It is important for us to know.

The Problem:


Extramammary Paget’s disease (EMPD) is a rare disease – and while it’s rare, there are more than 7,000 additional diseases classified as “rare diseases”, affecting between 25 and 30 million Americans, according to the National Institute of Health. Approximately 95 percent have no medical treatment that has been approved by the FDA. There are often so few patients with a very rare condition that drug companies will not, or often cannot, do a clinical trial for every subtype of a rare condition. And without clinical trials to establish the viability of a particular medication, the FDA will not give its stamp of approval. Patients are then left fighting with their insurance companies for coverage of medications which typically require FDA approval for coverage.


The proposal for a solution:


The Access to Rare Indications Act (H.R. 6160) was introduced in the House of Representatives by Reps. Doris Matsui (D-Calif.), Mike Thompson (D-Calif.), Mike Kelly (R-Penn.) and Markwayne Mullin (R-Okla.). The bill recognizes that the vast majority of people with rare diseases don’t have an FDA-approved treatment, meaning their disease is not listed on a medication’s label, and their clinicians shouldn’t have to struggle to convince insurance companies that these “off-label” treatments are medically necessary. The bill will ensure parity in coverage for Medicare and Medicaid beneficiaries with rare diseases by expanding the evidence to justify “medically necessary” treatments to sources beyond official FDA approval, such as peer-reviewed journal articles, clinical guidelines, and experts recognized by their peers in the relevant professional societies. 


For more information:
 https://www.statnews.com/2022/06/01/the-access-to-rare-indications-act-could-be-a-game-changer-for-millions-of-americans/

Take action by notifying your Congressperson:

Find their contact information at: https://www.house.gov/representatives

Feel free to use the sample letter provided below or some similar communication to convey your support for this legislation.

Dear Representative __________________:

I am writing you to encourage your support of H.R. 6160, the Access to Rate Indications Act of 2021, currently before the Committee on Ways and Means and the Subcommittee on Health of the Committee on Energy and Commerce.

I am currently suffering from the “rare disease” ______________________.  This bill is of critical importance to me and the more than 25 million other Americans who, like me, suffer from one of the 7,000+ “rare diseases” recognized by medical professionals but not eligible for coverage under Medicare, Medicaid and most private insurance plans.  Because each of these diseases is relatively rare, there are generally not enough active patients at any one time to conduct the sort of clinical trials that are generally needed to receive FDA approval.  And without FDA approval, these diseases cannot be included “on label” with any specific medication that rare disease experts are currently recommending to their patients.  Medicare, Medicaid, and private insurance companies will typically refuse to cover treatments that are not “on label”, so I and more than 25 million other Americans are stuck with either having to decline any treatment of our diseases or pay the full, prohibitively expense cost for the medication that could treat them.

The Access to Rate Indications Act of 2021 addresses this inequity in medical insurance coverage by providing prescription drug coverage under Medicare, Medicaid, and private insurances for these rare diseases on the basis of other professionally-accepted sources for justifying medical treatment, such as peer-reviewed research and specialized medical expert opinion.  This would close a gaping hole in the equal health insurance access for all Americans suffering from diseases, whether they be “rare” or not.

Please add your voice and effort to the advancement and passage of this legislation.  You will be adding your voice to the legitimate pleas from more than 25 million other Americans for equitable access to health insurance protection from diseases that are no less harmful and dangerous than cancer or heart disease. I believe that I should not have to face the choice between bankruptcy or death just because my disease is not mainstream, and I would hope you would also not want to face that choice in the future if a similar fate were to befall you, as it has me.

Sincerely,

________________________________