Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services and under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions.

Existing law sets forth a schedule of benefits under the Medi-Cal program, including pharmacy benefits (Medi-Cal Rx) and durable medical equipment. The department announced that, effective June 1, 2022, personal home blood pressure monitoring devices, and blood pressure cuffs for use with those devices, are a covered benefit under Medi-Cal Rx as a pharmacy-billed item.

This bill would make self-measured blood pressure (SMBP) devices and SMBP services, as defined, covered benefits under the Medi-Cal program subject to utilization controls, as specified. The bill would state the intent of the Legislature that those covered devices and services be no less in scope than the devices and services that are recognized under specified existing billing codes or their successors. The bill would condition implementation of that coverage on receipt of any necessary federal approvals and the availability of federal financial participation.

Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services and under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions.

Existing law sets forth a schedule of benefits under the Medi-Cal program, including pharmacy benefits (Medi-Cal Rx) and durable medical equipment. The department announced that, effective June 1, 2022, personal home blood pressure monitoring devices, and blood pressure cuffs for use with those devices, are a covered benefit under Medi-Cal Rx as a pharmacy-billed item.

This bill would make self-measured blood pressure (SMBP) devices and SMBP services, as defined, covered benefits under the Medi-Cal program subject to utilization controls. controls, as specified. The bill would state the intent of the Legislature that those covered devices and services be no less in scope than the devices and services that are recognized under specified existing billing codes or their successors. The bill would condition implementation of that coverage on receipt of any necessary federal approvals and the availability of federal financial participation.

Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services and under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions.

Existing law sets forth a schedule of benefits under the Medi-Cal program, including pharmacy benefits (Medi-Cal Rx) and durable medical equipment. The department announced that, effective June 1, 2022, personal home blood pressure monitoring devices, and blood pressure cuffs for use with those devices, are a covered benefit under Medi-Cal Rx as a pharmacy-billed item.

This bill would make self-measured blood pressure (SMBP) devices and SMBP services, as defined, covered benefits under the Medi-Cal program for the treatment of high blood pressure. subject to utilization controls. The bill would state the intent of the Legislature that those covered devices and services be consistent in scope with no less in scope than the devices and services that are recognized under specified existing billing codes or their successors. The bill would condition implementation of that coverage on receipt of any necessary federal approvals and the availability of federal financial participation.

Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services and under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions.

Existing law sets forth a schedule of benefits under the Medi-Cal program, including pharmacy benefits (Medi-Cal Rx) and durable medical equipment. The department announced that, effective June 1, 2022, personal home blood pressure monitoring devices, and blood pressure cuffs for use with those devices, are a covered benefit under Medi-Cal Rx as a pharmacy-billed item.

This bill would make self-measured blood pressure (SMBP) devices and SMBP services, as defined, covered benefits under the Medi-Cal program for the treatment of high blood pressure. The bill would state the intent of the Legislature that those covered devices and services be consistent in scope with devices and services that are recognized under specified existing billing codes or their successors. The bill would condition implementation of that coverage on receipt of any necessary federal approvals and the availability of federal financial participation.

 VETO  

Bill No: SB 694

Author: Eggman (D)

Amended: 9/1/23

Vote: 27

SENATE HEALTH COMMITTEE: 11-0, 4/19/23

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

NO VOTE RECORDED: Hurtado

SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/18/23

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

SENATE FLOOR: 40-0, 5/25/23

AYES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk

SENATE FLOOR: 39-0, 9/13/23

AYES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk

NO VOTE RECORDED: Caballero

ASSEMBLY FLOOR: 78-0, 9/12/23 - See last page for vote

SUBJECT: Medi-Cal: self-measured blood pressure devices and services

SOURCE: American Heart Association

California Chronic Care Coalition

DIGEST:

This bill adds self-measured blood pressure (SMBP) devices and SMBP services, as defined, as covered benefits under the Medi-Cal program for the treatment of high blood pressure.

ANALYSIS:

Existing law:

1. Establishes the Medi-Cal program, administered by the Department of Health Care Services (DHCS), under which low-income individuals are eligible for medical coverage. [WIC §14000, et seq.]
2. Establishes a schedule of benefits under the Medi-Cal program, which includes benefits required under federal law and benefits provided at the state’s option but for which federal financial participation through Medicaid is available. The schedule of benefits includes outpatient services, durable medical equipment, and medical supplies. [WIC §14132]

This bill:

1. Adds SMBP devices as a covered benefit under the Medi-Cal program. States that “SMBP device” includes, but is not limited to, an automated blood pressure monitor or a blood pressure cuff. States that the intent of the Legislature is to cover the same scope of devices that are recognized under Healthcare Common Procedure Coding System (HCPCS) Code A4670, A4663, or A4670, or their respective successors.
2. Adds SMBP services as a covered benefit under the Medi-Cal program. States that “SMBP service” includes, but is not limited to, staff time for patient education and training, separate self-measurements, collection of daily reports by the patient or caregiver to the health care provider, or communication of blood pressure readings and treatment plans to the patient, only to the extent that additional support and education are required and documented by the provider. States that the intent of the Legislature that covered SMBP services be consistent in scope with services that are recognized under CPT Code 99473 or 99474, or their respective successors.
3. Conditions the implementation of this bill upon the receipt of federal approvals and federal financial participation.
4. Makes legislative findings that DHCS covers SMBP devices under Medi-Cal Rx as a pharmacy-billed item and that various states provide coverage for SMBP devices, services, or both. Declares the Legislature’s intent to statutorily cover as benefits in the Medi-Cal program, not only SMBP devices, but also SMBP services, for the purposes of promoting the health of Medi-Cal beneficiaries with hypertension or another diagnosis that supports the use of an at-home blood pressure monitor.

Comments

1. Author’s statement. According to the author, almost 30% of adults in California have been diagnosed with high blood pressure, with communities of color, particularly African-Americans and American Indians, being disproportionately impacted. High blood pressure is a major, yet controllable, risk factor contributing to heart disease and stroke, two of the leading causes of death worldwide, as well as maternal mortality, and kidney damage. SMBP monitoring is an evidence-based strategy that can improve blood pressure control for individuals with high blood pressure and is most effective when an individual has access to a validated blood pressure device for home use coupled with ongoing clinical support. California’s Medi-Cal program, which serves over 15 million low-income Californians, has currently adopted the uniform medical billing code for SMBP devices, but not the accompanying clinical services to evaluate and educate patients using such devices. Providing SMBP services to Medi-Cal recipients can help them to monitor and ultimately better control their blood pressure. It will also help those patients who have high blood pressure readings in the doctor’s office, due to anxiety avoid unneeded medication.
2. Hypertension prevalence and disparities. According to a 2021 report on chronic conditions by the California Health Care Foundation, in 2019, high blood pressure, also known as hypertension, was the second most common chronic condition in California. As with most chronic conditions, the prevalence rates are not distributed proportionately among the various racial and ethnic groups in California. Native Hawaiian/Pacific Islander, Black, and American Indian/Alaska Native Californians have a prevalence rate of 42.8%, 38.3%, and 36.5% respectively. On the other hand, white, Latinx, and Asian American Californians have a prevalence rate of 28.6%, 22.9%, and 21.6% respectively. Other reports, including the American Heart Association journal, have a higher prevalence rate for Latinx, particularly subgroups such as males or youth.
3. Current Medi-Cal coverage of SMBP devices and services. SMBP devices are blood pressure monitors and cuffs that individuals can use at home to monitor their blood pressure. SMBP services includes the medical staff time needed to make use of the patient-collected blood pressure information, including time to review the results of SMBP devices, device calibration, and patient education. Like many devices and services, these are not specifically listed in state law as a Medi-Cal benefit. With certain exceptions, state law establishes broad categories of benefits that are covered, subject to utilization controls designed to establish whether the device or service is medically necessary. DHCS describes the details of covered benefits, and establishes and updates utilization controls in various Medi-Cal provider manuals. SMBP devices have long been covered in the provider manuals as durable medical equipment. Prior to the establishment of Medi-Cal Rx, which carved out pharmacy services from Medi-Cal managed care plans into a statewide prescription drug coverage program, plans often covered SMBP devices as pharmacy benefits instead because obtaining such devices at a pharmacy was simpler than an order for durable medical equipment. When Medi-Cal Rx made this no longer possible for plans, Medi-Cal consumers began having difficulty accessing SMBP devices in a timely manner. DHCS announced that effective June 1, 2022, SMBP monitors and cuffs would be a covered benefit under Medi-Cal Rx as a pharmacy-billed item. This bill does not change how SMBP devices are covered; it merely codifies the coverage.

On the other hand, while SMBP services would ostensibly be covered as medically necessary services, the provider manuals make no mention of these services nor of the codes described in this bill, thus billing for these services could be difficult. The Cardiology section of the General Medicine manual does describe coverage for ambulatory blood pressure monitoring, which involves a more complicated device that is worn by the individual continuously so that automated blood pressure readings may be taken. The description of ambulatory blood pressure monitoring includes interpretation of the results by a Medi-Cal provider. Providers may still be able to bill for these services through a managed care plan, though absent specific mention in the provider manual, coverage by all plans is not guaranteed. According to 2022 analysis by the American Medical Association, 19 other states provide specified coverage for the SMBP services as proposed in this bill, and another three states provide specified coverage for at least the initial the patient education and training and device calibration that this bill would require.

