Current Legislation in the Battle Against Alzheimer's Disease

Specialty Pharmacy Times, September/October 2015, Volume 6, Issue 5

Policy makers are working to address the needs of patients with Alzheimer's disease.

Policy makers are working to address the needs of patients with Alzheimer’s disease.

According to the National Institute of Aging, Alzheimer’s disease is an irreversible brain disorder that slowly destroys memory and thinking skills and the ability to carry out simple tasks. For most individuals, the onset of the disease appears during their mid-60s.1

Alzheimer’s is a progressive disease in which dementia symptoms gradually worsen over time; it accounts for 60% to 80% of dementia cases and is not part of the normal aging process. Although this disease is associated with older patients, it does not discriminate based on age: up to 5% of individuals with the disease have early-onset Alzheimer’s, which often appears when the patient is in their 40s or 50s.2

The history of this disease can be traced to Dr. Alois Alzheimer, who, in 1906, noted changes in the brain tissue of a patient who had died of a mental illness. According to the National Institute on Aging, “Her symptoms included memory loss, language problems, and unpredictable behavior. After she died, he examined her brain and found many abnormal clumps (now called amyloid plaques) and tangled bundles of fibers (now called neurofibrillary, or tau, tangles).”

Along with loss of connections among nerve cells in the brain, these amyloid plaques and tau tangles are among the main features of Alzheimer’s disease.1 The statistics regarding Alzheimer’s are staggering: Alzheimer’s is ranked as the sixth leading cause of death in the United States, but recent estimates indicate the disorder may rank third, just behind heart disease and cancer, as a cause of death for older people.

Of the 5.3 million Americans with Alzheimer’s disease, it is estimated that 5.1 million are 65 years and older and approximately 200,000 are under 65 years. As the Baby Boomer generation continues to age, it is estimated that by 2025, the number of individuals 65 years and older with Alzheimer’s disease will increase 40% to 7.1 million.

By 2050, the number is expected to increase to 13.8 million. It is estimated that this year alone, 700,000 individuals in the United States 65 years and older will die with this disease.

According to the Alzheimer’s Association, this is the only disease among the top 10 causes of death in America that cannot be prevented, cured, or slowed.3

Even more alarming is Alzheimer’s cost to our health care system:

  • In 2015, the direct costs of caring for those with the disease in the United States will total an estimated $226 billion, with half of those costs borne by Medicare.
  • Average per-person Medicare spending for those 65 years and older who have Alzheimer’s and other dementias is 3 times higher than for seniors without dementia. Medicaid payments are 19 times higher.
  • Nearly 1 in 5 Medicare dollars is spent on people with Alzheimer’s disease and other dementias. It is projected that in 2050, that amount will be $1 in every $3.3

Unfortunately, this disease has no curative or breakthrough drug available. A majority of the medications in today’s market only treat its cognitive symptoms by essentially masking the underlying memory loss, confusion, and analytical problems.

The FDA has approved several medications to treat Alzheimer’s disease symptoms: donepezil (Aricept), galantamine (Razadyne), memantine (Namenda), and rivastigmine (Exelon, Namzaric). There are also several drugs to combat the disease currently going through clinical trials.4

As the search for a marketplace cure continues, federal policymakers have been active with 5 Congressional bills seeking to combat Alzheimer’s disease. The bill that seems to have the most momentum nationwide is S.857, “Health Outcomes, Planning and Education (HOPE) for Alzheimer’s Act of 2015,” which is sponsored by Sen. Debbie Stabenow (D-MI).

The bill proposes to provide Medicare coverage of an initial comprehensive care plan for Medicare beneficiaries newly diagnosed with Alzheimer’s disease and related dementias. The bill has a companion in HR 1559, sponsored by Rep. Chris Smith (R-NJ).

Quoted in a recent article as saying “This is really a family disease,” Sen. Stabenow is working with Congressional members for additional research funding for the National Institutes of Health (NIH) with a goal of $2 billion set aside for Alzheimer’s research.5

Below are other important Congressional bills:

  • HR 3090, sponsored by Rep. Maxine Waters (D-CA), proposes to amend the Public Health Service Act to authorize grants for training and support services for Alzheimer’s patients and their families.
  • HR 3091, also sponsored by Rep. Waters, seeks to amend the Violent Crime Control and Law Enforcement Act of 1994 to reauthorize the Missing Alzheimer’s Disease Patient Alert Program.
  • HR 3092, sponsored by Rep Waters, proposes to direct the US Postal Service to issue and sell an Alzheimer’s disease research semipostal stamp. The stamp must be made available to the public for 6 years, and proceeds from the sale must be transferred to the NIH for research purposes.
  • Lastly, HR 1468, sponsored by Rep. Smith, seeks to galvanize US government programs in support of brain health for patients with autism, hydrocephalus, and Alzheimer’s and other forms of dementia.

