Existing law, until January 1, 2028, and to the extent funds are made available for these purposes, requires the State Department of Public Health to collect data on the incidence of neurodegenerative disease in California, and requires a hospital, facility, physician and surgeon, or other health care provider diagnosing or providing treatment to a patient for a neurodegenerative disease to report each case of a neurodegenerative disease to the department, as prescribed. Existing law specifies that for this purpose, neurodegenerative disease may include, but need not be limited to, amyotrophic lateral sclerosis (ALS), among other diseases.

This bill would require the term neurodegenerative disease to include, but not be limited to, ALS.

Existing law, until January 1, 2028, and to the extent funds are made available for these purposes, requires the State Department of Public Health to collect data on the incidence of neurodegenerative disease in California, and requires a hospital, facility, physician and surgeon, or other health care provider diagnosing or providing treatment to a patient for a neurodegenerative disease to report each case of a neurodegenerative disease to the department, as prescribed. Existing law specifies that for this purpose, neurodegenerative disease may include, but need not be limited to, amyotrophic lateral sclerosis (ALS), among other diseases.

This bill would require the term neurodegenerative disease to include, but not be limited to, ALS.

Existing law, until January 1, 2028, and to the extent funds are made available for these purposes, requires the State Department of Public Health to collect data on the incidence of neurodegenerative disease in California, and requires a hospital, facility, physician and surgeon, or other health care provider diagnosing or providing treatment to a patient for a neurodegenerative disease to report each case of a neurodegenerative disease to the department, as prescribed. Existing law specifies that for this purpose, neurodegenerative disease may include, but need not be limited to, amyotrophic lateral sclerosis (ALS), among other diseases.

This bill would require the term neurodegenerative disease to include, but not be limited to, ALS.

Existing law, until January 1, 2028, and to the extent funds are made available for these purposes, requires the State Department of Public Health to collect data on the incidence of neurodegenerative disease, as defined, disease in California, and requires a hospital, facility, physician and surgeon, or other health care provider diagnosing or providing treatment to a patient for a neurodegenerative disease to report each case of a neurodegenerative disease to the department, as prescribed. Existing law specifies that for this purpose, neurodegenerative disease may include, but need not be limited to, amyotrophic lateral sclerosis (ALS), among other diseases.

This bill would make a technical, nonsubstantive change to that provision. require the term neurodegenerative disease to include, but not be limited to, ALS.

Existing law, until January 1, 2028, and to the extent funds are made available for these purposes, requires the State Department of Public Health to collect data on the incidence of neurodegenerative disease, as defined, in California, and requires a hospital, facility, physician and surgeon, or other health care provider diagnosing or providing treatment to a patient for a neurodegenerative disease to report each case of a neurodegenerative disease to the department, as prescribed.

This bill would make a technical, nonsubstantive change to that provision.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 424

Author:(Bryan)

As Amended Ver:September 5, 2023

Majority vote

SUMMARY

Requires the Department of Public Health (DPH), as part of the system it will establish for the collection of information on the incidence and prevalence of neurodegenerative disease, to also collect information on amyotrophic lateral sclerosis disease (ALS/Lou Gehrig's disease). Makes a conforming change in the definition of neurodegenerative disease.

Senate Amendments

Are technical, clarifying, and add co-authors.

COMMENTS

According to the National Institutes of Health, neurodegenerative diseases affect millions of people worldwide. Alzheimer's disease and Parkinson's disease are the most common neurodegenerative diseases. In the United States, as many as 6.2 million people may have Alzheimer's disease, according to a report from the Alzheimer's Disease Association in 2022. Nearly a million Americans are living with Parkinson's disease, according to the Parkinson's Foundation. Neurodegenerative diseases include ALS, Friedreich ataxia, Huntington's disease, Lewy body disease, and Spinal muscular atrophy.

Neurodegenerative diseases occur when nerve cells in the brain or peripheral nervous system lose function over time and ultimately die. Although certain treatments may help relieve some of the physical or mental symptoms associated with neurodegenerative diseases, slowing their progression is not currently possible, and no cures exist. The likelihood of developing a neurodegenerative disease rises dramatically with age. In the coming decades, more Americans may be affected by neurodegenerative diseases, especially as life expectancy increases. Scientists recognize that the combination of a person's genes and environment contributes to their risk of developing a neurodegenerative disease. For example, someone might have a gene that makes them more susceptible to Parkinson's disease, but their environmental exposures can affect whether, when, and how severely they are affected.

One of the provisions of AB 133 (Budget Committee), Chapter 143, Statutes of 2021, an omnibus health trailer bill, was the establishment of the California Neurodegenerative Disease Registry Program within DPH, expanding the California Parkinson's Disease Registry, to collect information on the incidence and prevalence of neurodegenerative diseases. This bill clarifies that the registry program will also collect information on the incidence and prevalence of ALS/Lou Gehrig's disease; and, makes a conforming change in the definition of neurodegenerative disease.

ALS. ALS, also known as Lou Gehrig's Disease, is a rare neurological disease that affects motor neurons – those nerve cells in the brain and spinal cord that control voluntary muscle movement. Voluntary muscles are those we choose to move to produce movements like chewing, walking, and talking. The disease is progressive, meaning the symptoms get worse over time. ALS has no cure and there is no effective treatment to reverse its progression.