1. California Health Benefits Review Program (CHBRP) analysis. AB 1996 (Thomson, Chapter 795, Statutes of 2002) requests the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996, and reviewed this bill. Key findings include:
   1. Coverage impacts and enrollees covered. While coverage (and utilization) of the SMBP devices is not expected to change, there would be an increase in both coverage and utilization for SMBP education/calibration and 30-day data collection services. Coverage for the education/calibration service would increase from 91% of enrollees at baseline to 100% postmandate, and coverage for the data collection service would increase from 74% at baseline to 100%. This will result in an additional coverage for 986,130 enrollees and 2,848,820 enrollees for the services related to the devices.
   2. Medical effectiveness. A preponderance of evidence suggests that, relative to usual care, SMBP devices are effective at supporting clinically significant reductions of systolic and diastolic blood pressure but are not effective at supporting blood pressure control (defined as achieving a blood pressure level below a threshold identified by the patient’s provider or by study coordinators). There is insufficient evidence to assess the direct impact of SMBP devices on complications of hypertension, quality of life, or use of acute care services, although they are associated with reduction in blood pressure, which can reduce the risk that a person with hypertension will develop complications or need acute care services. There is insufficient evidence to assess the impact of the SMBP device-related services required by this bill.
   3. Utilization. To estimate the utilization that is expected in 30-day data collection service for the 26% of Medi-Cal beneficiaries who would gain coverage postmandate, the number of persons with new coverage (2,848,820 854) was multiplied by the utilization rate for those who were already covered. At baseline, utilization rate of education/calibration service for those with coverage was .0012% of total beneficiaries or .046% of beneficiaries who received the devices. Postmandate, the utilization for the 3,468,854 who received additional coverage would be 64 services. The total service use would increase postmandate from 130 to 170, an increase of .30.1%. In sum, there would be no increase in use of devices postmandate, an increase in education/calibration of 110 services, and an increase in 30-day data collection of 40 services.
   4. Impact on expenditures. Unit costs (the amounts providers can receive for providing the devices and the services) are limited: $43 for the device, $14 for the education/calibration service, and $11 for the 30-day data collection service. Increased utilization at these rates would raise total 2024 expenditures by Medi-Cal for enrollees from $36,606,800,000 to $36,606,802,000, an increase of $2,000 (0.000005%). Given the small change in utilization and overall cost ($2000) postmandate, there is expected to be only a minimal (<.01%) change on administrative expenses.
   5. Public health. Although SMBP devices are found to be medically effective in helping people lower their blood pressure values, CHBRP concludes that passage of this bill would have no measurable short-term public health impact due to a marginal increase in previously low levels of utilization. For these reasons, CHBRP also concludes that this bill would have no measurable impact on disparities in health outcomes (by gender, race/ethnicity, sexual orientation/gender identity, or other determinants) in the first 12 months. It also would have no impact on premature death and societal economic losses. However, CHBRP also concludes that in the long term, there is potential for a public health impact should awareness of coverage and subsequent utilization expand among Medi-Cal providers and beneficiaries. The analysis states that Medi-Cal beneficiaries with hypertension who receive and use an SMBP device may be better able to lower their blood pressure values. Lower blood pressure (even if not fully controlled) is associated with better cardiovascular outcomes: fewer strokes, less cardiovascular disease, and less kidney failure.

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

According to the Assembly Appropriations Committee DHCS estimates costs of approximately $5 million per year for SMBP services ($2 million to $2.5 million General Fund).

SUPPORT: (Verified 9/11/23)

American Heart Association (co-source)

California Chronic Care Coalition (co-source)

American College of Obstetricians and Gynecologists District IX

California Academy of Family Physicians

California Black Health Network

California Chapter American College of Cardiology

California Health+Advocates

California Retired Teachers Association

Center for Elders' Independence

Community Clinic Association of Los Angeles County

Public Health Advocates

Western Center on Law & Poverty

OPPOSITION: (Verified 9/11/23)

None received

ARGUMENTS IN SUPPORT: Co-sponsors American Heart Association and California Chronic Care Coalition write that improving the diagnosis, treatment, and control of hypertension is critical for improving the cardiovascular health of all Americans and reducing major cost drivers in the health care system. A key component to achieve this is SMBP monitoring, an evidence-based strategy that can improve blood pressure control for individuals with hypertension. They state that several national and international hypertension guidelines, including the American Heart Association and American College of Cardiology have included it in their recommendations as useful for helping confirm diagnosis of high blood pressure along with assisting in titration of blood pressure-lowering medications. The US Surgeon General and the American Medical Association have also affirmed the importance of SMBP monitoring to manage hypertension. In addition to the health and economic impacts, they also point to the racial disparities and the particular impact of high blood pressure on maternal health. Finally, they state that by codifying Medi-Cal coverage of SMBP devices and services, this bill would provide clarity to health care providers, guarantee coverage for patients, and save state resources.

None received

GOVERNOR'S VETO MESSAGE:

This bill would require self-measured blood pressure devices and related services to be covered benefits within the Medi-Cal program.

While I appreciate the author's goal to support Medi-Cal beneficiaries with hypertension and related conditions, new Medi-Cal benefits must be considered as part of the annual budget process. In 2022, the Department of Health Care Services (DHCS) added coverage for self-measured blood pressure devices into the Medi-Cal pharmacy benefit. However, the addition of patient education, data collection, and required communication about treatment plans is an expansion of covered services. DHCS estimates additional annual costs to the Medi-Cal program in the millions of dollars from the General Fund to implement this bill. These costs must be considered alongside other budgetary priorities.

In partnership with the Legislature, we enacted a budget that closed a shortfall of more than $30 billion through balanced solutions that avoided deep program cuts and protected education, health care, climate, public safety, and social service programs that are relied on by millions of Californians. This year, however, the Legislature sent me bills outside of this budget process that, if all enacted, would add nearly $19 billion of unaccounted costs in the budget, of which $11 billion would be ongoing. With our state facing continuing economic risk and revenue uncertainty, it is important to remain disciplined when considering bills with significant fiscal implications, such as this measure.

ASSEMBLY FLOOR: 78-0, 9/12/23

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, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Rendon, Reyes, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Robert Rivas

NO VOTE RECORDED: Jones-Sawyer, McKinnor

Prepared by: Jen Flory / HEALTH / (916) 651-4111

10/19/23 10:47:59

**** END ****

 UNFINISHED BUSINESS  

Bill No: SB 694

Author: Eggman (D)

Amended: 9/1/23

Vote: 21

SENATE HEALTH COMMITTEE: 11-0, 4/19/23

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

NO VOTE RECORDED: Hurtado

SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/18/23

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

SENATE FLOOR: 40-0, 5/25/23

AYES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk

ASSEMBLY FLOOR: 78-0, 9/12/23 - See last page for vote

SUBJECT: Medi-Cal: self-measured blood pressure devices and services

SOURCE: American Heart Association

California Chronic Care Coalition

DIGEST:

This bill adds self-measured blood pressure (SMBP) devices and SMBP services, as defined, as covered benefits under the Medi-Cal program for the treatment of high blood pressure.

Assembly Amendments

make only minor technical changes such as clarifying billing codes and procedures and requiring that SMBP devices meet United States Food and Drug Administration device requirements.

ANALYSIS:

Existing law:

1. Establishes the Medi-Cal program, administered by the Department of Health Care Services (DHCS), under which low-income individuals are eligible for medical coverage. [WIC §14000, et seq.]
2. Establishes a schedule of benefits under the Medi-Cal program, which includes benefits required under federal law and benefits provided at the state’s option but for which federal financial participation through Medicaid is available. The schedule of benefits includes outpatient services, durable medical equipment, and medical supplies. [WIC §14132]

This bill:

1. Adds SMBP devices as a covered benefit under the Medi-Cal program. States that “SMBP device” includes, but is not limited to, an automated blood pressure monitor or a blood pressure cuff. States that the intent of the Legislature is to cover the same scope of devices that are recognized under Healthcare Common Procedure Coding System (HCPCS) Code A4670, A4663, or A4670, or their respective successors.
2. Adds SMBP services as a covered benefit under the Medi-Cal program. States that “SMBP service” includes, but is not limited to, staff time for patient education and training, separate self-measurements, collection of daily reports by the patient or caregiver to the health care provider, or communication of blood pressure readings and treatment plans to the patient, only to the extent that additional support and education are required and documented by the provider. States that the intent of the Legislature that covered SMBP services be consistent in scope with services that are recognized under CPT Code 99473 or 99474, or their respective successors.
3. Conditions the implementation of this bill upon the receipt of federal approvals and federal financial participation.
4. Makes legislative findings that DHCS covers SMBP devices under Medi-Cal Rx as a pharmacy-billed item and that various states provide coverage for SMBP devices, services, or both. Declares the Legislature’s intent to statutorily cover as benefits in the Medi-Cal program, not only SMBP devices, but also SMBP services, for the purposes of promoting the health of Medi-Cal beneficiaries with hypertension or another diagnosis that supports the use of an at-home blood pressure monitor.

