Response to Comments: Scalp Cooling for the Prevention of Chemotherapy-Induced Alopecia

I am an advance practice oncology nurse and have been working with cancer patients for 12 years. I work with an oncology team that covers cancer patients of all disease types. When I first heard about the technology of scalp cooling, our organization (and patients) were skeptical given the extreme costs and limited insurance coverage for the procedures. Access to scalp cooling is paramount to promote well-being, improved body image, and coping with cancer. A major barrier to patients wanting to have scalp cooling relates to the lack of coverage and subsequent insurance reimbursement. We encounter a significant population of Medicare patients who are on a fixed income who must choose between medications or housing each month – if it is not covered by insurance, these patients will not even have access to the procedure, creating inequities in an already vulnerable population. Thank you so much for your support and consideration.

Thank you for your comment.

Oncology nurses are privileged to support people with cancer through their entire cancer experience, whether that is through treatment and into survivorship or as they face their end-of-life journey. Today, we write to share our strong support for proposed coverage of scalp hypothermia devices for the prevention of chemotherapy-induced alopecia (CIA). We agree that these devices are reasonable and necessary for patients with solid tumors, which is aligned with our belief that all patients should have equal access to management and mitigation strategies for toxicities of their cancer-related treatments, including alopecia. This proposed coverage policy, if finalized as drafted, will continue to realize that aim.

We applaud Palmetto for being the first Medicare Administrative Contractor (MAC) to propose coverage for scalp cooling, thus paving the way for broader access to this important technology for cancer patients. The associated local coverage article highlights recent coding that has been established for this service (HCPCS codes 0062T and 0063T), and we note that the Centers for Medicare and Medicaid Services (CMS) continues to confirm payment for these codes as part of its CY 2024 Outpatient Prospective Payment System (OPPS). We wish to ensure scalp cooling is also paid under the Medicare Physician Fee Schedule (PFS), and that Palmetto establishes fair and reasonable pricing for these codes. This will continue to improve access to scalp hypothermia, thus reducing disparities related to socioeconomic status for this intervention.

Thank you for considering our comments.

Thank you for your comment. Palmetto GBA feels it has established fair and reasonable pricing for these codes.

We strongly recommend adoption of this proposed Palmetto LCD, “Scalp Cooling for the Prevention of Chemotherapy-Induced Alopecia.”

Our mission is to connect people with trusted breast cancer information and a community of support. To deliver on that promise, we offer comprehensive information about breast cancer side effects such as hair loss through our heavily trafficked website; key partnerships; and our programs, outreach, and services. A key priority of our advocacy efforts is addressing disparities in breast cancer care, which includes ensuring evidence-based, reasonable, and necessary therapies are available to all people who are eligible to receive them. Palmetto’s approval of this LCD could significantly impact Medicare patient accessibility to an FDA-cleared scalp cooling solution that greatly impacts the well-being and treatment outcomes for patients with breast and other solid tumors.

Chemotherapy-caused alopecia is one of the most dreaded aspects of cancer treatment. Hair loss removes the veil of normality from cancer patients’ lives and can prompt children, partners, friends, employers, and others to treat their loved one differently, consciously, or subconsciously. A significant minority of patients may not adhere to standard recommended chemotherapy treatment because of their fear of this visible side effect; research shows approximately 8% of patients either decline chemotherapy altogether or seek other treatments rather than the one indicated for their diagnosis. For those who move forward with the recommended chemotherapy treatment, chemotherapy-induced hair loss inflicts significant emotional distress, resulting in social isolation and detrimental body image and, in some cases, a loss of self-confidence.

We have witnessed the positive impact that FDA-cleared scalp cooling has had on the lives of members of our community. Among premenopausal and older adult patients, preventing hair loss has allowed parents and grandparents to reassure children that life can continue as normally as possible during breast cancer treatment. For the many U.S. workers diagnosed with cancer, preserving their hair during chemotherapy affords them greater privacy and more control over the flow of information to employers. For those whose cultural beliefs about hair are central to their identity, preserving their hair has allowed them to move their lives forward while coping with the disease. Whatever their reasons, our community members tell us that preserving as much of their hair as they can gives them a greater sense of control and dignity, protecting them from signaling to the world that they are ill.

In our experience, the most significant barrier to scalp cooling technology is the cost required from self-pay. Among the top questions our patients report having after learning about scalp cooling is cost. Removing cost as a barrier for Medicare beneficiaries ensures equitable access to those coping with breast and other solid cancers. As an organization that supports access to therapies that improve quality of life, we strongly support the proposed LCD to ensure scalp cooling technology is available to our community, regardless of their circumstances.

Thank you for your comment.

I represent 6 infusion center locations and want to send a couple of comments regarding coverage of scalp cooling. As a provider of Scalp Cooling, we see the benefit this offers our patients and the positive impact regarding the psychosocial aspects of cancer treatment. Not only does the lack of payer coverage make the access to this care cost prohibitive for many patients, it further adds to the overall disparities of access to all cancer care options to patients of a lesser economic and social status. All patients should have access to all types of cancer care including the option for scalp cooling and payer coverage is a great step toward lessening that disparity.

