Breast cancer screening: what the plan covers and what your report must say

It is a coverage and information law. Its statement of motives explains the technical problem behind it: breast tissue density negatively affects the mammogram’s effectiveness as a screening tool, because dense tissue appears white on the mammogram and **cancer also appears white**, so it may be masked. The same statement cites the figures it relies on — that mammography detects 98% of cancer in women with fatty breasts but only 48% in women with the densest breasts, per the American Medical Association of September 19, 2002, and that 40% of women have dense tissue. **We reproduce those figures as what they are: the data the law’s statement of motives cites, not a clinical recommendation of ours.** From there come the law’s two orders: to guarantee every woman knows her breast density as part of her mammogram report, and to guarantee access to early detection tests.

It depends on the benefit. For the baseline mammogram, women between thirty-five (35) and thirty-nine (39). For the annual mammogram, women forty (40) or older. For the annual mammogram with follow-up treatment or supplemental diagnostic tests, two groups: women forty (40) or older **whose breast tissue is classified as heterogeneously dense or extremely dense, as determined on their mammogram by a radiologist** on the American College of Radiology’s BI-RADS density scale; and **women at high risk of developing breast cancer** due to family history, their own history as a cancer patient, the presence of high-risk markers in their genetic profile, or **some other factor determined by their doctor** — that last clause leaves the door open to clinical judgment.

• Being in one of the age or risk groups Article 2 describes, and having coverage with an insurer, health service organization, plan or entity contracted to offer health benefits in Puerto Rico, including the Government Health Plan.Verified against the official source
• For supplemental tests based on density: that a radiologist has classified the tissue as heterogeneously dense or extremely dense on the mammogram, per the American College of Radiology’s BI-RADS scale.Verified against the official source

• The mammogram report. The law regulates its content, so that report is both the procedure’s document and the evidence of whether the facility complied: it must carry the tissue density classification and, if the tissue is dense, the notification whose text the law writes out.

1. 1

   Step 1: What the plan must cover

   Article 2 requires providing, **as part of the preventive care benefits of its basic coverage**, mammograms and other breast cancer diagnostic and screening tests, per acceptable practices, under three subsections: **(a) a baseline mammogram for women between thirty-five (35) and thirty-nine (39)**; **(b) an annual mammogram for women forty (40) or older**; and **(c) an annual mammogram, follow-up treatment or supplemental diagnostic tests** for the two groups the law describes — women 40 or older with heterogeneously dense or extremely dense tissue per BI-RADS, and women at high risk. Note subsection (c) is not merely "another mammogram": it expressly includes follow-up treatment and supplemental tests. The obligation reaches a broad universe of payers the law enumerates: insurers and health service organizations organized under the Insurance Code, every insurance plan providing services in Puerto Rico, every other entity contracted to offer health benefits, every entity excluded under Article 1.070 of the Insurance Code, the Health Insurance Administration and every entity contracted to offer health services or health insurance through the ASES act.

2. 2

   Step 2: What follow-up may include

   Article 3 describes the content of follow-up treatment or supplemental tests for women 40 or older with dense tissue, and clarifies the list is **not limiting**: **(a)** evaluation of the potential risk of developing breast cancer using a cancer risk assessment program, performed by an oncologist or other physician experienced in selecting and interpreting breast cancer risk models; **(b)** patient education on the risks, benefits and other considerations of the different available tests using magnetic resonance imaging (MRI), ultrasound, tomosynthesis or any other modality; **(c)** the recommendations issued by the American College of Radiology, the American Cancer Society, the American Medical Association, the American Society of Clinical Oncology, the United States Preventive Services Task Force, the Society of Breast Imaging or another organization widely recognized as expert authority; and **(d)** any other course of action determined by the physician in practicing their profession and grounded in their clinical judgment. The law adds two balancing clarifications: nothing in it shall be understood as limiting or replacing periodic mammograms, nor as a mandate favoring the selection of one course of treatment or test over another.

3. 3

   Step 3: The doctor’s judgment governs the test

   Article 3 closes with a safeguard worth knowing because it protects the patient in the opposite direction: **under no circumstance may a physician be required to perform any diagnostic test or follow-up treatment if, according to their professional judgment, it does not represent a benefit for the patient or may cause her harm**. That is, the law creates a right to have the plan cover, not an obligation to undergo everything covered: the clinical decision remains with the doctor and the patient.

