Major Legal Cases We’re Tracking in 2024
The Arthritis Foundation is closely watching major legal cases that could drastically reshape health care for arthritis patients. Access to medications, preventive care, and reliable online health information are all at stake.
By Alisa Vidulich Casavant, MPH, Policy Director | Feb. 29, 2024
In 2024, the Arthritis Foundation is keeping a close watch on some big legal challenges that could impact health care for all patients, including those living with arthritis. From FDA drug review authority to insurance coverage for preventive services, Medicare drug pricing negotiations and copay assistance, these developments are crucial for ensuring access to treatments and services for patients.
Read more below on how these cases may reshape patients’ access to health care and reliable information in the future.
Drug Approval Authority
In the legal case FDA v. Alliance for Hippocratic Medicine, the Arthritis Foundation and several other organizations representing patients with serious health conditions are urging the U.S. Supreme Court to overturn a decision by a lower court. The decision calls into question the use of scientific methods and review in approving drugs and shifts that responsibility to courts. It could further politicize the FDA as well as medications themselves, making it harder for patients to trust the safety of FDA-approved medications. This case involves a dispute over the drug approval process for a medication called mifepristone, which has been available since 2000. While patients can still access the medication for now, the outcome of this case could impact future access to FDA-approved treatments. It is essential to preserve the FDA’s authority and expertise in ensuring the safety and effectiveness of medications. We anticipate a ruling this spring/summer 2024.
Preventive Services Coverage
U.S. Court of Appeals for the Fifth Circuit is considering a case, Braidwood v. Becerra, that could impact the coverage and cost to patients of certain preventive services under the Affordable Care Act. Currently, many preventive screenings and services are covered for patients without any extra costs. These include screenings for conditions including osteoporosis, cancer, heart disease, mental health, fall prevention interventions for older adults, as well as counseling for healthy living habits.
The Arthritis Foundation and other patient groups are speaking up to share information with the courts to ensure that access to these no-cost preventive services remain protected. Recent court decisions have temporarily paused any changes that could limit this coverage, but the outcome of the case will ultimately determine whether patients can continue to receive these vital services without added expenses. This issue is important for patient access to preventive care without financial barriers.
Medicare Drug Pricing Negotiations
Pending litigation involving challenges to a new law called the Inflation Reduction Act, which was passed by Congress in 2022, allows the federal government to negotiate drug prices with pharmaceutical companies for certain expensive medications covered by Medicare. These negotiations aim to lower prescription costs for Medicare beneficiaries, including seniors and people with certain disabilities, including many patients living with arthritis. The Arthritis Foundation has been actively involved in this legislation for years, encouraging patients to participate in listening sessions and submitting comments to provide important input to CMS. Many pharmaceutical companies have filed lawsuits against the law, and these cases could impact the outcome of negotiations. We are monitoring these conversations and legal proceedings in our goal to ensure patients can afford and access their medications needed to manage arthritis.
A Win! Copay Assistance Counts Toward Patient Cost-Sharing
In January 2024, the Arthritis Foundation celebrated the U.S. Department of Health and Human Services’ (HHS) decision to drop its appeal of a U.S. District Court ruling. As a result, accessing prescription drugs is easier for people with serious, chronic conditions such as arthritis. This decision means that a 2020 rule requiring insurers to count copay assistance toward a patient’s deductible and out-of-pocket maximum is now in full effect. This is a big win for patients because copay accumulators have made it harder for many patients to afford their medications. Now, patients can better leverage financial copay assistance to manage the high costs of their treatments, ensuring they can continue to access the medications they need to manage their arthritis effectively.
Please contact Alisa Casavant, Policy Director, with any questions.
In 2024, the Arthritis Foundation is keeping a close watch on some big legal challenges that could impact health care for all patients, including those living with arthritis. From FDA drug review authority to insurance coverage for preventive services, Medicare drug pricing negotiations and copay assistance, these developments are crucial for ensuring access to treatments and services for patients.
Read more below on how these cases may reshape patients’ access to health care and reliable information in the future.
Drug Approval Authority
In the legal case FDA v. Alliance for Hippocratic Medicine, the Arthritis Foundation and several other organizations representing patients with serious health conditions are urging the U.S. Supreme Court to overturn a decision by a lower court. The decision calls into question the use of scientific methods and review in approving drugs and shifts that responsibility to courts. It could further politicize the FDA as well as medications themselves, making it harder for patients to trust the safety of FDA-approved medications. This case involves a dispute over the drug approval process for a medication called mifepristone, which has been available since 2000. While patients can still access the medication for now, the outcome of this case could impact future access to FDA-approved treatments. It is essential to preserve the FDA’s authority and expertise in ensuring the safety and effectiveness of medications. We anticipate a ruling this spring/summer 2024.
Preventive Services Coverage
U.S. Court of Appeals for the Fifth Circuit is considering a case, Braidwood v. Becerra, that could impact the coverage and cost to patients of certain preventive services under the Affordable Care Act. Currently, many preventive screenings and services are covered for patients without any extra costs. These include screenings for conditions including osteoporosis, cancer, heart disease, mental health, fall prevention interventions for older adults, as well as counseling for healthy living habits.
The Arthritis Foundation and other patient groups are speaking up to share information with the courts to ensure that access to these no-cost preventive services remain protected. Recent court decisions have temporarily paused any changes that could limit this coverage, but the outcome of the case will ultimately determine whether patients can continue to receive these vital services without added expenses. This issue is important for patient access to preventive care without financial barriers.
Medicare Drug Pricing Negotiations
Pending litigation involving challenges to a new law called the Inflation Reduction Act, which was passed by Congress in 2022, allows the federal government to negotiate drug prices with pharmaceutical companies for certain expensive medications covered by Medicare. These negotiations aim to lower prescription costs for Medicare beneficiaries, including seniors and people with certain disabilities, including many patients living with arthritis. The Arthritis Foundation has been actively involved in this legislation for years, encouraging patients to participate in listening sessions and submitting comments to provide important input to CMS. Many pharmaceutical companies have filed lawsuits against the law, and these cases could impact the outcome of negotiations. We are monitoring these conversations and legal proceedings in our goal to ensure patients can afford and access their medications needed to manage arthritis.
A Win! Copay Assistance Counts Toward Patient Cost-Sharing
In January 2024, the Arthritis Foundation celebrated the U.S. Department of Health and Human Services’ (HHS) decision to drop its appeal of a U.S. District Court ruling. As a result, accessing prescription drugs is easier for people with serious, chronic conditions such as arthritis. This decision means that a 2020 rule requiring insurers to count copay assistance toward a patient’s deductible and out-of-pocket maximum is now in full effect. This is a big win for patients because copay accumulators have made it harder for many patients to afford their medications. Now, patients can better leverage financial copay assistance to manage the high costs of their treatments, ensuring they can continue to access the medications they need to manage their arthritis effectively.
Please contact Alisa Casavant, Policy Director, with any questions.
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