Comments

1. Author’s statement. According to the author, almost 30% of adults in California have been diagnosed with high blood pressure, with communities of color, particularly African-Americans and American Indians, being disproportionately impacted. High blood pressure is a major, yet controllable, risk factor contributing to heart disease and stroke, two of the leading causes of death worldwide, as well as maternal mortality, and kidney damage. SMBP monitoring is an evidence-based strategy that can improve blood pressure control for individuals with high blood pressure and is most effective when an individual has access to a validated blood pressure device for home use coupled with ongoing clinical support. California’s Medi-Cal program, which serves over 15 million low-income Californians, has currently adopted the uniform medical billing code for SMBP devices, but not the accompanying clinical services to evaluate and educate patients using such devices. Providing SMBP services to Medi-Cal recipients can help them to monitor and ultimately better control their blood pressure. It will also help those patients who have high blood pressure readings in the doctor’s office, due to anxiety avoid unneeded medication.
2. Hypertension prevalence and disparities. According to a 2021 report on chronic conditions by the California Health Care Foundation, in 2019, high blood pressure, also known as hypertension, was the second most common chronic condition in California. As with most chronic conditions, the prevalence rates are not distributed proportionately among the various racial and ethnic groups in California. Native Hawaiian/Pacific Islander, Black, and American Indian/Alaska Native Californians have a prevalence rate of 42.8%, 38.3%, and 36.5% respectively. On the other hand, white, Latinx, and Asian American Californians have a prevalence rate of 28.6%, 22.9%, and 21.6% respectively. Other reports, including the American Heart Association journal, have a higher prevalence rate for Latinx, particularly subgroups such as males or youth.
3. Current Medi-Cal coverage of SMBP devices and services. SMBP devices are blood pressure monitors and cuffs that individuals can use at home to monitor their blood pressure. SMBP services includes the medical staff time needed to make use of the patient-collected blood pressure information, including time to review the results of SMBP devices, device calibration, and patient education. Like many devices and services, these are not specifically listed in state law as a Medi-Cal benefit. With certain exceptions, state law establishes broad categories of benefits that are covered, subject to utilization controls designed to establish whether the device or service is medically necessary. DHCS describes the details of covered benefits, and establishes and updates utilization controls in various Medi-Cal provider manuals. SMBP devices have long been covered in the provider manuals as durable medical equipment. Prior to the establishment of Medi-Cal Rx, which carved out pharmacy services from Medi-Cal managed care plans into a statewide prescription drug coverage program, plans often covered SMBP devices as pharmacy benefits instead because obtaining such devices at a pharmacy was simpler than an order for durable medical equipment. When Medi-Cal Rx made this no longer possible for plans, Medi-Cal consumers began having difficulty accessing SMBP devices in a timely manner. DHCS announced that effective June 1, 2022, SMBP monitors and cuffs would be a covered benefit under Medi-Cal Rx as a pharmacy-billed item. This bill does not change how SMBP devices are covered; it merely codifies the coverage.

On the other hand, while SMBP services would ostensibly be covered as medically necessary services, the provider manuals make no mention of these services nor of the codes described in this bill, thus billing for these services could be difficult. The Cardiology section of the General Medicine manual does describe coverage for ambulatory blood pressure monitoring, which involves a more complicated device that is worn by the individual continuously so that automated blood pressure readings may be taken. The description of ambulatory blood pressure monitoring includes interpretation of the results by a Medi-Cal provider. Providers may still be able to bill for these services through a managed care plan, though absent specific mention in the provider manual, coverage by all plans is not guaranteed. According to 2022 analysis by the American Medical Association, 19 other states provide specified coverage for the SMBP services as proposed in this bill, and another three states provide specified coverage for at least the initial the patient education and training and device calibration that this bill would require.

1. California Health Benefits Review Program (CHBRP) analysis. AB 1996 (Thomson, Chapter 795, Statutes of 2002) requests the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996, and reviewed this bill. Key findings include:
   1. Coverage impacts and enrollees covered. While coverage (and utilization) of the SMBP devices is not expected to change, there would be an increase in both coverage and utilization for SMBP education/calibration and 30-day data collection services. Coverage for the education/calibration service would increase from 91% of enrollees at baseline to 100% postmandate, and coverage for the data collection service would increase from 74% at baseline to 100%. This will result in an additional coverage for 986,130 enrollees and 2,848,820 enrollees for the services related to the devices.
   2. Medical effectiveness. A preponderance of evidence suggests that, relative to usual care, SMBP devices are effective at supporting clinically significant reductions of systolic and diastolic blood pressure but are not effective at supporting blood pressure control (defined as achieving a blood pressure level below a threshold identified by the patient’s provider or by study coordinators). There is insufficient evidence to assess the direct impact of SMBP devices on complications of hypertension, quality of life, or use of acute care services, although they are associated with reduction in blood pressure, which can reduce the risk that a person with hypertension will develop complications or need acute care services. There is insufficient evidence to assess the impact of the SMBP device-related services required by this bill.
   3. Utilization. To estimate the utilization that is expected in 30-day data collection service for the 26% of Medi-Cal beneficiaries who would gain coverage postmandate, the number of persons with new coverage (2,848,820 854) was multiplied by the utilization rate for those who were already covered. At baseline, utilization rate of education/calibration service for those with coverage was .0012% of total beneficiaries or .046% of beneficiaries who received the devices. Postmandate, the utilization for the 3,468,854 who received additional coverage would be 64 services. The total service use would increase postmandate from 130 to 170, an increase of .30.1%. In sum, there would be no increase in use of devices postmandate, an increase in education/calibration of 110 services, and an increase in 30-day data collection of 40 services.
   4. Impact on expenditures. Unit costs (the amounts providers can receive for providing the devices and the services) are limited: $43 for the device, $14 for the education/calibration service, and $11 for the 30-day data collection service. Increased utilization at these rates would raise total 2024 expenditures by Medi-Cal for enrollees from $36,606,800,000 to $36,606,802,000, an increase of $2,000 (0.000005%). Given the small change in utilization and overall cost ($2000) postmandate, there is expected to be only a minimal (<.01%) change on administrative expenses.
   5. Public health. Although SMBP devices are found to be medically effective in helping people lower their blood pressure values, CHBRP concludes that passage of this bill would have no measurable short-term public health impact due to a marginal increase in previously low levels of utilization. For these reasons, CHBRP also concludes that this bill would have no measurable impact on disparities in health outcomes (by gender, race/ethnicity, sexual orientation/gender identity, or other determinants) in the first 12 months. It also would have no impact on premature death and societal economic losses. However, CHBRP also concludes that in the long term, there is potential for a public health impact should awareness of coverage and subsequent utilization expand among Medi-Cal providers and beneficiaries. The analysis states that Medi-Cal beneficiaries with hypertension who receive and use an SMBP device may be better able to lower their blood pressure values. Lower blood pressure (even if not fully controlled) is associated with better cardiovascular outcomes: fewer strokes, less cardiovascular disease, and less kidney failure.

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

According to the Assembly Appropriations Committee DHCS estimates costs of approximately $5 million per year for SMBP services ($2 million to $2.5 million General Fund).

SUPPORT: (Verified 9/11/2023)

American Heart Association (co-source)

California Chronic Care Coalition (co-source)

American College of Obstetricians and Gynecologists District IX

California Academy of Family Physicians

California Black Health Network

California Chapter American College of Cardiology

California Health+Advocates

California Retired Teachers Association

Center for Elders' Independence

Community Clinic Association of Los Angeles County

Public Health Advocates

Western Center on Law & Poverty

OPPOSITION: (Verified 9/11/2023)

None received

ARGUMENTS IN SUPPORT: Co-sponsors American Heart Association and California Chronic Care Coalition write that improving the diagnosis, treatment, and control of hypertension is critical for improving the cardiovascular health of all Americans and reducing major cost drivers in the health care system. A key component to achieve this is SMBP monitoring, an evidence-based strategy that can improve blood pressure control for individuals with hypertension. They state that several national and international hypertension guidelines, including the American Heart Association and American College of Cardiology have included it in their recommendations as useful for helping confirm diagnosis of high blood pressure along with assisting in titration of blood pressure-lowering medications. The US Surgeon General and the American Medical Association have also affirmed the importance of SMBP monitoring to manage hypertension. In addition to the health and economic impacts, they also point to the racial disparities and the particular impact of high blood pressure on maternal health. Finally, they state that by codifying Medi-Cal coverage of SMBP devices and services, this bill would provide clarity to health care providers, guarantee coverage for patients, and save state resources.

ASSEMBLY FLOOR: 78-0, 9/12/23

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, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Rendon, Reyes, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Robert Rivas

NO VOTE RECORDED: Jones-Sawyer, McKinnor

Prepared by: Jen Flory / HEALTH / (916) 651-4111

9/12/23 19:10:56

**** END ****

SENATE THIRD READING

STR Bill Id:SB 694

Author:(Eggman)

As Amended Ver:September 1, 2023

Majority vote

SUMMARY

Requires Medi-Cal to cover self-measured blood pressure (SMBP) devices and related services, as specified.

Major Provisions

COMMENTS

1. Blood Pressure (BP) and Hypertension. BP is the pressure of blood pushing against the walls of the body’s arteries. According to the federal Centers for Disease Control and Prevention, BP normally rises and falls throughout the day, but it can damage the heart and cause health problems if it stays high for a long time. Hypertension, also called high BP, is BP that is higher than normal. This preventable and treatable condition contributes to more than 500,000 premature deaths annually in the United States. Controlling BP is important to preventing premature death. Nearly half of adults in the United States (47%, or 116 million) either have hypertension or are taking medication to control hypertension. Only about a quarter of adults with hypertension have their condition under control.

A greater percentage of men (50%) have hypertension than women (44%). Hypertension is more common in non-Hispanic Black adults (56%) than in non-Hispanic white adults (48%), non-Hispanic Asian adults (46%), or Hispanic adults (39%).