ALS is a type of motor neuron disease. As motor neurons degenerate and die, they stop sending messages to the muscles, which causes the muscles to weaken, start to twitch (fasciculations), and waste away (atrophy). Eventually, the brain loses its ability to initiate and control voluntary movements. Early symptoms include: muscle twitches in the arm, leg, shoulder, or tongue, muscle cramps, tight and stiff muscles (spasticity), muscle weakness affecting an arm, a leg, the neck, or diaphragm, slurred and nasal speech, and difficulty chewing or swallowing. As the disease progresses, muscle weakness and atrophy spread to other parts of your body. People with ALS may develop problems with:

1. Being able to stand or walk, get in or out of bed on their own, or use their hands and arms;
2. Chewing food and swallowing (dysphagia);
3. Speaking or forming words (dysarthria);
4. Breathing (dyspnea); individuals with ALS eventually lose the ability to breathe on their own and must depend on a ventilator;
5. Maintaining weight and malnourishment;
6. Muscle cramps and neuropathy (nerve damage or disease); and,
7. Anxiety and depression, because people with ALS usually remain able to reason, remember, understand, and are aware of their progressive loss of function.

Although not as common, people with ALS may also:

1. Experience problems with language or decision-making; and,
2. Develop a form of dementia over time.

ALS doesn't affect your ability to taste, touch, or smell, or hear. Most people with ALS die from respiratory failure, usually within three to five years from when the symptoms first appear. However, about 10% of people with ALS survive for a decade or more.

According to the Author

ALS is a devastating neurodegenerative disease with no official diagnostic test nor effective treatment mechanism. It can affect one in every 400 adults and has a two to five year life expectancy rate after diagnosis, yet there is currently no way for our state to track ALS diagnoses and prevalence the way we do with other diseases, such as cancer. By collecting and reporting ALS data, we will provide a robust foundation for medical research that will help us better understand and, in time, find a treatment or even cure for this horrible disease. It will also help us improve patient care for those who are currently living with ALS, ensuring that they and their families have the resources and support they need as they navigate the challenges of such a life-altering disease.

Arguments in Support

The Golden West Chapter of the ALS Association writes in support of this bill and states that this bill simply makes certain DPH prioritizes ALS as one of the neurodegenerative diseases in the Neurodegenerative Disease Registry. ALS is a devastating neurodegenerative disease and robs a person of their ability to speak, swallow, move, and breathe. ALS can strike anyone of nearly any age, most who are diagnosed are between the age of 40 to 65. As such, adults have a 1:400 chance of being diagnosed with ALS. Nearly 90% of those diagnosed with ALS have no idea how or why they contracted the disease and the remaining 10% have a familial genetic mutation causing their disease. California has the largest ALS population in the country, and we have the largest number of veterans. The veteran community is particularly vulnerable as the incidence of ALS is twice that of the general patient population. Little is understood about the environmental, biological, or other factors that may cause ALS. California needs its own ALS registry to better understand the demographics of the ALS community. A registry will provide valuable information about how traditionally underserved communities are impacted by ALS. Data related to the role that ethnicity, sex, and gender play as risk factors for ALS is desperately needed.

Arguments in Opposition

The Department of Finance is opposed to this bill because the additional workload associated with this bill creates new General Fund costs for DPH that are not included in the Administration’s spending plan.

FISCAL COMMENTS

According to the Senate Appropriations Committee, DPH estimates annual General Fund costs of $1 million for staffing resources to support research and evaluation of the additional neurodegenerative disease.

VOTES:

ASM HEALTH: 15-0-0

YES: Wood, Waldron, Aguiar-Curry, Arambula, Boerner Horvath, Wendy Carrillo, Flora, Vince Fong, Maienschein, McCarty, Joe Patterson, Rodriguez, Santiago, Villapudua, Weber

ASM APPROPRIATIONS: 15-0-1

YES: Holden, Megan Dahle, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Hart, Lowenthal, Mathis, Papan, Pellerin, Sanchez, Weber, Ortega

ABS, ABST OR NV: Robert Rivas

ASSEMBLY FLOOR: 80-0-0

YES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones- Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

UPDATED

VERSION: September 5, 2023

CONSULTANT: Lara Flynn / HEALTH / (916) 319-2097 FN: 0001827

 THIRD READING  

Bill No: AB 424

Author: Bryan (D), et al.

Amended: 9/5/23 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 12-0, 6/28/23

AYES: Eggman, Nguyen, Glazer, Gonzalez, Grove, Hurtado, Limón, Menjivar, Roth, Rubio, Wahab, Wiener

SENATE APPROPRIATIONS COMMITTEE: 7-0, 9/1/23

AYES: Portantino, Jones, Ashby, Bradford, Seyarto, Wahab, Wiener

ASSEMBLY FLOOR: 80-0, 5/31/23 - See last page for vote

SUBJECT: Neurodegenerative disease registry

SOURCE: Golden West Chapter of the ALS Association

DIGEST:

This bill requires the California Department of Public Health, under the California Neurodegenerative Disease Registry Program, to collect information on the incidence and prevalence of amyotrophic lateral sclerosis.

Amendments delete two past operative dates and add Assembly Members Dixon and Zbur as coauthors.

ANALYSIS:

Existing law:

1. Establishes the California Department of Public Health (CDPH) to be vested with all the duties, powers, purposes, functions, responsibilities, and jurisdiction as they relate to public health, as specified. [HSC §131050]

1. Establishes the California Neurodegenerative Disease Registry Program (CNDRP), and requires CDPH to establish a system for the collection of information determining the incidence and prevalence of neurodegenerative disease, which may include Alzheimer’s disease, multiple sclerosis (MS), Huntington’s disease, and amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. Sunsets the CNDRP on January 1, 2028. [HSC §103871]
2. Requires CDPH, through the CNDRP, to designate the specified neurodegenerative diseases as a disease required to be reported in the state or any part of the state. Requires CDPH to provide notification of the mandatory reporting of neurodegenerative disease on its website and to provide that information to associations representing physicians and hospitals, as well as directly to the Medical Board of California at least 90 days prior to requiring information to be reported. [HSC §103871]
3. Requires, beginning July, 1, 2023, a hospital, facility, physician, or other health care provider diagnosing or providing treatment for a patient with a neurodegenerative disease to report each case to CDPH, as specified. [HSC §103871]

This bill requires CDPH, under the CNDRP, to collect information on the incidence and prevalence of ALS, and makes conforming changes in the definition of “neurodegenerative disease.”

