As a patient advocacy organization, the Cutaneous Lymphoma Foundation benefits from collaborating with other organizations whose focus is U.S. policy and regulation. These organizations uncover the issues that impact the patient community and support actions for requesting change or implementation of policy-frequently referred to as "asks." They do the heavy lifting of identifying the asks we bring to the attention of members of Congress on Capitol Hill or other governing agencies, such as the FDA.
These advocacy organizations include, but are not limited to, the following: Coalition of Skin Diseases (CSD), Haystack Project, and Everylife Foundation.
The following are the current asks that the Foundation supports and encourages our patient community within the United States to advocate on behalf of.
Despite the large and increasing number of Americans with skin disease, the largest investor in skin disease studies – the National Institutes of Health (NIH) – has seen minimal funding increases over the past decade. In fact, the NIH and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) received less funding in Fiscal Year 2024 than in Fiscal Year 2023. Ultimately, funding for skin diseases – which impact over a quarter of all Americans – is woefully inadequate.
Continued and increased funding is essential for both the NIH and NIAMS, as well as the Chronic Diseases Education and Awareness (CDEA) Program at the Centers for Disease Control and Prevention (CDC). This program seeks to provide collaborative opportunities for chronic disease communities that lack dedicated funding from ongoing CDC activities. Such a mechanism allows public health experts at the CDC to review project proposals on an annual basis and direct resources to high impact efforts in a flexible fashion.
Source: Coalition of Skin Diseases. https://skincoalition.org/take-action/#/
Step-therapy protocols require patients to first try and fail insurer-preferred medications before their prescribed treatment is covered. While insurers use this method to control costs, it can negatively impact patients' health and may lead to higher medical expenses over time.
The Safe Step Act amends the Employee Retirement Income Security Act of 1974 (ERISA) to require a group health plan to establish an exception process to medication step-therapy protocol:
- When the treatment is contraindicated;
- Expected to be ineffective;
- Likely to cause an adverse reaction;
- Expected to decrease the individual’s ability to perform daily activities or occupational responsibilities; or
- The individual is stable based on the prescription drugs already selected.
The legislation would also require that requests be granted in a timely manner — within three days after receipt of the request or 24 hours when the protocol jeopardizes the life or health of the individual.
Information source: Alliance of Specialty Medicine. https://bit.ly/4dDppZa
Copay assistance programs help patients reduce out-of-pocket costs for prescription drugs by applying manufacturer coupons to their payments. However, some health plans use copay accumulator or maximizer programs, which prevent these coupons from counting toward patients’ annual cost-sharing requirements, such as deductibles. Once the coupon value is depleted, patients must cover the full cost before insurance benefits apply.
The HELP Copays Act (S. 864/H.R. 830) aims to protect patients by requiring insurance companies to count copay assistance toward these cost-sharing requirements. This legislation is designed to help patients fully benefit from manufacturer-provided coupons, ensuring they receive financial relief beyond the initial discount.
The Help Copays Act was initially introduced as H.R. 5801.
Source: Haystack Project. https://bit.ly/3XV7Qhe
The Pharmacy Benefit Manager (PBM) Reform Act, previously introduced as the Pharmacy Benefit Manager Transparency Act, would ban deceptive unfair pricing schemes; prohibit arbitrary claw backs of payments made to pharmacies; and require PBMs to report to the Federal Trade Commission (FTC) how much money they make through spread pricing and pharmacy fees. PMB reform would increase transparency – resulting in improved access and affordability to often life-saving prescription drugs.
Source: Coalition of Skin Diseases. https://skincoalition.org/take-action/#/
Given the challenges of rare disease therapy development, new therapies are few and far between. This means that many rare disease patients are left to rely on unapproved or “off-label” use of drugs approved by the FDA for more common conditions to treat the symptoms of their diseases. (For example, off-label use of interferon, topical steroids, and other drugs used to treat skin conditions is frequently done and quite helpful in managing cutaneous lymphoma.)
The increase in prices for these drugs, or lack of access to them because an insurer will not cover it due to being off-label, creates limitations for effective treatment for some patients as there may be no alternatives suitable to managing their form of the disease.
By statute, Medicare can generally only cover medications used in accordance with their FDA-approved label or for indications common enough to be recognized in Medicare-approved reference publications.
The PROTECT Rare Act would:
- Allow Medicare and Medicaid to use additional sources, including compendia and peer reviewed literature, to meet the criteria for “medically accepted indication,” which is the standard that must be met for Part D and Medicaid coverage. (This builds on 1993 legislation that improved access to cancer care by allowing cancer drugs to be considered “medically accepted” if included in certain compendia or supported by clinical evidence in peer-reviewed medical literature.)
- Require private payers to create an expedited review pathway for formulary exception, reconsideration, and/or appeal of any denial of coverage for a drug or biological prescribed for a patient with a rare disorder, including off-label prescriptions.
Source: Dear Colleague letter from Congresswoman Matsui, inviting her fellow congressional offices to cosponsor the Protect Rare Act made available on the Haystack Project website. https://bit.ly/4eRWW32
Coalition of Skin Diseases
The CSD's Take Action page provides a summary of its asks and a search tool for finding your elected officials: https://skincoalition.org/take-action/#/
EveryLife Foundation/Rare Disease Legislative Advocates (RDLA)
The RDLA's Take Action page provides a summary of its asks and form letters where you can add a personal statement to send to your members of Congress: https://everylifefoundation.org/rare-advocates/take-action/
Haystack Project
The Haystack Project provides a form letter to which you can add a personal statement related to the Protect Rare Act to email to your members of Congress: https://haystackproject.org/protectrare
USA Government
The USA government offers a search tool for finding your elected federal, territorial or local officials: https://www.usa.gov/elected-officials