4. 4

   Step 4: What your mammogram report must say

   Article 5 orders the Secretary of Health to issue or amend the regulation of radiological medicine practice for three purposes. First, to conform it to the federal Mammography Quality Standards Act of 1992 (Public Law 102-539). Second, **to require radiological facilities to preserve mammograms and reports in the patient’s medical record for a period of no less than five (5) years; and where no additional mammograms of the patient are performed at the facility, to preserve them for a term of no less than ten (10) years**. Third, to require that reports contain: summaries with breast density data specifying the tissue classification as determined by a radiologist using the BI-RADS scale; and patient education information including **the definitions of the BI-RADS scale categories, the implications of her tissue classification for her health and the available health care resources and alternatives, the benefits supplemental testing could represent for her, the radiation dose received by the tissue during the study, and the justification for recommending additional or supplemental tests**, including the benefit to the patient of performing them.

5. 5

   Step 5: The notice the law writes word for word

   When the patient is determined to have breast tissue classified as heterogeneously dense or extremely dense, Article 5 orders the report to **include the following notification**, and writes it out literally. We quote it in full because any reader can check whether her report carries it: **"Your mammogram shows that you have dense breast tissue. Having dense breast tissue is normal. Forty percent (40%) of women have dense breast tissue. The presence of dense tissue in the breast makes it harder to detect cancer with a mammogram and may be associated with an increased risk of developing breast cancer. We provide this information to draw your attention to this important factor and to encourage you to discuss with your doctor the implications of having dense breast tissue and other risk factors in the possible development of breast cancer. Together with your doctor, you can decide which other screening alternatives best fit your needs. A report of your results was sent to your doctor."** The law adds that the Secretary of Health **may amend that notification by Regulation** in order to advance the law’s purposes, so the text may change by regulation; we publish the one the law carries.

6. 6

   Step 6: Where non-compliance is reported

   Article 6 designates two forums depending on the plan: **every patient may report non-compliance with this Act before the Office of the Insurance Commissioner of Puerto Rico**, under the procedure established in Act 194-2011, the "Puerto Rico Health Insurance Code"; and **in the case of Government Health Plan beneficiary patients, they may report non-compliance before the Health Insurance Administration (ASES)**. Article 7 orders OCS to establish the necessary regulation and authorizes it to impose **the penalties provided in the Puerto Rico Insurance Code** for violations charged against health insurance organizations, insurers or third-party administrators, for each incident in which non-compliance is proven, provided there is conclusive evidence, and subject to Act 38-2017 on Uniform Administrative Procedure. **We publish no fine amounts: the law refers them to the Insurance Code and does not write them.** A note on the text: Article 2 cites the ASES act as **Act 72-1993** and Article 6 cites it as **Act 72-2013**. We flag the discrepancy as it appears in the compilation and do not silently pick one.

For the test, before your doctor and the radiological facility. For coverage non-compliance, before the Office of the Insurance Commissioner under the Health Insurance Code procedure (Act 194-2011); and if you are a Government Health Plan beneficiary, before the Health Insurance Administration (ASES). What we do not publish: the complaint form, address, phone, resolution deadline, fine amounts — which the law refers to the Insurance Code — or the regulation OCS and the Health Department must adopt. That is why cost and processing time stay unverified: the law orders coverage as a preventive care benefit, but sets no copays, deductibles or deadlines.

• Waiting until 40 without asking: the law covers a baseline mammogram between 35 and 39.
• Accepting a report without the density classification: the law orders the report to include it on the BI-RADS scale.
• Not looking for the dense-tissue notification: the law writes its text word for word, so you can check whether it is there.
• Believing density coverage is only another mammogram: Article 2(c) includes follow-up treatment and supplemental diagnostic tests.
• Thinking high risk is limited to family history: the law includes your own history as a cancer patient, high-risk genetic markers and any other factor your doctor determines.
• Assuming the law requires undergoing every covered test: no physician may be required to perform a test that in their judgment does not benefit the patient or may harm her.
• Reporting to the wrong forum: OCS for private plans, ASES for Government Health Plan beneficiaries.
• Giving up on an old mammogram: they must be preserved for no less than five years, and ten if no additional studies were done at that facility.

These are the government pages this guide is based on.

• Oficina del Comisionado de Seguros (OCS)

  OCS

  bvirtualogp.pr.gov

• Office of the Insurance Commissioner (OCS)

  OCS

  www.ocs.pr.gov

• Health Insurance Administration (ASES)

  ASES

  www.ases.pr.gov