Comments

1. Author’s statement. According to the author, ALS is a devastating neurodegenerative disease with no official diagnostic test nor effective treatment mechanism. It can affect one in every 400 adults and has a two to five year life expectancy rate after diagnosis, yet there is currently no way for our state to track ALS diagnoses and prevalence the way that we do with other diseases, such as cancer. By collecting and reporting ALS data, we will provide a robust foundation for medical research that will help us better understand and, in time, find a treatment or even cure for this horrible disease. It will also help us improve patient care for those who are currently living with ALS, ensuring that they and their families have the resources and support they need as they navigate the challenges of such a life-altering disease.
2. Implementation of the CNDRP. In its April 2023 CNDRP Implementation Guide, CDPH states that as a result of the CNDRP, the existing California Parkinson's Disease Registry will expand to collect additional disease conditions. Current law states that neurodegenerative disease may include, but is not limited to, Alzheimer’s disease, MS, Huntington’s disease, and ALS. CDPH decides what specific neurodegenerative disease will be reportable. Health care providers diagnosing or providing treatment for a patient with a neurodegenerative disease are required to report each case of a neurodegenerative disease to CDPH via the CNDRP, which conducted two virtual listening sessions, held a public comment period, and conducted key informant interviews with stakeholders, providers, and subject matter experts prior to the July 1, 2023, reporting requirement. According to CDPH, based on the feedback and input from stakeholders, clinicians, and subject matter experts about which conditions to add to the program, CNDRP will begin collecting data for diagnosis or treatment of MS occurring on or after July 1, 2023, and is considering designating Alzheimer’s disease as a reportable disease on July 1, 2025. CDPH is scheduled to post data on the next neurodegenerative disease by July 1, 2025. For CDPH to add another disease to the registry, they would host additional listening sessions to seek input from stakeholders and subject matter experts for purposes of determining the second neurodegenerative disease posting on the CNDRP.
3. ALS. According to the National Institute of Neurological Disorders and Stroke, ALS is a rare neurological disease that affects motor neurons—those nerve cells in the brain and spinal cord that control voluntary muscle movement. Voluntary muscles are those we choose to move to produce movements like chewing, walking, and talking. ALS is progressive, meaning the symptoms get worse over time, and has no cure or effective treatment to reverse its progression. As motor neurons degenerate and die, they stop sending messages to the muscles, which causes the muscles to weaken, start to twitch, and waste away. Eventually, the brain loses its ability to initiate and control voluntary movements. Early symptoms include muscle twitches in the arm, leg, shoulder, or tongue; muscle cramps; tight and stiff muscles; muscle weakness affecting an arm, leg, neck, or diaphragm; slurred and nasal speech; and, difficulty chewing or swallowing. As the disease progresses, muscle weakness and atrophy spread to other parts of the body, which develop problems such as not be able to stand or walk, get in or out of bed on one’s own, or use one’s hands and arms; speak or form words; breathe on one’s own and depend on a ventilator; and, anxiety and depression, because people with ALS usually remain able to reason, remember, understand, and are aware of their progressive loss of function. Although not as common, people with ALS may also experience problems with language or decision-making and develop a form of dementia over time. ALS doesn't affect one’s ability to taste, touch, smell, or hear. Most people with ALS die from respiratory failure, usually within three to five years from when the symptoms first appear. However, about 10% of people with ALS survive for a decade or more.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

According to the Senate Appropriations Committee, CDPH estimates annual General Fund costs of $1 million for staffing resources to support research and evaluation of the additional neurodegenerative disease.

SUPPORT: (Verified 9/5/23)

Golden West Chapter of the ALS Association (source)

California ALS Research Network

The ALS Association

Numerous individuals

OPPOSITION: (Verified 9/5/23)

Department of Finance

ARGUMENTS IN SUPPORT: The sponsor and supporters of this bill state that ALS is a devastating neurodegenerative disease, and few who are diagnosed survive longer than two to five years from diagnosis. ALS robs a person of their ability to speak, swallow, move, and breathe. ALS can strike anyone of nearly any age. Most who are diagnosed are between the ages of 40 and 65. As such, adults have a 1:400 chance of being diagnosed with ALS. Nearly 90% of those diagnosed with ALS have no idea how or why they contracted the disease. The remaining 10% have a familial genetic mutation causing their disease. Supporters argue that California has the largest ALS population in the country, and we have the largest number of veterans. The veteran community is particularly vulnerable, as the incidence of ALS is twice that of the general patient population. Little is understood about the environmental, biological, or other factors that may cause ALS. Adding to the urgent need for more information about who has ALS and why, there are no U.S. Food and Drug Administration-approved therapies that meaningfully slow or stop the progression of the disease. California needs its own ALS registry so that we can better understand the demographics of the ALS community. A registry will provide valuable information about how traditionally underserved communities are impacted by ALS. Data related to the role that ethnicity, sex, and gender play as risk factors for ALS is desperately needed. An ALS registry will enable the state to better identify where people who are diagnosed with ALS live so that we can ensure that they are connected to the resources they need to their lives to the fullest.

ARGUMENTS IN OPPOSITION: The Department of Finance is opposed to this bill because the additional workload associated with this bill creates new General Fund costs for CDPH that are not included in the Administration’s spending plan.

ASSEMBLY FLOOR: 80-0, 5/31/23

AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

Prepared by: Reyes Diaz / HEALTH / (916) 651-4111

9/6/23 13:17:44

**** END ****

SENATE COMMITTEE ON

Senator Anthony Portantino, Chair

2023 - 2024 Regular Session

AB 424 (Bryan) - Neurodegenerative disease registry

Bill Summary:

AB 424 would require the California Department of Public Health (CDPH), under its existing neurodegenerative disease reporting program, to collect information on the incidence and prevalence of amyotrophic lateral sclerosis (ALS).

