LCIS - involuntary placement in database

kitkit

Hello friends,

Please let me know if I am unreasonable.  I wrote several months ago about my diagnosis of PLCIS, and, after extensive help from everyone on these boards and individual research have decided to begin tamoxifin shortly.

Yesterday I received a letter from the "UCLA Mind Body Study" which is evaluating the effects of different breast cancer treatments on a woman's health and cognitive functioning.  I think that it is wonderful that the study is occurring.  What disturbs me is that the text of the letter makes it clear that "every cancer diagnosed in Calfiornia is required by law to be reported to the California Department of Public Health" which maintains a registry that will release names to "qualified researchers" who have received approval from a federally approved Committee for the Protection of Human Subjects..."

My breast surgeon and oncologist both ascribe to the view that LCIS is a "marker" for increased risk of breast cancer, and is not, in fact, breast cancer.  I know that there are others who have different views, but I think it is safe to say that whether LCIS is cancer is a matter of dispute within the medical community.  I don't want to be identified as a cancer patient in a database if I am not in actuality a cancer patient.  There are disclosures that would be triggered for insurance purposes, and on doctor office initial visit forms that I was not planning to make.  Maybe someday I will be compelled to make that disclosure, but not yet.  Yes, I know I would disclose I take tamoxifin, but that is a drug that some high risk women may take who do not have breast cancer as currently defined.

I do not think that women diagnosed with LCIS should have their names disclosed by doctors as cancer patients to a registry unless they give their consent to do so.  Am I wrong?  This has nothing to do with my eagerness to participate in any study that helps others fight this dreaded disease.

Thank you for listening,

Kitkit 

leaf

This is how the nci describes LCIS. The term lobular carcinoma in situ (LCIS) is misleading. This lesion is more appropriately termed lobular neoplasia. Strictly speaking, it is not known to be a premalignant lesion, but rather a marker that identifies women at an increased risk for subsequent development of invasive breast cancer.http://www.cancer.gov/cancertopics/pdq/treatment/breast/HealthProfessional/page6

As far as confidentiality is concerned, I have no direct experience on this level.  But I do know that some infectious diseases (such as tuberculosis, and other diseases that can pose a health threat to others)  do have to be reported to county/health registries by prescribers.

This is what the NCI said about confidentiality for databases in the late 1990s. http://www3.cancer.gov/confidentiality.html#7

If you had an insurance company pay for your biopsy/pathology reading, then it is my understanding they they have the right to know your diagnosis.  I may be wrong about this, but that is my understanding. If you have further treatment or extra surveillance, your insurance company with want to know why.   Genetic testing has further confidentiality protections, but I think  it may still be the case if your insurance company pays for the testing, they can know the results. One genetic counselor recommended if you are concerned about confidentiality of genetic testing (no matter what the laws are), to try to pay for your genetic testing first out of pocket, and if you get a negative result, then ask your insurance company to re-imburse you.

Most patient info is (supposedly) protected by HIPPA.

Who Must Follow These Laws

We call the entities that must follow the HIPAA regulations covered entities.  

Covered entities include:

• Health Plans, including health insurance companies, HMOs, company health plans, and certain government programs that pay for health care, such as Medicare and Medicaid.
  
  
• Most Health Care Providers—those that conduct certain business electronically, such as electronically billing your health insurance—including most doctors, clinics, hospitals, psychologists, chiropractors, nursing homes, pharmacies, and dentists. 
  
  
• Health Care Clearinghouses—entities that process nonstandard health information they receive from another entity into a standard (i.e., standard electronic format or data content), or vice versa.

(emphasis mine) http://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/index.html

I would guess that a cancer registry would include this clearinghouse description, but I am not sure.

*********

According to this website,here are SOME the people who do NOT have to follow HIPPA.

Examples of organizations that do not have to follow the Privacy and Security Rules include:

• life insurers,
• employers,
• workers compensation carriers,
• many schools and school districts,
• many state agencies like child protective service agencies,
• many law enforcement agencies,
• many municipal offices.

http://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/index.html

When questionaires ask if I have had cancer, I must admit I have not been consistent in my answer.  I know on my last mammogram, they listed me as having breast cancer.  (I have classic LCIS and nothing worse.)

I don't know how a researcher got your name.  Personally, I have registered with https://www.researchmatch.org/ so that I may be able to help someone else, particularly with some of my conditions.  In their protocol, they repeatedly say Remember, the researcher will not be able to contact you directly unless you give your permission for them to do so.  I may have given up some potential confidentiality by signing up.  This choice, of course, is not for everyone.

  I totally support whatever feelings and choice you have about confidentiality about your medical condition(s).

macksix6

You may not have an invasive cancer at present but with LCIS you will require additional surveillance of bi annual mamograms overlapped with MRI's, perhaps more biopsies and medication treatment. This is not the norm so there is no hiding the fact that your breast condition is something other than normal. I am sorry that you feel this is an invasion of your privacy but the unfortunate fact is you have a breast condition that needs to be watched.

leaf

I am not sure that the Cancer Registry (?SEER) maintains your identifiable information.  If you still have the flier, perhaps you may want to call the researchers and find out how they got your information.  If necessary, you can play 'dumb', like you didn't understand the last part of the letter. 

redsox

Each state runs a state cancer registry and cancer is a reportable (legally required to be reported) disease.  Exactly what cases must be reported is governed by state law with stringent requirements for confidentiality.  Any research investigators who want to use the data must meet rigorous standards and extensive review. 

The state cancer registry database is used to generate basic statistics and trends on disease incidence and mortality.  Depending on the the state the database may be used for purposes beyond those.  If cases were reported only on a voluntary basis the database would be useless for the purpose of computing disease incidence. Each state has its own laws but some coordination is provided through the Centers for Disease Control and Prevention (which does not get identifiable data):

http://www.cdc.gov/cancer/npcr/

And yes, your insurance company already knows far more about your diagnosis and treatment than the cancer registry does.  

Peaches70

Kitkit,

I empathize with your concern about being considered a "cancer" patient, when you are told that LCIS is not cancer. While it is certainly true that your health insurance company knows all about your diagnosis, how you are classified can impact your ability to get life insurance. I recently went through this myself. I was applying for an LI policy and was given a very high rate. I too only have LCIS. However, on some of my reports, it says "breast cancer" and on one about my biopsy, it is called a "partial mastectomy". I can only wonder if that information was shared, resulting in the inflated quote for life insurance.

msippiqueen

I get your concern.

When having a colonoscopy recently, the stated primary reason written for this procedure, on a form to go to my ins co was "s/p breast cancer". My two diagnosis from two different institutions are AHL or LCIS. Some medical professionals call it cancer, some don't.

Some use language to minimize LCIS as a non-starter in the breast cancer spectrum. Calling LCIS no big deal.

I imagine the insurance companies will take the stark opposite approach. 

As for privacy, sadly there major loopholes.  I just had a long discussion with one of my pharmacist about his (major) employer submitting each and every drug I take to my ins co, even when I've requested that not be done and have paid cash. He told me next time to notify him or another pharmacist to be sure this does not happen.

As for studies, beware. Check out the Atlantic Monthly magazine article on Lies Damed Lies, and the Medical Community. I am unable to post a link but google will get you there quickly.