal or family medical history, screening and diagnostic imaging (with no limitation applied on frequency) for the detection of breast cancer, including 2D or 3D  mammograms, breast ultrasounds, breast magnetic resonance imaging, or other technologies (as determined in accordance with such applicable criteria or guidelines).

Federal Insurance Legislation
Congresswoman Rosa DeLauro (Connecticut) will soon introduce federal legislation that requires insurers to cover no-cost additional breast imaging for women with dense breasts or at higher risk for breast cancer. Given DB-i’s experience in bill analysis, Executive Director JoAnn Pushkin and Chief Scientific Advisor Dr. Wendie Berg were asked to review and offer input on bill language. We are particularly delighted that the DB-i tagline “Find it Early” is being used as the bill’s name!  More news on the introduction of the Find it Early Act will follow.

Federal Standardized Dense Breast Notification
The proposed insurance legislation complements the national “dense breast” reporting standard, also under development. As a reminder, the FDA is advancing a standard for breast density notification for American women and anticipates that this will happen by early 2023. Until that time, details on individual state inform laws are available here.

Tennessee State Insurance Law:
Over a dozen U.S. states have active bills for varying levels of breast imaging insurance coverage. News! A Tennessee state bill has just been signed into law. Learn more about the Tennessee law and other state “inform” and insurance laws in DB-i’s legislation MAP or TABLE. (Please note, the effective date of the TN law is dependent on when it is assigned a “public chapter number”; we will provide that info when it is available.)

Newly Published:
MAB member Dr. Paula Gordon’s review article, The Impact of Dense Breasts on the Stage of Breast Cancer at Diagnosis: A Review and Options for Supplemental Screening is just out in Current Oncology. The article addresses the issue of dense breasts and the impact on the stage of breast cancer at the time of diagnosis and discusses options for supplemental screening.

U.S. National “Density” Reporting Standard

As you may recall, 2019 saw progress on both the federal legislative and regulatory fronts for a national breast density reporting standard for patients and referring providers (learn more HERE).  The federal law directs the FDA, through the regulatory process, to develop reporting language and ensure that mammography reports and summaries received by patients and their providers include appropriate information about breast density – though no timeline was included.

So, where are we now?  Next steps would be the publication of the FDA/MQSA Final Rule and implementation period. While that was originally anticipated in Sept/Oct of 2020, updated timing has not yet been announced. In the meantime, individual state “inform” laws remain in effect and guide reporting requirements.

Federal U.S. legislation signed last year mandated that the FDA develop a national “density” reporting standard to be included in patient letters and health provider reports (learn more HERE).

The March 2019 proposed rule/language is still in the development process and we reached out to our friends at the FDA for an update. Feedback provided is that the most current information regarding publication of the rule is still the Spring 2020 Unified Agenda which anticipates that the final rule will be published in September 2020. At that time, we will also learn the implementation period of the new rule (proposed period was 18 months).

We will keep you apprised of developments as we learn them!

Pennsylvania Insurance Law
Signed on July 1st, the new law requires insurers to cover breast MRIs and ultrasounds for women with:

• Extremely dense breast tissue
• High-risk factors for breast cancer such as a personal history of breast cancer, a family history of breast cancer or a genetic predisposition
• Heterogeneously dense breast tissue and one other high-risk factor

The patient may still be responsible for out-of-pocket expenses (copay/deductible/co-insurance). The law goes into effect August 30, 2020 but is subject to individual policy applicability dates. For more information on state inform and insurance laws, click HERE for DB-i U.S. map content (or HERE for data in table format).

New Research
DB-i UK Education Ambassador Dr. Nick Perry is lead author on a new study published in Diagnostics 2020, Mammographic Breast Density and Urbanization: Interactions with BMI, Environmental, Lifestyle and Other Patient Factors. The study examined the association of various factors, including both residing in and working in the urban setting, with mammographic breast density.