Fiscal Impact:

The CDPH estimates annual General Fund costs of $1 million for staffing resources to support research and evaluation of the additional neurodegenerative disease.  

Background:

According to the National Institute of Neurological Disorders and Stroke, ALS is a rare neurological disease that affects motor neurons, those nerve cells in the brain and spinal cord that control voluntary muscle movement. ALS is progressive, meaning the symptoms get worse over time, and has no cure or effective treatment to reverse its progression. As motor neurons degenerate and die, they stop sending messages to the muscles, which causes the muscles to weaken, start to twitch, and waste away. Eventually, the brain loses its ability to initiate and control voluntary movements.

Current law requires CDPH, beginning January 1, 2023, to establish a system for the collection of information determining the incidence and prevalence of neurodegenerative disease, which may include Alzheimer’s disease, multiple sclerosis, Huntington’s disease, and ALS. Current law also requires CDPH to designate the specified neurodegenerative diseases as a disease required to be reported in the state and requires CDPH to provide notification of the mandatory reporting of neurodegenerative disease on its website and to provide that information to associations representing physicians and hospitals, as well as directly to the Medical Board of California at least 90 days prior to requiring information to be reported.

Proposed Law:

AB 424 would require, rather than permit, CDPH to collect information on the incidence and prevalence of ALS under its existing neurodegenerative disease reporting program.

-- END --

SENATE COMMITTEE ON HEALTH

Senator Dr. Susan Talamantes Eggman, Chair

BILL NO: AB 424

SUBJECT: Neurodegenerative disease registry

SUMMARY:

Requires the California Department of Public Health, under the California Neurodegenerative Disease Registry Program, to collect information on the incidence and prevalence of amyotrophic lateral sclerosis.

Existing law:

1. Establishes the California Department of Public Health (CDPH) to be vested with all the duties, powers, purposes, functions, responsibilities, and jurisdiction as they relate to public health, as specified. [HSC §131050]

1. Establishes the California Neurodegenerative Disease Registry Program (CNDRP), and requires CDPH to establish a system for the collection of information determining the incidence and prevalence of neurodegenerative disease, which may include Alzheimer’s disease, multiple sclerosis (MS), Huntington’s disease, and amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. Sunsets the CNDRP on January 1, 2028. [HSC §103871]
2. Requires CDPH, through the CNDRP, to designate the specified neurodegenerative diseases as a disease required to be reported in the state or any part of the state. Requires CDPH to provide notification of the mandatory reporting of neurodegenerative disease on its website and to provide that information to associations representing physicians and hospitals, as well as directly to the Medical Board of California at least 90 days prior to requiring information to be reported. [HSC §103871]
3. Requires, beginning July, 1, 2023, a hospital, facility, physician, or other health care provider diagnosing or providing treatment for a patient with a neurodegenerative disease to report each case to CDPH, as specified. [HSC §103871]

This bill: Requires CDPH, under the CNDRP, to collect information on the incidence and prevalence of ALS, and makes conforming changes in the definition of “neurodegenerative disease.”

FISCAL EFFECT:

According to the Assembly Appropriations Committee, CDPH estimates it will need approximately $1 million annually for three additional staff to support research and evaluation of ALS (General Fund). CDPH indicates it based the estimate on multiple sclerosis and Alzheimer's disease cases and projections.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, ALS is a devastating neurodegenerative disease with no official diagnostic test nor effective treatment mechanism. It can affect one in every 400 adults and has a two to five year life expectancy rate after diagnosis, yet there is currently no way for our state to track ALS diagnoses and prevalence the way that we do with other diseases, such as cancer. By collecting and reporting ALS data, we will provide a robust foundation for medical research that will help us better understand and, in time, find a treatment or even cure for this horrible disease. It will also help us improve patient care for those who are currently living with ALS, ensuring that they and their families have the resources and support they need as they navigate the challenges of such a life-altering disease.
2. Implementation of the CNDRP. In its April 2023 CNDRP Implementation Guide, CDPH states that as a result of the CNDRP, the existing California Parkinson's Disease Registry will expand to collect additional disease conditions. Current law states that neurodegenerative disease may include, but is not limited to, Alzheimer’s disease, MS, Huntington’s disease, and ALS. CDPH decides what specific neurodegenerative disease will be reportable. Health care providers diagnosing or providing treatment for a patient with a neurodegenerative disease are required to report each case of a neurodegenerative disease to CDPH via the CNDRP, which conducted two virtual listening sessions, held a public comment period, and conducted key informant interviews with stakeholders, providers, and subject matter experts prior to the July 1, 2023, reporting requirement. According to CDPH, based on the feedback and input from stakeholders, clinicians, and subject matter experts about which conditions to add to the program, CNDRP will begin collecting data for diagnosis or treatment of MS occurring on or after July 1, 2023, and is considering designating Alzheimer’s disease as a reportable disease on July 1, 2025. CDPH is scheduled to post data on the next neurodegenerative disease by July 1, 2025. For CDPH to add another disease to the registry, they would host additional listening sessions to seek input from stakeholders and subject matter experts for purposes of determining the second neurodegenerative disease posting on the CNDRP.
3. ALS. According to the National Institute of Neurological Disorders and Stroke, ALS is a rare neurological disease that affects motor neurons—those nerve cells in the brain and spinal cord that control voluntary muscle movement. Voluntary muscles are those we choose to move to produce movements like chewing, walking, and talking. ALS is progressive, meaning the symptoms get worse over time, and has no cure or effective treatment to reverse its progression. As motor neurons degenerate and die, they stop sending messages to the muscles, which causes the muscles to weaken, start to twitch, and waste away. Eventually, the brain loses its ability to initiate and control voluntary movements. Early symptoms include muscle twitches in the arm, leg, shoulder, or tongue; muscle cramps; tight and stiff muscles; muscle weakness affecting an arm, leg, neck, or diaphragm; slurred and nasal speech; and, difficulty chewing or swallowing. As the disease progresses, muscle weakness and atrophy spread to other parts of the body, which develop problems such as not be able to stand or walk, get in or out of bed on one’s own, or use one’s hands and arms; speak or form words; breathe on one’s own and depend on a ventilator; and, anxiety and depression, because people with ALS usually remain able to reason, remember, understand, and are aware of their progressive loss of function. Although not as common, people with ALS may also experience problems with language or decision-making and develop a form of dementia over time. ALS doesn't affect one’s ability to taste, touch, smell, or hear. Most people with ALS die from respiratory failure, usually within three to five years from when the symptoms first appear. However, about 10% of people with ALS survive for a decade or more.
4. Related legislation. SB 344 (Rubio) revises provisions of law related to the Ken Maddy California Cancer Registry to make various changes, including to permit individuals who are authorized to access the confidential data in cancer registries to participate in data sharing with other authorized individuals. SB 344 is set to be heard in the Assembly Health Committee on June 27, 2023.