Further, the lack of payer coverage creates a barrier for some infusion centers to be able to financially justify being able to afford leasing the equipment necessary to provide this service to their patients. Payer coverage would be the beginning of allowing infusion centers, outpatient hospital infusion, and physician offices the possibility to recoup some of the out-of-pocket expense associated with monthly equipment leasing and therefore be able to afford more machines to service more patients or simply to be able to expand access to all patients.

Additionally, specific to coding and coverage we would ask that coding be allowed for a one-time setup charge with a separate code that would allow charging for the cooling treatment for each date of service. Also the per treatment code should be time based. I didn't hear anyone talk during the presentation today about the specifics of how the cap works. The cap stays on during the patient’s drug treatment but after the drug infusion is complete the cap stays on the patient and they continue to receive the cooling treatment for an additional 2-3 hours depending on the drug regimen. So in terms of chair time, that infusion chair can't be turned over to allow another patient to start a different treatment until the previous patient's scalp cooling treatment is complete. So just like infusion treatment codes are time based on how long the drug was administered, the scalp cooling should also have a time associated with a start and stop to account and be reimbursed for based on time per date of service.

Thank you for your comment. The codes 0662T and 0663T are the codes as described by CPT^®. That language cannot be changed by a Local Coverage Determination (LCD). Palmetto GBA feels it has established fair and reasonable pricing for these codes.

We are in strong support of the proposed LCD issued by the Palmetto MAC on June 8, 2023 “Scalp Cooling for the Prevention of Chemotherapy-Induced Alopecia.”

By adopting this LCD, which is recommending coverage be considered “reasonable and necessary” for FDA cleared devices, for all patients without any of the listed contraindications, Palmetto can greatly improve patient access to technology that is both FDA cleared and recommended by the National Comprehensive Cancer Network (NCCN).

Scalp cooling is a standalone mechanized therapy provided before, during and after chemotherapy administration. It has evolved from primitive ice bags placed on the patient’s head prompting safety concerns, to the current FDA-cleared machine-based cooling systems that are used in cancer treatment centers at over 700 locations in the United States, including 43 NCCN and NCI-designated Comprehensive Cancer Centers. Scalp cooling is found in the 2019 NCCN Guidelines and Compendium as a Category 2A treatment option.

The DigniCap^® Scalp Cooling System from Dignitana, received FDA clearance December 8, 2015 to reduce chemotherapy-induced alopecia in breast cancer patients, with FDA clearance expanded to include all solid tumors on July 3, 2017. The Paxman Scalp Cooling System was FDA cleared to reduce alopecia in breast cancer patients on April 20, 2017, and for all solid tumors on June 7, 2018.

For the scalp cooling procedure, a patient is measured and fitted with a cap and the cooling unit is calibrated for time and intensity of therapy customized for each patient according to their chemotherapy regimen. The cap is connected to a compact, mobile refrigeration unit which circulates liquid coolant at low pressure through a special cooling cap on the patient’s head.

Scalp cooling treatment starts at least 30 minutes before the infusion of chemotherapy. Cooling continues throughout the infusion of cytotoxic agents (typically one to five hours) and for up to 180 minutes after the infusion is completed, with the post-infusion duration dependent on the chemotherapy regimen. During the entire cooling procedure, nurses monitor the patient for clinical issues (e.g., headache, anxiety, discomfort, and poor tolerability of the cold) and manage any technical difficulties with the cooling apparatus. The physician provides direct supervision of scalp cooling before, during, and after delivery of chemotherapy. Communication between physicians, and allied health professionals are needed to provide this supportive care service to patients.

The treatment of cancer with chemotherapy is associated with demonstrated reductions in disease recurrence and mortality. However, it is also associated with significant side effects affecting quality of life, and the willingness of some patients to receive recommended chemotherapy regimens. Specifically, chemotherapy-induced alopecia:

• Causes up to 10% of patients to forego chemotherapy or request a less efficacious treatment

• Is considered the most feared side effect of treatment by >75% of patients

• Is often the most traumatic side effect of treatment leading to social isolation

• Can affect self-image more than mastectomy

The LCD includes a robust summary of the current scalp cooling data available, summarizing proven safety, efficacy and tolerability of FDA cleared scalp cooling devices.

We appreciate what you all have done and committed to this space at the Palmetto MAC in putting forth this proposed LCD. Adopting this LCD would allow Palmetto Medicare providers to make treatment decisions and grant access for Medicare beneficiaries to the benefits of scalp cooling. It would also decrease the financial barriers to access for scalp cooling, and greatly improve patient access to scalp cooling.

References were provided for review.

Thank you for your comment as well as the additional references. As Palmetto GBA feels the LCD already has a robust literature base, Palmetto GBA will not add those to the LCD.

