As part of our continuing public policy activities, we have been monitoring the incremental implementation of the Affordable Care Act (ACA). Many of you know that the Act is currently under review by the Supreme Court but right now its the law of the land. Part of the act includes establishing a list of Essential Health Benefits (the things that must be uniformly covered in health plans under the Act). The proposed rules related to prescription drug coverage benefits would allow plans to limit their coverage to only one drug per category or class (like Zoloft but not Lexepro, for example). The NFXF joined with 104 other organizations to urge a change in this proposed rule to remove this limitation. For those of you interested, here’s the letter.

April 11, 2012

Honorable Kathleen Sebelius
Secretary, U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Secretary Sebelius:

The 104 undersigned organizations write on behalf of the more than 133 million Americans living with chronic diseases and disabilities and their caregivers. We respectfully urge you to revise, for 2014, the proposed Essential Health Benefits (EHB) prescription drug coverage standard, as put forth in the December 2011 “Essential Health Benefits Bulletin,” and to address critical aspects not mentioned in the bulletin including strong federal oversight mechanisms and patient protections involving medical necessity and anti-discrimination.

Inadequate Formulary Minimum Access to comprehensive prescription drug benefits is critical for the millions of Americans who live with chronic diseases and disabilities. The need for patients and physicians to have at their disposal as many options as possible in the treatment and diagnosis of chronic diseases and disabilities cannot be overstated. Individuals’ symptoms and response to medications vary on a case-by-case basis, making it imperative that patients and their caregivers have as many treatment options as possible.

The bulletin states that EHB plans must only cover one drug per therapeutic category or class covered by a selected state benchmark plan to meet the EHB standard. This is wholly inadequate to meet the complex needs of patients with chronic diseases and disabilities, and runs counter to the government’s existing minimum prescription drug coverage standards, including under the Medicare Part D program. Furthermore, this threshold is far lower than current standard practice in the private insurance market. As states begin to choose insurance plans to serve as their benchmarks for the EHB package, it is likely that state-selected plans will include a far more robust drug formulary than one drug per category or class. To set such a low threshold would violate the Affordable Care Act’s mandate that EHBs should model a typical employer plan.

For all of these reasons, we respectfully urge you, as you draft regulations on this topic, to revise, for 2014, the proposed leniency on drug coverage and require plans to ensure patients have adequate access to necessary medication by meeting the breadth of the formulary offered by the state-selected benchmark plan. The proposed standard requiring qualified plans to cover one drug per category or class is unacceptable.

In addition to the concerns with the proposed formulary structure, uncertainty remains about other issues that are crucial to ensuring the EHB best meets the needs of patients. We urge you to continue to develop policies that address federal oversight and patient protections.

Medical Necessity Determinations and Appeals Processes The EHB regulation must outline clear, understandable standards for medical necessity determinations. Plans must use medical necessity criteria that are objective, clinically valid, and compatible with generally accepted principles of care. A health intervention should be covered if it is an otherwise covered category of service, not specifically excluded, recommended by the treating health care professional recognized under state or federal law, and determined by the health plan’s medical director to be medically necessary. Any denials issued by a plan based on lack of medical necessity must explain to the patient in clear language the criteria used to make the determination, and the process of appealing a decision should also be clearly communicated.

Anti-discrimination Provisions The regulation must also provide for oversight of plan benefit design to avoid discrimination caused by certain plan design elements. There should be specific oversight mechanisms to review plan utilization management policies to ensure that practices are neither unfair nor discriminatory. Further, there should be a requirement for plans to disclose to all prospective and current members their utilization management techniques and limits on services.

Federal Oversight Responsibilities Finally, while we understand the desire to allow flexibility to states to implement the EHB and state exchanges, states are currently engaged in widely different levels of implementation activities. Many governors are refusing all participation in the development of exchanges. We encourage the Department to include federal oversight mechanisms to ensure that states are choosing appropriate benchmarks and that qualified health plans meet all appropriate and necessary criteria.

Thank you for taking immediate action to revise, for 2014, the proposed EHB prescription drug coverage standard and to further develop processes to ensure patients receive necessary medications and the best possible care.

Sincerely,

Adult Congenital Heart Association
Advocacy for Patients with Chronic Illness, Inc.
AIDS Action Baltimore
Alliance for Aging Research
Alzheimer’s Association
Alzheimer’s Foundation of America (AFA)
American Academy of Neurology
American Academy of Oral and Maxillofacial Pathology
American Academy of Physician Assistants
American Autoimmune Related Diseases Association
American Foundation for Suicide Prevention/SPAN USA
American Lung Association
American Mental Health Counselors Association
American Parkinson Disease Association
American Psychiatric Association
American Society of Transplantation (AST)
Amyloidosis Support Groups Inc
ARPKD/CHF Alliance
Arthritis Foundation
Association of Community Cancer Centers
Asthma and Allergy Foundation of America
Autism National Committee
BayBio
Bladder Cancer Advocacy Network (BCAN)
Brain Injury Association of America
CADASIL Together We Have Hope Nonprofit Organization
Celiac Disease Center at Columbia University
Christopher & Dana Reeve Foundation
Coalition of Heritable Disorders of Connective Tissue (CHDCT)
Colon Cancer Alliance
Community Access National Network (CANN)
Cooley’s Anemia Foundation
COPD Foundation
CurePSP
Depression and Bipolar Support Alliance (DBSA)
Digestive Disease National Coalition
Fabry Support & Information Group
Families USA
Family Voices
Friends of Cancer Research
Genetic Alliance
Global Healthy Living Foundation
Hemophilia Federation of America
Hepatitis Foundation International
Huntington’s Disease Society of America
Immune Deficiency Foundation
International Essential Tremor Foundation
International Federation of Marfan Syndrome Organizations (IFMSO)
International WAGR Syndrome Association
Interstitial Cystitis Association
Intracranial Hypertension Research Foundation
Japanese American Citizens League
Jeffrey Modell Foundation
KS&A
Lupus Foundation of America
Lupus Research Institute National Coalition
Maryland Hepatitis Coalition
Mended Little Hearts
Men’s Health Network
Mental Health America
Mental Health America of Colorado
Michael J. Fox Foundation for Parkinson’s Research
Moebius Syndrome Foundation
National Alliance on Mental Illness
National Alopecia Areata Foundation
National Association of People with AIDS
National Council for Community Behavioral Healthcare
National Gaucher Foundation
National Health Council
National Kidney Foundation
National Marfan Foundation
National Medical Association
National Multiple Sclerosis Society
National Organization for Rae Disorders (NORD)
National Parkinson Foundation
National Psoriasis Foundation
National Viral Hepatitis Roundtable
National Women’s Law Center
OWL-The Voice of Midlife and Older Women
Parkinson’s Action Network
Parkinson’s Disease Foundation (PDF)
Pediatric Stroke Network, Inc.
Prevent Cancer Foundation
Project DOCC – Delivery of Chronic Care
Pulmonary Hypertension Association
PXE International
RetireSafe
Scleroderma Foundation
Society for Women’s Health Research
Spina Bifida Association
Sudden Cardiac Arrest Association
The AIDS Institute
The National Fragile X Foundation
The Parkinson Alliance
Tremor Action Network
Tuberous Sclerosis Alliance
United Spinal Association
US Hereditary Angioedema Association
US Pain Foundation
Veterans Health Council
VHL Family Alliance
Vietnam Veterans of America
VillageCare
Women Against Prostate Cancer