AB 511 (Dixon) allows an individual to designate on their tax return that a specified amount in excess of the taxpayer’s personal income tax liability be transferred to the California ALS Research Network Voluntary Tax Contribution Fund. AB 511 is set to be heard in the Senate Appropriations Committee on June 26, 2023.

1. Prior legislation. AB 133 (Committee on Budget, Chapter 143, Statutes of 2021) established the CNDRP, which sunsets on January, 1, 2028.

AB 2325 (Bonilla, Chapter 354, Statutes of 2016) required, beginning January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to CDPH utilizing electronic means in a standardized format approved by CDPH.

1. Support. The sponsor and supporters of this bill state that ALS is a devastating neurodegenerative disease, and few who are diagnosed survive longer than two to five years from diagnosis. ALS robs a person of their ability to speak, swallow, move, and breathe. ALS can strike anyone of nearly any age. Most who are diagnosed are between the ages of 40 and 65. As such, adults have a 1:400 chance of being diagnosed with ALS. Nearly 90% of those diagnosed with ALS have no idea how or why they contracted the disease. The remaining 10% have a familial genetic mutation causing their disease. Supporters argue that California has the largest ALS population in the country, and we have the largest number of veterans. The veteran community is particularly vulnerable, as the incidence of ALS is twice that of the general patient population. Little is understood about the environmental, biological, or other factors that may cause ALS. Adding to the urgent need for more information about who has ALS and why, there are no U.S. Food and Drug Administration-approved therapies that meaningfully slow or stop the progression of the disease. California needs its own ALS registry so that we can better understand the demographics of the ALS community. A registry will provide valuable information about how traditionally underserved communities are impacted by ALS. Data related to the role that ethnicity, sex, and gender play as risk factors for ALS is desperately needed. An ALS registry will enable the state to better identify where people who are diagnosed with ALS live so that we can ensure that they are connected to the resources they need to their lives to the fullest.

SUPPORT AND OPPOSITION:

Support: Golden West Chapter of The ALS Association (sponsor)

The ALS Association

Numerous individuals

Oppose: None received

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 424

Author:(Bryan)

As Amended Ver:March 23, 2023

Majority vote

SUMMARY

Requires the Department of Public Health (DPH), as part of the system it will establish for the collection of information on the incidence and prevalence of neurodegenerative disease, to also collect information on amyotrophic lateral sclerosis disease (ALS/Lou Gehrig's disease). Makes a conforming change in the definition of neurodegenerative disease.

Major Provisions

COMMENTS

According to the National Institutes of Health, neurodegenerative diseases affect millions of people worldwide. Alzheimer's disease and Parkinson's disease are the most common neurodegenerative diseases. In the United States, as many as 6.2 million people may have Alzheimer's disease, according to a report from the Alzheimer's Disease Association in 2022. Nearly a million Americans are living with Parkinson's disease, according to the Parkinson's Foundation. Neurodegenerative diseases include ALS, Friedreich ataxia, Huntington's disease, Lewy body disease, and Spinal muscular atrophy.

Neurodegenerative diseases occur when nerve cells in the brain or peripheral nervous system lose function over time and ultimately die. Although certain treatments may help relieve some of the physical or mental symptoms associated with neurodegenerative diseases, slowing their progression is not currently possible, and no cures exist. The likelihood of developing a neurodegenerative disease rises dramatically with age. In the coming decades, more Americans may be affected by neurodegenerative diseases, especially as life expectancy increases. Scientists recognize that the combination of a person's genes and environment contributes to their risk of developing a neurodegenerative disease. For example, someone might have a gene that makes them more susceptible to Parkinson's disease, but their environmental exposures can affect whether, when, and how severely they are affected.

One of the provisions of AB 133 (Committee on Budget), Chapter 143, Statutes of 2021, an omnibus health trailer bill, was the establishment of the California Neurodegenerative Disease Registry Program within DPH, expanding the California Parkinson's Disease Registry, to collect information on the incidence and prevalence of neurodegenerative diseases. This bill clarifies that the registry program will also collect information on the incidence and prevalence of ALS/Lou Gehrig's disease; and, makes a conforming change in the definition of neurodegenerative disease.

ALS. ALS, also known as Lou Gehrig's Disease, is a rare neurological disease that affects motor neurons—those nerve cells in the brain and spinal cord that control voluntary muscle movement. Voluntary muscles are those we choose to move to produce movements like chewing, walking, and talking. The disease is progressive, meaning the symptoms get worse over time. ALS has no cure and there is no effective treatment to reverse its progression.

