Sample Language for Legislation
The Rapunzel Project advocates for all safe and efficacious scalp cooling devices. We believe legislation should address insurance reimbursement to make this treatment more accessible and affordable to more patients.
We do not believe legislation should dictate the treatment modality, e.g. manual caps versus machine caps.
Pennsylvania’s proposed language is particularly noteworthy for its clarity in explicitly including manual caps as well as scalp cooling machines.
California’s language is particularly problematic as it excludes manual caps.
Manual caps have never been required to obtain FDA clearance because they are neither provided nor operated by healthcare facilities. They are leased privately by the patient, brought to the treatment center as the patient’s personal property, and used with privately arranged assistance. Manual caps have more than 25 years of demonstrated safety and efficacy, and continue to be used successfully by thousands of cancer patients in the USA and around the world.
Patients who do not live near clinics that have the machines, patients having the harshest chemo, AC (anthracyclines), and other patients, depending on their circumstances, need to be able to use manual caps to save their hair. They should not be excluded from expense reimbursement.
Excerpts from Scalp Cooling Coverage Statutes
NEW YORK
Effective date: January 1, 2026
“Scalp cooling system” means any device used to cool the human scalp to prevent or reduce hair loss during cancer chemotherapy treatment, provided that such device is designed and intended for repeated use and is primarily and customarily used to serve a medical purpose.
LOUISIANA
Effective date: January 1, 2027
“Scalp cooling system” means any device used to cool the human scalp to prevent or reduce hair loss during chemotherapy treatment for cancer, provided that such device is designed and intended for repeated use and is primarily and customarily used to serve a medical purpose.
WEST VIRGINIA
Effective date: January 1, 2027
“Scalp cooling system” is defined as a device used to prevent or reduce hair loss during chemotherapy, designed for repeated use, and primarily serving a medical purpose.
MARYLAND
Effective date: January 1, 2027
“Scalp cooling system” means a device used to cool the human scalp to prevent or reduce hair loss in connection with chemotherapy to treat cancer that is designed and intended for repeated use and primarily and customarily used to serve a medical purpose.
CONNECTICUT
Effective date: January 1, 2027
“Scalp cooling system” means any device designed and intended for repeated medical use to cool the human scalp to prevent or reduce hair loss as a result of chemotherapy.
CALIFORNIA
Proposed
“Scalp cooling” is defined as the use of a medical device or system cleared by the federal Food and Drug Administration (FDA) applied to the scalp before, during, or after the administration of chemotherapy to reduce the incidence or severity of chemotherapy-induced alopecia (hair loss).
“Scalp cooling” does not include non-FDA-cleared cold caps or any non-FDA-cleared scalp cooling products, regardless of whether those products are described as “cold cap therapy” or similar terminology.
MASSACHUSETTS
Proposed
“Scalp cooling system” means any device used to cool the human scalp to prevent or reduce hair loss during cancer chemotherapy treatment, provided that such device is designed and intended for repeated use and is primarily and customarily used to serve a medical purpose.
NEW JERSEY
Proposed
“Scalp cooling system” means any device used to cool the human scalp to prevent or reduce hair loss during cancer chemotherapy treatment, so long as the device is designed and intended for repeated use and is primarily and customarily used to serve a medical purpose.
OHIO
Proposed
“Scalp cooling system” means any device used to cool the human scalp to prevent or reduce hair loss during cancer chemotherapy treatment, provided that such device is designed and intended for repeated use and is primarily and customarily used to serve a medical purpose.
PENNSYLVANIA
Proposed
“Scalp cooling system treatment” means treatment using a device that cools the human scalp to prevent or reduce hair loss during cancer chemotherapy treatment, if the device is designed and intended for repeated use and is primarily and customarily used to serve a medical purpose. The term includes treatment using a cold cap or a refrigerated scalp cooling system.
VERMONT
Proposed
“Scalp cooling system” means any device used to cool the human scalp to prevent or reduce hair loss during cancer chemotherapy treatment, provided that the device is designed and intended for repeated use and is primarily and customarily used to serve a medical purpose.