1. SMBP Devices and Services. According to the American Medical Association, medical evidence and clinical guidelines published over the last decade have highlighted the importance of 24-hour ambulatory monitoring as the reference standard, and SMBP monitoring as an acceptable alternative for obtaining BP to diagnose and treat hypertension. This type of monitoring can provide an accurate picture of someone’s BP over time, including identifying "white coat hypertension" (higher BP readings in a doctor’s office) and "masked hypertension" (lower BP readings in a doctor’s office). Modern SMBP devices consist of a small monitor with a digital readout, which attaches to a cuff that inflates and deflates, similar to BP monitors found in health facilities. The American Heart Association suggests taking BP readings daily when using these SMBP devices.
2. Medi-Cal Coverage of SMBP Devices. Medi-Cal covers SMBP devices as medical supplies. Specifically, Medi-Cal reimburses eligible pharmacy providers for personal home BP monitoring devices and BP cuffs though Medi-Cal Rx, the statewide system providing Medi-Cal covered pharmacy benefits. Medi-Cal Rx guidance describes coverage parameters as follows:
   1. A specified diagnosis code that justifies medical necessity for cardiovascular monitoring for a chronic condition or on a regular basis is required;
   2. Documentation of medical necessity in the electronic file or on the prescription is required;
   3. Some products require prior authorization demonstrating medical necessity; and,
   4. Medi-Cal Rx allows one BP monitoring kit (monitor plus cuff) every five years and an additional cuff every year. An approved prior authorization request demonstrating medical necessity can override these quantity and frequency restrictions.
3. Medi-Cal Coverage of SMBP Services. Medi-Cal covers medically necessary outpatient benefits, including SMBP services if deemed medically necessary. This bill specifies legislative intent that coverage of SMBP services be no less in scope than a group of SMBP-specific Current Procedural Terminology codes (codes used to describe and bill for medical services).
4. California Health Benefits Review Program (CHBRP) analysis. CHBRP, an analytical team housed in the University of California with a statutory charge to review legislative benefit mandates, analyzed the impact of this bill. In its analysis, CHBRP notes the following impacts:
   1. Enrollees covered.
      1. Devices. At baseline, CHBRP estimates 100% of Medi-Cal beneficiaries currently have coverage for SMBP devices. Post-mandate, there would be no change.
      2. Services. At baseline, 91% Medi-Cal beneficiaries have coverage for the SMBP device-related education/calibration service through their Medi-Cal managed care plan. Post-mandate, coverage for this device-related service would increase for 9% of Medi-Cal beneficiaries. At baseline, 74% of Medi-Cal beneficiaries have coverage for the SMBP device-related data collection service through their Medi-Cal managed care plan. Post-mandate, coverage for this device-related service would increase for 26% of Medi-Cal beneficiaries.
   2. Utilization. Utilization of the education/calibration service would increase from 1,010 to 1,120 uses per year (an 11% increase). Utilization of the 30-day data collection service would increase from 130 to 170 uses per year (a 31% increase).

According to the Author

Almost 30% of adults in California have been diagnosed with high BP, with communities of color, particularly African-Americans and Native Americans, being disproportionately impacted. The author notes high BP is a major, yet controllable, risk factor contributing to heart disease and stroke, two of the leading causes of death worldwide, as well as maternal mortality and kidney damage. The author asserts SMBP monitoring is an evidence-based strategy that can improve BP control for individuals with high BP and is most effective when an individual has access to a validated BP device for home use coupled with ongoing clinical support. The author points out California’s Medi-Cal program, which serves over 15 million low-income Californians, has currently adopted uniform medical billing codes for SMBP devices, but not the accompanying clinical services to evaluate and educate patients using such devices.

Arguments in Support

Cosponsors American Heart Association and California Chronic Care Coalition write that improving the diagnosis, treatment, and control of hypertension is critical for improving health and reducing health care costs. A key component to achieve this is SMBP monitoring, an evidence-based strategy that can improve BP control for individuals with hypertension. They state that trusted guidelines and organizations, including the American Heart Association and American College of Cardiology, have included it in their recommendations as useful for helping confirm diagnosis of high BP along with assisting in titration of BP-lowering medications. In addition to the health and economic impacts, they point to racial disparities and the particular impact of high BP on maternal health. Finally, they indicate that codifying Medi-Cal coverage of SMBP devices and services would provide clarity to health care providers and guarantee coverage for patients.

Arguments in Opposition

There is no known opposition.

FISCAL COMMENTS

According to the Assembly Appropriations Committee, the Department of Health Care Services (DHCS) estimates costs of approximately $5 million per year for SMBP services ($2 million to $2.5 million General Fund).

DHCS provided the following information and assumptions to support this estimate:

1. SMBP devices are available as a pharmacy benefit via Medi-Cal Rx and as a Healthcare Common Procedure Coding System (HCPCS)-billed medical benefit through Fee-For-Service (FFS) Medi-Cal and Medi-Cal managed care plans. On June 1, 2022, SMBP devices became a covered Medi-Cal Rx pharmacy benefit. During 2022, no claims for the devices were billed to the medical benefit using HCPCS codes; all claims in fiscal year 2022 were billed through pharmacy benefit codes. DHCS does not expect this to change, and does not expect an increase in utilization of SMBPs as a result of this bill.
2. 104,408 members would obtain an SMBP through Medi-Cal upon passage of this bill.
3. 8% of members who obtain an SMBP would use the education/calibration services, at a one-time cost of $12 per member.
4. 30% of members who obtain an SMBP would choose to send the SMBP data to their providers, at a monthly cost of $13.47.
5. Managed care providers will bill the Medi-Cal managed care plan for providing SMBP services, and managed care plans will reimburse providers at the FFS rates.
6. DHCS will increase capitation rates for the projected value of the amount that MCPs reimburse providers.
7. DHCS expects the SMBP devices to continue to be billed through the pharmacy benefit for all Medi-Cal members.

VOTES

SENATE FLOOR: 40-0-0

YES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk

ASM HEALTH: 14-0-1

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

ABS, ABST OR NV: Flora

ASM APPROPRIATIONS: 11-0-5

YES: Holden, Bryan, Calderon, Wendy Carrillo, Mike Fong, Hart, Lowenthal, Papan, Pellerin, Weber, Wilson

ABS, ABST OR NV: Megan Dahle, Dixon, Mathis, Sanchez, Soria

UPDATED

VERSION: September 1, 2023

CONSULTANT: Lisa Murawski / HEALTH / (916) 319-2097 FN: 0001559

Date of Hearing: August 23, 2023

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Chris Holden, Chair

SBPCA Bill Id:SB 694

Author:(Eggman) – As Amended Ver:June 12, 2023

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

SUMMARY:

This bill requires the Department of Health Care Services (DHCS) to cover self-measured blood pressure (SMBP) devices and SMBP-related services as Medi-Cal benefits.

Specifically, this bill:

1. Adds SMBP devices as a covered benefit under the Medi-Cal program, subject to utilization controls.
   
2. Defines "SMBP device" to include an automated blood pressure (BP) monitor or a BP cuff.
3. Adds SMBP services as a covered benefit under the Medi-Cal program for the treatment of high BP.
   
4. Defines “SMBP service” to include staff time for SMBP using a device validated for clinical accuracy, patient education and training, device calibration, separate self-measurements, collection of daily reports by the patient or caregiver to the health care provider, or communication of BP readings and treatment plans to the patient.
5. Declares the Legislature’s intent that covered SMBP devices and services be no less in scope than services of specified Healthcare Common Procedure Coding System (HCPCS) and Current Procedural Terminology (CPT) Code, or their respective successors.
   
6. Conditions implementation of this bill upon receipt of federal approvals and federal financial participation.
   

FISCAL EFFECT:

DHCS estimates costs of approximately $5 million per year for SMBP services ($2 million to $2.5 million General Fund).

DHCS provided the following information and assumptions to support this estimate:

• SMBP devices are available as a pharmacy benefit via Medi-Cal Rx and as a Healthcare Common Procedure Coding System (HCPCS)-billed medical benefit through Fee-For-Service (FFS) Medi-Cal and Medi-Cal managed care plans. On June 1, 2022, SMBP devices became a covered Medi-Cal Rx pharmacy benefit. During 2022, no claims for the devices were billed to the medical benefit using HCPCS codes; all claims in FY 2022 were billed through pharmacy benefit codes. DHCS does not expect this to change, and does not expect an increase in utilization of SMBPs as a result of this bill.
• 104,408 members would obtain an SMBP through Medi-Cal upon passage of this bill.
• 8% of members who obtain an SMBP would use the education/calibration services, at a one-time cost of $12 per member.
• 30% of members who obtain an SMBP would choose to send the SMBP data to their providers, at a monthly cost of $13.47.
• Managed care providers will bill the Medi-Cal managed care plan for providing SMBP services, and managed care plans will reimburse providers at the FFS rates.
• DHCS will increase capitation rates for the projected value of the amount that MCPs reimburse providers.
• DHCS expects the SMBP devices to continue to be billed through the pharmacy benefit for all Medi-Cal members

COMMENTS:

1. Purpose. This bill is sponsored by the American Heart Association and California Chronic Care Coalition. According to the author:
   

In California, almost 30% of adults have been diagnosed with high blood pressure, with communities of color, particularly African-Americans and American Indians, being disproportionately impacted. High blood pressure is a major, yet controllable, risk factor contributing to heart disease and stroke, two of the leading causes of death worldwide, as well as maternal mortality, and kidney damage. Self-measured blood pressure (SMBP) monitoring is an evidence-based strategy that can improve blood pressure control for individuals with high blood pressure and is most effective when an individual has access to a validated blood pressure device for home use coupled with ongoing clinical support. California’s Medi-Cal program, which serves over 15 million low-income Californians, has currently adopted the uniform medical billing code for SMBP devices, but not the accompanying clinical services to evaluate and educate patients using such devices. Providing SMBP services to Medi-Cal recipients can help them to monitor and ultimately better control their blood pressure. It will also help those patients who have high blood pressure readings in the doctor’s office due to anxiety avoid unneeded medication.

1. Background. SMBP devices are currently available as a pharmacy benefit via Medi-Cal Rx and a HCPCS-billed medical benefit through FFS Medi-Cal and Medi-Cal managed care plans. SMBP services are only available as a medical benefit, if a managed care plan elects to cover those services.

SMBP support services are not a Medi-Cal benefit, but can be optionally covered by a managed care plan. DHCS states that SB 694 will require DHCS to establish a new FFS rate. DHCS assumes FFS rates for SMBP services will be established at 80% of the Medicare rate pursuant to the California Medicaid State Plan.