ALS is a type of motor neuron disease. As motor neurons degenerate and die, they stop sending messages to the muscles, which causes the muscles to weaken, start to twitch (fasciculations), and waste away (atrophy). Eventually, the brain loses its ability to initiate and control voluntary movements. Early symptoms include: muscle twitches in the arm, leg, shoulder, or tongue, muscle cramps, tight and stiff muscles (spasticity), muscle weakness affecting an arm, a leg, the neck, or diaphragm, slurred and nasal speech, and difficulty chewing or swallowing. As the disease progresses, muscle weakness and atrophy spread to other parts of your body. People with ALS may develop problems with:

1. Being able to stand or walk, get in or out of bed on their own, or use their hands and arms;
2. Chewing food and swallowing (dysphagia);
3. Speaking or forming words (dysarthria);
4. Breathing (dyspnea); individuals with ALS eventually lose the ability to breathe on their own and must depend on a ventilator;
5. Maintaining weight and malnourishment;
6. Muscle cramps and neuropathy (nerve damage or disease); and,
7. Anxiety and depression, because people with ALS usually remain able to reason, remember, understand, and are aware of their progressive loss of function.

Although not as common, people with ALS may also:

1. Experience problems with language or decision-making; and,
2. Develop a form of dementia over time.

ALS doesn't affect your ability to taste, touch, or smell, or hear. Most people with ALS die from respiratory failure, usually within three to five years from when the symptoms first appear. However, about 10% of people with ALS survive for a decade or more.

According to the Author

ALS is a devastating neurodegenerative disease with no official diagnostic test nor effective treatment mechanism. It can affect one in every 400 adults and has a two to five year life expectancy rate after diagnosis, yet there is currently no way for our state to track ALS diagnoses and prevalence the way we do with other diseases, such as cancer. By collecting and reporting ALS data, we will provide a robust foundation for medical research that will help us better understand and, in time, find a treatment or even cure for this horrible disease. It will also help us improve patient care for those who are currently living with ALS, ensuring that they and their families have the resources and support they need as they navigate the challenges of such a life-altering disease.

Arguments in Support

The Golden West Chapter of the ALS Association writes in support of this bill and states that this bill simply makes certain DPH prioritizes ALS as one of the neurodegenerative diseases in the Neurodegenerative Disease Registry. ALS is a devastating neurodegenerative disease and robs a person of their ability to speak, swallow, move, and breathe. ALS can strike anyone of nearly any age, most who are diagnosed are between the age of 40 to 65. As such, adults have a 1:400 chance of being diagnosed with ALS. Nearly 90% of those diagnosed with ALS have no idea how or why they contracted the disease and the remaining 10% have a familial genetic mutation causing their disease. California has the largest ALS population in the country, and we have the largest number of veterans. The veteran community is particularly vulnerable as the incidence of ALS is twice that of the general patient population. Little is understood about the environmental, biological, or other factors that may cause ALS. Adding to the urgent need for more information about who has ALS and why. California needs its own ALS registry to better understand the demographics of the ALS community. A registry will provide valuable information about how traditionally underserved communities are impacted by ALS. Data related to the role that ethnicity, sex, and gender play as risk factors for ALS is desperately needed. A registry is a tool for enabling a deeper understanding of the patient population which can be used to inform clinical trial enrollment and improve engagement and participation of the ALS patient community in research opportunities.

Arguments in Opposition

There is no known opposition to this bill.

FISCAL COMMENTS

According to the Assembly Appropriations Committee, DPH estimates it will need approximately $1 million annually for three additional staff to support research and evaluation of ALS (General Fund). DPH indicates it based the estimate on multiple sclerosis and Alzheimer's disease cases and projections

VOTES

ASM HEALTH: 15-0-0

YES: Wood, Waldron, Aguiar-Curry, Arambula, Boerner Horvath, Wendy Carrillo, Flora, Vince Fong, Maienschein, McCarty, Joe Patterson, Rodriguez, Santiago, Villapudua, Weber

ASM APPROPRIATIONS: 15-0-1

YES: Holden, Megan Dahle, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Hart, Lowenthal, Mathis, Papan, Pellerin, Sanchez, Weber, Ortega

ABS, ABST OR NV: Robert Rivas

UPDATED

VERSION: March 23, 2023

CONSULTANT: Rosielyn Pulmano / HEALTH / (916) 319-2097 FN: 0000552

Date of Hearing: May 3, 2023

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Chris Holden, Chair

ABPCA Bill Id:AB 424

Author:(Bryan) – As Amended Ver:March 23, 2023

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill requires the California Department of Public Health (CDPH), as part of the system it must establish for the collection of information on the incidence and prevalence of neurodegenerative disease, to also collect information on amyotrophic lateral sclerosis disease (ALS, also known as Lou Gehrig’s disease).

FISCAL EFFECT:

CDPH estimates it will need approximately $1 million annually for three additional staff to support research and evaluation of ALS (General Fund). CDPH indicates it based the estimate on multiple sclerosis and Alzheimer’s disease cases and projections.           

COMMENTS:

1. Purpose. This bill is sponsored by the Golden West Chapter of the ALS Association. According to the author:
   

California has the largest ALS population in the country, and we have the largest number of veterans – who are at twice the risk of ALS than the general patient population.

The ALS registry at the US Centers for Disease Control and Prevention (CDC) is a woefully inadequate tool to …understand the impact of ALS on local communities, inform patient care and resource allocation, and provide support for leading edge research.

California needs its own ALS registry so that we can:

• 1. better understand the demographics of the ALS community
  2. better identify where people who are diagnosed with ALS live so that we can ensure that they are connected to the resources they need to live life to the fullest with ALS
  3. better segment the patient community to improve clinical trial enrollment
  4. improve engagement and participation of the ALS patient community in research opportunities.

