October 3, 2022 

The Honorable Chiquita Brooks-LaSure 


Centers for Medicare & Medicaid Services 

U.S. Department of Health and Human Services 

Re: Addressing Copay Accumulator Adjustment Policies in the 2024 Notice of Benefit and Payment Parameters 

Dear Administrator Brooks-LaSure, 

The All Copays Count Coalition (ACCC), on behalf of the 73 undersigned organizations, urges CMS to ensure patients receive the full benefit of copay assistance by repealing 42 CFR §156.130(h) and clarifying that insurers must count any assistance paid by or on behalf of a patient toward their annual deductible and out-of-pocket limit. We appreciate the Biden-Harris Administration’s commitment to increasing access to health care but have been disappointed that CMS has not put a halt to health plan and pharmacy benefit manager (PBM) use of copay accumulator adjustment policies (CAAPs) and other policies that prevent copay assistance from supporting patients in need. These policies allow health plans and PBMs to profit from assistance intended to help patients by not counting it towards the enrollee’s annual deductible and out-of-pocket limit. They disproportionately target the most financially vulnerable patients with serious and chronic health conditions and undermine pre-existing condition protections provided by the Affordable Care Act (ACA). The ACCC strongly urges CMS to address these policies in the 2024 Notice of Benefit and Payment Parameters (NBPP) and we respectfully request an opportunity to meet with you to discuss this concerning issue. 

The ACCC represents the interests of patients with chronic and serious health conditions who rely on copay assistance to make medically necessary drug treatments affordable. For patients with serious, chronic health conditions, including life-threatening illnesses, ongoing and continuous access to medication is essential. However, these patients often face multiple barriers to the therapies they need to treat their conditions, such as administrative hurdles like prior authorization and step therapy that limit access to specialty medications. And once approved, patients often face skyrocketing deductibles and steep cost-sharing requirements. For millions of insured Americans living with complex chronic conditions, the only way to afford their specialty or brand medications, which often do not have generic alternatives, is by using copay assistance. 

We strongly agree with CMS’s position that “manufacturer-sponsored patient assistance programs can be helpful to patients in obtaining necessary medications.” Yet with CAAPs in place, plans benefit instead of the patient. With 83% of commercial market enrollees now in plans that have an accumulator adjustment policy, vulnerable patients are left unable to benefit from assistance needed to access their medications. The use of CAAPs increased exponentially following CMS’ adoption of CFR §156.130(h), which exempted manufacturer copay assistance from the ACA’s limits on cost-sharing, in direct conflict with the ACA’s statutory definition (Section 1302(c)(3)), which says: “Cost sharing means any expenditure required by or on behalf of an enrollee with respect to essential health benefits….” 

Insurers and PBMs contend that use of copay assistance drives up drug costs and health spending. The facts suggest otherwise. First, copay assistance is not offered for the vast majority of prescriptions for branded drugs with generic alternatives. In fact, recent data shows that for all commercial market claims for products that have copay assistance, only 3.4 percent of assistance being used is for branded drugs that may have a generic alternative. If copay assistance programs were driving patients away from generic alternatives, then this share would be significantly higher. Second, when patients cannot access the medications they need, it ends up costing the health system more money due to complications and worsening health. Research has found that the cost of patients not receiving optimal medication therapy is over $528 billion each year in the United States. 

Repealing §156.130(h) and clarifying that insurers must count any assistance paid by or on behalf of a patient toward their annual deductible and out-of-pocket limit, as 14 states and Puerto Rico have now done, is the simplest way to protect all patients’ access to treatment and ensure that patients – rather than insurers – benefit from manufacturer copay assistance. 

With the health and welfare of patients being our common goal, the undersigned members of the ACCC respectfully urge CMS to consider addressing the permissibility of CAAPs in the 2024 NBPP or sooner and we request the opportunity to meet with you directly about this issue. Please do not hesitate to contact Rachel Klein, Deputy Executive Director of The AIDS Institute, at rklein@taimail.org to schedule a meeting or ask any questions. 


AIDS Foundation Chicago 

AIDS United 

Aimed Alliance 

Alliance Community Healthcare Inc. 

Alliance for Patient Access 


American Academy of HIV Medicine 

American Cancer Society Cancer Action Network 

American College of Rheumatology 

Arthritis Foundation 

Association for Clinical Oncology 

Association for Women in Rheumatology 

Bleeding Disorders Foundation of North Carolina 

Cancer Support Community 


Chronic Care Policy Alliance 

CLL Society 

Coalition of State Rheumatology Organizations 

Color of Crohn’s and Chronic Illness 

Crohn’s & Colitis Foundation 

Cystic Fibrosis Foundation 

Cystic Fibrosis Research Institute 

Derma Care Access Network 

Dermatology Nurses’ Association 

Diabetes Leadership Council (DLC) 

Diabetes Patient Advocacy Coalition (DPAC) 

Epilepsy Foundation 

Foundation For Sarcoidosis Research 

FORCE: Facing Our Risk of Cancer Empowered 

Gaucher Community Alliance 

Georgia AIDS Coalition 

Georgia Equality 

Georgia Watch 

Global Healthy Living Foundation 

Haystack Project 


Hemophilia Council of California 

Hemophilia Federation of America 

Hemophilia Of Georgia 

HIV + Hepatitis Policy Institute 

HIV Dental Alliance 

HIV Medicine Association 

ICAN, International Cancer Advocacy Network 

Immune Deficiency Foundation 

Infusion Access Foundation 

International Foundation for AiArthritis 

Jewish Democratic Women’s Salon 

Legal Action Center 

Looms for Lupus 

Lupus and Allied Diseases Association, Inc. 

Lupus Foundation of America 

Mesothelioma Applied Research Foundation 

MLD Foundation 

Multiple Sclerosis Association of America 

Multiple Sclerosis Foundation 


National Eczema Association 

National Hemophilia Foundation 

National Infusion Center Association 

National Multiple Sclerosis Society 

National Organization for Rare Disorders 

National Psoriasis Foundation 


New Georgia Project Action Fund 

Partnership to Advance Cardiovascular Health 

Patient Access Network (PAN) Foundation 

Pulmonary Hypertension Association 

Rheumatology Nurses Society 

Susan G. Komen 

The AIDS Institute 

The Assistance Fund 

The Headache and Migraine Policy Forum 

Western Pennsylvania Bleeding Disorders Foundation 

CC: Dr. Ellen Montz, Deputy Administrator & Director, CCIIO; 

Jeff Wu, Deputy Director for Policy, CCIIO