1. Related Legislation. AB 365 (Aguiar Curry) adds continuous glucose monitors to the Medi-Cal schedule of benefits. AB 365 is pending in Senate Appropriations Committee.
   
2. Prior Legislation. SB 446 (Stone), of the 2019-20 Legislative Session, would have implemented hypertension medication management services in Medi-Cal. SB 446 was held on suspense in Senate Appropriations Committee. >

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

Date of Hearing: June 20, 2023

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

SBPCA Bill Id:SB 694

Author:(Eggman) – As Amended Ver:June 12, 2023

SENATE VOTE: 40-0

SUBJECT: Medi-Cal: self-measured blood pressure devices and services.

SUMMARY: Requires Medi-Cal to cover self-measured blood pressure (SMBP) devices and related services. Specifically, this bill:

1. Adds SMBP devices as a covered benefit under the Medi-Cal program, subject to utilization controls. Defines “SMBP device” as including, but not limited to, an automated blood pressure (BP) monitor or a BP cuff.
2. Adds SMBP services as a covered benefit under the Medi-Cal program for the treatment of high BP. States that “SMBP service” includes, but is not limited to, staff time for SMBP using a device validated for clinical accuracy, patient education and training, device calibration, separate self-measurements, collection of daily reports by the patient or caregiver to the health care provider, or communication of BP readings and treatment plans to the patient.
3. Declares the Legislature’s intent that covered SMBP devices and services be no less than the scope of specified Healthcare Common Procedure Coding System and Current Procedural Terminology (CPT) Code, or their respective successors.
4. Conditions the implementation of this bill upon the receipt of federal approvals and federal financial participation (FFP).
5. Makes findings that SMBP devices are covered under Medi-Cal Rx as a pharmacy-billed item and that various states provide coverage for SMBP devices, services, or both. Declares the Legislature’s intent to cover SMBP services as well as devices, to promote the health of Medi-Cal beneficiaries with high BP.

EXISTING LAW:

1. Establishes the Medi-Cal program, administered by the Department of Health Care Services (DHCS), under which low-income individuals are eligible for medical coverage. [Welfare and Institutions Code (WIC) §14000, et seq.]
2. Establishes a schedule of benefits under the Medi-Cal program, which includes benefits required under federal law and benefits provided at the state’s option but for which FFP through Medicaid is available. The schedule of benefits includes outpatient services, durable medical equipment, and medical supplies. [WIC §14132]

FISCAL EFFECT: According to the Senate Committee on Appropriations:

1. Unknown General Fund costs for DHCS to administer the provisions.
2. The California Health Benefits Review Program (CHBRP) estimates a $2,000 increase in Medi-Cal expenditures per year.
3. Assuming FFP, costs for benefit expenditures would be shared by the General Fund and federal funds.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, almost 30% of adults in California have been diagnosed with high BP, with communities of color, particularly African-Americans and Native Americans, being disproportionately impacted. The author notes high BP is a major, yet controllable, risk factor contributing to heart disease and stroke, two of the leading causes of death worldwide, as well as maternal mortality and kidney damage. The author asserts SMBP monitoring is an evidence-based strategy that can improve BP control for individuals with high BP and is most effective when an individual has access to a validated BP device for home use coupled with ongoing clinical support. The author points out California’s Medi-Cal program, which serves over 15 million low-income Californians, has currently adopted uniform medical billing codes for SMBP devices, but not the accompanying clinical services to evaluate and educate patients using such devices.
2. BACKGROUND.
   1. BP and Hypertension. BP is the pressure of blood pushing against the walls of arteries that carry blood away from the heart. According to the federal Centers for Disease Control and Prevention (CDC), BP normally rises and falls throughout the day, but it can damage the heart and cause health problems if it stays high for a long time. Hypertension, also called high BP, is BP that is higher than normal. This preventable and treatable condition contributes to more than 500,000 premature deaths annually in the United States. Controlling BP is important to preventing premature death. Nearly half of adults in the United States (47%, or 116 million) either have hypertension or are taking medication to control hypertension. Only about a quarter of adults with hypertension have their condition under control.
      
      The CDC states uncontrolled hypertension is common, but certain groups of people are more likely to have control over their high BP than others. A greater percentage of men (50%) have hypertension than women (44%). Hypertension is more common in non-Hispanic Black adults (56%) than in non-Hispanic white adults (48%), non-Hispanic Asian adults (46%), or Hispanic adults (39%).
   2. SMBP Devices and Services. According to the American Medical Association (AMA), medical evidence and clinical guidelines published over the last decade have highlighted the importance of 24-hour ambulatory monitoring as the reference standard, and SMBP monitoring as an acceptable alternative for obtaining BP to diagnose and treat hypertension. This type of monitoring can provide an accurate picture of someone’s BP over time, including identifying “white coat hypertension” (higher BP readings in a doctor’s office) and “masked hypertension” (lower BP readings in a doctor’s office). Modern SMBP devices consist of a small monitor with a digital readout, which attaches to a cuff that inflates and deflates, similar to BP monitors found in health facilities. The American Heart Association suggests taking BP readings daily when using these SMBP devices.
   3. Medi-Cal Coverage of SMBP Devices. Medi-Cal covers SMBP devices as medical supplies. Specifically, Medi-Cal reimburses eligible pharmacy providers for personal home BP monitoring devices and BP cuffs though Medi-Cal Rx, the statewide system providing Medi-Cal covered pharmacy benefits. Medi-Cal Rx guidance describes coverage parameters as follows:
      1. A specified diagnosis code that justifies medical necessity for cardiovascular monitoring for a chronic condition or on a regular basis is required;
      2. Documentation of medical necessity in the electronic file or on the prescription is required;
      3. Some products require prior authorization demonstrating medical necessity; and,
      4. Medi-Cal Rx allows one BP monitoring kit (monitor plus cuff) every five years and an additional cuff every year. An approved prior authorization request demonstrating medical necessity can override these quantity and frequency restrictions.
   4. Medi-Cal Coverage of SMBP Services. Medi-Cal covers medically necessary outpatient benefits, including SMBP services if deemed medically necessary. Although two codes specific to SMBP services are not listed as covered Medi-Cal benefits, similar services including BP monitoring, patient education, and communication of a treatment plan may be provided as part of an office visit, which is billed under Evaluation and management (E/M) codes. There are different levels of E/M codes, which are determined by the physician’s or other health professional’s medical decision-making or time involved. Longer time spent delivering services and more complex medical decision-making are coded as such, and are generally reimbursed at higher rates. Additionally, according to the Medi-Cal provider manual, Medi-Cal reimburses for codes related to SMBP, including, for example:
      1. CPT code 99091 (Collection and interpretation of physiologic data (e.g., electrocardiogram, BP, glucose monitoring), digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional), requiring a minimum of 30 minutes of time, each 30 days.
      2. CPT code 99454 (Remote monitoring of physiologic parameter(s) (e.g., weight, BP, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days

DHCS does not list two specific codes that facilitate reimbursement for SMBP services, described below, as covered benefits in the relevant Medi-Cal provider manuals, although Medi-Cal managed care plans may reimburse for these codes. This bill specifies legislative intent that coverage of SMBP services be no less in scope than the following SMBP-specific CPT codes, which were both established beginning January 1, 2020:

• • 1. CPT code 99473 (Self-measured BP, patient education/training and device calibration). According to the AMA, which establishes CPT codes, CPT code 99473 can be submitted when physician practice staff provide training, device setup and calibration of SMBP devices validated for clinical accuracy for patients, and patients are instructed to properly monitor their BP at home. This code can only be submitted once.
    2. CPT code 99474 (Self-measured BP, separate self-measurements, communication of treatment plan to the patient). According to the AMA, physicians can also submit CPT code 99474 once a month for ongoing treatment decisions. This code can be used when patients and/or caregivers report their BP readings back to the practice—whether it is done electronically or in person with a SMBP recording log—which then allow the physician to make ongoing treatment decisions based on the average of the patient’s BP readings.
  1. CHBRP analysis. AB 1996 (Thomson), Chapter 795, Statutes of 2002, requests the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996. SB 125 (Hernandez), Chapter 9, Statutes of 2015, added an impact assessment on essential health benefits (EHBs), and legislation that impacts health insurance benefit designs, cost sharing, premiums, and other health insurance topics. CHBRP states the following in its analysis of this bill mandating coverage for SMBP devices and services:
     1. Enrollees covered.
        1. Devices. At baseline, CHBRP estimates 100% of Medi-Cal beneficiaries currently have coverage for SMBP devices. Post-mandate, there would be no change.
        2. Services. At baseline, 91% Medi-Cal beneficiaries have coverage for the SMBP device-related education/calibration service through their Medi-Cal managed care plan. Post-mandate, coverage for this device-related service would increase for 9% of Medi-Cal beneficiaries. At baseline, 74% of Medi-Cal beneficiaries have coverage for the SMBP device-related data collection service through their Medi-Cal managed care plan. Post-mandate, coverage for this device-related service would increase for 26% of Medi-Cal beneficiaries.
     2. Utilization. Utilization of the education/calibration service would increase from 1,010 to 1,120 uses per year (an 11% increase). Utilization of the 30-day data collection service would increase from 130 to 170 uses per year (a 31% increase).
     3. Impact on expenditures. According to CHBRP, unit costs (the amounts providers can receive for providing the devices and the services) are $43 for the device, $14 for the education/calibration service, and $11 for the 30-day data collection service. This bill would not alter unit costs.
        1. Medi-Cal. Total expenditures by Medi-Cal for enrollment of beneficiaries in managed care would rise from $36,606,800,000 to $36,606,802,000, an increase of $2,000 (0.000005%), based on increased utilization.
        2. The California Public Employees' Retirement System (CalPERS). This bill would not impact CalPERS enrollees’ benefit coverage.
        3. Number of Uninsured in California. CHBRP expects no measurable change in the number of uninsured persons due to the enactment of this bill.
     4. EHBs. This bill would not result in new benefit coverage that exceeds the definition of EHBs, because it only affects Medi-Cal.
     5. Medical effectiveness. According to CHBRP, a preponderance of evidence suggests that, relative to usual care, SMBP devices are effective at supporting clinically significant reductions of BP but are not effective at supporting BP control (defined as achieving a level below a threshold identified by the patient’s provider or by study coordinators). There is insufficient evidence to assess the direct impact of SMBP devices on complications of hypertension, quality of life, or use of acute care services, although they are associated with reduction in BP, which can reduce the risk that a person with hypertension will develop complications or need acute care services.
     6. Public health. According to CHBRP, this bill would have no measurable short-term public health impact due to a marginal increase in previously low levels of utilization.