1. ALS. ALS is a rare neurological disease that affects motor neurons – nerve cells in the brain and spinal cord that control voluntary muscle movement. As motor neurons degenerate and die, they stop sending messages to the muscles, which causes the muscles to weaken, start to twitch, and atrophy. Eventually, the brain loses its ability to initiate and control voluntary movements. Early symptoms include: muscle twitches and cramps, tight and stiff muscles (spasticity), muscle weakness affecting limbs, the neck, or diaphragm, slurred and nasal speech, and difficulty chewing or swallowing. As the disease progresses, muscle weakness and atrophy spread to other parts of the body. People with ALS may develop problems with standing, walking, using their hands and arms, chewing, swallowing, speaking, and breathing, eventually losing the ability to breathe on their own and requiring a ventilator. Although not as common, people with ALS may also experience problems with language or decision-making, and they may develop a form of dementia over time. ALS does not affect the ability to taste, touch, or smell, or hear and, as those with ALS are aware of the disease progression, they may become anxious or depressed. Most people with ALS die from respiratory failure, usually within three to five years from when the symptoms first appear.
2. Neurodegenerative Disease Registry. The Legislature created the Richard Paul Hemann Parkinson’s Disease Program with SB 97 (Committee on Budget), Chapter 52, Statutes of 2017. AB 133 (Committee on Budget), Chapter 143, Statutes of 2022, eliminated the sunset on the Parkinson's Disease Program and requires the program to transition into the California Neurodegenerative Disease Registry Program. AB 133 directs CDPH, beginning January 1, 2023, to collect data on the incidence of neurodegenerative disease in California, and it states neurodegenerative disease may include ALS. This bill amends the statute to specify that ALS is included in neurodegenerative disease.
3. Related Legislation.
   
   1. AB 511 (Dixon) allows an individual to designate on their tax return that a specified amount in excess of the taxpayer’s personal income tax liability be transferred to the California ALS Research Network Voluntary Tax Contribution Fund. AB 511 is pending in this committee.
   2. SB 344 (Rubio) requires, rather than authorizes, CDPH to establish regional cancer registries and requires the director of CDPH to maintain a statewide registry infrastructure that maximizes California’s existing regional registry infrastructure funding through the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program. SB 344 is pending in Senate Appropriations Committee.
4. Prior Legislation. AB 133, (Committee on Budget), Chapter 143, Statutes of 2022, eliminated the sunset on the Parkinson's Disease Program and requires the program to transition into the California Neurodegenerative Disease Registry Program. AB 133 directs CDPH, beginning January 1, 2023, to collect data on the incidence of neurodegenerative disease in California and requires hospitals, physicians and other health care providers to report diagnoses and treatment of neurodegenerative diseases to CDPH. AB 133 sunsets the Neurodegenerative Disease Registry on January 1, 2028.

Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081

Date of Hearing: April 11, 2023

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 424

Author:(Bryan) – As Amended Ver:March 23, 2023

SUBJECT: Neurodegenerative disease registry.

SUMMARY: Requires the Department of Public Health (DPH), as part of the system it will establish for the collection of information on the incidence and prevalence of neurodegenerative disease, to also collect information on amyotrophic lateral sclerosis disease (ALS/Lou Gehrig’s disease). Makes a conforming change in the definition of neurodegenerative disease.

EXISTING LAW:

1. Requires DPH, beginning January 1, 2023, to collect data on the incidence of neurodegenerative diseases in California. [Health and Safety Code Section § 103871]
2. Requires DPH to establish a system for the collection of information determining the incidence and prevalence of neurodegenerative diseases. Requires DPH to designate the specified neurodegenerative diseases as a disease required to be reported; requires all cases of neurodegenerative disease diagnosed or treated in California to be reported to DPH. Requires DPH to designate the specified neurodegenerative diseases as a disease required to be reported in the state or any part of the state. Requires all cases of neurodegenerative disease diagnosed or treated in California to be reported to DPH. [Id.]
3. Requires DPH to provide notification of the mandatory reporting of neurodegenerative disease on its internet website and to also provide that information to associations representing physicians and hospitals and directly to the Medical Board of California at least 90 days prior to requiring information be reported. [Id.]
4. Requires, beginning July 1, 2023, a hospital, facility, physician and surgeon, or other health care provider diagnosing or providing treatment for a patient with a neurodegenerative disease to report each case of a neurodegenerative disease to DPH in a format prescribed by DPH. [Id.]
5. Requires a physician and surgeon, hospital, outpatient clinic, and any other facility, individual, or agency providing diagnostic or treatment services to a patient with a neurodegenerative disease to grant DPH or the authorized representative access to all records that would identify a case of a neurodegenerative disease or would establish characteristics of a neurodegenerative disease, treatment of a neurodegenerative disease, or medical status of any identified patient with a neurodegenerative disease. [Id.]
   
6. Defines “neurodegenerative disease” to include, but not be limited to, Alzheimer’s disease, multiple sclerosis, and Huntington’s disease. [Id.]
   

FISCAL EFFECT: Unknown. This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, ALS is a devastating neurodegenerative disease with no official diagnostic test nor effective treatment mechanism. It can affect one in every 400 adults and has a two to five year life expectancy rate after diagnosis, yet there is currently no way for our state to track ALS diagnoses and prevalence the way we do with other diseases, such as cancer. By collecting and reporting ALS data, we will provide a robust foundation for medical research that will help us better understand and, in time, find a treatment or even cure for this horrible disease. It will also help us improve patient care for those who are currently living with ALS, ensuring that they and their families have the resources and support they need as they navigate the challenges of such a life-altering disease.
2. BACKGROUND. According to the National Institutes of Health, neurodegenerative diseases affect millions of people worldwide. Alzheimer’s disease and Parkinson’s disease are the most common neurodegenerative diseases. In the United States, as many as 6.2 million people may have Alzheimer’s disease, according to a report from the Alzheimer's Disease Association in 2022. Nearly a million Americans are living with Parkinson’s disease, according to the Parkinson’s Foundation. Neurodegenerative diseases include ALS, Friedreich ataxia, Huntington's disease, Lewy body disease, and Spinal muscular atrophy.
   
