Aimed Monthly
This issue of Aimed Monthly includes a new report on nonmedical switching, two upcoming webinars, biomarker maps, copay accumulator lawsuit, state legislative updates, and more.
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Report Examines Consequences of Non-Medical Switching for Patients with Mental Health Conditions
A new report from the Alliance for Mental Health Care Access entitled The Dangers of Non-Medical Switching for Mental Health Patients examines the effects of non-medical switching on patients with mental health conditions. The report illuminates the harmful side effects and expensive consequences of the practice. For example, more than 40 percent of patients surveyed reported that, after switching medications, the next drug did not work as well as their previous treatment. Read the full report here.
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CCSS Sends Letter of Support for Dietary Supplement Listing Act of 2022
On May 18, 2022, the Collaborative for Cannabinoid Science and Safety (CCSS) sent a letter to U.S. Senators Durbin and Braun commending their introduction of the Dietary Supplement Listing Act of 2022 (S.4090). If passed, this bill would require dietary supplement manufacturers to list their products with the Food and Drug Administration (FDA). Read the full letter here.
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FDA Sends Warning Letters to Four Companies for Selling Unapproved CBD Products
On May 26, 2022, the Food and Drug Administration (FDA) sent warning letters to Free State Oils, Kingdom Harvest, Kahm CBD, and Hope Botanicals for selling products that contain cannabidiol (CBD) that are intended for use in food-producing animals. In its letter, the FDA explained that there is currently a lack of research available on the residual amount of CBD in human foods, such as meat, milk, and eggs, produced by animals that consume CBD. The FDA called on these companies to cease violating federal law within 15 days. Read the FDA’s news release here.
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Conversation with Aimed Alliance Featured in Patient Empowerment Network Activity Guide
Aimed Alliance’s staff attorney, Ashira Vantrees, spoke with the Patient Empowerment Network for their May 2022 Activity Guide on “How Does Health Policy Impact Me?” Ashira spoke with patient advocate, Mary Leer, regarding the importance of the Cancer Drug Parity Act; the Patient Protection and Affordable Care Act (“ACA”); and the need for health care reform in the United States. View the conversation here.
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Aimed Alliance and PACH To Host HR.com Webinars on
June 7 and June 16
Join Aimed Alliance and the Partnership to Advance Cardiovascular Health (PACH) for two webinars on HR.com in June. The first webinar, Non-Medical Switching: The Harmful and Unintended Consequences Affecting Patients, will be hosted on June 7 from 12:00 PM to 1:00 PM ET. Register for the first webinar here. The second webinar, Reducing Health Care Barriers in a Diverse Workforce with Peripheral Artery Disease, will be hosted on June 16 from 12:00 PM to 1:00 PM ET. Register for the second webinar here.
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Leading Women's Health Forward: Virtual Policy Discussion
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Aimed Alliance Releases Biomarker Maps
Aimed Alliance has launched two new maps to track active and enacted biomarker legislation. Biomarker testing provides health care professionals with important information that can help health care providers select and monitor appropriate treatments and develop more personalized treatment plans for patients. Yet, due to lack of coverage and burdensome prior authorization policies, these tests are not as widely available as they should be. Therefore, states have begun introducing legislation that would require health plans to cover biomarker testing and limit how health plans can impose prior authorization on biomarker testing. View our Active Legislation Map here and our Enacted Laws Map here.
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Aimed Alliance Summarizes Court's Best Price Rule Decision on Copay Accumulators
On May 17, 2022, the United States District Court for the District of Columbia granted PhRMA’s motion for summary judgment and vacated and set aside the 2020 accumulator rule. Aimed Alliance’s analysis of the case can be found here. The full decision can be read here.
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Aimed Alliance Adds Johnson & Johnson's Lawsuit Against SaveonSP to Its Lawsuit Tracking Resource
On May 4, 2022, Johnson & Johnson filed a complaint in the United States District Court for the District of New Jersey against SaveOnSP over SaveOnSP’s copay maximizer program. Johnson & Johnson is seeking damages and asking the Court to prohibit SaveOnSP from continuing its maximizer program for Johnson & Johnson’s/Janssen’s drugs. To learn more about the case, read Aimed Alliance’s summary here.
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Aimed Alliance Adds FAQ to Copay Accumulator 101 Hub
Aimed Alliance updated its Copay Accumulator 101 Hub to include a Frequently Asked Questions (FAQ) section. The new FAQ section answers a wide variety of questions—from how consumers can review their plan materials to determine whether their plans use copay accumulators to how consumers can convince their employers that copay accumulators should not be adopted by their employer-sponsored health plans. If you still have questions about copay accumulators and maximizers, please email your question to policy@aimedalliance.org .
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Copay Accumulators
Step Therapy
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Colorado passed HB 1370: HB 1370 prohibits mid-year formulary changes, places additional guardrails on step-therapy protocols; requires health plans to offer at least 25 percent of their plans on the state exchange; and requires 25 percent of non-exchange plans to include co-payment only structures for all prescription drugs. Read more here.
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New York Senate has passed S.8191! S.8191 would create additional step-therapy guardrails for step therapy protocols, such as requiring a step-therapy override request to be honored for 12 months, and prohibiting step-therapy protocols from requiring patients to step through an off-label medication, try and fail on more than one medication, try and fail on a medication for more than 30 days, and try and fail on a medication they have previously failed on within the last 12 months.
Prior Authorization
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White House National Drug Control Strategy Recommends Access to Digital Therapies
Recently, the White House released its 2022 National Drug Control Strategy, which proposed actions to curb substance use disorders and drug poisonings in the United States. The Strategy adopted a recommendation by ACTION for PDTs member, the Center for U.S. Policy, and recognized the role evidence-based digital therapies could play in helping treat substance use disorders. The Strategy recommended that federal and private health plans cover FDA-cleared and evidence-based digital therapies, as well as health care providers’ costs in administering them. Read the 2022 National Drug Control Strategy here.
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