1. SUPPORT. Cosponsors American Heart Association and California Chronic Care Coalition write that improving the diagnosis, treatment, and control of hypertension is critical for improving health and reducing health care costs. A key component to achieve this is SMBP monitoring, an evidence-based strategy that can improve BP control for individuals with hypertension. They state that trusted guidelines and organizations, including the American Heart Association and American College of Cardiology, have included it in their recommendations as useful for helping confirm diagnosis of high BP along with assisting in titration of BP-lowering medications. In addition to the health and economic impacts, they point to racial disparities and the particular impact of high BP on maternal health. Finally, they indicate that codifying Medi-Cal coverage of SMBP devices and services would provide clarity to health care providers and guarantee coverage for patients.
2. RELATED LEGISLATION. A number of bills this session add additional Medi-Cal benefits. In particular, AB 365 (Aguiar Curry) would add another medical device, continuous glucose monitors, to the Medi-Cal schedule of benefits. AB 365 is pending referral in the Senate.
3. PREVIOUS LEGISLATION. SB 446 (Stone) of 2019 would have implemented hypertension medication management services in Medi-Cal. SB 446 was held on suspense in the Senate Appropriations Committee.

REGISTERED SUPPORT / OPPOSITION:

Support

American Heart Association (cosponsor)

California Chronic Care Coalition (cosponsor)

American College of Obstetricians and Gynecologists (ACOG), District IX
California Academy of Family Physicians
California Access Coalition
California Black Health Network
California Chapter American College of Cardiology
California Health+Advocates

California Retired Teachers Association
Center for Elders' Independence
Community Clinic Association of Los Angeles County
Health Net
Public Health Advocates
Western Center on Law & Poverty, Inc.

Opposition

None on file.

Analysis Prepared by: Lisa Murawski / HEALTH / (916) 319-2097

 THIRD READING  

Bill No: SB 694

Author: Eggman (D)

Introduced: 2/16/23

Vote: 21

SENATE HEALTH COMMITTEE: 11-0, 4/19/23

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

NO VOTE RECORDED: Hurtado

SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/18/23

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

SUBJECT: Medi-Cal: self-measured blood pressure devices and services

SOURCE: American Heart Association

California Chronic Care Coalition

DIGEST:

This bill adds self-measured blood pressure (SMBP) devices and SMBP services, as defined, as covered benefits under the Medi-Cal program for the treatment of high blood pressure.

ANALYSIS:

Existing law:

1. Establishes the Medi-Cal program, administered by the Department of Health Care Services (DHCS), under which low-income individuals are eligible for medical coverage. [WIC §14000, et seq.]
2. Establishes a schedule of benefits under the Medi-Cal program, which includes benefits required under federal law and benefits provided at the state’s option but for which federal financial participation through Medicaid is available. The schedule of benefits includes outpatient services, durable medical equipment, and medical supplies. [WIC §14132]

This bill:

1. Adds SMBP devices as a covered benefit under the Medi-Cal program for the treatment of high blood pressure. States that “SMBP device” includes, but is not limited to, an automated blood pressure monitor or a blood pressure cuff. States that the intent of the Legislature is to cover the same scope of devices that are recognized under Healthcare Common Procedure Coding System (HCPCS) Code A4670 or A4663, or their respective successors.
2. Adds SMBP services as a covered benefit under the Medi-Cal program for the treatment of high blood pressure. States that “SMBP service” includes, but is not limited to, staff time for SMBP using a device validated for clinical accuracy, patient education and training, device calibration, separate self-measurements, collection of daily reports by the patient or caregiver to the health care provider, or communication of blood pressure readings and treatment plans to the patient. States that the intent of the Legislature that covered SMBP services be consistent in scope with services that are recognized under CPT Code 99473 or 99474, or their respective successors.
3. Conditions the implementation of this bill upon the receipt of federal approvals and federal financial participation.
4. Makes legislative findings that DHCS covers SMBP devices under Medi-Cal Rx as a pharmacy-billed item and that various states provide coverage for SMBP devices, services, or both. Declares the Legislature’s intent to statutorily cover as benefits in the Medi-Cal program, not only SMBP devices, but also SMBP services, for the purposes of promoting the health of Medi-Cal beneficiaries with high blood pressure.

Comments

1. Author’s statement. According to the author, almost 30% of adults in California have been diagnosed with high blood pressure, with communities of color, particularly African-Americans and American Indians, being disproportionately impacted. High blood pressure is a major, yet controllable, risk factor contributing to heart disease and stroke, two of the leading causes of death worldwide, as well as maternal mortality, and kidney damage. SMBP monitoring is an evidence-based strategy that can improve blood pressure control for individuals with high blood pressure and is most effective when an individual has access to a validated blood pressure device for home use coupled with ongoing clinical support. California’s Medi-Cal program, which serves over 15 million low-income Californians, has currently adopted the uniform medical billing code for SMBP devices, but not the accompanying clinical services to evaluate and educate patients using such devices. Providing SMBP services to Medi-Cal recipients can help them to monitor and ultimately better control their blood pressure. It will also help those patients who have high blood pressure readings in the doctor’s office, due to anxiety avoid unneeded medication.
2. Hypertension prevalence and disparities. According to a 2021 report on chronic conditions by the California Health Care Foundation, in 2019, high blood pressure, also known as hypertension, was the second most common chronic condition in California. As with most chronic conditions, the prevalence rates are not distributed proportionately among the various racial and ethnic groups in California. Native Hawaiian/Pacific Islander, Black, and American Indian/Alaska Native Californians have a prevalence rate of 42.8%, 38.3%, and 36.5% respectively. On the other hand, white, Latinx, and Asian American Californians have a prevalence rate of 28.6%, 22.9%, and 21.6% respectively. Other reports, including the American Heart Association journal, have a higher prevalence rate for Latinx, particularly subgroups such as males or youth.
3. Current Medi-Cal coverage of SMBP devices and services. SMBP devices are blood pressure monitors and cuffs that individuals can use at home to monitor their blood pressure. SMBP services includes the medical staff time needed to make use of the patient-collected blood pressure information, including time to review the results of SMBP devices, device calibration, and patient education. Like many devices and services, these are not specifically listed in state law as a Medi-Cal benefit. With certain exceptions, state law establishes broad categories of benefits that are covered, subject to utilization controls designed to establish whether the device or service is medically necessary. DHCS describes the details of covered benefits, and establishes and updates utilization controls in various Medi-Cal provider manuals. SMBP devices have long been covered in the provider manuals as durable medical equipment. Prior to the establishment of Medi-Cal Rx, which carved out pharmacy services from Medi-Cal managed care plans into a statewide prescription drug coverage program, plans often covered SMBP devices as pharmacy benefits instead because obtaining such devices at a pharmacy was simpler than an order for durable medical equipment. When Medi-Cal Rx made this no longer possible for plans, Medi-Cal consumers began having difficulty accessing SMBP devices in a timely manner. DHCS announced that effective June 1, 2022, SMBP monitors and cuffs would be a covered benefit under Medi-Cal Rx as a pharmacy-billed item. This bill does not change how SMBP devices are covered; it merely codifies the coverage.

On the other hand, while SMBP services would ostensibly be covered as medically necessary services, the provider manuals make no mention of these services nor of the codes described in this bill, thus billing for these services could be difficult. The Cardiology section of the General Medicine manual does describe coverage for ambulatory blood pressure monitoring, which involves a more complicated device that is worn by the individual continuously so that automated blood pressure readings may be taken. The description of ambulatory blood pressure monitoring includes interpretation of the results by a Medi-Cal provider. Providers may still be able to bill for these services through a managed care plan, though absent specific mention in the provider manual, coverage by all plans is not guaranteed. According to 2022 analysis by the American Medical Association, 19 other states provide specified coverage for the SMBP services as proposed in this bill, and another three states provide specified coverage for at least the initial the patient education and training and device calibration that this bill would require.