State lawmakers are also seeking solutions:

  • In 2014, Florida enacted HB 709 and HB 711, which established the Ed and Ethel Moore Alzheimer’s Disease Research Program to fund research leading to the prevention of, or a cure for, Alzheimer’s disease. The Alzheimer’s Disease Research Grant Advisory Board was created to allocate research grants through a peer-reviewed, competitive process to identify and fund the best proposals to expand Florida’s Alzheimer research.
  • Additionally, the laws now require the Division of Emergency Management to develop and maintain a registration program for special needs shelters, which provide shelter and services to individuals with Alzheimer’s disease in emergency situations. It also requires the Florida Department of Elder Affairs to provide incentive-based funding for memory disorder clinics.6
  • This year, Illinois enacted SB 1846 to combat Alzheimer’s, which provides that the State Police, in cooperation with the Silver Search Task Force, will develop a coordinated statewide awareness program to be used when a person 21 years or older who is believed to have Alzheimer’s disease, related dementia, or other dementia-like cognitive impairment is reported missing.
  • This past summer, New Jersey introduced several bills related to this topic. S-2959/A-4100 proposes that hospitals note Alzheimer’s diagnoses prominently to ensure patients receive adequate hospital care. S-2960/A-4331 requires training of homemaker-home health aides in the care of patients with Alzheimer’s disease or related disorders, and S-2961/A4188 states that Alzheimer’s disease and related disorders may be listed as a secondary cause of death on a death certificate, when appropriate.

Although it is unlikely that a cure for Alzheimer’s disease will be found in the short term, it is encouraging that so many are driven to take a tough stance against the disease. With determined researchers and policy makers teaming up to find a solution, it is only a matter of time before we can beat this devastating disease. SPT

References

  • About Alzheimer’s disease: Alzheimer’s basics. National Institute on Aging website. www.nia.nih.gov/alzheimers/topics/alzheimers-basics.
  • What is Alzheimer’s? Alzheimer’s Association website. www.alz.org/alzheimers_disease_what_is_alzheimers.asp.
  • 2015 Alzheimer’s disease facts and figures. Alzheimer’s Association website. www.alz.org/facts/overview.asp.
  • Drugs for Alzheimer’s disease 2014 update. EdInformatics website. www.edinformatics.com/news/alzheimers_drugs.htm.
  • Tower M. Sen. Debbie Stabenow touts Alzheimer’s legislation in Saginaw. MLive website. April 2, 2015 www.mlive.com/news/saginaw/index.ssf/2015/04/sen_debbie_stabenow_touts_alzh.html.
  • Gov. Scott signs legislation supporting Floridians with Alzheimer’s [press release]. Tallahassee, FL: The Office of Governor Rick Scott; June 18, 2014. http://elderaffairs.state.fl.us/doea/press/2014/Press%20Release-%20Alzheimer's%20Legislation-%20EOG.pdf.

About the Author

Ron Lanton III, Esq, is president of True North Political Solutions, LLC. He has over 20 combined years of government affairs and legal experience. This includes activities on the municipal, state, and federal levels of government. Most recently, he worked for a pharmaceutical wholesaler where he created and oversaw the company’s government affairs department, served as their exclusive lobbyist, and advocated for the company’s various health care customers. Prior to that, Ron worked at a government affairs consulting firm in Arlington, Virginia, where he focused on health care, energy, commerce, and transportation issues. He has also clerked for a federal magistrate, was appointed as a municipal commissioner on environmental issues, and has served as consultant to Wall Street firms on financial issues. He has been a featured industry speaker on issues such as pharmaceutical safety and health care cost containment. Ron earned his juris doctor from The Ohio State University Moritz College of Law and a bachelor of arts from Miami University of Ohio. He is also a “40 Under 40” award recipient. He is admitted to practice law in New York, Illinois, and the District of Columbia.