I am submitting the below public comment in support of this proposed LCD:

Acknowledge your strong support of the proposed LCD.

• We have been involved in projects related to hair loss and scalp cooling and have been leading the way in collecting efficacy and safety data and developing information channels for both patients and physicians.
• CHILL stands for Cancer-related Hair Loss, International Leadership and Linkage. Its Executive Board includes members from our association. In June 2017, CHILL launched a registry for collecting evidence-based data about scalp cooling in order to provide patient information and clinical guidance. The registry collects data about severity of hair loss with and without scalp cooling, and the platform facilitates the exchange of information among patients, physicians, nurses, and researchers. The CHILL website is intended for patients with cancer who are receiving chemotherapy and for whom there is a chance of hair loss.
• In addition to setting up the CHILL Registry, we have collaborated on a revised chapter on hair loss (Management of Alopecia Due to Cancer Therapies) for the 2018 Second Edition of the MASCC Textbook on Cancer Supportive Care and Survivorship. The chapter highlights the significance of alopecia to patients and scalp cooling as the most effective prevention strategy for chemotherapy induced alopecia.
• In May 2022, the Association Francophone des Soins Oncologiques de Support (AFSOS) –has published a guideline entitled “Alopecia and Cancer.” The aim of this guideline is to provide guidance to oncology caregivers on prevention of chemotherapy induced alopecia. This document presents a study (The Scalp Trial, Nangia et al. 2017) recommending Paxman as an effective automated scalp cooling system for the prevention of CIA.
• The 2023 MASCC/JASCC/ISOO Annual Meeting in Nara (Japan) made global research accessible to all healthcare professionals interested in using scalp cooling with their patients by hosting a Meet the Experts session on “Scalp Cooling and Cryotherapy: Latest Advancements to Address Chemotherapy-Induced Alopecia and Peripheral Neuropathy.” A multidisciplinary panel of speakers provided the most recent data on the use of scalp cooling to reduce chemotherapy-induced alopecia, including the increased rate of hair regrowth seen as a result during treatment, the first published long-term study of scalp cooling, and treatment impact from a patient advocate. The session highlighted how cancer centers globally can be involved in ongoing research efforts through the international scalp cooling registry and presented an update from research teams currently conducting trials using cryocompression to mitigate chemotherapy-induced peripheral neuropathy.

Explain your relationship to patients using FDA cleared scalp cooling.

• Our association is an international, interdisciplinary non-profit organization dedicated to the practice, education, and research of supportive care in cancer. Our mission is to continually improve the supportive care of people with cancer – from diagnosis through to survival or end-of-life care. Supportive care is the prevention and management of the adverse effects of cancer and its treatment. Chemotherapy-induced hair loss (alopecia) is a common, significant, and distressing side effect of cancer therapy and presents a major supportive care challenge by impacting patients’ wellbeing and potentially affecting outcomes. Scalp cooling has been shown to be effective for preventing hair loss for many patients’, and long-term safety data are available.
• Our association provides invaluable resources for health care professionals including medical students, residents, and fellows, oncologists, general practitioners, nurses, and allied health professionals to support their work in supportive care and help improve clinical practice.

Add any additional detail as to why access to scalp cooling is so important for patients suffering from chemotherapy induced alopecia from your perspective.

• Side effect of hair loss can be traumatic for some patients and can have a detrimental impact on the patient’s quality of life. Scalp cooling therapy can offer many benefits to patients and has shown that it boosts patients’ confidence and self-esteem and gives them control over the chemo process, bringing them some level of peace during the cancer treatment. These benefits can help patients’ course of treatment and improve outcomes by improving their attitude and facing cancer treatment more positively. Otherwise, patients may choose to not be compliant with the cancer treatment in order to avoid hair loss.

Emphasize the importance of allowing all patients access to scalp cooling, and the importance of ensuring coverage for Medicare beneficiaries.

• Scalp cooling is recommended by the National Comprehensive Cancer Network (NCCN) as a standard of care treatment of alopecia. It is important that all patients have access to scalp cooling and are provided financial support to help pay for scalp-cooling supplies.

Thank you for your comment.

My husband has recently undergone 4 of his 6 initial chemo treatments for metastatic prostate cancer.

Not only, as I’m sure you are aware, is the entire cancer treatment process a physical challenge, but his mental well-being has also been affected. It’s quite difficult to undergo the radical treatments, lose weight (which also changes your physical appearance), but the last straw is to lose your hair. Not just the hair on your head, but your facial hair as well. He lost his beard and mustache.

This is nothing but an unnecessary additional blow to one’s psyche.

We asked for a cold cap at the institution where he is being treated and they said that only insurance could approve it, that it was provided by a third-party vendor.

Now… if this was “standard” practice, and cancer clinics had the equipment available, I’m sure the costs wouldn’t be so prohibitive or time consuming. Using a third-party vendor is just extra expense and requires extra bureaucracy to implement.

Providing an extra layer of compassion to patients would help to embolden their progress towards recovery.

Thank you for your comment.