1. California Health Benefits Review Program (CHBRP) analysis. AB 1996 (Thomson, Chapter 795, Statutes of 2002) requests the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996, and reviewed this bill. Key findings include:
   1. Coverage impacts and enrollees covered. While coverage (and utilization) of the SMBP devices is not expected to change, there would be an increase in both coverage and utilization for SMBP education/calibration and 30-day data collection services. Coverage for the education/calibration service would increase from 91% of enrollees at baseline to 100% postmandate, and coverage for the data collection service would increase from 74% at baseline to 100%. This will result in an additional coverage for 986,130 enrollees and 2,848,820 enrollees for the services related to the devices.
   2. Medical effectiveness. A preponderance of evidence suggests that, relative to usual care, SMBP devices are effective at supporting clinically significant reductions of systolic and diastolic blood pressure but are not effective at supporting blood pressure control (defined as achieving a blood pressure level below a threshold identified by the patient’s provider or by study coordinators). There is insufficient evidence to assess the direct impact of SMBP devices on complications of hypertension, quality of life, or use of acute care services, although they are associated with reduction in blood pressure, which can reduce the risk that a person with hypertension will develop complications or need acute care services. There is insufficient evidence to assess the impact of the SMBP device-related services required by this bill.
   3. Utilization. To estimate the utilization that is expected in 30-day data collection service for the 26% of Medi-Cal beneficiaries who would gain coverage postmandate, the number of persons with new coverage (2,848,820 854) was multiplied by the utilization rate for those who were already covered. At baseline, utilization rate of education/calibration service for those with coverage was .0012% of total beneficiaries or .046% of beneficiaries who received the devices. Postmandate, the utilization for the 3,468,854 who received additional coverage would be 64 services. The total service use would increase postmandate from 130 to 170, an increase of .30.1%. In sum, there would be no increase in use of devices postmandate, an increase in education/calibration of 110 services, and an increase in 30-day data collection of 40 services.
   4. Impact on expenditures. Unit costs (the amounts providers can receive for providing the devices and the services) are limited: $43 for the device, $14 for the education/calibration service, and $11 for the 30-day data collection service. Increased utilization at these rates would raise total 2024 expenditures by Medi-Cal for enrollees from $36,606,800,000 to $36,606,802,000, an increase of $2,000 (0.000005%). Given the small change in utilization and overall cost ($2000) postmandate, there is expected to be only a minimal (<.01%) change on administrative expenses.
   5. Public health. Although SMBP devices are found to be medically effective in helping people lower their blood pressure values, CHBRP concludes that passage of this bill would have no measurable short-term public health impact due to a marginal increase in previously low levels of utilization. For these reasons, CHBRP also concludes that this bill would have no measurable impact on disparities in health outcomes (by gender, race/ethnicity, sexual orientation/gender identity, or other determinants) in the first 12 months. It also would have no impact on premature death and societal economic losses. However, CHBRP also concludes that in the long term, there is potential for a public health impact should awareness of coverage and subsequent utilization expand among Medi-Cal providers and beneficiaries. The analysis states that Medi-Cal beneficiaries with hypertension who receive and use an SMBP device may be better able to lower their blood pressure values. Lower blood pressure (even if not fully controlled) is associated with better cardiovascular outcomes: fewer strokes, less cardiovascular disease, and less kidney failure.

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

According to the Senate Appropriations Committee:

• Unknown General Fund costs for the Department of Health Care Services to administer the provisions.
• The California Health Benefits Review Program (CHBRP) estimates a $2,000 increase in Medi-Cal expenditures per year.
• Assuming federal financial participation, costs for benefit expenditures would be shared by the General Fund and federal funds.

SUPPORT: (Verified 5/18/23)

American Heart Association (co-source)

California Chronic Care Coalition (co-ssource)

American College of Obstetricians and Gynecologists District IX

California Academy of Family Physicians

California Black Health Network

California Chapter American College of Cardiology

California Health+Advocates

California Retired Teachers Association

Center for Elders' Independence

Community Clinic Association of Los Angeles County

Public Health Advocates

Western Center on Law & Poverty

OPPOSITION: (Verified 5/18/23)

None received

ARGUMENTS IN SUPPORT: Co-sponsors American Heart Association and California Chronic Care Coalition write that improving the diagnosis, treatment, and control of hypertension is critical for improving the cardiovascular health of all Americans and reducing major cost drivers in the health care system. A key component to achieve this is SMBP monitoring, an evidence-based strategy that can improve blood pressure control for individuals with hypertension. They state that several national and international hypertension guidelines, including the American Heart Association and American College of Cardiology have included it in their recommendations as useful for helping confirm diagnosis of high blood pressure along with assisting in titration of blood pressure-lowering medications. The US Surgeon General and the American Medical Association have also affirmed the importance of SMBP monitoring to manage hypertension. In addition to the health and economic impacts, they also point to the racial disparities and the particular impact of high blood pressure on maternal health. Finally, they state that by codifying Medi-Cal coverage of SMBP devices and services, this bill would provide clarity to health care providers, guarantee coverage for patients, and save state resources.

Prepared by: Jen Flory / HEALTH / (916) 651-4111

5/20/23 13:05:27

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SENATE COMMITTEE ON APPROPRIATIONS

Senator Anthony Portantino, Chair

2023 - 2024 Regular Session

SB 694 (Eggman) - Medi-Cal: self-measured blood pressure devices and services

Bill Summary:

SB 694 would add self-measured blood pressure (SMBP) devices and SMBP services, as defined, as covered benefits under the Medi-Cal program for the treatment of high blood pressure.

Fiscal Impact:

• Unknown General Fund costs for the Department of Health Care Services to administer the provisions.
• The California Health Benefits Review Program (CHBRP) estimates a $2,000 increase in Medi-Cal expenditures per year.
• Assuming federal financial participation, costs for benefit expenditures would be shared by the General Fund and federal funds.

Background:

The Medi-Cal program, administered by the Department of Health Care Services (DHCS), provides medical coverage for eligible low-income individuals. Current law establishes a schedule of benefits under the Medi-Cal program, which includes benefits required under federal law and benefits provided at the state’s option but for which federal financial participation through Medicaid is available. The schedule of benefits includes outpatient services, durable medical equipment, and medical supplies.

SMBP devices are blood pressure monitors and cuffs that individuals can use at home to monitor their blood pressure. SMBP services includes the medical staff time needed to make use of the patient-collected blood pressure information, including time to review the results of SMBP devices, device calibration, and patient education. Like many devices and services, these are not specifically listed in state law as a Medi-Cal benefit. With certain exceptions, state law establishes broad categories of benefits that are covered, subject to utilization controls designed to establish whether the device or service is medically necessary. DHCS describes the details of covered benefits, and establishes and updates utilization controls in various Medi-Cal provider manuals.

DHCS announced that effective June 1, 2022, SMBP devices such as monitors and cuffs would be a covered benefit under Medi-Cal Rx as a pharmacy-billed item. On the other hand, while SMBP services would ostensibly be covered as medically necessary services, the provider manuals make no mention of these services nor of the codes that could be used to facilitate billing.

Proposed Law:

Specific provisions of the bill would:

• Add SMBP devices as a covered benefit under the Medi-Cal program for the treatment of high blood pressure. State that “SMBP device” includes, but is not limited to, an automated blood pressure monitor or a blood pressure cuff.
• Add SMBP services as a covered benefit under the Medi-Cal program for the treatment of high blood pressure. State that “SMBP service” includes, but is not limited to, staff time for SMBP using a device validated for clinical accuracy, patient education and training, device calibration, separate self-measurements, collection of daily reports by the patient or caregiver to the health care provider, or communication of blood pressure readings and treatment plans to the patient.
• Condition the implementation of this bill upon the receipt of federal approvals and federal financial participation.

Staff Comments: According to the California Health Benefits Review Program (CHBRP), as SB 694 would make no change in benefit coverage for SMBP devices, no measurable change in utilization would be expected. Use of devices would be expected to remain at approximately 27,080 devices per year. Utilization of the education/calibration service would increase from 1,010 to 1,120 uses per year. Utilization of the 30-day data collection service would increase from 130 to 170 uses per year. CHBRP assumes the amounts providers can receive for providing services are limited to $14 for the education/calibration service and $11 for the 30- day data collection service. Based on these assumptions, CHBRP estimates a $2,000 increase in total Medi-Cal expenditures.

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SENATE COMMITTEE ON HEALTH

Senator Dr. Susan Talamantes Eggman, Chair

BILL NO: SB 694

SUBJECT: Medi-Cal: self-measured blood pressure devices and services

SUMMARY:

Adds self-measured blood pressure (SMBP) devices and SMBP services, as defined, as covered benefits under the Medi-Cal program for the treatment of high blood pressure.

Existing law:

1. Establishes the Medi-Cal program, administered by the Department of Health Care Services (DHCS), under which low-income individuals are eligible for medical coverage. [WIC §14000, et seq.]
2. Establishes a schedule of benefits under the Medi-Cal program, which includes benefits required under federal law and benefits provided at the state’s option but for which federal financial participation through Medicaid is available. The schedule of benefits includes outpatient services, durable medical equipment, and medical supplies. [WIC §14132]

This bill:

1. Adds SMBP devices as a covered benefit under the Medi-Cal program for the treatment of high blood pressure. States that “SMBP device” includes, but is not limited to, an automated blood pressure monitor or a blood pressure cuff. States that the intent of the Legislature is to cover the same scope of devices that are recognized under Healthcare Common Procedure Coding System (HCPCS) Code A4670 or A4663, or their respective successors.
2. Adds SMBP services as a covered benefit under the Medi-Cal program for the treatment of high blood pressure. States that “SMBP service” includes, but is not limited to, staff time for SMBP using a device validated for clinical accuracy, patient education and training, device calibration, separate self-measurements, collection of daily reports by the patient or caregiver to the health care provider, or communication of blood pressure readings and treatment plans to the patient. States that the intent of the Legislature that covered SMBP services be consistent in scope with services that are recognized under CPT Code 99473 or 99474, or their respective successors.
3. Conditions the implementation of this bill upon the receipt of federal approvals and federal financial participation.
4. Makes legislative findings that DHCS covers SMBP devices under Medi-Cal Rx as a pharmacy-billed item and that various states provide coverage for SMBP devices, services, or both. Declares the Legislature’s intent to statutorily cover as benefits in the Medi-Cal program, not only SMBP devices, but also SMBP services, for the purposes of promoting the health of Medi-Cal beneficiaries with high blood pressure.

FISCAL EFFECT:

This bill has not been analyzed by a fiscal committee.