   Neurodegenerative diseases occur when nerve cells in the brain or peripheral nervous system lose function over time and ultimately die. Although certain treatments may help relieve some of the physical or mental symptoms associated with neurodegenerative diseases, slowing their progression is not currently possible, and no cures exist. The likelihood of developing a neurodegenerative disease rises dramatically with age. In the coming decades, more Americans may be affected by neurodegenerative diseases, especially as life expectancy increases. Scientists recognize that the combination of a person’s genes and environment contributes to their risk of developing a neurodegenerative disease. For example, someone might have a gene that makes them more susceptible to Parkinson’s disease, but their environmental exposures can affect whether, when, and how severely they are affected.
   
   One of the provisions of AB 133 (Committee on Budget), Chapter 143, Statutes of 2021, an omnibus health trailer bill, was the establishment of the California Neurodegenerative Disease Registry Program within DPH, expanding the California Parkinson’s Disease Registry, to collect information on the incidence and prevalence of neurodegenerative diseases. This bill clarifies that the registry program will also collect information on the incidence and prevalence of ALS/Lou Gehrig’s disease; and, makes a conforming change in the definition of neurodegenerative disease.
   
   ALS. ALS, also known as Lou Gehrig's Disease, is a rare neurological disease that affects motor neurons—those nerve cells in the brain and spinal cord that control voluntary muscle movement. Voluntary muscles are those we choose to move to produce movements like chewing, walking, and talking. The disease is progressive, meaning the symptoms get worse over time. ALS has no cure and there is no effective treatment to reverse its progression.
   
   ALS is a type of motor neuron disease. As motor neurons degenerate and die, they stop sending messages to the muscles, which causes the muscles to weaken, start to twitch (fasciculations), and waste away (atrophy). Eventually, the brain loses its ability to initiate and control voluntary movements. Early symptoms include: muscle twitches in the arm, leg, shoulder, or tongue, muscle cramps, tight and stiff muscles (spasticity), muscle weakness affecting an arm, a leg, the neck, or diaphragm, slurred and nasal speech, and difficulty chewing or swallowing. As the disease progresses, muscle weakness and atrophy spread to other parts of your body. People with ALS may develop problems with:
3. Being able to stand or walk, get in or out of bed on their own, or use their hands and arms;
4. Chewing food and swallowing (dysphagia);
5. Speaking or forming words (dysarthria);
6. Breathing (dyspnea); individuals with ALS eventually lose the ability to breathe on their own and must depend on a ventilator;
7. Maintaining weight and malnourishment;
8. Muscle cramps and neuropathy (nerve damage or disease); and,
9. Anxiety and depression, because people with ALS usually remain able to reason, remember, understand, and are aware of their progressive loss of function.

Although not as common, people with ALS may also:

1. Experience problems with language or decision-making; and,
2. Develop a form of dementia over time.

ALS doesn't affect your ability to taste, touch, or smell, or hear. Most people with ALS die from respiratory failure, usually within three to five years from when the symptoms first appear. However, about 10% of people with ALS survive for a decade or more.

1. SUPPORT. The Golden West Chapter of the ALS Association writes in support of this bill and states that this bill simply makes certain DPH prioritizes ALS as one of the neurodegenerative diseases in the Neurodegenerative Disease Registry. ALS is a devastating neurodegenerative disease and robs a person of their ability to speak, swallow, move, and breathe. ALS can strike anyone of nearly any age, most who are diagnosed are between the age of 40 to 65. As such, adults have a 1:400 chance of being diagnosed with ALS. Nearly 90% of those diagnosed with ALS have no idea how or why they contracted the disease and the remaining 10% have a familial genetic mutation causing their disease. California has the largest ALS population in the country, and we have the largest number of veterans. The veteran community is particularly vulnerable as the incidence of ALS is twice that of the general patient population. Little is understood about the environmental, biological, or other factors that may cause ALS. Adding to the urgent need for more information about who has ALS and why.
   
   California needs its own ALS registry to better understand the demographics of the ALS community. A registry will provide valuable information about how traditionally underserved communities are impacted by ALS. Data related to the role that ethnicity, sex, and gender play as risk factors for ALS is desperately needed. A registry is a tool for enabling a deeper understanding of the patient population which can be used to inform clinical trial enrollment and improve engagement and participation of the ALS patient community in research opportunities.
2. RELATED LEGISLATION.
   
   1. SB 344 (Rubio) requires, rather than authorizes, DPH to designate any demographic parts of the state as regional cancer incidence reporting areas and establish regional cancer registries. Requires the DPH Director to maintain a statewide registry infrastructure that maximizes and strengthens California’s existing regional registry infrastructure funding through the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program. SB 344 passed the Senate Health Committee on March 29, 2023 with a vote of 12 to 0 and is currently pending hearing in the Senate Judiciary Committee.
   2. AB 511 (Dixon) allows an individual to designate on their tax return that a specified amount in excess of the taxpayer’s personal income tax liability be transferred to the California ALS Research Network Voluntary Tax Contribution Fund. AB 511 is pending hearing in the Assembly Revenue and Taxation Committee.
3. PREVIOUS LEGISLATION.
   1. AB 2325 (Bonilla), Chapter 354, Statutes of 2016, required, beginning January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to DPH utilizing electronic means in a standardized format approved by DPH.
   2. AB 133, among other things, eliminated the sunset on the Parkinson's Disease Program, in order to transition the program into the California Neurodegenerative Disease Registry Program, which requires DPH to collect data on the incidence of neurodegenerative diseases in California. Requires hospitals, physicians and other health care providers to report diagnoses and treatment of patients for a neurodegenerative disease to DPH. Sunsets the Neurodegenerative Disease Registry on January 1, 2028.

REGISTERED SUPPORT / OPPOSITION:

Support

Golden West Chapter of the ALS Association

Opposition

None on file.

Analysis Prepared by: Rosielyn Pulmano / HEALTH / (916) 319-2097