COMMENTS:

1. Author’s statement. According to the author, almost 30% of adults in California have been diagnosed with high blood pressure, with communities of color, particularly African-Americans and American Indians, being disproportionately impacted. High blood pressure is a major, yet controllable, risk factor contributing to heart disease and stroke, two of the leading causes of death worldwide, as well as maternal mortality, and kidney damage. SMBP monitoring is an evidence-based strategy that can improve blood pressure control for individuals with high blood pressure and is most effective when an individual has access to a validated blood pressure device for home use coupled with ongoing clinical support. California’s Medi-Cal program, which serves over 15 million low-income Californians, has currently adopted the uniform medical billing code for SMBP devices, but not the accompanying clinical services to evaluate and educate patients using such devices. Providing SMBP services to Medi-Cal recipients can help them to monitor and ultimately better control their blood pressure. It will also help those patients who have high blood pressure readings in the doctor’s office, due to anxiety avoid unneeded medication.
2. Hypertension prevalence and disparities. According to a 2021 report on chronic conditions by the California Health Care Foundation, in 2019, high blood pressure, also known as hypertension, was the second most common chronic condition in California. As with most chronic conditions, the prevalence rates are not distributed proportionately among the various racial and ethnic groups in California. Native Hawaiian/Pacific Islander, Black, and American Indian/Alaska Native Californians have a prevalence rate of 42.8%, 38.3%, and 36.5% respectively. On the other hand, white, Latinx, and Asian American Californians have a prevalence rate of 28.6%, 22.9%, and 21.6% respectively. Other reports, including the American Heart Association journal, have a higher prevalence rate for Latinx, particularly subgroups such as males or youth.
3. Current Medi-Cal coverage of SMBP devices and services. SMBP devices are blood pressure monitors and cuffs that individuals can use at home to monitor their blood pressure. SMBP services includes the medical staff time needed to make use of the patient-collected blood pressure information, including time to review the results of SMBP devices, device calibration, and patient education. Like many devices and services, these are not specifically listed in state law as a Medi-Cal benefit. With certain exceptions, state law establishes broad categories of benefits that are covered, subject to utilization controls designed to establish whether the device or service is medically necessary. DHCS describes the details of covered benefits, and establishes and updates utilization controls in various Medi-Cal provider manuals. SMBP devices have long been covered in the provider manuals as durable medical equipment. Prior to the establishment of Medi-Cal Rx, which carved out pharmacy services from Medi-Cal managed care plans into a statewide prescription drug coverage program, plans often covered SMBP devices as pharmacy benefits instead because obtaining such devices at a pharmacy was simpler than an order for durable medical equipment. When Medi-Cal Rx made this no longer possible for plans, Medi-Cal consumers began having difficulty accessing SMBP devices in a timely manner. DHCS announced that effective June 1, 2022, SMBP monitors and cuffs would be a covered benefit under Medi-Cal Rx as a pharmacy-billed item. This bill does not change how SMBP devices are covered; it merely codifies the coverage.

On the other hand, while SMBP services would ostensibly be covered as medically necessary services, the provider manuals make no mention of these services nor of the codes described in this bill, thus billing for these services could be difficult. The Cardiology section of the General Medicine manual does describe coverage for ambulatory blood pressure monitoring, which involves a more complicated device that is worn by the individual continuously so that automated blood pressure readings may be taken. The description of ambulatory blood pressure monitoring includes interpretation of the results by a Medi-Cal provider. Providers may still be able to bill for these services through a managed care plan, though absent specific mention in the provider manual, coverage by all plans is not guaranteed. According to 2022 analysis by the American Medical Association, 19 other states provide specified coverage for the SMBP services as proposed in this bill, and another three states provide specified coverage for at least the initial the patient education and training and device calibration that this bill would require.

1. California Health Benefits Review Program (CHBRP) analysis. AB 1996 (Thomson, Chapter 795, Statutes of 2002) requests the University of California to assess legislation proposing a mandated benefit or service and prepare a written analysis with relevant data on the medical, economic, and public health impacts of proposed health plan and health insurance benefit mandate legislation. CHBRP was created in response to AB 1996, and reviewed this bill. Key findings include:
   1. Coverage impacts and enrollees covered. While coverage (and utilization) of the SMBP devices is not expected to change, there would be an increase in both coverage and utilization for SMBP education/calibration and 30-day data collection services. Coverage for the education/calibration service would increase from 91% of enrollees at baseline to 100% postmandate, and coverage for the data collection service would increase from 74% at baseline to 100%. This will result in an additional coverage for 986,130 enrollees and 2,848,820 enrollees for the services related to the devices.
   2. Medical effectiveness. A preponderance of evidence suggests that, relative to usual care, SMBP devices are effective at supporting clinically significant reductions of systolic and diastolic blood pressure but are not effective at supporting blood pressure control (defined as achieving a blood pressure level below a threshold identified by the patient’s provider or by study coordinators). There is insufficient evidence to assess the direct impact of SMBP devices on complications of hypertension, quality of life, or use of acute care services, although they are associated with reduction in blood pressure, which can reduce the risk that a person with hypertension will develop complications or need acute care services. There is insufficient evidence to assess the impact of the SMBP device-related services required by this bill.
   3. Utilization. To estimate the utilization that is expected in 30-day data collection service for the 26% of Medi-Cal beneficiaries who would gain coverage postmandate, the number of persons with new coverage (2,848,820 854) was multiplied by the utilization rate for those who were already covered. At baseline, utilization rate of education/calibration service for those with coverage was .0012% of total beneficiaries or .046% of beneficiaries who received the devices. Postmandate, the utilization for the 3,468,854 who received additional coverage would be 64 services. The total service use would increase postmandate from 130 to 170, an increase of .30.1%. In sum, there would be no increase in use of devices postmandate, an increase in education/calibration of 110 services, and an increase in 30-day data collection of 40 services.
   4. Impact on expenditures. Unit costs (the amounts providers can receive for providing the devices and the services) are limited: $43 for the device, $14 for the education/calibration service, and $11 for the 30-day data collection service. Increased utilization at these rates would raise total 2024 expenditures by Medi-Cal for enrollees from $36,606,800,000 to $36,606,802,000, an increase of $2,000 (0.000005%). Given the small change in utilization and overall cost ($2000) postmandate, there is expected to be only a minimal (<.01%) change on administrative expenses.
   5. Public health. Although SMBP devices are found to be medically effective in helping people lower their blood pressure values, CHBRP concludes that passage of this bill would have no measurable short-term public health impact due to a marginal increase in previously low levels of utilization. For these reasons, CHBRP also concludes that this bill would have no measurable impact on disparities in health outcomes (by gender, race/ethnicity, sexual orientation/gender identity, or other determinants) in the first 12 months. It also would have no impact on premature death and societal economic losses. However, CHBRP also concludes that in the long term, there is potential for a public health impact should awareness of coverage and subsequent utilization expand among Medi-Cal providers and beneficiaries. The analysis states that Medi-Cal beneficiaries with hypertension who receive and use an SMBP device may be better able to lower their blood pressure values. Lower blood pressure (even if not fully controlled) is associated with better cardiovascular outcomes: fewer strokes, less cardiovascular disease, and less kidney failure.
2. Related legislation. A number of bills this session add additional Medi-Cal benefits:
   1. SB 541 (Menjivar) would add immunization against human papillomavirus to persons who are 18 years of age or younger to the Medi-Cal schedule of benefits. SB 541 passed by a vote of 10-1 when it was heard in this committee on April 12, 2023;
   2. AB 365 (Aguiar Curry) would add continuous glucose monitors to the Medi-Cal schedule of benefits. AB 365 is set to be heard in the Assembly Appropriations Committee on April 19, 2023;
   3. AB 425 (Alvarez) would add pharmacogenomic testing as a covered benefit under Medi-Cal. AB 425 is set to be heard in the Assembly Appropriations Committee on April 19, 2023;
   4. AB 847 (L. Rivas) would extend the Medi-Cal pediatric palliative care benefit to individuals over age 21 for those who were determined eligible for the benefit prior to age 21. AB 847 is set to be heard in the Assembly Health Committee on April 18, 2023; and,
   5. AB 1644 (Bonta) would add medically supportive food and nutrition intervention plans to the Medi-Cal schedule of benefits. AB 1644 is pending in the Assembly Health Committee.
3. Support. Co-sponsors American Heart Association and California Chronic Care Coalition write that improving the diagnosis, treatment, and control of hypertension is critical for improving the cardiovascular health of all Americans and reducing major cost drivers in the health care system. A key component to achieve this is SMBP monitoring, an evidence-based strategy that can improve blood pressure control for individuals with hypertension. They state that several national and international hypertension guidelines, including the American Heart Association and American College of Cardiology have included it in their recommendations as useful for helping confirm diagnosis of high blood pressure along with assisting in titration of blood pressure-lowering medications. The US Surgeon General and the American Medical Association have also affirmed the importance of SMBP monitoring to manage hypertension. In addition to the health and economic impacts, they also point to the racial disparities and the particular impact of high blood pressure on maternal health. Finally, they state that by codifying Medi-Cal coverage of SMBP devices and services, this bill would provide clarity to health care providers, guarantee coverage for patients, and save state resources.

SUPPORT AND OPPOSITION:

Support: American Heart Association (co-sponsor)

California Chronic Care Coalition (co-sponsor)

American College of Obstetricians and Gynecologists District IX

California Academy of Family Physicians

California Black Health Network

California Chapter American College of Cardiology

California Health+Advocates

California Retired Teachers Association

Center for Elders' Independence

Community Clinic Association of Los Angeles County (CCALAC)

Public Health Advocates

Western Center on Law & Poverty

Oppose: None received.

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